Cancer Biomarker Market Size & Outlook, 2026-2034

Cancer Biomarker Market Overview

The cancer biomarker market size is valued at USD 38.5 billion in 2025 and is estimated to reach USD 120 billion by 2034, growing at a CAGR of 12.8% during the forecast period. The main drivers of growth in this market are the increasing incidence of cancer worldwide, growing research on cancer biomarkers, growing use of biomarkers in drug discovery and development and individualized treatment approaches and technical developments. 

Key Market Insights

• North America dominated the cancer biomarker market with the largest revenue share of 45.6% in 2025.
• Asia Pacific is expected to be the fastest-growing region in the Cancer Biomarker market during the forecast period at a CAGR of 14.2%.
• By cancer type, the breast cancer segment held a significant market share of 25.3% in 2025.
• By application, the personalized medicine segment is expected to be the fastest growing during the forecast period at a CAGR of 13.6%.
• The US dominates the market, valued at USD 12 billion in 2024 and reaching USD 13.4 billion in 2025. 

Market Revenue Figures

• 2025 Market Size: USD 38.5 Billion
• 2034 Projected Market Size: USD 120 Billion
• CAGR (2026-2034): 12.8%
• Dominating Region: North America
• Fastest-growing Region: Asia Pacific

Biomarkers in oncology are the molecules secreted by a tumor or a specific response of the human body, indicating the presence of cancer. Biomarkers enable cancer detection at an early stage and facilitate high-speed noninvasive diagnosis using various genomics and proteomics tools. Biomarkers are used for various applications such as cancer diagnostics, drug discovery and development, prognostics, personalized medicine, and others. The increasing demand for biomarkers in drug discovery and the development of personalized medicine are boosting the growth of the global market. Research collaborations by various institutions and key market players to develop biomarkers for disease diagnosis are one of the major factors anticipated to impact the growth of the cancer biomarkers market.

Latest Market Trends

Technological Advancements in Biomarker Discovery

Technological advancements in biomarker discovery are transforming the cancer diagnostics landscape. AI, machine learning and big data analytics enable rapid analysis of genomic, proteomic, and metabolomic data to identify novel biomarkers with higher sensitivity and specificity. Automated workflows streamline laboratory processes, while bioinformatics tools integrate multi-omics datasets for better patient stratification and predictive modeling. These innovations accelerate early cancer detection, optimize targeted therapies, and support personalized medicine approaches. Combined with high-throughput screening and advanced assay platforms, technological advancements are driving efficiency, accuracy, and clinical adoption in biomarker discovery and cancer management.

Rise of Liquid Biopsy

Rise of liquid biopsy is a key trend reshaping cancer diagnostics. Liquid biopsies, including circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and exosomes, provide non-invasive, real-time monitoring of cancer. They enable early detection, track treatment response, and identify relapse risk without the need for invasive tissue biopsies. Integration with precision medicine allows tailored therapies based on molecular profiles. The growing adoption of liquid biopsy platforms is fueled by advances in sequencing technologies, bioinformatics, and regulatory support, making them increasingly essential for personalized oncology and improving patient outcomes across multiple cancer types.

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Market Driver

Increasing Burden of Cancer Cases

The global cancer burden is rising, with millions of new cases diagnosed each year. Aging populations, lifestyle factors such as tobacco use, poor diet, sedentary behavior, and environmental exposures are driving this growth. As cancer becomes more prevalent, healthcare systems face increasing pressure to detect it earlier and more accurately. Cancer biomarkers are crucial for early diagnosis, enabling timely treatment and improved survival rates. This growing need for precise and early detection is fueling demand for biomarker-based tests across hospitals, diagnostic laboratories, and research institutions, positioning them as essential tools in modern oncology care.

Market Restraint

High Cost and Complexity of Biomarker Discovery and Validation

A major challenge in the cancer biomarkers market is the high cost and complexity of biomarker discovery and validation. The process begins with basic research to identify candidate biomarkers and progresses through multi-stage clinical trials to ensure accuracy, specificity, and reliability. Developing diagnostic tools compatible with genomic sequencing and bioinformatics systems requires significant financial investment. Companies must navigate stringent regulatory requirements from authorities such as the FDA and EMA, including extensive trial documentation. These factors make the market capital-intensive, limiting participation from smaller players and slowing the pace of innovation and commercialization in biomarker development.

Market Opportunity

Growing R&D Investments

Growing R&D investments is a major opportunity in the cancer biomarkers market. Increased funding from governments, private investors, and pharmaceutical companies is accelerating biomarker discovery, validation, and commercialization. This investment supports advanced technologies such as genomic and proteomic profiling, liquid biopsies, and AI-driven analytics, enabling faster, more accurate, and personalized cancer diagnostics. Higher R&D spending also fosters collaborations between biotech firms, hospitals, and research institutes, driving innovation and expanding product pipelines. As a result, rising R&D investment advances scientific breakthroughs and strengthens the market’s growth potential and adoption of biomarker-based solutions globally.

