Cancer Biomarkers Market

Cancer Biomarkers Market (2nd Edition): Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Biomarker (HER2, MET, EGFR, PD-L1, NTRK, ALK, Novel Biomarkers and Other Biomarkers), Type of Cancer (Breast Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer, Thyroid Cancer, Bladder Cancer, Melanoma, Non-Hodgkins Lymphoma, Endometrial Cancer, Kidney Cancer and Leukemia) and Key Geographical Regions (North America, Europe and Asia-Pacific)

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Cancer Biomarker Market Size

The cancer biomarker market size is projected to grow from $ 28.6 billion in 2024 to $ 46.7 billion by 2035, representing a CAGR of 5% during the forecast period from 2024 to 2035. 

Cancer Biomarkers Market, By Key Geographical Region, 2024-2035 (USD Billion)

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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 been 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. This personalized approach has also been referred to as oncology precision medicine. 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, owing to the 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), Single Nucleotide Variants (SNV), Copy Number Variants (CNV) 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. Having captured the interest of both established companies and start-ups, the cancer biomarker market is poised to grow at a healthy CAGR in the forecast period.

Cancer Biomarkers Market Share Insights

The market research report presents an in-depth analysis of the various companies that are engaged in the global cancer biomarkers market, across different segments, as defined in the table below:

Cancer Biomarkers Market: Report Attributes / Market Segmentations

Key Report Attribute Details
Historical Trend 2018-2022
Base Year 2023
Forecast Period 2024-2035
Market Size 2024 $28.6 Billion
Market Size 2035 $46.7 Billion
Growth rate CAGR of 5% from 2024 to 2035
Type of Biomarker
  • HER2
  • MET
  • EGFR
  • PD-L1
  • NTRK
  • ALK
  • Novel Biomarkers
  • Other Biomarkers
Type of Cancer
  • Breast Cancer
  • Prostate Cancer
  • Colorectum Cancer
  • Lung Cancer
  • Thyroid Cancer
  • Bladder Cancer
  • Melanoma
  • Non-Hodgkins Lymphoma
  • Endometrial Cancer
  • Kidney Cancer
  • Leukemia
Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
Leading Market Players
  • Agilent
  • ARUP Laboratories
  • BioReference
  • Foundation Medicine
  • OncoDNA
  • Q² Solutions
  • Thermo Fisher Scientific
  • YuceBio
  • Asper Biogene
  • Caris Life Sciences
  • CeGaT
  • Genekor Medical
  • Guardant Health
  • Labcorp
  • MedGenome
  • NeoGenomics Laboratories
  • Nonacus
  • Oxford Gene Technology
  • Personal Genome Diagnostics
  • PhenoPath
  • Positive Biosciences
  • Quest Diagnostics
  • Tempus
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  • Market Landscape Analysis
  • Product Competitiveness Analysis
  • Clinical Trial Analysis
  • Publication Analysis
  • Big Pharma Players Benchmark Analysis
  • Market Size and Opportunity Analysis

One of the key objectives of this market report was to estimate the current cancer biomarker market size, opportunity and the future growth potential over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2024-2035. 

The market report also features the likely distribution of the current and forecasted opportunity within the global cancer biomarkers market across various segments, such as type of biomarker (Human Epidermal Growth Factor Receptor 2 (HER2), Mesenchymal Epithelial Transition (MET), Epidermal Growth Factor Receptor (EGFR), Programmed Death-Ligand 1 (PD-L1), Neurotrophic Tyrosine Receptor Kinase (NTRK), Anaplastic Lymphoma Kinase (ALK) and Other Biomarkers), type of cancer (breast cancer, prostate cancer, colorectum cancer, lung cancer, thyroid cancer, bladder cancer, melanoma, non-hodgkin lymphoma, endometrial cancer, kidney cancer and leukemia) and key geographical regions (North America, Europe, Asia Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

  • Chief Technical Officer and Former Director of Preclinical Development & Strategic Partnerships, Large Company, US
  • Business Manager, Mid-sized Company, Germany
  • Former Chief Scientific Officer, Large Company, US

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Cancer Biomarkers Market Segmentation Overview

Market Share by Type of Biomarker

Based on the type of biomarker, the cancer biomarkers market is categorized into HER2, MET, EGFR, PD-L1, NTRK, ALK, novel biomarkers and other biomarkers. The HER2 biomarker occupies the highest market share in 2024. However, MET and EGFR biomarker segments are expected to witness substantial growth in the coming years.

