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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

www.rootsanalysis.com
Submitted 34 day(s) ago by Alberto Brando

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

www.rootsanalysis.com
Submitted 34 day(s) ago by Alberto Brando

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

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.

www.rootsanalysis.com
Submitted 34 day(s) ago by Alberto Brando

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

With two approved drugs and close to 300 clinical / preclinical product candidates, the bispecific antibody therapeutics pipeline has evolved significantly over the past few years, claims Roots Analysis

www.rootsanalysis.com
Submitted 34 day(s) ago by Alberto Brando

With various target combinations and novel mechanisms of action, bispecific antibodies are presently recognized as a potent class of targeted therapies, with the potential to be used as treatment options for a variety of disease indications. Several pipeline candidates have recently entered mid to late-stage (phase II and above) trials and are anticipated to enter the market over the next 5-10 years.

To order this 370+ page report, which features 90+ figures and 110+ tables, please visit this link

The USD 6.9 billion financial opportunity (by 2030) within the bispecific antibody therapeutics market has been analyzed across the following segments:

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

Antibody Formats

Asymmetric
Fragments
Symmetric
Others

Key Geographical Regions

North America
Europe
Asia-Pacific

The Bispecific Antibody Therapeutics Market (4^th Edition), 2020-2030 report features the following companies, which we identified to be key players in this domain:

Amgen
Ablynx
AbbVie
Affibody
Affimed
Alphamab
AstraZeneca
Avillion
Chugai Pharmaceuticals
Eddingpharm
GSK
Merck
Merus
Roche
Regeneron Pharmaceuticals
Taisho Pharmaceuticals
Zymeworks

Table of Contents

Preface

2. Executive Summary
Introduction
Market Overview
Bispecific Antibody Therapeutics: Technology Platforms
Drug Profiles
Key Insights
Benchmark Analysis: Big Pharma Players
Partnerships and Collaborations
Contract Services for Bispecific Antibody Therapeutics
Clinical Trial Analysis
Case Study: Regulatory Guidelines for Bispecific Antibodies
Case Study: Promotional / Marketing Strategies
SWOT Analysis

Market Forecast and Opportunity Analysis

Concluding Remarks

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/bispecific-antibodies/286.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The bispecific antibody therapeutics market is projected to grow at an annualized rate of ~16%, in the span of 2019 to 2030

www.rootsanalysis.com
Submitted 34 day(s) ago by Alberto Brando

Roots Analysis has done a detailed study on Bispecific Antibody Therapeutics Market (4^th Edition), 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 370+ page report, which features 90+ figures and 110+ tables, please visit this link

Key Market Insights

With two approved drugs and close to 300 clinical / preclinical product candidates, the bispecific antibody therapeutics pipeline has evolved significantly over the past few years
The pipeline features drug candidates that target a wide range of biological antigens based on different antibody formats through novel mechanisms of action; more than 50% of these act by retargeting or activation of T-Cells
To gain a competitive edge in the market, developers are actively exploring novel biological targets and mechanisms of action to treat diverse disease indications
Although start-ups and mid-sized firms are spearheading the innovation, several big pharmaceutical companies are also actively engaged
In order to cater to the evolving needs of developers, technology providers have established presence across different regions; the US and EU have emerged as the key hubs
Close to 50,000 patients were estimated to have been enrolled in clinical trials evaluating bispecific antibody therapeutics, across various geographical locations and phases of development
The increasing interest of stakeholders in this domain can also be gauged by the rising product development / commercialization, R&D and technology licensing deals being signed across various regions
Given the complexities associated with the development of bispecific antibodies, contract organizations have become an indispensable part of the development and manufacturing process of antibody therapeutics
In order to keep patients and healthcare professionals informed and aware of the developments, companies are deploying diverse promotional strategies for their respective products

For more information, please visit https://www.rootsanalysis.com/reports/view_document/bispecific-antibodies/286.html

Table of Contents

PREFACE
1.1.                   Chapter Outlines
1.2.                   Research Methodology
1.3.                   Chapter Outlines
EXECUTIVE SUMMARY

