Global Cancer Biomarkers Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Biomarkers Type;
Protein Biomarkers, Genetic Biomarkers, and OthersBy Cancer Type;
Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, and OthersBy Services;
Sample Preparation, Assay Development , and Biomarkers & TestingBy Profiling Technology;
OMICS Technology, Imaging Technology, Immunoassays, Cytogenetics, and BioinformaticsBy Application;
Risk Assessment, Prognostics, Disease Diagnosis, and Drug Discovery & DevelopmentBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global Cancer Biomarkers Market (USD Million), 2021 - 2031
Cancer Biomarkers Market was valued at USD 6,269.97 million in the year 2024. The size of this market is expected to increase to USD 14,650.55 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 12.9%.
Global Cancer Biomarkers Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 12.9 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 12.9 % |
Market Size (2024) | USD 6,269.97 Million |
Market Size (2031) | USD 14,650.55 Million |
Market Concentration | Low |
Report Pages | 365 |
Major Players
- 23andMe
- Abbott Laboratories
- Affymetrix Inc.
- Agilent Technologies, Inc
- Ambry Genetics
- Biomerieux S.A
- Celera Corporation
- Hologic, Inc
- Illumina, Inc
- Roche AG
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Cancer Biomarkers Market
Fragmented - Highly competitive market without dominant players
The Cancer Biomarkers Market is experiencing strong growth as healthcare providers prioritize early cancer detection and personalized treatment strategies. Biomarkers are essential tools for identifying malignancies at early stages, significantly improving therapeutic outcomes. Approximately 55% of oncology diagnostics now incorporate biomarker-based approaches, highlighting their pivotal role in precision oncology.
Enhancing Treatment Precision
The use of cancer biomarkers in determining optimal treatment plans is gaining traction, with nearly 48% of current oncology treatment regimens including biomarker analysis. These biomarkers help tailor therapies based on individual tumor profiles, offering improved response rates and minimizing unnecessary interventions.
Technological Progress Fueling Market Expansion
Advancements in genomic and proteomic platforms are accelerating the adoption of sophisticated biomarker tests. High-throughput technologies now represent more than 42% of cancer biomarker development efforts. Such innovations support the detection of cancer-specific molecular signatures with greater accuracy and clinical reliability.
Wider Clinical Application and Market Outlook
Cancer biomarkers have evolved into indispensable tools across various stages of oncology care. Around 60% of clinical trials now utilize biomarker endpoints to assess treatment success and disease progression. This deep integration is propelling market growth and shaping the future of targeted cancer diagnostics and therapies.
Global Cancer Biomarkers Market Recent Developments
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In November 2023, Agilent received FDA approval for PD-L1 IHC 22C3 pharmDx in gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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In May 2022, Illumina introduced a new pan-cancer companion diagnostic to match patients with rare genetic mutations to targeted therapy.
Segment Analysis
In this report, the Global Cancer Biomarkers Market has been segmented by Biomarkers Type, Cancer Type, Services, Profiling Technology, Application, and Geography.
Global Cancer Biomarkers Market, Segmentation by Biomarkers Type
The Global Cancer Biomarkers Market has been segmented by Biomarkers Type into Protein Biomarkers, Genetic Biomarkers and Others.
Protein Biomarkers
Protein biomarkers dominate the global cancer biomarkers market, capturing approximately 40% of the overall share. These biomarkers play a crucial role in the early detection and monitoring of various cancers, such as breast, lung, and colorectal cancers. Their ability to indicate disease progression and treatment effectiveness makes them an essential tool in oncology diagnostics.
Genetic Biomarkers
Making up about 35% of the market, genetic biomarkers are vital for advancing precision medicine. Comprising DNA, RNA, and epigenetic markers, these biomarkers help in assessing inherited cancer risks and identifying tumor-specific mutations. Their role in guiding targeted therapies and predicting patient responses enhances the effectiveness of cancer treatment.
Others
The remaining 25% of the market falls under the "Others" category, which includes cellular, lipid, and metabolomic biomarkers. Though less prevalent, these biomarkers are gaining interest for their role in rare cancer diagnostics and multi-omics analysis, offering more comprehensive insights for improving patient outcomes.
