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Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030

  • ID: 4801463
  • Report
  • Region: Global
  • 390 Pages
  • Roots Analysis
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FEATURED COMPANIES

  • AbbVie
  • Caprion Biosciences
  • ExcellaBio
  • Impact Genetics
  • MultiVir
  • Promega
  • MORE

Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have proven to be fatal. A prominent concern is associated with deciding the type of treatment option to be used for specific cancers. Patients suffering from a singular type of cancer, who may be at the same stage of the disease, have been demonstrated to exhibit different molecular profiles, and thereby, may respond differently to recommended drug/therapy types. In order to address this concern, pharmaceutical developers and healthcare professionals have adopted a more personalized approach to disease diagnosis and treatment. Over time, several molecular markers have been identified and characterized, and many have been validated for use in making important treatment-related decisions.

The role of single analyte biomarkers, such as PD-L1, BRAF, and EGFR, has been well-established across multiple cancer indications. However, due to subtle differences in genomic makeup of individual patients, these biomarkers alone have been shown to be insufficient in determining how patients are likely to respond to various drug/therapy types. Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers, based on genome/exome profiles. Novel biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumor infiltrating lymphocytes (TILs) and certain others, are presently being investigated across numerous clinical studies. Presently, several diagnostics-focused companies have developed/are developing analytical tests for these biomarkers, which are intended to assist physicians in making personalized treatment-related decisions. It is worth highlighting that many big pharmaceutical players have demonstrated an interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers.
Scope of the Report

The ‘Cancer Biomarkers Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030’ report features an extensive study of the current landscape and future outlook of the immuno-oncology biomarkers testing market (focusing particularly on TMB, MSI and TILs (CD3+, CD4+, CD8+, FOXP3+)). It provides an in-depth analysis, highlighting the capabilities of the various companies engaged in this domain.

Amongst various elements, the report includes:

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

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for novel immuno-oncology biomarker testing services over the coming decade. Based on several parameters, the research provides an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030. In addition, the report provides the likely distribution of the future opportunity based on [A] biomarker (MSI / MMR, TILs, TMB), [B] disease indications (blood cancer, blood cancer, colon cancer, colorectal cancer, lung cancer, melanoma, prostate cancer and others), [C] analytical technique used (immunohistochemistry, next-generation sequencing, polymerase chain reaction and others), [D] application area (research use, clinical use, commercial use), and [E] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, the research has provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’s evolution.

The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • AbbVie
  • Caprion Biosciences
  • ExcellaBio
  • Impact Genetics
  • MultiVir
  • Promega
  • MORE

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 Immuno-Oncology 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. Novel Immuno-Oncology Biomarker 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
4.3.5. Analysis by Genes Evaluated
4.3.6. Analysis by Sample Input
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
4.4.6. Analysis by Sample Input
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
4.5.6. Analysis by Sample Input
4.6. Market Landscape Summary: Analysis by Type of Biomarker and Disease Indication
 
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. Foundation Medicine
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Product/Service Portfolio
6.2.3.1. Novel Biomarker Testing Products/Services
6.2.3.1.1. FoundationOne CDx
6.2.3.1.2. FoundationOne Liquid
6.2.3.1.3. FoundationOne Heme
6.2.4. Recent Developments and Future Outlook
6.3. Lal PathLabs
6.3.1. Company Overview
6.3.2. Financial Information
6.3.3. Product/Service Portfolio
6.3.3.1. Novel Biomarker Testing Products/Services
6.3.3.1.1. Microsatellite Instability (MSI) by PCR
6.3.3.1.2. OncoPro NCCN Lung Cancer Panel (*9 Genes *MSI)
6.3.3.1.3. OncoPro Liquid Biopsy 73 Gene Panel with MSI
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. Novel Biomarker Testing Products/Services
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. Novel Biomarker Testing Products/Services
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. Novel Biomarker Testing Products/Services
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. Novel Biomarker Testing Products/Services
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. Novel Biomarker Testing Products/Services
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. Novel Immuno-Oncology 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
7.5. Publication Analysis: TMB
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: MSI/MMR
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
7.7. Publication Analysis: TILs
7.7.1. Analysis by Year of Publication, 2016-2019
7.7.2. Analysis by Disease Indication
7.7.3. Analysis by Analytical Technique Used
7.7.4. 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. Novel Immuno-Oncology 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
9.9 Clinical Trials Summary: Analysis by Phase and Biomarker
9.10 Overall Clinical Trials Summary: Analysis by Phase and Disease Indication
 
