Global Novel Immuno-Oncology Biomarker Testing Market Report, 2019-2030 - Focus on TMB, MSI and TILs (CD3+, CD4+, CD8+, FOXP3+) -

DUBLIN--()--The "Novel Immuno-Oncology Biomarker Testing Market, 2019-2030" report has been added to's offering.

This 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.

Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have proven to be fatal.

A prominent concern is associated with deciding the type of treatment option to be used for specific cancers. Patients suffering from a singular type of cancer, who may be at the same stage of the disease, have been demonstrated to exhibit different molecular profiles, and thereby may respond differently to recommended drug/therapy types. In order to address this concern, pharmaceutical developers and healthcare professionals have adopted a more personalized approach to disease diagnosis and treatment. Over time, several molecular markers have been identified and characterized, and many have been validated for use in making important treatment-related decisions.

The role of single analyte biomarkers, such as PD-L1, BRAF, and EGFR, has been well-established across multiple cancer indications. However, due to subtle differences in genomic makeup of individual patients, these biomarkers alone have been shown to be insufficient in determining how patients are likely to respond to various drug/therapy types.

Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers, based on genome/exome profiles. Novel biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumor infiltrating lymphocytes (TILs) and certain others, are presently being investigated across numerous clinical studies.

Presently, several diagnostics-focused companies have developed/are developing analytical tests for these biomarkers, which are intended to assist physicians in making personalized treatment-related decisions. It is worth highlighting that many big pharmaceutical players have demonstrated an interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers.

Amongst various elements, the report includes:

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

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for novel immuno-oncology biomarker testing services over the coming decade. Based on several parameters, the research provides an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030.

In addition, the report provides the likely distribution of the future opportunity based on:

  • [A] biomarker (MSI / MMR, TILs, TMB)
  • [B] disease indications (blood cancer, blood cancer, colon cancer, colorectal cancer, lung cancer, melanoma, prostate cancer and others)
  • [C] analytical technique used (immunohistochemistry, next-generation sequencing, polymerase chain reaction and others)
  • [D] application area (research use, clinical use, commercial use)
  • [E] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, the research has provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.

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

Future Growth Opportunities

  • Increasing Focus on Precision Medicine
  • Rise in Number of Biomarker-based Clinical Trials
  • Emerging Technologies for Biomarker Assessment
  • Development of Companion Diagnostic Products
  • and Other Opportunities...

Key Topics Covered

1. Preface

2. Executive Summary

3. Introduction

4. Current Market Landscape

5. Product Competitiveness Analysis

6. Company Profiles

7. Publication Analysis

8. Innovative Designs for Biomarker-Based Clinical Trials

9. Clinical Trial Analysis

10. Market Forecast

11. Future Growth Opportunities

12. Case Study: Analysis of Needs of Stakeholders in the Companion Diagnostics Industry

13. Case Study: Analysis of Value Chain in the Companion Diagnostics Industry

14. Clinical Trials & Key Biomarkers: A Big Pharma Perspective

15. Executive Insights

16. Appendix 1: Tabulated Data

17. Appendix 2: List of Companies & Organizations

Companies Mentioned

  • AbbVie
  • ACT Genomics
  • Admera Health
  • AITbiotech
  • Ambry Genetics
  • Amgen
  • ARUP Laboratories
  • Asper Biogene
  • AstraZeneca
  • Barbara Ann Karmanos Cancer Institute
  • Bayer
  • Biocartis
  • Biodesix
  • Biotype Innovation
  • Boehringer Ingelheim
  • Brigham and Women's Hospital
  • Bristol-Myers Squibb
  • Cancer Genetics
  • Cancer Research Institute
  • Cancer Treatment Centers of America
  • Caprion Biosciences
  • Caris Life Sciences
  • CBLPath
  • CeGaT
  • Celator Pharmaceuticals (Subsidiary of Jazz Pharmaceuticals)
  • Cell IDx
  • CGC Genetics
  • Chugai Pharmaceutical
  • City of Hope National Medical Center
  • Clarient Diagnostic Services (Acquired by NeoGenomics Laboratories)
  • Cofactor Genomics
  • Columbia University
  • Craig Hallum Capital Group
  • DIAN Diagnostics Group
  • Dr Lal PathLabs
  • EasyDNA
  • Eli Lilly
  • EMD Serono
  • Epic Sciences
  • European Organization for Research and Treatment of Cancer
  • ExcellaBio
  • Federal Association of German Pathologists
  • Foundation Medicine
  • Fox Chase Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Genekor
  • Genentech
  • Genetron
  • and many more...

For more information about this report visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biomarkers, Oncology

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biomarkers, Oncology