Biomarkers Market to Reach US$ 148.88B by 2032 | CAGR 11.9% | North America Leads with 40% Share | Key Players: Thermo Fisher Scientific, QIAGEN, Merck KGaA, Bruker, Bio-Rad, Siemens Healthineers.

Market Overview

The global Biomarkers market reached US$ 60.76 billion in 2024 and is projected to reach US$ 148.88 billion by 2032, growing at a CAGR of 11.9% during the forecast period 2025-2032.

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Biomarkers, or biological markers, are measurable indicators that can be objectively evaluated to assess normal biological processes, pathogenic processes, or responses to therapeutic interventions. They play a critical role in disease diagnosis, monitoring progression, predicting outcomes, and evaluating treatment effectiveness. Biomarkers are essential for understanding disease mechanisms, identifying novel therapeutic targets, and enabling personalized medicine. In clinical practice, they are widely used to detect the presence and severity of diseases, making them invaluable tools for clinicians, researchers, and pharmaceutical companies.

Recent Developments:

✅ Europe Vocal & Voice Biomarkers Growth (2026): A new report highlighted the rising use of voice-based biomarkers for early disease detection and monitoring, underscoring innovation beyond traditional molecular markers.

✅ Precision Oncology Collaboration (2026): 10x Genomics announced a multi-year collaboration with Dana-Farber Cancer Institute to analyze tumor samples using single-cell and spatial profiling, aiming to identify biomarkers tied to treatment response and resistance and to advance precision oncology diagnostics.

✅ Vocal Biomarkers Market Expansion: The vocal biomarkers segment is projected to grow significantly, with market size expected to reach around USD 4.67 billion by 2033, driven by increasing research into non-invasive digital biomarkers for mental health and neurological conditions.

✅ Consumer Health Testing Innovations: Hims & Hers Health, Inc. launched Hims Labs, a holistic health testing experience that tracks key biomarkers over time and provides personalized insights, reflecting growing consumer demand for accessible biomarker monitoring outside traditional clinical settings.

✅ New FDA-Approved Biomarker Diagnostic Test (2025): Biocartis NV received FDA approval for the IdyllaTM CDx MSI Test, a fully automated biomarker assay for detecting microsatellite instability in colorectal cancer, enabling faster companion diagnostics supporting precision therapies.

✅ Major Industry R&D Partnerships: NEC Corporation partnered with Biomy, Inc. to develop AI/deep learning-based digital pathology platforms to discover new pathological biomarkers and support precision medicine, particularly in cancer care.

✅ Roche Biomarker Test Launch (2025): Roche introduced the Elecsys PRO-C3 test, designed to evaluate liver fibrosis severity using biomarker analysis, expanding non-invasive marker-based diagnostics.

✅ Strategic Acquisitions in Diagnostics (2025): Eurofins Scientific acquired SYNLAB's clinical diagnostics operations in Spain, enhancing access to patient samples and diagnostic capabilities that support biomarker discovery and application.

✅ Expanded IVD Assay Development (2025): Biodesix expanded its partnership with Bio-Rad to develop advanced ddPCR-based assays for sensitive genomic biomarker detection in oncology, accelerating clinical validation.

✅ Clinical Trial Progress in Lung Cancer Biomarkers: BioMark Diagnostics advanced its HANSE lung cancer screening trial, analyzing thousands of samples using proprietary metabolic biomarkers, marking a key milestone in global clinical validation efforts.

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Key Players:

Thermo Fisher Scientific Inc. | QIAGEN NV | Merck KGaA | BRUKER CORPORATION | Bio-Rad Laboratories, Inc. | Siemens Healthineers AG | Abbott Laboratories | Agilent Technologies Inc. | Myriad Genetics | Somru BioScience Inc.

Key Highlights:

• Thermo Fisher Scientific Inc. - Holds an estimated 13.0% share, offering a broad portfolio of biomarker discovery tools, analytical instruments, reagents, and diagnostic platforms.

• QIAGEN NV - Holds an estimated 11.5% share, providing sample preparation, molecular diagnostics, and biomarker assay solutions for research and clinical applications.

• Merck KGaA - Holds an estimated 9.0% share, focusing on biomarker reagents, life science research tools, and precision medicine solutions.

• BRUKER CORPORATION - Holds an estimated 8.5% share, supplying analytical instruments and mass spectrometry platforms for biomarker identification and proteomics research.

