Cancer Biomarker Market

Cancer Biomarker Market: Focus on TMB Testing, Microsatellite Instability (MSI) Testing and TILs Testing, 2019 - 2030

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Cancer Biomarker Market Overview

The cancer biomarker market is estimated to be worth $868 million in 2030 and is expected to grow at CAGR of over 18.3% during the forecast period. 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 biomarkers in cancer, 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 cancer biomarker market and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers.

The context of cancer biomarkers market report, published by Roots Analysis This image highlights the initiatives undertaken by big pharma players in cancer biomarkers domain List of cancer biomarkers testing service providers from the research report of Roots Analysis

Recent Developments in Cancer Biomarker Market:

Several recent developments have taken place in the field of cancer biomarker market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In September 2023, Ibex launched Galen Breast HER2, with an aim to support improved biomarker scoring in breast cancer patients. 
  • In July 2023, Quest Diagnostics in collaboration with Envision introduced new prostate cancer biomarker test to meet the critical clinical requirement for identifying and distinguishing potentially aggressive prostate cancer cases in men. 
  • In February 2023, Guardant Health entered into a partnership with Lunit in order to enhance cancer biomarker detection.

Key Companies in Cancer Biomarker Market 

Examples of key companies engaged in cancer biomarker market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Dr Lal PathLabs, Foundation Medicine, NeoGenomics Laboratories, Novogene, Q2 Solutions, Personal Genome Diagnostics and Shenzhen Yuce Biotechnology. This market report includes an easily searchable excel database of all the companies providing cancer biomarkers testing, worldwide.

Scope of the Report

The ‘Cancer Biomarker Market: Focus on TMB, MSI / MMR and TILs Testing, 2019-2030’ market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the cancer biomarker market. It provides an in-depth analysis, highlighting the capabilities of the various companies engaged in cancer biomarker market.

Current market landscape of cancer biomarkers based tests, prepared by Roots Analysis Competitive analysis of cancer biomarkers tests, from Roots Analysis report This image provides information about completed, ongoing and planned clinical studies of cancer biomarkers

Amongst various elements, the market research 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 biomarker testing companies 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 biomarkers in cancer, 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.


The key objective of cancer biomarker market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for cancer biomarker market during the forecast period. 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 forecast 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.

This image presents review of scientific articles related to cancer biomarkers The current and future market trends of cancer biomarkers tests according to Roots Analysis The market segments of cancer biomarkers tests based on the research report of Roots Analysis

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

Frequently Asked Questions

Question 1: What are cancer biomarkers?

Answer: Cancer biomarkers encompass a range of characteristics that serve as measurable indicators of cancer risk, occurrence, or patient outcomes, including molecular, cellular, physiologic, or imaging-based features. These biomarkers play crucial role in cancer diagnosis, risk assessment, treatment personalization, prognosis, and monitoring of disease progression.

Question 2: What is the cancer biomarker market size?

Answer: The cancer biomarkers market size is estimated to be worth $28.6 billion in 2024.

Question 3: What is the growth rate (CAGR) of the cancer biomarkers market?

Answer: The cancer biomarker market is expected to grow at compounded annual growth rate (CAGR) of 5% during the forecast period 2024-2035.

Question 4: Which region has the highest share of the cancer biomarkers industry?

Answer: Currently, North America and Europe collectively capture over 65% of the market share

Question 5: What are the key growth drivers in the cancer biomarkers industry?

Answer: The importance of biomarkers in informing clinical decisions and personalized medicine, advancements in molecular characterization enabling identification of novel therapeutics and ongoing research in diagnostic, predictive, and prognostic biomarkers are some of the key growth drivers.

Question 6: Who are the leading players in the cancer biomarkers market?

Answer: Examples of key players engaged in the cancer biomarkers industry (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilent, ARUP Laboratories, BioReference, Foundation Medicine, OncoDNA, Q² Solutions, Thermo Fisher Scientific and YuceBio.

Question 7: What biomarkers are FDA-approved for cancer?

Answer: The FDA has approved several biomarkers for cancer diagnosis and treatment. Three key FDA-approved predictive biomarkers that are widely used in clinical practice are PD-L1, MSI/MMR, and TMB.

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