INTRODUCTION

3.1. Chapter Overview

3.2. Concept of an Antibody

3.3. Structure of an Antibody

3.4. Functions of an Antibody

3.5. Mechanism of Action of an Antibody

3.6. Concept of Monoclonal Antibodies

3.7. Antibody Therapeutics

3.8. Historical Evolution of Antibody Therapeutics

3.9. Types of Advanced Antibody Therapeutics

3.9.1. Fc Engineered and Glycoengineered Antibodies

3.9.2. Antibody Fragments

3.9.3. Fusion Proteins

3.9.4. Intrabodies

3.9.5. Bispecific Antibodies

3.10. Bispecific Antibody Formats

3.10.1. Single-Chain-based Formats (Fc Independent Antibody Formats)

3.10.1.1. Tandem scFvs (single-chain variable fragments) and Triple bodies

3.10.1.2. Bispecific Single-Domain Antibody Fusion Proteins

3.10.1.3. Diabodies / Diabody Derivatives

3.10.1.4. Fusion Proteins

3.10.1.5. Fusion Proteins Devoid of Fc Regions

3.10.2. Immunoglobulin G (IgG)-based Formats (Fc Dependent Antibody Formats)

3.10.2.1. Quadromas

3.10.2.2. Knobs-Into-Holes

3.10.2.3. Dual Variable Domain Ig

3.10.2.4. IgG-scFv

3.10.2.5. Two-in-one or Dual Action Fab (DAF) Antibodies

3.10.2.6. Half Molecule Exchange

3.10.2.7. κλ- Bodies

3.11. Mechanisms of Action of Bispecific Antibodies

3.11.1. Retargeting Immune Effectors (NK Cells and T Cells) to Tumor Cells

3.11.2. Directly Targeting Malignant / Tumor Cells

3.11.3. Retargeting of Toxins

3.11.5. Targeting Tumor Angiogenesis

3.11.6. Other Mechanisms

3.12. Applications of Bispecific Antibodies

4 MARKET OVERVIEW

4.1. Chapter Overview

4.2. Bispecific Antibody Therapeutics: Developer Landscape

4.2.1. Analysis by Year of Establishment

4.2.2. Analysis by Company Size

4.2.3. Analysis by Geographical Location

4.3. Bispecific Antibody Therapeutics: Clinical Pipeline

4.3.1. Analysis by Phase of Development

4.3.2. Analysis by Target Antigen

4.3.3. Analysis by Type of Antibody Format

4.3.4. Analysis by Mechanism of Action

4.3.5. Analysis by Disease Indication

4.3.6. Analysis by Therapeutic Area

4.3.7. Analysis by Broader Disease Segment

4.3.8. Analysis by Route of Administration

4.3.9. Analysis by Mode of Administration

4.3.10. Analysis by Patient Segment

4.4. Bispecific Antibody Therapeutics: Early Stage Pipeline

4.4.1. Analysis by Phase of Development

4.4.2. Analysis by Target Antigen

4.4.4. Analysis by Mechanism of Action

4.4.5. Analysis by Therapeutic Area

4.4.6. Analysis by Broader Disease Segment

4.6. Bispecific Antibody Therapeutics: Combination Therapy Candidates

4.7. Bispecific Antibody Therapeutics: Non-Industry Players

4.8. Emerging Novel Antibody Therapeutic Modalities

5 Bispecific Antibody Therapeutics: Technology Platforms

5.1. Chapter Overview

5.2. Bispecific Antibody Therapeutics: List of Technology Platforms

5.3. Bispecific Antibody Therapeutics: Technology Platform Profiles

5.3.1. Bispecific T-cell Engager (BiTE®) (Amgen)

5.3.1.1. Overview

5.3.1.2. Technology Details

5.3.1.3. Structure of BiTE® Bispecific Antibodies

5.3.1.4. Pipeline of BiTE® Bispecific Antibodies

5.3.1.5. Advantages of BiTE® Bispecific Antibodies

5.3.1.6. Partnerships and Collaborations

5.3.2. DuoBody® (Genmab)

5.3.2.1. Overview

5.3.2.2. Technology Details

5.3.2.3. Structure of DuoBody® Bispecific Antibodies

5.3.2.4. Pipeline of DuoBody® Bispecific Antibodies

5.3.2.5. Advantages of DuoBody® Bispecific Antibodies

5.3.2.6. Partnerships and Collaborations

5.3.3. Xmab™ Antibody Engineering Platform (Xencor)

5.3.3.1. Overview

5.3.3.2. Technology Details

5.3.3.3. Pipeline of Xmab™ Bispecific Antibodies

5.3.3.4. Advantages of Xmab™ Bispecific Antibodies

5.3.3.5. Partnerships and Collaborations

5.3.4. WuXibodyTM Bispecific Engineering Platform (WuXi Biologics)

5.3.4.1. Overview

5.3.4.2. Pipeline of WuXibodyTM Bispecific Antibodies

5.3.4.3. Advantages of WuXibodyTM Bispecific Antibodies

5.3.4.4. Partnerships and Collaborations

5.3.5. Anticalin® (Pieris Pharmaceuticals)

5.3.5.1. Overview

5.3.5.2. Structure of Anticalin® Bispecific Fusion Proteins

5.3.5.3. Pipeline of Anticalin® Bispecific Fusion Proteins

5.3.5.4. Advantages of Anticalin® Bispecific antibody Platform

5.3.5.5. Partnerships and Collaborations

5.3.6. Azymetric™ (Zymeworks)

5.3.6.1. Overview

5.3.6.2. Technology Details

5.3.6.3. Structure of Azymetric™ Bispecific Antibodies

5.3.6.4. Pipeline of Azymetric™ Bispecific Antibodies

5.3.6.5. Advantages of the AzymetricTM Bispecific Antibodies

5.3.6.6. Partnerships and Collaborations

5.4. Geographical Distribution of Technology Providers

5.5. Bispecific Antibody Technology Platforms: Comparative Analysis

6 DRUG PROFILES

6.1. Chapter Overview

6.2. Marketed Drug Profiles

6.2.1. Blincyto™ / Blinatumomab / AMG103 / MT103 (Amgen)

6.2.1.1. Company Overview

6.2.1.1.1. Financial Performance

6.2.1.2. Drug Overview

6.2.1.2.1. Mechanism of Action and Targets

6.2.1.2.2. Dosage

6.2.1.2.3. Current Development Status

6.2.1.2.4. Development Process

6.2.1.2.5. Annual Sales

6.2.2. Hemlibra® / Emicizumab / RG6013 / ACE910 / RO5534262 (Chugai Pharmaceutical / Roche)

6.2.2.1. Company Overview

6.2.2.1.1. Financial Performance

6.2.2.2. Drug Overview

6.2.2.2.1. Mechanism of Action and Targets

6.2.2.2.2. Dosage

6.2.2.2.4. Development Process

6.2.2.2.5. Annual Sales

6.3. Late Stage Drug Profiles

6.4. RG7716 / RO6867461 / Faricimab (Roche / Genentech)

6.4.1 Drug Overview

6.5. Ozoralizumab / TS-152 / ATN103 (Ablynx / Eddingpharm / Taisho Pharmaceuticals)

6.5.1 Drug Overview

6.6. ABT-165 (AbbVie)

6.6.1 Overview of Drug, Current Development Status and Clinical Results

6.7. ABY-035 (Affibody)

6.7.1. Drug Overview

6.8. AFM13 (Affimed)

6.8.1 Drug Overview

6.9. AMG 570 / MEDI0700 (Amgen)

6.9.1. Drug Overview

6.10. KN026 (Alphamab)

6.10.1. Drug Overview

6.11. KN046 (Alphamab)

6.11.1. Drug Overview

6.12. M1095 / ALX-0761 (Merck / Ablynx / Avillion)

6.12.1. Drug Overview

6.13. M7824 / Bintrafusp Alfa (Merck / GlaxoSmithKline)

6.13.1. Drug Overview

6.14. MCLA-128 (Merus)

6.14.1. Drug Overview

6.15. MEDI3902 / Gremubamab (MedImmune /AstraZeneca)

6.15.1. Drug Overview

6.16. Drug Overview

6.17. REGN1979 (Regeneron)

6.17.1. Drug Overview 6.18. ZW25 (Zymeworks)

6.18.1. Drug Overview

7 KEY INSIGHTS

7.1. Chapter Overview

7.2. Bispecific Antibody Therapeutics: Analysis by Therapeutic Area and Phase of Development

7.3. Bispecific Antibody Therapeutics: Spider-Web Analysis based on Mechanism of Action

7.4. Bispecific Antibody Therapeutics: Two-Dimensional Scatter Plot Analysis based on Target Combinations

7.4.1 Key Parameters

7.5. Logo Landscape: Analysis of Developers by Company Size

8 BENCHMARK ANALYSIS: BIG PHARMA PLAYERS

8.1. Chapter Overview

8.2. Top Pharmaceutical Companies

8.2.1. Analysis by Target Antigen

8.2.2. Analysis by Type of Antibody Format

8.2.3. Analysis by Mechanism of Action

8.2.4. Analysis by Therapeutic Area

8.2.5. Analysis by Type of Partnership

9 PARTNERSHIPS AND COLLABORATIONS

9.1. Chapter Overview

9.2. Partnership Models

9.3. Bispecific Antibody Therapeutics: Partnerships and Collaborations

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. Most Active Developers: Analysis by Number of Partnerships

