Cancer And Tumor Biomarker-based Assay Market (2025 - 2033) Size, Share & Trends Analysis Report By Cancer Type (Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer), By Biomarker Type, By End-use, By Region, And Segment Forecasts

Cancer And Tumor Biomarker-based Assay Market Summary

The global cancer and tumor biomarker-based assay market size was estimated at USD 10.97 billion in 2024 and is projected to reach USD 26.81 billion by 2033, growing at a CAGR of 10.50% from 2025 to 2033, driven by the growing demand for early diagnosis, personalized treatment, and precision oncology. Biomarker assays-covering genomic, proteomic, and metabolomic markers-enable clinicians to detect cancers earlier, predict disease progression, and guide therapy selection with higher accuracy.

Advances in technologies such as next-generation sequencing (NGS), liquid biopsy, and multiplex immunoassays are enhancing assay sensitivity and throughput while reducing turnaround times. Pharmaceutical companies increasingly collaborate with diagnostic developers to create companion diagnostics for targeted therapies, further fueling market growth.

Rapid advances in analytic platforms are transforming biomarker testing. Next-generation sequencing (NGS) platforms have become faster, cheaper and more flexible, enabling broad genomic panels, tumor profiling and discovery of rare variants at scale - which drives demand for assay development and clinical adoption. Meanwhile, liquid biopsy (cfDNA, CTCs, exosomes) allows minimally invasive serial monitoring, early detection and therapy resistance tracking; its convenience expands testing volumes beyond tissue-only workflows. Multiplex PCR/immunoassay platforms and digital pathology/imaging biomarkers further enable simultaneous measurement of multiple markers from limited samples, improving diagnostic yield and cost per actionable result. Together these technologies lower per-test costs, shorten time-to-result for certain workflows, and unlock new clinical use cases (screening, MRD, monitoring), all of which expand total addressable market and invite investment from diagnostics firms and pharma co-development partners.

The shift to targeted oncology therapeutics has created a tight coupling between drugs and the biomarker tests that identify eligible patients. As more targeted therapies and immunotherapies receive approvals tied to specific genomic, proteomic or immunologic signatures, pharma companies increasingly require validated companion diagnostics for clinical trials and regulatory approval. This raises demand for clinically validated biomarker assays across indications and supports higher price-per-test economics when tests are linked directly to expensive therapies. Furthermore, broader adoption of comprehensive genomic profiling and tumor-agnostic approvals increases use of multiplex assays and panel testing, concentrating spend on assays that can guide multiple treatment decisions. These dynamics fuel M&A and partnerships between diagnostic companies and drug developers, accelerating commercial rollouts of biomarker assays globally.

Biomarker assays used for treatment selection-especially companion diagnostics-face stringent regulatory pathways that affect time-to-market and commercialization costs. Regulatory agencies require rigorous analytical validation, clinical validation, and often co-submission or alignment with therapeutic approvals; novel biomarkers or rare variants complicate sample accrual for validation studies. Varying regional frameworks (e.g., FDA, EMA, and evolving IVD rules) create complexity for global launches and can force iterative studies or label differences across geographies. Additionally, regulators increasingly scrutinize clinical utility and real-world performance, pushing manufacturers to generate post-market evidence and to adopt quality systems (IVDR compliance, clinical evidence generation), which raises development timelines and CAPEX but ultimately improves clinical confidence and payer acceptance.

Market Concentration & Characteristics

Next-generation sequencing (NGS), liquid biopsy, and AI-based data analytics are just a few of the innovations propelling the market for cancer and tumor biomarker-based assays. Personalized therapy selection, non-invasive monitoring, and earlier detection are made possible by these technologies. Innovation is positioned as a crucial competitive differentiator in this dynamic market thanks to ongoing R&D investments and the integration of multiplex assays, which improve diagnostic accuracy and workflow efficiency.

Major diagnostic and biotechnology companies are purchasing smaller businesses to increase their technological capabilities and test portfolios, which is changing the landscape of cancer biomarker assays. Access to companion diagnostic platforms, international distribution networks, and proprietary biomarkers is accelerated by this consolidation. These strategic agreements improve market positioning, expedite regulatory approvals, and encourage the quicker incorporation of cutting-edge biomarker technologies into workflows for precision oncology.

