Cancer Biomarkers Market

Cancer Biomarkers Market Outlook (2025 to 2035)

The global cancer biomarkers market is worth USD 14,200 million in 2025. Based on Fact.MR analysis, the cancer biomarkers market will rise at a 13% CAGR and hit USD 48,438 million by 2035.

The sudden spike arises from the escalating need for early diagnosis methods and individualized medicine approaches employing biomarker-based diagnostic tests to individualize cancer therapy for patients. Proteomics, genomics, and digital pathology advancements have bolstered the establishment of highly sensitive and specific biomarkers.

Such technological advancements are facilitating earlier detection of disease and more precise prognostic predictions, which have a direct impact on treatment and survival rates. The rise in cancer incidence worldwide has also boosted the demand for better diagnostic technologies, further substantiating the growth of the cancer biomarkers market.

The shift to non-invasive testing technologies, such as liquid biopsy, has been a key growth driver. They are less painful for the patient and more compliant with equivalent diagnostic effectiveness, and therefore, a clinician's and patient's favorite.

The incorporation of biomarkers into drug development pipelines also enhances clinical trial efficiency and success rates, encouraging pharma companies to invest heavily in biomarker-driven research. Rising investments in healthcare and improved diagnostic facilities in emerging economies are driving regional growth.

Increased investment by the public and private sectors is also fostering the launch of new biomarker tests, specifically in breast, lung, and colorectal cancer segments, which are among the highest incidence types globally. Despite reimbursement challenges and regulatory hurdles, the cancer biomarkers industry remains on a high-growth track.

Leading players are leveraging strategic mergers, partnerships, and technology associations to counteract fragmentation in the cancer biomarkers market and maintain highly streamlined product development and commercialization activities throughout the forecast period.

Key Metrics

Metric	Value
Estimated Global Size in 2025	USD 14,200 million
Projected Global Size in 2035	USD 48,438 million
CAGR (2025 to 2035)	13%

Fact.MR Survey Results for Industry Dynamics Based on Stakeholder Perspectives

The cancer biomarkers market is evolving rapidly, driven by the need for early diagnosis, personalized treatment, and mass-producible diagnostics. Priorities for leading stakeholders are to integrate biomarkers with targeted therapy and reduce its cost, particularly in emerging industries.

There are regional differences in priorities: North America is concentrating on precision oncology fueled by AI, Europe is emphasizing standardization and automation, and Asia-Pacific is prioritizing low-cost, mass-producible solutions for rural roll-out.

Adoption of technology is occurring unevenly-AI, multi-omics, and point-of-care kits are increasing, but attitudes regarding ROI are different geographically. Regulatory and infrastructure barriers continue, and global shortages in qualified staff and disintegrated compliance systems continue to impede momentum.

Emerging investments are converging on AI discovery platforms, automation, and handheld diagnostics, with a region-dependent focus on collaborations, clinical trials, and decentralized screening. Regulatory effects differ, ranging from streamlined FDA channels in the U.S. to China's speeded-up innovations and intricately post-Brexit relationships in the UK.

Strategic drivers involve increasing regulatory preparedness, adopting AI and 5G for efficiency, and cross-sector collaborations. Key risks such as regulatory slowdowns, reimbursement discrepancies, and data privacy risks need to be addressed.

Shifts in the Market from 2020 to 2024 and Future Trends 2025 to 2035

Between 2020 and 2024, the cancer biomarkers market grew tremendously due to the exponential growth in molecular diagnostics and personalized medicine. During this time, the focus was more on liquid biopsy technology to enable non-invasive and earlier cancer detection.

The demand for biomarkers to detect early-stage cancer, personalized treatment approaches, and companion diagnostics augmented as health experts sought more accurate and effective methods to monitor and treat cancer. The COVID-19 pandemic also fast-tracked the adoption of digital health technologies, further increasing biomarker testing as a convenient and integrated part of telemedicine-based patient care.

The future of 2025-2035 represents a big change for the cancer biomarkers market. Next-generation biomarkers with increased specificity and sensitivity will be developed on the basis of advances in genomics, proteomics, and artificial intelligence.

The industry will also experience massive expansion in the application of multi-omics technologies, which combine data on genomics, transcriptomics, proteomics, and metabolomics to develop a wider understanding of cancer biology.

