Research

The endocannabinoid system targeted therapeutics market is projected to be over USD 5 billion by 2030, growing at an annualized rate of 30%, claims Roots Analysis

Submitted 11 hour(s) ago by Harry sins

So far, more than 100 different types of cannabinoids have been identified and there is a growing body of evidence supporting the benefits of this class of compounds in offering symptomatic relief for a wide variety of chronic health conditions

London

Roots Analysis has announced the addition of “Endocannabinoid System Targeted Therapeutics Market, 2020-2030” report to its list of offerings.

Over time, extensive R&D on the potential health benefits of cannabis, have enabled medical researchers to identify a number of pharmacologically active ingredients that offer clinical benefit, minus the addictive properties of the crude substance. Currently, several stakeholders in the pharmaceutical industry are actively engaged in the efforts to develop leads based on natural and synthetic derivatives of cannabinoids.

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Key Market Insights

Over 175 drugs targeting the endocannabinoid system are currently under development

Most cannabinoid-based drug candidates are being developed to target the CB1 and CB2 receptors. Nearly 45% of such drugs are presently being investigated in clinical trials, while 50% are in the preclinical / discovery phase. Majority of these therapies (60%) are designed for oral administration.

More than 60 companies claim to develop endocannabinoid system targeted therapeutics

Post 2010, there has been a significant rise in the number of companies working in this domain; such companies represent 63% of the total number of players. Majority of the firms engaged in this domain (74%) are based in North America, followed by those headquartered in Asia-Pacific (16%), Europe (8%) and Latin America (2%).

Partnership activity has grown at an annualized rate of 35%, between 2017 and 2019

The maximum number of partnerships were observed in 2019 within this segment of the pharmaceutical industry. Majority of these agreements were reported to have been inked for research purposes (20%). In addition, more than 35 merger / acquisition deal were signed between 2016 and 2020; service / facility expansion emerged as the most prominent key value drivers for such agreements.

Close to 600 grants were awarded for supporting research on endocannabinoid system targeted therapeutics, since 2016

Almost 45% of the total amount awarded in the form of grants, was under the R01 (in support of health-related research and development based on the mission of the NIH) mechanism. Further, grants (394) worth USD 147 million were awarded to research projects related to endocannabinoid system.

At present, therapies intended for the treatment of neurological disorders represent the majority share of the overall endocannabinoid system targeted therapeutics market

Most of the therapies targeting neurological disorders are intended for the treatment of epilepsy. In addition to neurological disorders, therapies intended for autoimmune disorders, cancer and genetic disorders are likely to capture significant market opportunity in the foreseen future.

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Key Questions Answered

Who are the leading industry players in this market?
What are the key clinical conditions addressed by endocannabinoid system targeted therapeutics?
What are the biological receptors targeted by cannabinoid-based therapies?
What are the factors that are likely to influence the evolution of this market?
What are the initiatives undertaken by start-ups and big pharma players engaged in this domain?
What kind of partnership models are commonly adopted by stakeholders in this industry?
How is the current and future market opportunity likely to be distributed across key market segments?

The over USD 5 billion (by 2030) financial opportunity within the endocannabinoid system targeted therapeutics market has been analyzed across the following segments:

Target Disease Indication

Cancer
Genetic Disorders
Neurological Indications
Others

Route of Administration

Oral
Inhalation

Key Geographies

North America
Europe
Asia-Pacific and the Rest of the World

The report features inputs from eminent industry stakeholders, according to whom, endocannabinoid system targeted therapeutics are considered as a promising alternative for the treatment of a diverse array of symptoms associated with a myriad of human diseases. The report includes detailed transcripts of the discussions held with industry experts.

Oludare Odumosu (Chief Executive Officer, Zelira Therapeutics)
Andrea Small-Howard (Chief Scientific Officer, GB Sciences)
Steeve Néron (Chief Operating Officer, Tetra Bio-Pharma)
Stephen Dahmer (Chief Medical Officer, Vireo Health)
Anthony Kievid (Director of Business Development, Echo Pharmaceuticals)
JANAKAN KRISHNARAJAH (Chief Operating Officer and Chief Medical Officer, iX Biopharma)

The research includes detailed profiles of key players (listed below); each profile features an overview of the company, its financial information (if available), drug portfolio, recent developments and an informed future outlook.

GW Pharmaceuticals
Corbus Pharmaceuticals
Tilray
Tetra Bio-Pharma
Botanix Pharmaceuticals
Kalytera Therapeutics
Therapix Biosciences
Echo Pharmaceuticals
Avicanna
GB Sciences

For additional details, please visit
https://www.rootsanalysis.com/reports/view_document/endocannabinoid-therapeutics/316.html or email sales@rootsanalysis.com

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Contact:
Gaurav Chaudhary
+1 (415) 800 3415

+44 (122) 391 1091
Gaurav.Chaudhary@rootsanalysis.com

Elastomeric Closure Components Market for Vials, Cartridges and Syringes, 2019-2030: Focus on Caps, Needle Shields, Plungers, Stoppers, Seals, Tip Caps and Other Closures’ report features a comprehensive study of the current scenario and future potential

Submitted 11 hour(s) ago by Harry sins

To order this detailed 400+ page report, please visit this link

Key Inclusions

A detailed assessment of the current market landscape of companies manufacturing elastomeric container closures, featuring information on the type of closure (cap, needle shield, plunger, seal, stopper, and tip cap), type of respective primary container(s) (vial, syringe, and cartridge), elastomeric material(s) used for fabricating the aforementioned closures (such as bromobutyl, chlorobutyl, and others), drug type(s) that are compatible with elastomeric closures, sterilization status of closures (pre-sterilized and unsterilized), affiliated sterilization technique (if the closure(s) is available in the pre-sterilized format), scale of production (small scale, and large scale), type of customization (if available), affiliated dimensions, along with compliance certifications of the product.
A comprehensive analysis on the packaging trends of over 230 drug products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014), featuring an assessment of the packaging requirements of various container-closure systems based on parameters, such as year of approval of drug, type of molecule, dosage form, route of administration, holding temperature, type of packaging material(s) used for manufacturing primary container and affiliated closure, and leading drug developers (in terms of number of drugs packaged using elastomeric closures).
An analysis of various developments / recent trends related to elastomeric packaging materials, offering insights on [A] partnerships and collaborations established within the industry, and [B] recent global conferences related to pharmaceutical packaging industry.
Elaborate profiles of key players in this domain (shortlisted on the basis of size of product portfolio), featuring a brief overview of the company (including information on company headquarters, year of establishment, number of employees, and key members of the executive team), financial information (if available), detailed description of proprietary elastomeric closures, recent developments, and an informed future outlook.
A case study on the role of robotics in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. It includes profiles of industry players offering such equipment for the aseptic processing of pharmaceutical products.
An elaborate discussion on emerging trends (such as focus on personalized therapies, shift towards more flexible packaging, upgrading packaging components to enhance drug product safety, and growing adoption of smart packaging solutions) that are likely to have an impact on the future adoption of elastomeric container-closure components in the pharmaceutical packaging industry. It also features a Harvey ball analysis, highlighting the relative effect of each trend on the overall pharmaceutical packaging industry.
An in-depth analysis to estimate the current and future demand for elastomeric closures across key primary packaging containers, including vials, syringes and cartridges, in different regions for the period 2019-2030. Input parameters considered for this analysis include current supply of different primary packaging components and their respective closures and the estimated the proportion of elastomeric closures that are likely to be supplied, which is indicative of the demand.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Type of packaging container
- Vials
- Syringes
- Cartridges

Type of packaging closure
- Seal
- Stopper
- Cap
- Plunger
- Barrel
- Needle Shield

Sterilization status
- Pre-sterilized
- Unsterilized

Key geographical regions
North America
Europe
Asia Pacific
Rest of the World

To request sample pages, please visit this link

Key Questions Answered

What are the popular types of elastomeric materials and coatings being used for the fabrication of closures for parenteral containers (vials, ampoules and syringes)?
What are the types of drugs which require elastomeric closures to ensure minimize the risk of extractables and leachables?
Who are the leading manufacturers of elastomeric closures across the globe?
What is the relative popularity of various types of elastomeric materials used for the packaging of different closure types?
How do parameters such as dosage form, route of administration and storage temperature of drugs, influence choice of elastomeric closures?
What is the proportion of closures available in pre-sterilized format in the market?
What are the popular sterilizing techniques used for pre-sterilization of closures?
What are the key drivers of partnership activity in this industry?
What are the key challenges associated with the manufacturing of elastomeric components?
What are the key considerations for choosing materials for fabricating closures?
What are the benefits of pre-sterilized closures? Who are the key players that offer pre-sterilized container-closure kits / systems?
Which are latest innovations in the field of elastomeric packaging materials?
What is the current and future demand for parenteral containers and their respective closures from 2019 to 2030?
What are the key factors that are likely to influence the evolution of the elastomeric closures market?
How is the current and future market opportunity likely to be distributed across key market segments and geographies?

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Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Currently, there are over 240 closures, fabricated using a variety of elastomeric materials, available for use in parenteral primary packaging containers; majority of these products are available in the ready-to-use format, claims Roots Analysis

Submitted 11 hour(s) ago by Harry sins

The materials used to fabricate pharmaceutical packaging components are extremely important to preserving the stability, efficacy and safety of drug formulations. In fact, according to the USFDA, in the last two years, there have been over 2,000 drug and device recalls owing to packaging-related concerns. Elastomeric closures, with various types of coatings (such as FluoroTec® and Teflon®), have emerged as a promising option for developing closures for pharmaceutical containers.

To order this 400+ page report, which features 185+ figures and 235+ tables, please visit this link

The USD 9.3 billion (by 2030) financial opportunity within elastomeric closures market has been analyzed across the following segments:

Type of packaging container
- Vials
- Syringes
- Cartridges

Type of packaging closure
- Seal
- Stopper
- Cap
- Plunger
- Barrel
- Needle Shield

Sterilization status
- Pre-sterilized
- Unsterilized

Key geographical regions
North America
Europe
Asia Pacific
Rest of the World

The Elastomeric Closure Components Market For Vials, Cartridges and Syringes, 2019-2030 report features the following companies, which we identified to be key players in this domain:

Aptar Pharma
Daikyo Seiko
Datwyler Group
DWK Life Sciences
Hebei First Rubber Medical Technology (a Part of DESHENG Group)
Jiangsu Hualan New Pharmaceutical Material
Lonstroff (a Part of Sumitomo Rubber Industries)
Ompi (a Part of Stevanato Group)
West Pharmaceutical Services

Table of Contents

Preface

2. Executive Summary
Introduction
Market Landscape
Company Profiles
Packaging Trend Analysis for Recently Approved Drugs
Recent Developments
Demand Analysis
Market Forecast
Case Study: Robotics in Pharmaceutical Packaging
Emerging Trends in Pharmaceutical Packaging
Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/elastomeric-closures-market-focus-on-parenteral-containers-2019-2030/255.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The elastomeric closures market is projected to reach USD 9.3 Billion by 2030, growing at an annualized rate of 6.7%, claims Roots Analysis

Submitted 11 hour(s) ago by Harry sins

Roots Analysis has done a detailed study on Elastomeric Closure Components Market For Vials, Cartridges and Syringes, 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 400+ page report, which features 185+ figures and 235+ tables, please visit this link

Key Market Insights

The elastomeric container closures market is fragmented, featuring the presence of a large number of established players; a relatively larger proportion of small-sized players are based in developing geographies
Currently, there are over 240 closures, fabricated using a variety of elastomeric materials, available for use in parenteral primary packaging containers; majority of these products are available in the ready-to-use format
Over time, companies have established preferences regarding fabrication materials for container-closure systems for different drug classes in order to ensure that their products are free from chemical impurities
A number of conferences related to pharmaceutical packaging have been organized in the recent past; in addition, stakeholders have also entered into strategic agreements to strengthen their product portfolios
In order to cope up with emerging trends in the pharmaceutical packaging market, it is important for container closure manufacturers to improve existing practices to cater to the changing needs of drug developers
The global demand for elastomeric closures is presently driven by rising adoption of parenteral containers; in future, pre-sterilized and coated closures are anticipated to drive the demand at a relatively faster pace
The overall market is poised to grow steadily; the opportunity is likely to be well-distributed across various types of containers, types of closures and regions

For more information, please visit https://www.rootsanalysis.com/reports/view_document/elastomeric-closures-market-focus-on-parenteral-containers-2019-2030/255.html

Table of Contents

PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

EXECUTIVE SUMMARY

INTRODUCTION

3.1. Chapter Overview

3.2. Pharmaceutical Packaging

3.2.1. Types of Pharmaceutical Packaging

3.2.2. Innovation in Pharmaceutical Packaging

3.2.3. Traditional Aseptic Pharmaceutical Filling Operations

3.2.4. Limitations of Traditional Primary Packaging

3.3. Role of Containers-Closures Systems in Pharmaceutical Packaging

3.4. Types of Closures Used in Pharmaceutical Packaging

3.4.1. Closures for Prefilled Syringes / Syringes

3.4.2. Closures for Vials

3.4.3. Closures for Cartridges

3.5. Key Considerations for Choosing Materials for Fabricating Closures

3.6. Elastomeric Packaging Materials

3.6.1. Key Properties of Elastomeric Packaging Materials

3.6.2. Popular Types of Elastomeric Packaging Materials

3.6.3. Regulatory Guidelines for Elastomeric Closures

3.6.4. Manufacturing Process for Elastomeric Closures

3.6.5. Quality Assessment Tests for Elastomeric Closures

3.6.6. Advantages and Limitations of Elastomeric Packaging Materials

3.7. Concluding Remarks

MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Elastomeric Closures for Parenteral Containers: List of Products