Market Share by Type of Cancer

Based on the type of cancer, the cancer biomarkers market is segmented into Breast Cancer, Prostate Cancer, Colorectum Cancer, Lung Cancer, Thyroid Cancer, Bladder Cancer, Melanoma, Non-Hodgkins Lymphoma, Endometrial Cancer, Kidney Cancer and Leukemia. Currently, the market is driven by breast cancer biomarkers and lung cancer biomarkers; however, in the coming future, we anticipate cancer biomarker market for leukemia to grow at a significant pace. This can be attributed to the increasing focus on minimally invasive methods such as, liquid biopsy, which could revolutionize testing of cancer biomarkers in blood.

Market Share by Key Geographical Regions

This segment highlights the distribution of global cancer biomarkers market across various geographies, such as North America, Europe, Asia-Pacific and Rest of the World. According to our projections, the cancer biomarkers market in North America is likely to capture the majority (45%) share, and this trend is unlikely to change in the future as well. It is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively high CAGR (14%), during the period 2024-2035.

Cancer Biomarkers Market: Key Insights

The “Cancer Biomarkers Market (2nd Edition): Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Biomarker (HER2, MET, EGFR, PD-L1, NTRK, ALK, Novel Biomarkers and Other Biomarkers), Type of Cancer (Breast Cancer, Prostate Cancer, Colorectum Cancer, Lung Cancer, Thyroid Cancer, Bladder Cancer, Melanoma, Non-Hodgkin Lymphoma, Endometrial Cancer, Kidney Cancer and Leukemia) and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World)” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the companies involved in the cancer biomarkers market. The market report highlights the efforts of several cancer biomarker testing solution providers engaged in this rapidly emerging segment of pharmaceutical industry. Key takeaways of the cancer biomarkers market report are briefly discussed below.

Significance of Cancer Biomarkers in Personalized Cancer Care

The increasing interest in cancer biomarkers is driven by their pivotal role in personalized cancer care. Biomarkers, which are biological indicators of genetic alterations, are essential for customizing treatments to specific types of cancers. By understanding the characteristics of tumors through biomarkers, physicians can personalize the treatments based on the specific properties of cancer cells. These biomarkers not only aid in determining the nature and severity of the cancer but also inform treatment decisions by revealing what fuels the cancer's growth and survival, enabling the selection of the most effective therapies for each patient.

Furthermore, the utilization of cancer biomarkers has transformed cancer treatment by facilitating targeted therapies and immunotherapies. Biomarker testing, which can be conducted using various samples such as body tissues or blood, enables the identification of molecular features of cancer cells. This information assists in characterizing the precise nature of the cancer and guiding treatment decisions.

By identifying biomarkers through molecular testing, patients can avoid ineffective treatments and commence therapies tailored to target the specific biomarkers associated with their cancer. This personalized approach to cancer care not only enhances treatment outcomes but also reduces unnecessary procedures and improves patient quality of life. These factors will drive the cancer biomarkers market growth over the forecast period.

Competitive Landscape of Cancer Biomarker Companies Offering Novel Biomarker Testing Solutions

The novel cancer biomarkers market features the presence of 50 cancer biomarker testing solutions providers. It is worth highlighting that more than 50% of these companies are large and very large firms, indicating the presence of well-established players in this market.

Further, majority of these companies are headquartered in North America (~70%) followed by Europe and Asia-Pacific. It is worth highlighting that big pharma companies are also providing testing solutions for the evaluation of novel cancer biomarkers. For instance, Roche provides cancer biomarker testing solution called the Ventana MMR RxDx Panel, which aids in the assessment of the MSI biomarker.

Clinical Trial Analysis: Close to 620 Trials are Evaluating Novel Cancer Biomarkers to Diagnose Myriad of Cancer Indications

Close to 620 clinical trials have been registered across different geographical regions to evaluate various novel biomarkers for cancer detection. Majority (>40%) of these trials were registered in Europe. Further, the maximum number of patients (32,202) have been enrolled in clinical trials conducted in Europe, which account for 43% of the overall enrollment. It is worth mentioning that Merck is conducting the maximum number of trials in this industry for various cancer indications, including bladder cancer, breast cancer, colorectal cancer, gastrointestinal cancer, gynecological cancer, head and neck cancer, kidney cancer, liver cancer, lung cancer, prostate cancer and skin cancer.

