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

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.

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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

1.                     PREFACE

1.1.       Scope of the Report

1.2.       Research Methodology

1.3.       Chapter Outlines

2.         EXECUTIVE SUMMARY

3.         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

10.        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)

11.        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

12.        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

13.        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

14.        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

15.        EXECUTIVE INSIGHTS

16.        APPENDIX 1: TABULATED DATA

17.        APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com