10. MARKET FORECAST
10.1. Chapter Overview
10.2. Key Assumptions and Forecast Methodology
10.3. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030
10.3.1. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (By Value)
10.3.2. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (By Volume)
10.4. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (By Value)
10.4.1. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR (By Value)
10.4.2. Novel Immuno-Oncology Biomarker Testing Market for TILs (By Value)
10.4.3. Novel Immuno-Oncology Biomarker Testing Market for TMB (By Value)
10.5. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (By Volume)
10.5.1. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR (By Volume)
10.5.2. Novel Immuno-Oncology Biomarker Testing Market for TILs (By Volume)
10.5.3. Novel Immuno-Oncology Biomarker Testing Market for TMB (By Volume)
10.6. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (By Value)
10.6.1. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer (By Value)
10.6.2. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer (By Value)
10.6.3. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer (By Value)
10.6.4. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer (By Value)
10.6.5. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer (By Value)
10.6.6. Novel Immuno-Oncology Biomarker Testing Market for Melanoma (By Value)
10.6.7. Novel Immuno-Oncology Biomarker Testing Market for Prostate Cancer (By Value)
10.6.8. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications (By Value)
10.7. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (By Volume)
10.7.1. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer (By Volume)
10.7.2. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer (By Volume)
10.7.3. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer (By Volume)
10.7.4. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer (By Volume)
10.7.5. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer (By Volume)
10.7.6. Novel Immuno-Oncology Biomarker Testing Market for Melanoma (By Volume)
10.7.7. Novel Immuno-Oncology Biomarker Testing Market for Prostate (By Volume)
10.7.8. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications (By Volume)
10.8. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (By Value)
10.8.1. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (By Value)
10.8.2. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (By Value)
10.8.3. Novel Immuno-Oncology Biomarker Testing Market in for Polymerase Chain Reaction, 2019-2030 (By Value)
10.8.4. Novel Immuno-Oncology Biomarker Testing Market for Other Analytical Techniques Used, 2019-2030 (By Value)
10.9. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (By Volume)
10.9.1. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (By Volume)
10.9.2. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (By Volume)
10.9.3. Novel Immuno-Oncology Biomarker Testing Market for Polymerase Chain Reaction, 2019-2030 (By Volume)
10.9.4. Novel Immuno-Oncology Biomarker Testing Market for Other Techniques Used, 2019-2030 (By Volume)
10.10. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (By Value)
10.10.1. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (By Value)
10.10.2. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (By Value)
10.10.3. Novel Immuno-Oncology Biomarker Testing Market for Commercial Use, 2019-2030 (By Value)
10.11. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (By Volume)
10.11.1. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (By Volume)
10.11.2. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (By Volume)
10.11.3. Novel Immuno-Oncology Biomarker Testing Market in for Commercial Use, 2019-2030 (By Volume)
10.12. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (By Value)
10.12.1. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (By Value)
10.12.2. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (By Value)
10.12.3. Novel Immuno-Oncology Biomarker Testing Market in Asia Pacific, 2019-2030 (By Value)
10.12.4. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (By Value)
10.13. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (By Volume)
10.13.1. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (By Volume)
10.13.2. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (By Volume)
10.13.3. Novel Immuno-Oncology Biomarker Testing Market in Asia Pacific, 2019-2030 (By Volume)
10.13.4. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (By Volume)
 
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 TRIALS AND KEY BIOMARKERS: A BIG PHARMA PERSPECTIVE
14.1. Chapter Overview
14.2. Scope and Methodology
14.3. List of Biomarker-based Clinical Trials of Big Pharmaceutical Companies
14.3.1. Analysis by Trial Registration Year
14.3.2. Analysis by Phase of Development
14.3.3. Analysis by Recruitment Status
14.3.4. Analysis by Therapy Design
14.3.5. Analysis by Type of Cancer Therapy
14.3.6. Analysis by Type of Biomarker
14.3.6.1. Analysis by Trial Registration Year and Biomarker
14.3.6.1. Analysis by Phase of Development and Biomarker
14.3.7. Analysis by Disease Indication
14.3.7.1. Analysis by Trial Registration Year and Disease Indication
14.3.7.2. Analysis by Phase of Development and Disease Indication
14.3.8. Geographical Analysis of Clinical Trials
14.3.8.1. Analysis by Number of Clinical Trials and Geography
14.3.8.2. Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status
14.3.8.3. Analysis by Enrolled Patient Population and Geography
14.3.8.4. Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status
14.3.9. Analysis of Key Players
14.3.9.1. Key Players: Analysis by Trial Registration Year
14.3.9.1. Key Players: Analysis by Biomarker
14.3.9.1. Key Players: Analysis by Disease Indication
 