Market Trend Analysis: Increase in Article Publications Reflect the Rising Interest of Companies in Novel Cancer Biomarkers

Over 475 articles related to novel cancer biomarkers have been published, since 2019, highlighting the substantial efforts made by industry stakeholders and researchers in cancer biomarkers market. Around 95% of these publications were research articles, followed by review articles, care reports and method articles. In addition, the maximum number of articles focused on cancer biomarkers were filed by Frontiers Media, BioMed Central, MDPI, Impact Journals, Nature Publishing Group UK, John Wiley and Sons, Dove and Elsevier.

Cancer Biomarkers Market Size: MET Biomarker to Hold the Largest Market Share

The overall cancer biomarkers market is estimated to be worth $ 28.6 billion in 2024. With further increase in the adoption of cancer biomarkers, the market growth is expected to increase at a CAGR of 5% over the forecast period. It is worth highlighting that, in terms of type of biomarkers, MET is expected to capture majority of the cancer biomarkers market share during the forecast period. This can be attributed to the high global incidence of lung cancer and the continuous development of multiple drugs targeting MET for treating various cancers, including non-small-cell lung cancer (NSCLC).

Regional Analysis: North America Holds the Largest Market Share of Cancer Biomarkers Market; Asia Pacific to be the Fastest Growing Market

Presently, North America and Europe capture more than 65% of the cancer biomarker market size. In recent years, owing to the large investment in cancer research and development, North America has witnessed a tremendous increase in the adoption of biomarker testing for oncological disorders. It is worth highlighting that, in the coming years, owing to the anticipated improvement in the establishment of insurance coverage for biomarker testing in Asia Pacific, this region is likely to grow at a higher CAGR as compared to other regions.

Key Players in Cancer Biomarkers Market

Examples of key companies engaged in developing testing solutions for novel cancer biomarkers (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. This market report includes an easily searchable excel database of all the companies offering novel cancer biomarker testing solutions.

Cancer Biomarkers Market Report Coverage

The cancer biomarkers market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market research report includes:

