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

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

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 a specific cancer. 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 cancer 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 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 cancer biomarkers, namely TMB, MSI / MMR and TILs (including CD3+, CD4+, CD8+ and FOXP3+), based on a number of relevant parameters, such as year of establishment, size of employee base, location of headquarters, availability status of the test, biomarkers analyzed, application areas, disease indication(s) evaluated, analytical techniques utilized, turnaround time, sample input and others.

An insightful 2X2 representation of the results of a detailed competitiveness analysis of various tests (segregated across different biomarker groups), taking into consideration the supplier power (size of employee base) and specific test related parameters, such as, application area of the test, turnaround time and other key specifications.

Elaborate profiles of leading analytical testing service providers focused on immuno-oncology biomarkers (shortlisted based on strength of service portfolio), featuring a brief overview of the company, its financial information (if available), information on biomarker testing related service(s), recent developments and an informed future outlook.

A detailed publication analysis of over 180 research articles that have been published since 2016, highlighting the key focus areas of ongoing research activity related to immuno-oncology biomarkers, namely TMB, MSI / MMR and TILs. It highlights the prevalent research trends related to the year of publication, disease indications, analytical technique used for biomarker assessment, and type of cancer therapy evaluated.

A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of cancer biomarkers, namely TMB, MSI / MMR and TILs, based on various parameters, such as trial registration year, trial recruitment status, trial phase, trial design, indication(s) evaluated, leading industry and non-industry players, and geographical locations of trials.

A discussion on the upcoming opportunities (such as development of companion diagnostics, emerging technologies for biomarker assessment, and others) that are likely to impact the evolution of this market over the coming years.

A discussion on various steps involved in development operations of companion diagnostics, namely R&D, clinical evaluation, manufacturing and assembly, negotiations with payers / insurance providers and marketing / sales activities, and the cost requirements across each of the aforementioned stages.

A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in the development of companion diagnostic products.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for cancer biomarkers market over the coming decade. Based on several parameters, we have provided 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, we have provided 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, we have 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.


RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

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 cancer 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 cancer 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 cancer 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 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 cancer 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.

LIST OF COMPANIES

The following companies and organizations have been mentioned in the report:

1. AbbVie
2. ACT Genomics
3. Admera Health
4. AITbiotech
5. Ambry Genetics
6. Amgen
7. ARUP Laboratories
8. Asper Biogene
9. AstraZeneca
10. Barbara Ann Karmanos Cancer Institute
11. Bayer
12. Biocartis
13. Biodesix
14. Biotype Innovation
15. Boehringer Ingelheim
16. Brigham and Women's Hospital
17. Bristol-Myers Squibb
18. Federal Association of German Pathologists
19. Cancer Genetics
20. Cancer Research Institute
21. Cancer Treatment Centers of America
22. Caprion Biosciences
23. Caris Life Sciences
24. CBLPath
25. CeGaT
26. Celator Pharmaceuticals (Subsidiary of Jazz Pharmaceuticals)
27. Cell IDx
28. CGC Genetics
29. Chugai Pharmaceutical
30. CIRCULOGENE
31. City of Hope National Medical Center
32. Clarient Diagnostic Services (Acquired by NeoGenomics Laboratories)
33. Cofactor Genomics
34. Columbia University
35. Craig Hallum Capital Group
36. CTOAM
37. German Society of Pathology
38. DIAN Diagnostics Group
39. Dr Lal PathLabs
40. EasyDNA
41. Eli Lilly
42. EMD Serono
43. Epic Sciences
44. European Organization for Research and Treatment of Cancer
45. ExcellaBio
46. Foundation Medicine
47. Fox Chase Cancer Center
48. Fred Hutchinson Cancer Research Center
49. Genekor
50. Genentech
51. Genetron
52. Genomics For Life
53. Genoptix
54. GenPath Diagnostics
55. Geneseeq Technology
56. Gilead Sciences
57. GlaxoSmithKline
58. Gradalis
59. Guardant Health
60. HalioDx
61. HistoGeneX
62. Horizon Healthcare Services
63. Illumina
64. Immatics Biotechnologies
65. Impact Genetics
66. Innovent Biologics
67. The Institute of Cancer Research, London
68. Intermountain Healthcare
69. Invitae
70. IQVIA
71. Johns Hopkins University
72. Johnson & Johnson
73. KEW
74. KingMed Diagnostics
75. LabCorp
76. Lantheus Medical Imaging
77. L.E.M laboratory
78. Massachusetts General Hospital
79. MD Anderson Cancer Center
80. MedImmune
81. Memorial Sloan Kettering Cancer Center
82. Merck
83. Metropolis
84. Miltenyi Biotec
85. MultiVir
86. Nanostring Technologies
87. NantHealth
88. National Cancer Institute
89. NEO New Oncology
90. NeoGenomics Laboratories
91. Novartis
92. Novogene
93. OmniSeq
94. OncoDNA
95. PathGroup
96. PentaBase
97. PerkinElmer
98. Personal Genome Diagnostics
99. Personalis
100. Pfizer
101. PhenoPath
102. Positive Bioscience
103. Promega
104. Q2 Solutions
105. QIAGEN
106. Quality Assurance Initiative Pathology
107. Quest Diagnostics
108. Regeneron Pharmaceuticals
109. Roche
110. Roswell Park Cancer Institute
111. Sanofi
112. Sarah Cannon Research Institute
113. SeraCare Life Sciences
114. Shanghai HAORAN Biotechnology
115. Shenzhen Yuce Biotechnology
116. Sidney Kimmel Comprehensive Cancer Center
117. Sun Yat-sen University
118. Sysmex
119. Takeda Pharmaceutical
120. Tempus
121. The Netherlands Cancer Institute
122. Thermo Fisher Scientific
123. UNICANCER
124. University of Pittsburgh
125. University of Washington
126. Ventana Medical Systems
127. Viapath
128. Wake Forest University Health Sciences