4.2.1. Analysis by Type of Closure

4.2.1.1. Analysis by Type of Closure and Headquarters of Manufacturer

4.2.1.2. Analysis by Type of Closure and Size of Player

4.2.2. Analysis by Type of Container

4.2.3. Analysis by Type of Elastomeric Material

4.2.4. Analysis by Drug Class

4.2.5. Analysis by Sterilization Status

4.2.6. Analysis by Sterilization Technique

4.2.7. Analysis by Type of Coating

4.3. Elastomeric Closures for Parenteral Containers: List of Manufacturers

4.3.1. Analysis by Year of Establishment

4.3.2. Analysis by Company Size

4.3.3. Analysis by Location of Headquarters

4.3.4. Analysis by Target Market

4.3.5. Analysis by Scale of Production

4.3.6. Leading Manufacturers: Analysis by Number of Products

4.3.7. Manufacturer Landscape: Analysis by Company Size and Location of Headquarters

4.4. Elastomeric Closures for Parenteral Containers: Recent Initiatives of Players

4.5. Concluding Remarks

COMPANY PROFILES

5.1. Chapter Overview

5.2. Key Players Based in North America

5.2.1. Aptar Pharma (a Part of AptarGroup)

5.2.1.1. Company Overview

5.2.1.2. Financial Information

5.2.1.3. Product Portfolio

5.2.1.4. Recent Developments and Future Outlook

5.2.2. DWK Life Sciences

5.2.2.1. Company Overview

5.2.2.2. Product Portfolio

5.2.2.3. Recent Developments and Future Outlook

5.2.3. West Pharmaceutical Services

5.2.3.1. Company Overview

5.2.3.2. Financial Information

5.2.3.3. Product Portfolio

5.2.3.4. Recent Developments and Future Outlook

5.3. Key Players Based in Europe

5.3.1. Datwyler Sealing Solutions (a Part of Datwyler Group)

5.3.1.1. Company Overview

5.3.1.2. Financial Information

5.3.1.3. Product Portfolio

5.3.1.4 Recent Developments and Future Outlook

5.3.2. Lonstroff (a Part of Sumitomo Rubber Industries)

5.3.2.1. Company Overview

5.3.2.2. Financial Information

5.3.2.2. Product Portfolio

5.3.2.3. Recent Developments and Future Outlook

5.3.3. Ompi (a Part of Stevanato Group)

5.3.3.1. Company Overview

5.3.3.2. Product Portfolio

5.3.3.3. Recent Developments and Future Outlook

5.4. Key Players Based in Asia-Pacific

5.4.1 Daikyo Seiko

5.4.1.1. Company Overview

5.4.1.2. Product Portfolio

5.4.1.3. Recent Developments and Future Outlook

5.4.2. Hebei First Rubber Medical Technology (a Part of DESHENG Group)

5.4.2.1. Company Overview

5.4.2.2. Product Portfolio

5.4.2.3. Recent Developments and Future Outlook

5.4.3. Jiangsu Hualan New Pharmaceutical Material

5.4.3.1. Company Overview

5.4.3.2. Product Portfolio

5.4.3.3. Recent Developments and Future Outlook

PACKAGING TRENDS ANALYSIS FOR RECENTLY APPROVED DRUGS

6.1. Chapter Overview

6.2. List of Approved Drugs (2014-2018)

6.2.1. Analysis by Year of Approval

6.2.2. Analysis by Type of Molecule

6.2.3. Analysis by Type of Biologic

6.2.4. Analysis by Holding Temperature Range

6.2.5. Analysis by Type of Container

6.2.6. Analysis by Type of Container and Year of Approval

6.2.7. Analysis by Type of Container and Type of Molecule

6.2.8. Analysis by Type of Container and Dosage Form

6.2.9. Analysis by Type of Container and Route of Administration

6.2.10. Analysis by Type of Container and Holding Temperature Range

6.2.11. Popular Type of Material Used for Containers

6.2.12. Analysis by Type of Closure

6.2.13. Analysis by Type of Closure and Year of Approval

6.2.14. Analysis by Type of Closure and Type of Molecule

6.2.15. Analysis by Type of Closure and Dosage Form

6.2.16. Analysis by Type of Closure and Route of Administration

6.2.17. Analysis by Type of Closure and Holding Temperature Range

6.2.18. Popular Type of Material Used for Closures

6.2.19. Analysis by Type of Elastomeric Material Used for Closures and Dosage Form

6.2.20. Analysis by Type of Elastomeric Material Used for Closures and Route of Administration

6.2.21. Analysis by Type of Elastomeric Material Used for Closures and Holding Temperature Range

6.2.22. Analysis by Type of Elastomeric Material Used for Closures

6.2.23. Most Active Players: Analysis by Number of Drugs Packaged Using Elastomeric Closures

6.2.24. Concluding Remarks

RECENT DEVELOPMENTS

7.1. Chapter Overview

7.2. Pharmaceutical Packaging Industry: Partnership Activity

7.2.1. Partnership Models

7.2.2. List of Partnerships and Collaborations

7.2.2.1. Analysis by Year of Partnership

7.2.2.2. Analysis by Type of Partnership

7.2.2.3. Analysis by Focus Area

7.2.2.4. Most Active Players: Analysis by Number of Partnerships

7.3. Elastomeric Container Closures in Pharmaceutical Packaging Industry: Recent Expansions

7.4. Pharmaceutical Packaging Industry: Recent Conferences

7.4.1. List of Recent Conferences

7.4.1.1. Analysis by Year of Occurrence

7.4.1.2. Analysis by Geography

7.4.2. Elastomeric Container Closures: List of Recent Conferences

7.4.2.1. Analysis by Focus Area / Agenda

7.4.3. Geographical Mapping of Conferences

7.5. Concluding Remarks

DEMAND ANALYSIS

8.1. Chapter Overview

8.2. Scope and Methodology

8.3. Global Demand for Elastomeric Closures, 2019-2030

8.3.1. Analysis by Type of Primary Container

8.3.1.1. Global Demand for Elastomeric Closures for Vials

8.3.1.2. Global Demand for Elastomeric Closures for Syringes

8.3.1.3. Global Demand for Elastomeric Closures for Cartridges

8.3.2. Analysis by Type of Closure

8.3.2.1. Global Demand for Elastomeric Seals

8.3.2.2. Global Demand for Elastomeric Stoppers

8.3.2.3. Global Demand for Elastomeric Caps

8.3.2.4. Global Demand for Elastomeric Plungers

8.3.2.5. Global Demand for Elastomeric Barrels

8.3.2.6. Global Demand for Elastomeric Needle Shields

8.3.3. Analysis by Sterilization Status

8.3.3.1. Global Demand for Pre-Sterilized Elastomeric Closures

8.3.3.1.1. Global Demand for Pre-Sterilized Elastomeric Seals

8.3.3.1.2. Global Demand for Pre-Sterilized Elastomeric Stoppers

8.3.3.1.3. Global Demand for Pre-Sterilized Elastomeric Caps

8.3.3.1.4. Global Demand for Pre-Sterilized Elastomeric Plungers

8.3.3.1.5. Global Demand for Pre-Sterilized Elastomeric Barrels

8.3.3.1.6. Global Demand for Pre-Sterilized Elastomeric Needle Shields

8.3.3.2. Global Demand for Unsterilized Elastomeric Closures

8.3.3.2.1. Global Demand for Unsterilized Elastomeric Seals

8.3.3.2.2. Global Demand for Unsterilized Elastomeric Stoppers

8.3.3.2.3. Global Demand for Unsterilized Elastomeric Caps

8.3.3.2.4. Global Demand for Unsterilized Elastomeric Plungers

8.3.3.2.5. Global Demand for Unsterilized Elastomeric Barrels

8.3.3.2.6. Global Demand for Unsterilized Elastomeric Needle Shields

8.3.4. Analysis by Geography

8.3.4.1. Demand for Elastomeric Closures in North America

8.3.4.1.1. Demand for Elastomeric Seals in North America

8.3.4.1.2. Demand for Elastomeric Stoppers in North America

8.3.4.1.3. Demand for Elastomeric Caps in North America

8.3.4.1.4. Demand for Elastomeric Plungers in North America

8.3.4.1.5. Demand for Elastomeric Barrels in North America

8.3.4.1.6. Demand for Elastomeric Needle Shields in North America

8.3.4.2. Demand for Elastomeric Closures in Europe

8.3.4.2.1. Demand for Elastomeric Seals in Europe

8.3.4.2.2. Demand for Elastomeric Stoppers in Europe

8.3.4.2.3. Demand for Elastomeric Caps in Europe

8.3.4.2.4. Demand for Elastomeric Plungers in Europe

8.3.4.2.5. Demand for Elastomeric Barrels in Europe

8.3.4.2.6. Demand for Elastomeric Needle Shields in Europe

8.3.4.3. Demand for Elastomeric Closures in Asia-Pacific

8.3.4.3.1. Demand for Elastomeric Seals in Asia-Pacific

8.3.4.3.2. Demand for Elastomeric Stoppers in Asia-Pacific

8.3.4.3.3. Demand for Elastomeric Caps in Asia-Pacific

8.3.4.3.4. Demand for Elastomeric Plungers in Asia-Pacific

8.3.4.3.5. Demand for Elastomeric Barrels in Asia-Pacific

8.3.4.3.6. Demand for Elastomeric Needle Shields in Asia-Pacific

8.3.4.4. Demand for Elastomeric Closures in Rest of the World

8.3.4.4.1. Demand for Elastomeric Seals in Rest of the World

8.3.4.4.2. Demand for Elastomeric Stoppers in Rest of the World

8.3.4.4.3. Demand for Elastomeric Caps in Rest of the World

8.3.4.4.4. Demand for Elastomeric Plungers in Rest of the World

8.3.4.4.5. Demand for Elastomeric Barrels in Rest of the World

8.3.4.4.6. Demand for Elastomeric Needle Shields in Rest of the World

8.4. Concluding Remarks

MARKET FORECAST

9.1. Chapter Overview

9.2. Forecast Methodology and Key Assumptions

9.3. Global Elastomeric Closures Market, 2019-2030

9.3.1. Global Elastomeric Closures Market, 2019-2030: Distribution by Type of Primary Container

9.3.1.1. Global Elastomeric Closures Market for Vials, 2019-2030

9.3.1.2. Global Elastomeric Closures Market for Syringes, 2019-2030

9.3.1.3. Global Elastomeric Closures Market for Cartridges, 2019-2030

9.3.2. Global Elastomeric Closures Market, 2019-2030: Distribution by Type of Closure

9.3.2.1. Global Elastomeric Closures Market for Seals, 2019-2030

9.3.2.2. Global Elastomeric Closures Market for Stoppers, 2019-2030

9.3.2.3. Global Elastomeric Closures Market for Caps, 2019-2030

9.3.2.4. Global Elastomeric Closures Market for Plungers, 2019-2030

9.3.2.5. Global Elastomeric Closures Market for Barrels, 2019-2030

9.3.2.6. Global Elastomeric Closures Market for Needle Shields, 2019-2030

9.3.3. Global Elastomeric Closures Market, 2019-2030: Distribution by Sterilization Status

9.3.3.1. Global Pre-Sterilized Elastomeric Closures Market, 2019-2030

9.3.3.1.1. Global Pre-Sterilized Elastomeric Closures Market for Seals, 2019-2030

9.3.3.1.2. Global Pre-Sterilized Elastomeric Closures Market for Stoppers, 2019-2030

9.3.3.1.3. Global Pre-Sterilized Elastomeric Closures Market for Caps, 2019-2030

9.3.3.1.4. Global Pre-Sterilized Elastomeric Closures Market for Plungers, 2019-2030

9.3.3.1.5. Global Pre-Sterilized Elastomeric Closures Market for Barrels, 2019-2030

9.3.3.1.6. Global Pre-Sterilized Elastomeric Closures Market for Needle Shields, 2019-2030

9.3.3.2. Global Unsterilized Elastomeric Closures Market, 2019-2030

9.3.3.2.1. Global Unsterilized Elastomeric Closures Market for Seals, 2019-2030

9.3.3.2.2. Global Unsterilized Elastomeric Closures Market for Stoppers, 2019-2030

9.3.3.2.3. Global Unsterilized Elastomeric Closures Market for Caps, 2019-2030

9.3.3.2.4. Global Unsterilized Elastomeric Closures Market for Plungers, 2019-2030

9.3.3.2.5. Global Unsterilized Elastomeric Closures Market for Barrels, 2019-2030

9.3.3.2.6. Global Unsterilized Elastomeric Closures Market for Needle Shields, 2019-2030

9.3.4. Global Elastomeric Closures Market, 2019-2030: Distribution by Geography

9.3.4.1. Elastomeric Closures Market in North America, 2019-2030

9.3.4.1.1. Elastomeric Closures Market for Seals in North America, 2019-2030

9.3.4.1.2. Elastomeric Closures Market for Stoppers in North America, 2019-2030

9.3.4.1.3. Elastomeric Closures Market for Caps in North America, 2019-2030

9.3.4.1.4. Elastomeric Closures Market for Plungers in North America, 2019-2030

9.3.4.1.5. Elastomeric Closures Market for Barrels in North America, 2019-2030

9.3.4.1.6. Elastomeric Closures Market for Needle Shields in North America, 2019-2030

9.3.4.2. Elastomeric Closures Market in Europe, 2019-2030

9.3.4.2.1. Elastomeric Closures Market for Seals in Europe, 2019-2030

9.3.4.2.2. Elastomeric Closures Market for Stoppers in Europe, 2019-2030

9.3.4.2.3. Elastomeric Closures Market for Caps in Europe, 2019-2030

9.3.4.2.4. Elastomeric Closures Market for Plungers in Europe, 2019-2030

9.3.4.2.5. Elastomeric Closures Market for Barrels in Europe, 2019-2030

9.3.4.2.6. Elastomeric Closures Market for Needle Shields in Europe, 2019-2030

9.3.4.3. Elastomeric Closures Market in Asia-Pacific, 2019-2030

9.3.4.3.1. Elastomeric Closures Market for Seals in Asia-Pacific, 2019-2030

9.3.4.3.2. Elastomeric Closures Market for Stoppers in Asia-Pacific, 2019-2030

9.3.4.3.3. Elastomeric Closures Market for Caps in Asia-Pacific, 2019-2030

9.3.4.3.4. Elastomeric Closures Market for Plungers in Asia-Pacific, 2019-2030

9.3.4.3.5. Elastomeric Closures Market for Barrels in Asia-Pacific, 2019-2030

9.3.4.3.6. Elastomeric Closures Market for Needle Shields in Asia-Pacific, 2019-2030

9.3.4.4. Elastomeric Closures Market in Rest of the World, 2019-2030

9.3.4.4.1. Elastomeric Closures Market for Seals in Rest of the World, 2019-2030

9.3.4.4.2. Elastomeric Closures Market for Stoppers in Rest of the World, 2019-2030

9.3.4.4.3. Elastomeric Closures Market for Caps in Rest of the World, 2019-2030

9.3.4.4.4. Elastomeric Closures Market for Plungers in Rest of the World, 2019-2030

9.3.4.4.5. Elastomeric Closures Market for Barrels in Rest of the World, 2019-2030

9.3.4.4.6. Elastomeric Closures Market for Needle Shields in Rest of the World, 2019-2030

9.4. Concluding Remarks

CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACKAGING

10.1. Chapter Overview

10.2. Role of Robots in the Pharmaceutical Industry

10.2.1. Key Considerations for Selecting a Robotic System

10.2.2. Advantages of Robotic Systems

10.2.3. Disadvantages of Robotic Systems

10.3. Companies Providing Robots for Pharmaceutical Industry

10.4. Companies Providing Equipment Integrated with Robotic Systems for Pharmaceutical Packaging

10.4.1. Aseptic Technologies

10.4.1.1. Crystal® L1 Robot Line

10.4.1.2. Crystal® SL1 Robot Line

10.4.2. AST

10.4.2.1. ASEPTiCell® Series

10.4.2.2. ASEPTiCell® VSM-25

10.4.3. Bosch Packaging Technology

10.4.3.1. ATO

10.4.4. Dara Pharmaceutical Packaging

10.4.4.1. SYX-E CARTRIDGE + RABS

10.4.5. Fedegari Group

10.4.5.1. Fedegari Isolator

10.4.6. IMA

10.4.6.1. INJECTA

10.4.6.2. STERI LIF3

10.4.7. Steriline

10.4.7.1. Nest Filling Line RNFM

10.4.8. Vanrx Pharmasystems

10.4.8.1. Microcell Vial Filler

10.4.8.2. SA25 Aseptic Filling Workcell

EMERGING TRENDS IN PHARMACEUTICAL PACKAGING

11.1. Chapter Overview

11.2. Shift Towards Self-Medication using Advanced Drug Delivery Devices

11.3. Focus on Developing Improved Packaging Components and Ongoing Efforts to Optimize Manufacturing Costs

11.4. Availability of Modular Facilities

11.5. Initiatives Focused on Automation of Fill / Finish Operations

11.6. Establishment of Business Relationships Focused on Designing Compatible Packaging Materials for Various Drug Products

11.7. Increasing Activity in Developing Regions

11.8. Growing Adoption of Smart Packaging Solutions

11.9. Concluding Remarks

EXECUTIVE INSIGHTS

12.1. Chapter Overview

12.2. Aseptic Technologies

12.2.1. Company Snapshot

12.2.2. Interview Transcript: Julien Maréchal, Business Development and Technology Director

12.3. BioPhorum Operations Group

12.3.1. Company Snapshot

13.3.2. Interview Transcript: Malcolm Gilmore, Facilitator

12.4. Lonstroff

12.4.1. Company Snapshot

12.4.2. Interview Transcript: Marco Pederiva, Marketing and Sales Director

12.5. PYRAMID Laboratories

12.5.1. Company Snapshot

12.5.2. Interview Transcript: Konstantin Kazarian, Business Development Project Manager

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The elastomeric closures market is projected to reach USD 9.3 Billion by 2030, growing at an annualized rate of 6.7%, claims Roots Analysis

Submitted 11 hour(s) ago by Harry sins

Driven by the growing complexity of modern pharmacological interventions, industry stakeholders have developed container-closures systems using more versatile materials; in this context, elastomers have demonstrated significant potential

Roots Analysis is pleased to announce the publication of its recent study, titled, “Elastomeric Closure Components Market For Vials, Cartridges and Syringes, 2019-2030.”

The report features a comprehensive study of the current scenario and future potential of the elastomeric, primary packaging closure market. It features an in-depth analysis, highlighting the various types of elastomeric closures including stoppers, needle shields and plungers, available in the market for various types of primary packaging containers, such as cartridges, syringes and vials. In addition to other elements, the study includes:

A detailed assessment of the current market landscape of companies manufacturing elastomeric container closures.
A comprehensive analysis on the packaging trends of over 230 drug products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014).
An analysis of various developments / recent trends related to elastomeric packaging materials.
Elaborate profiles of key players in this domain (shortlisted on the basis of size of product portfolio).
A case study on the role of robotics in pharmaceutical manufacturing and fill / finish operations.
An elaborate discussion on emerging trends that are likely to have an impact on the future adoption of elastomeric container-closure components in the pharmaceutical packaging industry.
An in-depth analysis to estimate the current and future demand for elastomeric closures across key primary packaging containers, including vials, syringes and cartridges, in different regions for the period 2019-2030.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of packaging container
- Vials
- Syringes
- Cartridges

Type of packaging closure
- Seal
- Stopper
- Cap
- Plunger
- Barrel
- Needle Shield

Sterilization status
- Pre-sterilized
- Unsterilized

Key geographical regions
North America
Europe
Asia Pacific
Rest of the World

Key companies covered in the report

Aptar Pharma
Daikyo Seiko
Datwyler Group
DWK Life Sciences
Hebei First Rubber Medical Technology (a Part of DESHENG Group)
Jiangsu Hualan New Pharmaceutical Material
Lonstroff (a Part of Sumitomo Rubber Industries)
Ompi (a Part of Stevanato Group)
West Pharmaceutical Services

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/elastomeric-closures-market-focus-on-parenteral-containers-2019-2030/255.html

Other Recent Offerings

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030’ report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices.

Submitted 2 day(s) ago by Harry sins

To order this detailed 550+ page report, please visit this link

Key Inclusions

A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap-analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services.
A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).
An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.
A benchmark analysis, highlighting the key focus areas of very small-sized, small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Medical Device Class

Class I
Class II
Class III

Therapeutic Area

Cardiovascular Disorders
CNS Disorders
Metabolic Disorders
Oncological Disorders
Ophthalmological Disease
Orthopedic Disorders
Pain Disorders
Respiratory Disorders
Others

Type of Regulatory Affairs Service

Pharmacies GAP-Analysis
Pharmacies Legal Representation
Pharmacies Notified Body Selection
Product Labelling-related Services
Product Registration and Clinical Trial Applications
Regulatory Document Submissions
Regulatory Writing and Publishing
Risk Management-related Services
Technical Dossier Set-up
Vigilance & Medical Device Report

Key Geographical Regions

North America
Europe
Asia-Pacific and Rest of the World

To request sample pages, please visit this link

Key Questions Answered

Who are the leading CROs offering regulatory affairs-management services for medical devices?
What are differences in regulatory guidelines for medical device approval, across various geographies?
What are the key performance indicators used by sponsors to evaluate potential service providers?
What are the popular outsourcing models used by medical device companies for regulatory affairs-management purposes?
What are the key challenges faced by medical device developers / manufacturers in terms of regulations related to medical device approvals?
How is the current and future market opportunity likely to be distributed across key market segments?

You may also be interested in the following titles:

Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities, claims Roots Analysis

Submitted 2 day(s) ago by Harry sins

More than 130 medical devices were approved by the FDA since January 2018, while several are currently being evaluated across more than 9,500 (active) clinical trials, worldwide. Even though technical innovation has enabled the development of a variety of versatile medical devices, product approval, given stringent regulatory standards, is still a concern.

To order this 550+ page report, which features 245+ figures and 250+ tables, please visit this link

The USD 820 million (by 2030) financial opportunity within the contract regulatory affairs-management services market for medical devices has been analyzed across the following segments:

Medical Device Class

Class I
Class II
Class III

Therapeutic Area

Cardiovascular Disorders
CNS Disorders
Metabolic Disorders
Oncological Disorders
Ophthalmological Disease
Orthopedic Disorders
Pain Disorders
Respiratory Disorders
Others

Type of Regulatory Affairs Service

Pharmacies GAP-Analysis
Pharmacies Legal Representation
Pharmacies Notified Body Selection
Product Labelling-related Services
Product Registration and Clinical Trial Applications
Regulatory Document Submissions
Regulatory Writing and Publishing
Risk Management-related Services
Technical Dossier Set-up
Vigilance & Medical Device Report

Key Geographical Regions

North America
Europe
Asia-Pacific and Rest of the World

The Contract Regulatory Affairs-Management Market for Medical Devices, 2019-2030 report features the following companies, which we identified to be key players in this domain:

CTI Clinical Trial and Consulting Services
CROMSOURCE
ICON
Intertek
Medpace
MIC Medical
North American Science Associates (NAMSA)
Parexel
PharmaLex
Premier Research
Société Générale de Surveillance (SGS)
Underwriters Laboratory (UL)

Table of Contents

Preface

2. Executive Summary
Introduction
Role of Regulatory Affairs in Medical Device Supply Chain
Regulatory and Reimbursement Landscape for Medical Devices
Competitive Landscape
Company Profiles
Competitive Benchmarking
Guide to Regulatory Outsourcing Models
Medical Device Regulatory Affairs: Key Performance Indicators
Market Forecast
Conclusion
Survey Insights
Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The contract regulatory affairs-management services market for medical devices is estimated to be worth USD 820 million by 2030, growing at a CAGR of 6.9%,

Submitted 2 day(s) ago by Harry sins

Roots Analysis has done a detailed study on Medical Device CROs for Regulatory Affairs Management Market, 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 550+ page report, which features 245+ figures and 250+ tables, please visit this link

Key Market Insights

Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities
The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies
Service providers are catering to a diverse clientele, enabling sponsors to compliance to the standards of both regional and international regulators
Owing to the high competition, companies involved in this domain are steadily expanding their capabilities in order to augment their respective service portfolios and comply to evolving industry benchmarks
CROs are actively engaged in expanding their global footprint in order to enable their clients to navigate the technical and regulatory complexities across various geographies
The medical device regulatory affairs outsourcing market is anticipated to grow at an annualized rate of 6.8%; the opportunity is likely to be distributed across different therapeutic areas and geographies
Based on prevalent and anticipated trends, the revenue share will vary across important market segments, such as different types of services, size of service provider and device class

For more information, please visit https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html

Table of Contents

PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY
INTRODUCTION
3.1. Chapter Overview

3.2. Contract Research Organizations (CROs)

3.2.1. Evolution of CROs

3.3. Role of CROs in the Medical Device Industry

3.4. Types of Medical Device CROs

3.5. Types of Services Offered by CROs

3.5.1. Types of Regulatory Affairs-Related Services Offered by CROs

3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices

3.7. Key Considerations for Selecting a Suitable CRO Partner

3.8. Advantages of Working with CROs

3.9. Risks and Challenges Related to Working with CROs

3.10. Concluding Remarks

ROLE OF REGULATORY AFFAIRS IN MEDICAL DEVICE SUPPLY CHAIN

4.1. Chapter Overview

4.2. Overview of Medical Device Supply Chain

4.2.1. Importance of Regulatory Affairs in Medical Device Supply Chain

4.2.1.1. Concept and Feasibility Assessment Stage

4.2.1.2. Preclinical Stage

4.2.1.3. Manufacturing / Production Stage

4.2.1.4. Marketing Stage

4.2.1.5. Post-Marketing Stage

4.3. Factors Affecting the Medical Device Supply Chain

4.4. Key Performance Indicators for Medical Device Supply Chain Management

4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain

4.5.1. Digitalization of the Medical Device Supply Chain

REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES

5.1. Chapter Overview

5.2. General Regulatory and Reimbursement Guidelines for Medical Devices

5.3. Regulatory and Reimbursement Landscape in North America

5.3.1. The US Scenario

5.3.1.1. Regulatory Authority

5.3.1.2. Review / Approval Process

5.3.1.3. Reimbursement Landscape

5.3.1.3.1. Payer Mix

5.3.1.3.2. Reimbursement Process

5.3.2. The Canadian Scenario

5.3.2.1. Regulatory Authority

5.3.2.2. Review / Approval Process

5.3.2.3. Reimbursement Landscape

5.3.2.3.1. Payer Mix

5.3.2.3.2. Reimbursement Process

5.3.3. The Mexican Scenario

5.3.3.1. Regulatory Authority

5.3.3.2. Review / Approval Process

5.3.3.3. Reimbursement Landscape

5.3.3.3.1. Payer Mix

5.4. Regulatory and Reimbursement Landscape in Europe

5.4.1. Overall Scenario

5.4.1.1. Overall Regulatory Authority

5.4.1.2. Overall Review / Approval Process

5.4.2. The UK Scenario

5.4.2.1. Regulatory Authority

5.4.2.2. Review / Approval Process

5.4.2.3. Reimbursement Landscape

5.4.2.3.1. Payer Mix

5.4.2.3.2. Reimbursement Process

5.4.3. The French Scenario

5.4.3.1. Regulatory Authority

5.4.3.2. Review / Approval Process

5.4.3.3. Reimbursement Landscape

5.4.3.3.1. Payer Mix

5.4.3.3.2. Reimbursement Process

5.4.4. The German Scenario

5.4.4.1. Regulatory Authority

5.4.4.2. Review / Approval Process

5.4.4.3. Reimbursement Landscape

5.4.4.3.1. Payer Mix

5.4.4.3.2. Reimbursement Process

5.4.5. The Italian Scenario

5.4.5.1. Regulatory Authority

5.4.5.2. Review / Approval Process

5.4.5.3. Reimbursement Landscape

5.4.5.3.1. Payer Mix

5.4.5.3.2. Reimbursement Process

5.4.6. The Spanish Scenario

5.4.6.1. Regulatory Authority

5.4.6.2. Review / Approval Process

5.4.6.3. Reimbursement Landscape

5.4.6.3.1. Payer Mix

5.4.6.3.2. Reimbursement Process

5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World

5.5.1. The Australian Scenario

5.5.1.1. Regulatory Authority

5.5.1.2. Review / Approval Process

5.5.1.3. Reimbursement Landscape

5.5.1.3.1. Payer Mix

5.5.1.3.2. Reimbursement Process

5.5.2. The Brazilian Scenario

5.5.2.1. Regulatory Authority

5.5.2.2. Review / Approval Process

5.5.2.3. Reimbursement Landscape

5.5.2.3.1. Payer Mix

5.5.2.3.2. Reimbursement Process

5.5.3. The Chinese Scenario

5.5.3.1. Regulatory Authority

5.5.3.2. Review / Approval Process

5.5.3.3. Reimbursement Landscape

5.5.3.3.1. Payer Mix

5.5.3.3.2. Reimbursement Process

5.5.4. The Indian Scenario

5.5.4.1. Regulatory Authority

5.5.4.2. Review / Approval Process

5.5.4.3. Reimbursement Landscape

5.5.4.3.1. Payer Mix

5.5.5. The Israeli Scenario

5.5.5.1. Regulatory Authority

5.5.5.2. Review / Approval Process

5.5.5.3. Reimbursement Landscape

5.5.5.3.1. Payer Mix

5.5.6. The Japanese Scenario

5.5.6.1. Regulatory Authority

5.5.6.2. Review / Approval Process

5.5.6.3. Reimbursement Landscape

5.5.6.3.1. Payer Mix

5.5.6.3.2. Reimbursement Process

5.5.7. The New Zealand Scenario

5.5.7.1. Regulatory Authority

5.5.7.2. Review / Approval Process

5.5.7.3. Reimbursement Landscape

5.5.7.3.1. Payer Mix

5.5.7.3.2. Reimbursement Process

5.5.8. The Singaporean Scenario

5.5.8.1. Regulatory Authority

5.5.8.2. Review / Approval Process

5.5.8.3. Reimbursement Landscape

5.5.8.3.1. Payer Mix

5.5.8.3.2. Reimbursement Process

5.5.9. The South Korea Scenario

5.5.9.1. Regulatory Authority

5.5.9.2. Review / Approval Process

5.5.9.3. Reimbursement Landscape

5.5.9.3.1. Payer Mix

5.5.9.3.2. Reimbursement Process

5.5.10. The South African Scenario

5.5.10.1. Regulatory Authority

5.5.10.2. Review / Approval Process

5.5.10.3. Reimbursement Landscape

5.5.11. The Taiwanese Scenario

5.5.11.1. Regulatory Authority

5.5.11.2. Review / Approval Process

5.5.11.3. Reimbursement Landscape

5.5.11.3.1. Payer Mix

5.5.11.3.2. Reimbursement Process

5.5.12. The Thailand Scenario

5.5.12.1. Regulatory Authority

5.5.12.2. Review / Approval Process

5.5.12.3. Reimbursement Landscape

5.6. Comparison of Regional Regulatory Environment

5.7. Concluding Remarks

COMPETITIVE LANDSCAPE

6.1. Chapter Overview

6.2. CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies

6.2.1. Analysis by Year of Establishment

6.2.2. Analysis by Size of Employee Base

6.2.3. Analysis by Location of Headquarters

6.2.4. Analysis by Company Size and Geography

6.3. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Area of Specialization

6.3.1. Analysis by Area of Specialization

6.4. CROs Offering Medical Device Regulatory Services: Information on Type of Regulatory Affairs-Related Services Offered

6.4.1. Analysis by Type of Regulatory Affairs-Related Service Offered

6.4.2. Analysis by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered

6.5. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type of Additional Services Offered

6.5.1. Analysis by Type of Additional Services Offered

6.6. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Device Class

6.6.1. Analysis by Device Class

6.7. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type and Size of Clientele

6.7.1. Analysis by Type and Size of Clientele

6.8. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Medical Device Regulatory Compliance Authorities

6.8.1. Analysis by Medical Device Regulatory Compliance Authorities

6.9. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Region-wise)

6.9.1. Analysis by Geographical Reach (Region-Wise)

6.10. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Country-wise)

6.10.1. Analysis by Geographical Reach (Country-Wise)

COMPANY PROFILES

7.1. Chapter Overview

7.2. CROs Headquartered in North America

7.2.1. CTI Clinical Trial and Consulting (CTI)

7.2.1.1. Company Overview

7.2.1.2. Service Portfolio

7.2.1.3. Future Outlook

7.2.2. Medpace

7.2.2.1. Company Overview

7.2.2.2 Financial Information

7.2.2.3. Service Portfolio

7.2.2.4. Future Outlook

7.2.3. NAMSA

7.2.3.1. Company Overview

7.2.3.2. Service Portfolio

7.2.3.3. Future Outlook

7.2.4. PAREXEL

7.2.4.1. Company Overview

7.2.4.2 Financial Information

7.2.4.3. Service Portfolio

7.2.4.4. Future Outlook

7.2.5. Premier Research

7.2.5.1. Company Overview

7.2.5.2. Service Portfolio

7.2.5.3. Future Outlook

7.2.6. Underwriters Laboratory (UL)

7.2.6.1. Company Overview

7.2.6.2. Service Portfolio

7.2.6.3. Future Outlook

7.3. CROs Headquartered in Europe

7.3.1. CROMSOURCE

7.3.1.1. Company Overview

7.3.1.2. Service Portfolio

7.3.1.3 Future Outlook

7.3.2. ICON

7.3.2.1. Company Overview

7.3.2.2 Financial Information

7.3.2.3. Service Portfolio

7.3.2.4. Future Outlook

7.3.3. Intertek

7.3.3.1. Company Overview

7.3.3.2 Financial Information

7.3.3.3. Service Portfolio

7.3.3.4. Future Outlook

7.3.4. PharmaLex

7.3.4.1. Company Overview

7.3.4.2. Service Portfolio

7.3.4.3 Future Outlook

7.3.5. Société Générale de Surveillance (SGS)

7.3.5.1. Company Overview

7.3.5.2. Service Portfolio

7.3.5.3 Future Outlook

7.3.4. SteriPack

7.3.4.1. Company Overview

7.3.4.2. Service Portfolio

7.3.4.3 Future Outlook

7.4. CROs Headquartered in Asia-Pacific and Rest of the World

7.4.1. MIC Medical

7.4.1.1. Company Overview

7.4.1.2. Service Portfolio

7.4.1.3 Recent Developments

COMPETITIVE BENCHMARKING

8.1. Chapter Overview

8.2. Benchmark Analysis: Methodology

8.3. Region-wise Benchmark Analysis

8.3.1. North America, Peer Group I

8.3.2. North America, Peer Group II

8.3.3. North America, Peer Group III

8.3.4. North America, Peer Group IV

8.3.5. Europe, Peer Group V

8.3.6. Europe, Peer Group VI

8.3.7. Europe, Peer Group VII

8.3.8. Europe, Peer Group VIII

8.3.9. Asia Pacific and Rest of the World, Peer Group IX

8.3.10. Asia Pacific and Rest of the World, Peer Group X

8.3.11. Asia Pacific and Rest of the World, Peer Group XI

8.3.12. Asia Pacific and Rest of the World, Peer Group XII

8.4. Concluding Remarks

GUIDE TO REGULATORY OUTSOURCING MODELS

9.1. Chapter Overview

9.2. Guiding Models for Regulatory Outsourcing

9.2.1. Functional Service Providers (FSP) Model: Large Medical Device Developers

9.2.1.1. Vendor Evaluation

9.2.2. End-to-End Model: Small-Sized Medical Device Developers

9.2.2.1. Vendor Evaluation

9.2.3. Hybrid Model: Mid-Sized Medical Device Developers

9.2.3.1. Vendor Evaluation

9.3. Concluding Remarks

MEDICAL DEVICE REGULATORY AFFAIRS: KEY PERFORMANCE INDICATORS

10.1. Chapter Overview

10.2. Definition and Importance of Key Performance Indicators

10.3. Key Considerations for Selection of Key Performance Indicators

10.4. Types of Key Performance Indicators

10.4.1. Financial Indicators

10.4.1.1. Most Important KPIs

10.4.1.1.1. Financial Stability

10.4.1.1.2. Cost of Services Offered

10.4.1.1.3. Comparative Analysis of Financial Indicators

10.4.1.2. Industry Perspective

10.4.1.2.1. Sponsor (Big Pharma) Perspective

10.4.1.2.2. Contract Service Providers’ Perspective

10.4.2. Process / Capability Indicators

10.4.2.1. Most Important KPIs

10.4.2.1.1. Proximity to Sponsor

10.4.2.1.2. Capability to Innovate / Mitigate Risk

10.4.2.1.3. Strength of Service Portfolio

10.4.2.1.4. Comparative Analysis of Process / Capability Indicators

10.4.2.2. Industry Perspective

10.4.2.2.1. Sponsor (Big Pharma) Perspective

10.4.2.2.2. Contract Service Providers’ Perspective

10.4.3. Market Reputation Indicators

10.4.3.1. Most Important KPIs

10.4.3.1.1. Flexibility / Adaptability

10.4.3.1.2. Time Management

10.4.3.1.3. Quality / Reliability

10.4.3.1.4. Regulatory Compliance / Track Record

10.4.3.1.5. Comparative Analysis of Market Reputation Indicators

10.4.3.2. Industry Perspective

10.4.3.2.1. Sponsor (Big Pharma) Perspective

10.4.3.2.2. Contract Service Providers’ Perspective

10.5. Comparison of Key Performance Indicators

10.6. Concluding Remarks

MARKET FORECAST

11.1 Chapter Overview

11.2. Forecast Methodology and Key Assumptions

11.3. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030

11.4. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030

11.4.1. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030

11.4.1.1. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030

11.4.1.2. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030

11.4.2. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030

11.4.2.1. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030

11.4.2.2. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030

11.4.2.3. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030

11.4.2.4. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030

11.4.2.5. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030

11.4.2.6. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030

11.4.3. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030

11.4.3.1. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030

11.4.3.2. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030

11.4.3.3. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030

11.4.3.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030

11.4.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030

11.5. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030

11.5.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030

11.5.2. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030

11.5.3. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030

11.5.4. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services, 2019-2030

11.5.5. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030

11.5.6. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030

11.5.7. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030

11.5.8. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service, 2019-2030

11.5.9. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030

11.5.10. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030

11.6. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030

11.6.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030

11.6.2. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030

11.6.3. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030

11.7. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030

11.7.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030

11.7.2. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System (CNS) Disorders, 2019-2030

