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

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    April 2019

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    390

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Example Insights

Biomarkers - Context Biomarkers - Big Pharma Initiatives Biomarkers - Service Providers
Biomarkers - Market Overview Biomarkers - Product Competitiveness Analysis Biomarkers - Clinical Trials
Biomarkers - Publications Biomarkers - Market Forecast Biomarkers - Market Prediction

 

Overview

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.

Contents

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.

Table of Contents

1.                  PREFACE

1.1.               Scope of the Report

1.2.               Research Methodology

1.3.               Chapter Outlines

2.                  EXECUTIVE SUMMARY

3.                  INTRODUCTION

3.1.               Chapter Overview

3.2.               Cancer Immunotherapy

3.2.1.            Cancer Immunotherapy Biomarkers

3.2.2.            Identification of a Candidate Biomarker

3.2.3.            Need for Novel Cancer Biomarkers

3.3.               Tumor Mutation Burden (TMB)

3.3.1.            Overview

3.3.2.            Variation of TMB across Multiple Indications

3.3.3.            Methods for Measurement of TMB

3.3.4.            Factors Affecting Measurement of TMB

3.3.5.            Initiatives for Assessment of TMB as a Potential Biomarker

3.4.               Microsatellite Instability / Mismatch Repair Deficiency (MSI / MMR)

3.4.1.            Overview

3.4.2.            Variation of MSI across Multiple Indications

3.4.3.            Methods of Measurement of MSI

3.5.               Tumor Infiltrating Lymphocytes and Other Novel Biomarkers

4                   CURRENT MARKET LANDSCAPE

4.1.               Chapter Overview

4.2.               Cancer Biomarkers Testing Services: Overall Market Landscape

4.2.1.            Analysis by Year of Establishment

4.2.2.            Analysis by Company Size

4.2.3.            Analysis by Geographical Location

4.2.4.            Analysis by Test Availability

4.2.5.            Analysis by Type of Biomarker

4.2.6.            Analysis by Application Area

4.2.7.            Analysis by Disease Indication

4.2.8.            Analysis by Analytical Technique Used

4.2.9.            Analysis by Turnaround Time

4.2.10.          Analysis by Sample Input

4.2.11.          Analysis by Nucleic Acid Tested

4.2.12.          Key Players: Analysis by Type of Biomarker

4.3.               TMB Tests

4.3.1.            Analysis by Application Area

4.3.2.            Analysis by Disease Indication

4.3.3.            Analysis by Analytical Technique Used

4.3.4.            Analysis by Turnaround Time

4.4.               MSI / MMR Tests

4.4.1.            Analysis by Application Area

4.4.2.            Analysis by Disease Indication

4.4.3.            Analysis by Analytical Technique Used

4.4.4.            Analysis by Turnaround Time

4.5.               TIL-based Tests

4.5.1.            Analysis by Application Area

4.5.2.            Analysis by Disease Indication

4.5.3.            Analysis by Analytical Technique Used

4.5.4.            Analysis by Turnaround Time

 

5                   PRODUCT COMPETITIVENESS ANALYSIS

5.1.               Chapter Overview

5.2.               Product Competitiveness Analysis: Key Assumptions and Methodology

5.2.1.            Tests for the Assessment of TMB

5.2.2.            Tests for the Assessment of MSI / MMR

5.2.3.            Tests for the Assessment of TILs

6                   COMPANY PROFILES        

6.1.               Chapter Overview

6.2.               Dr Lal PathLabs

6.2.1.            Company Overview     

6.2.2.            Financial Information  

6.2.3.            Product / Service Portfolio       

6.2.3.1.         Biomarkers Testing Portfolio  

6.2.3.1.1.      Microsatellite Instability (MSI) by PCR          

6.2.3.1.2.      OncoPro NCCN Lung Cancer Panel (*9 Genes *MSI)           

6.2.3.1.3.      OncoPro Liquid Biopsy 73 Gene Panel with MSI       

6.2.4.            Recent Developments and Future Outlook      

6.3.               Foundation Medicine   

6.3.1.            Company Overview     

6.3.2.            Financial Information  

6.3.3.            Product / Service Portfolio       

6.3.3.1.         Biomarkers Testing Portfolio  

6.3.3.1.1.      FoundationOne CDx    

6.3.3.1.2.      FoundationOne Liquid 

6.3.3.1.3.      FoundationOne Heme  

6.3.4.            Recent Developments and Future Outlook      

                    