• Bio-Rad Laboratories, Inc. - Holds an estimated 9.5% share, specializing in molecular biology reagents, immunoassays, and diagnostic kits for biomarker detection.

• Siemens Healthineers AG - Holds an estimated 12.0% share, offering diagnostic imaging, laboratory diagnostics, and integrated biomarker-based solutions for clinical applications.

• Abbott Laboratories - Holds an estimated 10.0% share, providing immunoassays, molecular diagnostics, and biomarker testing solutions for clinical and research use.

• Agilent Technologies Inc. - Holds an estimated 8.0% share, focusing on analytical instruments, LC/MS, and biomarker research technologies for precision medicine.

• Myriad Genetics - Holds an estimated 6.5% share, specializing in genetic testing, molecular diagnostics, and biomarker-driven personalized medicine.

• Somru BioScience Inc. - Holds an estimated 2.0% share, providing specialized biomarker assay development and protein engineering solutions for research and clinical applications.

Market Segmentation:

By Product Type:
Diagnostic biomarkers lead with around 22% share, widely used for disease detection and clinical decision-making. Monitoring biomarkers account for 15%, enabling assessment of disease progression and treatment response. Predictive biomarkers hold 13%, guiding therapy selection and efficacy prediction. Susceptibility/risk biomarkers comprise 10%, prognostic biomarkers 12%, pharmacodynamic/response biomarkers 8%, safety biomarkers 7%, and others account for 13% of the market.

By Application:
Drug discovery and development is the largest segment with 28%, driven by biomarker use in target identification, clinical trials, and companion diagnostics. Disease diagnostics hold 25%, supporting early detection and treatment monitoring. Disease risk assessment accounts for 12%, personalized medicine 20%, and others comprise 15%, covering academic research, biomarker libraries, and epidemiology applications.

By End-User:
Pharmaceutical companies dominate with 40%, leveraging biomarkers for drug development, clinical trials, and companion diagnostics. Biotechnology companies hold 30%, using biomarkers for innovative therapies, personalized medicine, and diagnostic kit development. Research centers and institutes account for 30%, focusing on biomarker discovery, validation, and translational research.

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Regional Insights:

North America leads the global biomarkers market with an estimated 40% share. The region benefits from advanced healthcare infrastructure, high R&D investment, strong pharmaceutical and biotechnology presence, and early adoption of biomarker-based diagnostics. The United States and Canada are driving growth through government initiatives supporting precision medicine, clinical trials, and regulatory frameworks for companion diagnostics.

Europe holds around 25% of the market, fueled by robust healthcare systems, strong research collaborations, and increasing adoption of personalized medicine solutions. Key markets such as Germany, the UK, and France are investing heavily in biomarker discovery, translational research, and molecular diagnostics, supporting market expansion.

Asia-Pacific accounts for approximately 20%, driven by rapidly growing pharmaceutical and biotech sectors, rising incidence of chronic diseases, expanding healthcare infrastructure, and increasing government funding for biomarker research in countries such as China, India, Japan, and South Korea.

Market Dynamics:

Driver: Increasing Novel Approaches
The global biomarkers market is being driven by novel approaches such as next-generation sequencing (NGS), proteomics, and metabolomics, which allow researchers to analyze a broader spectrum of biological signatures, including genetic variations, protein profiles, and metabolic pathways. These advanced techniques enable the identification of novel and comprehensive biomarkers for a wide range of disorders. Importantly, they allow for early disease detection, even before symptoms manifest, by identifying subtle changes in biological fingerprints associated with disease onset.

Major companies are actively introducing innovative products to accelerate disease diagnosis and precision medicine. For example:
September 2024 - Genialis: Launched Genialis krasID, the first biomarker algorithm capable of predicting patient response and clinical benefit to KRAS inhibitors (KRASi) across tissue types and mutation variants. The tool supports drug development from early preclinical phases (compound differentiation and selection), to clinical trials (patient selection and combination therapy identification), and to market access and clinical care (companion diagnostics development and clinical decision support).

October 2022 - Koneksa: Launched a clinical pipeline featuring biomarkers across neuroscience, oncology, respiratory, and other therapeutic areas. With 15 digital biomarker programs in development, the company is preparing to launch several upcoming clinical studies to validate novel biomarkers.

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