Regional Analysis

North America dominated the market with the largest revenue share of 45.6% in 2025 driven by its advanced healthcare infrastructure, substantial investment in cancer research, and strong adoption of precision medicine. The region benefits from a robust presence of leading pharmaceutical and biotechnology companies, significant public and private funding, and high awareness among patients and healthcare professionals about early cancer detection. Additionally, favorable regulatory frameworks in the U.S. and Canada support the development and commercialization of advanced biomarker-based diagnostic and therapeutic tools, further reinforcing North America’s leadership in the global cancer biomarkers market.

The US remains the leading country in the global market, supported by advanced research, robust regulatory frameworks, and extensive clinical trial activity. Strong adoption of biomarkers in precision medicine and drug development enhances patient outcomes, while efficient biotech companies leverage AI and advanced technologies for rapid biomarker discovery. These capabilities position the US at the forefront of diagnostics and therapeutics, driving innovation, accelerating commercialization, and maintaining its dominant role in the global cancer biomarker landscape.

Asia Pacific's Market Trends

Asia Pacific is expected to be the fastest-growing region in the market during the forecast period at a CAGR of 14.2% driven by rising cancer prevalence, improving healthcare access, and increasing investment in healthcare technologies. Countries like China, India, and Japan are witnessing rapid progress in genomics research, biomarker-based clinical trials, and personalized medicine. Government initiatives for cancer screening, growing public awareness, and a strong local biotech industry further support market expansion, positioning Asia Pacific as a key emerging hub for innovation and adoption of cancer biomarker diagnostics and therapeutics globally.

China leads the Asia Pacific cancer biomarker market due to increased healthcare funding, upgraded laboratory infrastructure, and a growing focus on genomic research. Government policies supporting biomarker adoption, along with large-scale public health initiatives, leverage the country’s robust biotech ecosystem and local innovation capabilities. These factors position China as a key player in biomarker discovery and application, fostering strong collaborations with international pharmaceutical companies and enhancing its role in both research and clinical implementation of advanced biomarker-based diagnostics and therapeutics.

European Market Trends

Europe has performed strongly in the market, supported by robust research networks, cross-industry collaborations, and government-funded healthcare innovation programs. The region’s emphasis on personalized medicine and streamlined regulatory pathways facilitates the clinical translation of biomarkers. A strong academic expertise and commitment to evidence-based healthcare accelerate biomarker validation in the region, enhancing diagnostic and therapeutic applications. These factors collectively drive steady market growth, positioning Europe as a key hub for innovation, clinical adoption, and commercialization of advanced biomarker-based solutions in oncology.

Germany dominates Europe’s market, driven by advanced research facilities, a strong pharmaceutical industry, and robust clinical infrastructure. Collaborative efforts between academia and biotech companies accelerate biomarker validation and commercialization. The country’s focus on precision medicine and leadership in molecular diagnostics reinforces its market position, fostering innovation and adoption of advanced biomarker-based solutions, and solidifying Germany as a central hub for biomarker research, clinical application, and commercialization in the European oncology landscape.

Latin America Market Trends

Latin America is witnessing growth in the cancer biomarkers market, driven by rising cancer prevalence, increasing awareness, and supportive government initiatives. The region is placing greater emphasis on advanced diagnostics and precision medicine, particularly to address the growing incidence of breast, prostate, and colorectal cancers. This focus is fueling demand for personalized therapies and biomarker-based diagnostic tools, enabling early detection, targeted treatment, and improved patient outcomes. Investments in healthcare infrastructure, expansion of clinical research, and adoption of innovative technologies are further supporting the region’s market growth, positioning Latin America as an emerging hub for biomarker-driven oncology solutions.

Brazil is the leading country in Latin America’s market, fueled by its large population, rising cancer prevalence, and expanding healthcare infrastructure. Government initiatives promoting early diagnosis, increased awareness campaigns, and growing adoption of advanced diagnostics and precision medicine contribute to market growth. Growing investment in clinical research, partnerships with global pharmaceutical and biotech companies, and focus on personalized therapies strengthen the country’s position as the regional leader. This is making the country a primary hub for biomarker-based diagnostics and therapeutic innovation in Latin America.

Middle East & African Market Trends

The Middle East & Africa (MEA) cancer biomarkers market is gaining momentum as healthcare systems respond to rising cancer prevalence and the need for early diagnosis. Increased investments in oncology research, precision medicine initiatives, especially in Saudi Arabia, the UAE, and South Africa, and expanding diagnostic infrastructure are key growth drivers. Governments are prioritizing biomarker testing within national cancer programs, while partnerships with global biotech firms and adoption of technologies like liquid biopsy are enhancing clinical capabilities. However, disparities in healthcare access, fragmented regulatory frameworks, and limited awareness continue to challenge widespread adoption.

