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
[email protected]