Apart from this, the utilization of machine learning and artificial intelligence to discover biomarkers and analyze data will make cancer diagnosis and treatment, as well as monitoring, even more precise and faster. Along with that, personalized Companion diagnostics for targeted therapy will also be encouraged, which can improve cancer therapies.

A Comparative Market Shift Analysis (2020 to 2024 vs. 2025 to 2035)

2020 to 2024	2025 to 2035
Growing need for early cancer detection, liquid biopsy advancement, and precision medicine.	The onset of next-generation multi-omics biomarkers, AI-enabled biomarker identification, and expanding use of companion diagnostics.
Targeting liquid biopsy, AI-enabled diagnostic imaging, and enhanced molecular profiling methods.	Combining genomics, proteomics, and metabolomics with AI helps to develop biomarkers and analyze data.
Targeting oncology, with biomarkers facilitating early detection, therapy choice, and prognosis prediction.	Expansion into other therapeutic areas, such as neurology and immunology, with more targeted and personalized diagnostics.
High costs, regulatory barriers, and the requirement for standardized testing procedures across healthcare systems.	Requirement for improved regulatory frameworks and reduced costs to facilitate broad adoption, particularly in emerging markets.
More regulatory approvals for liquid biopsy and molecular diagnostic tests.	Greater focus on regulatory approval for multi-omics and AI-based diagnostic tools.
Healthcare professionals prefer non-invasive and high-throughput diagnostic solutions.	Growing need for integrative and comprehensive solutions that enable personalized and precision therapies.

Country-wise Analysis of the Cancer Biomarkers Market

Country	CAGR (2025 to 2035)
U.S.	10.1%
UK	9.0%
France	8.5%
Germany	8.8%
Italy	8.1%
South Korea	7.7%
Japan	8.0%
China	10.6%
Australia-New Zealand	8.2%

The U.S.

The U.S. cancer biomarkers market is expected to register a growth of 10.1% CAGR throughout the study period. Being a global oncology research and precision medicine leader, the U.S. has established a robust platform for cancer biomarker development and adoption.

The need for early detection, accurate diagnosis, and personalized treatment planning is driving investment in genomics, proteomics, and metabolomics-based biomarker platforms. Continued collaboration among pharma firms, academia, and diagnostic firms is continuing to result in new biomarker-based tests.

Worldwide access to next-generation sequencing and liquid biopsy platforms is driving the cancer biomarkers market ahead. Regulatory policies such as the FDA's breakthrough designation for companion diagnostics are enabling faster approval and adoption into clinical practice.

High rates of cancer incidence, particularly among the elderly populations, reaffirm the necessity of precise prognostic and predictive technologies. In addition, the presence of substantial funding from public health organizations and private investors is accelerating biomarker validation studies. The integration of AI and machine learning with biomarker analysis further enhances diagnostic accuracy and clinical significance, solidifying the U.S. growth trajectory through 2035.

UK

The UK cancer biomarkers market is expected to grow at 9.0% CAGR during the forecast period. Increased interest in early-stage detection of cancer and the nationwide push for precision medicine is driving adoption towards biomarker-based diagnostics.

Rolling out the scope of genomic testing by NHS Genomic Medicine Service is creating engines for increased usage of biomarkers in practice. The country is also assisted with gigantic-scale biobanks and organized cancer registries facilitating the generation of real-world evidence.

Public and private diagnostic developers' synergy is introducing advanced assays for treatment choices on the basis of biomarkers. Accelerated uptake of molecular diagnostics in routine oncology regimens, supplemented by government-funded innovation programs, accelerates the demand.

Ongoing clinical trials and a well-governed setup enable the persistent emergence of new biomarkers in various kinds of cancers. The drive toward cancer mortality control through focused screening programs is propelling the UK onto a trajectory of sustainable and significant expansion.

France

The French cancer biomarkers market will grow at an 8.5% CAGR during the forecast period. France has prioritized personalized medicine through national cancer plans, creating a supportive research and implementation climate for cancer biomarkers. Standardization of molecular profiling of cancer treatment guidelines is increasing, especially in breast, lung, and colorectal cancers.

High-level cancer centers across France are expanding biomarker testing capacity by leveraging centralized diagnostic laboratories and genomic platforms. The country's investment in translational research and biobank infrastructure supports biomarker validation across several patient cohorts.

