Oncology Biomarkers Market Size, Share, and Trends Analysis, By Type (Breast Cancer, Prostate Cancer, Colorectal Cancer, Others), By Biomarker Type (Genetic Biomarkers, Epigenetic Biomarkers, Others), Technology (Imaging Technologies), By Application (Diagnostics), By End-Use (Hospitals, Ambulatory Centers, Others), and By Region, Forecast 2025-2032

Oncology Biomarkers Market Overview and Key Insights:

The global oncology biomarkers market reached USD 29.14 billion in 2024 and is expected to register a revenue CAGR of 11.8% during the forecast period. Rising incidence of cancer, growing shift toward personalized medicine, increasing expansion of non-invasive liquid biopsy techniques, and rising adoption of companion diagnostics are expected to drive revenue growth of the market.

Market Drivers:

Rising incidence of cancer is the major factor driving revenue growth of the market. Cancer cases are expected to increase significantly due to aging populations, lifestyle changes, and environmental factors. According to the World Health Organization (WHO), approximately 20 million new cancer cases and 9.7 million cancer-related deaths were recorded in 2022. This number is expected to rise significantly, with cancer cases projected to reach 35 million by the year 2050. Healthcare systems are now under pressure to adopt more precise and cost-effective diagnostic tools. Oncology biomarkers help clinicians identify specific genetic, proteomic, or epigenetic alterations associated with various cancer types. It facilitates targeted therapies and improves patient outcomes. The growing clinical reliance on biomarker-based diagnostics and treatment decision-making is leading to increased investments in research, development, and commercialization of biomarker technologies, and drives revenue growth of the market.

The pharma and biotec companies are working on research & development of diagnostic products and kits, and upgrading their existing product portfolio of such products, which is driving the growth of this market. For instance, on 13 April 2023, Agilent Technologies Inc. announced NGS Assay for Comprehensive Genomic Profiling (CGP) for advancing precision oncology. The Agilent SureSelect Cancer CGP Assay is designed for somatic variant profiling for a broad range of solid tumor types. This type of technological innovation strengthens broader integration of genomic profiling into routine oncology care and boost revenue growth of the market.

Market Opportunity:

Advancements in genomics and proteomics are creating significant opportunities for the market. It allows more precise, comprehensive, and high-throughput analysis of cancer-related molecular alterations. Advanced technologies such as Next-Generation Sequencing (NGS), mass spectrometry, and transcriptomics have revolutionized the identification and validation of novel biomarkers associated with tumor initiation, progression, and therapeutic response. These innovations allow researchers and clinicians to detect a wide range of genetic mutations, protein expressions, and signaling pathways with greater accuracy and efficiency. This technological progress is attracting increased investment from pharmaceutical companies and diagnostics developers for biomarker-based solutions.

In January 2025, for instance, Thermo Fisher Scientific launched Olink Reveal, a high-plex proteomics platform designed to make biomarker discovery more accessible by lowering both costs and setup complexity. This innovative solution allows researchers to efficiently identify circulating biomarkers across various applications, establishing a new benchmark for affordability and scalability in proteomics. The demand for biomarker-based solutions expands as more stakeholders adopt this type of scalable and affordable technology, which drives revenue growth of the market.

Recent Trends:

One recent trend in the oncology biomarkers market is the integration of Artificial Intelligence (AI) & big data analytics. It enables faster and more accurate discovery, validation, and clinical interpretation of complex biomarker data. AI-driven algorithms and machine learning models are now employed to identify patterns, predict treatment responses, and uncover novel biomarker candidates that would be difficult to detect through conventional methods. These technologies also increase real-time decision-making in clinical settings by automating data analysis from genomic, proteomic, and imaging sources.

In December 2024, HealthCare Global Enterprises Limited (HCG), a leading cancer care network in India, is working with Accenture to boost cancer research and treatment using advanced AI tools. These include generative AI and deep learning applied to complex, multi-omic patient data. This is the first program of its kind in South Asia. It will use Accenture’s generative AI studios to drive new research focused on discovering drug targets, mechanisms, pathways, and biomarkers linked to various types of cancer.

Restraints & Challenges:

Limited availability of high-quality biospecimens represents a significant barrier to the revenue growth of the oncology biomarkers market. Biomarker discovery and validation rely mainly on access to well-preserved, clinically annotated tissue and fluid samples. However, challenges such as inconsistent collection standards, lack of centralized biobanks, and ethical constraints on sample sharing hinder the availability of these critical resources. It becomes difficult to conduct robust clinical studies without reliable biospecimens. It slows down the development and regulatory approval of new biomarker-based tests and restrains revenue growth of the market.

Type Segment Insights and Analysis:

Based on the type, the oncology biomarkers market is segmented into breast cancer, prostate cancer, colorectal cancer, cervical cancer, liver cancer, lung cancer, melanoma, leukemia, and others.