Saudi Arabia dominates the Middle East & Africa market, driven by substantial government investment in healthcare infrastructure, oncology research, and precision medicine initiatives. The country benefits from well-established diagnostic facilities, strong collaborations with global biotech and pharmaceutical companies, and national programs promoting early cancer detection. Rising awareness among patients and healthcare professionals, coupled with regulatory support for advanced diagnostics, positions Saudi Arabia at the forefront of biomarker adoption in the region, making it the primary hub for cancer biomarker development, clinical application, and innovation in the MEA market.

Cancer Type Insights

The breast cancer segment held a significant market share of 25.3% in 2025 driven by high global prevalence in women and strong support from government and non-government initiatives. Established biomarker tests like BRCA1/BRCA2, HER2, and hormone receptor markers have advanced precision diagnostics and personalized therapies. Extensive R&D and early screening investments, especially in developed countries, have accelerated clinical adoption of biomarkers, reinforcing the segment’s leadership and supporting improved treatment outcomes in breast cancer management.

The other cancer types segment, including carcinomas, leukemias, lymphomas, skin, and CNS cancers, is expected to be the fastest growing at a CAGR of 16.5% during the forecast period. Growth is driven by rising investment in biomarkers for rare and aggressive cancers, along with AI-driven platforms and multi-omics technologies that accelerate biomarker discovery and validation. The increasing number of clinical trials and the expansion of therapeutic applications beyond common cancers are fueling market growth, making this segment a key area of opportunity in cancer biomarker development.

Application Insights 

The diagnostics segment dominated the cancer biomarkers market in 2025 with a 46.5% share, driven by the growing use of biomarkers in drug development and personalized cancer therapies. Biomarkers are widely integrated into screening programs for breast, colorectal, and prostate cancers, offering high sensitivity and specificity for accurate clinical decisions while reducing invasive procedures. Additionally, regulatory approvals and reimbursement support for diagnostic assays have strengthened the segment’s market dominance, making it a central component of modern oncology diagnostics and patient care.

The personalized medicine segment is projected to be the fastest growing in the cancer biomarkers market at a CAGR of 13.6%, fueled by increasing demand for tailored cancer therapies. By targeting biomarkers, treatments can be optimized to a patient’s genetic profile, maximizing efficacy and minimizing side effects. Growth is fueled by advances in NGS technologies, expanded use of companion diagnostics, and rising biomarker-focused clinical trials.

Competitive Landscape

The cancer biomarkers market is moderately fragmented, featuring both established diagnostics giants and a wide range of emerging innovators. More than 100 novel biomarker solutions, many leveraging NGS and proteomics, are commercially available, illustrating technological diversity and fragmented competitive participation. Competition centers on advanced technologies including NGS, liquid biopsies, proteomics and AIenhanced analytics allowing both incumbents and emerging firms to differentiate based on test sensitivity, coverage, and clinical utility.

Guardant Health - An Emerging Market Player

Guardant Health, Inc. is a US precision oncology company specializing in liquid biopsy cancer diagnostics that detect genomic and epigenomic biomarkers from blood samples, offering a non-invasive alternative to traditional tissue biopsies. It has become a major emerging player in the cancer biomarker market due to strong adoption of its tests for treatment selection, disease monitoring, and early detection.

• In July 2025, Guardant Health’s Shield multi-cancer detection (MCD) blood test received FDA Breakthrough Device designation for its ability to detect multiple cancer types in average-risk individuals aged 45 and older.
• In May 2025, Guardant expanded its Guardant360 Liquid test with advanced smart liquid biopsy applications, enabling deeper molecular profiling for optimal treatment decisions.

List of key players in Cancer Biomarker Market

1. Hoffmann-La Roche Ltd.
2. Thermo Fisher Scientific Inc.
3. Illumina, Inc.
4. QIAGEN N.V.
5. Abbott Laboratories
6. Bio-Rad Laboratories, Inc.
7. Agilent Technologies, Inc.
8. bioMérieux SA
9. Becton, Dickinson and Company (BD)
10. Myriad Genetics, Inc.

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Key Developments

• In 2025, Myriad Genetics, Inc. (US) collaborated with Gabbi (US), a telehealth solution for breast cancer risk assessment & specialist care services. The companies will collaborate to provide an integrated offering that combines Gabbi’s risk assessment program and access to breast specialists with Myriad’s MyRisk with RiskScore Hereditary Cancer Test.
• In November 2025, Abbott announced an agreement to acquire Exact Sciences, which will enable it to enter the cancer diagnostics segment.
• In July 2025, Illumina, Inc. launched the TruSight Oncology 500 v2 advanced genomic profiling assay with enhanced features such as built-in HRD detection and streamlined data analysis.
• In July 2025, Bio-Rad Laboratories, Inc. Announced the acquisition of Stilla Technologies, enhancing its digital PCR capabilities and expanding its precision assay offerings.