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
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 Cancer Biomarkers Testing Service Providers: Distribution by Year of Establishment
Figure 4.2 Cancer Biomarkers Testing Service Providers: Distribution by Company Size
Figure 4.3 Cancer Biomarkers Testing Service Providers: Distribution by Geographical Location
Figure 4.4 Cancer Biomarker Tests: Distribution by Test Availability
Figure 4.5 Cancer Biomarker Tests: Distribution by Type of Biomarker
Figure 4.6 Cancer Biomarker Tests: Distribution by Application Area
Figure 4.7 Cancer Biomarker Tests: Distribution by Disease Indication
Figure 4.8 Cancer Biomarker Tests: Distribution by Analytical Technique Used
Figure 4.9 Cancer Biomarker Tests: Distribution by Turnaround Time
Figure 4.10 Cancer Biomarker Tests: Distribution by Sample Input
Figure 4.11 Cancer Biomarker Tests: Distribution by Nucleic Acid Tested
Figure 4.12 Cancer Biomarkers Testing Services: 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 MSI / MMR Tests: Distribution by Application Area
Figure 4.18 MSI / MMR Tests: Distribution by Disease Indication
Figure 4.19 MSI / MMR Tests: Distribution by Analytical Technique Used
Figure 4.20 MSI / MMR Tests: Distribution by Turnaround Time
Figure 4.21 TIL-based Tests: Distribution by Application Area
Figure 4.22 TIL-based Tests: Distribution by Disease Indication
Figure 4.23 TIL-based Tests: Distribution by Analytical Technique Used
Figure 4.24 TIL-based Tests: Distribution by Turnaround Time
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 Dr Lal PathLabs: Annual Revenues, 2014-2018 (INR Million)
Figure 6.2 Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)
Figure 6.3 Foundation Medicine: Product / Service Portfolio
Figure 6.4 Product / Service Portfolio: Genomic Testing
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 TIL-focused Publications: Distribution by Year of Publication, 2016-2019
Figure 7.16 TIL-focused Publications: Distribution by Disease Indication
Figure 7.17 TIL-focused Publications: Distribution by Analytical Technique Used
Figure 7.18 TIL-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 TIL-focused Clinical Trials: Distribution by Trial Registration Year
Figure 9.22 TIL-focused Clinical Trials: Distribution by Trial Recruitment Status
Figure 9.23 TIL-focused Clinical Trials: Distribution by Trial Phase
Figure 9.24 TIL-focused Clinical Trials: Distribution by Trial Design
Figure 9.25 TIL-focused Clinical Trials: Distribution by Disease Indication
Figure 9.26 TIL-focused Clinical Trials: Most Active Players
Figure 9.27 TIL-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Figure 9.28 TIL-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Figure 9.29 TIL-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Figure 9.30 TIL-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Figure 9.31 Clinical Trials Summary: Distribution by
Registration Year and Biomarker
Figure 9.32 Clinical Trials Summary: Distribution by Registration Year and Disease Indication
Figure 10.1 Global Cancer Biomarkers Testing Market: 2019-2030 (USD Million)
Figure 10.2 Global Cancer Biomarkers Testing Market: 2019-2030 (Units Million)
Figure 10.3 Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (USD Million)
Figure 10.4 Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (Units Million)
Figure 10.5 Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (USD Million)
Figure 10.6 Cancer Biomarkers Testing Market: Distribution by Type of Test and Geography, 2019-2030 (USD Million)
Figure 10.7 Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (Units Million)
Figure 10.8 Cancer Biomarkers Testing Market: Distribution by Type of Test and Geography, 2019-2030 (Units Million)
Figure 10.9 Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (USD Million)
Figure 10.10 Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (Units Million)
Figure 10.11 Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (USD Million)
Figure 10.12 Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (USD Million)
Figure 10.13 Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (Units Million)
Figure 10.14 Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (Units Million)