Market expansion and product commercialization are greatly impacted by regulatory frameworks. Although they increase development costs and timelines, rigorous validation and approval procedures under FDA, EMA, and IVDR guidelines guarantee assay reliability and clinical utility. While preserving patient safety and diagnostic precision, standardized worldwide standards and changing regulations for liquid biopsy assays, laboratory-developed tests (LDTs), and companion diagnostics are promoting innovation.

Companies are broadening their biomarker assay portfolios to include multi-analyte panels, circulating tumor DNA (ctDNA) tests, and proteomic-based assays. Expansion into immuno-oncology biomarkers and multi-cancer early detection platforms supports personalized treatment strategies. Product diversification also addresses unmet needs across therapy selection, disease monitoring, and minimal residual disease detection, driving stronger adoption across hospital laboratories and oncology research centers globally.

As businesses enter emerging markets in the Middle East, Asia-Pacific, and Latin America, regional expansion strategies are essential to market growth. These areas have increasing rates of cancer, better healthcare facilities, and government programs that support precision medicine. Wider access to biomarker diagnostics in a variety of clinical and financial contexts is made possible by collaborations with regional labs, technology transfers, and the development of affordable assays.

Cancer Type Insights

On the basis of cancer type, breast cancer market accounted for the largest market share of 23.43% in 2024. Rising global breast cancer incidence, increasing awareness of early detection, and advancements in molecular diagnostics are key growth drivers. Biomarker-based assays such as HER2, BRCA1/2, ER/PR, and PIK3CA tests play a vital role in diagnosis, prognosis, and targeted therapy selection. The growing adoption of liquid biopsy, NGS panels, and companion diagnostics for personalized treatment is further accelerating demand. Supportive reimbursement policies, ongoing clinical trials, and the integration of AI-driven biomarker analysis are enhancing diagnostic accuracy and accessibility, positioning the breast cancer biomarker segment as one of the most dynamic areas within oncology diagnostics.

The lung cancer segment in the cancer and tumor biomarker-based assay market is experiencing rapid growth, driven by the increasing global burden of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Rising adoption of molecular biomarker testing for genes such as EGFR, ALK, KRAS, ROS1, and PD-L1 is transforming diagnosis and therapy selection. The shift toward non-invasive liquid biopsy assays for early detection and monitoring of treatment response is further accelerating market growth. Technological advancements in next-generation sequencing (NGS) and immunoassays, along with supportive regulatory approvals for companion diagnostics, are expanding precision oncology applications.

Biomarker Type Insights

Genetic / Genomic biomarkers held the largest market share in 2024 and anticipated to grow at the fastest rate over the forecast period, driven by the increasing use of molecular profiling to guide personalized cancer therapy. These biomarkers enable the identification of genetic mutations, gene fusions, and expression changes linked to tumor progression and treatment response. Advances in next-generation sequencing (NGS), PCR, and microarray technologies have enhanced test accuracy, throughput, and cost efficiency. The rising adoption of comprehensive genomic profiling (CGP) for targeted therapy selection and resistance monitoring is further propelling demand.

The protein biomarker segment in the Cancer and tumor biomarker-based assay market grow steady. Protein biomarkers, including CEA, CA-125, PSA, AFP, and HER2, play a critical role in cancer detection, prognosis, and therapy monitoring. Increasing use of immunoassays, mass spectrometry, and ELISA-based techniques has improved the sensitivity and specificity of protein detection. The growing demand for non-invasive and rapid diagnostic assays, along with their integration into multiplex and point-of-care platforms, is accelerating market adoption. Moreover, advancements in proteomics research, coupled with rising investments in early cancer detection and personalized treatment approaches, are driving strong growth for protein biomarker-based assays across oncology diagnostics.

End Use Insights

In 2024, hospitals and cancer centers held a 44.34% market share, dominating the industry. The demand for biomarker assays incorporated into standard oncology workflows is fueled by these facilities' roles as the main centers for diagnosis, treatment planning, and monitoring. The use of liquid biopsy platforms, immunohistochemistry (IHC), and next-generation sequencing (NGS) enables accurate, individualized cancer treatment. In order to use companion diagnostics and thorough genomic profiling for therapy selection, hospitals are working more and more with diagnostic companies. Adoption is further aided by growing awareness of early detection, expanding oncology infrastructure, and encouraging reimbursement policies.