Global Cancer Biomarkers Market, Segmentation by Cancer Type
The Global Cancer Biomarkers Market has been segmented by Cancer Type into Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer and Others.
Breast Cancer
Breast cancer biomarkers account for about 22% of the global cancer biomarkers market. They are instrumental in enabling early detection, guiding treatment planning, and predicting hormone therapy effectiveness, especially in patients with estrogen or HER2-positive tumors.
Lung Cancer
Holding an estimated 18% share, lung cancer biomarkers are essential for diagnosing and managing non-small cell lung cancer (NSCLC). Mutations in EGFR, ALK, and KRAS genes are commonly detected to facilitate targeted treatment strategies.
Prostate Cancer
Comprising around 15% of the market, prostate cancer biomarkers such as PSA and PCA3 are commonly used for early screening and monitoring recurrence. These markers are vital for determining treatment necessity and risk management.
Colorectal Cancer
Colorectal cancer biomarkers represent approximately 13% of the market and are used to detect genetic alterations like KRAS and BRAF mutations. They support effective treatment selection and monitoring, particularly in late-stage colorectal cancer.
Cervical Cancer
With a 10% market share, cervical cancer biomarkers play a pivotal role in early screening and risk assessment. Markers such as HPV DNA and p16INK4a help identify precancerous conditions and guide clinical decisions.
Global Cancer Biomarkers Market, Segmentation by Services
The Global Cancer Biomarkers Market has been segmented by Services into Sample Preparation, Assay Development and Biomarkers & Testing.
Sample Preparation
Sample preparation services make up around 30% of the global cancer biomarkers market. These services are critical in ensuring the quality and integrity of biological samples before testing. They help reduce contamination risks and enable accurate biomarker analysis, supporting the demand for precision diagnostics.
Assay Development
Contributing to approximately 25% of the market, assay development involves the design, validation, and refinement of biomarker tests. It is essential for the development of reliable diagnostic tools and plays a crucial role in expanding applications in personalized medicine.
Biomarkers & Testing
Holding the largest share at 45%, the Biomarkers & Testing segment encompasses the full spectrum of biomarker analysis — from detection and validation to clinical interpretation. It is key to supporting cancer diagnosis, prognosis, and treatment planning, making it the backbone of cancer biomarker services.
Global Cancer Biomarkers Market, Segmentation by Profiling Technology
The Global Cancer Biomarkers Market has been segmented by Profiling Technology into OMICS Technology, Imaging Technology, Immunoassays, Cytogenetics and Bioinformatics.
OMICS Technology
OMICS technology leads the cancer biomarker profiling segment with a market share of approximately 35%. Encompassing genomics, proteomics, metabolomics, and transcriptomics, it provides a comprehensive view of cancer biology, driving advancements in precision oncology and targeted therapies.
Imaging Technology
With around 20% market share, imaging technology plays a crucial role in non-invasive biomarker detection. Tools like PET, MRI, and CT scans enable precise tumor visualization and are essential for assessing treatment efficacy and disease progression.
Immunoassays
Holding close to 18% of the market, immunoassays are key for early cancer detection. These assays utilize antigen-antibody interactions to identify biomarkers with high specificity and are frequently used in routine diagnostic workflows.
Cytogenetics
Accounting for about 15% of the market, cytogenetics involves studying chromosomal abnormalities that contribute to cancer. This technology is particularly valuable in diagnosing hematological malignancies and guiding therapeutic decisions.
Bioinformatics
Representing roughly 12% of the market, bioinformatics is essential for processing and interpreting vast data from OMICS and other technologies. It enables biomarker discovery, stratifies patient populations, and supports personalized medicine approaches.
Global Cancer Biomarkers Market, Segmentation by Application
The Global Cancer Biomarkers Market has been segmented by Application into Risk Assesment, Prognostics, Disease Diagnosis and Drug Discovery & Development.
Risk Assessment
Risk assessment applications represent about 20% of the global cancer biomarkers market. These biomarkers are essential for identifying individuals at an elevated risk of developing cancer due to genetic predispositions or environmental exposures, facilitating early monitoring and preventive care.
