(MENAFN- GlobeNewsWire - Nasdaq) The global biomarkers market is projected to grow from USD 67.95 billion in 2026 to USD 112.10 billion by 2031, registering a 10.5% CAGR. Growth is driven by precision medicine, companion diagnostics, AI, bioinformatics, digital pathology and multi-omics technologies. Predictive biomarkers led the efficacy segment in 2025, while immunoassays held the largest technology share. Asia Pacific is forecast to be the fastest-growing region. Key players include Roche, Abbott, Thermo Fisher Scientific, QIAGEN, Merck KGaA and Illumina.Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "Biomarkers Market by Offering, Type, Research Area, Technology, Disease, Application - Global Forecast to 2031" has been added to ResearchAndMarkets.com's offering.
The global biomarkers market is projected to grow from USD 67.95 billion in 2026 to USD 112.10 billion by 2031, registering a compound annual growth rate of 10.5% during the forecast period. Market expansion is being supported by the adoption of precision medicine and companion diagnostics, alongside the integration of artificial intelligence, digital pathology, bioinformatics, genomics, proteomics and multi-omics technologies.
Predictive biomarkers lead the efficacy biomarkers segment
By type, the biomarkers market comprises safety, efficacy and validation biomarkers. Efficacy biomarkers are further segmented into predictive, surrogate, pharmacodynamic and prognostic biomarkers. Predictive biomarkers represented the largest share of the efficacy biomarkers segment in 2024, with their leading position continuing into 2025. Growth is primarily associated with their role in identifying patients most likely to respond to specific therapies, supporting personalized treatment selection, clinical decision-making and improved outcomes.
Predictive biomarker adoption is increasing across oncology, autoimmune diseases and infectious diseases. The expanding number of companion diagnostic approvals is also strengthening market demand. In June 2026, the FDA approved Roche's first companion diagnostic for assessing PTEN protein status in prostate cancer. The VENTANA PTEN assay supports the identification of patients eligible for more targeted treatment decisions.
Immunoassays retain the largest technology share
The biomarkers market is segmented by technology into immunoassays, next-generation sequencing, polymerase chain reaction, mass spectrometry, chromatography and other platforms. Immunoassays held the largest market share in 2025, supported by their specificity and broad applicability across oncology, cardiology, infectious diseases and other clinical areas.
Compatibility with clinical diagnostics and research applications, combined with scalability, automation and high-throughput testing capabilities, continues to support immunoassay adoption. Major market participants are enhancing their platforms to expand diagnostic offerings. Roche provides the Elecsys Anti-p53 immunoassay for cancer diagnostics, while Abbott continues to expand its ARCHITECT and Alinity immunoassay systems for infectious disease testing and chronic condition monitoring.
Asia Pacific is expected to record the fastest regional growth
The report analyzes North America, Europe, Asia Pacific, Latin America, the Middle East and Africa. Asia Pacific is projected to register the highest CAGR from 2026 to 2031. Regional growth is being driven by healthcare infrastructure expansion in China, India and Japan, together with investments in precision medicine, genomic research and diagnostic innovation.
The increasing prevalence of cancer, cardiovascular disorders, metabolic diseases and infectious diseases is accelerating demand for biomarker-based diagnostics and personalized treatment strategies. Additional growth factors include expanding clinical trial activity, greater adoption of companion diagnostics, supportive biotechnology and life sciences initiatives, and rapid implementation of genomics, proteomics and AI-enabled analytics. Strengthening local biopharmaceutical manufacturing and evolving regulatory frameworks are also improving commercialization opportunities, positioning Asia Pacific as an important center for biomarkers market growth and innovation.
Research coverage and market analysis
The research categorizes the global biomarkers market by offering, type, research area, technology, disease indication and end user. It evaluates market drivers, restraints, opportunities and challenges while assessing competitive positioning, market shares, growth strategies and product portfolios. The report also reviews business profiles, solutions, approvals, product launches, collaborations, partnerships, agreements, acquisitions, investments, funding activity, vendor valuations, financial metrics and other recent industry developments.
Key growth drivers include the rising adoption of precision medicine and companion diagnostics; greater use of NGS, PCR, proteomics and multi-omics platforms; increasing application of biomarkers in drug discovery and clinical trial design; and the growing burden of cancer, cardiovascular, neurological and infectious diseases. Expansion of liquid biopsy and minimally invasive biomarker testing, together with AI, digital pathology and bioinformatics integration, is also supporting market development.
Market restraints include the high cost of advanced biomarker discovery and validation, as well as complex regulatory and reimbursement pathways. Opportunities include the co-development of biomarkers with targeted therapies and immunotherapies, expansion of blood-based biomarkers for oncology and neurology, advances in proteomics and spatial biology, and increasing outsourcing of biomarker assay development and validation. Principal challenges include translating discovery biomarkers into clinically validated tests and addressing patient heterogeneity and disease complexity.
The report provides detailed insights into research and development pipelines, emerging technologies, high-growth markets, untapped geographies and investment trends. It is designed to help established companies and new entrants evaluate revenue opportunities, understand the competitive environment, strengthen market positioning and develop effective go-to-market strategies.
Primary research respondent profile
By respondent: supply side, 70%; demand side, 30%. By designation: managers, 45%; CXOs and directors, 30%; executives, 25%. By region: North America, 40%; Europe, 25%; Asia Pacific, 25%; Latin America, 5%; Middle East and Africa, 5%.
Companies profiled in the biomarkers market report
Companies covered include F. Hoffmann-La Roche Ltd. (Switzerland), Merck KGaA (Germany), Abbott (US), Thermo Fisher Scientific, Inc. (US), QIAGEN (Germany), Charles River Laboratories (US), Eurofins Scientific (Luxembourg), LabCorp (US), Revvity (US), bioMerieux (France), Guardant Health (US), JSR Corporation/Crown Biosciences (Japan), Agilent Technologies, Inc. (US), Bio-Rad Laboratories (US), Illumina, Inc. (US), Quanterix (US), Meso Scale Diagnostics, LLC (US), Intertek Group Plc (UK), Meridian Bioscience (US), BioAgilytix Labs (US), R-Biopharm AG (Germany), Enzo Biochem (US), WuXi AppTec (China), Standard BioTools (US), Diatech Pharmacogenetics (Italy), Synexa Life Sciences BV (Netherlands), Proteome Sciences (UK), Pillar Biosciences (US), StressMarq Biosciences Inc. (Canada), Sebia (France), Bio-Techne (US), C2N Diagnostics (US), NorthEast Bioanalytical Laboratories (US), Signosis (US) and Myriad Genetics, Inc. (US).
Benefits for biomarkers market stakeholders
The report provides revenue estimates for the overall market and its subsegments, enabling stakeholders to assess commercial opportunities and competitive dynamics. Its product innovation, market development, diversification and competitive assessment coverage supports strategic planning across biomarker discovery, assay development, clinical validation, diagnostics and personalized medicine.
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