11.7.3. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030

11.7.4. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030

11.7.5. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030

11.7.6. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030

11.7.7. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030

11.7.8. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030

11.7.9. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030

11.8. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service and Geography

11.8.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030

11.8.2. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030

11.8.3. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030

11.8.4. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030

11.8.5. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030

11.8.6. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030

11.8.7. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030

11.8.8. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030

11.8.9. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030

11.8.10. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030

11.8.11. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030

11.8.12. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030

11.8.13. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in North America, 2019-2030

11.8.14. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Europe, 2019-2030

11.8.15. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Asia-Pacific, 2019-2030

11.8.16. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Rest of the World, 2019-2030

11.8.17. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030

11.8.18. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030

11.8.19. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030

11.8.20. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030

11.8.21. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030

11.8.22. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030

11.8.23. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030

11.8.24. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030

11.8.25. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030

11.8.26. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030

11.8.27. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030

11.8.28. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030

11.8.29. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in North America, 2019-2030

11.8.30. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Europe, 2019-2030

11.8.311. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Asia-Pacific, 2019-2030

11.8.32. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Rest of the World, 2019-2030

11.8.33. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030

11.8.34. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030

11.8.35. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030

11.8.36. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030

11.8.37. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030

11.8.38. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030

11.8.39. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030

11.8.40. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030

11.9. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class and Geography

11.9.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030

11.9.2. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030

11.9.3. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030

11.9.4. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030

11.9.5. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030

11.9.6. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030

11.9.7. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030

11.9.8. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030

11.9.9. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030

11.9.10. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030

11.9.11. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030

11.9.12. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030

11.10. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area and Geography

11.10.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030

11.10.2. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030

11.10.3. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030

11.10.4. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030

11.10.5. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030

11.10.6. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030

11.10.7. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030

11.10.8. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030

11.10.9. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030

11.10.10. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030

11.10.11. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030

11.10.12. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030

11.10.13. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030

11.10.14. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030

11.10.15. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030

11.10.16. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030

11.10.17. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030

11.10.18. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030

11.10.19. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030

11.10.20. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030

11.10.21. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030

11.10.22. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030

11.10.23. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030

11.10.24. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030

11.10.25. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030

11.10.26. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030

11.10.27. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030

11.10.28. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030

11.10.29. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030

11.10.30. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030

11.10.31. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030

11.10.32. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030

11.10.33. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030

11.10.34. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030

11.10.35. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030

11.10.36. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030

11.11. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Company Size, 2019-2030

11.11.1. Medical Device Regulatory Affairs Outsourcing Market for Small-Sized Companies, 2019-2030

11.11.2. Medical Device Regulatory Affairs Outsourcing Market for Mid-Sized Companies, 2019-2030

11.11.3. Medical Device Regulatory Affairs Outsourcing Market for Large Companies, 2019-2030

11.12. Concluding Remarks

CONCLUSION

12.1. Chapter Overview

12.2. Key Takeaways

SURVEY INSIGHTS

13.1. Chapter Overview

13.2. Company Specifics of Respondents

13.3. Designation of Respondents

13.4. Types of Regulatory Affairs-Related Services

13.5. Analysis by Geographical Reach

13.6. Type and Size of Clientele

13.7. Average Number of Projects

13.8. Proportion of Clients Outsourcing Regulatory Affairs-Related Services

13.9. Cost of Outsourcing Regulatory Affairs-Related Services

13.10. Current and Future Market Opportunity

EXECUTIVE INSIGHTS

14.1. Chapter Overview

14.2. A+ Science

14.2.1. Company Snapshot

14.2.2. Interview Transcript: Tania Persson, Business Development Manager

14.3. AtoZ-CRO

14.3.1. Company Snapshot

14.3.2. Interview Transcript: Alexa Foltin-Mertgen, Business Development Manager

14.4. CROMSOURCE

14.4.1. Company Snapshot

14.4.2. Interview Transcript: Troy Mccall, Chief Operating Officer

14.5. CW Research & Management

14.5.1. Company Snapshot

14.5.2. Interview Transcript: Christian Wolflehner, Managing Director, Clinical Trial Specialist

14.6. HungaroTrial

14.6.1 Company Snapshot

14.6.2. Interview Transcript: Antal Solyom, Director of Medical Device Unit

14.7. Metrics Research

14.7.1 Company Snapshot

14.7.2. Interview Transcript: Dr. Nazish Urooj, Senior Manager, Medical & Clinical Operations

14.8. Vyomus Consulting

14.8.1 Company Snapshot

14.8.2. Interview Transcript: Dr. C Omprakash, Technical Director and Partner

APPENDIX I: TABULATED DATA

APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The contract regulatory affairs-management services market for medical devices is estimated to be worth USD 820 million by 2030, growing at a CAGR of 6.9%, claims Roots Analysis

Submitted 2 day(s) ago by Harry sins

Over the years, outsourcing has become a popular trend with the medical device industry, allowing innovators to leverage the technical and regulatory expertise of contract service providers in order to expedite time to market

Roots Analysis is pleased to announce the publication of its recent study, titled, “Medical Device CROs for Regulatory Affairs Management Market, 2019-2030.”

The report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain.
A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies.
An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America, Europe, Asia-Pacific and rest of the world.
Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies.
A benchmark analysis, highlighting the key focus areas of very small-sized, small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups.
An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Medical Device Class
Class I
Class II
Class III

Therapeutic Area
Cardiovascular Disorders
CNS Disorders
Metabolic Disorders
Oncological Disorders
Ophthalmological Disease
Orthopedic Disorders
Pain Disorders
Respiratory Disorders
Others

Type of Regulatory Affairs Service
Pharmacies GAP-Analysis
Pharmacies Legal Representation
Pharmacies Notified Body Selection
Product Labelling-related Services
Product Registration and Clinical Trial Applications
Regulatory Document Submissions
Regulatory Writing and Publishing
Risk Management-related Services
Technical Dossier Set-up
Vigilance & Medical Device Report

Key Geographical Regions
North America
Europe
Asia-Pacific and Rest of the World

Key companies covered in the report

CTI Clinical Trial and Consulting Services
CROMSOURCE
ICON
Intertek
Medpace
MIC Medical
North American Science Associates (NAMSA)
Parexel
PharmaLex
Premier Research
Société Générale de Surveillance (SGS)
Underwriters Laboratory (UL)

For more information please click on the following link

https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html

Other Recent Offerings

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The “Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030” report features an extensive study of the current market landscape and future opportunities for companies with capabilities in continuous manufacturing (both innovator comp

Submitted 2 day(s) ago by Harry sins

To order this 310+ page report, which features 110+ figures and 200+ tables, please visit this link

Key Inclusions

A detailed assessment of the overall landscape of companies with capabilities for continuous manufacturing, along with information on a number of relevant parameters, such as year of establishment, company size, purpose of manufacturing (in-house and contract services), scale of operation (preclinical, clinical and commercial), location of headquarters, location of manufacturing facilities, type of drug molecule (biologic and small molecule), type of continuous manufacturing related service(s) offered (process development, API manufacturing, intermediate manufacturing, drug product manufacturing, and packaging and fill / finish), type of dosage form (solid and liquid), and installed capacity and batch size (if available).
Elaborate profiles of some of the key contract manufacturers active in the pharmaceutical and biopharmaceutical continuous manufacturing market in North America, Europe and Asia-Pacific. Each profile features an overview of the company, along with information related to its service portfolio, continuous manufacturing capabilities and facilities, recent developments and an informed future outlook.
An analysis of the various partnerships related to continuous manufacturing, which have been established since 2013, based on several parameters, such as year of an agreement, the type of partnership (research agreements, facility development / establishment agreements, technology enhancement agreements, service alliances, process development agreements, manufacturing agreements and other relevant agreements), scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid). It also provides the regional distribution of the collaborations.
An analysis of the expansions related to continuous manufacturing, which have been established since 2013, based on several parameters, such as year of an expansion and the type of expansion (facility / plant expansion, technology installation, technology enhancement and service expansion), geographical location of the facility, scale of operation (preclinical, clinical and commercial), type of drug molecule (biologic and small molecule), type of continuous manufacturing related service (API manufacturing, intermediate manufacturing and end product manufacturing) and type of dosage form (solid and liquid).
An estimate of the global, continuous manufacturing capacity, based on the capacities of various industry stakeholders (as available on their respective company websites). The study examines the distribution of capacity, based on the type of drug molecule (biologic and small molecule), company size (small-sized, mid-sized and large), scale of operation (preclinical, clinical and commercial), location of headquarters (North America, Europe and Asia-Pacific) and location of manufacturing facilities (North America, Europe and Asia-Pacific).
A study of the various grants that have been awarded to research institutes engaged in projects related to continuous manufacturing, between 2014 and 2019, highlighting multiple parameters, such as year of award, type of grant, grant amount, focus area, support period, popular recipient organizations, type of recipient organization, funding institute center, funding mechanism and prominent program officers.
An in-depth analysis of the various patents that have been filed / granted related to continuous manufacturing till 2019. It includes information on key parameters, such as patent type, publication year, geographical location, CPC symbol, emerging focus areas, type of applicant and leading industry / non-industry players (in terms of the size of intellectual property portfolio). It also features a three-dimensional bubble analysis (based on patent citation count, publication year, extended geographical reach), as well as a patent benchmarking and a detailed valuation analysis.
Initiatives taken by the leading pharmaceutical companies (in terms of revenues), covering both partnered as well as in-house projects.
A review of the companies offering modular facilities / modular cleanrooms, with information on their geographical location (North America, Europe, Asia-Pacific and rest of the world), year of establishment, company size (small-sized, mid-sized or large) and type of industries served (pharmaceutical, biotechnology or others). It also includes information on the recent projects undertaken / executed by the companies providing modular facilities.
A case study of the companies offering technologies / equipment (continuous blenders and mixers, continuous granulators, continuous dryers, continuous compressors, continuous coaters, flow reactors, continuous filtration, distillation and centrifugation equipment, continuous chromatography, PAT technology and other technologies) that can potentially be used in a continuous manufacturing process, providing information on the geographical location of potential stakeholders and the type of technology / equipment provided.
A case study on the roadmap for the adoption of continuous manufacturing technique, discussing different strategies that can be followed by the company in order to adopt this technology or transition from batch manufacturing to continuous manufacturing.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Purpose of Manufacturing
In-House
Contract service
Scale of Operation
Commercial
Preclinical / Clinical
Type of Continuous Manufacturing related Service
API Manufacturing
End Product manufacturing
Type of Drug Molecule
Biologic
Small Molecule
Type of dosage form
Solid
Liquid
Key Geographical Regions
North America
Europe
Asia Pacific
Transcripts of interviews held with the following senior level representatives of stakeholder companies
Andrea Adamo, Founder and Chief Executive Officer, Zaiput Flow technologies
Bayan Takizawa, Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals
Nick Thomson, Senior Director Chemical Research and Development, Pfizer
Himanshu Gadgil, Director and Chief Scientific Officer, Enzene Biosciences
Eric Fang, Chief Scientific Officer, Snapdragon Chemistry)
Ian Houson, Technical Project Manager, Continuous Manufacturing and Crystallization, University of Strathclyde

To request sample pages, please visit this link

Key Questions Answered

Who are the key players engaged in continuous manufacturing of small molecules and biologics?
What is the installed, global capacity for continuous manufacturing?
What are the key growth drivers within this domain?
What are the various paths to evolution within this industry?
Who are the other key stakeholders (modular facility providers and technology / equipment developers) in this domain?
How is the current and future market opportunity likely to be distributed across key market segments?

You may also be interested in the following titles:

Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028
Biopharma Contract Manufacturing Market (3rd Edition), 2019 - 2030
China Pharmaceutical Contract Manufacturing Services Market, 2020-2030
China Biopharmaceutical Contract Manufacturing Market, 2020 - 2030

Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Over 60 companies across the globe claim to manufacture drug products / drug substances using the continuous manufacturing technique, either for in-house requirements or for contract service engagements, claims Roots Analysis

Submitted 2 day(s) ago by Harry sins

The COVID-19 pandemic has severely impaired the overall pharmaceutical supply chain, mostly owing to the absence of workers at manufacturing sites and restrictions imposed on distribution networks. In this context, continuous manufacturing offers a viable solution given the fact that continuous processes are largely automated. In fact, the FDA (and other regulatory bodies) have also expressed interest in advocating a shift to the use of advanced manufacturing technologies, such as continuous manufacturing.

To order this 310+ page report, which features 110+ figures and 200+ tables, please visit this link

The USD 1.9 billion (by 2030) financial opportunity within the continuous manufacturing market has been analyzed across the following segments:

Purpose of Manufacturing
In-House
Contract service

Scale of Operation
Commercial
Preclinical / Clinical

Type of Continuous Manufacturing related Service
API Manufacturing
End Product manufacturing

Type of Drug Molecule
Biologic
Small Molecule

Type of dosage form
Solid
Liquid

Key Geographical Regions
North America
Europe
Asia Pacific

The Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030 report features the following companies, which we identified to be key players in this domain:

AbbVie Contract Manufacturing
Ajinomoto Bio-Pharma Services
Almac
Boehringer Ingelheim BioXcellence
Cambrex
CordonPharma
Hovione
Kaneka
Lonza
Patheon
SK biotek

Table of Contents

Preface

2. Executive Summary
Introduction
Market Landscape
Companies with Expertise in Continuous Manufacturing in North America: Profiles
Companies with Expertise in Continuous Manufacturing in Europe: Profiles
Companies with Expertise in Continuous Manufacturing in Asia-Pacific: Profiles
Recent Partnerships and Collaborations
Recent Expansions
Capacity Analysis
Academic Grant Analysis
Patent Analysis
Initiatives of Companies with In-House Continuous Manufacturing Capabilities
Case Study: Modular Facilities in pharmaceutical / Biotechnological Industry

Case Study: Technology and Equipment Providers

Case Study: Roadmap for the Adoption of Continuous Manufacturing Processes

Market Forecast and Opportunity Analysis

Conclusion

Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/continuous-manufacturing/308.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The continuous manufacturing market is projected to grow at an annualized rate of over 15%, till 2030

Submitted 2 day(s) ago by Harry sins

Roots Analysis has done a detailed study on Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030, covering key aspects of the industry and identifying future growth opportunities.

To order this 310+ page report, which features 110+ figures and 200+ tables, please visit this link

Key Market Insights

Eminent representatives from prominent contract service provider companies / organizations are both optimistic and cautious regarding the rising interest in continuous flow technologies, and its adoption
Over 60 companies across the globe claim to manufacture drug products / drug substances using the continuous manufacturing technique, either for in-house requirements or for contract service engagements
The market landscape features the presence of several well-established players, most of which claim to manufacture small molecules via the continuous technique, and are based in the developed geographies
Companies have established continuous drug manufacturing facilities for diverse types of dosage forms in various geographies; Europe and North America have emerged as the key hubs for these facilities
Several patents have been filed / granted specifically related to continuous manufacturing of pharmaceutical substances, both industry and non-industry players are actively involved in such efforts
Organizations have also extended financial support to aid the research efforts being put by various stakeholders in this domain; the current focus is on investigation of continuous manufacturing technologies
Over time, there has been a lot of activity in this arena, including the establishment of several partnerships and investments in capability and capacity expansions and new facilities worldwide
Most of the continuous manufacturing capacity belongs to established companies (in-house manufacturers and CMOs), accounting for over 70% of the available capacity across various geographies
Involvement of various other stakeholders including continuous equipment providers and modular facility providers is likely to revolutionize the overall manufacturing domain
As the adoption of continuous manufacturing technologies increases, the market is likely to witness significant growth; in the short term, majority of service-based revenues is likely to come from drug product related projects

For more information, please visit https://www.rootsanalysis.com/reports/view_document/continuous-manufacturing/308.html

Table of Contents

TABLE OF CONTENTS

PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

EXECUTIVE SUMMARY

INTRODUCTION

3.1. Chapter Overview

3.2. Historical Evolution of Continuous Manufacturing

3.3. Continuous Manufacturing in the Pharmaceutical Industry

3.3.1. Regulatory Landscape

3.3.2. Early Adopters of Continuous Manufacturing

3.3.3. Anticipated Shift to Continuous Manufacturing

3.3.4. Advantages of Continuous Manufacturing

3.3.5. Key Challenges Associated with Continuous Manufacturing

3.3.6. Future Perspectives

MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Companies with Expertise in Continuous Manufacturing: Overall Market Landscape

4.2.1. Analysis by Year of Establishment

4.2.2. Analysis by Company Size

4.2.3. Analysis by Purpose of Manufacturing

4.2.4. Analysis by Scale of Operation

4.2.5. Analysis by Location of Headquarters

4.2.6. Analysis by Location of Continuous Manufacturing Facilities

4.2.7. Analysis by Type of Drug Molecule

4.2.8. Analysis by Type of Continuous Manufacturing Related Service

4.2.9. Analysis by Type of Dosage Form

4.2.10. Heat Map: Analysis by Company Size and Location of Headquarters

4.2.11. Information on Production Capacity

4.2.12. Logo Landscape: Analysis by Year of Establishment and Company Size

4.2.13. Grid Representation: Analysis by Scale of Operation, Type of Continuous Manufacturing Related Service and Type of Dosage Form