6.4.               NeoGenomics Laboratories     

6.4.1.            Company Overview     

6.4.2.            Financial Information  

6.4.3.            Product / Service Portfolio       

6.4.3.1.         Biomarkers Testing Portfolio  

6.4.3.1.1.      NeoTYPE Discovery Profile for Solid Tumors

6.4.3.1.2.      MSI Analysis / MMR Panel by IHC    

6.4.3.1.3.      MultiOmyx Tumor Infiltrating Lymphocyte Panel     

6.4.4.            Recent Developments and Future Outlook      

6.5.               Novogene         

6.5.1.            Company Overview     

6.5.2.            Product / Service Portfolio       

6.5.2.1.         Biomarkers Testing Portfolio  

6.5.2.1.1.      NovoPM Cancer Panel 

6.5.2.1.2.      NovoPM TMB

6.5.2.1.3.      NovoPM bTMB

6.5.2.1.4.      NovoPM MSI

6.5.3.            Recent Developments and Future Outlook

6.6.               Q2 Solutions     

6.6.1.            Company Overview     

6.6.2.            Product / Service Portfolio       

6.6.2.1.         Biomarkers Testing Portfolio  

6.6.2.1.1.      TMB Assay      

6.6.2.1.2.      MSI Assay        

6.6.2.1.3.      TILs Testing     

6.6.3.            Recent Developments and Future Outlook

                    

