The global biomarkers market is projected to reach USD 104.15 billion by 2030, up from USD 62.39 billion in 2025, growing at a compound annual growth rate (CAGR) of 10.8% during the forecast period. Market expansion is primarily driven by the increasing application of biomarkers in drug discovery and development, rising prevalence of cancer, and growing adoption of personalized medicine approaches.

Biomarkers, biological indicators of normal or pathological processes, are playing a critical role in early disease detection, patient stratification, and targeted therapy development. Their integration into drug development pipelines is enabling more precise and effective treatments, particularly in oncology, neurology, cardiology, and infectious diseases. Additionally, advancements in digital biomarkers, AI-enabled analytics, and multiplex assay platforms are accelerating research and clinical application, creating substantial growth opportunities for market players.

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Market Drivers: Personalized Medicine and Rising Disease Prevalence

The growth of the biomarker market is fueled by the increasing prevalence of cancer and other chronic diseases, which emphasizes the need for early diagnosis and personalized treatment strategies. Biomarkers help clinicians tailor therapies to individual patients based on genetic, proteomic, and molecular profiles, improving outcomes and reducing adverse effects.

The integration of artificial intelligence (AI) and machine learning (ML) in biomarker discovery and diagnostics is also transforming the market. AI platforms enhance biomarker identification, accelerate clinical trials, and facilitate the development of precision medicine solutions, providing competitive advantages to leading companies.

Competitive Landscape and Key Players

The biomarkers market is highly fragmented, with key players adopting strategies such as new product launches, acquisitions, collaborations, partnerships, and geographical expansions to strengthen their market positions. Major companies include F. Hoffmann-La Roche Ltd (Switzerland), Merck KGaA (Germany), Thermo Fisher Scientific, Inc. (US), Abbott Laboratories (US), and QIAGEN (Germany).

Recent Market Highlights and Strategic Developments:

• In January 2025, Quanterix Corporation acquired Akoya Biosciences, combining their technologies to offer integrated solutions for blood- and tissue-based protein biomarkers.
• In May 2025, Roche launched the VENTANA MET (SP44) RxDx Assay, identifying non-small cell lung cancer patients eligible for targeted therapies.
• In September 2024, QIAGEN collaborated with Eli Lilly to develop a diagnostic test for APOE genotyping, aimed at identifying patients at risk for Alzheimer’s disease.
• Emerging companies are leveraging AI and ML, exemplified by the April 2025 partnership between Ignite Biomedical and Liquid Biosciences to discover biomarkers for substance use disorder, enhancing diagnosis and treatment options.

F. Hoffmann-La Roche Ltd (Switzerland)

Roche is a dominant player in the biomarker market, leveraging its integrated diagnostics-pharmaceutical business model, global reach, and ongoing innovation. Its Diagnostics division encompasses Core Lab, Molecular Lab, Pathology Lab, Point of Care, and Diabetes Care, offering biomarker-based assays, companion diagnostics, and digital platforms for oncology, cardiology, neurology, infectious diseases, and diabetes.

In 2023, Roche’s Diagnostics division processed over 29 billion tests across 100,000+ platforms, reflecting strong global demand. The company launched more than 20 diagnostic assays between 2022 and May 2025, including the FDA-approved VENTANA MET (SP44) RxDx Assay. Roche has also partnered with PathAI for AI-based pathology algorithms and Neuron23 to utilize digital biomarkers in Parkinson’s disease trials. These initiatives reinforce Roche’s leadership in biomarker development and application.

Merck KGaA (Germany)

Merck KGaA contributes to the biomarker market through its Life Science segment, which provides biomarker assays, consumables, software, and services for research and diagnostics. Its Science & Lab Solutions division focuses on biomarker discovery, validation, and analysis.

Merck strengthened its capabilities through collaborations such as the January 2025 partnership with Qpentions Labworks to automate assay workflows using the Flex robotic workstation, and the June 2024 collaboration with the Michael J. Fox Foundation to support the SMCXPRQ immunoassay platform for early Parkinson’s disease detection. These efforts highlight Merck’s emphasis on automation, precision, and disease-specific biomarker research.

Other Key Players

• Thermo Fisher Scientific, Inc. (US) leads in proteomic and genomic biomarker research, offering high-throughput sequencing tools and multiplex assay platforms.
• Abbott Laboratories (US) focuses on disease-specific biomarker diagnostics, especially in cardiovascular and infectious diseases, while ensuring global accessibility.
• QIAGEN (Germany) advances molecular diagnostics and bioinformatics platforms, co-developing companion diagnostics and forming strategic partnerships to accelerate biomarker application.

Market Outlook and Emerging Opportunities

The remaining 90–92% of the market is shared by regional and emerging vendors, presenting opportunities for niche biomarker developers and early-stage innovation. Growth is further driven by:

• Expanding personalized medicine adoption, where biomarkers guide targeted therapies.
• Technological innovation, including AI, ML, and digital biomarker platforms.
• Collaborative research, fostering partnerships between healthcare providers, pharmaceutical companies, and academic institutions.
• Therapeutic diversification, with biomarkers applied across oncology, neurology, cardiology, and rare diseases.

Conclusion

The global biomarkers market is poised for significant growth through 2030, driven by personalized medicine, AI-enabled research, and rising demand for early disease detection and targeted therapies. Leading players, including Roche, Merck, Thermo Fisher, Abbott, and QIAGEN, are enhancing their portfolios and technological capabilities to remain competitive, while emerging companies leverage innovation and partnerships to capture market opportunities. This dynamic environment is reshaping the future of diagnostics, research, and patient care worldwide.Request Sample Pages : https://www.marketsandmarkets.com/requestsampleNew.asp?id=43