9.3.5. Most Active Contract Manufacturers: Analysis by Number of Manufacturing Agreements

9.3.6. Regional Analysis

9.3.7. Intercontinental and Intracontinental Agreements

10 CONTRACT SERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS

10.1. Chapter Overview

10.2. Manufacturing of Bispecific Antibody Therapeutics

10.2.1. Key Manufacturing Considerations and Challenges

10.2.2. Contract Manufacturing Organizations (CMOs)

10.2.2.1. Introduction to CMOs

10.2.2.2. Bispecific Antibody Therapeutics: List of CMOs

10.2.3. Contract Research Organizations (CROs)

10.2.3.1. Introduction to CROs

10.2.3.2. Bispecific Antibody Therapeutics: List of CROs

10.3. Key Considerations for Selecting a Suitable CMO / CRO Partner

11 CLINICAL TRIAL ANALYSIS

11.1. Chapter Overview

11.2. Methodology

11.3. Bispecific Antibody Therapeutics: Clinical Trial Analysis

11.3.1. Analysis by Trial Registration Year

11.3.2. Analysis by Trial Recruitment Status

11.3.3. Analysis by Trial Phase

11.3.4. Analysis by Trial Design

11.3.5. Analysis by Disease Indication

11.3.6. Analysis by Therapeutic Area

11.3.7. Most Active Players

11.3.8. Analysis by Number of Clinical Trials and Geography

11.3.9. Analysis by Enrolled Patient Population and Geography

12 CASE STUDY: REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES

12.1. Chapter Overview

12.2. Guidelines Issued by Regulatory Authorities

12.2.1. US Food and Drug Administration (FDA)

12.2.1.1. Pharma Companies Response to the FDA Draft Guidance

12.2.2. World Health Organization (WHO)

12.2.3. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

13 CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES

13.1. Chapter Overview

13.2. Overview of Channels Used for Promotional Campaigns

13.3. Summary: Product Website Analysis

13.4. Summary: Patient Support Services and Informative Downloads

13.5. Promotional Analysis: Blincyto™

13.5.1. Drug Overview

13.5.2. Product Website analysis

13.5.2.1. Messages for Healthcare Professionals

13.5.2.1.1. For MRD Positive B‑cell precursor ALL

13.5.2.1.2. For Relapsed or Refractory B-cell precursor ALL

13.5.2.2. Message for Patients

13.5.3. Patient Support Services and Informative Downloads

13.5.4. Other Promotional Strategies

13.5.4.1. Presence in Conferences

13.6. Promotional Analysis: Hemlibra®

13.6.1. Drug Overview

13.6.2. Product Website Analysis

13.6.2.1. Messages for Healthcare Professionals

13.6.2.1.1. For Hemophilia A without Factor VIII Inhibitors

13.6.2.1.2. For Hemophilia A with Factor VIII Inhibitors

13.6.2.3. Messages for Patients

13.6.3. Patient Support Services and Informative Downloads

13.6.3.1. Co-pay Program

13.6.3.2. Independent Co-pay Assistance Foundation

13.6.3.3. Genentech Patient Foundation

13.6.4. Other Promotional Strategies

13.6.4.1. Presence in Conferences

14 SWOT ANALYSIS

14.1. Chapter Overview

14.2. Strengths

14.3. Weaknesses

14.4. Opportunities

14.5. Threats

14.6. Concluding Remarks

15 MARKET FORECAST AND OPPORTUNITY ANALYSIS

15.1. Chapter Overview

15.2. Scope and Limitations

15.3. Forecast Methodology and Key Assumptions

15.4. Overall Bispecific Antibody Therapeutics Market, 2019-2030

15.4.1. Bispecific Antibody Therapeutics Market: Analysis by Therapeutic Area

15.4.2. Bispecific Antibody Therapeutics Market: Analysis by Mechanism of Action

15.4.3. Bispecific Antibody Therapeutics Market: Analysis by Target Antigen

15.4.4. Bispecific Antibody Therapeutics Market: Analysis by Antibody Format

15.4.5. Bispecific Antibody Therapeutics Market: Analysis by Key Players

15.4.6. Bispecific Antibody Therapeutics Market: Analysis by Geography

15.5. Bispecific Antibody Market: Value Creation Analysis

15.6. Bispecific Antibody Therapeutics Market: Product-wise Sales Forecasts

15.6.1. Blincyto

15.6.1.1. Target Patient Population

15.6.1.2. Sales Forecast

15.6.1.3. Net Present Value

15.6.1.4. Value Creation Analysis

15.6.2. Hemlibra

15.6.2.1. Target Patient Population

15.6.2.2. Sales Forecast

15.6.2.3. Net Present Value

15.6.2.4. Value Creation Analysis

15.6.3. RG7716

15.6.3.1. Target patient Population

15.6.3.2. Sales Forecast

15.6.3.3. Net Present Value

15.6.3.4. Value Creation Analysis

15.6.4. Ozoralizumab

15.6.4.1. Target Patient Population

15.6.4.2. Sales Forecast

15.6.4.3. Net Present Value

15.6.4.4. Value Creation Analysis

15.6.5. ABY-035

15.6.5.1. Target Patient Population

15.6.5.2. Sales Forecast

15.6.5.3. Net Present Value

15.6.5.4. Value Creation Analysis

15.6.6. AFM13

15.6.6.1. Target Patient Population

15.6.6.2. Sales Forecast

15.6.6.3. Net Present Value

15.6.6.4. Value Creation Analysis

15.6.7. M1095

15.6.7.1. Target Patient Population

15.6.7.2. Sales Forecast

15.6.7.3. Net Present Value

15.6.7.4. Value Creation Analysis

15.6.8. MEDI3902

15.6.8.1. Target Patient Population

15.6.8.2. Sales Forecast

15.6.8.3. Net Present Value

15.6.8.4. Value Creation Analysis

15.6.9. ABT-981

15.6.9.1. Target Patient Population

15.6.9.2. Sales Forecast

15.6.9.3. Net Present Value

15.6.9.4. Value Creation Analysis

15.6.10. SAR156597

15.6.10.1. Target Patient Population

15.6.10.2. Sales Forecast

15.6.10.3. Net Present Value

15.6.10.4. Value Creation Analysis

16 CONCLUDING REMARKS

17 EXECUTIVE INSIGHTS

17.1. Chapter Overview

17.2. CytomX Therapeutics

17.2.1. Company Snapshot

17.2.2. Interview Transcript: Siobhan Pomeroy, Senior Director, Business Development (Q3 2017)

17.3. F-star

17.3.1. Company Snapshot

17.3.2. Interview Transcript: Jane Dancer, Chief Business Officer (Q3 2017)

17.4. Innovent Biologics

17.4.1. Company Snapshot

17.4.2. Interview Transcript: Yinjue Wang, Associate Director, Process Development (Q3 2017)

17.5. Synimmune

17.4.1. Company Snapshot

17.4.2. Interview Transcript: Ludger Große-Hovest, Chief Scientific Officer, and Martin Steiner, Chief Executive Officer

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The “Liquid Biopsy and Other Non-Invasive Cancer Diagnostics Market (3rd Edition), 2019-2030: Focus on Circulating Tumor Markers such as CTCs, ctDNA, cfDNA, Exosomes and Other Biomarkers” report features an extensive study of the current market landscape,

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

To order this 350+ page report, please visit this link

Key Inclusions

A detailed review of the overall landscape of the non-invasive cancer diagnostics market, featuring information on the developers of such products and analyses based on a number of relevant parameters, such as year of establishment, company size, geographical location, current development status of proprietary liquid biopsy test (under development, research use only, and available), type of product (assay kit, software / algorithm and device), type of tumor marker analyzed (CTCs, ctDNA, cfDNA, exosomes, and others), key applications (early diagnosis, treatment selection, patient monitoring and recurrence monitoring), type of analyte used (blood, urine and others) and target cancer indications.
An analysis of the various partnerships pertaining to non-invasive cancer diagnostics, which have been established between 2016 and 2019, based on various parameters, such as type of partnership, year of partnership, type of tumor marker, target cancer indications and the most active players.
An analysis of the investments made in companies engaged in the development of non-invasive cancer diagnostics, including details of seed financing, venture capital financing, debt financing, grants, and capital raised via IPOs and subsequent public offerings.
An analysis of the initiatives of big pharma players, highlighting the key focus areas of such companies and analysis based on various relevant parameters, such as stage of development of their proprietary non-invasive cancer diagnostic test(s), key applications, type of tumor marker and target disease indications.
A detailed acquisition target analysis, taking into consideration the historical trend of the activity of the companies that have acquired other firms since 2016, and offering a means for other industry stakeholders to identify potential acquisition targets.
Elaborate profiles of the key players engaged in this domain, featuring a brief overview of the company, its financial information (if available), a detailed description of its product portfolio, recent developments and an informed future outlook
Informed estimates of the existing market size and the future growth opportunities for non-invasive cancer diagnostics. Based on various parameters, such as number of available / under development products and estimated annual adoption rates, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030.