4.2.14. Geographical Map: Analysis by Location of Continuous Manufacturing Facilities and Type of Drug Molecule

COMPANIES WITH EXPERTISE IN CONTINUOUS MANUFACTURING IN NORTH AMERICA: PROFILES

5.1. Chapter Overview

5.2. AbbVie Contract Manufacturing

5.2.1. Company Overview

5.2.2. Service Portfolio

5.2.3. Continuous Manufacturing Capabilities and Facilities

5.2.4. Recent Developments and Future Outlook

5.3. Cambrex

5.3.1. Company Overview

5.3.2. Service Portfolio

5.3.3. Continuous Manufacturing Capabilities and Facilities

5.3.4. Recent Developments and Future Outlook

5.4. Patheon

5.4.1. Company Overview

5.4.2. Service Portfolio

5.4.3. Continuous Manufacturing Capabilities and Facilities

5.4.4. Recent Developments and Future Outlook

5.5. SK biotek

5.5.1. Company Overview

5.5.2. Service Portfolio

5.5.3. Continuous Manufacturing Capabilities and Facilities

5.5.4. Recent Developments and Future Outlook

COMPANIES WITH EXPERTISE IN CONTINUOUS MANUFACTURING IN EUROPE: PROFILES

6.1. Chapter Overview

6.2. Ajinomoto Bio-Pharma Services

6.2.1. Company Overview

6.2.2. Service Portfolio

6.2.3. Continuous Manufacturing Capabilities and Facilities

6.2.4. Recent Developments and Future Outlook

6.3. Almac

6.3.1. Company Overview

6.3.2. Service Portfolio

6.3.3. Continuous Manufacturing Capabilities and Facilities

6.3.4. Recent Developments and Future Outlook

6.4. Boehringer Ingelheim BioXcellence™

6.4.1. Company Overview

6.4.2. Service Portfolio

6.4.3. Continuous Manufacturing Capabilities and Facilities

6.4.4. Recent Developments and Future Outlook

6.5. CordonPharma

6.5.1. Company Overview

6.5.2. Service Portfolio

6.5.3. Continuous Manufacturing Capabilities and Facilities

6.5.4. Recent Developments and Future Outlook

6.6. Hovione

6.6.1. Company Overview

6.6.2. Service Portfolio

6.6.3. Continuous Manufacturing Capabilities and Facilities

6.6.4. Recent Developments and Future Outlook

6.7. Lonza

6.7.1. Company Overview

6.7.2. Service Portfolio

6.7.3. Continuous Manufacturing Capabilities and Facilities

6.7.4. Recent Developments and Future Outlook

COMPANIES WITH EXPERTISE IN CONTINUOUS MANUFACTURING IN ASIA-PACIFIC: PROFILES

7.1. Chapter Overview

7.2. Kaneka

7.2.1. Company Overview

7.2.2. Service Portfolio

7.2.3. Continuous Manufacturing Capabilities and Facilities

7.2.4. Recent Developments and Future Outlook

7.3. WuXi AppTec

7.3.1. Company Overview

7.3.2. Service Portfolio

7.3.3. Continuous Manufacturing Capabilities and Facilities

7.3.4. Recent Developments and Future Outlook

RECENT PARTNERSHIPS AND COLLABORATIONS

8.1. Chapter Overview

8.2. Partnership Models

8.3. List of Partnerships and Collaborations

8.3.1. Analysis by Year of Partnership

8.3.2. Analysis by Type of Partnership

8.3.3. Analysis by Scale of Operation

8.3.4. Analysis by Type of Drug Molecule

8.3.5. Analysis by Type of Continuous Manufacturing Related Service

8.3.6. Analysis by Type of Dosage Form

8.3.7. Most Active Players: Analysis by Number of Partnerships

8.3.8. Regional Analysis

8.3.8.1. Intercontinental and Intracontinental Agreements

RECENT EXPANSIONS

9.1. Chapter Overview

9.2. Recent Expansions

9.2.1. Analysis by Year of Expansion

9.2.2. Analysis by Type of Expansion

9.2.3. Analysis by Expanded Scale of Expansion

9.2.4. Analysis by Type of Drug Molecule

9.2.5. Analysis by Type of Continuous Manufacturing Related Service

9.2.6. Analysis by Type of Dosage Form

9.2.7. Most Active Players: Analysis by Number of Expansions

9.2.8. Regional Analysis

9.2.8.1. Analysis by Location of Expansion Project

CAPACITY ANALYSIS

10.1. Chapter Overview

10.2. Assumptions and Methodology

10.3. Global, Continuous Manufacturing Capacity for Small Molecule APIs

10.3.1. Analysis by Company Size

10.3.2. Analysis by Purpose of Manufacturing

10.3.3. Analysis by Scale of Operation

10.3.4. Analysis by Location of Headquarters

10.3.4. Analysis by Location of Continuous Manufacturing Facilities

10.4. Global, Continuous Manufacturing Capacity for Small Molecule End Products

10.4.1. Analysis by Company Size

10.4.2. Analysis by Purpose of Manufacturing

10.4.3. Analysis by Scale of Operation

10.4.4. Analysis by Location of Headquarters

10.4.5. Analysis by Location of Continuous Manufacturing Facilities

10.5. Global, Continuous Manufacturing Capacity for Biologic

10.5.1. Analysis by Company Size

10.5.2. Analysis by Purpose of Manufacturing

10.5.3. Analysis by Scale of Operation

10.5.4. Analysis by Location of Headquarters

10.5.5. Analysis by Location of Continuous Manufacturing Facilities

ACADEMIC GRANT ANALYSIS

11.1. Chapter Overview

11.2. Scope and Methodology

11.3. Continuous Manufacturing: List of Academic Grants

11.3.1. Analysis by Number of Grants

11.3.2. Analysis by Activity Code

11.3.3. Analysis by Grant Amount

11.3.4. Analysis by Focus Area

11.3.5. Analysis by Support Period

11.3.6 Popular Recipient Organizations: Analysis by Number of Grants

11.3.7 Analysis by Type of Recipient Organization

11.3.8. Analysis by Funding Institute Centre

11.3.9. Analysis by Funding Mechanism

11.3.10. Prominent Program Officers: Analysis by Number of Grants

PATENT ANALYSIS

12.1. Chapter Overview

12.2. Scope and Methodology

12.3. Continuous Manufacturing: Patent Analysis

12.3.1. Analysis by Publication Year

12.3.2. Analysis by Geography

12.3.3. Analysis by CPC Symbols

12.3.4. Emerging Focus Areas

12.3.5. Analysis by Type of Applicant

12.3.6. Leading Players: Analysis by Number of Patents

12.3.7. Continuous Manufacturing: Three-Dimensional Bubble Analysis

12.3.8. Continuous Manufacturing: Patent Valuation Analysis

12.3.8.1. Leading Patents: Information by Number of Citations

INITIATIVES OF COMPANIES WITH IN-HOUSE CONTINUOUS MANUFACTURING CAPABILITIES

13.1. Chapter Overview

13.2. Continuous Manufacturing Initiatives of Leading Companies

13.2.1. AbbVie

13.2.1.1. Partnered Initiatives

13.2.1.2 In-House Initiatives

13.2.2. Amgen

13.2.2.1. Partnered Initiatives

13.2.2.2. In-House Initiatives

13.2.3. Bristol-Myers Squibb

13.2.3.1. Partnered Initiatives

13.2.3.2. In-House Initiatives

13.2.4. GlaxoSmithKline

13.2.4.1. Partnered Initiatives

13.2.4.2. In-House Initiatives

13.2.5. Merck

13.2.5.1. Partnered Initiatives

13.2.5.2. In-House Initiatives

13.2.6. Novartis

13.2.6.1. Partnered Initiatives

13.2.6.2. In-House Initiatives

13.2.7. Pfizer

13.2.7.1. Partnered Initiatives

13.2.7.2. In-House Initiatives

13.2.8. Roche

13.2.8.1. Partnered Initiatives

13.2.8.2. In-House Initiatives

13.2.9. Sanofi

13.2.9.1. Partnered Initiatives

13.2.9.2. In-House Initiatives

CASE STUDY: MODULAR FACILITIES IN PHARMACEUTICAL / BIOTECHNOLOGY INDUSTRY

14.1. Chapter Overview

14.2. Historical Background

14.3. Concept of Modularization

14.3.1. Types of Modules

14.3.2. Modular Construction Process

14.4. Modular Construction in the Pharmaceutical Industry

14.4.1. Advantages of Modular Construction in the Pharmaceutical Industry

14.5. Modular Facility Manufacturers

14.5.1. Distribution by Industry Served

14.5.2. Distribution by Geography

14.5.3. Modular Projects Executed / Undertaken

14.6. Modular Pharmaceutical Cleanrooms

14.6.1. Cleanroom Classification and Current Standards

14.6.2. Advantages of Modular Cleanrooms

14.6.3. Regulations and Standards Concerning Modular Cleanroom Construction

14.7. Modular Cleanroom Providers

14.7.1. Distribution by Industry Served

14.7.2. Distribution by Geography

14.7.3. Type of Modular Cleanrooms Offered

CASE STUDY: TECHNOLOGY AND EQUIPMENT PROVIDERS

15.1. Chapter Overview

15.2. Types of Continuous Manufacturing Technologies

15.3. Equipment and Technologies for Continuous Manufacturing Small Molecules and Biologics

15.3.1. Continuous Blending and Mixing Equipment

15.3.2. Continuous Granulating Equipment

15.3.3. Continuous Drying Equipment

15.3.4. Continuous Compression Equipment

15.3.5. Continuous Coating Equipment

15.3.6. Continuous Filtration, Continuous Distillation and Continuous Centrifugation Equipment

15.3.7. Continuous Chromatography Equipment

15.3.8. Continuous Reactors / Bioreactors

15.3.9. Full Line Continuous Platforms

15.3.10. Process Analytical Technologies

15.3.11. Other Technologies

15.4. Logo Landscape: Analysis of Technology Providers by Number and Type of Equipment

CASE STUDY: ROADMAP FOR THE ADOPTION OF CONTINUOUS MANUFACTURING PROCESSES

16.1. Chapter Overview

16.2. Key Strategies for the Adoption of Continuous Manufacturing Processes

16.2. 1. Phase I: Process Development and Implementation

16.2. 2. Phase II: Equipment / Technology Development and Installation

16.2. 3. Phase III: Facility / Plant Development and Establishment

16.2. 4. Phase IV: Product Development and Manufacturing

MARKET FORECAST AND OPPORTUNITY ANALYSIS

17.1. Chapter Overview

17.2. Forecast Methodology and Key Assumptions

17.3. Overall, Continuous Manufacturing Market, 2020-2030

17.3.1. Continuous Manufacturing Market: Distribution by Purpose of Manufacturing, 2020-2030

17.3.2. Continuous Manufacturing Market: Distribution by Scale of Operation, 2020-2030

17.3.3. Continuous Manufacturing Market: Distribution by Type of Drug Molecule, 2020-2030

17.3.4. Continuous Manufacturing Market: Distribution by Type of Continuous Manufacturing Related Service, 2020-2030

17.3.5. Continuous Manufacturing Market: Distribution by Type of Dosage Form, 2020-2030

17.3.6. Continuous Manufacturing Market: Distribution by Key Geographical Regions, 2020-2030

17.4. Continuous Manufacturing Market for Small Molecule, 2020-2030

17.4.1. Distribution by Purpose of Manufacturing, 2020-2030

17.4.2. Distribution by Scale of Operation, 2020-2030

17.4.3. Distribution by Type of Continuous Manufacturing Related Service, 2020-2030

17.4.4. Distribution by Key Geographical Regions, 2020-2030

17.5. Continuous Manufacturing Market for Biologic, 2020-2030

17.5.1. Distribution by Purpose of Manufacturing, 2020-2030

17.5.2. Distribution by Scale of Operation, 2020-2030

17.5.3. Distribution by Type of Continuous Manufacturing Related Service, 2020-2030

17.5.4. Distribution by Key Geographical Regions, 2020-2030

CONCLUSION

18.1. Chapter Overview

18.2. Key Takeaways

EXECUTIVE INSIGHTS

19.1. Chapter Overview

19.2. Zaiput Flow Technologies

19.2.1. Company Snapshot

19.2.2. Interview Transcript: Andrea Adamo, Founder and Chief Executive Officer

19.3. CONTINUUS Pharmaceuticals

19.3.1. Company Snapshot

19.3.2. Interview Transcript: Bayan Takizawa, Co-Founder and Chief Business Officer

19.4. Snapdragon Chemistry

19.4.1. Company Snapshot

19.4.2. Interview Transcript: Eric Fang, Chief Scientific Officer

19.5. Enzene Biosciences

19.5.1. Company Snapshot

19.5.2. Interview Transcript: Himanshu Gadgil, Director and Chief Scientific Officer

19.6. Pfizer

19.6.1. Company Snapshot

19.6.2. Interview Transcript: Nick Thomson, Senior Director Chemical Research and Development

19.7. University of Strathclyde

19.7.1. Company Snapshot

19.7.2. Interview Transcript: Ian Houson, Technical Project Manager

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The continuous manufacturing market is estimated to be worth around USD 2 billion in 2030, predicts Roots Analysis

Submitted 2 day(s) ago by Harry sins

Recent advances in the manufacturing technologies have prompted pharmaceutical companies to consider shifting from the traditional multi-step, batch manufacturing processes to faster, and relatively more efficient continuous manufacturing

Roots Analysis is pleased to announce the publication of its recent study, titled, “Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030.”

The report features an extensive study of the current market landscape and future opportunities for companies with capabilities in continuous manufacturing (both innovator companies with in-house expertise and contract manufacturers). It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes:

A detailed assessment of the overall landscape of companies with capabilities for continuous manufacturing
Elaborate profiles of some of the key contract manufacturers active in the pharmaceutical and biopharmaceutical continuous manufacturing market
An analysis of the various partnerships related to continuous manufacturing, which have been established since 2013
An analysis of the expansions related to continuous manufacturing, which have been established since 2013
An estimate of the global, continuous manufacturing capacity, based on the capacities of various industry stakeholders (as available on their respective company websites).
A study of the various grants that have been awarded to research institutes engaged in projects related to continuous manufacturing, between 2014 and 2019
An in-depth analysis of the various patents that have been filed / granted related to continuous manufacturing till 2019
Initiatives taken by the leading pharmaceutical companies (in terms of revenues), covering both partnered as well as in-house projects.
A review of the companies offering modular facilities / modular cleanrooms
A case study of the companies offering technologies / equipment
A case study on the roadmap for the adoption of continuous manufacturing technique
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Purpose of Manufacturing
In-House
Contract service
Scale of Operation
Commercial
Preclinical / Clinical
Type of Continuous Manufacturing related Service
API Manufacturing
End Product manufacturing
Type of Drug Molecule
Biologic
Small Molecule
Type of dosage form
Solid
Liquid
Key Geographical Regions
North America
Europe
Asia Pacific

Transcripts of interviews held with the following senior level representatives of stakeholder companies
Andrea Adamo, Founder and Chief Executive Officer, Zaiput Flow technologies
Bayan Takizawa, Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals
Nick Thomson, Senior Director Chemical Research and Development, Pfizer
Himanshu Gadgil, Director and Chief Scientific Officer, Enzene Biosciences
Eric Fang, Chief Scientific Officer, Snapdragon Chemistry)
Ian Houson, Technical Project Manager, Continuous Manufacturing and Crystallization, University of Strathclyde

Key companies covered in the report

AbbVie Contract Manufacturing
Ajinomoto Bio-Pharma Services
Almac
Boehringer Ingelheim BioXcellence
Cambrex
CordonPharma
Hovione
Kaneka
Lonza
Patheon
SK biotek
WuXi AppTec

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/continuous-manufacturing/308.html

Other Offerings

Pharmaceutical Contract Manufacturing Market (2nd Edition), 2018-2028
Biopharma Contract Manufacturing Market (3rd Edition), 2019 - 2030
China Pharmaceutical Contract Manufacturing Services Market, 2020-2030
China Biopharmaceutical Contract Manufacturing Market, 2020 - 2030

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The “China Pharmaceutical Contract Manufacturing Services Market, 2020-2030” report features an extensive study of the current market landscape and future opportunities associated with the pharmaceutical contract manufacturing market in China

Submitted 3 day(s) ago by Harry sins

Key Inclusions

A review of the current market landscape of companies offering pharmaceutical contract manufacturing services in China, along with information on year of establishment, company size, location of headquarters, type of product (active pharmaceutical ingredients (APIs), intermediates and finished dosage formulations (FDFs)), type of FDFs, type of packaging and number of manufacturing facilities.
A detailed landscape of the pharmaceutical manufacturing facilities in China, including an analysis based on location of these facilities, highlighting key manufacturing hubs.
A brief discussion of various guidelines laid down by regulatory authorities in China for the manufacturing of pharmaceuticals. It also provides information on various challenges, related to regulatory scrutiny, faced by pharmaceutical manufacturers in China.
Elaborate profiles of key players that offer a diverse range of capabilities for the manufacturing of pharmaceutical products in China. Each profile includes an overview of the company, information related to its pharmaceutical manufacturing service portfolio, details related to its manufacturing facilities, recent developments, and an informed future outlook.
A review of the pharmaceutical manufacturing related initiatives of the top 10 big pharma players (shortlisted from the top companies of 2019 by revenues), featuring a [A] analysis by investments made, with detailed information on investments related to R&D centers and manufacturing facilities in established and emerging regions of China, [B] Harvey ball framework, presenting a summary of all initiatives
A case study of the key recent developments (including partnerships and acquisitions) pertaining to the manufacturing of pharmaceutical drugs, during 2014-2020 (till February), based on several parameters, such as year of partnership, type of partnership and geography.
A detailed capacity analysis based on the individual reactor capacities of various industry stakeholders, taking into consideration parameters, such as company size (small-sized, mid-sized, large and very large), and location of the manufacturing facility (Eastern China, Southern China and Northern China).
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field. It also includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Key Geographical Regions

Eastern China
Southern China
Northern China

Type of Product

Active Pharmaceutical Ingredients (APIs)
Drug Products

Type of Drug Product

Solid
Liquid / Semi-Solid
Injectable
Others

Scale of Operation

Clinical
Commercial

Company Size

Small
Mid-Sized
Large / Very Large

To request sample pages, please visit this link

Key Questions Answered

Who are the leading China-based pharmaceutical CMOs engaged in the production of APIs, intermediates and FDFs?
What are the key manufacturing hubs within China (in terms of number of manufacturing facilities)?
What is the current installed capacity for manufacturing of pharmaceuticals, in China?
What are the major market trends and driving factors that are likely to impact the growth of the pharmaceutical manufacturing market in China?
What is the likely short-term and long-term impact of the COVID-19 pandemic on the pharmaceutical contract manufacturing industry in China?
What kind of initiatives are being undertaken by big pharmaceutical players for pharmaceutical manufacturing in China?
How is the current and future market opportunity likely to be distributed across key market segments?

You may also be interested in the following titles:

Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Presently, over 100 CMOs across the globe claim to have manufacturing facilities in China, offering services for pharmaceutical API, intermediates and FDF manufacturing, claims Roots Analysis

Submitted 3 day(s) ago by Harry sins

A growing economy, large population base, and innovation-friendly environment are other key parameters that are anticipated to drive the growth of the pharmaceutical contract manufacturing market in China. Further, in order to meet the growing demand for their services, CMOs having manufacturing facilities in China are actively expanding their existing capacities and capabilities in the region.

To order this 200+ page report, which features 85+ figures and 100+ tables, please visit this link

The USD 13 billion (by 2030) financial opportunity within the pharmaceuticals contract manufacturing market in China has been analyzed across the following segments:

Key Geographical Regions

Eastern China
Southern China
Northern China

Type of Product

Active Pharmaceutical Ingredients (APIs)
Drug Products

Type of Drug Product

Solid
Liquid / Semi-Solid
Injectable
Others

Scale of Operation

Clinical
Commercial

Company Size

Small
Mid-Sized
Large / Very Large

The China Pharmaceutical Contract Manufacturing Services Market, 2020-2030 report features the following companies, which we identified to be key players in this domain:

2Y-Chem
Aurisco Pharmaceutical
ChemPartner
Dorrapharma
Hubei Biocause Pharmaceutical
Infoark
Ningbo Menovo Pharmaceutical
Shandong Xinhua Pharmaceutical
Shanghai Acebright Pharmaceuticals
STA Pharmaceutical
Zhejiang Huahai Pharmaceutical

Table of Contents

Preface

2. Executive Summary
Introduction
Case Study: Comparison of Small Molecules and Large Molecules
Market Overview
Manufacturing Facilities of Pharmaceutical CMOs in China
Pharmaceutical Manufacturing Regulations in China
Company Profiles
Big Pharma Initiatives in China
Recent Trends
Capacity Analysis
SWOT Analysis
Market Forecast

Case Study: Impact of Coronavirus Outbreak
Conclusion

Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/china-pharmaceutical-contract-manufacturing/312.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The contract manufacturing market for Pharmaceuticals in China is projected to grow at an annualized rate of ~8.9%, till 2030

Submitted 3 day(s) ago by Harry sins

Roots Analysis has done a detailed study on China Pharmaceutical Contract Manufacturing Services Market, 2020-2030, covering key aspects of the industry and identifying key future growth opportunities.

To order this 200+ page report, which features 85+ figures and 100+ tables, please visit this link

Key Market Insights

Presently, over 100 CMOs across the globe claim to have manufacturing facilities in China, offering services for pharmaceutical API, intermediates and FDF manufacturing
CMOs have established manufacturing facilities across different regions of China; Eastern China has emerged as a popular hub, serving as a base of operations for many contract service providers
The current, installed manufacturing capacity of pharmaceutical CMOs in China is estimated to be over 46 million liters; interestingly, capacity utilization has been observed to be ~75% over the last few years
Big pharma players have also invested significantly in this region for initiatives related to the establishment or expansion of R&D centers and manufacturing facilities focused on pharmaceutical products
Innovator companies are expected to continue outsourcing clinical and commercial manufacturing operations to China-based CMOs; the contract services industry in the region is likely to grow at a CAGR of ~8.9%
In the long-term, the projected future opportunity is anticipated to be well distributed across various market segments, such as different types of products (APIs and FDFs), region (eastern china, southern china, western china) and others

For more information, please visit https://www.rootsanalysis.com/reports/view_document/china-pharmaceutical-contract-manufacturing/312.html

Table of Contents

PREFACE
1.1. Scope of the Report
1.2.                  Research Methodology
1.3.                  Chapter Outlines

2.                     EXECUTIVE SUMMARY
INTRODUCTION
3.1. Chapter Overview
3.2.                  Need for Outsourcing in the Pharmaceutical Industry
3.3.                  Overview of the Pharmaceutical Contract Manufacturing
3.4.                  Evolution of the Pharmaceutical Contract Manufacturing Industry
3.4.1.               Traditional Contract Manufacturing Organizations (CMOs)

3.4.2.               Modern CMOs
3.5.                  Services Offered by CMOs
3.6.                  Pharmaceutical Contract Manufacturing Scenario in China

3.7. Advantages and Challenges associated with Outsourcing Pharmaceutical Manufacturing to China-based CMOs

CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES
4.1. Chapter Overview
4.2. Small Molecule and Large Molecule Drugs / Therapies

4.2.1.                Comparison of General Characteristics
4.2.2.                Comparison of Manufacturing Processes
4.2.3.                Comparison of Key Manufacturing-related Challenges

MARKET OVERVIEW
5.1. Chapter Overview
5.2. Chinese Pharmaceutical CMOs with Manufacturing Facilities in China: List of Companies

5.2.1.                Analysis by Year of Establishment
5.2.2.                Analysis by Company Size
5.2.3.                Analysis by Location of Headquarters

5.2.4.                Analysis by Type of Product (API and FDF)
5.2.5.                Analysis by Type of FDF
5.2.6.                Analysis by Type of Packaging

5.2.7. Analysis by Manufacturing Facilities

5.3. Non-Chinese Pharmaceutical CMOs with Manufacturing Facilities in China: List of Companies

5.3.1. Analysis by Year of Establishment

5.3.2. Analysis by Company Size

5.3.3. Analysis by Location of Headquarters

5.3.4. Analysis by Type of Product (API and FDF)

5.3.5. Analysis by Type of FDF

5.3.6. Analysis by Type of Packaging

5.3.7 Analysis by Manufacturing Facilities

MANUFACTURING FACILITIES OF PHARMACEUTICAL CMOs IN CHINA
6.1.                  Chapter Overview
6.2.                  Chinese Pharmaceutical CMOs: List of Manufacturing Facilities

6.2.1.                Analysis by CMO Manufacturing Facilities in Eastern China
6.2.2.                Analysis by CMO Manufacturing Facilities in Southern China
6.2.3.                Analysis by CMO Manufacturing Facilities in Northern China
PHARMACEUTICAL MANUFACTURING REGULATIONS IN CHINA

7.1. Chapter Overview

7.1.1. Health Authorities in China

7.1.2. Overview of Regulatory Guidelines in China

COMPANY PROFILES

8.1. Chapter Overview

8.2. 2Y-Chem

8.2.1. Company Overview

8.2.2. Service Portfolio

8.2.3. China-based Manufacturing Facilities and Capabilities

8.2.4. Recent Developments and Future Outlook

8.3. Aurisco Pharmaceutical

8.3.1. Company Overview

8.3.2. Service Portfolio

8.3.3. China-based Manufacturing Facilities and Capabilities

8.3.4. Recent Developments and Future Outlook

8.4. ChemPartner

8.4.1. Company Overview

8.4.2. Service Portfolio

8.4.3. China-based Manufacturing Facilities and Capabilities

8.4.4. Recent Developments and Future Outlook

8.5. Dorrapharma

8.5.1. Company Overview

8.5.2. Service Portfolio

8.5.3. China-based Manufacturing Facilities and Capabilities

8.5.4. Recent Developments and Future Outlook

8.6. Hubei Biocause Pharmaceutical

8.6.1. Company Overview

8.6.2. Service Portfolio

8.6.3. China-based Manufacturing Facilities and Capabilities

8.6.4. Recent Developments and Future Outlook

8.7. Infoark

8.7.1. Company Overview

8.7.2. Service Portfolio

8.7.3. China-based Manufacturing Facilities and Capabilities

8.7.4. Recent Developments and Future Outlook

8.8. Ningbo Menovo Pharmaceutical

8.8.1. Company Overview

8.8.2. Service Portfolio

8.8.3. China-based Manufacturing Facilities and Capabilities

8.8.4. Recent Developments and Future Outlook

8.9. Shandong Xinhua Pharmaceutical

8.9.1. Company Overview

8.9.2. Service Portfolio

8.9.3. China-based Manufacturing Facilities and Capabilities

8.9.4. Recent Developments and Future Outlook

8.10. Shanghai Acebright Pharmaceuticals

8.10.1. Company Overview

8.10.2. Service Portfolio

8.10.3. China-based Manufacturing Facilities and Capabilities

8.10.4. Recent Developments and Future Outlook

8.11. STA Pharmaceutical

8.11.1. Company Overview

8.11.2. Service Portfolio

8.11.3. China-based Manufacturing Facilities and Capabilities

8.11.4. Recent Developments and Future Outlook

8.12. Zhejiang Huahai Pharmaceutical

8.12.1. Company Overview

8.12.2. Service Portfolio

8.12.3. China-based Manufacturing Facilities and Capabilities

8.12.4. Recent Developments and Future Outlook

BIG PHARMA INITIATIVES IN CHINA

9.1. Chapter Overview

9.2. Big Pharma Players: List of Initiatives

9.2.1. Analysis by Number of Initiatives

9.2.2. Analysis by Year of Initiative

9.2.3. Analysis by Company and Year of Initiative

9.2.4. Analysis by Type of Initiative

9.3. Benchmark Analysis of Big Pharma Players

9.3.1. Harvey Ball Analysis: Summary of Investments Made

9.3.2. Geographical Analysis by Investments Made (Facility Specific)

RECENT TRENDS

10.1. Chapter Overview

10.2. CMOs with Manufacturing Facilities in China: List of Partnerships

10.3. Analysis by Year and Type of Partnership

10.4. Logo Landscape of Key Partners

10.5. Geographical Analysis

CAPACITY ANALYSIS

11.1. Chapter Overview

11.2. Key Assumptions and Methodology

11.3. CMOs with Manufacturing Facilities in China: Installed Capacity

11.3.1. Analysis by Company Size

11.3.2. Analysis by Location of Chinese Manufacturing Facilities

11.3.2.1. Capacity Analysis: Eastern China

11.3.2.2. Capacity Analysis: Southcentral China

11.3.2.3. Capacity Analysis: Northern China

SWOT ANALYSIS

12.1. Chapter Overview

12.2. Comparison of SWOT Factors

12.3. Concluding Remarks

MARKET FORECAST

13.1. Chapter Overview

13.2. Forecast Methodology and Key Assumptions

13.3. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030

13.4. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Distribution by Geography

13.4.1. Pharmaceutical Contract Manufacturing Services Market in Eastern China, 2020-2030

13.4.2. Pharmaceutical Contract Manufacturing Services Market in Southern China, 2020-2030

13.4.3. Pharmaceutical Contract Manufacturing Services Market in Northern China, 2020-2030

13.5. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Distribution by Type of Product

13.5.1. API Contract Manufacturing Services Market in China, 2020-2030

13.5.1.1. API Contract Manufacturing Services Market in China, 2020-2030: Distribution by Geography

13.5.1.1.1. API Contract Manufacturing Services Market in Eastern China, 2020-2030

13.5.1.1.2. API Contract Manufacturing Services Market in Southern China, 2020-2030

13.5.1.1.3. API Contract Manufacturing Services Market in Northern China, 2020-2030

13.5.2. Drug Product Contract Manufacturing Services Market in China, 2020-2030

13.5.2.1. Drug Product Contract Manufacturing Services Market in China, 2020-2030: Distribution by Geography

13.5.2.1.1. Drug Product Contract Manufacturing Services Market in Eastern China, 2020-2030

13.5.2.1.2. Drug Product Contract Manufacturing Services Market in Southern China, 2020-2030

13.5.2.1.3. Drug Product Contract Manufacturing Services Market in Northern China, 2020-2030

13.5.2.2. Drug Product Contract Manufacturing Services Market in China, 2020-2030: Distribution by Type of Drug Product

13.5.2.2.1. Drug Product Contract Manufacturing Services Market in China, 2020-2030: Share of Solid Drug Product

13.5.2.2.2. Drug Product Contract Manufacturing Services Market in China, 2020-2030: Share of Liquid and Semi Solid Drug Product

13.5.2.2.3. Drug Product Contract Manufacturing Services Market in China, 2020-2030: Share of Injectable Drug Product

13.5.2.2.4. Drug product Contract Manufacturing Services Market in China, 2020-2030: Share of Other Drug Products

13.6. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Distribution by Scale of Operation

13.6.1. Clinical Scale Contract Manufacturing Services Market in China, 2020-2030

13.6.2. Commercial Scale Contract Manufacturing Services Market in China, 2020-2030

13.7. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Distribution by Size of Manufacturers

13.7.1. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Share of Small Companies

13.7.2. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Share of Mid-sized Companies

13.7.3. Pharmaceutical Contract Manufacturing Services Market in China, 2020-2030: Share of Large / Very Large Companies

CASE STUDY: IMPACT OF CORONAVIRUS OUTBREAK

14.1. Chapter Overview

14.2. Current Opinions and Recuperative Initiatives of Key Players

14.2.1. Wuxi AppTec

14.2.2. Porton Pharma Solutions

14.2.3. Lonza

14.3. Impact on Future Market Opportunity for Pharmaceutical CMOs in China

CONCLUSION

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The contract manufacturing market for Pharmaceuticals in China is estimated to be worth USD 13 billion in 2030, predicts Roots Analysis

Submitted 3 day(s) ago by Harry sins

Owing to reasons, such as a booming economy and availability of skilled labor, outsourcing to Asian CMOs, primar

Owing to reasons, such as a booming economy and availability of skilled labor, outsourcing to Asian CMOs, primarily in China, is considered an attractive business model to pharmaceutical developers / sponsors, across the world

Roots Analysis is pleased to announce the publication of its recent study, titled, “China Pharmaceutical Contract Manufacturing Services Market, 2020-2030.”

The report features an extensive study of the current market landscape and future opportunities associated with the pharmaceutical contract manufacturing market in China. The study also features a detailed analysis, highlighting the capabilities of pharmaceutical CMOs in this region. Amongst other elements, the report features:

A detailed assessment of the current market landscape of pharmaceutical contract manufacturers in China engaged in the development of active pharmaceutical ingredients (APIs), intermediates and finished dosage formulations (FDFs).
A detailed landscape of the pharmaceutical manufacturing facilities in China, including an analysis based on location of these facilities, highlighting key manufacturing hubs.
A brief discussion of various regulatory guidelines in China and various challenges, related to regulatory scrutiny, faced by pharmaceutical manufacturers in China.
Detailed profiles of key players that offer a diverse range of capabilities for the manufacturing of pharmaceutical products in China.
A review of the pharmaceutical manufacturing related initiatives of the top 10 big pharma players (shortlisted from the top companies of 2019 by revenues).
An analysis of the partnerships and acquisitions that have been established in this domain, in the recent past.
A detailed capacity analysis based on the installed reactor capacities of the manufacturing facilities in China.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Key Geographical Regions

Eastern China
Southern China
Northern China

Type of Product

Active Pharmaceutical Ingredients (APIs)
Drug Products

Type of Drug Product

Solid
Liquid / Semi-Solid
Injectable
Others

Scale of Operation

Clinical
Commercial

Company Size

Small
Mid-Sized
Large / Very Large

Key players covered in the report

2Y-Chem
Aurisco Pharmaceutical
ChemPartner
Dorrapharma
Hubei Biocause Pharmaceutical
Infoark
Ningbo Menovo Pharmaceutical
Shandong Xinhua Pharmaceutical
Shanghai Acebright Pharmaceuticals
STA Pharmaceutical
Zhejiang Huahai Pharmaceutical

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/china-pharmaceutical-contract-manufacturing/312.html

Other Recent Offerings

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

ily in China, is considered an attractive business model to pharmaceutical developers / sponsors, across the world

Roots Analysis is pleased to announce the publication of its recent study, titled, “China Pharmaceutical Contract Manufacturing Services Market, 2020-2030.”