15. EXECUTIVE INSIGHTS
 
16. APPENDIX 1: TABULATED DATA
 
17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Figures
Figure 3.1. Cancer Immunity Cycle
Figure 3.2. Cancer Immunotherapies and Affiliated Mechanisms of Action
Figure 3.3. Immune Checkpoint Inhibitors and Affiliated Mechanisms of Action
Figure 3.4. Evolution of TMB as an Immunotherapy Biomarker
Figure 4.1. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Year of Establishment
Figure 4.2. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Company Size
Figure 4.3. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Geographical Location
Figure 4.4. Novel Immuno-Oncology Biomarker Tests: Distribution by Test Availability
Figure 4.5. Novel Immuno-Oncology Biomarker Tests: Distribution by Type of Biomarker
Figure 4.6. Novel Immuno-Oncology Biomarker Tests: Distribution by Application Area
Figure 4.7. Novel Immuno-Oncology Biomarker Tests: Distribution by Disease Indication
Figure 4.8. Novel Immuno-Oncology Biomarker Tests: Distribution by Analytical Technique Used
Figure 4.9. Novel Immuno-Oncology Biomarker Tests: Distribution by Turnaround Time
Figure 4.10. Novel Immuno-Oncology Biomarker Tests: Distribution by Sample Input
Figure 4.11. Novel Immuno-Oncology Biomarker Tests: Distribution by Nucleic Acid Tested
Figure 4.12. Novel Immuno-Oncology Biomarker Tests: Distribution by Key Players and Type of Biomarker
Figure 4.13. TMB Tests: Distribution by Application Area
Figure 4.14. TMB Tests: Distribution by Disease Indication
Figure 4.15. TMB Tests: Distribution by Analytical Technique Used
Figure 4.16. TMB Tests: Distribution by Turnaround Time
Figure 4.17. TMB Tests: Distribution by Sample Input
Figure 4.18. MSI/MMR Tests: Distribution by Application Area
Figure 4.19. MSI/MMR Tests: Distribution by Disease Indication
Figure 4.20. MSI/MMR Tests: Distribution by Analytical Technique Used
Figure 4.21. MSI/MMR Tests: Distribution by Turnaround Time
Figure 4.22. MSI/MMR Tests: Distribution by Sample Input
Figure 4.23. TIL-based Tests: Distribution by Application Area
Figure 4.24. TIL-based Tests: Distribution by Disease Indication
Figure 4.25. TIL-based Tests: Distribution by Analytical Technique Used
Figure 4.26. TIL-based Tests: Distribution by Turnaround Time
Figure 4.27. TIL-based Tests: Distribution by Sample Input
Figure 4.28. Novel Immuno-Oncology Biomarker Tests Summary: Distribution by Biomarker and Disease Indication
Figure 5.1. Product Competitiveness Analysis: Tests for the Assessment of TMB
Figure 5.2. Product Competitiveness Analysis: Tests for the Assessment of MSI/MMR
Figure 5.3. Product Competitiveness Analysis: Tests for the Assessment of TILs
Figure 6.1. Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)
Figure 6.2. Foundation Medicine: Product/Service Portfolio
Figure 6.3. Product/Service Portfolio: Genomic Testing
Figure 6.4. LalPath Labs: Annual Revenues, 2014-2018 (INR Million)
Figure 6.5. NeoGenomics Laboratories: Annual Revenues, 2014-2018 (USD Million)
Figure 6.6. Product/Service Portfolio: Biomarker Testing
Figure 6.7. Novogene: Product/Service Portfolio
Figure 6.8. NovoPM Cancer Panel: Process Workflow, Turnaround Time and Sample Requirement
Figure 6.9. Q2 Solutions: Product/Service Portfolio
Figure 6.10. Personal Genome Diagnostics: Product/Service Portfolio
Figure 6.11. Shenzhen Yuce Biotechnology: Product/Service Portfolio
Figure 6.12. YuceOne ICIs Test: Clinical Significance
Figure 7.1. Publication Analysis: Distribution by Year of Publication, 2016-2019
Figure 7.2. Publication Analysis: Distribution by Year of Publication and Type of Biomarker
Figure 7.3. Publication Analysis: Distribution by Year of Publication and Disease Indication
Figure 7.4. Publication Analysis: Distribution by Year of Publication and Analytical Technique Used
Figure 7.5. Publication Analysis: Distribution by Year of Publication and Type of Cancer Therapy
Figure 7.6. Publication Analysis: Most Popular Journals
Figure 7.7. TMB-focused Publications: Distribution by Year of Publication, 2016-2019
Figure 7.8. TMB-focused Publications: Distribution by Disease Indication
Figure 7.9. TMB-focused Publications: Distribution by Analytical Technique Used
Figure 7.10. TMB-focused Publications: Most Popular Journals
Figure 7.11. MSI/MMR-focused Publications: Distribution by Year of Publication, 2016-2019
Figure 7.12. MSI/MMR-focused Publications: Distribution by Disease Indication
Figure 7.13. MSI/MMR-focused Publications: Distribution by Analytical Technique Used
Figure 7.14. MSI/MMR-focused Publications: Most Popular Journals
Figure 7.15. TILs-focused Publications: Distribution by Year of Publication, 2016-2019
Figure 7.16. TILs-focused Publications: Distribution by Disease Indication
Figure 7.17. TILs-focused Publications: Distribution by Analytical Technique Used
Figure 7.18. TILs-focused Publications: Most Popular Journals
Figure 8.1. Enrichment Clinical Trial Design: Key Process Steps
Figure 8.2. All-Comers Clinical Trial Design: Key Process Steps
Figure 8.3. Mixture/Hybrid Clinical Trial Design: Key Process Steps
Figure 8.4. Adaptive Clinical Trial Design: Key Process Steps
Figure 9.1. TMB-focused Clinical Trials: Distribution by Trial Registration Year
Figure 9.2. TMB-focused Clinical Trials: Distribution by Trial Recruitment Status
Figure 9.3. TMB-focused Clinical Trials: Distribution by Trial Phase
Figure 9.4. TMB-focused Clinical Trials: Distribution by Trial Design
Figure 9.5. TMB-focused Clinical Trials: Distribution by Disease Indication
Figure 9.6. TMB-focused Clinical Trials: Most Active Players
Figure 9.7. TMB-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Figure 9.8. TMB-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Figure 9.9. TMB-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Figure 9.10. TMB-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Figure 9.11. MSI/MMR-focused Clinical Trials: Distribution by Trial Registration Year
Figure 9.12. MSI/MMR-focused Clinical Trials: Distribution by Trial Recruitment Status
Figure 9.13. MSI/MMR-focused Clinical Trials: Distribution by Trial Phase
Figure 9.14. MSI/MMR-focused Clinical Trials: Distribution by Trial Design
Figure 9.15. MSI/MMR-focused Clinical Trials: Distribution by Disease Indication
Figure 9.16. MSI/MMR-focused Clinical Trials: Most Active Players
Figure 9.17. MSI/MMR-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Figure 9.18. MSI/MMR-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Figure 9.19. MSI/MMR-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Figure 9.20. MSI/MMR-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Figure 9.21. TILs-focused Clinical Trials: Distribution by Trial Registration Year
Figure 9.22. TILs-focused Clinical Trials: Distribution by Trial Recruitment Status
Figure 9.23. TILs-focused Clinical Trials: Distribution by Trial Phase
Figure 9.24. TILs-focused Clinical Trials: Distribution by Trial Design
Figure 9.25. TILs-focused Clinical Trials: Distribution by Disease Indication
Figure 9.26. TILs-focused Clinical Trials: Most Active Players
Figure 9.27. TILs-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Figure 9.28. TILs-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Figure 9.29. TILs-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Figure 9.30. TILs-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Figure 9.31. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Registration Year and Biomarker
Figure 9.32. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Registration Year and Disease Indication
Figure 9.33. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Phase and Biomarker
Figure 9.34. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Phase and Disease Indication
