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Oncology Biomarker Market to Lead USD 113.54 Bn by 2034

Oncology Biomarker Market Advancements in AI and Testing

The oncology biomarker market is valued at USD 38.62 billion in 2025 and is projected to reach USD 113.54 billion by 2034, growing at a CAGR of 12.73%. The report covers market segments by biomarker type, including genomic (35% share in 2024) and proteomic biomarkers, application types such as diagnostic testing (50% share in 2024) and prognostic testing, and cancer types including breast (25% share) and lung cancer, with regional insights across North America, Europe, Asia Pacific, Latin America, and MEA.

Category: Diagnostics Insight Code: 6326 Format: PDF / PPT / Excel

The global oncology biomarker market size is calculated at US$ 34.16 billion in 2024, grew to US$ 38.62 billion in 2025, and is projected to reach around US$ 113.54 billion by 2034. The market is expanding at a CAGR of 12.73% between 2025 and 2034.

Oncology Biomarker Market Size 2024 to 2034

Due to the growth in cancer cases globally, the use of oncology biomarkers for various purposes is increasing. The industries are using them to develop advanced diagnostics and support the development of novel treatment options, where they are also leveraging AI to advance biomarker discovery and development. Additionally, the growing innovations supported by the investment and increasing awareness are also driving their demand. Furthermore, the companies are investing, collaborating, developing, and launching various biomarker diagnostics tools and techniques, promoting the market growth.

Key Takeaways

  • Oncology biomarker industry poised to reach USD 34.16 billion by 2024.
  • Forecasted to grow to USD 113.54 billion by 2034.
  • Expected to maintain a CAGR of 12.73% from 2025 to 2034.
  • North America held approximately a 35% share in the global oncology biomarker market in 2024.
  • Europe is expected to be a significantly growing region during the forecast period.
  • By biomarker type, the genomic biomarkers segment held an approximate 35% share in the market in 2024.
  • By biomarker type, the proteomic biomarkers segment is expected to be the fastest growing during the forecast period.
  • By application type, the diagnostic testing segment held approximately a 50% share in the market in 2024.
  • By application type, the prognostic testing segment is expected to be the fastest growing during the forecast period.
  • By cancer type, the breast cancer segment held approximately a 25% share in the market in 2024.
  • By cancer type, the lung cancer segment is expected to be the fastest-growing during the forecast period.
  • By end user, the hospitals and diagnostic laboratories segment held an approximate 40% share in the global oncology biomarker market in 2024.
  • By end user, the research and academic institutes segment is expected to be the fastest growing during the forecast period.

Key Indicators and Highlights

Table Scope
Market Size in 2025 USD 38.62 Billion
Projected Market Size in 2034 USD 113.54 Billion
CAGR (2025 - 2034) 12.73%
Leading Region North America by 35%
Market Segmentation By Biomarker Type, By Application, By Cancer Type, By End-User, By Region
Top Key Players F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., bioMérieux SA, Merck & Co., Inc., Hologic, Inc., Sino Biological Inc., Myriad Genetics, Inc., Caris Life Sciences, Guardant Health, Foundation Medicine, Inc., Exact Sciences Corporation, NeoGenomics Laboratories, Inc., Adaptive Biotechnologies Corporation, 23andMe, Inc., Quest Diagnostics Incorporated

What is an Oncology Biomarker?

The oncology biomarker market is driven by the growing global cancer burden and the increasing shift towards personalized medicine. The oncology biomarker encompasses the development, validation, and application of biomarkers biological molecules found in blood, tissues, or other body fluids, that aid in the detection, diagnosis, prognosis, and treatment of various cancers. They play a crucial role in early cancer detection, monitoring disease progression, and assessing therapeutic responses, as well as in the development of personalized medicine.

Oncology Biomarker Market Outlook

  • Industry Growth Overview: The growing cancer rates and advancements in personalized medicines are the factors responsible for the oncology biomarker industry growth. Additionally, the growing investments in cancer R&D and increasing technological innovations in omics and liquid biopsy technologies are other actors fuelling the market growth.
  • Major Investors: The major pharmaceutical companies and prominent venture capital firms contribute as the major investors in the market. They are offering funding to technological innovations to accelerate the discovery of new oncology biomarkers for targeted therapies and personalized medicines.
  • Startup Ecosystem: The startup ecosystem is focusing on the development of liquid biopsies and leveraging AI for early and more precise cancer detection. Additionally, they are being supported by significant funding, which is helping them to overcome the high developmental cost and regulatory hurdles.