Figure 10.15 Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (USD Million)
Figure 10.16 Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (USD Million)
Figure 10.17 Cancer Biomarkers Testing Market for TMB: Distribution by Disease Indication, 2019-2030 (USD Million)
Figure 10.18 Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (USD Million)
Figure 10.19 Cancer Biomarkers Testing Market of TMB: Distribution by Type of Test, 2019-2030 (USD Million)
Figure 10.20 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (USD Million)
Figure 10.21 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Disease Indication, 2019-2030 (USD Million)
Figure 10.22 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (USD Million)
Figure 10.23 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of Test, 2019-2030 (USD Million)
Figure 10.24 Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (USD Million)
Figure 10.25 Cancer Biomarkers Testing Market for TILs: Distribution by Disease Indication, 2019-2030 (USD Million)
Figure 10.26 Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (USD Million)
Figure 10.27 Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (USD Million)
Figure 10.28 Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (Units Million)
Figure 10.29 Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (Units Million)
Figure 10.30 Cancer Biomarkers Testing Market for TMB: Distribution by Disease Indication, 2019-2030 (Units Million)
Figure 10.31 Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (Units Million)
Figure 10.32 Cancer Biomarkers Testing Market for TMB: Distribution by Type of Test, 2019-2030 (Units Million)
Figure 10.33 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (Units Million)
Figure 10.34 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Disease Indication, 2019-2030 (Units Million)
Figure 10.35 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (Units Million)
Figure 10.36 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of Test, 2019-2030 (Units Million)
Figure 10.37 Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (Units Million)
Figure 10.38 Cancer Biomarkers Testing Market for TILs: Distribution by Disease Indication, 2019-2030 (Units Million)
Figure 10.39 Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (Units Million)
Figure 10.40 Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (Units Million)
Figure 11.1 Cancer Biomarkers 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 Clinical Trial Analysis: Cumulative Distribution by Registration Year
Figure 14.2 Clinical Trial Analysis: Distribution by Most Popular Biomarkers
Figure 14.3 Clinical Trial Analysis: Distribution by Moderately Popular Biomarkers
Figure 14.4 Clinical Trial Analysis: Distribution by Less Popular / Other Biomarkers
Figure 14.5 Word Cloud: Other Emerging Biomarkers
Figure 14.6 Clinical Trial Analysis: Distribution by Registration Year and Most Popular Biomarkers
Figure 14.7 Clinical Trial Analysis: Distribution by Registration Year and Moderately Popular Biomarkers
Figure 14.8 Clinical Trial Analysis: Distribution by Registration Year of Less Popular / Other Biomarkers
Figure 14.9 Clinical Trial Analysis: Distribution by Most Popular Indications
Figure 14.10 Clinical Trial Analysis: Distribution by Moderately Popular Indications
Figure 14.11 Clinical Trial Analysis: Distribution by Less Popular / Other Indications
Figure 14.12 Word Cloud: Other Emerging Indications
Figure 14.13 Clinical Trial Analysis: Distribution by Registration Year and Most Popular Indications
Figure 14.14 Clinical Trial Analysis: Distribution by Trial Registration Year and Moderately Popular Indications
Figure 14.15 Clinical Trial Analysis: Distribution by Trial Registration Year and Less Popular / Other Indications
Figure 14.16 Clinical Trial Analysis: Distribution by Trial Phase
Figure 14.17 Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Biomarkers
Figure 14.18 Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Biomarkers
Figure 14.19 Clinical Trial Analysis: Distribution by Trial Phase and Less Popular / Other Biomarkers
Figure 14.20 Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Indications
Figure 14.21 Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Indications