Figure 10.1. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (USD Million)
Figure 10.2. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (Units, Million)
Figure 10.3. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (USD Million)
Figure 10.4. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR, 2019-2030 (USD Million)
Figure 10.5. Novel Immuno-Oncology Biomarker Testing Market for TILs, 2019-2030(USD Million)
Figure 10.6. Novel Immuno-Oncology Biomarker Testing Market for TMB, 2019-2030 (USD Million)
Figure 10.7. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (Units, Million)
Figure 10.8. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR, 2019-2030 (Units, Million)
Figure 10.9. Novel Immuno-Oncology Biomarker Testing Market for TILs, 2019-2030(Units, Million)
Figure 10.10. Novel Immuno-Oncology Biomarker Testing Market for TMB, 2019-2030 (Units, Million)
Figure 10.11. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (USD Million)
Figure 10.12. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer, 2019-2030 (USD Million)
Figure 10.13. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer, 2019-2030 (USD Million)
Figure 10.14. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer, 2019-2030 (USD Million)
Figure 10.15. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer, 2019-2030 (USD Million)
Figure 10.16. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer, 2019-2030 (USD Million)
Figure 10.17. Novel Immuno-Oncology Biomarker Testing Market for Melanoma, 2019-2030 (USD Million)
Figure 10.18. Novel Immuno-Oncology Biomarker Testing Market for Prostate Cancer, 2019-2030 (USD Million)
Figure 10.19. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications, 2019-2030 (USD Million)
Figure 10.20. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (Units, Million)
Figure 10.21. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer, 2019-2030 (Units, Million)
Figure 10.22. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer, 2019-2030 (Units, Million)
Figure 10.23. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer, 2019-2030 (Units, Million)
Figure 10.24. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer, 2019-2030 (Units, Million)
Figure 10.25. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer, 2019-2030 (Units, Million)
Figure 10.26. Novel Immuno-Oncology Biomarker Testing Market for Melanoma, 2019-2030 (Units, Million)
Figure 10.27. Novel Immuno-Oncology Biomarker Testing Market for Prostate Cancer, 2019-2030 (Units, Million)
Figure 10.28. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications, 2019-2030 (Units, Million)
Figure 10.29. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (USD Million)
Figure 10.30. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (USD Million)
Figure 10.31. Novel Immuno-Oncology Biomarker Testing Market for Polymerase Chain Reaction, 2019-2030 (USD Million)
Figure 10.32. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (USD Million)
Figure 10.33. Novel Immuno-Oncology Biomarker Testing Market for Other Techniques Used, 2019-2030 (USD Million)
Figure 10.34. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (Units, Million)
Figure 10.35. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (Units Million)
Figure 10.36. Novel Immuno-Oncology Biomarker Testing Market for Polymerase Chain Reaction, 2019-2030 (Units Million)
Figure 10.37. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (Units Million)
Figure 10.38. Novel Immuno-Oncology Biomarker Testing Market for Other Techniques Used, 2019-2030 (Units Million)
Figure 10.39. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (USD Million)
Figure 10.40. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (USD Million)
Figure 10.41. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (USD Million)
Figure 10.42. Novel Immuno-Oncology Biomarker Testing Market for Commercial Use, 2019-2030 (USD Million)
Figure 10.43. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (Units, Million)
Figure 10.44. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (Units, Million)
Figure 10.45. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (Units, Million)
Figure 10.46. Novel Immuno-Oncology Biomarker Testing Market for Commercial Use, 2019-2030 (Units, Million)
Figure 10.47. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (USD Million)
Figure 10.48. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (USD Million)
Figure 10.49. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (USD Million)
Figure 10.50. Novel Immuno-Oncology Biomarker Testing Market in Asia-Pacific, 2019-2030 (USD Million)
Figure 10.51. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (USD Million)
Figure 10.52. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (Units, Million)
Figure 10.53. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (Units, Million)
Figure 10.54. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (Units, Million)
Figure 10.55. Novel Immuno-Oncology Biomarker Testing Market in Asia-Pacific, 2019-2030 (Units, Million)
Figure 10.56. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (Units, Million)
Figure 11.1. Novel Immuno-Oncology Biomarker Testing: Future Growth Opportunities
Figure 12.1. Stakeholder Needs Analysis: Comparison of Needs of Different Stakeholders
Figure 12.2. Stakeholder Needs Analysis: Comparison of Needs of Companion Diagnostics Developers
Figure 12.3. Stakeholder Needs Analysis: Needs of Regulatory Authorities
Figure 12.4. Stakeholder Needs Analysis: Needs of Testing Laboratories
Figure 12.5. Stakeholder Needs Analysis: Needs of Payers/Insurance Providers
Figure 12.6. Stakeholder Needs Analysis: Needs of Physicians
Figure 12.7. Stakeholder Needs Analysis: Needs of Patients
Figure 13.1. Companion Diagnostics Development: Primary Operations
Figure 13.2. Companion Diagnostics Development: Components of the Value Chain
Figure 13.3. Companion Diagnostics Value Chain: Cost Contribution
Figure 13.4. Companion Diagnostics Value Chain: Cost Associated with Research and Product Development
Figure 13.5. Companion Diagnostics Value Chain: Costs Associated with Manufacturing and Assembly
Figure 13.6. Companion Diagnostics Value Chain: Costs Associated with Clinical Trials, FDA Approval and Other Administrative Tasks
Figure 13.7. Companion Diagnostics Value Chain: Costs Associated with Patient Negotiation and KoL Engagement
Figure 13.8. Companion Diagnostics Value Chain: Costs Associated with Marketing and Sales
Figure 14.1. Biomarker-based Clinical Trials of Big Pharmaceutical Companies: Cumulative Distribution by Trial Registration Year, 2016-2019
Figure 14.2. Clinical Trial Analysis: Distribution by Trial Registration Year and Biomarker
Figure 14.3. Clinical Trial Analysis: Distribution by Trial Registration Year and Disease Indication
Figure 14.4. Clinical Trial Analysis: Distribution by Phase of Development
Figure 14.5. Clinical Trial Analysis: Distribution by Trial Phase and Biomarker
Figure 14.6. Clinical Trial Analysis: Distribution by Trial Phase and Disease Indication
Figure 14.7. Clinical Trial Analysis: Distribution by Recruitment Status
Figure 14.8. Clinical Trial Analysis: Distribution by Therapy Design
Figure 14.9. Clinical Trial Analysis: Overall Distribution by Biomarkers
Figure 14.10. Clinical Trial Analysis: Distribution by Type of Cancer Therapy
Figure 14.11. Clinical Trial Analysis: Most Active Players
Figure 14.12. Clinical Trial Analysis: Geographical Distribution by Number of Trials
Figure 14.13. Clinical Trial Analysis: Geographical Distribution by Enrolled Patient Population
Figure 14.14. Clinical Trial Analysis: Geographical Distribution by Trial Registration Year and Recruitment Status