The diagnostic laboratories segment is expected to grow at the fastest compound annual growth rate (CAGR) over the forecast period, driven by the increasing demand for specialized molecular testing and high-throughput analysis. These labs, which provide cutting-edge platforms like NGS, PCR, flow cytometry, and immunoassays, are essential to the identification, validation, and routine clinical testing of biomarkers. For oncology clinics and hospitals, centralized labs offer cost savings, standardized results, and quicker turnaround times. Service portfolios have been further broadened by the emergence of liquid biopsy testing, comprehensive genomic profiling (CGP), and multi-cancer early detection (MCED) assays. This market is expected to continue growing, especially in emerging healthcare markets, thanks to strategic partnerships, accreditation programs, and the growing trend toward outsourced testing services.

Regional Insights

North America Cancer And Tumor Biomarker-based Assay Market Trends

North America dominates the cancer and tumor biomarker-based assay market with a revenue share of 41.58% in 2024 due to advanced healthcare infrastructure, high cancer prevalence, and strong adoption of precision diagnostics. Early adoption of companion diagnostics and next-generation sequencing (NGS) is advantageous for the area. The American Cancer Society estimates that more than 2 million new cases of cancer will occur in 2025. Hospitals and labs continue to grow as a result of FDA approvals of biomarker assays and expanding genomic testing programs.

U.S. Cancer And Tumor Biomarker-based Assay Market Trends

The U.S. leads the global market, driven by high rates of lung, breast, prostate, and colorectal cancers. Strong investments in molecular diagnostics and AI-based biomarker discovery enhance innovation. Commercialization is supported by the presence of significant players like Guardant Health, Illumina, and Thermo Fisher Scientific. Precision oncology solutions are becoming more and more popular across the country due to rising demand for liquid biopsy assays and government programs like the Cancer Moonshot.

Europe Cancer And Tumor Biomarker-based Assay Market Trends

Europe represents a significant market share owing to the widespread integration of biomarker testing into national cancer control strategies. NGS and IHC assays have been quickly adopted in nations like Germany, France, and Italy. Nearly 23% of all cancer cases worldwide occur in Europe, according to the WHO. Assay reliability is guaranteed by the In Vitro Diagnostic Regulation (IVDR), which encourages investment and innovation throughout the continent.

The UK market is expanding due to the NHS Genomic Medicine Service and nationwide precision medicine programs. Over 375,000 new cases of cancer are reported each year, increasing the need for early detection assays. Biomarker discovery is being accelerated by collaborations between government-funded research projects, academic institutions, and diagnostic developers. The nation is positioned as a major center for oncology innovation in Europe due to its emphasis on liquid biopsy and AI-driven diagnostics.

Germany holds a strong position within the European biomarker assay market, supported by advanced healthcare infrastructure and a growing burden of cancer, with more than 500,000 new cases annually. Market growth is encouraged by the nation's focus on companion diagnostics as well as partnerships between medical facilities, pharmaceutical companies, and biotech companies. Germany's leadership in precision oncology diagnostics is being further reinforced by the growing use of NGS panels and multiplex assays for therapy selection.

Asia Pacific Cancer And Tumor Biomarker-based Assay Market Trends

The Asia Pacific region is projected to witness the fastest growth due to rising cancer prevalence, increasing healthcare expenditure, and improving diagnostic infrastructure. Genomic profiling and liquid biopsy technologies are being widely adopted by countries such as China, Japan, and India. Nearly half of all cancer cases worldwide occur in Asia, according to GLOBOCAN. Regional market expansion is also being fueled by government initiatives that support early screening and localized biomarker assay manufacturing.

Japan’s market is growing steadily, driven by high incidences of gastric, colorectal, and lung cancers, and an aging population. To tailor treatment, the nation prioritizes companion diagnostics and genomic sequencing initiatives. Innovation is supported by a strong partnership between hospitals and diagnostic manufacturers such as Sysmex and Fujifilm. Two major factors propelling market expansion are the use of multi-gene panel testing and increased regulatory support for precision medicine.

China represents a rapidly expanding market fueled by increasing cancer burden-over 4.8 million new cases annually-and strong government investment in precision medicine. The rise of domestic NGS providers, growing use of liquid biopsy, and expansion of oncology testing centers are driving growth. Initiatives such as the Healthy China 2030 plan and collaboration with global diagnostic firms are improving biomarker access and accelerating early detection capabilities.