Prognostics
With a market share of approximately 25%, prognostic biomarkers provide valuable information about the likely course of cancer. They help in estimating disease progression, risk of recurrence, and survival outcomes, aiding physicians in optimizing treatment decisions.
Disease Diagnosis
Disease diagnosis is the largest application area, accounting for nearly 35% of the market. Cancer biomarkers are widely used in the early detection and accurate classification of malignancies, significantly improving diagnostic efficiency and reducing the need for invasive methods.
Drug Discovery & Development
Contributing about 20%, the drug discovery and development segment utilizes biomarkers to accelerate research. They assist in identifying promising drug targets, evaluating treatment efficacy, and supporting the advancement of personalized oncology therapeutics.
Global Cancer Biomarkers Market, Segmentation by Geography
In this report, the Global Cancer Biomarkers Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
Global Cancer Biomarkers Market Share (%), by Geographical Region, 2024
North America
North America dominates the global cancer biomarkers market with an estimated 40% share. The region benefits from robust healthcare infrastructure, strong research and development initiatives, and widespread adoption of personalized medicine and advanced diagnostic technologies.
Europe
Accounting for nearly 25%, Europe continues to see strong growth in the cancer biomarkers space. Supportive regulatory frameworks, increasing cancer incidence, and growing investments in biomarker research programs are key drivers in this market.
Asia Pacific
With a market share of about 20%, Asia Pacific is emerging as a high-growth region. Countries like China, India, and Japan are witnessing increased demand due to a rising cancer burden, improving healthcare infrastructure, and expanding biotech investments.
Middle East and Africa
The Middle East and Africa hold close to 8% of the global market. Although constrained by infrastructure gaps, the region is gradually advancing through government healthcare initiatives, increased oncology research, and improving diagnostic capabilities.
Latin America
Representing approximately 7% of the market, Latin America is steadily progressing due to enhanced healthcare access, national cancer programs, and collaborations with international life science companies focused on biomarker development.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Cancer Biomarkers Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
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Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunities Analysis
Drivers
- Rising global cancer incidence and mortality
- Increased focus on personalized cancer therapy
- Growing adoption of minimally invasive diagnostics
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Advancements in biomarker detection technologies - Continuous innovation in biomarker detection technologies has significantly enhanced the ability to identify and monitor cancer-specific biomarkers with higher sensitivity and specificity. These advancements have led to the development of sophisticated diagnostic tools, such as next-generation sequencing (NGS), digital PCR, and high-throughput multiplex assays, which allow for comprehensive analysis of molecular signatures. As a result, accuracy and speed in cancer detection have improved, allowing clinicians to make more informed treatment decisions.
The integration of machine learning and AI algorithms into biomarker analysis represents another breakthrough. These tools process large datasets to uncover subtle molecular patterns and disease correlations. With such precise technology, early-stage cancer detection has become more reliable, increasing survival rates through earlier intervention and personalized treatment plans.
Further advancements include non-invasive techniques like liquid biopsies that detect biomarkers from blood, saliva, or other bodily fluids. These methods are less invasive for patients and are gaining popularity in clinical settings, leading to faster diagnoses and increased patient comfort. The growing adoption of these innovations is driving broader demand for biomarker diagnostics.
As technologies become more accessible and affordable, adoption is expanding across global healthcare systems. Increased awareness among healthcare professionals and patients is reinforcing the demand for cancer biomarker detection, making it a crucial driver in market expansion.
Restraints
- High costs of biomarker validation
- Limited awareness in developing regions
- Complexity in regulatory approval processes
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Inadequate reimbursement for biomarker tests - Despite advancements in technology, lack of adequate reimbursement for biomarker tests continues to hinder the cancer biomarkers market. Many insurance providers and healthcare systems lag in updating policies to cover newly developed diagnostics, particularly those still undergoing validation. This results in higher out-of-pocket expenses for patients and limited market access.
The problem is more pronounced in developing regions with constrained healthcare budgets. Even in developed countries, inconsistencies across insurers and states create access disparities. As a result, even clinically beneficial biomarker tests often remain underutilized due to financial limitations faced by providers and patients.
The lack of reimbursement also poses a challenge for companies developing biomarker tests. Without guaranteed financial return, investment in new diagnostic tools becomes risky. This reduces innovation and delays commercial availability, creating a bottleneck in the growth of the industry.