List of Tables
Table 3.1. List of Currently Approved Predictive Biomarkers
Table 4.1. Novel Immuno-Oncology Biomarker Testing Services: Information on Type of Biomarker Assessed and Test Availability
Table 4.2. Novel Immuno-Oncology Biomarker Tests: Information on Key Test Specifications
Table 6.1. Novel Immuno-Oncology Biomarker Testing Services: List of Companies Profiled
Table 6.2. Foundation Medicine: Recent Developments and Future Outlook
Table 6.3. LalPath Labs: Recent Developments and Future Outlook
Table 6.4. NeoGenomics Laboratories: Recent Developments and Future Outlook
Table 6.5. Novogene: Recent Developments and Future Outlook
Table 6.6. Q2 Solutions: Recent Developments and Future Outlook
Table 6.7. Personal Genome Diagnostics: Recent Developments and Future Outlook
Table 6.8. Shenzhen Yuce Biotechnology: Recent Developments and Future Outlook
Table 16.1. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Year of Establishment
Table 16.2. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Company Size
Table 16.3. Novel Immuno-Oncology Biomarker Testing Services: Distribution by Geographical Location
Table 16.4. Novel Immuno-Oncology Biomarker Tests: Distribution by Test Availability
Table 16.5. Novel Immuno-Oncology Biomarker Tests: Distribution by Type of Biomarker
Table 16.6. Novel Immuno-Oncology Biomarker Tests: Distribution by Application Area
Table 16.7. Novel Immuno-Oncology Biomarker Tests: Distribution by Disease Indication
Table 16.8. Novel Immuno-Oncology Biomarker Tests: Distribution by Analytical Technique Used
Table 16.9. Novel Immuno-Oncology Biomarker Tests: Distribution by Turnaround Time
Table 16.10. Novel Immuno-Oncology Biomarker Tests: Distribution by Sample Input
Table 16.11. Novel Immuno-Oncology Biomarker Tests: Distribution by Nucleic Acid Tested
Table 16.12. Novel Immuno-Oncology Biomarker Tests: Distribution by Key Players and Type of Biomarker
Table 16.13. TMB Tests: Distribution by Application Area
Table 16.14. TMB Tests: Distribution by Disease Indication
Table 16.15. TMB Tests: Distribution by Analytical Technique Used
Table 16.16. TMB Tests: Distribution by Turnaround Time
Table 16.17. TMB Tests: Distribution by Sample Input
Table 16.18. MSI/MMR Tests: Distribution by Application Area
Table 16.19. MSI/MMR Tests: Distribution by Disease Indication
Table 16.20. MSI/MMR Tests: Distribution by Analytical Technique Used
Table 16.21. MSI/MMR Tests: Distribution by Turnaround Time
Table 16.22. MSI/MMR Tests: Distribution by Sample Input
Table 16.23. TIL-based Tests: Distribution by Application Area
Table 16.24. TIL-based Tests: Distribution by Disease Indication
Table 16.25. TIL-based Tests: Distribution by Analytical Technique Used
Table 16.26. TIL-based Tests: Distribution by Turnaround Time
Table 16.27. TIL-based Tests: Distribution by Sample Input
Table 16.28. Novel Immuno-Oncology Biomarker Tests Summary: Distribution by Biomarker and Disease Indication
Table 16.29. Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)
Table 16.30. LalPath Labs: Annual Revenues, 2014-2018 (INR Million)
Table 16.31. NeoGenomics Laboratories: Annual Revenues, 2014-2018 (USD Million)
Table 16.32. Publication Analysis: Distribution by Year of Publication, 2016-2019
Table 16.33. Publication Analysis: Distribution by Year of Publication and Type of Biomarker
Table 16.34. Publication Analysis: Distribution by Year of Publication and Disease Indication
Table 16.35. Publication Analysis: Distribution by Year of Publication and Analytical Technique Used
Table 16.36. Publication Analysis: Distribution by Year of Publication and Type of Cancer Therapy
Table 16.37. Publication Analysis: Most Popular Journals
Table 16.38. TMB-focused Publications: Distribution by Year of Publication, 2016-2019
Table 16.39. TMB-focused Publications: Distribution by Disease Indication
Table 16.40. TMB-focused Publications: Distribution by Analytical Technique Used
Table 16.41. TMB-focused Publications: Most Popular Journals
Table 16.42. MSI/MMR-focused Publications: Distribution by Year of Publication, 2016-2019
Table 16.43. MSI/MMR-focused Publications: Distribution by Disease Indication
Table 16.44. MSI/MMR-focused Publications: Distribution by Analytical Technique Used
Table 16.45. MSI/MMR-focused Publications: Most Popular Journals
Table 16.46. TILs-focused Publications: Distribution by Year of Publication, 2016-2019
Table 16.47. TILs-focused Publications: Distribution by Disease Indication
Table 16.48. TILs-focused Publications: Distribution by Analytical Technique Used
Table 16.49. TILs-focused Publications: Most Popular Journals
Table 16.50. TMB-focused Clinical Trials: Distribution by Trial Registration Year
Table 16.51. TMB-focused Clinical Trials: Distribution by Trial Recruitment Status
Table 16.52. TMB-focused Clinical Trials: Distribution by Trial Phase
Table 16.53. TMB-focused Clinical Trials: Distribution by Trial Design
Table 16.54. TMB-focused Clinical Trials: Distribution by Disease Indication
Table 16.55. TMB-focused Clinical Trials: Most Active Players
Table 16.56. TMB-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Table 16.57. TMB-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Table 16.58. TMB-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Table 16.59. TMB-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Table 16.60. MSI/MMR-focused Clinical Trials: Distribution by Trial Registration Year
Table 16.61. MSI/MMR-focused Clinical Trials: Distribution by Trial Recruitment Status
Table 16.62. MSI/MMR-focused Clinical Trials: Distribution by Trial Phase
Table 16.63. MSI/MMR-focused Clinical Trials: Distribution by Trial Design
Table 16.64. MSI/MMR-focused Clinical Trials: Distribution by Disease Indication
Table 16.65. MSI/MMR-focused Clinical Trials: Most Active Players
Table 16.66. MSI/MMR-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Table 16.67. MSI/MMR-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Table 16.68. MSI/MMR-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Table 16.69. MSI/MMR-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Table 16.70. TILs-focused Clinical Trials: Distribution by Trial Registration Year
Table 16.71. TILs-focused Clinical Trials: Distribution by Trial Recruitment Status
Table 16.72. TILs-focused Clinical Trials: Distribution by Trial Phase
Table 16.73. TILs-focused Clinical Trials: Distribution by Trial Design
Table 16.74. TILs-focused Clinical Trials: Distribution by Disease Indication
Table 16.75. TILs-focused Clinical Trials: Most Active Players
Table 16.76. TILs-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Table 16.77. TILs-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Table 16.78. TILs-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Table 16.79. TILs-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Table 16.80. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Registration Year and Biomarker
Table 16.81. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Registration Year and Disease Indication