How Do the AI Technological Shifts Impact the Oncology Biomarker Market?

The cancer diagnosis, treatment, and prognosis are being transformed, due to the growing impact of AI, as it helps to discover biomarker signatures important for early detection and treatment of cancer, enhancing the precision medicine development. Machine learning and deep learning diagnostics are being used to identify patterns in large datasets, promoting the development of biomarkers to provide accurate and effective therapies. Therefore, the use of AI in cancer biomarker discovery is increasing, enhancing early diagnosis, targeted therapy development, and patient outcomes.

For instance,

  • In October 2025, an AI tool named DOLPHIN, which can detect previously invisible disease markers inside single cells, was developed by the researchers of McGill University. Additionally, analysis of pancreatic cancer patients' single-cell data and detection of more than 800 disease markers previously missed by conventional tools was provided by this tool.

Growing R&D investments: To deal with the growing cancer cases, the industries are contributing to the increased oncology R&D to develop early and accurate detection kits and targeted treatment options, increasing the demand for biomarkers. Therefore, the investments from various sources are encouraging these developments.

For instance,

  • In September 2025, a successful closing of $8 million funding round was announced by FYR Bio. Moreover, the expansion of the company in oncology, along with an emphasis on neuroscience like neuro-oncology and neurodegeneration, will be supported by this funding.
  • In July 2025, a $10 million Securities Purchase Agreement was secured by Predictive Oncology Inc. from Yorkville Advisors Global, LP. This capital will be used to expand the availability of the company's ChemoFx tumor profiling technology in the U.S. market and launch in Europe.

Table: Latest Launched Oncology Biomarker Platforms

Company Platform Application Source
Bangkok Dusit Medical Services Public Company Limited (BDMS) BDMS SPOT-MAS Detects early-stage cancer cells of ten major cancer types - ovarian, breast, gastric, lung, head, liver, neck, oesophageal, pancreatic, colorectal, and endometrial cancers BDMS Launches SPOT-MAS Early Cancer Screening Programme
Ataraxis AI and MEDSIR Integrated artificial intelligence into multiple major international trials Identify biomarkers and optimize treatment MEDSIR and Ataraxis AI Launch Research Collaboration to Evaluate AI-Powered Platform as a Predictive Tool in Breast Cancer Randomized Clinical Trials
Exact Sciences Corp. Cancerguard™ test Analyze multiple biomarker classes and detect a wide range of cancers Exact Sciences Launches Cancerguard™, First-of-Its-Kind Mul…
Biodesix and Association of Pulmonary Advanced Practice Providers (APAPP) CME-accredited educational programs focused on diagnostic biomarkers in Lung Nodule and Lung Cancer patient programs  Address the critical need for improved lung cancer detection Biodesix Launches First-Ever Lung Cancer Biomarker Education Program for APPs | BDSX Stock News
Metropolis Healthcare TruHealth Cancer Screen 360 Integrated Cancer Screening Panel Metropolis Healthcare launches TruHealth cancer screen 360 to strengthen preventive oncology in India - Express Healthcare
Akoya Biosciences and Enable Medicine Enable Pan-Cancer Atlas Filter and analyze data by biomarker expression, clinical metadata, and tissue type Breakthrough 100M-Cell Cancer Atlas Launches for Biomarker Discovery | AKYA Stock News
LuNGS Alliance Free Lung NGS (Next Generation Sequencing) biomarker testing To drive awareness about precision oncology as an essential, accessible, and affordable treatment plan for lung cancer treatment LuNGS Alliance launches free lung NGS biomarker testing for lung cancer patients in India - Express Pharma

Segmental Insights

How Genomic Biomarkers Segment Dominated the Oncology Biomarker Market in 2024?

By biomarker type, the genomic biomarkers segment led the market with approximately 35% share in 2024, as they helped in detecting cancer mutations. They were also used for the development of targeted therapies. Additionally, the growth in companion diagnostics has also increased their use.