  • A preface providing an introduction to the full report, Cancer Biomarkers Market (2nd Edition), till-2035.
Cancer Biomarkers Market Type of Biomarker Cancer Biomarkers Market Macroeconomic Factors Cancer Biomarkers Market Penetration Growth
  • An outline of the systematic research methodology adopted to conduct the study on cancer biomarkers market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An overview of economic factors that impact the cancer biomarker market outlook, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
  • An executive summary of the key insights captured during our research, offering a high-level view of the current landscape of cancer biomarker industry and its likely evolution in the short to mid and long term.
  • A general overview of cancer biomarkers, providing details on the need for cancer biomarkers in healthcare industry. It also provides information on different types of cancer biomarkers with their identification methods. Additionally, it features a discussion on the novel biomarkers, their variations and methods of measurements of these biomarkers.
  • A detailed assessment of the overall market landscape of testing solutions for novel cancer biomarkers, along with information on several relevant parameters, such as type of biomarkers (Microsatellite instability / Mismatch Repair (MSI / MMR), Tumor Mutational Burden (TMB), Tumor Infiltrating Lymphocytes (TILs), Single Nucleotide Variants (SNV) and Copy Number Variation (CNV)), profiling technology used (genomics technologies, immunoassay, bioinformatics, cytogenetics and other profiling technologies), analytical technique used (next generation sequencing, polymerase chain reaction, immunohistochemistry, whole exome sequencing and other technique used), turnaround time, sample input (FFPE tissue, blood, plasma and other bodily fluids), type nucleic acid tested (DNA and RNA), type of cancer (bladder cancer, breast cancer, CNS cancer, colon / colorectal cancer, endometrial cancer, gastrointestinal cancer, hematologic cancer, lung cancer, melanoma, ovarian cancer, prostate cancer and others / unspecified indication) and application area (research and development, diagnostics, prognostics, disease risk assessment and other / unspecified applications). In addition, the chapter provides a detailed list of developers engaged in offering novel cancer biomarker testing solutions, along with analysis based on various parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters (North America, Europe and Asia-Pacific) of the players involved in this market space.
  • An insightful product competitiveness analysis of the novel cancer biomarker testing solutions based on product versatility (in terms of number of biomarkers evaluated and number of cancers targeted) and product competitiveness (in terms of number of profiling technologies used, number of analytical techniques used, number of sample inputs required and turnaround time). 
  • Elaborate profiles of prominent players offering novel cancer biomarker testing solutions (shortlisted based on the number of solutions offered) engaged in cancer biomarkers market. Each profile features a brief overview of the company (including information on its year of establishment, number of employees, location of headquarters and leadership team), financial information, cancer biomarker testing solutions portfolio, recent developments and an informed future outlook.
  • A case study on the innovative study designs involved in conducting biomarker-based clinical trial to evaluate drugs for oncological disorders. It provides details on the structure of each study design, highlighting their respective advantages and challenges.
Cancer Biomarkers Market Testing Solutions Cancer Biomarkers Market Product Portfolio Cancer Biomarkers Market Future Outlook
  • A comprehensive clinical trial analysis of completed, ongoing and planned studies, focused on the assessment of novel cancer biomarkers, namely TMB, MSI / MMR, SNV, CNV and TILs, based on various parameters, such as trial registration year, trial status, trial phase, enrolled patient population, type of sponsor / collaborator, most active players (in terms of number of registered trials), study design, target therapeutic area and key geographical regions.
  • A detailed publication analysis of over 630 articles that have been published during the period 2019-2023, highlighting the key focus areas of ongoing research related to novel cancer biomarkers, namely TMB, MSI / MMR, SNV, CNV and TILs. It highlights the prevalent trends based on the year of publication, type of publication, type of cancer, copyright holders, emerging focus areas, most active publishers (in terms of number of publications) and key journals (in terms of journal impact factor and number of articles published).
  • A detailed benchmark analysis of various big pharma players (shortlisted on the basis of the revenues generated in 2023) engaged in cancer biomarkers domain, featuring spider web representations, comparing the initiatives of big pharmaceutical players on the basis of multiple relevant parameters and a heat map representation highlighting the distribution of big pharmaceutical companies across various parameters.
  • A discussion on various steps, involved in the production of companion diagnostics, which includes R&D process, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities and the cost distribution across each of the aforementioned stages.
  • A detailed discussion on the upcoming opportunities for cancer biomarker testing solution 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.
  • A detailed cancer biomarkers market forecast analysis with our estimates of the existing market size, market value and future opportunity for cancer biomarker companies over the next 12 years. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market size during the forecast period 2024-2035. 
  • Detailed projections of the current and future opportunity within the cancer biomarkers market across different types of biomarkers, such as HER2, MET, EGFR, PD-L1, NTRK, ALK, novel biomarkers and other biomarkers.
  • Detailed projections of the current and future opportunity within the cancer biomarker market across different types of cancer, such as breast cancer, prostate cancer, colorectum cancer, lung cancer, thyroid cancer, bladder cancer, melanoma, non-hodgkin lymphoma, endometrial cancer, kidney cancer and leukemia.
  • Detailed projections of the current and future opportunity within the cancer biomarkers market across different key geographical regions, such as North America, Europe, Asia-Pacific and Rest of the World. 
Cancer Biomarkers Market Key Winning Strategies Cancer Biomarkers Market Clinical Trial Aanalysis Cancer Biomarkers Market Big Pharma Players

Recent Developments In Cancer Biomarkers Market

Several recent developments have taken place in the field of cancer biomarkers. 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 trends that have been outlined in our cancer biomarkers market analysis.

  • In November 2023, XtalPi signed an agreement with CK Life Sciences to develop cancer molecular diagnostic models utilizing AI and cancer biomarker data.
  • In October 2023, Ono entered into a research agreement with Turbine to discover and validate new therapeutic targets in oncology. Turbine will supply insights on target mechanisms of action and cancer biomarkers, expediting drug development at Ono.
  • In February 2023, Tempus inked a deal with Actuate Therapeutics to identify and validate cancer biomarkers for individuals who may benefit from Actuate's GSK-3 inhibitor elraglusib treatment. 

Author(s): Pemba Lahmo, Vaibhav Singh 

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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