Additionally, regulatory pathways and reimbursement practices are supportive of biomarker adoption and utilization in hospitals, research centers and diagnostic laboratories. As biomarker-driven therapies receive approval, the use of companion diagnostics will increase to stratify a patient population

Key Drifts:

What Are the Trends Shaping the Oncology Biomarker Market?

• Liquid Biopsy and Non-Invasive Testing: Liquid biopsy is becoming a more common minimally invasive method
• Integration of AI & Big Data Analytics: Artificial intelligence and machine learning are now being applied to large biomarker data sets to identify new signatures, predict patient response, and accelerate drug-biomarker co-development.
• Multi-Omics Approaches: Multi-omics approaches that integrate genomic, proteomic
• Companion Diagnostics Expansion: Moreover, an increasing number of companion diagnostics are being approved by the FDA and EMA, which can then be used to stratify patients and personalize treatment plans, especially with the increasing number of targeted therapies available for the treatment of cancer.
• Public-Private Collaborations & Data Sharing: Public-private collaborations to build national and international genomic databases
  

  Significant Challenge:

  A key challenge in the oncology biomarker space is the regulatory burden and the expense associated with clinical validation. When validating a marker for clinical use, particularly as a companion diagnostic, there is a need for large, well-designed trials, analytical validation and regulatory approval, all of which is highly time-consuming and costly, particularly when integrating biomarker discovery in genomics, proteomics and multiple-omics platforms
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  Regional Analysis:

  North America continues to lead in the oncology biomarker industry, mainly due to the region's well-established healthcare framework, active research ecosystem, and favorable regulatory environment. The U.S. is ahead of its North American peers as a result of broad adoption of next-generation sequencing, advanced molecular diagnostics in the oncology centers biobanks

  Europe is becoming the fastest growing region in the oncology biomarker category. The In Vitro Diagnostic Regulation (IVDR) will improve harmonization of biomarker assays and drive standardization throughout member states. Various European countries (including Germany, the UK, France and the Netherlands) are expanding previous national genomics programs and establishing cross-border collaborations to facilitate sharing of information and validating biomarkers. Furthermore, the the Health Data Space initiative will support cross-border exchange of genomic data, which will enhance clinical validation. Regulatory support and co-development of biomarker/drug submissions with the European Medicines Agency (EMA) are also helping companies to more quickly introduce companion diagnostics on the market.

  Segmental Insights:

  By Biomarker Type:

  Genomic biomarkers, which include DNA mutations, gene fusions, and copy-number variations, remain essential to precision oncology strategies

  There will also be rapid growth in proteomic biomarkers that reflect expression level, phosphorylation status, and pathways of signaling. Furthermore, as proteomics platforms (mass spectrometry, multiplex immunoassays, etc.) achieve higher levels of sensitivity and scale, they provide a dynamic measure of treatment response and mechanisms of resistance. Such unique measures of real-time tumor behavior make proteomics valuable for prognostic and predictive potential.

  By Application Type:

  Diagnostic testing currently leads the oncology biomarker market. This may include genomic panels, immunohistochemistry, and liquid biopsy that can be applied to both diagnose cancer early or stratify patients for treatment. Diagnostic biomarkers are primary in directing therapy selection and informing the clinician as to which treatment instructed toward a targeted therapy, if possible.

  Prognostic biomarker testing is poised for rapid growth as clinicians are increasingly interested in predicting disease progression, recurrence risk, and, ultimately patient survival. Emerging biomarkers (genomic, proteomic, transcriptomic) are being further validated to stratify patients into high- or low-risk categories to inform follow-up and adjuvant therapy and surveillance.

  By Cancer Type:

  Breast cancer represents a large share of the oncology biomarker market, primarily thanks to well-defined biomarkers ER, PR, HER2 status, and PIK3CA mutations. There are many companion diagnostics for biomarkers associated with targeted therapies, including PI3K inhibitors. The prevalence of breast cancer and biomarker-directed therapies make it by far the largest share.

  Lung cancer biomarker adoption is happening quickly as new therapies, including targeted therapies and immunotherapies, become available. Biomarkers, including EGFR, ALK, ROS1, among others, are being adopted rapidly. Emerging biomarkers, tumor mutational burden (TMB) and circulating tumor DNA, also contribute to lung cancer biomarker adoption. The high unmet need, combined with frequent testing and monitoring needs, leads lung cancer to be one of the fastest growing segments in the oncology biomarker market.

  By End User:

  Hospitals and diagnostic laboratories are the leading end-user segment in the market since these are primary sites of in vitro diagnostics

  Research and academic institutes are set to see the fastest growth across end users, as they represent the driving force for biomarker discovery, validation, and clinical translation. Research and academic institutes are also involved in translational research, early-phase clinical trials, and biobank activities. Coupled with partnerships with biotech and pharmaceutical companies

  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.

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  Oncology biosimilars are among the fastest-growing segments

  The global DNA methylation market

  Recent Developments:

  In February 2025, Acrivon Therapeutics' OncoSignature assay, developed using its AP3 proteomics platform, was granted Breakthrough Device status by the FDA for identifying endometrial cancer patients likely to benefit from its CHK1/2 inhibitor ACR-368.

  Oncology Biomarker Market Key Players List:

  • 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
    

  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
      
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