The report features an extensive study of the current market landscape and future opportunities associated with the pharmaceutical contract manufacturing market in China. The study also features a detailed analysis, highlighting the capabilities of pharmaceutical CMOs in this region. Amongst other elements, the report features:

A detailed assessment of the current market landscape of pharmaceutical contract manufacturers in China engaged in the development of active pharmaceutical ingredients (APIs), intermediates and finished dosage formulations (FDFs).
A detailed landscape of the pharmaceutical manufacturing facilities in China, including an analysis based on location of these facilities, highlighting key manufacturing hubs.
A brief discussion of various regulatory guidelines in China and various challenges, related to regulatory scrutiny, faced by pharmaceutical manufacturers in China.
Detailed profiles of key players that offer a diverse range of capabilities for the manufacturing of pharmaceutical products in China.
A review of the pharmaceutical manufacturing related initiatives of the top 10 big pharma players (shortlisted from the top companies of 2019 by revenues).
An analysis of the partnerships and acquisitions that have been established in this domain, in the recent past.
A detailed capacity analysis based on the installed reactor capacities of the manufacturing facilities in China.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Key Geographical Regions

Eastern China
Southern China
Northern China

Type of Product

Active Pharmaceutical Ingredients (APIs)
Drug Products

Type of Drug Product

Solid
Liquid / Semi-Solid
Injectable
Others

Scale of Operation

Clinical
Commercial

Company Size

Small
Mid-Sized
Large / Very Large

Key players covered in the report

2Y-Chem
Aurisco Pharmaceutical
ChemPartner
Dorrapharma
Hubei Biocause Pharmaceutical
Infoark
Ningbo Menovo Pharmaceutical
Shandong Xinhua Pharmaceutical
Shanghai Acebright Pharmaceuticals
STA Pharmaceutical
Zhejiang Huahai Pharmaceutical

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/china-pharmaceutical-contract-manufacturing/312.html

Other Recent Offerings

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The “China Biopharmaceutical Contract Manufacturing Market, 2020-2030” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of biopharmaceuticals in China.

Submitted 3 day(s) ago by Harry sins

To order this detailed 250+ page report, please visit this link

Key Inclusions

A detailed review of the overall landscape of companies offering contract manufacturing services for biopharmaceuticals in China, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number of manufacturing facilities, as well as location of these facilities, type of business segment, type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, stability studies, quality assurance and control, scale-up, downstream processing, regulatory support, data analytics and reporting, and others), type of biologic(s) manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression system(s) used (mammalian, microbial and others), type of bioreactor(s) used (single-use bioreactors and stainless steel bioreactors) and its mode of operation (batch, fed-batch and perfusion), type of packaging, and affiliations to regulatory accreditations and certifications (if any).
An analysis of the various partnerships pertaining to biopharmaceutical manufacturing in China, which have been established since 2016, based on several parameters, such as the year of partnership, type of partnership model adopted, scale of operation, type of biologic, focus area of the deal, target indication, most active players (in terms of number of partnerships signed), and geography.
An analysis of the various expansion initiatives undertaken by contract manufacturers in China, in order to augment their capabilities, over the period 2016-2020 (till February), taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation of manufacturing facility, type of biologic and location of manufacturing facility.
A clinical trial analysis of completed and active studies related to biopharmaceuticals that have been / are being / are likely to be conducted in China, based on trial registration year, trial phase, trial recruitment status, type of sponsor / collaborator, geography and number of patients enrolled.
An estimate of the overall, installed capacity for manufacturing biopharmaceuticals, based on data reported by industry stakeholders in the public domain; it highlights the distribution of available biopharmaceutical production capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), key geographical regions (China, Hong-Kong, Taiwan) and expression system used.
A review of recent initiatives undertaken by big pharma players in China for the manufacturing of biopharmaceuticals, highlighting trends across various parameters, such as number of initiatives, year of initiative, and benchmark analysis of big pharma players.
A qualitative analysis, highlighting the various factors that need to be taken into consideration by drug / therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biopharmaceutical products. Each profile features an overview of the company, its financial performance (if available), information on its service portfolio, details related to manufacturing capabilities and facilities, recent developments (partnerships and expansions), and an informed future outlook.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field. It also includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Type of Product

API
FDF

Type of Expression System Used

Mammalian
Microbial
Others

Scale of Operation

Preclinical / Clinical
Commercial

Size of Manufacturers

Small
Mid-sized
Large / Very Large

Type of Biologic

Antibody
Vaccine
Others

To request sample pages, please visit this link

Key Questions Answered

Who are the leading biopharmaceutical contract manufacturers in China?
What is the annual clinical demand for biopharmaceuticals in China?
What is the current installed capacity for manufacturing biopharmaceuticals in China?
What kind of partnership models are commonly adopted by stakeholders engaged in this domain?
What were the various expansion initiatives carried out by Chinese biopharmaceutical CMOs?
What were the different biopharmaceutical focused initiatives undertaken by big pharma players in the recent past, in China?
How is the current and future market opportunity likely to be distributed across key market segments?

You may also be interested in the following titles:

Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Over 35 CMOs / CDMOs in China claim to offer a variety of services related to development and manufacturing of a wide range of biotherapeutic products, claims Roots Analysis

Submitted 3 day(s) ago by Harry sins

Owing to benefits, such as reduced manufacturing costs, availability of cheap and skilled labor, and a supportive regulatory landscape, biopharmaceutical developers from across the globe, are increasingly outsourcing their manufacturing operations to China based CMOs. Further, in order to meet the growing demand for their services, Chinese CMOs are actively consolidating / expanding their capabilities through partnerships and / or dedicated expansion initiatives.

To order this 250+ page report, which features 100+ figures and 120+ tables, please visit this link

The USD 2.6 billion (by 2030) financial opportunity within the China biopharmaceutical contract manufacturing market has been analyzed across the following segments:

Type of Product

API
FDF

Type of Expression System Used

Mammalian
Microbial
Others

Scale of Operation

Preclinical / Clinical
Commercial

Size of Manufacturer

Small
Mid-sized
Large / Very Large

Type of Biologic

Antibody
Vaccine
Others

The China Biopharmaceutical Contract Manufacturing Market, 2020-2030 report features the following companies, which we identified to be key players in this domain:

ChemPartner Biologics
JHL Biotech
JOINN Biologics
MabPlex
Mycenax Biotech
WuXi AppTec

Table of Contents

Preface

2. Executive Summary
Introduction
Case Study: Comparison of Small Molecules and Large Molecules
Competitive Landscape
Company Profiles
Partnerships
Recent Expansions
Clinical Trial Analysis
Regional Capability Analysis
Capacity Analysis
Big Pharma Biopharmaceutical Manufacturing Initiatives in China
Make Versus Buy Decision Making Framework
Market Sizing and Opportunity Analysis

COVID-19 Impact on China Biopharmaceutical CMO Market

SWOT Analysis

Future of the China Biopharmaceutical CMO Market

Interview Transcripts

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/china-biopharmaceutical-contract-manufacturing/313.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The Chines biopharmaceutical contract manufacturing market is projected to grow at an annualized rate of ~13%, till 2030

Submitted 3 day(s) ago by Harry sins

Roots Analysis has done a detailed study on China Biopharmaceutical Contract Manufacturing Market, 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 250+ page report, which features 100+ figures and 120+ tables, please visit this link

Key Market Insights

Over 35 CMOs / CDMOs in China claim to offer a variety of services related to development and manufacturing of a wide range of biotherapeutic products
Several players provide one-stop solutions and are capable of operating at various scales; the landscape includes a mix of both established players and new entrants
In order to cater to the evolving needs of clients / sponsors, CMOs have established facilities across different regions of China; Eastern China, with the maximum number of sites, has emerged as a manufacturing hub
With over 80 deals inked in past five years, there has been a surge in the partnership activity within this domain; majority of these collaborations were signed for the development and manufacturing of antibody-based products
Big pharma players have also made significant investments in this region, including establishing new facilities, expanding existing R&D centers and growing manufacturing facilities, focused on biotherapeutics
We expect global biopharmaceutical developers to continue to outsource their manufacturing operations to China in the long term; we anticipate the CMO industry in the region to grow at an annualized rate of ~13%, till 2030

For more information, please visit https://www.rootsanalysis.com/reports/view_document/china-biopharmaceutical-contract-manufacturing/313.html

Table of Contents

PREFACE
1.1. Scope of the Report
1.2.      Research Methodology
1.3.      Chapter Outlines

2.         EXECUTIVE SUMMARY
INTRODUCTION
3.1. Chapter Overview

Overview of Biopharmaceuticals

3.3. Manufacturing of Biopharmaceuticals

3.3.1. Types of Expression Systems Used

3.3.1.1. Bacterial Expression Systems

3.3.1.2. Yeast Expression Systems

3.3.1.3. Insect Expression Systems

3.3.1.4. Plant Expression Systems

3.3.1.5. Mammalian Expression Systems

3.3.1.6. Fungal Expression Systems

3.3.2. Processing Steps

3.3.2.1. Upstream Processing

3.3.2.2. Downstream Processing

3.4. Overview of Contract Manufacturing

3.4.1. Contract Manufacturing Scenario in China

3.5. Need for Outsourcing in the Biopharmaceutical Industry

3.5.1. Biopharmaceutical Outsourcing in China: Regulatory Scenario

3.6. Commonly Outsourced Operations in the Biopharmaceutical Industry

3.7. Basic Guidelines for Selecting a CMO Partner

3.8. Advantages of Outsourcing Manufacturing Services

3.8.1. Benefits of Engaging Chinese Contract Service Providers

3.9. Risks and Challenges Associated with Biopharmaceutical Contract Manufacturing

3.9.1. Challenges Associated with Engaging Chinese Contract Service Providers

3.10. Future Perspective

CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES

4.1. Chapter Overview

4.2. Small Molecule and Large Molecule Drugs / Therapies

4.2.1. Comparison of Key Characteristics

4.2.2. Comparison of Manufacturing Processes

4.2.3. Comparison of Key Manufacturing-Related Challenges

COMPETITIVE LANDSCAPE

5.1. Chapter Overview

5.2. Chinese Biopharmaceutical Contract Manufacturers: Overall Market Landscape

5.2.1. Analysis by Year of Establishment

5.2.2. Analysis by Company Size

5.2.3. Analysis by Scale of Operation

5.2.4. Analysis by Location of Headquarters

5.2.5. Analysis by Location of Manufacturing Facilities

5.2.6. Analysis by Type of Product

5.2.7. Analysis by Types of Services Offered

5.2.8. Analysis by Type of Biologic

5.2.9. Analysis by Expression System Used

5.2.10. Analysis by Type of Bioreactor Used

5.2.11. Analysis by Mode of Operation of Bioreactor

5.2.12. Analysis by Packaging Form Used

5.2.13. Analysis by Regulatory Accreditations / Certifications

COMPANY PROFILES

6.1 Chapter Overview

6.2 ChemPartner Biologics

6.2.1. Company Overview

6.2.2. Service Portfolio

6.2.3. Manufacturing Facilities and Capabilities

6.2.4. Recent Developments and Future Outlook

6.3. JHL Biotech

6.3.1. Company Overview

6.3.2. Service Portfolio

6.3.3. Manufacturing Facilities and Capabilities

6.3.4. Recent Developments and Future Outlook

6.4. JOINN Biologics

6.4.1. Company Overview

6.4.2. Service Portfolio

6.4.3. Manufacturing Facilities and Capabilities

6.4.4. Recent Developments and Future Outlook

6.5 MabPlex

6.5.1. Company Overview

6.5.2. Service Portfolio

6.5.3. Manufacturing Facilities and Capabilities

6.5.4. Recent Developments and Future Outlook

6.6. Mycenax Biotech

6.6.1. Company Overview

6.6.2. Service Portfolio

6.6.3. Manufacturing Facilities and Capabilities

6.6.4. Recent Developments and Future Outlook

6.7. WuXi AppTec

6.7.1. Company Overview

6.7.2. Financial Information

6.7.3. Service Portfolio

6.7.4. Manufacturing Facilities and Capabilities

6.7.5. Recent Developments and Future Outlook

PARTNERSHIPS

7.1 Chapter Overview

7.2. Partnership Models

7.3. Chinese Biopharmaceutical Contract Manufacturers: Recent Partnerships

7.3.1. Analysis by Year of Partnership

7.3.2. Analysis by Type of Partnership

7.3.3. Analysis by Scale of Operation

7.3.4. Analysis by Type of Biologic

7.3.5. Analysis by Focus Area

7.3.6. Analysis by Therapeutic Area

7.3.7. Most Active Players: Analysis by Number of Partnerships

7.3.8. Geographical Analysis

7.3.9. Geographical Distribution by Number of Partnerships

7.3.10. Intercontinental and Intracontinental Agreements

RECENT EXPANSIONS

8.1. Chapter Overview

8.2. Chinese Biopharmaceutical Contract Manufacturers: Recent Expansions

8.2.1. Analysis by Year of Expansion

8.2.2. Analysis by Type of Expansion

8.2.3. Analysis by Scale of Operation

8.2.4. Analysis by Type of Biologic

8.2.5. Analysis by Location of Expansion Project

8.2.6. Analysis by Capacity of Expanded Facility

8.2.7. Most Active Players: Analysis by Number of Expansions

8.2.8. Analysis by Region

CLINICAL TRIAL ANALYSIS

9.1. Chapter Overview

9.2. Scope and Methodology

9.3 Clinical Trial Analysis: Biologic Drugs

9.3.1. Analysis by Trial Registration Year

9.3.2. Analysis by Trial Phase

9.3.3. Analysis by Trial Status

9.3.4. Geographical Analysis by Number of Clinical Trials

9.3.5. Geographical Analysis by Enrolled Patient Population

9.3.6. Analysis of Enrolled Patient Population by Trial Registration Year

9.3.7. Analysis of Enrolled Patient Population by Trial Phase

9.3.8. Analysis by Type of Sponsor / Collaborator

9.3.9. Most Active Players: Analysis by Number of Registered Trials

9.3.10. Analysis by Clinical Trial Center

REGIONAL CAPABILITY ANALYSIS

10.1. Chapter Overview

10.2. Assumptions and Key Parameters

10.3. Overall Landscape of Chinese Biopharmaceutical Contract Manufacturers

10.4. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Northern China

10.5. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Eastern China

10.6. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Central China

10.7. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Southern China

CAPACITY ANALYSIS

11.1. Chapter Overview

11.2. Assumptions and Methodology

11.3. Chinese Biopharmaceutical Contract Manufactures: Installed Capacity

11.3.1. Analysis by Company Size

11.3.2. Analysis by Scale of Operation

11.3.3. Analysis by Expression System Used

11.3.4. Analysis by Location of Manufacturing Facility

11.3.5. Analysis by Company Size and Location of Manufacturing Facility

11.3.6. Analysis by Company Size and Location of Manufacturing Facility

11.4. Concluding Remarks

BIG PHARMA BIOPHARMACEUTICAL MANUFACTURING INITIATIVES IN CHINA

12.1. Chapter Overview

12.2. List of Biopharmaceutical R&D and Manufacturing Initiatives of Big Pharma Players in China

12.2.1. Analysis by Number of Initiatives

12.2.2. Analysis by Year of Initiative

12.2.3. Analysis by Company and Year of Initiative

12.2.4. Analysis by Type of Initiative

12.2.5. Analysis by Type of Biologic

12.3. Competitive Benchmarking of Big Pharmaceutical Players

12.3.1. Harvey Ball Analysis: Big Pharma Investment Summary

12.3.2. Geographical Analysis by Investment Made

MAKE VERSUS BUY DECISION MAKING FRAMEWORK

13.1. Chapter Overview

13.2. Assumptions and Key Parameters

13.3. Chines Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making

13.4. Conclusion

MARKET SIZING AND OPPORTUNITY ANALYSIS

14.1. Chapter Overview

14.2. Key Assumptions and Forecast Methodology

14.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030

14.3.1. Biopharmaceutical Contract Manufacturing Market in China for APIs, 2020-2030

14.3.2. Biopharmaceutical Contract Manufacturing Market in China for FDFs, 2020-2030

14.4. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Expression System Used

14.4.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Mammalian Systems

14.4.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Microbial Systems

14.4.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Other Expression Systems

14.5. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Scale of Operation

14.5.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Preclinical / Clinical Scale Operations

14.5.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Commercial Operations

14.6. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Size of Manufacturers

14.6.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Small Companies

14.6.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Mid-sized Companies

14.6.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Large and Very Large Companies

14.7. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Type of Biologic

14.7.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Antibodies

14.7.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Vaccines

14.7.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Other Biologics

COVID-19 Impact on China Biopharmaceutical CMO Market

15.1. Chapter Overview

15.2. Evaluation of Impact of COVID-19 Outbreak

15.2.1. Initiatives and Opinions of Key Players

15.2.1.1. WuXi AppTec

15.2.1.2. Boehringer Ingelheim

15.2.1.3. GE Healthcare

15.2.1.4. Lonza

15.2.1.5. AmbioPharm

15.2.2. Impact of China Biopharmaceutical Contract Manufacturing Market

15.3. Key Strategies to Adopt: A Bird’s Eye View

15.3.1. Immediate Steps

15.3.2. Short / Long-Term Steps

SWOT ANALYSIS

16.1. Chapter Overview

16.2. Strengths

16.3. Weaknesses

16.4. Opportunities

16.5. Threats

16.6. Comparison of SWOT Factors

16.7. Concluding Remarks

FUTURE OF THE CHINA BIOPHARMACEUTICAL CMO MARKET

17.1. Chapter Overview

17.2. Outsourcing Activities Anticipated to Increase in Future

17.3. Shift from One-time Contracts to Strategic Partnerships

17.4. Adoption of Innovative Technologies

17.4.1. Single Use Bioreactors

17.4.2. Novel Bioprocessing Techniques

17.4.3. Bioprocess Automation

17.5. Growing Popularity of the Quality by Design Principle in Bioprocessing

17.6. Increasing Focus on Niche Therapeutic Areas

17.7. Biosimilars Market to Contribute to Contract Service Revenues

17.8. Capability and Facility Expansions to Establish One Stop Shop Expertise

17.9. Increase in Financial In-flow and Outsourcing Budgets

17.10. Challenges Faced by Sponsors and Service Providers

17.10.1. Concerns Associated with Single Use Systems

17.10.2. Issues Related to Capacity Fluctuations

17.11. Concluding Remarks

INTERVIEW / SURVEY TRANSCRIPT(S)
APPENDIX 1: TABULATED DATA
APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The Chinese biopharmaceutical contract manufacturing market is estimated to be worth USD 2.6 billion in 2030, predicts Roots Analysis

Submitted 3 day(s) ago by Harry sins

The growing biopharma industry in China has resulted in the creation of lucrative business opportunities for contract service providers; region-specific advantages have also attracted several foreign sponsors entities over the last few years

Roots Analysis is pleased to announce the publication of its recent study, titled, “China Biopharmaceutical Contract Manufacturing Market, 2020-2030.”

The report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of biopharmaceuticals in China. The study also features a detailed analysis of key drivers and trends related to this evolving domain. In addition to other elements, the study includes:

A detailed assessment of the current market landscape of companies offering contract manufacturing services for biopharmaceuticals in China.
An analysis of the partnerships that have been established in this domain, in the recent past.
An analysis of the expansion initiatives undertaken by contract manufacturers in China, in order to augment their capabilities, in the recent past.
A detailed analysis of more than 1500 clinical trials related to biopharmaceuticals that have been / are being / are likely to be conducted in China.
An estimate of the overall, installed capacity for manufacturing biopharmaceuticals, based on data reported by industry stakeholders in the public domain.
An analysis of the initiatives of big biopharma players engaged in this domain.
A qualitative analysis, highlighting the various factors that need to be taken into consideration by drug / therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
Detailed profiles of key players that have a diverse range of capabilities for the development, manufacturing, and packaging of biopharmaceutical products.
A case study comparing the key characteristics of large molecule and small molecule drugs.
A discussion on industry affiliated trends, key drivers, and challenges, under a SWOT framework, which are likely to impact the evolution of this field.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of Product

API
FDF

Type of Expression System Used

Mammalian
Microbial
Others

Scale of Operation

Preclinical / Clinical
Commercial

Size of Manufacturer

Small
Mid-sized
Large / Very Large

Type of Biologic

Antibody
Vaccine
Others

Key companies covered in the report

ChemPartner Biologics
JHL Biotech
JOINN Biologics
MabPlex
Mycenax Biotech
WuXi AppTec

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/china-biopharmaceutical-contract-manufacturing/313.html

Other Recent Offerings

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

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The cell therapy manufacturing market is projected to grow at an annualized rate of >16.5%, till 2030

Submitted 6 day(s) ago by Harry sins

Roots Analysis has done a detailed study on Cell Therapy Manufacturing Market (3^rd Edition), 2019 - 2030, covering various important aspects of the industry and identifying key future growth opportunities.

To order this 550+ page report, which features 160+ figures and 250+ tables, please visit this link

Key Market Insights

More than 100 industry players and over 60 non-industry players currently claim to manufacture different types of cell therapies, either for in-house requirements or on contract basis
The market is fragmented, featuring both established players and new entrants, which claim to operate at various scales and manufacture a diverse range of cell therapies
In order to cater to the growing needs of clients / sponsors, companies have established presence across different regions; presently, the US, the UK and China are the key hubs for cell therapy manufacturing
In recent years, a significant increase in partnership activity has been observed in this domain; in fact, therapy developers have already inked manufacturing deals with both indigenous and international experts
In order to enhance core competencies related to the domain, both drug developers and CMOs are actively investing in expanding their existing infrastructure and capabilities
Cell therapy manufacturers are also gradually opting to automate various operations in the supply chain; the primary objective is to achieve favorable bench-to-clinic timelines and cut down on production related losses
Currently, the installed global capacity for cell therapy manufacturing is estimated to be spread across 2+ million square feet of dedicated cleanroom area distributed across various scales of operation
More than 70,000 patients were estimated to have been enrolled in cell therapy related clinical trials; the demand for cell therapies is anticipated to grow significantly over the next decade
Revenues from manufacturing operations of T-cell therapies are anticipated to capture higher market share; the benefit will be realized by both autologous and allogeneic therapies across different regions the world
Clinical scale manufacturing operations are likely to drive the future market size, taking into consideration both in-house and contract service requirements

For more information, please visit https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

Table of Contents

PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

EXECUTIVE SUMMARY

INTRODUCTION

3.1. Context and Background

3.2. Introduction to Cell Therapies

3.2.1. Comparison of Cell Therapies and Other Biotechnology Products

3.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)