By biomarker type, the proteomic biomarkers segment is expected to show the highest growth during the predicted time. Their use is increasing to identify the disease state in the body and the treatment responses as well. Moreover, they are also being used in liquid biopsies for early and easier cancer detection.

Which Application Type Segment Held the Dominating Share of the Oncology Biomarker Market in 2024?

By application type, the diagnostic testing segment held the dominating share of approximately 50% in the market in 2024, driven by the increased use of oncology biomarkers in early cancer detection. Moreover, they were also used in the non-invasive diagnosis, as well as supported the development of personalized medicines. Similarly, their increased application in companion diagnostics also increased their use.

By application type, the prognostic testing segment is expected to show the fastest growth rate during the predicted time. In prognostic testing, the biomarkers are being used to predict disease outcomes and enhance the selection of personalized treatment options. It also helps in detecting the recurrence of cancer, ensuring optimal treatment for the patients.

What Made Breast Cancer the Dominant Segment in the Oncology Biomarker Market in 2024?

By cancer type, the breast cancer segment led the market with approximately a 25% share in 2024, due to growth in its incidence rates. This increased the demand for biomarkers for their early and accurate diagnosis and prognosis. Additionally, growing awareness also promoted their use in testing and development of therapies.

By cancer type, the lung cancer segment is expected to show the highest growth during the upcoming years. The biomarkers are being used in the development of early diagnostic techniques for lung cancers. Moreover, the growing use of liquid biopsies and targeted therapies is also increasing their use.

Why Did the Hospitals and Diagnostic Laboratories Segment Dominate in the Oncology Biomarker Market in 2024?

By end user, the hospitals and diagnostic laboratories segment held the largest share of approximately 40% in the global market in 2024, as they are the primary point of patient care. Moreover, the large volume of patients increased the use of oncology biomarkers. Additionally, diverse cancer cases and advanced instruments contributed to their continuous use.

By end user, the research and academic institutes segment is expected to show the fastest growth rate during the upcoming years. The growing cancer R&D is increasing the use of oncology biomarkers for various applications. Additionally, the growing collaborations and government funding are promoting these advancements.

Regional Insights

Oncology Biomarker Market Share, By Region, 2024 (%)

Advanced Healthcare Drives North America

North America dominated the oncology biomarker market with 35% in 2024, due to the presence of a robust healthcare infrastructure, which increased the use of oncology biomarkers for the development of diagnostic technologies. Moreover, the growing incidence of cancer has increased their use for the early detection of cancer and development of personalized medicines, where their development and innovations are supported by investments and funding. Thus, this contributed to the market growth.

U.S. Driven by Growing Advancements

The growing cases of cancer in the U.S. are increasing the demand for oncology biomarkers for developing advanced diagnostic and treatment options. Moreover, the industries are also utilizing them to advance the development of personalized medicine, targeted therapies, and liquid biopsies. Additionally, the investments and funding are encouraging their development.

For instance,

  • In March 2025, to set up a Cancer Immunotherapy Biomarker Core, a total of $3 million was awarded to the University of Houston by the Cancer Prevention and Research Institute of Texas as a part of a $93 million grant package. The most comprehensive and currently feasible targeted proteomic cancer biomarker screens will be provided to the researchers in Texas through this state-of-the-art facility.

Increasing R&D Propels Canada

The industries and institutes of Canada are increasing the use of oncology biomarkers due to growing research and development. This, in turn, is driving their clinical trials, where the innovations are supported by government funds. Additionally, increasing awareness is growing their use for early cancer detection.

Growing Cancer Burden Boosts Europe

Europe is expected to host a significantly growing oncology biomarker market during the forecast period, due to the growing cancer burden, which is increasing the use of biomarkers for early detection. At the same time, the growing technological advancements, along with government support, are increasing their use and making them more affordable. Similarly, the expanding healthcare sector is increasing its use for R&D, genomics, clinical trials, diagnostics, and precision medicine developments, promoting the market growth.

Oncology Biomarker Market Value Chain Analysis

R&D

To discover, integrate, and validate new biomarkers for effective personalized cancer detection and treatment with the use of advanced multi-omics technologies, AI, and liquid biopsies are the main focus of the R&D of oncology biomarkers.

Key Players: F. Hoffmann-La Roche Ltd., Illumina, Inc., Thermo Fisher Scientific Inc., Abbott Laboratories, QIAGEN N.V.