6.7.               Personal Genome Diagnostics 

6.7.1.            Company Overview     

6.7.2.            Product / Service Portfolio       

6.7.2.1.         Biomarkers Testing Portfolio  

6.7.2.1.1.      PGDx elio Tissue Complete Assay      

6.7.2.1.2.      PlasmaSELECT-R 64   

6.7.2.1.3.      CancerXOME-R           

6.7.2.1.4.      CancerSELECT-R 125 

6.7.2.1.5.      MutatorDETECT          

6.7.3.            Recent Developments and Future Outlook      

6.8.               Shenzhen Yuce Biotechnology

6.8.1.            Company Overview     

6.8.2.            Product / Service Portfolio       

6.8.2.1.         Biomarkers Testing Portfolio  

6.8.2.1.1.      YuceOne Plus   

6.8.2.1.2.      YuceOne ICIs   

6.8.2.1.3.      ct-DNA TMB   

6.8.2.1.4.      Microsatellite (MSI) Test         

6.8.3.            Recent Developments and Future Outlook      

7                   PUBLICATION ANALYSIS

7.1.               Chapter Overview

7.2.               Methodology

7.3.               Cancer Biomarkers: List of Publications

7.3.1.            Analysis by Year of Publication, 2016-2019

7.3.2.            Analysis by Year of Publication and Type of Biomarker

7.3.3.            Analysis by Year of Publication and Disease Indication

7.3.4.            Analysis by Year of Publication and Analytical Technique Used

7.3.5.            Analysis by Year of Publication and Type of Cancer Therapy

7.3.6.            Most Popular Journals

7.4.               Publication Analysis: TMB

7.4.1.            Analysis by Year of Publication, 2016-2019

7.4.2.            Analysis by Disease Indication

7.4.3.            Analysis by Analytical Technique Used

7.4.4.            Most Popular Journals

7.5.               Publication Analysis: MSI / MMR

7.5.1.            Analysis by Year of Publication, 2016-2019

7.5.2.            Analysis by Disease Indication

7.5.3.            Analysis by Analytical Technique Used

7.5.4.            Most Popular Journals

7.6.               Publication Analysis: TILs

7.6.1.            Analysis by Year of Publication, 2016-2019

7.6.2.            Analysis by Disease Indication

7.6.3.            Analysis by Analytical Technique Used

7.6.4.            Most Popular Journals

8                   INNOVATIVE DESIGNS FOR BIOMARKER-BASED CLINICAL TRIALS

8.1.               Background and Context

8.2.               Biomarker-based Clinical Trial Designs

8.2.1.            Enrichment Design

8.2.2.            All-Comers Design

8.2.3.            Mixture / Hybrid Design

8.2.4.            Adaptive Design

8.3                Regulatory Considerations

9                   CLINICAL TRIAL ANALYSIS

9.1.               Chapter Overview

9.2.               Methodology

9.3.               Cancer Biomarkers: List of Clinical Trials

9.4.               Clinical Trial Analysis: TMB

9.4.1.            Analysis by Trial Registration Year

9.4.2.            Analysis by Trial Recruitment Status

9.4.3.            Analysis by Trial Phase

9.4.4.            Analysis by Trial Design

9.4.5.            Analysis by Disease Indication

9.4.6.            Most Active Players

9.4.7.            Analysis by Number of Clinical Trials and Geography

9.4.8.            Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.4.9.            Analysis by Enrolled Patient Population and Geography

9.4.10.          Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.5.               Clinical Trial Analysis: MSI / MMR

9.5.1.            Analysis by Trial Registration Year

9.5.2.            Analysis by Trial Recruitment Status

9.5.3.            Analysis by Trial Phase

9.5.4.            Analysis by Trial Design

9.5.5.            Analysis by Disease Indication

9.5.6.            Most Active Players

9.5.7.            Analysis by Number of Clinical Trials and Geography

9.5.8.            Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.5.9.            Analysis by Enrolled Patient Population and Geography

9.5.10.          Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.6.               Clinical Trial Analysis: TILs

9.6.1.            Analysis by Trial Registration Year

9.6.2.            Analysis by Trial Recruitment Status

9.6.3.            Analysis by Trial Phase

9.6.4.            Analysis by Trial Design

9.6.5.            Analysis by Disease Indication

9.6.6.            Most Active Players

9.6.7.            Analysis by Number of Clinical Trials and Geography

9.6.8.            Analysis by Number of Clinical Trials, Trial Phase and Recruitment Status

9.6.9.            Analysis by Enrolled Patient Population and Geography

9.6.10.          Analysis by Enrolled Patient Population, Trial Phase and Recruitment Status

9.7                Clinical Trials Summary: Analysis by Registration Year and Biomarker

9.8                Clinical Trials Summary: Analysis by Registration Year and Disease Indication

10.                MARKET FORECAST

10.1.             Chapter Overview

10.2.             Assumptions

10.3              Forecast Methodology

10.4.             Global Cancer Biomarkers Testing Market, 2019-2030 (By Value)

10.5.             Global Cancer Biomarkers Testing Market, 2019-2030 (By Volume)

10.6.             Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (By Value)

10.7.             Cancer Biomarkers Testing Market: Distribution by Geography, 2019-2030 (By Volume)

10.8.             Cancer Biomarkers Testing Market: Distribution by Type of Test, 2019-2030 (By Value)

10.8.1.          Cancer Biomarkers Testing Market: Distribution by Type of test and Geography, 2019-2030 (By Value)

10.9.             Cancer Biomarkers Testing Market: Distribution by Type of test, 2019-2030 (By Volume)

10.9.1.          Cancer Biomarkers Testing Market: Distribution by Type of test and Geography, 2019-2030 (By Volume)

10.10.           Cancer Biomarkers Testing Market: Distribution by Disease Indication, 2019-2030 (By Value)

10.11.           Cancer Biomarkers Testing Market:  Distribution by Disease Indication, 2019-2030 (By Volume)

10.12.           Cancer Biomarkers Testing Market:  Distribution by Analytical Technique, 2019-2030 (By Value)

10.12.1.        Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (By Value)

10.13.           Cancer Biomarkers Testing Market: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.13.1.        Cancer Biomarkers Testing Market: Distribution by Analytical Technique and Geography, 2019-2030 (By Volume)