Breast cancer segment accounted for largest revenue share in 2024 due to the rising prevalence of breast cancer across the globe. According to the World Health Organization (WHO), in 2022, breast cancer affected 2.3 million women worldwide and led to 670,000 deaths. It is found in women across all countries and can develop at any age after puberty, though the likelihood increases with age.  Oncology biomarkers play a critical role in identifying genetic and molecular changes specific to breast cancer. It enables targeted therapies and improves patient outcomes. This growing clinical reliance on biomarker-based diagnostics and treatment planning is leading to higher adoption rates, greater investment in biomarker research and drives revenue growth of this segment.

Lung cancer segment is expected to grow at a robust CAGR during the forecast period due to the rising number of cases among the elderly population across the globe. Most lung cancer diagnoses occur in individuals aged 65 and above. According to National Institutes of Health (NIH), in 2022, lung cancer accounted for 2,480,675 newly reported cases worldwide. As lung cancer remains one of the most prevalent and deadly cancers, there is growing demand for early and accurate diagnostic tools to improve survival rates. Oncology biomarkers are increasingly used to detect genetic mutations, predict treatment responses, and monitor disease progression in lung cancer patients. The surge of clinical applications of biomarkers in lung cancer drives revenue growth of this segment.

Biomarker Type Segment Insights and Analysis:

Based on biomarker type, the oncology biomarkers market is segmented into genetic biomarkers, proteomic biomarkers, glycoprotein biomarkers, epigenetic biomarkers, metabolic biomarkers, cellular biomarkers and others.

The genetic biomarkers segment accounted for largest revenue share in 2024 due to the continuous advancements in genomic technologies like Next-Generation Sequencing (NGS), which allow for the accurate detection of cancer-linked mutations. A global push toward personalized treatments is further increasing demand, as genetic biomarkers are essential for matching patients to targeted therapies, companion diagnostics, and clinical trials. Moreover, rising cancer incidence, increased research funding, and greater investment from both public and private sectors are supporting the development and adoption of genetic biomarker tests, thereby boosting revenues growth of this segment.

In October 2024, MEDiC Life Sciences, a biotech startup from Silicon Valley, partnered with Korea’s Hanmi Pharmaceutical to identify cancer biomarkers using MEDiC’s MCAT platform. This advanced genomics tool maps millions of gene-to-drug interactions to discover SLS biomarkers. It is a combination of genetic mutations that show synthetic lethality with specific cancer drugs.

End-Use Segment Insights and Analysis:

Based on end-use, the Oncology Biomarkers market is segmented into hospitals & clinics, ambulatory centers, academic and cancer research institutes, diagnostic laboratories, Contract Research Organizations (CROs), and others.

The hospitals & clinics segment accounted for the largest revenue share in 2024. These healthcare facilities serve as the primary point for diagnosing, treating, and monitoring cancer patients. It increases demand for integrated biomarker-based diagnostics at the point of care. Hospitals are investing in advanced molecular diagnostics like NGS and proteomics to efficiently guide treatment decisions and improve patient outcomes. Their robust infrastructure, skilled staff, and ability to administer both tests and therapies in one setting make them ideal adopters of comprehensive biomarker solutions.

Diagnostic laboratories segment is expected to register a fast revenue growth rate during the forecast period. Equipped with advanced technologies like NGS, PCR, and proteomics platforms, these labs process large volumes of samples with speed and accuracy. They are supporting early cancer detection, prognostics, and treatment monitoring.  Their expertise in customizing Lab-Developed Tests (LDTs) enables tailored diagnostic solutions that meet specific clinical needs, especially in cases where commercial assays are unavailable.  The combination of technical capability, clinical integration, and strategic partnerships boosts revenue growth of this segment.

Geographical Outlook:

Oncology biomarkers market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America Oncology Biomarkers Market:

Market in North America accounted for largest revenue share in 2024 due to the high prevalence of cancer, advanced healthcare infrastructure, and substantial public and private funding in the region, especially in the U.S. and Canada. In 2022, the United States recorded 1,851,238 new cancer cases, while in 2023, cancer was responsible for 613,349 deaths across the country. The National Cancer Institute estimates that in 2025, the United States will see approximately 2,041,910 new cancer diagnoses and 618,120 cancer-related deaths. This growing disease burden increases the demand for early detection, precise diagnosis, and targeted treatment strategies, all of which rely heavily on biomarker-based solutions. This factor drives revenue growth of the market in this region.

In addition, the rapid regulatory approvals and substantial public and private funding boost revenue growth of the market in the region.  In August 2024, for instance, Illumina, Inc., an American leader in DNA sequencing and array technologies, announced that the FDA had approved its in Vitro Diagnostic (IVD) test, TruSight Oncology (TSO) Comprehensive, along with its first two companion diagnostic (CDx) uses. This test analyzes more than 500 genes in a patient’s solid tumor, significantly improving the chances of detecting immuno-oncology or other clinically actionable biomarkers that can guide targeted therapies or support clinical trial participation.