3.2.3. Current Market Landscape of ATMPs

3.3. Overview of Cell Therapy Manufacturing

3.4. Cell Therapy Manufacturing Models

3.4.1. Centralized Manufacturing

3.4.2. Decentralized Manufacturing

3.5. Scalability of Cell Therapy Manufacturing

3.5.1. Scale-up

3.5.2. Scale-out

3.6. Types of Cell Therapy Manufacturers

3.7. Key Manufacturing-related Challenges

3.8. Factors Influencing Cell Therapy Manufacturing

3.9. Automating Cell Therapy Manufacturing

3.10. Cell Therapy Manufacturing Supply Chain

3.11. Future Perspectives

MARKET OVERVIEW

4.1. Chapter Overview

4.2. Cell Therapy Manufacturers (Industry Players): Overall Market Landscape

4.2.1. Analysis by Location of Headquarters

4.2.2. Analysis by Location of Manufacturing Facility

4.2.3. Analysis by Type of Cells Manufactured

4.2.4. Analysis by Source of Cells

4.2.5. Analysis by Scale of Operation

4.2.6. Analysis by Type of Cell Culture

4.2.7. Analysis by Purpose of Production

4.2.8. Analysis by Manufacturing Capabilities / Services

4.3. Cell Therapy Manufacturers (Non-Industry Players): Overall Market Landscape

4.3.1. Analysis by Location of Headquarters

4.3.2. Analysis by Location of Manufacturing Facility

4.3.3. Analysis by Type of Cells Manufactured

4.3.4. Analysis by Source of Cells

4.3.5. Analysis by Scale of Operation

4.3.6. Analysis by Type of Cell Culture

4.3.7. Analysis by Purpose of Production

4.3.8. Analysis by Manufacturing Capabilities / Services

4.4. Cell Therapy Manufacturing: Role of Logistics Service Providers

REGULATORY LANDSCAPE

5.1. Chapter Overview

5.2. Current Scenario

5.2.1. Regulatory Guidelines in the US

5.2.2. Regulatory Guidelines in Europe

5.2.3. Regulatory Guidelines in Japan

5.2.4. Conditional Approvals

5.3. Regulatory Accreditations for Cell Therapy Manufacturing

5.3.1. Facilities Approved by Regulators to Manufacture Cell Therapies

5.4. Summary of Guidelines for Clinical-Stage Manufacturing of Cell Therapies

5.5. Existing Challenges to Clinical-Stage Manufacturing

5.5.1. Variability in Regulatory Guidelines across Different Geographies

5.6. Conclusion

ROADMAPS FOR OVERCOMING EXISTING CHALLENGES

6.1. Chapter Overview

6.2. Roadmap for the US

6.2.1. Cell Processing

6.2.2. Cell Preservation, Distribution and Handling

6.2.3. Process Automation and Data Analytics

6.2.4. Process Monitoring and Quality Control

6.2.5. Standardization and Regulatory Support

6.2.6. Workforce Development

6.2.7. Supply Chain and Logistics

6.3. Roadmaps for Other Geographies

6.3.1. Europe

6.3.2. Asia Pacific

AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING

7.1. Chapter Overview

7.2. Automation of Cell Therapy Manufacturing Processes

7.2.1. Closed Systems

7.2.2. Single-use Systems

7.2.3. Modular Systems

7.3. Case Studies

7.3.1. Roadmap to Developing an Automated Cell Manufacturing / Processing Device

7.3.2. Automating Cell Therapy Manufacturing

7.4. GMP-in-a-Box

7.5. List of Automation Service Providers

7.6. Comparative Analysis of Manual and Automated Processes

7.7. Concluding Remarks

PROFILES: INDUSTRY PLAYERS

8.1. Chapter Overview

8.2. Service Providers in the US

8.2.1 Cognate BioServices

8.2.1.1. Company Overview

8.2.1.2. Service Portfolio

8.2.1.3. Manufacturing Capabilities

8.2.1.4. Partnerships

8.2.1.5. Future Outlook

8.2.2. FUJIFILM Cellular Dynamics

8.2.2.1. Company Overview

8.2.2.2. Service Portfolio

8.2.2.3. Manufacturing Capabilities

8.2.2.4. Partnerships

8.2.2.5. Future Outlook

8.2.3. KBI Biopharma

8.2.3.1. Company Overview

8.2.3.2. Service Portfolio

8.2.3.3. Manufacturing Capabilities

8.2.3.4. Partnerships

8.2.3.5. Future Outlook

8.2.4. Hitachi Chemical Advanced Therapeutics Solutions

8.2.4.1. Company Overview

8.2.4.2. Service Portfolio

8.2.4.3. Manufacturing Capabilities

8.2.4.4. Partnerships

8.2.4.5. Future Outlook

8.2.5. Waisman Biomanufacturing

8.2.5.1. Company Overview

8.2.5.2. Service Portfolio

8.2.5.3. Manufacturing Capabilities

8.2.5.4. Partnerships

8.2.5.5. Future Outlook

8.3. Service Providers in Europe

8.3.1. BioNTech Innovative Manufacturing Services

8.3.1.1. Company Overview

8.3.1.2. Service Portfolio

8.3.1.3. Manufacturing Capabilities

8.3.1.4. Partnerships

8.3.1.5. Future Outlook

8.3.2. Cell and Gene Therapy Catapult

8.3.2.1. Company Overview

8.3.2.2. Service Portfolio

8.3.2.3. Manufacturing Capabilities

8.3.2.4. Partnerships

8.3.2.5. Future Outlook

8.3.3. Lonza

8.3.3.1. Company Overview

8.3.3.2. Service Portfolio

8.3.3.3. Manufacturing Capabilities

8.3.3.4. Partnerships

8.3.3.5. Future Outlook

8.3.4. MaSTherCell

8.3.4.1. Company Overview

8.3.4.2. Service Portfolio

8.3.4.3. Manufacturing Capabilities

8.3.4.4. Partnerships

8.3.4.5. Future Outlook

8.3.5. Roslin Cell Therapies

8.3.5.1. Company Overview

8.3.5.2. Service Portfolio

8.3.5.3. Manufacturing Capabilities

8.3.5.4. Partnerships

8.3.5.5. Future Outlook

8.4. Service Providers in Asia Pacific

8.4.1. Cell Therapies

8.4.1.1. Company Overview

8.4.1.2. Service Portfolio

8.4.1.3. Manufacturing Capabilities

8.4.1.4. Partnerships

8.4.1.5. Future Outlook

8.4.2. Japan Tissue Engineering (J-TEC)

8.4.2.1. Company Overview

8.4.2.2. Service Portfolio

8.4.2.3. Manufacturing Capabilities

8.4.2.4. Partnerships

8.4.2.5. Future Outlook

8.4.3. MEDINET

8.4.3.1. Company Overview

8.4.3.2. Service Portfolio

8.4.3.3. Manufacturing Capabilities

8.4.3.4. Partnerships

8.4.3.5. Future Outlook

8.4.4. Nikon CeLL innovation

8.4.4.1. Company Overview

8.4.4.2. Service Portfolio

8.4.4.3. Manufacturing Capabilities

8.4.4.4. Partnerships

8.4.4.5. Future Outlook

8.4.5. WuXi Advanced Therapies

8.4.5.1. Company Overview

8.4.5.2. Service Portfolio

8.4.5.3. Manufacturing Capabilities

8.4.5.4. Partnerships

8.4.5.5. Future Outlook

PROFILES: NON-INDUSTRY PLAYERS

9.1. Chapter Overview

9.2. Center for Cell and Gene Therapy, Baylor College of Medicine

9.2.1. Overview

9.2.2. Operating Segments

9.2.3. Service Portfolio

9.2.4. Manufacturing Facilities and Capabilities

9.3. Centre for Cell Manufacturing Ireland, National University of Ireland

9.3.1. Overview

9.3.2. Service Portfolio

9.3.3. Manufacturing Facilities and Capabilities

9.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania

9.4.1. Overview

9.4.2. Service Portfolio

9.4.3. Manufacturing Facilities and Capabilities

9.5. Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital

9.5.1. Overview

9.5.2. Service Portfolio

9.5.3. Manufacturing Facilities and Capabilities

9.6. Laboratory for Cell and Gene Medicine, Stanford University

9.6.1. Overview

9.6.2. Service Portfolio

9.6.3. Manufacturing Facilities and Capabilities

9.7. Molecular and Cellular Therapeutics, University of Minnesota

9.7.1. Overview

9.7.2. Service Portfolio

9.7.3. Manufacturing Facilities and Capabilities

9.8. Newcastle Cellular Therapies Facility, Newcastle University

9.8.1. Overview

9.8.2. Service Portfolio

9.8.3. Manufacturing Facilities and Capabilities

9.9. Rayne Cell Therapy Suite, King’s College London

9.9.1. Overview

9.9.2. Manufacturing Facilities and Capabilities

9.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine

9.10.1. Overview

9.10.2. Manufacturing Facilities and Capabilities

9.11. Sydney Cell and Gene Therapy

9.11.1. Overview

9.11.2. Manufacturing Facilities and Capabilities

ROLE OF NON-PROFIT ORGANIZATIONS

10.1. Chapter Overview

10.2. Cell Therapy Manufacturing Service Providers: Non-Profit Organizations

10.2.1. CellCAN

10.2.2. Cell Therapy Manufacturing Cooperative Research Center (CTM CRC)

10.2.3. National Cell Manufacturing Consortium (NCMC)

10.2.4. California Institute of Regenerative Medicine (CIRM)

10.3. Cell Therapy Manufacturing: Affiliated International Societies

PARTNERSHIPS

11.1. Chapter Overview

11.2. Partnership Models

11.3. Cell Therapy Manufacturing: List of Partnerships

11.3.1. Analysis by Year of Partnership

11.3.2. Analysis by Type of Partnership Model

11.3.3. Analysis by Year and Type of Partnership Model

11.4. Analysis by Type of Cells

11.5. Analysis by Scale of Operation

11.6. Geographical Analysis

11.6.1. Continent-wise Distribution

11.6.2. Country-wise Distribution

11.7. Most Active Players: Analysis by Number of Partnerships

11.8. Cell Therapy Manufacturing: List of Acquisitions

11.8.1. Analysis by Year and Type of Cells

11.8.2. Geographical Analysis

11.8.3. Ownership Change Matrix

FACILITY EXPANSIONS

12.1. Chapter Overview

12.2. Cell Therapy Manufacturing: List of Expansions

12.2.1. Cumulative Year-wise Distribution

12.2.2. Analysis by Type of Cells

12.2.3. Analysis by Scale of Operation

12.2.3. Analysis by Purpose of Expansion

12.2.4. Analysis by Location of Manufacturing Facility

12.2.5. Analysis by Region and Purpose of Expansion

CAPACITY ANALYSIS

13.1. Chapter Overview

13.2. Key Assumptions and Methodology (Industry Players)

13.2.1 Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)

13.2.1.1. Analysis by Size of Manufacturer

13.2.1.2. Analysis by Scale of Operation

13.2.1.3. Analysis by Location of Manufacturing Facility

13.2.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)

13.2.2.1. Analysis by Size of Manufacturer

13.2.2.2. Analysis by Scale of Operation

13.2.2.3. Analysis by Location of Manufacturing Facility

13.3. Key Assumptions and Methodology (Non-Industry Players)

13.3.1. Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)

13.3.1.1. Analysis by Scale of Operation

13.3.1.2. Analysis by Location of Manufacturing Facility

13.3.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)

13.3.2.1. Analysis by Scale of Operation

13.3.2.2. Analysis by Location of Manufacturing Facility

13.4 Concluding Remarks

DEMAND ANALYSIS

14.1 Chapter Overview

14.2 Key Assumptions and Methodology

14.3 Cell Therapy Manufacturing: Overall Annual Demand

14.3.1. Analysis by Type of Cells

14.3.2. Analysis by Scale of Operations

14.3.3. Analysis by Geography

COST PRICE ANALYSIS

15.1. Chapter Overview

15.2. Factors Contributing to the High Price of Cell Therapies

15.3. Pricing Models for Cell Therapies

15.3.1. Based on Associated Costs for T-cell Therapies

15.3.2. Based on Associated Costs for Stem Cell Therapies

15.3.3. Based on Availability of Competing Products

15.3.4. Based on Target Patient Segment

15.3.5. Based on Opinions of Industry Experts

15.4. Cell Therapy Cost Optimization

15.4.1. Role of Cost of Goods Sold

15.4.2. Role of Automation

15.4.3. Role of Cell Therapy Contract Manufacturing Organizations

15.5. Reimbursement-related Considerations for Cell Therapies

15.5.1. Case Study: The National Institute for Health and Care Excellence’s (NICE) Appraisal of CAR-T Therapies

MAKE VERSUS BUY DECISION MAKING FRAMEWORK

16.1. Chapter Overview

16.2. Make versus Buy Decision Making: Analytical Output

MARKET SIZING AND OPPORTUNITY ANALYSIS

17.1. Chapter Overview

17.2. Scope of the Forecast

17.3. Forecast Methodology

17.4. Input Tables and Key Assumptions

17.5. Overall Cell Therapy Manufacturing Market, 2019-2030

17.5.1. Cell Therapy Manufacturing Market, 2019-2030: Distribution by Type of Cell Therapy

17.5.2. Cell Therapy Manufacturing Market, 2019-2030: Distribution by Source of Cells

17.5.3. Cell Therapy Manufacturing Market, 2019-2030: Distribution by Scale of Operation

17.5.4. Cell Therapy Manufacturing Market, 2019-2030: Distribution by Purpose of

Production

17.5.5. Cell Therapy Manufacturing Market, 2019-2030: Geographical Distribution

17.6. Market Opportunity in Commercial Scale Manufacturing of Cell-based Therapies

17.6.1. Overall Commercial Scale Manufacturing Market for T-cell Therapies, 2019-2030

17.6.1.1. Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, and TIL Therapy)

17.6.1.2. Distribution by Source of Cells

17.6.1.3. Geographical Distribution

17.6.2. Overall Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, 2019-2030

17.6.2.1. Distribution by Type of Therapy (Dendritic Cell Therapy, and Tumor Cell Therapy)

17.6.2.2. Distribution by Source of Cells

17.6.2.3. Geographical Distribution

17.6.3. Overall Commercial Scale Manufacturing Market for NK Cell Therapies, 2019-2030

17.6.3.1. Distribution by Source of Cells

17.6.3.2. Geographical Distribution

17.6.4. Overall Commercial Scale Manufacturing Market for Stem Cell Therapies, 2019-2030

17.6.4.1. Distribution by Source of Cells

17.6.4.2. Geographical Distribution

17.7. Market Opportunity in Clinical Scale Manufacturing of Cell-based Therapies

17.7.1. Overall Clinical Scale Manufacturing Market for T-cell Therapies, 2019-2030

17.7.1.1. Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy and TIL Therapy)

17.7.1.2. Distribution by Source of Cells

17.7.1.3. Geographical Distribution

17.7.2. Overall Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, 2019-2030

17.7.2.1. Distribution by Type of Therapy (Dendritic Cell Therapy, Tumor Cell Therapy)

17.7.2.2. Distribution by Source of Cells

17.7.2.3. Geographical Distribution

17.7.3. Overall Clinical Scale Manufacturing Market for NK Cell Therapies, 2019-2030

17.7.3.1. Distribution by Source of Cells

17.7.3.2. Geographical Distribution

17.7.4. Overall Clinical Scale Manufacturing Market for Stem Cell Therapies, 2019-2030

17.7.4.1. Distribution by Source of Cells

17.7.4.2. Geographical Distribution

KEY INSIGHTS

18.1. Chapter Overview

18.2. Cell Therapy Manufacturers: Grid Analysis

18.3. Cell Therapy Manufacturers: Logo Landscape by Type of Cell Therapy

18.3.1. Logo Landscape: Immune Cell Manufacturers

18.3.2. Logo Landscape: Stem Cell Manufacturers

18.4. Cell Therapy Manufacturers: World Map Representation of Location of Manufacturing Facility

18.4.1. Industry Players

18.4.2. Non-Industry Players

SWOT ANALYSIS

19.1. Chapter Overview

19.2. Strengths

19.3. Weaknesses

19.4. Opportunities

19.5. Threats

19.6. Comparison of SWOT Factors

19.6.1. Concluding Remarks

CONCLUSION

20.1. Chapter Overview

20.2. Key Takeaways

SURVEY ANALYSIS

21.1. Chapter Overview

21.2. Seniority Level of Respondents

21.3. Type of Cell Therapy

21.4. Scale of Operation

21.5. Source of Cells

21.6. Type of Cell Culture System

22.7. Availability of Fill / Finish Services

INTERVIEW TRANSCRIPTS

22.1. Chapter Overview

22.2. Lion TCR

22.2.1. Company Overview

22.2.2. Interview Transcript: Victor Lietao Li, Co-Founder and Chief Executive Officer

22.3. Cell Therapies

22.3.1. Company Overview

22.3.2. Interview Transcript: Tim Oldham, Chief Executive Officer

22.4. CiMaas

22.4.1. Company Overview

22.4.2. Interview Transcript: Gerard MJ Bos, Chief Executive Officer

22.5. Gracell Biotechnologies

22.5.1. Company Overview

22.5.2. Interview Transcript: Wei (William) Cao, Chief Executive Officer

22.6. Glycostem Therapeutics

22.6.1. Company Overview

22.6.2. Interview Transcript: Troels Jordansen, Chief Executive Officer

22.7. Kadimastem

22.7.1. Company Overview

22.7.2. Interview Transcript: Arik Hasson, Executive VP Research and Development

22.8. Bio Elpida

22.8.1. Company Overview

22.8.2. Interview Transcript: Gilles Devillers, General Manager

22.9. Center for Commercialization of Cancer Immunotherapy / C3i

22.9.1. Company Overview

22.9.2. Interview Transcript: Arnaud Deladeriere, Manager, Business Development & Operations-cGMP Manufacturing Unit

22.10. Waisman Biomanufacturing

22.10.1. Company Overview

22.10.2. Interview Transcript: Brian Dattilo, Manager of Business Development

22.11. RoslinCT

22.11.1. Company Overview

22.11.2. Interview Transcript: Fiona Bellot, Business Development Manager

22.12. Yposkesi

22.12.1. Company Overview

22.12.2. Interview Transcript: Mathilde Girard, Leader, Cell Therapy Innovation and Development

22.13. University of Minnesota

22.13.1. Organization Overview

22.13.2. Interview Transcript: David Mckenna, Professor and American Red in Transfusion Medicine

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Growing at an annualized rate of over 16.5%, the cell therapy manufacturing market is estimated to reach close to USD 11 Billion by 2030, claims Roots Analysis

Submitted 6 day(s) ago by Harry sins

Manufacturing cell therapies is technically and financially demanding; as a result, despite therapy developers gradually strengthening their in-house expertise, they are also becoming increasingly reliant on contract service providers

Roots Analysis is pleased to announce the publication of its recent study, titled, “Cell Therapy Manufacturing Market (3^rd Edition), 2019 - 2030.”

The report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:

An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective cell therapy manufacturing capabilities, over the period 2015-2019.
An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established in the period 2014-2019.
Informed estimates of the annual commercial and clinical demand for cell therapies, in terms of number of cells produced and area dedicated to manufacturing.
An estimate of the overall, installed capacity for manufacturing cell-based therapies based on information reported by industry stakeholders in the public domain A competitiveness analysis of biological targets, featuring insightful pictorial summaries and representations.
A detailed analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models / approaches that may be adopted by manufacturers while deciding the prices of their proprietary offerings.
A qualitative analysis, highlighting the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
An elaborate discussion on the role of automation technologies in improving current manufacturing methods.
A discussion on cell therapy manufacturing regulations across various geographies, including North America, Europe, and Asia Pacific.
Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services.
A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
Type of therapy
T-cell therapies (CAR-T therapies, TCR therapies, TIL therapies)
Dendritic cell therapies
Tumor cell therapies
NK cell therapies
Stem cell therapies

Source of cells
Autologous
Allogeneic

Scale of operation
Clinical
Commercial

Purpose of manufacturing
Contract manufacturing
In-house manufacturing

Key geographical regions
North America
Europe
Asia Pacific
Rest of the world

Key companies covered in the report

BioNTech Innovative Manufacturing Services
Cell Therapies
Cell and Gene Therapy Catapult
Center for Cell and Gene Therapy, Baylor College of Medicine
Centre for Cell Manufacturing Ireland, National University of Ireland
Clinical Cell and Vaccine Production Facility, University of Pennsylvania
Cognate BioServices
FUJIFILM
Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital
Hitachi Chemical
KBI Biopharma
Laboratory for Cell and Gene Medicine, Stanford University
Lonza
MaSTherCell
MEDINET
Molecular and Cellular Therapeutics, University of Minnesota
Newcastle Cellular Therapies Facility, Newcastle University
Nikon CeLL innovation
Rayne Cell Therapy Suite, King’s College London
Roslin Cell Therapies
Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
Sydney Cell and Gene Therapy
WuXi Advanced Therapies

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html or email sales@rootsanalysis.com

You may also be interested in the following titles:

Contact:

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

The “Encapsulated Cell Therapies and Encapsulation Technologies Market” report features an extensive study of the current market landscape and future potential, offering an informed opinion on the likely adoption of these therapies / technologies over the

Submitted 6 day(s) ago by Harry sins

To order this 500+ page report, please visit this link

Key Inclusions

A detailed assessment of the current market landscape of encapsulated cell therapies and affiliated technologies, highlighting various target disease indications, phase of development, encapsulation method, type of cells / API, and route of administration, along with information on various stakeholder companies that are developing novel encapsulation methods / techniques for use in storage and transportation of cells, as well as other applications.
Comprehensive profiles of industry players that are currently engaged in the preclinical / clinical development of their proprietary encapsulated cell therapies, featuring an overview of the company, its financial information (if available), and a detailed description of its product(s), highlighting mechanism of action, current development status, and key preclinical / clinical trial results. Each profile also includes a list of recent developments, highlighting the key milestones achieved, partnership activity, and the likely strategies that may be adopted by these players to fuel growth in the in the foreseen future.
An in-depth analysis of the patents that have been published related to cell encapsulation technologies, since 2013. The analysis also highlights the key trends associated with these patents, across patent type, regional applicability, CPC classification, emerging focus areas, leading industry players (in terms of number of patents filed / granted), and current intellectual property-related benchmarks and valuation.
A comprehensive clinical trial analysis of completed, ongoing and planned studies of various encapsulated cell therapies. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, leading industry and non-industry players (in terms of number of trials conducted), study design, target therapeutic area, key indications, study focus, clinical endpoints, and enrolled patient population and regional distribution of trials.
An analysis of the partnerships that have been established in the domain in the period 2013-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals.
An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area.
A detailed study on the various grants that have been awarded to research institutes in this field.
An analysis highlighting potential strategic partners (for instance, manufacturers) for encapsulated therapy developers based on multiple parameters, such as therapeutic focus overlap, cell type overlap, research programs, existing collaborations, and developer strength.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Type of licensing deal payment
Upfront payment
Milestone payment

Therapeutic area
Metabolic disorder
Neurological disorder
Ophthalmic disorder
Oncological disorder

Target disease indication
Ataxia telangiectasia
Breast cancer
Diabetes
Glaucoma
Head and neck cancer
Macular telangectasia
Pancreatic cancer
Parkinson's disease
Retinitis pigmentosa

Type of encapsulation material used
Alginate-based microcapsule
Cellulose hydrogel
Medical-grade plastic
Red blood cell

Key geographical region
North America
Europe
Asia-Pacific and rest of the world

To request sample pages, please visit this link

Key Questions Answered

What are the prevalent R&D trends related to cell encapsulation technologies?
Which clinical conditions can be treated using encapsulated cell therapy products?
What are the key challenges faced by stakeholders engaged in this domain?
What are the key technology platforms that leverage the concept of cell encapsulation?
Who are the leading industry and non-industry players in this market?
What are the key geographies where research on encapsulated cell therapies is being conducted?
Who are the key investors in this domain?
Who are the key thought leaders with expertise in cell encapsulation technologies?
What kind of partnership models are commonly adopted by industry stakeholders?
Who are the potential strategic partners (for instance, manufacturers) for encapsulated therapy developers?
How is the current and future market opportunity likely to be distributed across key market segments?
What are the factors that are likely to influence the evolution of this upcoming market?

You may also be interested in the following titles:

Contact:

Gaurav Chaudhary

+1 (415) 800 3415

+44 (122) 391 1091
Gaurav.Chaudhary@rootsanalysis.com

More than 45 encapsulated cell therapies and encapsulation technologies are being evaluated across different phases of development by stakeholders across the globe, claims Roots Analysis

Submitted 6 day(s) ago by Harry sins

Extensive research on cell encapsulation strategies has enabled the development of a variety of technologies capable of immobilizing / enclosing therapeutic entities within biocompatible matrices / carriers. Such products offer a myriad of advantages, and have demonstrated the capability to address existing challenges related to cell therapies and certain other types of interventions as well.

To order this 500+ page report, which features 170+ figures and 395+ tables, please visit this link

The USD 3.7 billion (by 2030) financial opportunity within the encapsulated cell therapies and encapsulation technologies market has been analyzed across the following segments:

Type of licensing deal payment
Upfront payment
Milestone payment

Therapeutic area
Metabolic disorder
Neurological disorder
Ophthalmic disorder
Oncological disorder

Target disease indication
Ataxia telangiectasia
Breast cancer
Diabetes
Glaucoma
Head and neck cancer
Macular telangectasia
Pancreatic cancer
Parkinson's disease
Retinitis pigmentosa

Type of encapsulation material used
Alginate-based microcapsule
Cellulose hydrogel
Medical-grade plastic
Red blood cell

Key geographical region
North America
Europe
Asia-Pacific and rest of the world

The Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030 report features the following companies, which we identified to be key players in this domain:

ALTuCELL
Azellon Cell Therapeutics
Beta-Cell
Betalin Therapeutics
CellProtect Biotechnology
Diatranz Otsuka
Encellin
EryDel
Gloriana Therapeutics
Living Cell Technologies
MaxiVAX
Neurotech Pharmaceuticals
PharmaCyte Biotech
Semma Therapeutics
Sernova

Table of Contents

Preface
Executive Summary

Introduction

Current Market Landscape

Encapsulated Cell Therapies and Encapsulation Technologies for Metabolic Disorders: Company Profiles

Encapsulated Cell Therapies and Encapsulation Technologies for Non-Metabolic Disorders: Company Profiles

Patent Analysis

Clinical Trial Analysis

Recent Partnerships

Funding and Investment Analysis

Grant Analysis

Potential Strategic Partners

Market Forecast

Conclusion

Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://rootsanalysis.com/reports/view_document/cell-encapsulation-focus-on-therapeutics-and-technologies-2019-2030/249.html

Contact:

Gaurav Chaudhary

+1 (415) 800 3415

+44 (122) 391 1091
Gaurav.Chaudhary@rootsanalysis.com

Given the increasing number of licensing deals and the expected approval of multiple mid-late stage candidates, the encapsulated cell therapies and encapsulation technologies market is anticipated to evolve at a rapid pace over the next decade, predicts R

Submitted 6 day(s) ago by Harry sins

Roots Analysis has done a detailed study on Cell Encapsulation: Focus on Therapeutics and Technologies, 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 500+ page report, which features 170+ figures and 395+ tables, please visit this link

Key Market Insights

Presently, over 45 encapsulated cell therapies and encapsulation technologies are being evaluated across different phases of development by stakeholders across the world
Ongoing therapy development programs are evaluating different types of cells, encapsulated in a wide range of biocompatible materials, aiming to offer viable and effective treatment options for various diseases
In fact, majority of the product candidates are being developed for the treatment of metabolic disorders, primarily diabetes; big pharma are driving a significant proportion of research and development activity
Clinical research in this field is growing at a fast pace; encapsulated therapy products are evaluating a number of pre-marketing end points to validate safety / efficacy
Over the years, more than 3,000 patents have been granted / filed related to cell encapsulation technologies, demonstrating the heightened pace of research in this domain
Foreseeing a lucrative future, several private and public investors have made capital investments worth approximately USD 1 billion, across over 100 funding instances, since 2013
Growth in partnership activity reflects the rising interest of stakeholders in this domain; over 70% of deals have been inked related to therapies for metabolic disorders, involving both international and indigenous parties
An evaluation of more than 300+ stakeholders engaged in cell therapies domain reveals the presence of several likely strategic partners spread across different geographical regions
The short term opportunity in this market is likely to be driven by licensing activity and will depend on the untapped potential of novel cell encapsulation technologies in different application areas
As multiple mid-late stage encapsulated cell therapies get commercialized in near future across different regions, the long term opportunity is likely to be distributed across diverse indications and encapsulation materials
The enormous potential of encapsulated cell-based therapies / devices in the treatment of chronic disorders has captured the interest of several stakeholders in the industry

For more information, please visit https://rootsanalysis.com/reports/view_document/cell-encapsulation-focus-on-therapeutics-and-technologies-2019-2030/249.html