Latin America Cancer And Tumor Biomarker-based Assay Market Trends

The Latin American market is growing steadily, driven by improving healthcare infrastructure, rising awareness of early cancer detection, and expanding laboratory networks. Countries such as Brazil and Mexico are increasing adoption of PCR and immunoassay-based biomarker tests. Cancer prevalence is rising across the region, with over 1.4 million new cases annually. International partnerships and public health investments are helping introduce advanced molecular diagnostic technologies.

Brazil leads the Latin American biomarker assay market, supported by government-funded cancer programs and an increasing cancer incidence exceeding 700,000 new cases per year. Expanding diagnostic capacity in urban hospitals and research centers is driving growth. Adoption of NGS and IHC-based assays for breast, lung, and prostate cancers is rising, while partnerships with global companies improve test affordability and accessibility nationwide.

Middle East And Africa Cancer And Tumor Biomarker-based Assay Market Trends

The Middle East and Africa market is expanding as cancer prevalence rises due to lifestyle changes and population growth. According to WHO, cancer incidence in the region is expected to double by 2040. Growing investments in healthcare infrastructure, establishment of oncology centers, and adoption of molecular and immunoassay-based diagnostics are driving market development. Governments are emphasizing early detection and screening programs to reduce mortality rates.

Saudi Arabia’s market is growing rapidly, supported by national healthcare modernization efforts and an increasing focus on precision oncology. The country reports rising cases of breast, colorectal, and thyroid cancers. Government initiatives such as Vision 2030 and the establishment of specialized cancer centers are improving diagnostic access. Investments in molecular biomarker testing and partnerships with global diagnostic firms are accelerating market growth and innovation.

Key Cancer And Tumor Biomarker-based Assay Company Insights

The cancer and tumor biomarker-based assay market is highly competitive, with key players focusing on innovation, product expansion, and strategic collaborations. Major companies such as F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Inc., Illumina, Inc., and QIAGEN lead through strong portfolios in genomic and molecular diagnostics. Emerging players such as Guardant Health and Exact Sciences are advancing liquid biopsy and multi-cancer early detection technologies. Bio-Rad Laboratories, Agilent Technologies, Sysmex, Abbott, and bioMérieux strengthen global market reach through automation and assay integration. Companies such as Myriad Genetics, Hologic, and Quest Diagnostics are enhancing testing access via partnerships, clinical collaborations, and precision oncology solutions worldwide.

Recent Developments

• In September 2025, Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, announced the launch of the Cancerguard test - a new multi-cancer early detection (MCED) blood test now available in the United States as a laboratory-developed test (LDT). Cancerguard is the first commercially available MCED test to analyze multiple biomarker types, enabling the detection of a broad range of cancers, including those often diagnosed at advanced stages when treatment options are more limited.

• In February 2025, Labcorp (NYSE: LH), a global leader in innovative and comprehensive laboratory services, announced the clinical launch of Labcorp Plasma Complete - a circulating tumor DNA (ctDNA)-based comprehensive genomic profiling solution for patients with advanced solid tumors. This liquid biopsy test allows oncologists to conduct in-depth genomic profiling from a simple blood draw, supporting personalized treatment decisions.

• In August 2024, Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced that the U.S. Food and Drug Administration (FDA) approved its TruSight Oncology (TSO) Comprehensive in vitro diagnostic (IVD) test, along with its first two companion diagnostic (CDx) indications. This single test analyzes over 500 genes to provide a detailed profile of a patient’s solid tumor, enhancing the chances of identifying immuno-oncology or clinically actionable biomarkers that support targeted therapies or eligibility for clinical trials.

Cancer And Tumor Biomarker-based Assay Market Report Scope

Global Cancer And Tumor Biomarker-based Assay Market Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global cancer and tumor biomarker-based assay market based on cancer type, biomarker type, end use, and region:

• Cancer Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Breast Cancer

  • Lung Cancer

  • Colorectal Cancer

  • Prostate Cancer

  • Ovarian Cancer

  • Others

• Biomarker Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Genetic / Genomic biomarkers

  • Protein biomarkers

  • Epigenetic biomarkers

  • Others

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals and Cancer Centers

  • Diagnostic Laboratories

  • Others

• Regional Outlook (USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait