United States Biomarkers Market 2025 | Growth Drivers, Competitive Landscape & Investment Opportunities

Market Size and Growth

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

Key Development:

United States: Recent Biomarker Industry Developments

✅ In October 2025, Connecticut enacted legislation requiring health insurance providers to cover biomarker testing, effective January 2026. This policy aims to improve the diagnosis and treatment of chronic diseases such as Alzheimer's, cancer, and Parkinson's, enhancing access to early disease detection and personalized treatment planning.

✅ In August 2025, Molecular You secured $5 million in funding to expand its biomarker testing platform. The platform currently measures 250 biomarkers and aims to extend this to over 800, incorporating next-generation multi-omic assays for broader applications, including certain cancers.

✅ In July 2025, the U.S. FDA approved the Lumipulse blood test for Alzheimer's disease detection. This test offers a less invasive and more accessible method for early detection, measuring biomarkers pTau217 and beta-amyloid 1-42, with up to 97% accuracy in confirming negative results and 92% accuracy for positive results.

Japan: Recent Biomarker Industry Developments

✅ In September 2025, CurePSP launched the Biomarker Accelerator Program to transform the diagnosis and treatment of progressive supranuclear palsy (PSP). This initiative aims to bridge the gap between laboratory discoveries and clinical care, enhancing the understanding and management of PSP.

✅ In August 2025, a collaborative study in Japan developed a deep learning-enhanced chemiluminescence vertical flow assay for high-sensitivity cardiac troponin I testing. This assay enables rapid, low-cost, and precise quantification of cardiac troponin I, a key cardiac protein for assessing heart muscle damage and myocardial infarction.

✅ In July 2025, Japanese researchers introduced an artificial intelligence-derived vascular age biomarker using photoplethysmography. This novel digital biomarker assesses cardiovascular health by estimating vascular age, providing a non-invasive method for early detection of cardiovascular diseases.

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Biomarkers are measurable indicators of biological processes, disease states, or responses to therapy. They are widely used in diagnostics, drug development, and personalized medicine to detect diseases early, monitor progression, predict treatment response, and guide therapeutic decisions.

Recent Mergers and acquisitions:

United States: Recent M&A in Biomarker and Diagnostics

✅ In October 2025, BioCryst Pharmaceuticals announced its acquisition of Astria Therapeutics in a cash-and-stock deal valued at approximately $700 million. This strategic move aims to reinforce BioCryst's rare diseases portfolio by integrating Astria's lead drug candidate, navenibart, an injectable therapy in late-stage trials for hereditary angioedema. The acquisition is expected to close in Q1 2026.

✅ In August 2025, Yatiri Bio acquired NGeneBioAI, a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics. This acquisition strengthens Yatiri Bio's position in biomarker discovery and translational drug development, enhancing its AI-proteomics platform for applications in oncology, immunology, and neurodegeneration.

✅ In July 2025, Quanterix completed its acquisition of Akoya Biosciences, creating a platform for measuring biomarkers in blood and tissue. The deal, valued at $20 million in cash and 7.8 million shares, positions Quanterix as a leader in early disease detection across neurology, oncology, and immunology, expanding its addressable market to $5 billion.

Japan: Recent M&A in Biomarker and Diagnostics

✅ In July 2025, Tigermed completed its acquisition of Micron, a Japanese Contract Research Organization (CRO) specializing in medical imaging and clinical trial services. This acquisition enhances Tigermed's medical imaging capabilities across Japan and the Asia-Pacific region, adding the largest imaging expert team in Asia and advanced AI-powered imaging technology.

✅ In May 2025, a major Japanese healthcare provider announced the acquisition of a digital health startup specializing in AI-driven diagnostics. This move aims to integrate advanced analytics into patient care, enhancing service delivery and operational efficiency, and positioning the healthcare provider at the forefront of digital health innovation.

✅ In September 2025, Otsuka Pharmaceutical's Diagnostic Division inaugurated a new laboratory in Tokyo, focusing on biomarker and digital biomarker research. This initiative aims to strengthen connections with users and enhance diagnostic capabilities, contributing to advancements in precision medicine and personalized healthcare.

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 and Somru BioScience Inc. among others.

Growth Forecast Projected:

The Global Biomarkers Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Biomarkers Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Product Type: Diagnostic Biomarkers, Monitoring Biomarkers, Predictive Biomarkers, Susceptibility/Risk Biomarkers, Prognostic Biomarkers, Pharmacodynamic/Response Biomarkers, Safety Biomarkers, Others

➥ By Application: Drug Discovery and Development, Disease Diagnostics, Disease Risk Assessment, Personalized Medicine, Others

➥ By End-User: Pharmaceutical Companies, Biotechnology Companies, Research Centers and Institutes, Others

Regional Analysis for Biomarkers Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Biomarkers producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Biomarkers revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Biomarkers Market?

A: In 2024, the Biomarkers Market was valued at US$ 60.76 billion , reflecting its strong industry presence.

Q2: How large is the Biomarkers Market expected to be by 2032?

A: By 2032, industry forecasts suggest the Biomarkers Market will grow to around US$ 148.88 billion , demonstrating significant expansion.

Q3: What is the growth rate of the Biomarkers Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 11.9% during the forecast period from 2025 to 2032.

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