Table 16.82. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Phase and Biomarker
Table 16.83. Immuno-Oncology Biomarker-Focused Clinical Trials: Distribution by Trial Phase and Disease Indication
Table 16.84. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (USD Million)
Table 16.85. Global Novel Immuno-Oncology Biomarker Testing Market, 2019-2030 (Units, Million)
Table 16.86. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (USD Million)
Table 16.87. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR, 2019-2030 (USD Million)
Table 16.88. Novel Immuno-Oncology Biomarker Testing Market for TILs, 2019-2030 (USD Million)
Table 16.89. Novel Immuno-Oncology Biomarker Testing Market for TMB, 2019-2030 (USD Million)
Table 16.90. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Type of Biomarker, 2019-2030 (Units, Million)
Table 16.91. Novel Immuno-Oncology Biomarker Testing Market for MSI/MMR, 2019-2030 (Units, Million)
Table 16.92. Novel Immuno-Oncology Biomarker Testing Market for TILs, 2019-2030 (Units, Million)
Table 16.93. Novel Immuno-Oncology Biomarker Testing Market for TMB, 2019-2030 (Units, Million)
Table 16.94. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (USD Million)
Table 16.95. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer, 2019-2030 (USD Million)
Table 16.96. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer, 2019-2030 (USD Million)
Table 16.97. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer, 2019-2030 (USD Million)
Table 16.98. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer, 2019-2030 (USD Million)
Table 16.99. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer, 2019-2030 (USD Million)
Table 16.100. Novel Immuno-Oncology Biomarker Testing Market for Melanoma, 2019-2030 (USD Million)
Table 16.101. Novel Immuno-Oncology Biomarker Testing Market for Prostate Cancer, 2019-2030 (USD Million)
Table 16.102. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications, 2019-2030 (USD Million)
Table 16.103. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Disease Indication, 2019-2030 (Units, Million)
Table 16.104. Novel Immuno-Oncology Biomarker Testing Market for Blood Cancer, 2019-2030 (Units, Million)
Table 16.105. Novel Immuno-Oncology Biomarker Testing Market for Breast Cancer, 2019-2030 (Units, Million)
Table 16.106. Novel Immuno-Oncology Biomarker Testing Market for Colon Cancer, 2019-2030 (Units, Million)
Table 16.107. Novel Immuno-Oncology Biomarker Testing Market for Colorectal Cancer, 2019-2030 (Units, Million)
Table 16.108. Novel Immuno-Oncology Biomarker Testing Market for Lung Cancer, 2019-2030 (Units, Million)
Table 16.109. Novel Immuno-Oncology Biomarker Testing Market for Melanoma, 2019-2030 (Units, Million)
Table 16.110. Novel Immuno-Oncology Biomarker Testing Market for Prostate Cancer, 2019-2030 (Units, Million)
Table 16.111. Novel Immuno-Oncology Biomarker Testing Market for Other Cancer Indications, 2019-2030 (Units, Million)
Table 16.112. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (USD Million)
Table 16.113. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (USD Million)
Table 16.114. Novel Immuno-Oncology Biomarker Testing Market for Polymerase Chain Reaction, 2019-2030 (USD Million)
Table 16.115. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (USD Million)
Table 16.116. Novel Immuno-Oncology Biomarker Testing Market for Other Techniques Used, 2019-2030 (USD Million)
Table 16.117. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Analytical Technique Used, 2019-2030 (Units, Million)
Table 16.118. Novel Immuno-Oncology Biomarker Testing Market for Next Generation Sequencing, 2019-2030 (Units Million)
Table 16.119. Novel Immuno-Oncology Biomarker Testing Market for Polymerase Chain Reaction, 2019-2030 (Units Million)
Table 16.120. Novel Immuno-Oncology Biomarker Testing Market for Immunohistochemistry, 2019-2030 (Units Million)
Table 16.121. Novel Immuno-Oncology Biomarker Testing Market for Other Techniques Used, 2019-2030 (Units Million)
Table 16.122. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (USD Million)
Table 16.123. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (USD Million)
Table 16.124. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (USD Million)
Table 16.125. Novel Immuno-Oncology Biomarker Testing Market for Commercial Use, 2019-2030 (USD Million)
Table 16.126. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Application Area, 2019-2030 (Units, Million)
Table 16.127. Novel Immuno-Oncology Biomarker Testing Market for Research Use, 2019-2030 (Units, Million)
Table 16.128. Novel Immuno-Oncology Biomarker Testing Market for Clinical Use, 2019-2030 (Units, Million)
Table 16.129. Novel Immuno-Oncology Biomarker Testing Market for Commercial Use, 2019-2030 (Units, Million)
Table 16.130. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (USD Million)
Table 16.131. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (USD Million)
Table 16.132. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (USD Million)
Table 16.133. Novel Immuno-Oncology Biomarker Testing Market in Asia-Pacific, 2019-2030 (USD Million)
Table 16.134. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (USD Million)
Table 16.135. Global Novel Immuno-Oncology Biomarker Testing Market: Distribution by Geography, 2019-2030 (Units, Million)
Table 16.136. Novel Immuno-Oncology Biomarker Testing Market in North America, 2019-2030 (Units, Million)
Table 16.137. Novel Immuno-Oncology Biomarker Testing Market in Europe, 2019-2030 (Units, Million)
Table 16.138. Novel Immuno-Oncology Biomarker Testing Market in Asia-Pacific, 2019-2030 (Units, Million)
Table 16.139. Novel Immuno-Oncology Biomarker Testing Market in Rest of the World, 2019-2030 (Units, Million)
Table 16.140. Biomarker-based Clinical Trials of Big Pharmaceutical Companies: Cumulative Distribution by Trial Registration Year, 2016-2019
Table 16.141. Clinical Trial Analysis: Distribution by Trial Registration Year and Biomarker
Table 16.142. Clinical Trial Analysis: Distribution by Trial Registration Year and Disease Indication
Table 16.143. Clinical Trial Analysis: Distribution by Phase of Development
Table 16.144. Clinical Trial Analysis: Distribution by Trial Phase and Biomarker
Table 16.145. Clinical Trial Analysis: Distribution by Trial Phase and Disease Indication
Table 16.146. Clinical Trial Analysis: Distribution by Recruitment Status
Table 16.148. Clinical Trial Analysis: Distribution by Therapy Design
Table 16.149. Clinical Trial Analysis: Overall Distribution by Biomarkers
Table 16.150. Clinical Trial Analysis: Distribution by Type of Cancer Therapy
Table 16.151. Clinical Trial Analysis: Most Active Players
Table 16.152. Clinical Trial Analysis: Geographical Distribution by Number of Trials
Table 16.153. Clinical Trial Analysis: Geographical Distribution by Enrolled Patient Population
Table 16.154. Clinical Trial Analysis: Geographical Distribution by Trial Registration Year and Recruitment Status