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

Type of Tumor Marker

ctDNA
cfDNA
CTCs
Exosomes
Others

Application

Diagnosis / Early Diagnosis
Patient Monitoring
Recurrence Monitoring

Target Cancer Indication

Breast Cancer
Lung Cancer

Press Release: Variation 4 (Format 5)

Colorectal Cancer
Prostate Cancer
Bladder Cancer
Melanoma
Gastric Cancer
Pancreatic Cancer
Ovarian Cancer
Others

End Users

Hospitals
Research Institutes
Others

Key Geographical Regions

North America
Europe

Asia-Pacific
Rest of the World

The report also features inputs from eminent industry stakeholders, according to whom liquid biopsy has the potential to diagnose cancer at a very early stage by analyzing rare circulating tumour markers, thereby, facilitating appropriate / timely treatment decisions. The report includes detailed transcripts of discussions held with the following experts:

Joachim Fluhrer, Founder and Medical Director, Genostics
Shibichakravarthy Kannan, Founder and CEO, Theranosis Life Sciences
Abizar Lakdawalla, Founder, ProXeom
Philippe Nore, CEO and Co-founder, MiNDERA
Frank Szczepanski, President and CEO, IVDiagnostics
Mark Li, CEO, Resolution Bioscience
Brad Walsh, CEO, Minomic International
Anton Iliuk, President and Chief Technology Officer, Tymora Analytical Operations
Burkhard Jansen, Chief Medical Officer, DermTech
Christer Ericsson, Chief Scientific Officer, iCellate Medical
Jake Micallef, Chief Scientific Officer, VolitionRx
Nathalie Bernard, Marketing Director, OncoDNA
Riccardo Razzini, Sales and Marketing Manager, LCM Genect
Peter French, Strategic Technology Advisor, Sienna Cancer Diagnostics

To request sample pages, please visit this link

Key Questions Answered

What are the prevalent trends within the liquid biopsy market?
What are the key applications of liquid biopsy?
Apart from liquid biopsy, what are the other novel non-invasive cancer diagnostics?
What is the role of big pharma players in the non-invasive cancer diagnostics domain?
What are the prevalent financing and investment trends within the liquid biopsy market?
What are the most popular cancer indications for which non-invasive diagnostics are being developed?
Who are the key service providers for liquid biopsy products?
How is the current and future market opportunity likely to be distributed across key market segments?

Press Release: Variation 4 (Format 5)

You may also be interested in the following titles:

Contact Us:

Gaurav Chaudhary

+1 (415) 800 3415

+44 (122) 391 1091

Gaurav.Chaudhary@rootsanalysis.com

Nearly 300 non-invasive diagnostic tests, designed for the detection of various types of cancers, are either already available in the market or under development across the world

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

Given the invasive and cost-intensive nature of tissue biopsies, there is a significant unmet need for safer and more patient-friendly cancer diagnostics that are capable of offering highly accurate, and actionable insights related to the disease.

To order this 350+ page report, which features 150+ figures and 200+ tables, please visit this link

The financial opportunity within the liquid biopsy and other non-invasive cancer diagnostics market has been analyzed across the following segments:

Type of Tumor Marker

ctDNA
cfDNA
CTCs
Exosomes
Others

Application

Diagnosis / Early Diagnosis
Patient Monitoring
Recurrence Monitoring

Target Cancer Indication

Breast Cancer
Lung Cancer
Colorectal Cancer
Prostate Cancer
Bladder Cancer
Melanoma
Gastric Cancer
Pancreatic Cancer
Ovarian Cancer
Others

End Users

Hospitals
Research Institutes
Others

Key Geographical Regions

North America
Europe
Asia-Pacific
Rest of the World

The Liquid Biopsy and Other Non-Invasive Cancer Diagnostics Market (3rd Edition), 2019-2030: Focus on Circulating Tumor Markers such as CTCs, ctDNA, cfDNA, Exosomes and Other Biomarkers report features the following companies, which we identified to be key players in this domain:

Amoy Diagnostics
DiaCarta
HaploX Biotechnology
NeoGenomics
QIAGEN
Swift Biosciences
Sysmex Inostics
Thermo Fisher Scientific

Press Release: Variation 3 (Format 4)

Table of Contents

Preface

2. Executive Summary
Introduction

Non-Invasive Cancer Screening and Diagnosis
Market Landscape

Company Profiles
Partnerships and Collaborations

Funding and Investment Analysis
Liquid Biopsy: Initiatives of Big Pharma Players
Key Acquisition Targets

Other Non-Invasive Cancer Diagnostics
Market Sizing and Opportunity Analysis
Survey Insights

Conclusion
Executive Insights

Appendix 1: Tabulated Data

Appendix 2: List of Companies and Organizations

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Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

The non-invasive cancer diagnostics market is projected to grow at an annualized rate of ~20%, till 2030

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

Roots Analysis has done a detailed study on Liquid Biopsy and Other Non-Invasive Cancer Diagnostics Market (3rd Edition), 2019-2030: Focus on Circulating Tumor Markers such as CTCs, ctDNA, cfDNA, Exosomes and Other Biomarkers, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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Key Market Insights

Presently, nearly 300 non-invasive diagnostic tests, designed for the detection of various types of cancers, are either already available in the market or under development across the world
Several modern diagnostic tests claim to be capable of offering results in relatively short time periods, thereby, facilitating early diagnosis that is particularly beneficial in the treatment of different types of cancers
Over time, big pharma players have initiated product development programs, having invested significant capital, time and effort, on non-invasive diagnostic solutions for use across different oncological indications
Investors, having realized the untapped opportunity within this emerging segment of the cancer diagnostics market, have invested over USD 3 billion across 120 instances in the period between 2015 and 2019
The growing interest in this field is also reflected in the partnership activity; deals inked in the recent past are focused on a diverse range of tumor markers, involving both international and indigenous stakeholders
The projected future opportunity is anticipated to be driven by increasing patient population and distributed across various disease indications and application areas across key geographies
These tests are capable of detecting diverse tumor markers that cater to the needs of different stakeholders; in fact, opinions of industry experts confirm the vast potential of liquid biopsies in disease diagnosis / monitoring

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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 Statistics and Burden of the Disease

3.3. Importance of Early Cancer Detection

3.4. Cancer Screening and Diagnosis

3.5. Conventional Invasive Cancer Diagnostic Tests

3.5.1. Biopsy

3.5.1.1. Fine Needle Aspiration Biopsy

3.5.1.2. Core Needle Biopsy

3.5.1.3. Vacuum-Assisted Biopsy

3.5.1.4. Image-Guided Biopsy

Press Release: Variation 2 (Format 3)

