PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930115
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930115
The global cancer biomarkers market is a rapidly evolving segment of the oncology diagnostics and therapeutics landscape, playing a critical role in early cancer detection, treatment selection, and disease monitoring. Cancer biomarkers are biological molecules produced by tumors or generated by the body in response to cancer, enabling non-invasive and precise diagnosis through genomics and proteomics technologies.
Market Size and Forecast
According to Fortune Business Insights, the global cancer biomarkers market was valued at USD 42.87 billion in 2025. The market is projected to grow to USD 48.2 billion in 2026 and further reach USD 83.61 billion by 2034, registering a CAGR of 7.13% during the forecast period (2026-2034).
This sustained growth reflects increasing cancer prevalence, technological advancements in diagnostics, and expanding applications of biomarkers in personalized medicine and drug development.
Market Overview
Cancer biomarkers are extensively used across applications such as cancer diagnostics, prognostics, drug discovery and development, companion diagnostics, and personalized medicine. These biomarkers facilitate early disease detection, assess disease progression, and support treatment decision-making, significantly improving patient outcomes.
The increasing demand for precision oncology, along with the integration of biomarkers into clinical workflows, is strengthening their importance across healthcare systems globally. Furthermore, research collaborations between academic institutions and market players are accelerating biomarker discovery and validation.
Key Market Drivers
One of the primary drivers of the cancer biomarkers market is the rising global incidence of cancer, leading to growing demand for early diagnosis and targeted therapies. Biomarkers are increasingly used in disease risk assessment, therapy response evaluation, and companion diagnostics, fueling market expansion.
Additionally, strong research and development investments are driving innovation. According to the U.S. National Library of Medicine, approximately 1,515 cancer biomarkers are currently under clinical trials, highlighting a robust development pipeline that is expected to strengthen market growth during the forecast period.
Market Restraints
Despite strong growth prospects, the market faces challenges such as lack of reimbursement policies for biomarker testing in both emerging and developed economies. The high cost of cancer diagnosis and treatment, particularly in developing countries, limits patient access to biomarker testing and encourages reliance on lower-cost alternatives, restraining market growth to some extent.
Market Segmentation Analysis
By Cancer Type
Based on cancer type, the market is segmented into breast cancer, lung cancer, colorectal cancer, prostate cancer, and others.
The breast cancer segment dominated the market and is expected to hold a 32.59% share in 2026, driven by high disease prevalence, increased awareness, and ongoing research into novel biomarkers.
The lung cancer segment is anticipated to grow at a significant CAGR during the forecast period due to rising R&D investments and increasing lung cancer incidence globally.
By Biomarker Type
By biomarker type, the market includes PSA, HER-2, EGFR, KRAS, and others.
The HER-2 segment held the largest share, accounting for 33.34% in 2026, supported by its widespread use in breast cancer diagnosis. The HER-2 segment is projected to generate USD 14.25 billion in revenue by 2025.
Meanwhile, the EGFR biomarker segment is expected to grow at a faster pace, driven by increasing lung cancer prevalence.
By End User
Based on end user, the market is segmented into diagnostics & research laboratories, pharmaceutical & biotechnology companies, hospitals & specialty clinics, and others.
The diagnostics & research laboratories segment dominated the market with a 53.49% share in 2026, supported by rising test volumes and introduction of advanced diagnostic kits. Pharmaceutical and biotechnology companies are also witnessing growing demand due to increased use of biomarkers in drug discovery and development.
Regional Analysis
North America dominated the global cancer biomarkers market with a 35.94% share in 2025 and was valued at USD 17.29 billion in 2026. The U.S. market is projected to reach USD 15.03 billion by 2026, supported by advanced diagnostic technologies and strong R&D infrastructure.
Europe follows North America, with the UK projected to reach USD 2.19 billion and Germany USD 3.8 billion by 2026.
The Asia Pacific region is expected to grow at a significant CAGR, driven by increasing healthcare investments and adoption of biomarker-based diagnostics. The India market is projected to reach USD 1.35 billion by 2026, while Japan is expected to reach USD 3.40 billion by 2026.
Competitive Landscape
The cancer biomarkers market is semi-consolidated, with leading players including F. Hoffmann-La Roche Ltd., Abbott, Thermo Fisher Scientific, Bio-Rad Laboratories, and CENTOGENE N.V. Companies are focusing on new product launches, strategic collaborations, and regulatory approvals to strengthen their market position.
Conclusion
In conclusion, the global cancer biomarkers market is poised for strong growth from USD 42.87 billion in 2025 to USD 83.61 billion by 2034, driven by rising cancer prevalence, expanding applications in personalized medicine, and a strong pipeline of biomarker innovations. Despite reimbursement and cost-related challenges, continued advancements in diagnostics and increased research collaborations are expected to sustain long-term market expansion across developed and emerging regions.
Segmentation By Cancer Type
By Biomarker Type
By End User
By Geography