Regulatory agencies encourage the development of companion diagnostics, and reimbursement for targeted testing becomes more favorable. Academic centers play a key role in developing immuno-oncology-related biomarkers, where demand is rising rapidly. A strong public health commitment to stem diagnostic delays and tailor treatments will continue to propel the cancer biomarkers market forward.

Germany

The German cancer biomarkers market will expand at 8.8% CAGR during the period of study. A strong specialized oncology environment and a focus on unifying diagnostics and therapeutics in Germany are conducive to the growth of cancer biomarker adoption. Clinical demand for precision medicine technologies is rising, especially for targeted therapy for lung, breast, and hematologic cancers. Biomarker testing is getting increasingly integrated into standard cancer treatment pathways.

The country's decentralized healthcare structure allows regional cancer centers to develop specialized biomarker platforms, which are frequently financed by public sources. Bioinformatics and laboratory automation strengths in Germany increase scalability and diagnostic efficiency.

Pharmaceutical company collaboration for companion diagnostics development is growing, while hospitals invest in predictive analytics platforms based on biomarker data. Good scientific competence, beneficial reimbursement schemes, and continuing medical education efforts collectively propel the growth of the cancer biomarkers market.

Italy

Italy will expand at 8.1% CAGR throughout the study period. Rising cases of cancer and escalating focus on value-based care are fueling the use of cancer biomarkers in Italy. The utilization of molecular diagnostics in national guidelines for the treatment of cancer has gained prominence, particularly for managing colorectal, breast, and lung cancer.

Academic medical institutions and local health departments are increasingly investing in genomic sequencing laboratories and multiplex test kits. Government programs supportive of research into personalized oncology therapy, together with growing partnerships with global diagnostic firms, are building biomarker testing infrastructure.

Educational campaigns targeting clinicians are enhancing test use within routine care. Even though reimbursement heterogeneity remains a problem, policy discussions continue, implying the movement toward broader financial coverage for precision diagnostics.

South Korea

The South Korean cancer biomarkers market will expand at a 7.7% CAGR during the study period. Government emphasis on biotechnology and medical device innovation is propelling the adoption of advanced diagnostic tools, including cancer biomarkers. Personalized medicine is being implemented aggressively in public healthcare systems in South Korea, with more hospitals adopting molecular and genomic testing.

Strong local R&D capabilities, supported by government grants and institutional collaboration, are enabling the development of locally relevant biomarker tests. The country's advanced digital framework allows seamless incorporation of diagnostic data into electronic health records, enabling better tracking of patients and making treatment decisions easier. Liquid biopsy research is gaining momentum, especially in cancer detection at the earliest stages. Public education about public health and screening acceptance is also increasing, further boosting the growth of the cancer biomarkers market.

Japan

The Japanese cancer biomarkers market will increase at 8.0% CAGR during the study period. The high cancer rate and growing population of Japan have driven intense interest in early detection and customized treatment methods.

Biomarker-driven diagnostics lead to national cancer initiatives, and reimbursement for next-generation genomic analysis has picked up in the last few years. Academic medical centers and government research facilities are making investments in next-generation sequencing and biomarker discovery, particularly in lung and stomach cancers.

Companion diagnostics are being clinically used more and more, particularly with targeted therapies. Japan has a strong regulatory system for in-vitro diagnostics, which supports innovation while ensuring patient safety. Artificial intelligence incorporation in clinical laboratories enhances the interpretation of complex biomarker patterns. As patient-centered care is becoming a national priority, cancer biomarker testing will be one of the biggest growth drivers over the forecast period.

China

The Chinese cancer biomarkers market will increase by 10.6% CAGR over the forecast period. China is among the most vibrant growth prospects worldwide in the cancer biomarkers market. Rising incidence of cancer, rising health expenditure, and a large number of patients are fueling diagnostic services growth at a rapid rate.

Government-initiated healthcare reforms have been aimed at early cancer detection and personalized oncology. China has made significant hikes in its investment in genomic medicine, which enables rapid deployment of molecular diagnostics in city and regional cancer centers.

Active local biotech firm development of biomarker-based tests, typically with foreign collaborators. Widespread adoption of liquid biopsy and high-throughput sequencing platforms is transforming clinical practice. Growing public health awareness of cancer prevention and the digitalization of health infrastructure enable more extensive use of screening technologies. Strong regulatory momentum and healthcare digitalization in China will help drive the cancer biomarkers market ahead in the Asia-Pacific region.