3.5.1.5. Sentinel Node Biopsy

3.5.1.6. Surgical Biopsy

3.5.1.7. Endoscopic Biopsy

3.5.1.8. Bone Marrow Biopsy

3.5.2. Endoscopy

3.6. Need for Non-Invasive Approaches

3.7. Liquid Biopsy: Diagnosing Circulating Biomarkers

3.7.1. Circulating Tumor Cells

3.7.2. Circulating Tumor DNA

3.7.3. Exosomes

3.8. Costs and Benefits Associated with Liquid Biopsy and Non-Invasive Tests

3.9. Emerging Trends in Intellectual Property Related to Non-Invasive Cancer Diagnostics

3.10. Challenges Associated with Non-Invasive Cancer Diagnostics

3.11. Future Perspectives

NON-INVASIVE CANCER SCREENING AND DIAGNOSIS

4.1. Chapter Overview

4.2. Diagnostic Imaging

4.2.1. Magnetic Resonance Imaging (MRI)

4.2.2. Mammography

4.2.3. Bone Scan

4.2.4. Computerized Tomography (CT) Scan

4.2.5. Integrated Positron Emission Tomography (PET)-CT Scan

4.2.6. Ultrasound

4.2.7. X-ray Radiography (Barium Enema)

4.3. Screening Assays

4.3.1. Circulating Tumor Marker Test

4.3.2. Digital Rectal Exam (DRE)

4.3.3. Fecal Occult Blood Test (FOBT)

4.3.4. Multigated Acquisition (MUGA) Scan

4.3.5. Papanicolaou Test and Human Papilloma Virus Test

4.4. Advanced Non-Invasive Approaches

4.4.1. Cytogenetic / Gene Expression Studies

4.4.2. Molecular Signature-based Non-Invasive Methods

4.4.3. Saliva-based Oral Cancer Diagnostics

4.4.4. Vital Staining

4.4.5. Optical Biopsy

4.4.6. Other Diagnostic Techniques

MARKET LANDSCAPE

5.1. Chapter Overview

5.2. Liquid Biopsy Products: List of Developers

5.2.1. Analysis by Year of Establishment

5.2.2. Analysis by Company Size and Geographical Location

5.2.3. Leading Players

5.2.4. Analysis by Geography

5.3. Liquid Biopsy Products: List of Available / Under Development Products

5.3.1. Analysis by Status of Development

5.3.2. Analysis by Type of Product

5.3.3. Analysis by Application Area

Press Release: Variation 2 (Format 3)

5.3.4. Analysis by Target Cancer Indication

5.3.5. Analysis by Type of Tumor Marker

5.3.6. Analysis by End User

5.3.7. Analysis by Turnaround Time

5.4. Liquid Biopsy Products: List of Other Products, Kits and Consumables

5.5. Liquid Biopsy Products: List of Contract Service Providers

COMPANY PROFILES

6.1. Chapter Overview

6.2. Amoy Diagnostics

6.2.1. Company Overview

6.2.2. Financial Information

6.2.3. Liquid Biopsy Product Portfolio

6.2.4. Recent Developments and Future Outlook

6.3. DiaCarta

6.3.1. Company Overview

6.3.2. Liquid Biopsy Product Portfolio

6.3.3. Recent Developments and Future Outlook

6.4. HaploX

6.4.1. Company Overview

6.4.2. Liquid Biopsy Product Portfolio

6.4.3. Recent Developments and Future Outlook

6.5. NeoGenomics

6.5.1. Company Overview

6.5.2. Financial Information

6.5.3. Liquid Biopsy Product Portfolio

6.5.4. Recent Developments and Future Outlook

6.6. QIAGEN

6.6.1. Company Overview

6.6.2. Financial Information

6.6.3. Liquid Biopsy Product Portfolio

6.6.4. Recent Developments and Future Outlook

6.7. Swift Biosciences

6.7.1. Company Overview

6.7.2. Liquid Biopsy Product Portfolio

6.7.3. Recent Developments and Future Outlook

6.8. Sysmex Inostics

6.8.1. Company Overview

6.8.2. Liquid Biopsy Product Portfolio

6.8.3. Recent Developments and Future Outlook

6.9. Thermo Fisher Scientific

6.9.1. Company Overview

6.9.2. Financial Information

6.9.3. Liquid Biopsy Product Portfolio

6.9.4. Recent Developments and Future Outlook

PARTNERSHIPS AND COLLABORATIONS

7.1. Chapter Overview

Press Release: Variation 2 (Format 3)

7.2. Partnership Models

7.3. List of Partnerships and Collaborations

7.3.1. Analysis by Year of Partnership

7.3.2. Analysis by Type of Partnership

7.3.3. Analysis by Type of Tumor Marker

7.3.4. Analysis by Target Cancer Indication

7.3.5. Analysis by Type of Partner

7.3.6. Most Active Players: Analysis by Number of Partnerships

7.3.7. Regional Analysis

7.3.7.1. Intercontinental and Intracontinental Agreements

FUNDING AND INVESTMENT ANALYSIS

8.1. Chapter Overview

8.2. Types of Funding

8.3. List of Funding and Investment Instances

8.3.1. Analysis by Number of Funding Instances

8.3.2. Analysis by Amount Invested

8.3.3. Analysis by Type of Funding

8.3.4. Analysis by Target Cancer Indication

8.3.5. Analysis by Type of Tumor Marker

8.3.6. Most Active Players: Analysis by Amount Invested

8.3.7. Most Active Investors: Analysis by Number of Funding Instances

8.3.8. Regional Analysis by Amount Invested

8.4. Concluding Remarks

LIQUID BIOPSY: INITIATIVES OF BIG PHARMA PLAYERS

9.1. Chapter Overview

9.2. Top Pharmaceutical Companies

9.2.1. Analysis by Status of Development

9.2.2. Analysis by Type of Tumor Marker

9.2.3. Analysis by Application Area

9.2.4. Analysis by Target Cancer Indication

KEY ACQUISITION TARGETS

10.1. Chapter Overview

10.2. Scope and Methodology

10.3. Scoring Criteria and Key Assumptions

10.4. Potential Strategic Acquisition Targets in North America

10.5. Potential Strategic Acquisition Targets in Europe

10.6. Potential Strategic Acquisition Targets in Asia-Pacific / Rest of the World

10.7. Concluding Remarks

OTHER NON-INVASIVE CANCER DIAGNOSTICS

11.1. Chapter Overview

11.2. Non-Blood-based Biomarker Detection Tests

11.3. FOBT and Fecal Immunochemical Tests (FIT)

11.4. Pigmented Lesion Assays

11.5. Stool DNA (sDNA)-based Tests

11.6. Volatile Organic Compound (VOC) Detection Tests

11.7. Other Non-Invasive Cancer Diagnostics: Market Landscape

MARKET SIZING AND OPPORTUNITY ANALYSIS

12.1. Chapter Overview

12.2. Key Assumptions and Forecast Methodology

Press Release: Variation 2 (Format 3)

