Cancer Biomarkers Market Size, Share, Competitive Insights, Growth Dynamics, and Forecast Report 2032

The cancer biomarkers market focuses on biological molecules—such as proteins, genes, or other measurable indicators—used to detect, diagnose, monitor, and predict the progression or treatment response of various cancers. These biomarkers are critical in early cancer detection, personalized medicine, and drug development. Key types include genetic markers, protein biomarkers, and epigenetic indicators, applied through technologies like PCR, next-generation sequencing (NGS), immunoassays, and imaging. Market growth is driven by the rising global incidence of cancer, increasing demand for targeted therapies, and ongoing advances in genomics and proteomics. Pharmaceutical and biotechnology companies use biomarkers extensively in clinical trials to identify patient populations and monitor treatment efficacy. North America leads the market due to strong research infrastructure, high healthcare spending, and numerous biomarker-based diagnostic approvals, while Asia-Pacific is poised for rapid expansion as cancer prevalence rises and healthcare investments grow. Challenges include the high cost of biomarker tests, complex regulatory requirements, and the need for standardized validation across diverse patient populations.

The global cancer biomarkers market size was valued at USD 38.14 billion in 2024. The market is projected to grow from USD 42.87 billion in 2025 to USD 74.62 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period. North America dominated the cancer biomarkers market with a 35.99% share in 2024, supported by advanced diagnostic infrastructure, strong research funding, and the rising adoption of personalized medicine in oncology care.

Market Report Coverage

The report covers the cancer biomarkers market in depth, including segmentation by cancer type (breast, lung, colorectal, prostate, others), biomarker type (PSA, HER-2, EGFR, KRAS, others), end user (pharmaceutical & biotechnology companies; diagnostics & research labs; hospitals & specialty clinics; others), and geography (North America, Europe, Asia Pacific, Latin America, Middle East & Africa). Historical data spans 2019-2023, with base year 2024, estimate year 2025, and forecast period 2025-2032.

Market Drivers & Restraints

• Drivers: Rising cancer prevalence globally, demand for early and non‐invasive diagnostics; the shift toward personalized medicine; ongoing research collaborations to discover novel biomarkers; and the presence of many pipeline candidates under trial.

• Restraints: High costs associated with biomarker testing; limited reimbursement policies in many regions; low accessibility in some emerging markets; and preference sometimes for lower‐cost diagnostic methods.

Segmentation

By Cancer Type

The report divides the market by cancer type into breast cancer, lung cancer, colorectal cancer, prostate cancer, and others. Among these, the breast cancer segment dominated in 2024, thanks to its high incidence and growing emphasis on early detection and awareness.

The lung cancer segment is expected to grow at a significant CAGR during 2025‐2032, driven by increasing R&D investment in lung cancer biomarkers.

By Biomarker Type

The categories include PSA, HER-2, EGFR, KRAS, and others. In 2024, the HER-2 biomarker held the largest revenue share, mainly due to breast cancer prevalence and the introduction of novel tests, particularly liquid biopsy‐based diagnostics.

The EGFR biomarker segment is projected to grow fastest, aligned with rising lung cancer cases and increasing demand for diagnostic testing.

By End User

The market is segmented into pharmaceutical & biotechnology companies; diagnostics & research laboratories; hospitals & specialty clinics; and others. Diagnostics & research laboratories held the dominant share in recent years, due to the growing introduction of new diagnostic products.

Also, pharmaceutical & biotechnology companies are increasingly using these biomarkers for drug discovery and development; hospitals and specialty clinics are another growing channel due to increasing in‐patient testing.

Regional Insights

North America not only held the largest share (~35.99%) in 2024, but it also continues to lead in innovation, technology adoption, and clinical trial activity.

Europe is expected to record strong growth, with a projected CAGR of around 12.5% over the forecast period, driven by government‐backed initiatives for cancer screening and integration of biomarker testing in clinical guidelines.

Asia Pacific will show significant expansion, with China leading with a forecasted CAGR of approximately 13.90%. Key factors include rising investments in healthcare infrastructure, growing acceptance of biomarker‐based diagnostics, and strong pipeline developments. Japan also features, with its market expected to reach about USD 3.30 billion by 2025.

Competitive Landscape

The market is described as semi-consolidated. Leading players are focusing on expanding their product portfolios through novel biomarker tests, securing regulatory approvals, pursuing mergers & acquisitions, and forming research collaborations.

Top Companies in the Market:

• F. Hoffmann-La Roche Ltd.

• Abbott

• Thermo Fisher Scientific

• Bio-Rad Laboratories, Inc.

• CENTOGENE N.V.

• Axon Medchem

• Sino Biological Inc.

• R&D System

• BioVision Inc.

• Myriad RBM

• Other players

Explore the full research report with detailed insights and TOC:https://www.fortunebusinessinsights.com/industry-reports/cancer-biomarkers-market-100630 

Key Industry Development

In March 2021, Roche announced that it had received approval from the U.S. Food and Drug Administration for its VENTANA ALK (D5F3) CDx Assay as a companion diagnostic. This assay is the only test approved by the FDA as a companion diagnostic for LORBRENA, and it will help rapidly identify patients with the relevant cancer biomarker to enable more effective treatment.

Future Market Scope

The global cancer biomarkers market is expected to almost double in size from 2025 to 2032. Key growth areas include lung cancer biomarkers (fastest CAGR in cancer type), the EGFR biomarker segment, diagnostics & research labs end users, and regions like Asia Pacific, especially China and Japan. Further, personalized medicine and companion diagnostics are expected to shape product launches and regulatory prioritization.

Conclusion

With rising disease burden, technological progress, and increasing R&D pipeline, the cancer biomarkers market is poised for robust growth through 2032. Stakeholders across diagnostics, pharmaceuticals, public health, and regulatory authorities will find opportunity in biomarker innovation, regulatory approvals, and widening global access. The market’s trajectory signals not only commercial growth but also the potential for improved patient outcomes via earlier detection and precision treatment.

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