Figure 14.22 Clinical Trial Analysis: Distribution by Trial Phase and Less Popular / Other Indications
Figure 14.23 Clinical Trial Analysis: Distribution of Trials by Sponsor
Figure 14.24 Clinical Trial Analysis: Distribution by Sponsor and Most Popular Biomarkers
Figure 14.25 Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Biomarkers
Figure 14.26 Clinical Trial Analysis: Distribution by Sponsor and Most Popular Indications
Figure 14.27 Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Indications
Figure 14.28 Clinical Trial Analysis: Distribution by Trial Recruitment Status
Figure 14.29 Clinical Trial Analysis: Distribution of Trials by Therapy Design
Figure 14.30 Clinical Trial Analysis: Distribution of Trials by Recruitment Status
Figure 14.31 Clinical Trial Analysis: Distribution of Trials by Number of Clinical Trials by Enrolled Patient Population
Figure 14.32 Biomarker-focused Clinical Trials of Lung Cancer: Number of Trials and Affiliated Biomarkers
Figure 14.33 Biomarker-focused Clinical Trials of Breast Cancer: Number of Trials and Affiliated Biomarkers
Figure 14.34 Biomarker-focused Clinical Trials of Lymphoma: Number of Trials and Affiliated Biomarkers
Figure 14.35 Biomarker-focused Clinical Trials of Ovarian Cancer: Number of Trials and Affiliated Biomarkers
Figure 14.36 Biomarker-focused Clinical Trials of Prostate Cancer: Number of Trials and Affiliated Biomarkers
Figure 14.37 Biomarker-focused Clinical Trials of Melanoma: Number of Trials and Affiliated Biomarkers
Figure 14.38 Biomarker-focused Clinical Trials of Colon / Colorectal Cancer: Number of Trials and Affiliated Biomarkers
Figure 14.39 Biomarker-focused Clinical Trials of Head and Neck Cancer: Number of Trials and Affiliated Biomarkers
LIST OF TABLES
Table 3.1 List of Currently Approved Predictive Biomarkers
Table 4.1 Cancer Biomarkers Testing Services: Information on Type of Biomarker Assessed and Test Availability
Table 4.2 List of Currently Available Kits for Cancer Biomarkers Testing
Table 4.3 Cancer Biomarkers Tests: Information on Key Test Specifications
Table 6.1 Cancer Biomarkers Testing Services Providers: List of Companies Profiled
Table 6.2 Dr Lal PathLabs: Recent Developments and Future Outlook
Table 6.3 Foundation Medicine: 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 7.1 Cancer Biomarkers: List of Publications
Table 7.2 Cancer Biomarkers: Additional Information on Publications
Table 8.1 Summary: Biomarker-based Clinical Trial Designs
Table 9.1 Cancer Biomarkers: List of Clinical Trials
Table 12.1 Comparison of Interests / Needs of Stakeholders
Table 14.1 List of Likely Drug Candidates / Potential Collaborators for Diagnostic Developers
Table 14.2 List of Biomarkers across Moderately Popular Indications
Table 14.3 List of Biomarkers across Other Indications
Table 15.1 NeoGenomics Laboratories: Key Highlights
Table 15.2 Cell Idx: Key Highlights
Table 15.3 Metropolis: Key Highlights
Table 16.1 Cancer Biomarkers Testing Services: Distribution by Year of Establishment
Table 16.2 Cancer Biomarkers Testing Services: Distribution by Company Size
Table 16.3 Cancer Biomarkers Testing Services: Distribution by Geographical Location
Table 16.4 Cancer Biomarker Tests: Distribution by Test Availability
Table 16.5 Cancer Biomarker Tests: Distribution by Type of Biomarker
Table 16.6 Cancer Biomarker Tests: Distribution by Application Area
Table 16.7 Cancer Biomarker Tests: Distribution by Disease Indication
Table 16.8 Cancer Biomarker Tests: Distribution by Analytical Technique Used
Table 16.9 Cancer Biomarker Tests: Distribution by Turnaround Time
Table 16.10 Cancer Biomarker Tests: Distribution by Sample Input
Table 16.11 Cancer Biomarker Tests: Distribution by Nucleic Acid Tested
Table 16.12 Cancer 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 Cancer Biomarkers Tests Summary: Distribution by Biomarker and Disease Indication
Table 16.29 Dr Lal PathLabs: Annual Revenues, 2014-2018 (INR Million)
Table 16.30 Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD 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 TIL-focused Publications: Distribution by Year of Publication, 2016-2019
Table 16.47 TIL-focused Publications: Distribution by Disease Indication
Table 16.48 TIL-focused Publications: Distribution by Analytical Technique Used
Table 16.49 TIL-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 TIL-focused Clinical Trials: Distribution by Trial Registration Year
Table 16.71 TIL-focused Clinical Trials: Distribution by Trial Recruitment Status
Table 16.72 TIL-focused Clinical Trials: Distribution by Trial Phase
Table 16.73 TIL-focused Clinical Trials: Distribution by Trial Design
Table 16.74 TIL-focused Clinical Trials: Distribution by Disease Indication
Table 16.75 TIL-focused Clinical Trials: Most Active Players
Table 16.76 TIL-focused Clinical Trials: Distribution by Number of Clinical Trials and Geography
Table 16.77 TIL-focused Clinical Trials: Distribution by Number of Clinical Trials, Trial Phase and Recruitment Status
Table 16.78 TIL-focused Clinical Trials: Distribution by Enrolled Patient Population and Geography
Table 16.79 TIL-focused Clinical Trials: Distribution by Enrolled Patient Population, Trial Phase and Recruitment Status
Table 16.80 Clinical Trials Summary: Distribution by Trial Registration Year and Biomarker
Table 16.81 Clinical Trials Summary: Distribution by Trial Registration Year and Disease Indication
Table 16.84 Global Cancer Biomarkers Testing Market: 2019-2030 (USD Million)
Table 16.85 Global Cancer Biomarkers Testing Market: 2019-2030 (Units Million)
Table 16.86 Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (USD Million)
Table 16.87 Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (Units Million)
Table 16.88 Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (USD Million)
Table 16.89 Cancer Biomarkers Testing Market: Distribution by Type of Test and Geography, 2019-2030 (USD Million)
Table 16.90 Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (Units Million)
Table 16.91 Cancer Biomarkers Testing Market: Distribution by Type of Test and Geography, 2019-2030 (Units Million)
Table 16.92 Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (USD Million)
Table 16.93 Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (Units Million)
Table 16.94 Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (USD Million)
Table 16.95 Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (USD Million)
Table 16.96 Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (Units Million)
Table 16.97 Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (Units Million)
Table 16.98 Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (USD Million)
Table 16.99 Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (USD Million)
Table 16.100 Cancer Biomarkers Testing Market for TMB: Distribution by Disease Indication, 2019-2030 (USD Million)
Table 16.101 Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (USD Million)
Table 16.102 Cancer Biomarkers Testing Market of TMB: Distribution by Type of Test, 2019-2030 (USD Million)
Table 16.103 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (USD Million)
Table 16.104 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Disease Indication, 2019-2030 (USD Million)
Table 16.105 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (USD Million)
Table 16.106 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of Test, 2019-2030 (USD Million)
Table 16.107 Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (USD Million)
Table 16.108 Cancer Biomarkers Testing Market for TILs: Distribution by Disease Indication, 2019-2030 (USD Million)
Table 16.109 Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (USD Million)
Table 16.110 Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (USD Million)
Table 16.111 Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (Units Million)
Table 16.112 Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (Units Million)
Table 16.113 Cancer Biomarkers Testing Market for TMB: Distribution by Disease Indication, 2019-2030 (Units Million)
Table 16.114 Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (Units Million)
Table 16.115 Cancer Biomarkers Testing Market for TMB: Distribution by Type of Test, 2019-2030 (Units Million)
Table 16.116 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (Units Million)
Table 16.117 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Disease Indication, 2019-2030 (Units Million)
Table 16.118 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (Units Million)
Table 16.119 Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of Test, 2019-2030 (Units Million)
Table 16.120 Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (Units Million)
Table 16.121 Cancer Biomarkers Testing Market for TILs: Distribution by Disease Indication, 2019-2030 (Units Million)
Table 16.122 Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (Units Million)
Table 16.123 Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (Units Million)
Table 16.124 Clinical Trial Analysis: Cumulative Distribution by Registration Year
Table 16.125 Clinical Trial Analysis: Distribution by Most Popular Biomarkers
Table 16.126 Clinical Trial Analysis: Distribution by Moderately Popular Biomarkers
Table 16.127 Clinical Trial Analysis: Distribution by Less Popular / Other Biomarkers
Table 16.128 Word Cloud: Other Emerging Biomarkers
Table 16.129 Clinical Trial Analysis: Distribution by Registration Year and Most Popular Biomarkers
Table 16.130 Clinical Trial Analysis: Distribution by Registration Year and Moderately Popular Biomarkers
Table 16.131 Clinical Trial Analysis: Distribution by Registration Year of Less Popular /Other Biomarkers
Table 16.132 Clinical Trial Analysis: Distribution by Most Popular Indications
Table 16.133 Clinical Trial Analysis: Distribution by Moderately Popular Indications
Table 16.134 Clinical Trial Analysis: Distribution by Less Popular / Other Indications
Table 16.135 Word Cloud: Less Popular and Other Indications
Table 16.136 Clinical Trial Analysis: Distribution by Registration Year and Most Popular Indications
Table 16.137 Clinical Trial Analysis: Distribution by Trial Registration Year and Moderately Popular Indications
Table 16.138 Clinical Trial Analysis: Distribution by Trial Registration Year and Less Popular / Other Indications
Table 16.139 Clinical Trial Analysis: Distribution by Trial Phase
Table 16.140 Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Biomarkers
Table 16.141 Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Biomarkers
Table 16.142 Clinical Trial Analysis: Distribution by Trial Phase and Less Popular / Other Biomarkers
Table 16.143 Clinical Trial Analysis: Distribution by Trial Phase and Most Popular Indications
Table 16.144 Clinical Trial Analysis: Distribution by Trial Phase and Moderately Popular Indications
Table 16.145 Clinical Trial Analysis: Distribution by Trial Phase and Less Popular / Other Indications
Table 16.146 Clinical Trial Analysis: Distribution of Trials by Sponsor
Table 16.147 Clinical Trial Analysis: Distribution by Sponsor and Most Popular Biomarkers
Table 16.148 Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Biomarkers
Table 16.149 Clinical Trial Analysis: Distribution by Sponsor and Most Popular Indications
Table 16.150 Clinical Trial Analysis: Distribution by Sponsor and Moderately Popular Indications
Table 16.151 Clinical Trial Analysis: Distribution by Trial Recruitment Status
Table 16.152 Clinical Trial Analysis: Distribution of Trials by Therapy Design
Table 16.153 Clinical Trial Analysis: Distribution of Trials by Recruitment Status
Table 16.154 Clinical Trial Analysis: Distribution of Trials by Number of Clinical Trials by Enrolled Patient Population
Table 16.155 Biomarker-focused Clinical Trials of Lung Cancer: Number of Trials and Affiliated Biomarkers
Table 16.156 Biomarker-focused Clinical Trials of Breast Cancer: Number of Trials and Affiliated Biomarkers
Table 16.157 Biomarker-focused Clinical Trials of Lymphoma: Number of Trials and Affiliated Biomarkers
Table 16.158 Biomarker-focused Clinical Trials of Ovarian Cancer: Number of Trials and Affiliated Biomarkers
Table 16.159 Biomarker-focused Clinical Trials of Prostate Cancer: Number of Trials and Affiliated Biomarkers
Table 16.160 Biomarker-focused Clinical Trials of Melanoma: Number of Trials and Affiliated Biomarkers
Table 16.161 Biomarker-focused Clinical Trials of Colon / Colorectal Cancer: Number of Trials and Affiliated Biomarkers
Table 16.162 Biomarker-focused Clinical Trials of Head and Neck Cancer: Number of Trials and Affiliated Biomarkers

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