Australia-New Zealand

The Australia-New Zealand cancer biomarkers market is expected to record an 8.2% CAGR during the forecast period. There is a high rate of healthcare and ongoing cancer screening programs that support the development of biomarker-based diagnostics. Both countries have strong national cancer registries and participate in international genomic research partnerships, which promote biomarker discovery and clinical validation at a higher pace.

Hospitals and diagnostic laboratories are increasingly being outfitted with genomic sequencing technologies to enable precision medicine approaches to numerous cancers. Governmental health agencies are providing guidance and funding for individualized oncology approaches, making it easier for more clinical use of biomarker testing.

Partnerships among biotech companies and research institutions continue to generate new assays for early detection and selection of therapy. With demand for efficient, non-invasive testing on the rise, liquid biopsy and circulating tumor DNA technologies are gaining a good share. Continued investment in training, infrastructure, and public awareness will propel the cancer biomarkers market ahead.

Segment-wise Analysis

By Test Type

The cancer biomarkers market is segmented based on test type, wherein PSA (Prostate-Specific Antigen) Tests and CA (Cancer Antigen) Tests happen to be the most widely adopted diagnostic tools. The PSA tests segment will hold a share of around 12% by 2025, while CA tests claim about 11%.

The PSA test is a vital tool in the early detection and monitoring of prostate cancer. The test measures prostate-specific antigen levels in the blood and is used mainly in routine screenings for men aged 50 and above. It has seen widespread acceptance due to its non-invasive nature and ability to provide early warning for possible malignancies.

The biggest players include Abbott Laboratories, which has a high-throughput ARCHITECT PSA assay, and Roche Diagnostics, which has Elecsys PSA assays that are part of the Cobas systems with maximum utilization.

Meanwhile, Beckman Coulter, a subsidiary of Danaher, offers the Access Hybritech PSA assay that boasts high precision and automation compatibility. Other prominent players include Ortho Clinical Diagnostics with VITROS-compatible PSA tests and DiaSorin, which sells PSA assays in its LIAISON immunoassay systems.

CA tests play a key role in cancer detection, monitoring treatment response, and evaluating for recurrence of cancers. Examples include CA-125 for ovarian cancer, CA 19-9 for pancreatic cancer, and CA 15-3 for breast cancer. Siemens Healthineers is a dominant player in CA tests, offering CA marker assays in its ADVIA and Atellica platforms.

Bio-Rad Laboratories supplies immunoassay kits commonly used for oncology research and diagnostics. Fujirebio is best known for its Lumipulse CA marker portfolio, particularly in Asia Pacific and Europe. Thermo Fisher Scientific lists support for CA testing through ELISA kits and multiplexing biomarker panels.

In contrast, BD (Becton, Dickinson and Company) lists reagents and automated systems used in cancer biomarker laboratories. On the other hand, the growing global importance of early diagnostics, precision medicine, and cancer screening programs offers sturdy support for PSA and CA biomarker testing solutions.

By Disease Indication

By disease indications, the cancer biomarkers market is segmented into lung cancer and breast cancer. 20% of the market is dominated by breast cancer and 18% by lung cancer.

These biomarkers include HER2, estrogen receptor (ER), and progesterone receptor (PR), which are important for detection, prognosis, and therapy decisions in breast cancer. It Indicates hormone receptor status and tracks treatment options, especially in identifying patients eligible for targeted therapy, such as trastuzumab (Herceptin).

The major players in the segment include Roche Diagnostics, which has developed a very broad panel of tests toward breast cancer biomarkers using cobas systems, and Agilent Technologies, that have companion diagnostic tools such as immunohistochemistry (IHC) assays. Qiagen supports breast cancer detection with real-time PCR-based assays. Hologic provides molecular diagnostics tools that are in line with its solutions for the health of women.

In lung cancer, biomarkers such as EGFR, ALK, and PD-L1 are used to guide treatment decisions, especially targeted therapies and immunotherapies. The increasing prevalence of non-small cell lung cancer (NSCLC) has stimulated the urgent need for accurate and rapid biomarker tests.

Thermo Fisher Scientific provides NGS-based panels to do lung cancer profiling based on tests broadly. In the same context, Illumina backs precision medicine initiatives through its sequencing platforms. Foundation Medicine, a Roche subsidiary, offers FoundationOne CDx, an FDA-approved companion diagnostic that includes vital lung cancer biomarkers.

