Revenue, 2025

USD 38.62 Billion

Forecast, 2035

USD 128.00 Billion

CAGR, 2026-2035

12.73%

Report Coverage

Global

Oncology Biomarker Market Key Takeaways

• Oncology biomarker industry poised to reach USD 43.54 billion by 2026.
• Forecasted to grow to USD 128.00 billion by 2035.
• Expected to maintain a CAGR of 12.73% from 2026 to 2035.
• North America held approximately a 35% share in the global oncology biomarker market in 2025.
• 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 2025.
• 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 2025.
• 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 2025.
• 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 2025.
• By end user, the research and academic institutes segment is expected to be the fastest growing during the forecast period.

Oncology Biomarker Market Trends for 2026

The global oncology biomarker market size is calculated at US$ 38.62 billion in 2025, grew to US$ 43.54 billion in 2026, and is projected to reach around US$ 128.00 billion by 2035. The market is expanding at a CAGR of 12.73% between 2026 and 2035.

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.

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.

What are the Major Oncology Biomarker Market Trends?

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

Key Indicators and Highlights

Segmental Insights

By Biomarker Insight

How Genomic Biomarkers Segment Dominated the Oncology Biomarker Market in 2025?

By biomarker type, the genomic biomarkers segment led the market with approximately 35% share in 2025, 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.

By Application Insights

Which Application Type Segment Held the Dominating Share of the Oncology Biomarker Market in 2025?

By application type, the diagnostic testing segment held the dominating share of approximately 50% in the market in 2025, 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.

By Cancer Insights

What Made Breast Cancer the Dominant Segment in the Oncology Biomarker Market in 2025?

By cancer type, the breast cancer segment led the market with approximately a 25% share in 2025, 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.

By End User Insights

Why Did the Hospitals and Diagnostic Laboratories Segment Dominate in the Oncology Biomarker Market in 2025?

By end user, the hospitals and diagnostic laboratories segment held the largest share of approximately 40% in the global market in 2025, 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

Advanced Healthcare Drives North America

North America dominated the oncology biomarker market with 35% in 2025, 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.

Market Ecosystem Analysis

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?

• 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

Market Share Influence Assessment

Competitive Landscape

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