Table of Contents

PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

EXECUTIVE SUMMARY

INTRODUCTION

3.1. Context and Background

3.2. An Overview of Cell Therapies

3.2.1. Cell Therapy Manufacturing

3.2.2. Supply Chain

3.2.3. Key Challenges

3.3. An Introduction to Cell Encapsulation

3.3.1. Historical Overview

3.3.2. Cell Encapsulation Approaches

3.3.3. Encapsulation Materials

3.3.4. Advantages and Challenges

3.4. Potential Applications of Cell Encapsulation

3.4.1. Targeted Drug / Therapy Delivery

3.4.2. Immunoprotection

3.4.3. Storage and Transportation

3.5. Key Growth Drivers and Road-blocks

CURRENT MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Encapsulated Cell Therapies and Encapsulation Technologies: Developer Landscape

4.2.1. Distribution by Year of Establishment

4.2.2. Distribution by Geographical Location

4.2.3. Distribution by Size of Developers

4.2.4. Distribution by Type of Offering

4.3. Encapsulated Cell Therapies and Encapsulation Technologies: Development Pipeline

4.3.1. Distribution by Target Therapeutic Area

4.3.2. Distribution by Phase of Development

4.3.3. Distribution by Type of Cells and Other Encapsulated Components

4.3.4. Distribution by Type of Encapsulation Material Used

4.3.5. Distribution by Route of Administration

4.3.6. Distribution by Application Areas

4.4. Encapsulated Cell Therapies and Encapsulation Technologies: Initiatives of Big Pharmaceutical Players

ENCAPSULATED CELL THERAPIES AND ENCAPSULATION TECHNOLOGIES FOR METABOLIC DISORDERS: COMPANY PROFILES

5.1. Chapter Overview

5.2. Developers with Clinical Candidates

5.2.1. Beta-O2 Technologies

5.2.1.1. Company Overview

5.2.1.2. Financial Information

5.2.1.3. Product Description: ꞵAir Bio-artificial Pancreas

5.2.1.4. Recent Developments and Future Outlook

5.2.2. Diatranz Otsuka

5.2.2.1. Company Overview

5.2.2.2. Financial Information

5.2.2.3. Product Description: DIABECELL®

5.2.2.4. Recent Developments and Future Outlook

5.2.3. Sernova

5.2.3.1. Company Overview

5.2.3.2. Financial Information

5.2.3.3. Product Description: Cell Pouch System™

5.2.3.4. Recent Developments and Future Outlook

5.2.4. ViaCyte

5.2.4.1. Company Overview

5.2.4.2. Financial Information

5.2.4.3. Product Description: PEC-Direct™ and PEC-Encap™

5.2.4.4. Recent Developments and Future Outlook

5.3. Developers with Preclinical Candidates

5.3.1. ALTuCELL

5.3.2. Beta-Cell

5.3.3. Betalin Therapeutics

5.3.4. CellProtect Biotechnology

5.3.5. Defymed

5.3.6. Encellin

5.3.7. Kadimastem

5.3.8. PharmaCyte Biotech

5.3.9. Semma Therapeutics

5.3.10. Sigilon Therapeutics

5.3.11. Seraxis

5.3.12. SymbioCellTech

ENCAPSULATED CELL THERAPIES AND ENCAPSULATION TECHNOLOGIES FOR NON-METABOLIC DISORDERS: COMPANY PROFILES

6.1. Chapter Overview

6.2. Developers with Clinical Candidates

6.2.1. Azellon Cell Therapeutics

6.2.1.1. Company Overview

6.2.1.2. Financial Information

6.2.1.3. Product Description: Cell Bandage

6.2.1.4. Recent Developments and Future Outlook

6.2.2. EryDel

6.2.2.1. Company Overview

6.2.2.2. Financial Information

6.2.2.3. Product Description: EryDex System

6.2.2.4. Recent Developments and Future Outlook

6.2.3. Erytech Pharma

6.2.3.1. Company Overview

6.2.3.2. Financial Information

6.2.3.3. Product Description: GRASPA®

6.2.3.4. Recent Developments and Future Outloo

6.2.4. Gloriana Therapeutics

6.2.4.1. Company Overview

6.2.4.2. Financial Information

6.2.4.3. Product Description: EC-NGF

6.2.4.4. Recent Developments and Future Outlook

6.2.5. Living Cell Technologies

6.2.5.1. Company Overview

6.2.5.2. Financial Information

6.2.5.3. Product Description: NTCELL®

6.2.5.4. Recent Developments and Future Outlook

6.2.6. MaxiVAX

6.2.6.1. Company Overview

6.2.6.2. Financial Information

6.2.6.3. Product Description: MVX-ONCO-1

6.2.6.4. Recent Developments and Future Outlook

6.2.7. Neurotech Pharmaceuticals

6.2.7.1. Company Overview

6.2.7.2. Financial Information

6.2.7.3. Product Description: NT-501

6.2.7.4. Recent Developments and Future Outlook

6.2.8. PharmaCyte Biotech

6.2.8.1. Company Overview

6.2.8.2. Financial Information

6.2.8.3. Product Description: Cell-in-a-Box®

6.2.8.4. Recent Developments and Future Outlook

6.3. Developers with Preclinical Candidates

6.3.1. Beta-O2 Technologies

6.3.2. Sernova

6.3.3. Sigilon Therapeutics

PATENT ANALYSIS

7.1. Chapter Overview

7.2. Scope and Methodology

7.3. Encapsulated Cell Therapies and Encapsulation Technologies: Patent Analysis

7.3.1. Analysis by Publication Year

7.3.2. Analysis by Geographical Location

7.3.3. Analysis by CPC Classifications

7.3.4. Emerging Focus Areas

7.3.5. Leading Players: Analysis by Number of Patents

7.4. Encapsulated Cell Therapies and Encapsulation Technologies: Patent Benchmarking Analysis (Industry Players)

7.4.1. Analysis by Patent Characteristics

7.4.2. Analysis by Geographical Locatio

7.5. Encapsulated Cell Therapies and Encapsulation Technologies: Patent Valuation Analysis

7.6. Leading Patents: Analysis by Number of Citations

CLINICAL TRIAL ANALYSIS

8.1. Chapter Overview

8.2. Scope and Methodology

8.3. Encapsulated Cell Therapies and Encapsulation Technologies: List of Clinical Trials

8.3.1. Analysis by Trial Registration Year

8.3.2. Geographical Analysis by Number of Clinical Trials

8.3.3. Geographical Analysis by Enrolled Patient Population

8.3.4. Analysis by Phase of Development

8.3.5. Analysis by Study Design

8.3.6. Analysis by Type of Sponsor / Collaborator

8.3.7. Most Active Players: Analysis by Number of Registered Trials

8.3.8. Analysis by Trial Focus

8.3.9. Analysis by Therapeutic Area

8.3.10. Analysis by Clinical Endpoints

RECENT PARTNERSHIPS

9.1. Chapter Overview

9.2. Partnership Models

9.3. Encapsulated Cell Therapies and Encapsulation Technologies: Recent Collaborations and Partnerships

9.3.1. Analysis by Year of Partnership

9.3.2. Analysis by Type of Partnership

9.3.3. Analysis by Therapeutic Area

9.3.4. Analysis by Type of Cells and Other Encapsulated Components

9.3.5. Most Active Players: Analysis by Number of Partnerships

9.3.6. Analysis by Regions

9.3.6.1. Most Active Players

9.3.6.2. Intercontinental and Intracontinental Agreements

FUNDING AND INVESTMENT ANALYSIS

10.1. Chapter Overview

10.2. Types of Funding

10.3. Encapsulated Cell Therapies and Encapsulation Technologies: Recent Funding Instances

10.3.1. Analysis by Number of Funding Instances

10.3.2. Analysis by Amount Invested

10.3.3. Analysis by Type of Funding

10.3.4. Analysis by Number of Funding Instances and Amount Invested across Different Indications

10.3.5. Analysis by Amount Invested across Different Type of Cells and Other Encapsulated Components

10.3.6. Most Active Players: Analysis by Amount Invested

10.3.7. Most Active Investors: Analysis by Number of Instances

10.3.8. Geographical Analysis of Amount Invested

10.4. Concluding Remarks

GRANT ANALYSIS

11.1. Chapter Overview

11.2. Scope and Methodology

11.3. Encapsulated Cell Therapies and Encapsulation Technologies: List of Academic Grants

11.3.1. Analysis by Project Start Year

11.3.2. Analysis by Focus Area

11.3.3. Analysis by Support Period

11.3.4. Analysis by Type of Grant

11.3.5. Analysis by Amount Awarded

11.3.6. Analysis by Study Section

11.3.7. Analysis by Therapeutic Area

11.3.8. Analysis by Type of Cells and Other Encapsulated Components

11.3.9. Analysis by Type of Encapsulation Material

11.3.10. Leading Funding Institutes: Analysis by Number of Grants

11.3.11. Leading Recipient Organizations: Analysis by Number of Grants

POTENTIAL STRATEGIC PARTNERS

12.1. Chapter Overview

12.2. Scope and Methodology

12.3. Potential Strategic Partners for Cell Therapy Development

12.3.1. Opportunities in North America

12.3.1.1. Most Likely Partners for Cell Therapy Development

12.3.1.2. Likely Partners for Cell Therapy Development

12.3.1.3. Less Likely Partners for Cell Therapy Development

12.3.2. Opportunities in Europe

12.3.2.1. Most Likely Partners for Cell Therapy Development

12.3.2.2. Likely Partners for Cell Therapy Development

12.3.2.3. Less Likely Partners for Cell Therapy Development

12.3.3. Opportunities in Asia-Pacific and Rest of the World

12.3.3.1. Most Likely Partners for Cell Therapy Development

12.3.3.2. Likely Partners for Cell Therapy Development

12.3.3.3. Less Likely Partners for Cell Therapy Development

12.4. Potential Strategic Partners for Cell Therapy Manufacturing

12.4.1. Opportunities in North America

12.4.1.1. Most Likely Partners for Cell Therapy Manufacturing

12.4.1.2. Likely Partners for Cell Therapy Manufacturing

12.4.1.3. Less Likely Partners for Cell Therapy Manufacturing

12.4.2. Opportunities in Europe

12.4.2.1. Most Likely Partners for Cell Therapy Manufacturing

12.4.2.2. Likely Partners for Cell Therapy Manufacturing

12.4.2.3. Less Likely Partners for Cell Therapy Manufacturing

12.4.3. Opportunities in Asia-Pacific and Rest of the World

12.4.3.1. Most Likely Partners for Cell Therapy Manufacturing

12.4.3.2. Likely Partners for Cell Therapy Manufacturing

12.4.3.3. Less Likely Partners for Cell Therapy Manufacturing

MARKET FORECAST

13.1. Chapter Overview

13.2. Forecast Methodology and Key Assumptions

13.3. Overall Cell Encapsulation Technologies Market, 2019-2030

13.3.1. Cell Encapsulation Technologies Market by Upfront Payments, 2019-2030

13.3.2. Cell Encapsulation Technologies Market by Milestone Payments, 2019-2030

13.4. Overall Encapsulated Cell Therapies Market, till 2030

13.4.1. Encapsulated Cell Therapies Market: Distribution by Therapeutic Area

13.4.1.1. Encapsulated Cell Therapies Market for Eye Disorders, till 2030

13.4.1.2. Encapsulated Cell Therapies Market for Metabolic Disorders, till 2030

13.4.1.3. Encapsulated Cell Therapies Market for Neurological Disorders, till 2030

13.4.1.4. Encapsulated Cell Therapies Market for Oncological Disorders, till 2030

13.4.2. Encapsulated Cell Therapies Market: Distribution by Type of Encapsulation Material Used

13.4.2.1. Encapsulated Cell Therapies Market for Alginate-based Microcapsules, till 2030

13.4.2.2. Encapsulated Cell Therapies Market for Cellulose Hydrogels, till 2030

13.4.2.3. Encapsulated Cell Therapies Market for Medical-grade Plastics, till 2030

13.4.2.4. Encapsulated Cell Therapies Market for Red Blood Cells, till 2030

13.4.3. Encapsulated Cell Therapies Market: Distribution by Geography

13.4.3.1. Encapsulated Cell Therapies Market in North America, till 2030

13.4.3.2. Encapsulated Cell Therapies Market in Europe, till 2030

13.4.3.3. Encapsulated Cell Therapies Market in Asia-Pacific, till 2030

13.5. Encapsulated Cell Therapies for Eye Disorders: Distribution by Indication

13.5.1. Encapsulated Cell Therapies Market for Eye Disorders: Macular Telangectasia, till 2030

13.5.1.1. NT-501 (Neurotech Pharmaceuticals)

13.5.1.1.1. Target Patient Population

13.5.1.1.2. Sales Forecast

13.5.1.1.3. Geographical Distribution of Projected Opportunity

13.5.1.1.3.1. Projected Opportunity in the US

13.5.1.1.3.2. Projected Opportunity in EU5

13.5.1.1.3.3. Projected Opportunity in Rest of Europe

13.5.1.1.3.4. Projected Opportunity in Australia

13.5.2. Encapsulated Cell Therapies Market for Eye Disorders: Glaucoma, till 2030

13.5.2.1. NT-501 (Neurotech Pharmaceuticals)

13.5.2.1.1. Target Patient Population

13.5.2.1.2. Sales Forecast

13.5.2.1.3. Geographical Distribution of Projected Opportunity

13.5.2.1.3.1. Projected Opportunity in the US

13.5.2.1.3.2. Projected Opportunity in EU5

13.5.2.1.3.3. Projected Opportunity in Rest of Europe

13.5.2.1.3.4. Projected Opportunity in Australia

13.5.3. Encapsulated Cell Therapies Market for Eye Disorders: Retinitis Pigmentosa, till 2030

13.5.3.1. NT-501 (Neurotech Pharmaceuticals)

13.5.3.1.1. Target Patient Population

13.5.3.1.2. Sales Forecast

13.5.3.1.3. Geographical Distribution of Projected Opportunity

13.5.3.1.3.1. Projected Opportunity in the US

13.5.3.1.3.2. Projected Opportunity in EU5

13.5.3.1.3.3. Projected Opportunity in Rest of Europe

13.5.3.1.3.4. Projected Opportunity in Australia

13.6. Encapsulated Cell Therapies for Metabolic Disorders: Distribution by Indication

13.6.1. Encapsulated Cell Therapies Market for Metabolic Disorders: Type 1 Diabetes, till 2030

13.6.1.1. DIABECELL® (Diatranz Otsuka)

13.6.1.1.1. Target Patient Population

13.6.1.1.2. Sales Forecast

13.6.1.1.3. Geographical Distribution of Projected Opportunity

13.6.1.1.3.1. Projected Opportunity in the US

13.6.1.1.3.2. Projected Opportunity in Japan

13.6.1.1.3.3. Projected Opportunity in EU5

13.6.1.1.3.4. Projected Opportunity in Rest of Europe

13.6.1.1.3.5. Projected Opportunity in Australia

13.6.1.1.3.6. Projected Opportunity in New Zealand

13.7. Encapsulated Cell Therapies for Neurological Disorders: Distribution by Indication

13.7.1. Encapsulated Cell Therapies Market for Neurological Disorders: Ataxia Telangiectasia, till 2030

13.7.1.1. EryDex System (EryDel)

13.7.1.1.1. Target Patient Population

13.7.1.1.2. Sales Forecast

13.7.1.1.3. Geographical Distribution of Projected Opportunity

13.7.1.1.3.1. Projected Opportunity in EU5

13.7.1.1.3.2. Projected Opportunity in Rest of Europe

13.7.1.1.3.3. Projected Opportunity in the US

13.7.1.1.3.4. Projected Opportunity in Australia

13.7.1.1.3.5. Projected Opportunity in India

13.7.1.1.3.6. Projected Opportunity in Israel

13.7.1.1.3.7. Projected Opportunity in Tunisia

13.7.2. Encapsulated Cell Therapies Market for Neurological Disorders: Parkinson’s Disease, till 2030

13.7.2.1. NTCELL® (Living Cell Technologies)

13.7.2.2. Target Patient Population

13.7.2.2.1. Sales Forecast

13.7.2.2.2. Geographical Distribution of Projected Opportunity

13.7.2.2.2.1. Projected Opportunity in New Zealand

13.7.2.2.2.2. Projected Opportunity in the US

13.7.2.2.2.3. Projected Opportunity in Australia

13.7.2.2.2.4. Projected Opportunity in EU5

13.7.2.2.2.5. Projected Opportunity in Rest of Europe

13.8. Encapsulated Cell Therapies for Oncological Disorders: Distribution by Indication

13.8.1. Encapsulated Cell Therapies Market for Oncological Disorders: Pancreatic Cancer, till 2030

13.8.1.1. GRASPA® (Erytech Pharma)

13.8.1.1.1. Target Patient Population

13.8.1.1.2. Sales Forecast

13.8.1.1.3. Geographical Distribution of Projected Opportunity

13.8.1.1.3.1. Projected Opportunity in EU5

13.8.1.1.3.2. Projected Opportunity in Rest of Europe

13.8.1.1.3.3. Projected Opportunity in the US

13.8.2. Encapsulated Cell Therapies Market for Oncological Disorders: Non-Metastatic Pancreatic Cancer, till 2030

13.8.2.1. Cell-in-a-Box® (PharmaCyte Biotech)

13.8.2.1.1. Target Patient Population

13.8.2.1.2. Sales Forecast

13.8.2.1.3. Geographical Distribution of Projected Opportunity

13.8.2.1.3.1. Projected Opportunity in the US

13.8.2.1.3.2. Projected Opportunity in EU5

13.8.2.1.3.3. Projected Opportunity of Cell-in-a-Box in Rest of Europe

13.8.3. Encapsulated Cell Therapies Market for Oncological Disorders: Triple Negative Breast Cancer, till 2030

13.8.3.1. GRASPA (Erytech Pharma)

13.8.3.1.1. Target Patient Population

13.8.3.1.2. Sales Forecast

13.8.3.1.3. Geographical Distribution of Projected Opportunity

13.8.3.1.3.1. Projected Opportunity in EU5

13.8.3.1.3.2. Projected Opportunity in Rest of Europe

13.8.3.1.3.3. Projected Opportunity in the US

13.8.4. Encapsulated Cell Therapies Market for Oncological Disorders: Head and Neck Cancer, till 2030

13.8.4.1. MVX-ONCO-1 (MaxiVAX)

13.8.4.1.1. Target Patient Population

13.8.4.1.2. Sales Forecast

13.8.4.1.3. Geographical Distribution of Projected Opportunity

13.8.4.1.3.1. Projected Opportunity in EU5

13.8.4.1.3.2. Projected Opportunity in Rest of Europe

13.8.4.1.3.3. Projected Opportunity in the US

CONCLUSION

14.1. Cell-based Pharmacological Interventions are Characterized by Diverse Challenges, Most of which can be Mitigated using Various Encapsulation Strategies

14.2. The Pipeline Features Several Mid and Late Stage Encapsulated Therapy Products, Majority of which are intended for the Treatment of Metabolic Disorders

14.3. The Fragmented Developer Landscape Includes a Mix of Small and Mid-Sized Players; at Present, North America and Europe are Major Hubs of Development Activity

14.4. The Heightened Pace of Research in this Domain is Evident from the Rise in the Number of Patents Filed / Granted and the Clinical Studies Conducted in the Recent Years

14.5. Development Efforts in this Field have Drawn Significant Capital Investments from Private and Public Investors; this is Likely to Provide the Necessary Impetus to the Market’s Future Growth

14.6. Growth in Partnership Activity Reflects the Rising Interest of Industry Stakeholders; Most Agreements are Between Technology Providers and Cell Therapy Developers

14.7. Given the Increasing Number of Licensing Deals and the Expected Approval of Multiple Mid-Late Stage Candidates, the Market is Poised to Grow at a Significant Pace in the Coming Years

EXECUTIVE INSIGHTS

15.1. Chapter Overview

15.2. Erytech Pharma

15.2.1. Company Snapshot

15.2.2. Interview Transcript: Alexander Scheer, Chief Scientific Officer

15.3. Defymed

15.3.1. Company Snapshot

15.3.2. Interview Transcript: Manuel Pires, Business Developer

15.4. Kadimastem

15.4.1. Company Snapshot

15.4.2. Interview Transcript: Michel Revel, Chief Scientist and Galit Mazooz-Perlmuter, Business Development Manager

15.5. Aterelix

15.5.1. Company Snapshot

15.5.2. Interview Transcript: Mick Mclean, Chief Executive Officer

15.6. Neurotech Pharmaceuticals

15.6.1. Company Snapshot

15.6.2. Interview Transcript: Quinton Oswald, Former President and Chief Executive Officer

15.7. Seraxis

15.7.1. Company Snapshot

15.7.2. Interview Transcript: William L Rust, Founder and Chief Executive Officer

15.8. Beta-O2 Technologies

15.8.1. Company Snapshot

15.8.2. Interview Transcript: Yuval Avni, Former Chief Executive Officer

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact:

Gaurav Chaudhary

+1 (415) 800 3415

+44 (122) 391 1091
Gaurav.Chaudhary@rootsanalysis.com

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The “Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030” report features an extensive study of the current landscape and future outlook of the immuno-oncology biomarkers testing market (focusing particularly on TMB, MSI and TILs

Submitted 8 day(s) ago by Harry sins

To order this detailed 370+ page report, please visit this link

Key Inclusions

A detailed analysis of ongoing, biomarker-based clinical trials initiated by big pharmaceutical companies, featuring details on immuno-oncology biomarkers and disease indications being investigated, based on trial registration year, phase of development, recruitment status, therapy design and type of cancer therapy.
An analysis of the landscape of companies offering testing services for cancer biomarkers, namely TMB, MSI / MMR and TILs (including CD3+, CD4+, CD8+ and FOXP3+), based on a number of relevant parameters, such as year of establishment, size of employee base, location of headquarters, availability status of the test, biomarkers analyzed, application areas, disease indication(s) evaluated, analytical techniques utilized, turnaround time, sample input and others.
An insightful 2X2 representation of the results of a detailed competitiveness analysis of various tests (segregated across different biomarker groups), taking into consideration the supplier power (size of employee base) and specific test related parameters, such as, application area of the test, turnaround time and other key specifications.
Elaborate profiles of leading analytical testing service providers focused on immuno-oncology biomarkers (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial information (if available), information on biomarker testing related service(s), recent developments and an informed future outlook.
A detailed publication analysis of over 180 research articles that have been published since 2016, highlighting the key focus areas of ongoing research activity related to immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs. It highlights the prevalent research trends related to the year of publication, disease indications, analytical technique used for biomarker assessment, and type of cancer therapy evaluated.
A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of cancer biomarkers, namely TMB, MSI / MMR and TILs, based on various parameters, such as trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials.
A discussion on the upcoming opportunities (such as development of companion diagnostics, emerging technologies for biomarker assessment, and others) that are likely to impact the evolution of this market over the coming years.
A discussion on various steps involved in development operations of companion diagnostics, namely R&D, clinical evaluation, manufacturing and assembly, negotiations with payers / insurance providers and marketing / sales activities, and the cost requirements across each of the aforementioned stages.
A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Type of test

Laboratory Developed Tests (LDTs)
Companion Diagnostic Tests (CDx)

Type of disease indication

Breast cancer
Blood cancer
Colon / Colorectal cancer
Lung Cancer
Melanoma
Prostate Cancer

Type of cancer biomarker

TMB
MSI / MMR
TILs

Type of analytical technique

Next Generation Sequencing (NGS)
Polymerase Chain Reaction (PCR)
Immunohistochemistry (IHC)
Others

Key geographical regions

North America
Europe
Japan
China
Australia

To request sample pages, please visit this link

Key Questions Answered

What are key cancer indications for which novel cancer biomarker-based tests are available / under development?
Who are the leading service providers in this emerging market? How do such tests compare to each other (in terms of key specifications and strengths of developer entities)?
What are the prevalent R&D trends related to novel cancer biomarkers (in terms of clinical development activity, and number of publications)?
What are the major applications of biomarker-based analytical tests?
What are the different initiatives undertaken by big pharmaceutical companies to advance their cancer biomarker tests (in terms of clinical research activity)?
What are the upcoming opportunities for biomarker testing service providers that are likely to impact the evolution of the market over the coming years?
How is the current and future market opportunity likely to be distributed across key market segments, including different cancer indications (breast cancer, blood cancer, colon / colorectal cancer, lung cancer, melanoma, and prostate cancer)?

You may also be interested in the following titles:

Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

Presently, close to 50 companies are offering a variety of analytical testing solutions for the assessment of novel cancer biomarkers; majority of these tests are intended to facilitate important therapy-related decisions, claims Roots Analysis

Submitted 8 day(s) ago by Harry sins

Over time, pharmaceutical players have demonstrated significant interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of these novel biomarkers. Several companies have already developed / are developing analytical tests for novel cancer biomarkers (TMB, MSI / MMR and TILs), intended to assist physicians in making personalized treatment decisions.

To order this 370+ page report, which features 190+ figures and 180+ tables, please visit this link

The USD 860 million (by 2030) financial opportunity within the cancer biomarkers market has been analyzed across the following segments:

Type of test
Laboratory Developed Tests (LDTs)
Companion Diagnostic Tests (CDx)

Type of disease indication
Breast cancer
Blood cancer
Colon / Colorectal cancer
Lung Cancer
Melanoma
Prostate Cancer

Type of cancer biomarker
TMB
MSI / MMR
TILs

Type of analytical technique
Next Generation Sequencing (NGS)
Polymerase Chain Reaction (PCR)
Immunohistochemistry (IHC)
Others

Key geographical regions
North America
Europe
Japan
China
Australia

The Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030 report features the following companies, which we identified to be key players in this domain:

Foundation Medicine
NeoGenomics Laboratories
Novogene
Q² Solutions
Personal Genome Diagnostics
Dr Lal PathLabs
Shenzhen Yuce Biotechnology

Table of Contents

Preface

2. Executive Summary
Introduction
Current Market Landscape
Product Competitiveness Analysis
Company Profiles
Publication Analysis
Innovative Designs for Biomarker-Based Clinical Trials
Clinical Trial Analysis
Market Forecast
Future Growth Opportunities
Case Study: Analysis of Needs of Stakeholders in The Companion Diagnostics Industry
Case Study: Analysis of Value Chain in the Companion Diagnostics Industry
Clinical Research on Cancer Biomarkers: A Big Pharma Perspective

Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

To purchase a copy, please visit https://www.rootsanalysis.com/reports/view_document/cancer-biomarkers-market-focus-on-tmb-msi--mmr-and-tils-testing-2019--2030/253.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Cancer biomarkers market for TMB, MSI / MMR and TILs is projected to grow at an annualized rate of ~18%, till 2030

Submitted 8 day(s) ago by Harry sins

Roots Analysis has done a detailed study on Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030, covering key aspects of the industry and identifying key future growth opportunities.