12.3. Global Non-Invasive Cancer Diagnostics Market, 2019-2030

12.3.1. Global Liquid Biopsy Market, 2019-2030

12.3.1.1. Global Liquid Biopsy Market: Distribution by Application Area, 2019-2030

12.3.1.1.1. Global Liquid Biopsy Market for Early Diagnosis, 2019-2030

12.3.1.1.2. Global Liquid Biopsy Market for Patient Monitoring, 2019-2030

12.3.1.1.3. Global Liquid Biopsy Market for Recurrence Monitoring, 2019-2030

12.3.1.2. Global Liquid Biopsy Market: Distribution by Target Cancer Indication, 2019-2030

12.3.1.2.1. Global Liquid Biopsy Market for Breast Cancer, 2019-2030

12.3.1.2.2. Global Liquid Biopsy Market for Lung Cancer, 2019-2030

12.3.1.2.3. Global Liquid Biopsy Market for Colorectal Cancer, 2019-2030

12.3.1.2.4. Global Liquid Biopsy Market for Prostate Cancer, 2019-2030

12.3.1.2.5. Global Liquid Biopsy Market for Bladder Cancer, 2019-2030

12.3.1.2.6. Global Liquid Biopsy Market for Melanoma, 2019-2030

12.3.1.2.7. Global Liquid Biopsy Market for Gastric Cancer, 2019-2030

12.3.1.2.8. Global Liquid Biopsy Market for Pancreatic Cancer, 2019-2030

12.3.1.2.9. Global Liquid Biopsy Market for Ovarian Cancer, 2019-2030

12.3.1.3. Global Liquid Biopsy Market: Distribution by Type of Tumor Marker, 2019-2030

12.3.1.3.1. Global Liquid Biopsy Market for ctDNA, 2019-2030

12.3.1.3.2. Global Liquid Biopsy Market for cfDNA, 2019-2030

12.3.1.3.3. Global Liquid Biopsy Market for CTCs, 2019-2030

12.3.1.3.4. Global Liquid Biopsy Market for Exosomes, 2019-2030

12.3.1.3.5. Global Liquid Biopsy Market for Other Tumor Markers, 2019-2030

12.3.1.4. Global Liquid Biopsy Market: Distribution by Type of Analyte, 2019-2030

12.3.1.4.1. Global Liquid Biopsy Market for Blood, 2019-2030

12.3.1.4.2. Global Liquid Biopsy Market for Other Body Fluids, 2019-2030 (USD Billion)

12.3.1.5. Global Liquid Biopsy Market: Distribution by End User, 2019-2030

12.3.1.5.1. Global Liquid Biopsy Market for Hospitals, 2019-2030

12.3.1.5.2. Global Liquid Biopsy Market for Research Institutes, 2019-2030

12.3.1.5.3. Global Liquid Biopsy Market for Other End Users, 2019-2030

12.3.1.6. Global Liquid Biopsy Market: Distribution by Geography, 2019-2030

12.3.1.6.1. Liquid Biopsy Market in the US, 2019-2030

12.3.1.6.2. Liquid Biopsy Market in the UK, 2019-2030

12.3.1.6.3. Liquid Biopsy Market in Germany, 2019-2030

12.3.1.6.4. Liquid Biopsy Market in France, 2019-2030

12.3.1.6.5. Liquid Biopsy Market in Italy, 2019-2030

12.3.1.6.6. Liquid Biopsy Market in Spain, 2019-2030

12.3.1.6.7. Liquid Biopsy Market in Japan, 2019-2030

12.3.1.6.8. Liquid Biopsy Market in China, 2019-2030

12.3.1.6.9. Liquid Biopsy Market in India, 2019-2030

12.3.1.6.10. Liquid Biopsy Market in Australia, 2019-2030

12.3.2. Other Non-Invasive Cancer Diagnostics Market Forecast, 2019-2030

SURVEY INSIGHTS

13.1. Chapter Overview

13.2. Company Specifics of Respondents

13.3. Designation of Respondents

13.4. Type of Product Portfolio

13.5. Types of Products / Services Offered

13.6. Application Area

Press Release: Variation 2 (Format 3)

13.7. Status of Development of the Products

13.8. Likely Market Size

CONCLUSION

14.1. Timely Disease Detection and Subsequent Monitoring are Critical Elements of Patient Care

in the Field of Oncology

14.2. Introduction of Sophisticated Molecular Diagnostics has Facilitated Better Cancer

Management

14.3. Liquid Biopsy has Emerged as a Reliable Alternative to the Invasive Methods of Diagnosis

14.4. The Versatile and Patient Friendly Nature of these Diagnostic Tools Cater to a Wide Range

of Applications

14.5. The Interest is Gradually Rising with Participation of Several Start-ups Across Different

Geographies

14.6. In Addition to Liquid Biopsy, Development of Other Non-Invasive Tests will Further

Strengthen the Ongoing Innovation

14.7. Rising Venture Capital Support is Indicative of a Lucrative Future Potential

14.8. Primarily Led by Liquid Biopsy, the Non-Invasive Cancer Diagnostics Market has Emerged

as a Multi-Billion Dollar Market

EXECUTIVE INSIGHTS

15.1. Chapter Overview

15.2. Interview Transcript: Shibichakravarthy Kannan, Founder & Chief Executive Officer,

Theranosis Life Sciences

15.3. Interview Transcript: Anton Iliuk, President and Chief Technology Officer, Tymora Analytical

Operations

15.4. Interview Transcript: Peter French, Strategic Technology Advisor, Sienna Cancer

Diagnostics

15.5. Interview Transcript: Joachim Fluhrer, Founder and Medical Director, Genostics

15.6. Interview Transcript: Brad Walsh, Chief Executive Officer, Minomic International

15.7. Interview Transcript: Catalina Vasquez, Chief Operating Officer, Nanostics

15.8. Interview Transcript: Burkhard Jansen, Chief Medical Officer, DermTech

15.9. Interview Transcript: Frank Szczepanski, President and CEO, IVDiagnostics

15.10. Interview Transcript: Riccardo Razzini, Sales and Marketing Manager, LCM Genect

15.11. Interview Transcript: Nathalie Bernard, Marketing Director, OncoDNA

15.12. Interview Transcript: Abizar Lakdawalla, Founder, Proxeom

15.13. Interview Transcript: Mark Li, CEO, Resolution Bioscience

15.14. Interview Transcript: Christer Ericsson, Chief Scientific Officer, iCellate Medical

15.15. Interview Transcript: Philippe Nore, CEO and Co-founder, MiNDERA

15.16. Interview Transcript: Jake Micallef, Chief Scientific Officer, VolitionRx

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

The “Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030” report features an extensive study of the current market landscape of companies offering human factors engineering and usability testing services for medi

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

To order this detailed 200+ page report, please visit this link

Key Inclusions

A detailed assessment of the current market landscape of companies offering HFE and usability testing services based on several relevant parameters, including developer information (year of establishment, company size and location of headquarters), types of certifications obtained, types of HFE services offered in the concept phase (user research and use error risk analysis and management), design and development phase (prototype development and designing and interface development and designing), verification and validation phase (usability inspection, formative studies / usability verification, pre-validation testing / clinical trial, and summative studies / usability validation) and documentation / file compilation phase, types of other services offered (regulatory guidance, packaging and labeling, training and post market surveillance) and types of medical devices designed by the company (drug delivery devices, clinical use / care devices, diagnostic devices, therapeutic devices, home use medical devices and different laboratory and surgical equipment).
A detailed company competitiveness analysis of HFE and usability testing service providers, taking into consideration the supplier power (based on the year of establishment of developer) and other key specifications (such as core services offered, other services offered and types of medical devices designed) of players.
An elaborate discussion on the various guidelines established by major regulatory bodies, governing medical device HFE and usability testing services, across different regions.
A detailed discussion on the cost implications across various steps of the HFE and usability testing process.
Profiles of HFE and usability testing service providers (shortlisted on the basis of the number of services offered), featuring an overview of the company, details related to their HFE and usability testing service portfolio and an informed future outlook.
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 HFE and usability testing services market.