10.14.           Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (By Value)

10.15.           Cancer Biomarkers Testing Market for TMB, 2019-2030 (By Value)

10.15.1.        Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (By Value)

10.15.2.        Cancer Biomarkers Testing Market for TMB: Distribution by Cancer Indication, 2019-2030 (By Value)

10.15.3.        Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (By Value)

10.15.4.        Cancer Biomarkers Testing Market for TMB: Distribution by Type of test, 2019-2030 (By Value)

10.16.           Cancer Biomarkers Testing Market for MSI / MMR, 2019-2030 (By Value)

10.16.1.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (By Value)

10.16.2.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Cancer Indication, 2019-2030 (By Value)

10.16.3.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (By Value)

10.16.4.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of test, 2019-2030 (By Value)

10.17.           Cancer Biomarkers Testing Market for TILs, 2019-2030 (By Value)

10.17.1.        Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (By Value)

10.17.2.        Cancer Biomarkers Testing Market for TILs: Distribution by Cancer Indication, 2019-2030 (By Value)

10.17.3.        Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (By Value)

10.17.4.        Cancer Biomarkers Testing Market for TILs: Distribution by Type of test, 2019-2030 (By Value)

10.18.           Cancer Biomarkers Testing Market: Distribution by Biomarker, 2019-2030 (By Volume)

10.19.           Cancer Biomarkers Testing Market for TMB, 2019-2030 (By Volume)

10.19.1.        Cancer Biomarkers Testing Market for TMB: Distribution by Geography, 2019-2030 (By Volume)

10.19.2.        Cancer Biomarkers Testing Market for TMB: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.19.3.        Cancer Biomarkers Testing Market for TMB: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.19.4.        Cancer Biomarkers Testing Market for TMB: Distribution by Type of test, 2019-2030 (By Volume)

10.20.           Cancer Biomarkers Testing Market for MSI / MMR, 2019-2030 (By Volume)

10.20.1.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Geography, 2019-2030 (By Volume)

10.20.2.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.20.3.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Analytical Technique, 2019-2030 (By Volume)

10.20.4.        Cancer Biomarkers Testing Market for MSI / MMR: Distribution by Type of test, 2019-2030 (By Volume)

10.21.           Cancer Biomarkers Testing Market for TILs, 2019-2030 (By Volume)

10.21.1.        Cancer Biomarkers Testing Market for TILs: Distribution by Geography, 2019-2030 (By Volume)

10.21.2.        Cancer Biomarkers Testing Market for TILs: Distribution by Cancer Indication, 2019-2030 (By Volume)

10.21.3.        Cancer Biomarkers Testing Market for TILs: Distribution by Analytical Technique, 2019-2030 (By Value)

10.21.4.        Cancer Biomarkers Testing Market for TILs: Distribution by Type of Test, 2019-2030 (By Value)

11.                FUTURE GROWTH OPPORTUNITIES

11.1.             Chapter Overview

11.1.1.          Increasing Focus on Precision Medicine

11.1.2.          Rise in Number of Biomarker-based Clinical Trials

11.1.3.          Emerging Technologies for Biomarker Assessment

11.1.4.          Development of Companion Diagnostic Products

11.1.5.          Other Opportunities

12.                CASE STUDY: ANALYSIS OF NEEDS OF STAKEHOLDERS IN THE COMPANION DIAGNOSTICS INDUSTRY

12.1.             Chapter Overview

12.2.             Companion Diagnostics: Needs of Different Stakeholders

12.3.             Comparison of Needs of Various Stakeholders

12.3.1.          Needs of Drug Developers

12.3.2.          Needs of Companion Diagnostics Developers

12.3.3.          Needs of Regulatory Authorities

12.3.4.          Needs of Testing Laboratories

12.3.5.          Needs of Payers / Insurance Providers

12.3.6.          Needs of Physicians

12.3.7.          Needs of Patients

13.                CASE STUDY: ANALYSIS OF VALUE CHAIN IN THE COMPANION DIAGNOSTICS INDUSTRY

13.1.             Chapter Overview

13.2.             Companion Diagnostics: Components of the Value Chain

13.3.             Companion Diagnostics Value Chain: Cost Distribution

13.3.1.          Companion Diagnostics Value Chain: Costs Associated with Research and Product Development

13.3.2.          Companion Diagnostics Value Chain: Costs Associated with Costs Associated with Manufacturing and Assembly