Guardant Health contributes to the industry through its liquid biopsy platform Guardant360, which allows for the non-invasive detection of genomic alterations that are important to treatment relevant to lung cancer.

Competitive Outlook

The cancer biomarkers market is highly competitive owing to a diverse range of diagnostics companies, pharmaceutical giants, and genomics innovators.

Post-2024, competition is becoming more intense around the concepts of biomarker-based precision medicine, companion diagnostics, and MCED (multi-cancer early detection) panels. F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Illumina, Inc., QIAGEN, and Abbott Laboratories are some of the key players that dominate the landscape through diverse molecular diagnostics portfolios and extensive research collaborations.

Such diagnostics include biomarker discovery, companion diagnostics, and liquid biopsy solutions integrated into its oncology diagnostics offerings.

Roche further applies synergies between its diagnostics and pharmaceutical divisions to quicken drug development with biomarkers. Thermo Fisher Scientific improves its competitive strength with next-gen sequencing (NGS) platforms, the breadth of biomarker assay offerings, and acquisition strategies that add to its oncology diagnostic capabilities.

Illumina has been one of the leading companies in genomic sequencing and, thus, would serve as a backbone for biomarker discovery through its high-throughput platforms.

Due to the increasing pressure on developing novel methods for detecting cancers as early as possible, Illumina also partnered with various diagnostic developers looking for strategic partnerships in this field. QIAGEN produces PCR- and NGS-based assays and has strong collaborations with pharmaceutical companies, which has allowed it to develop a good position in companion diagnostics.

Abbott thus offers quite a plethora of tests on protein and genetic biomarkers, its advantage being in having vigorous global distribution networks.

Genomic Health and bioMérieux are small-scale players still innovating within highly specialized niche areas like prognostic assays and tumor-specific markers. Competitive strategy across the board has increasingly evolved toward regulation approvals, partnerships, and automation in oncology biomarker testing.

Market Share Analysis by Company

Company Name	Market Share (%)
F. Hoffmann-La Roche Ltd.	18-21%
Thermo Fisher Scientific Inc.	15-18%
Illumina, Inc.	13-16%
QIAGEN	10-13%
Abbott Laboratories	9-11%
Other Players (combined)	22-27%

Key Company Offerings and Activities

Company Name	Offerings & Activities
F. Hoffmann-La Roche Ltd.	Companion diagnostics, liquid biopsy platforms, biomarker-based clinical decision tools.
Thermo Fisher Scientific Inc.	NGS and PCR platforms, oncology biomarker assays, and diagnostic kits for targeted therapies.
Illumina, Inc.	Genomic sequencing platforms, MCED solutions, and biomarker panels for early detection.
QIAGEN	Molecular diagnostic kits, companion diagnostics, real-time PCR, and NGS workflows.
Abbott Laboratories	Immunoassays, blood-based biomarker diagnostics, molecular oncology testing systems.

Key Company Insights

F. Hoffmann-La Roche Ltd. (18-21%)

Key leader in the cancer biomarkers market with integrated diagnostics-pharma pipeline, known for personalized oncology diagnostics.

Thermo Fisher Scientific Inc. (15-18%)

A major force in NGS and biomarker assay development, with strong clinical lab partnerships.

Illumina, Inc. (13-16%)

Leading sequencing provider with growing influence in early detection and cancer genomics.

QIAGEN (10-13%)

Strong position in PCR/NGS diagnostics and pharma partnerships for companion diagnostics.

Abbott Laboratories (9-11%)

Global diagnostics player with a comprehensive protein and genomic biomarker test portfolio.

Key Players

• Abbott Laboratories
• Merck & Co., Inc.
• Thermo Fisher Scientific Inc.
• Illumina, Inc.
• bioMérieux SA
• QIAGEN
• Agilent Technologies, Inc.
• Hologic, Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd.
• Genomic Health, Inc.

Segmentation

• By Test Type :

  • PSA Tests
  • CTC Tests
  • AFP Tests
  • CA Tests
  • HER2 Tests
  • BRCA Tests
  • ALK Tests
  • CEA Tests
  • EGFR Mutation Tests
  • KRAS Mutation Tests
  • Others

• By Disease Indication :

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Melanoma
  • Blood Cancer
  • Prostate Cancer
  • Ovarian Cancer
  • Stomach Cancer
  • Liver Cancer
  • Others

• By Region :

  • North America
  • Europe
  • Asia Pacific
  • Latin America