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Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the state of the novel immuno-oncology biomarkers testing market in the short to mid-term and long term.

Chapter 3 provides a brief introduction to cancer immunotherapy and the various types of immunotherapies, including details on their mechanism of action and key advantages. It elaborates on the importance and applications of biomarkers, specifically in determining patients’ response towards checkpoint inhibitor-based immunotherapies. The chapter also highlights the key steps involved in the identification of a candidate biomarker, namely biomarker discovery, analytical validation, clinical relevance and clinical utility. In addition, it highlights the need for novel immuno-oncology biomarkers. Further, it includes a discussion on emerging classes of biomarkers, namely TMB, MSI / MMR and others, along with details regarding expression across various indications, analytical assessment methods and factors influencing expression.

Chapter 4 includes a comprehensive market landscape analysis of companies that offer testing services for novel immuno-oncology biomarkers, particularly for checking response towards immunotherapies. The chapter presents detailed analyses on the basis of year of establishment, size of employee base, location of headquarters, availability status of test (available / under development), biomarkers analyzed (TMB, MSI / MMR and TILs (CD3+, CD4+, CD8+ and FOXP3+), application area(s) (clinical use, research use, commercial use and both clinical / research use), disease indication(s) evaluated, analytical technique(s) utilized (immunohistochemistry, next generation sequencing, polymerase chain reaction  and others), turnaround time, sample input, number of genes analyzed and type of nucleic acid utilized. The chapter also provides a list of kits/test panels that are currently commercialized for testing of these biomarkers.

Chapter 5 features a comprehensive 2X2 analysis offering a comparative summary of all the tests within each biomarker category that we came across during our research. It compares the competitiveness of tests, by taking into consideration the supplier power (based on size of employee base) and certain test-related parameters, such as, application area of the test (clinical use, research use, commercial use, both clinical and research use), turnaround time, number of genes analyzed, sample input (cancer tissue only, both normal and cancer tissue) and technique utilized for biomarker assessment.

Chapter 6 provides detailed profiles of some of the important immuno-oncology biomarker testing services providers (shortlisted based on the strength of service portfolio). Each company profile includes a brief overview of the company, its financial data (if available), information on biomarker testing related service(s), recent developments and an informed future outlook.

Chapter 7 features a detailed publication analysis of over 180 research articles related to immuno-oncology biomarkers including TMB, MSI / MMR and TILs that have been published since 2016. The analysis was done for publications under each biomarker category and takes into consideration several parameters, including year of publication, disease indications, analytical technique on which the study was focused, most popular journal in which the study was published, and type of cancer therapy evaluated.

Chapter 8 provides information on the innovative clinical trial designs being used for conducting biomarker-based studies for oncology drugs. It provides details on the structure of each study design, highlighting their respective advantages and challenges.