13.3.3.          Companion Diagnostics Value Chain: Costs Associated with Clinical Trials, FDA Approval and Other Administrative Tasks

13.3.4.          Companion Diagnostics Value Chain: Costs Associated with Payer Negotiation and KoL Engagement

13.3.5.          Companion Diagnostics Value Chain: Costs Associated with Marketing and Sales

14.                CLINICAL RESEARCH ON CANCER BIOMARKERS: A BIG PHARMA PERSPECTIVE

14.1.                Chapter Overview

14.2.                Methodology

14.3.                Clinical Trial Analysis

14.3.1.             List of Likely Drug Candidates for IVD Developers

14.4.                Cumulative Distribution of Biomarker-based Trials by Registration Year, 2016-2019

14.4.1.             Analysis of Biomarker-based Trials of Most Popular Biomarkers

14.4.2.             Analysis of Biomarker-based Trials of Moderately Popular Biomarkers

14.4.3.             Analysis of Biomarker-based Trials of Less Popular / Other Biomarkers

14.4.4.             Word Cloud of Other Emerging Biomarkers

14.4.5.             Cumulative Distribution of Trials by Registration year and Most Popular Biomarkers

14.4.6.             Cumulative Distribution of Trials by Registration year and Moderately Popular Biomarkers

14.4.7.             Cumulative Distribution of Trials by Registration year and Less Popular / Other Biomarkers

14.5.                Distribution of Biomarker-based Trials by Most Popular Indications

14.5.1.             Distribution of Biomarker-based Trials by Moderately Popular Indications

14.5.2.             Distribution of Biomarker-based Trials by Less Popular / Other Indications

14.5.3.             Word Cloud of Other Emerging Indications in Biomarker-based Clinical Trials

14.5.4.             Cumulative Distribution of Trials by Registration year and Most Popular Indication

14.5.5.             Cumulative Distribution of Trials by Registration year and Moderately Popular Indications

14.5.6.             Cumulative Distribution of Trials by Registration year and Less Popular / Other Indications

14.6.                Analysis of Biomarker-based Trials by Phase of Development

14.6.1.             Analysis of Biomarker-based Trials by Phase of Development and Most Popular Biomarkers

14.6.2.             Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Biomarkers

14.6.3.             Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Biomarkers

14.6.4.             Analysis of Biomarker-based Trials by Phase of Development and Most Popular Indications

14.6.5.             Analysis of Biomarker-based Trials by Phase of Development and Moderately Popular Indications

14.6.6.             Analysis of Biomarker-based Trials by Phase of Development and Less Popular and Other Indications

14.7.                Analysis of Biomarker-based Trials by Sponsor

14.7.1.             Analysis of Biomarker-based Trials by Sponsor and Most Popular Biomarkers

14.7.2.             Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Biomarkers

14.7.3.             Analysis of Biomarker-based Trials by Sponsor and Most Popular Indications

14.7.4.             Analysis of Biomarker-based Trials by Sponsor and Moderately Popular Indications

14.8.                Analysis of Biomarker-based Trials by Recruitment Status

14.9.                Analysis of Biomarker-based Trials by Therapy Design

14.10.              Analysis of Biomarker-based Trials by Geography

14.10.1.           Analysis of Biomarker-based Trials by Trial Phase and Recruitment Status

14.11.              Clinical Trials Summary: Analysis by Biomarker and Most Popular Indications

14.12.              Clinical Trials Summary: Analysis by Biomarker and Moderately Popular Indications

14.13.              Clinical Trials Summary: Analysis by Biomarker and Other Emerging Indications

15.                EXECUTIVE INSIGHTS

                    

16.                APPENDIX 1: TABULATED DATA

17.                APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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

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

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