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

Type of tools used
Generative tools
Evaluative tools

Type of steps involved
Contextual analysis
Task analysis
Design analysis
Formative studies
Use risk analysis
Known use error analysis
Summative studies
Regulatory document preparation’

Device class
Class I medical devices
Class II medical devices
Class III medical devices

Key geographical regions
North America
Europe
Asia Pacific

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Key Questions Answered

Who are the leading players providing human factors engineering and usability testing services to medical device developers?
What is the cost associated with different steps of the human factors engineering and usability testing process for medical devices?
What kind of cost savings can be achieved through the adoption of the human factors engineering and usability testing approach for medical device development?
In the past, how has the adoption of human factors engineering and usability testing approaches impacted medical device recall rates?
How do the guidelines for human factors engineering and usability testing for medical devices, differ across key global regions?
What are the prevalent and emerging trends within the human factors engineering and usability testing service providers market?
How is the recent COVID-19 pandemic likely to impact human factors engineering and usability testing services market?
How is the current and future 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

More than 90 companies claim to offer human factors engineering and usability testing services, catering to needs across different stages of the medical device development process, for medical devices, claims Roots Analysis

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

Human factors engineering and usability testing have now become an essential part of product design across almost all industries, offering developers the chance to optimize proprietary products in alignment to the preferences of consumers

To order this 200+ page report, which features 120+ figures and 100+ tables, please visit this link

The USD 1 Billion (by 2030) financial opportunity within the human factors engineering and usability testing market has been analysed across the following segments:

Type of tools used
Generative tools
Evaluative tools

Type of steps involved
Contextual analysis
Task analysis
Design analysis
Formative studies
Use risk analysis
Known use error analysis
Summative studies
Regulatory document preparation’

Device class
Class I medical devices
Class II medical devices
Class III medical devices

Key geographical regions
North America
Europe
Asia Pacific

The Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030 report features the following companies, which we identified to be key players in this domain:

Agilis
Human Factors Consulting Service
Human Factors MD
User wise
Ximedica
Austrian Center for Medical Innovation and Technology (ACIMT)
Auxergo
THAY Medical
Ergotech
Jonathan Bar-Or Industrial Design

Table of Contents

Preface

2. Executive Summary
Introduction
Regulatory Landscape
Service Provider Landscape

Company Competitive Analysis
Company Profiles
Cost Implications Related to Human Factors Engineering and Usability Testing Process
Case Study: Medical Devices Recalls and Role of Human Factors Engineering
Market Forecast and Opportunity Analysis

Case Study: Impact of COVID-19 Pandemic on Human Factors Engineering and Usability Testing Services Market
SWOT 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/human-factors-engineering-and-usability-testing-services.html

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

The human factors engineering and usability testing service market is projected to grow at an annualized rate of ~14%, till 2030

www.rootsanalysis.com
Submitted 35 day(s) ago by Alberto Brando

Roots Analysis has done a detailed study on Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

To order this 200+ page report, which features 120+ figures and 100+ tables, please visit this link

Key Market Insights

Over time, a number of medical devices have been recalled due to various reasons; therefore, presently, HFE and usability testing is being perceived as a fundamental necessity in order to drive product development efforts
Currently, more than 90 companies claim to offer human factors engineering and usability testing services, catering to needs across different stages of the medical device development process
The market landscape is highly fragmented, featuring the presence of several well-established players and new entrants, many of which have varied service portfolios, focused on different types of medical devices
Players involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and gain an advantage over competitor firms
As device developers continue to rely on specialty service providers for critical inputs on device design, the HFE and usability testing services market is anticipated to register double digit growth in the long term

For more information, please visit https://www.rootsanalysis.com/reports/human-factors-engineering-and-usability-testing-services.html

Table of Contents

1. 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. Overview of Human Factors Engineering and Usability Testing

3.2.1. Human Factors Engineering (HFE)

3.2.2. Usability Testing

3.2.3. Ergonomics and Hedonomics

3.3. Human Factors Considerations for Medical Device Design

3.3.1. Users

3.3.2. Use Environment

3.3.3. Device-User Interface

3.4. Human Factors and Usability Testing Process

3.5. Advantages of Outsourcing HFE Testing Operations

3.6. Risks and Challenges Associated with Outsourcing HFE Testing Services

3.7. Key Considerations for Selecting an HFE and Usability Testing Partner

REGULATORY LANDSCAPE

4.1. Chapter Overview

4.2. Key Regulatory Authorities on Human Factors and Usability Testing Services

4.3. Regulatory Landscape in North America

4.3.1. FDA Recognized Standards on Human Factors

4.3.2. FDA Guidance Documents related to Human Factors

4.3.3. FDA Human Factors Engineering Process

4.4. Regulatory Landscape in Europe

4.4.1. EU-Recognized Standards on Human Factors

4.4.2. EU Human Factors Engineering Process

4.5. Human Factors Engineering Pathway: Comparison of Guidelines in the US and EU

4.5.1. Alignment between Regulations in the US and EU

4.5.2. Abbreviated Human Factors Engineering and Usability Testing

4.6. Concluding Remarks

SERVICE PROVIDER LANDSCAPE

5.1. Chapter Overview

5.2. Human Factors Engineering and Usability Testing Service Providers for Medical Devices: Overall Market Landscape

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 Types of Certifications Obtained

5.2.5. Analysis by Types of Medical Device Designed

5.2.6. Analysis by Types of Human Factors Engineering and Usability Testing Services Offered

5.2.6.1. Analysis by Types of Services Offered in the Concept Phase

5.2.6.2. Analysis by Types of Services Offered in the Design and Development Phase

5.2.6.3. Analysis by Types Services Offered in the Verification and Validation Phase

5.2.7. Analysis by Other Services Offered

5.3. Human Factors Engineering and Usability Testing Service Providers for Medical Devices Software: Overall Market Landscape