To unlock the full potential of biomarker-driven oncology care, healthcare systems must streamline reimbursement policies. Until consistent and supportive frameworks are implemented, this restraint will continue to impact the market’s scalability.
Opportunities
- Expanding use of liquid biopsy tests
- Growth in companion diagnostics integration
- Increasing investments in oncology research
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Emerging biomarkers for early cancer detection - The development of emerging biomarkers for early cancer detection presents a significant opportunity in the cancer biomarkers market. Detecting cancer at an early stage drastically improves treatment outcomes and reduces overall healthcare costs. Biomarkers capable of identifying cancer-related changes before symptoms appear are becoming a critical focus in research and development.
Novel biomarker types such as epigenetic indicators, exosomal markers, and circulating tumor DNA (ctDNA) are being explored. These biomarkers offer a more comprehensive view of tumor activity and allow for non-invasive detection through simple blood tests. Such tools are especially valuable for cancers that traditionally evade early diagnosis, like pancreatic and ovarian cancers.
Increased investment by pharma and diagnostic companies is accelerating progress in this area. With numerous clinical trials and cross-sector collaborations underway, the validation and commercial adoption of these early-detection biomarkers are gaining momentum. This trend reflects the global healthcare industry's shift toward preventive care and early intervention.
As more emerging biomarkers receive regulatory approval, they are poised to transform cancer screening and diagnosis practices. The opportunity to implement personalized, minimally invasive diagnostics will reshape how cancer is managed, offering substantial growth potential to the global market.
Competitive Landscape Analysis
Key players in Global Cancer Biomarkers Market include:
- 23andMe
- Abbott Laboratories
- Affymetrix Inc. (Thermo Fisher Scientific)
- Agilent Technologies, Inc
- Ambry Genetics
- Biomerieux S.A
- Celera Corporation (Quest Diagnostics)
- Hologic, Inc
- Illumina, Inc
- Roche AG
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Biomarkers Type
- Market Snapshot, By Cancer Type
- Market Snapshot, By Services
- Market Snapshot, By Profiling Technology
- Market Snapshot, By Application
- Market Snapshot, By Region
- Global Cancer Biomarkers Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Rising global cancer incidence and mortality
- Increased focus on personalized cancer therapy
- Growing adoption of minimally invasive diagnostics
- Advancements in biomarker detection technologies
- Restraint
- High costs of biomarker validation
- Limited awareness in developing regions
- Complexity in regulatory approval processes
- Inadequate reimbursement for biomarker tests
- Opportunities
- Expanding use of liquid biopsy tests
- Growth in companion diagnostics integration
- Increasing investments in oncology research
- Emerging biomarkers for early cancer detection
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Cancer Biomarkers Market, By Biomarkers Type, 2021 - 2031 (USD Million)
- Protein Biomarkers
- Genetic Biomarkers
- Others
- Global Cancer Biomarkers Market, By Cancer Type, 2021 - 2031 (USD Million)
- Breast Cancer
- Lung Cancer
- Prostate Cancer
- Colorectal Cancer
- Cervical Cancer
- Others
- Global Cancer Biomarkers Market, By Services, 2021 - 2031 (USD Million)
- Sample Preparation
- Assay Development
- Biomarkers & Testing
- Global Cancer Biomarkers Market, By Profiling Technology, 2021 - 2031 (USD Million)
- OMICS Technology
- Imaging Technology
- Immunoassays
- Cytogenetics
- Bioinformatics
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Global Cancer Biomarkers Market, By Application, 2021 - 2031 (USD Million)
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Risk Assesment
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Prognostics
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Disease Diagnosis
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Drug Discovery & Development
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- Global Cancer Biomarkers Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Cancer Biomarkers Market, By Biomarkers Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- 23andMe
- Abbott Laboratories
- Affymetrix Inc. (Thermo Fisher Scientific)
- Agilent Technologies, Inc
- Ambry Genetics
- Biomerieux S.A
- Celera Corporation (Quest Diagnostics)
- Hologic, Inc
- Illumina, Inc
- Roche AG
- Company Profiles
- Analyst Views
- Future Outlook of the Market