To order this 370+ page report, which features 190+ figures and 180+ tables, please visit this link

Key Market Insights

Several novel biomarkers are presently under investigation for a variety of cancer indications; the initiatives of big pharmaceutical companies are indicative of the growing interest in this domain
Presently, close to 50 companies are offering a variety of analytical testing solutions for the assessment of novel cancer biomarkers; majority of these tests are intended to facilitate important therapy-related decisions
Multiple tests are currently available for specific diseases indications; next generation sequencing has emerged as a key driver, enabling high throughput results and faster turnaround times
Companies involved in this domain are putting in significant efforts to develop efficient tests and differentiate their offerings, from those of other stakeholders, to maintain a competitive edge
Till date, close to 200 trials, evaluating the expression of novel biomarkers have been registered across different cancer indications, phases of development and geographical locations
The growing research activity in this domain is also evident across published scientific literature; several biomarker-focused studies are evaluating different types of immunotherapies
The growing interest in this field is also reflected by the 120+ partnerships have been signed in the last two years, involving both international and indigenous stakeholders
The opportunity is likely to be driven by the applicability of these tests across multiple cancer indications; the market is anticipated to grow as more biomarker based drugs get approved in the coming decade
The projected future opportunity is expected to be distributed across different application areas, types of analytical techniques used and various global regions

For more information, please visit https://www.rootsanalysis.com/reports/view_document/cancer-biomarkers-market-focus-on-tmb-msi--mmr-and-tils-testing-2019--2030/253.html

Table of Contents

PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

EXECUTIVE SUMMARY

INTRODUCTION

3.1. Chapter Overview

3.2. Cancer Immunotherapy

3.2.1. Cancer Immunotherapy Biomarkers

3.2.2. Identification of a Candidate Biomarker

3.2.3. Need for Novel Cancer Biomarkers

3.3. Tumor Mutation Burden (TMB)

3.3.1. Overview

3.3.2. Variation of TMB across Multiple Indications

3.3.3. Methods for Measurement of TMB

3.3.4. Factors Affecting Measurement of TMB

3.3.5. Initiatives for Assessment of TMB as a Potential Biomarker

3.4. Microsatellite Instability / Mismatch Repair Deficiency (MSI / MMR)

3.4.1. Overview

3.4.2. Variation of MSI across Multiple Indications

3.4.3. Methods of Measurement of MSI

3.5. Tumor Infiltrating Lymphocytes and Other Novel Biomarkers

4 CURRENT MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Cancer Biomarkers Testing Services: Overall Market Landscape

4.2.1. Analysis by Year of Establishment

4.2.2. Analysis by Company Size

4.2.3. Analysis by Geographical Location

4.2.4. Analysis by Test Availability

4.2.5. Analysis by Type of Biomarker

4.2.6. Analysis by Application Area

4.2.7. Analysis by Disease Indication

4.2.8. Analysis by Analytical Technique Used

4.2.9. Analysis by Turnaround Time

4.2.10. Analysis by Sample Input

4.2.11. Analysis by Nucleic Acid Tested

4.2.12. Key Players: Analysis by Type of Biomarker

4.3. TMB Tests

4.3.1. Analysis by Application Area

4.3.2. Analysis by Disease Indication

4.3.3. Analysis by Analytical Technique Used

4.3.4. Analysis by Turnaround Time

4.4. MSI / MMR Tests

4.4.1. Analysis by Application Area

4.4.2. Analysis by Disease Indication

4.4.3. Analysis by Analytical Technique Used

4.4.4. Analysis by Turnaround Time

4.5. TIL-based Tests

4.5.1. Analysis by Application Area

4.5.2. Analysis by Disease Indication

4.5.3. Analysis by Analytical Technique Used

4.5.4. Analysis by Turnaround Time

5 PRODUCT COMPETITIVENESS ANALYSIS

5.1. Chapter Overview

5.2. Product Competitiveness Analysis: Key Assumptions and Methodology

5.2.1. Tests for the Assessment of TMB

5.2.2. Tests for the Assessment of MSI / MMR

5.2.3. Tests for the Assessment of TILs

6 COMPANY PROFILES

6.1. Chapter Overview

6.2. Dr Lal PathLabs

6.2.1. Company Overview

6.2.2. Financial Information

6.2.3. Product / Service Portfolio

6.2.3.1. Biomarkers Testing Portfolio

6.2.3.1.1. Microsatellite Instability (MSI) by PCR

6.2.3.1.2. OncoPro NCCN Lung Cancer Panel (*9 Genes *MSI)

6.2.3.1.3. OncoPro Liquid Biopsy 73 Gene Panel with MSI

6.2.4. Recent Developments and Future Outlook

6.3. Foundation Medicine

6.3.1. Company Overview

6.3.2. Financial Information

6.3.3. Product / Service Portfolio

6.3.3.1. Biomarkers Testing Portfolio

6.3.3.1.1. FoundationOne CDx

6.3.3.1.2. FoundationOne Liquid

6.3.3.1.3. FoundationOne Heme

6.3.4. Recent Developments and Future Outlook

6.4. NeoGenomics Laboratories

6.4.1. Company Overview

6.4.2. Financial Information

6.4.3. Product / Service Portfolio

6.4.3.1. Biomarkers Testing Portfolio

6.4.3.1.1. NeoTYPE Discovery Profile for Solid Tumors

6.4.3.1.2. MSI Analysis / MMR Panel by IHC

6.4.3.1.3. MultiOmyx Tumor Infiltrating Lymphocyte Panel

6.4.4. Recent Developments and Future Outlook

6.5. Novogene

6.5.1. Company Overview

6.5.2. Product / Service Portfolio

6.5.2.1. Biomarkers Testing Portfolio

6.5.2.1.1. NovoPM Cancer Panel

6.5.2.1.2. NovoPM TMB

6.5.2.1.3. NovoPM bTMB

6.5.2.1.4. NovoPM MSI

6.5.3. Recent Developments and Future Outlook

6.6. Q2 Solutions

6.6.1. Company Overview

6.6.2. Product / Service Portfolio

6.6.2.1. Biomarkers Testing Portfolio

6.6.2.1.1. TMB Assay

6.6.2.1.2. MSI Assay

6.6.2.1.3. TILs Testing

6.6.3. Recent Developments and Future Outlook

6.7. Personal Genome Diagnostics

6.7.1. Company Overview

6.7.2. Product / Service Portfolio

6.7.2.1. Biomarkers Testing Portfolio

6.7.2.1.1. PGDx elio Tissue Complete Assay

6.7.2.1.2. PlasmaSELECT-R 64

6.7.2.1.3. CancerXOME-R

6.7.2.1.4. CancerSELECT-R 125

6.7.2.1.5. MutatorDETECT

6.7.3. Recent Developments and Future Outlook

6.8. Shenzhen Yuce Biotechnology

6.8.1. Company Overview

6.8.2. Product / Service Portfolio

6.8.2.1. Biomarkers Testing Portfolio

6.8.2.1.1. YuceOne Plus

6.8.2.1.2. YuceOne ICIs

6.8.2.1.3. ct-DNA TMB

6.8.2.1.4. Microsatellite (MSI) Test

6.8.3. Recent Developments and Future Outlook

7 PUBLICATION ANALYSIS

7.1. Chapter Overview

7.2. Methodology

7.3. Cancer Biomarkers: List of Publications

7.3.1. Analysis by Year of Publication, 2016-2019

7.3.2. Analysis by Year of Publication and Type of Biomarker

7.3.3. Analysis by Year of Publication and Disease Indication

7.3.4. Analysis by Year of Publication and Analytical Technique Used

7.3.5. Analysis by Year of Publication and Type of Cancer Therapy

7.3.6. Most Popular Journals

7.4. Publication Analysis: TMB

7.4.1. Analysis by Year of Publication, 2016-2019

7.4.2. Analysis by Disease Indication

7.4.3. Analysis by Analytical Technique Used

7.4.4. Most Popular Journals

7.5. Publication Analysis: MSI / MMR

7.5.1. Analysis by Year of Publication, 2016-2019

7.5.2. Analysis by Disease Indication

7.5.3. Analysis by Analytical Technique Used

7.5.4. Most Popular Journals

7.6. Publication Analysis: TILs

7.6.1. Analysis by Year of Publication, 2016-2019

7.6.2. Analysis by Disease Indication

7.6.3. Analysis by Analytical Technique Used

7.6.4. Most Popular Journals

8 INNOVATIVE DESIGNS FOR BIOMARKER-BASED CLINICAL TRIALS

8.1. Background and Context

8.2. Biomarker-based Clinical Trial Designs

8.2.1. Enrichment Design

8.2.2. All-Comers Design

8.2.3. Mixture / Hybrid Design

8.2.4. Adaptive Design

8.3 Regulatory Considerations

9 CLINICAL TRIAL ANALYSIS

9.1. Chapter Overview

9.2. Methodology

9.3. Cancer Biomarkers: List of Clinical Trials

9.4. Clinical Trial Analysis: TMB

9.4.1. Analysis by Trial Registration Year

9.4.2. Analysis by Trial Recruitment Status

9.4.3. Analysis by Trial Phase

9.4.4. Analysis by Trial Design

9.4.5. Analysis by Disease Indication

9.4.6. Most Active Players

9.4.7. Analysis by Number of Clinical Trials and Geography

9.4.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.4.9. Analysis by Enrolled Patient Population and Geography

9.4.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.5. Clinical Trial Analysis: MSI / MMR

9.5.1. Analysis by Trial Registration Year

9.5.2. Analysis by Trial Recruitment Status

9.5.3. Analysis by Trial Phase

9.5.4. Analysis by Trial Design

9.5.5. Analysis by Disease Indication

9.5.6. Most Active Players

9.5.7. Analysis by Number of Clinical Trials and Geography

9.5.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.5.9. Analysis by Enrolled Patient Population and Geography

9.5.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.6. Clinical Trial Analysis: TILs

9.6.1. Analysis by Trial Registration Year

9.6.2. Analysis by Trial Recruitment Status

9.6.3. Analysis by Trial Phase

9.6.4. Analysis by Trial Design

9.6.5. Analysis by Disease Indication

9.6.6. Most Active Players

9.6.7. Analysis by Number of Clinical Trials and Geography

9.6.8. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.6.9. Analysis by Enrolled Patient Population and Geography

9.6.10. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.7 Clinical Trials Summary: Analysis by Registration Year and Biomarker

9.8 Clinical Trials Summary: Analysis by Registration Year and Disease Indication

MARKET FORECAST

10.1. Chapter Overview

10.2. Assumptions

10.3 Forecast Methodology

10.4. Global Cancer Biomarkers Testing Market, 2019-2030 (By Value)

10.5. Global Cancer Biomarkers Testing Market, 2019-2030 (By Volume)

10.6. Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (By Value)

10.7. Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (By Volume)

10.8. Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (By Value)

10.8.1. Cancer Biomarkers Testing Market: Distribution by Type of test and Geography, 2019-2030 (By Value)

10.9. Cancer Biomarkers Testing Market: Distribution by Type of test, 2019-2030 (By Volume)

10.9.1. Cancer Biomarkers Testing Market: Distribution by Type of test and Geography, 2019-2030 (By Volume)

10.10. Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (By Value)

10.11. Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (By Volume)

10.12. Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (By Value)

10.12.1. Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019- 2030 (By Value)

10.13. Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.13.1. Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (By Volume)

10.14. Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (By Value)

10.15. Cancer Biomarkers Testing Market for TMB, 2019-2030 (By Value)

10.15.1. Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (By Value)

10.15.2. Cancer Biomarkers Testing Market for TMB: Distribution by Cancer Indication, 2019-2030 (By Value)

10.15.3. Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (By Value)

10.15.4. Cancer Biomarkers Testing Market for TMB: Distribution by Type of test, 2019-2030 (By Value)

10.16. Cancer Biomarkers Testing Market for MSI / MMR, 2019-2030 (By Value)

10.16.1. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (By Value)

10.16.2. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Cancer Indication, 2019-2030 (By Value)

10.16.3. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (By Value)

10.16.4. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of test, 2019-2030 (By Value)

10.17. Cancer Biomarkers Testing Market for TILs, 2019-2030 (By Value)

10.17.1. Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (By Value)

10.17.2. Cancer Biomarkers Testing Market for TILs: Distribution by Cancer Indication, 2019-2030 (By Value)

10.17.3. Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (By Value)

10.17.4. Cancer Biomarkers Testing Market for TILs: Distribution by Type of test, 2019-2030 (By Value)

10.18. Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (By Volume)

10.19. Cancer Biomarkers Testing Market for TMB, 2019-2030 (By Volume)

10.19.1. Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (By Volume)

10.19.2. Cancer Biomarkers Testing Market for TMB: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.19.3. Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.19.4. Cancer Biomarkers Testing Market for TMB: Distribution by Type of test, 2019-2030 (By Volume)

10.20. Cancer Biomarkers Testing Market for MSI / MMR, 2019-2030 (By Volume)

10.20.1. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (By Volume)

10.20.2. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.20.3. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.20.4. Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of test, 2019-2030 (By Volume)

10.21. Cancer Biomarkers Testing Market for TILs, 2019-2030 (By Volume)

10.21.1. Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (By Volume)

10.21.2. Cancer Biomarkers Testing Market for TILs: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.21.3. Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (By Value)

10.21.4. Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (By Value)

FUTURE GROWTH OPPORTUNITIES

11.1. Chapter Overview

11.1.1. Increasing Focus on Precision Medicine

11.1.2. Rise in Number of Biomarker-based Clinical Trials

11.1.3. Emerging Technologies for Biomarker Assessment

11.1.4. Development of Companion Diagnostic Products

11.1.5. Other Opportunities

CASE STUDY: ANALYSIS OF NEEDS OF STAKEHOLDERS IN THE COMPANION DIAGNOSTICS INDUSTRY

12.1. Chapter Overview

12.2. Companion Diagnostics: Needs of Different Stakeholders

12.3. Comparison of Needs of Various Stakeholders

12.3.1. Needs of Drug Developers

12.3.2. Needs of Companion Diagnostics Developers

12.3.3. Needs of Regulatory Authorities

12.3.4. Needs of Testing Laboratories

12.3.5. Needs of Payers / Insurance Providers

12.3.6. Needs of Physicians

12.3.7. Needs of Patients

CASE STUDY: ANALYSIS OF VALUE CHAIN IN THE COMPANION DIAGNOSTICS INDUSTRY

13.1. Chapter Overview

13.2. Companion Diagnostics: Components of the Value Chain

13.3. Companion Diagnostics Value Chain: Cost Distribution

13.3.1. Companion Diagnostics Value Chain: Costs Associated with Research and Product Development

13.3.2. Companion Diagnostics Value Chain: Costs Associated with Costs Associated with Manufacturing and Assembly

13.3.3. Companion Diagnostics Value Chain: Costs Associated with Clinical Trials, FDA Approval and Other Administrative Tasks

13.3.4. Companion Diagnostics Value Chain: Costs Associated with Payer Negotiation and KoL Engagement

13.3.5. Companion Diagnostics Value Chain: Costs Associated with Marketing and Sales

CLINICAL RESEARCH ON CANCER BIOMARKERS: A BIG PHARMA PERSPECTIVE

14.1. Chapter Overview

14.2. Methodology

14.3. Clinical Trial Analysis

14.3.1. List of Likely Drug Candidates for IVD Developers

14.4. Cumulative Distribution of Biomarker-based Trials by Registration Year, 2016-2019

14.4.1. Analysis of Biomarker-based Trials of Most Popular Biomarkers

14.4.2. Analysis of Biomarker-based Trials of Moderately Popular Biomarkers

14.4.3. Analysis of Biomarker-based Trials of Less Popular / Other Biomarkers

14.4.4. Word Cloud of Other Emerging Biomarkers

14.4.5. Cumulative Distribution of Trials by Registration year and Most Popular Biomarkers

14.4.6. Cumulative Distribution of Trials by Registration year and Moderately Popular Biomarkers

14.4.7. Cumulative Distribution of Trials by Registration year and Less Popular / Other Biomarkers

14.5. Distribution of Biomarker-based Trials by Most Popular Indications

14.5.1. Distribution of Biomarker-based Trials by Moderately Popular Indications

14.5.2. Distribution of Biomarker-based Trials by Less Popular / Other Indications

14.5.3. Word Cloud of Other Emerging Indications in Biomarker-based Clinical Trials

14.5.4. Cumulative Distribution of Trials by Registration year and Most Popular Indication

14.5.5. Cumulative Distribution of Trials by Registration year and Moderately Popular Indications

14.5.6. Cumulative Distribution of Trials by Registration year and Less Popular / Other Indications

14.6. Analysis of Biomarker-based Trials by Phase of Development

14.6.1. Analysis of Biomarker-based Trials by Phase of Development and Most Popular Biomarkers

14.6.2. Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Biomarkers

14.6.3. Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Biomarkers

14.6.4. Analysis of Biomarker-based Trials by Phase of Development and Most Popular Indications

14.6.5. Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Indications

14.6.6. Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Indications

14.7. Analysis of Biomarker-based Trials by Sponsor

14.7.1. Analysis of Biomarker-based Trials by Sponsor and Most Popular Biomarkers

14.7.2. Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Biomarkers

14.7.3. Analysis of Biomarker-based Trials by Sponsor and Most Popular Indications

14.7.4. Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Indications

14.8. Analysis of Biomarker-based Trials by Recruitment Status

14.9. Analysis of Biomarker-based Trials by Therapy Design

14.10. Analysis of Biomarker-based Trials by Geography

14.10.1. Analysis of Biomarker-based Trials by Trial Phase and Recruitment Status

14.11. Clinical Trials Summary: Analysis by Biomarker and Most Popular Indications

14.12. Clinical Trials Summary: Analysis by Biomarker and Moderately Popular Indications

14.13. Clinical Trials Summary: Analysis by Biomarker and Other Emerging Indications

EXECUTIVE INSIGHTS
APPENDIX 1: TABULATED DATA
APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Cancer biomarkers market for TMB, MSI / MMR and TILs is estimated to be worth USD 860 million in 2030, predicts Roots Analysis

Submitted 8 day(s) ago by Harry sins

Advances in biotechnology have enabled the identification of several novel biomarkers, which are presently being used for a variety of purposes, including diagnosis, drug development, clinical research and to facilitate therapy-related decisions

Roots Analysis is pleased to announce the publication of its recent study, titled, “Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019–2030.”

The report features an extensive study of the current landscape and future outlook of the immuno-oncology biomarkers testing market (focusing particularly on TMB, MSI and TILs (CD3+, CD4+, CD8+, FOXP3+)). It provides an in-depth analysis, highlighting the capabilities of the various companies engaged in this domain. Amongst various elements, the report includes:

A detailed analysis of ongoing, biomarker-based clinical trials initiated by big pharmaceutical companies.
An analysis of the landscape of companies offering testing services for cancer biomarkers, namely TMB, MSI / MMR and TILs (including CD3+, CD4+, CD8+ and FOXP3+).
An insightful 2X2 representation of the results of a detailed competitiveness analysis of various tests (segregated across different biomarker groups).
Elaborate profiles of leading analytical testing service providers focused on immuno-oncology biomarkers (shortlisted based on strength of service portfolio).
A detailed publication analysis of over 180 research articles that have been published since 2016, highlighting the key focus areas of ongoing research activity related to immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs.
A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of cancer biomarkers, namely TMB, MSI / MMR and TILs.
A discussion on the upcoming opportunities that are likely to impact the evolution of this market over the coming years.
A discussion on various steps involved in development operations of companion diagnostics
A comparative analysis of the needs of different stakeholders involved in the development of companion diagnostic products
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of test

Laboratory Developed Tests (LDTs)
Companion Diagnostic Tests (CDx)

Type of disease indication

Breast cancer
Blood cancer
Colon / Colorectal cancer
Lung Cancer
Melanoma
Prostate Cancer

Type of cancer biomarker

TMB
MSI / MMR
TILs

Type of analytical technique

Next Generation Sequencing (NGS)
Polymerase Chain Reaction (PCR)
Immunohistochemistry (IHC)
Others

Key geographical regions

North America
Europe
Japan
China
Australia

Key companies covered in the report

Foundation Medicine
NeoGenomics Laboratories
Novogene
Q² Solutions
Personal Genome Diagnostics
Dr Lal PathLabs
Shenzhen Yuce Biotechnology

For more information please click on the following link:

https://www.rootsanalysis.com/reports/view_document/cancer-biomarkers-market-focus-on-tmb-msi--mmr-and-tils-testing-2019--2030/253.html

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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The “Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade.

Submitted 8 day(s) ago by Harry sins

To order this detailed 370+ page report, please visit this link

Key Inclusions

A detailed review of the overall landscape of bispecific antibody therapeutics, including information on drug developers, phase of development (marketed, clinical, and preclinical / discovery) of the pipeline candidates, target antigen, type of antibody format, mechanism of action, target disease indication(s), therapeutic area, broader disease segment, route of administration, mode of administration and patient segment.
A comprehensive list of novel technology platforms that are either currently available or being developed by various firms for the generation of bispecific antibody therapeutics, along with detailed profiles of key technologies. The chapter also includes an insightful competitiveness analysis, featuring a three-dimensional bubble representation that highlights the key technologies that are being used for the development of bispecific antibodies, taking into consideration the early stage (discovery, preclinical, IND and phase I) and late stage (phase II and above) development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and size of the developer company. In addition, it consists of a schematic world map representation, highlighting the geographical locations of technology developers engaged in this domain.
Detailed profiles of marketed and clinical stage (phase II and phase III) bispecific antibody therapeutics. Each profile features an overview of the drug, details of the developer, along with its financial performance, mechanism of action and targets, dosage information, current clinical development status, development process, as well as details on annual sales (wherever available).
Key takeaways from the bispecific antibody therapeutics pipeline, featuring a [A] grid analysis, representing the distribution of the pipeline (on the basis of mechanisms of action of product candidates) across different therapeutic areas and stages of development, [B] a five-dimensional spider-web analysis, highlighting the most popular mechanisms of action based on a number of relevant parameters, including number of bispecific antibodies in early stage (phase I) and late stage of development (phase II and above), number of ongoing clinical trials, target therapeutic areas and the number of companies that are developing these molecules, [C] a two-dimensional scattered plot competitiveness analysis, for the various target combinations for clinical-stage bispecific antibodies and [D] the chapter also includes an insightful summary representation using the logos of different industry stakeholders, highlighting the distribution of companies based on the company size.
An analysis of the big biopharma players engaged in this domain, featuring a heat map based on various parameters, such as number of bispecific antibody therapeutics under development, target antigen, type of antibody format, mechanism of action and target therapeutic area.
An analysis of recent partnerships and collaboration agreements inked in this domain since 2016, covering research collaborations, product and technology licensing agreements, product development and commercialization agreements, manufacturing agreements, mergers / acquisitions, joint ventures, product development agreements and other deals.
A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, it includes a list of contract manufacturing organizations (CMOs) and contract research organizations (CROs). The chapter also highlights the key considerations for bispecific antibody developers while selecting a suitable CRO / CMO.
A clinical trial analysis of ongoing and planned studies related to bispecific antibody therapeutics, taking into consideration a number of relevant parameters, including trial registration year, trial recruitment status, trial phase, trial design, disease indication(s), focus therapeutic area, most active industrial and non-industrial players, and geographical location of the trial.
A review of the key promotional strategies that have been adopted by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®. It includes a detailed comparison of both the drugs based on the information available on their respective websites, such as patient support offerings, informative downloadable content, and product visibility in scientific conferences.
A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market.

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Therapeutic Area

Autoimmune Disorders
Eye Disorders
Genetic Disorders
Hematological Malignancies
Infectious Diseases
Inflammatory Disorders
Skin Disorders

Mechanism of Action

Cytokines Retargeting / Neutralization
Dual Ligands Blocking
T-cell Retargeting / Activation
Others

Target Antigens

CD3 x CD19
CD30 x CD16A
Factor IXa x Factor X
IL-1α x IL-1β
IL-13 x IL-4
IL-17A x Albumin
IL-17A x IL-17F
Psl x PcrV
VEGF-A x ANG2
Others

Key Players

Astra Zeneca
Amgen
AbbVie
Affirmed
Affibody
Merck
Roche
Sanofi
Taisho Pharmaceutical

Key Geographical Regions

North America
Europe
Asia-Pacific

The report features inputs from eminent industry stakeholders, according to whom this relatively novel class of antibody therapeutics is likely to garner significant interest among therapy developers and end users alike. The report includes detailed transcripts of discussions held with the following experts:

Martin Steiner (Chief Executive Officer, Synimmune)
Ludger Große-Hovest (Chief Scientific Officer, Synimmune)
Jane Dancer (Chief Business Officer, F-Star)
Siobhan Pomeroy (Senior Director, Business Development, Cytom X)
Yinjue Wang (Associate Director, Process Development, Innovent Biologics)

To request sample pages, please visit this link

Key Questions Answered

What are the key technologies used for the development of bispecific antibodies?
What are the key biological target combinations and antibody formats that are being explored for bispecific antibody development?
Who are the leading industry and non-industry players engaged in this market?
What kind of partnership models are commonly adopted by bispecific antibody developers?
Which CMOs offer services for manufacturing bispecific antibodies?
What are the regulatory guidelines issued by different organizations related to the development of bispecific antibodies?
What kind of promotional strategies are being used by developers of marketed bispecific antibody developers?
How is the current and future market opportunity (related to bispecific antibodies) likely to be distributed across key market segments?

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Contact Us

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

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