Asia Pacific Oncology Biomarkers Market:

Asia Pacific is expected to register a fast revenue growth rate during the forecast period due to the rise in cancer incidence and rapidly aging population in the region, especially in China, Japan, and India. In 2022, China reported over 4.8 million newly diagnosed cancer cases, with lung cancer being the most prevalent, accounting for more than 1.06 million of those cases. Regional governments of the country are responding with increased healthcare spending, national cancer control programs, and improvements in diagnostic infrastructure. It facilitates wider access to biomarker-based testing in the region and drives revenue growth of the market.

Technological adoption across the region also plays a key role for the revenue growth of the market. In May 2023, for instance, Fujitsu Limited, Kyoto University, and Chordia Therapeutics, Inc. launched field trials using Fujitsu’s AI-based causal discovery technology to identify biomarkers that could enhance the success rate or reduce the time required for clinical trials in cancer drug development. Such technological innovation accelerates the integration of biomarkers into pharmaceutical R&D pipelines and boosts revenue growth of the market in this region.

Europe Oncology Biomarkers Market:

Market in Europe accounted for a significant revenue share in 2024 due to the combination of healthcare, regulatory, and technological advancements. Public investment in precision medicine, through EU programs such as Horizon 2020 and national genomics initiatives, has significantly boosted research and development efforts and drives revenue growth of the market in this region. In addition, the rising cancer burden creates high demand for biomarkers across the region. In 2022, Europe reported a total of 4,471,422 new cancer cases, with the overall risk of developing cancer by age 75 estimated at 27.9%. Of these cases, 2,359,303 were diagnosed in males and 2,112,119 in females. This growing disease burden is prompting healthcare systems to adopt more advanced diagnostic tools like biomarkers for early detection, prognosis, and treatment stratification.

Competition Analysis:

The oncology biomarkers market is characterized by a consolidated structure, with few players competing across various segments and regions. List of major players included in the Oncology Biomarkers market report are:

• Abbott Laboratories
• Agilent Technologies Inc.
• Astellas Pharma Inc.
• bioMérieux SA
• Bio-Rad Laboratories Inc.
• Bristol-Myers Squibb Company
• DiagnoCure Inc.
• Eli Lilly and Company
• Exact Sciences Corp
• Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc
• Illumina, Inc
• INOVIQ Ltd
• QIAGEN N.V
• Myriad Genetics, Inc.

Strategic Developments in Oncology Biomarkers Market:

• On 02 June 2025, Oxford Cancer Biomarkers Ltd (OCB), a pioneer in molecular precision cancer diagnostics, announced a new collaboration with Mira Precision Health Inc. to expand the reach of its proprietary ToxNav test in the United States. ToxNav is an advanced precision oncology test designed to identify patients who are at high risk of experiencing severe toxicity from 5FU or capecitabine treatments.
• On 13 March 2025, Mainz Biomed N.V., a molecular genetic diagnostics company, signed a License and Option Agreement with Liquid Biosciences to gain access to a set of innovative mRNA biomarkers aimed at detecting pancreatic cancer through a non-invasive blood test. Under this agreement, both companies intend to jointly develop the test, to pursue future FDA submissions.
• On 07 January 2025, the ONCare Alliance, a network of 32 independent oncology practices, teamed up with Ovation.io, Inc., a human omics data firm, to develop new biomarker profiles and build a biorepository to support precision medicine. This initiative connects biospecimen collection methods typically used in clinical trials with real-world clinical data.

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights of The Oncology Biomarkers Market Report:

The Oncology Biomarkers market report offers a detailed analysis of market size, including historical revenue (in USD Billion) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Cancer Type Outlook (Revenue, USD Billion; 2022-2032)
  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Liver Cancer
  • Lung Cancer
  • Melanoma
  • Leukemia
  • Others

• Biomarker Type Outlook (Revenue, USD Billion; 2022-2032)
  • Genetic Biomarkers
  • Proteomic Biomarkers
  • Glycoprotein Biomarkers
  • Epigenetic Biomarkers
  • Metabolic Biomarkers
  • Cellular Biomarkers
  • Others

• Technology Outlook (Revenue, USD Billion; 2022-2032)
  • Imaging Technologies
  • Omics Technologies
  • Immunohistochemistry (IHC)
  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing (NGS)
  • Others

• Application Outlook (Revenue, USD Billion; 2022-2032)
  • Drug discovery and Development
  • Diagnostics
  • Personalized Medicine
  • Prognostics
  • Others

• End-Use Outlook (Revenue, USD Billion; 2022-2032)
  • Hospitals & Clinics
  • Ambulatory Centers
  • Academic and Cancer Research Institutes
  • Diagnostic Laboratories
  • Contract Research Organizations (CROs)
  • Others

• Regional Outlook (Revenue, USD Billion; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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