5.3.1. Analysis by Year of Establishment

5.3.2. Analysis by Company Size

5.3.3. Analysis by Location of Headquarters

COMPANY COMPETITIVENESS ANALYSIS

6.1. Chapter Overview

6.2. Assumptions and Key Parameters

6.3. Methodology

6.4. Company Competitiveness Analysis

6.4.1. Human Factors Engineering and Usability Testing Service Providers based in North America

6.4.2. Human Factors Engineering and Usability Testing Service Providers based in Europe

6.4.3. Human Factors Engineering and Usability Testing Service Providers based in Asia

Pacific / RoW

COMPANY PROFILES

7.1. Chapter Overview

7.2. Service Providers in North America

7.2.1. Agilis

7.2.1.1. Company Overview

7.2.1.2. Service Portfolio

7.2.1.3. Future Outlook

7.2.2. Human Factors Consulting Service

7.2.2.1. Company Overview

7.2.2.2. Service Portfolio

7.2.2.3. Future Outlook

7.2.3. Human Factors MD

7.2.3.1. Company Overview

7.2.3.2. Service Portfolio

7.2.3.3. Future Outlook

7.2.4. User wise

7.2.4.1. Company Overview

7.2.4.2. Service Portfolio

7.2.4.3. Future Outlook

7.2.5. Ximedica

7.2.5.1. Company Overview

7.2.5.2. Service Portfolio

7.2.5.3. Future Outlook

7.3. Service Providers in Europe

7.3.1. Austrian Center for Medical Innovation and Technology (ACMIT)

7.3.1.1. Company Overview

7.3.1.2. Service Portfolio

7.3.1.3. Future Outlook

7.3.2. Auxergo

7.3.2.1. Company Overview

7.3.2.2. Service Portfolio

7.3.2.3. Future Outlook

7.3.3. THAY Medical

7.3.3.1. Company Overview

7.3.3.2. Service Portfolio

7.3.3.3. Future Outlook

7.4. Service Providers in Asia Pacific

7.4.1. Ergotech

7.4.1.1. Company Overview

7.4.1.2. Service Portfolio

7.4.1.3. Future Outlook

7.4.2. Jonathan Bar-Or Industrial Design

7.4.2.1. Company Overview

7.4.2.2. Service Portfolio

7.4.2.3. Future Outlook

COST IMPLICATIONS RELATED TO HUMAN FACTORS ENGINEERING AND USABILITY TESTING PROCESS

8.1. Chapter Overview

8.2. Steps involved in Human Factors Engineering and Usability Testing Process

8.3. Cost Distribution across the Different Steps of Human Factors Engineering and Usability Testing Process

8.3.1. Costs Associated with Contextual Inquiry

8.3.2. Costs Associated with Task Analysis

8.3.3. Costs Associated with Human Factors Assessment for Device Design

8.3.4. Costs Associated with Formative Studies

8.3.5. Costs Associated with Risk Analysis

8.3.6. Costs Associated with Use Error Analysis

8.3.7. Costs Associated with Summative Studies

8.3.8 Costs Associated with Regulatory Document Preparation

CASE STUDY: MEDICAL DEVICE RECALLS AND ROLE OF HUMAN FACTORS ENGINEERING

9.1. Chapter Overview

9.2. Medical Device Recalls

9.3. Five Major Medical Device Recalls Till-date

9.3.1. West Pharmaceutical’s Fluid Transfer Systems

9.3.2. Magellan Diagnostics’ Blood Lead Testing Systems

9.3.3. Cook Medical’s Catheters

9.3.4. Abbott’s Cardiac Pacemakers

9.3.5. CareFusion’s Alaris Pump Module

9.4. Human Factors Engineering: Managing the Risk of Device Recalls

9.4.1. Cost Saving Potential Associated with Human Factors Engineering and Usability Testing

MARKET FORECAST AND OPPORTUNITY ANALYSIS

10.1. Chapter Overview

10.2. Key Assumptions and Forecast Methodology

10.3. Overall Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030

10.4. Human Factors Engineering and Usability Testing Services Market: Distribution by Type of Tools Used, 2020, 2025 and 2030

10.4.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools, 2020-2030

10.4.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools, 2020-2030

10.5. Human Factors Engineering and Usability Testing Services Market: Distribution by Types of Steps Involved in Usability Testing, 2020, 2025 and 2030

10.5.1. Human Factors Engineering and Usability Testing Services Market for Contextual Analysis, 2020-2030

10.5.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis, 2020-2030

10.5.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis, 2020-2030

10.5.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies, 2020-2030

10.5.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis, 2020-2030

10.5.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis, 2020-2030

10.5.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies, 2020-2030

10.5.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation, 2020-2030

10.6. Human Factors Engineering and Usability Testing Services Market: Distribution by Device Class, 2020,2025 and 2030

10.6.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices, 2020-2030

10.6.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices, 2020-2030

10.6.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices, 2020-2030

10.7. Human Factors Engineering and Usability Testing Services Market: Distribution by Geography, 2020,2025 and 2030

10.7.1. Human Factors Engineering and Usability Testing Services Market in North America, 2020-2030

10.7.1.1. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Types of Tools, 2020-2030

10.7.1.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in North America, 2020-2030

10.7.1.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in North America, 2020-2030

10.7.1.2. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Types of Steps Involved in Usability Testing, 2020-2030

10.7.1.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in North America, 2020-2030

10.7.1.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in North America, 2020-2030

10.7.1.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in North America, 2020-2030

10.7.1.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in North America, 2020-2030

10.7.1.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in North America, 2020-2030

10.7.1.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in North America, 2020-2030

10.7.1.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in North America, 2020-2030

10.7.1.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in North America, 2020-2030

10.7.1.3. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Distribution by Device Class, 2020-2030

10.7.1.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in North America, 2020-2030

10.7.1.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in North America, 2020-2030

10.7.1.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in North America, 2020-2030

10.7.2. Human Factors Engineering and Usability Testing Services Market in Europe, 2020-2030

10.7.2.1. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Types of Tools, 2020-2030

10.7.2.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in Europe, 2020-2030

10.7.2.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in Europe, 2020-2030

10.7.2.2. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Types of Steps Involved in Usability Testing, 2020-2030

10.7.2.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in Europe, 2020-2030

10.7.2.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in Europe, 2020-2030

10.7.2.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in Europe, 2020-2030

10.7.2.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in Europe, 2020-2030

10.7.2.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in Europe, 2020-2030

10.7.2.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in Europe, 2020-2030

10.7.2.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in Europe, 2020-2030

10.7.2.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in Europe, 2020-2030

10.7.2.3. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Distribution by Device Class, 2020-2030

10.7.2.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in Europe, 2020-2030

10.7.2.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in Europe, 2020-2030

10.7.2.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in Europe, 2020-2030

10.7.3. Human Factors Engineering and Usability Testing Services Market in Asia Pacific, 2020-2030

10.7.3.1. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Types of Tools, 2020-2030

10.7.3.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in Asia Pacific, 2020-2030

10.7.3.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in Asia Pacific, 2020-2030

10.7.3.2. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Types of Steps Involved in Usability Testing, 2020-2030

10.7.3.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in Asia Pacific, 2020-2030

10.7.3.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in Asia Pacific, 2020-2030

10.7.3.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in Asia Pacific, 2020-2030

10.7.3.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in Asia Pacific, 2020-2030

10.7.3.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in Asia Pacific, 2020-2030

10.7.3.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in Asia Pacific, 2020-2030

10.7.3.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in Asia Pacific, 2020-2030

10.7.3.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in Asia Pacific, 2020-2030

10.7.3.3. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Distribution by Device Class, 2020-2030

10.7.3.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in Asia Pacific, 2020-2030

10.7.3.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in Asia Pacific, 2020-2030

10.7.3.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in Asia Pacific, 2020-2030

10.7.4. Human Factors Engineering and Usability Testing Services Market in Rest of the World, 2020-2030

CASE STUDY: IMPACT OF COVID-19 PANDEMIC ON HUMAN FACTORS ENGINEERING AND USABILITY TESTING SERVICES MARKET

11.1. Chapter Overview

11.2. Impact of the COVID-19 Pandemic on the Approval of Medical Devices

11.2.1 The US Scenario

11.2.2. The European Scenario

11.3. Impact of COVID-19 Outbreak of Human Factors Engineering and Usability Testing Process

11.4. Impact of Future Market Opportunity for Human Factors Engineering and Usability Testing Market

11.5. Recuperative Strategies for CMO Business

11.5.1. Strategies for Implementation in the Short / Mid Term

11.5.2. Strategies for Implementation in the Long Term

SWOT ANALYSIS

12.1. Chapter Overview

12.2. Strengths

12.3. Weaknesses

12.4. Opportunities

12.5. Threats

12.6. Concluding Remarks

CONCLUSION

13.1. Chapter Overview

13.2. Key Takeaways

14 EXECUTIVE INSIGHTS

14.1. Chapter Overview

14.2. DCA Design International

14.2.1. Company Snapshot

14.2.2. Interview Transcript: Daniel Jenkins, Head of Research (Human Factors and Interaction)

14.3. THAY Medical

14.3.1. Company Snapshot

14.3.2. Interview Transcript: Greg Thay, Managing Director (THAY Medical)

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

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.

www.rootsanalysis.com
Submitted 36 day(s) ago by Alberto Brando

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

www.rootsanalysis.com
Submitted 36 day(s) ago by Alberto Brando

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

www.rootsanalysis.com
Submitted 36 day(s) ago by Alberto Brando

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

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

www.rootsanalysis.com
Submitted 36 day(s) ago by Alberto Brando

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

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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

www.rootsanalysis.com
Submitted 36 day(s) ago by Alberto Brando

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

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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