Clinical Trials and Regulatory Approvals

The clinical trials and regulatory approval of oncology biomarkers consist of the validation of their ability to predict patient response to targeted therapies, along with the drug safety and effective use of the companion diagnostic devices.

Key Players: F. Hoffmann-La Roche Ltd., Illumina, Inc., Thermo Fisher Scientific Inc., Guardant Health, QIAGEN N.V.

Patient Support and Services

The patient support and services of oncology biomarkers involve access to advocacy groups for emotional and practical guidance, comprehensive education, and counseling to help patients understand results and implications for treatment, and financial assistance to cover the testing and treatment costs.

Key Players: F. Hoffmann-La Roche Ltd., Illumina, Inc., Thermo Fisher Scientific Inc., Guardant Health, QIAGEN N.V.

Top Vendors and Their Offerings

  • Bio-Rad Laboratories, Inc.: The oncology biomarkers utilized by the company in the kits and assays consist of AKT1, PTEN, HER2, ESR1, and MSI.
  • Agilent Technologies: Companion diagnostic products such as HER2 IQFISH pharmDx, HercepTest Kits, PD-L1 IHC 22C3 pharmDx, and PD-L1 IHC 28-8 pharmDx were launched by the company.
  • QIAGEN N.V.: The products, such as BCR-ABL1 Mbcr RGQ RT-PCR Kit, Ipsogen JAK2 RGQ PCR Kit, Ipsogen JAK2 MutaScreen kit, etc, were launched by the company.
  • Illumina, Inc.: The company has launched various next-generation sequencing (NGS) platforms, such as iSeq 100 System, MiniSeq System, MiSeq Sequencing System, NextSeq 550 System, etc.
  • Abbott Laboratories: Different types of oncological immunoassays were launched by the company, including AFP, CA 125 II, CA 15-3, CA 19-9XR, CA 72-4*, CEA, CYFRA 21-1, Free PSA, etc.

Which are the Top Companies in the Oncology Biomarker Market?

Recent Developments in the Oncology Biomarker Market

  • In October 2025, to develop AI-powered tools for the identification of the most effective treatment options for pancreatic ductal adenocarcinoma (PDAC) patients, a collaboration between Genialis, which is an RNA biomarker company, and the Cleveland Clinic was announced.
  • In September 2025, exclusive worldwide rights to novel exosomal biomarker intellectual property were provided to INOVIQ by UniQuest. Thus, with this agreement, the freedom to develop and commercialize the biomarkers as part of its EXO-OC test, which is a blood test promoting the screening and early detection of ovarian cancer in asymptomatic women, will be provided to INOVIQ.

Segments Covered in the Report

By Biomarker Type

  • Genomic Biomarkers
  • Proteomic Biomarkers
  • Immunohistochemical Biomarkers
  • Metabolomic Biomarkers
  • Other Biomarkers

By Application

  • Diagnostic Testing
  • Prognostic Testing
  • Predictive Testing
  • Monitoring and Surveillance
  • Others

By Cancer Type

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Liver Cancer
  • Other Cancers

By End-User

  • Hospitals and Diagnostic Laboratories
  • Research and Academic Institutes
  • Pharmaceutical and Biotechnology Companies
  • Others

By Region 

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait

Tags

  • Last Updated: 16 October 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Rohan Patil is a seasoned market research professional with over 5+ years of focused experience in the healthcare sector, bringing deep domain expertise, strategic foresight, and analytical precision to every project he undertakes.

Learn more about Rohan Patil

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi plays a critical role in ensuring the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar

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FAQ's

The oncology biomarker market stands at USD 38.62 billion in 2025 and is expected to reach USD 113.54 billion by 2034, growing at a CAGR of 12.73% from 2024 to 2034.

North America is currently leading the oncology biomarker market share by 35% due to the presence of a robust healthcare infrastructure.

Some key players include F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., bioMérieux SA, and Merck & Co., Inc. 

The oncology biomarkers play a crucial role in early cancer detection, monitoring disease progression, and assessing therapeutic responses, as well as in the development of personalized medicine. 

Ministry of Health and Family Welfare, Government of India, National Institutes of Health, FDA, WHO, PIB, CDC.