Chapter 9 presents a comprehensive clinical trial analysis of completed, ongoing and planned studies involving immuno-oncology biomarkers (TMB, MSI / MMR and TILs). The analysis was done for clinical trials under each biomarker category across various parameters, such as current trial status, trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials.

Chapter 10 features a comprehensive market forecast, highlighting the future potential of novel immuno-oncology biomarkers testing services market till 2030. We have segmented the market on the basis of [A] biomarker (MSI / MMR, TILs, TMB), [B] disease indications (blood cancer, blood cancer, colon cancer, colorectal cancer, lung cancer, melanoma, prostate cancer and others), [C] type  of analytical technique used (immunohistochemistry, next generation sequencing, polymerase chain reaction and others), [D] application area  (research use, clinical use, commercial use), and [E] key geographical regions (North America, Europe, Asia-Pacific / Rest of the World).

Chapter 11 features a detailed discussion on the upcoming opportunities for testing services providers (such as rise in the number of biomarker-based oncology clinical trials, increasing focus on precision medicine, development of companion diagnostic products and others) in this field that are likely to impact the evolution of the market over the coming years.
 
Chapter 12 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need.

Chapter 13 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

Chapter 14 features a holistic view of ongoing, biomarker-based, oncology-focused clinical trials initiated by big pharmaceutical companies. For the purpose of understanding the prime focus of these players, we looked at the active clinical studies that have been registered post 2016. Further, the clinical trial data was analyzed on the basis of various parameters, such as trial registration year, phase of development, recruitment status, therapy design (monotherapy, combination therapy, multiple monotherapies, multiple combination therapies and, both monotherapies and combination therapies), type of cancer therapy, biomarker(s) evaluated (most popular biomarker, moderately popular biomarker and other biomarkers), disease indication(s) evaluated (most popular indications, moderately popular indications and other indications), and geographical location of the trials. In addition, we looked at the activity of each pharmaceutical player considered for the analysis across multiple aforementioned parameters. The chapter presents the data on cancer therapies that are being evaluated in these trials with information on targeted cancer indication and biomarker.

Chapter 15 is a collection of interview transcript(s) of discussions held with industry stakeholders, wherever the participants didn’t request anonymity.

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations mentioned in the report

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  • AbbVie
  • ACT Genomics
  • Admera Health
  • AITbiotech
  • Ambry Genetics
  • Amgen
  • ARUP Laboratories
  • Asper Biogene
  • AstraZeneca
  • Barbara Ann Karmanos Cancer Institute
  • Bayer
  • Biocartis
  • Biodesix
  • Biotype Innovation
  • Boehringer Ingelheim
  • Brigham and Women's Hospital
  • Bristol-Myers Squibb
  • Cancer Genetics
  • Cancer Research Institute
  • Cancer Treatment Centers of America
  • Caprion Biosciences
  • Caris Life Sciences
  • CBLPath
  • CeGaT
  • Celator Pharmaceuticals (Subsidiary of Jazz Pharmaceuticals)
  • Cell IDx
  • CGC Genetics
  • Chugai Pharmaceutical
  • CIRCULOGENE
  • City of Hope National Medical Center
  • Clarient Diagnostic Services (Acquired by NeoGenomics Laboratories)
  • Cofactor Genomics
  • Columbia University
  • Craig Hallum Capital Group
  • CTOAM
  • DIAN Diagnostics Group
  • Dr Lal PathLabs
  • EasyDNA
  • Eli Lilly
  • EMD Serono
  • Epic Sciences
  • European Organization for Research and Treatment of Cancer
  • ExcellaBio
  • Federal Association of German Pathologists
  • Foundation Medicine
  • Fox Chase Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Genekor
  • Genentech
  • Genetron
  • Genomics For Life
  • Genoptix
  • GenPath Diagnostics
  • German Society of Pathology
  • Gilead Sciences
  • GlaxoSmithKline
  • Gradalis
  • Guardant Health
  • HalioDx
  • HistoGeneX
  • Horizon Healthcare Services
  • Illumina
  • Immatics Biotechnologies
  • Impact Genetics
  • Innovent Biologics
  • Intermountain Healthcare
  • Invitae
  • IQVIA
  • Johns Hopkins University
  • Johnson & Johnson
  • KEW
  • KingMed Diagnostics
  • L.E.M laboratory
  • LabCorp
  • Lantheus Medical Imaging
  • Massachusetts General Hospital
  • MD Anderson Cancer Center
  • MedImmune
  • Memorial Sloan Kettering Cancer Center
  • Merck
  • Metropolis
  • Miltenyi Biotec
  • MultiVir
  • Nanostring Technologies
  • NantHealth
  • National Cancer Institute
  • NEO New Oncology
  • NeoGenomics Laboratories
  • Novartis
  • Novogene
  • OmniSeq
  • OncoDNA
  • PathGroup
  • PentaBase
  • PerkinElmer
  • Personal Genome Diagnostics
  • Personalis
  • Pfizer
  • PhenoPath
  • Positive Bioscience
  • Promega
  • Q2 Solutions
  • QIAGEN
  • Quality Assurance Initiative Pathology
  • Quest Diagnostics
  • Regeneron Pharmaceuticals
  • Roche
  • Roswell Park Cancer Institute
  • Sanofi
  • Sarah Cannon Research Institute
  • SeraCare Life Sciences
  • Shanghai HAORAN Biotechnology
  • Shenzhen Yuce Biotechnology
  • Sidney Kimmel Comprehensive Cancer Center
  • Sun Yat-sen University
  • Sysmex
  • Takeda Pharmaceutical
  • Tempus
  • The Institute of Cancer Research, London
  • The Netherlands Cancer Institute
  • Thermo Fisher Scientific
  • UNICANCER
  • University of Pittsburgh
  • University of Washington
  • Ventana Medical Systems
  • Viapath
  • Wake Forest University Health Sciences
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