The United States biomarkers market was valued at USD 19.58 Billion in 2025, driven by the rising inclination towards point of care testing across the region. The market is anticipated to grow at a CAGR of 8.20% during the forecast period of 2026-2035, with the values likely to reach USD 43.06 Billion by 2035. The market growth is driven by the preference for high sensitivity diagnosis and the rising application of biomarkers in diagnosis and treatment.
Base Year
Historical Period
Forecast Period
Biomarker adoption in the United States is accelerating due to rising demand for personalized medicine and targeted therapeutic approaches.
The increasing prevalence of chronic diseases is driving the need for early detection biomarkers across clinical and research settings.
Technological advancements in genomics and proteomics are expanding biomarker applications in diagnostics, drug development, and precision oncology.
Compound Annual Growth Rate
8.2%
Value in USD Billion
2026-2035
*this image is indicative*
Biomarkers are measurable indicators of biological processes, conditions, or diseases found in blood, tissues, or other body fluids. They help in diagnosing diseases, predicting treatment responses, and monitoring therapeutic outcomes. Commonly used in oncology, cardiology, and neurology, biomarkers enable early detection and personalized medicine. Advances in genomics and proteomics are driving biomarker discovery, making them vital tools for precision healthcare and drug development. The market is anticipated to grow at a CAGR of 8.20% during the forecast period of 2026-2035.
Advances In Clinical Biomarkers Supporting United States Market Growth
Rising investments in neurodegenerative disease research and increasing clinical focus on protein-based biomarkers are strengthening the market. For instance, in June 2024, PTC Therapeutics reported interim Phase 2 PIVOT-HD trial results for PTC518, showing dose-dependent reductions in mutant huntingtin (mHTT) protein in blood and CSF over 12 months, alongside positive trends in motor and cognitive assessments. These findings highlight the growing clinical value of biomarkers in monitoring treatment efficacy, positioning them as essential tools in disease progression tracking and therapy development.
Collaborative Innovations Accelerating Biomarker Assay Development in the United States
The demand for high-sensitivity diagnostic tools and precision medicine in neurology is driving partnerships for advanced assay platforms. For instance, in October 2024, ADx NeuroSciences and Alamar Biosciences announced a collaboration to co-develop biomarker assay solutions using Alamar’s NULISA™ platform and ARGO™ HT System. This partnership is set to enhance ultra-sensitive detection capabilities for neurological biomarkers, thereby expanding the scope of biomarker-driven therapeutic development and boosting technological progress in the U.S. biomarkers market over the forecast period.
Some of the notable trends include innovations empowered by latest technologies like artificial intelligence, adoption of non-invasive diagnostics and others.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product
Market Breakup by Type
Market Breakup by Application
Market Breakup by Technology
Market Breakup by Disease Indication
Market Breakup by End User
Market Breakup by Region
Immunoassays to Hold a Significant Market Share for Segmentation by Technology
Immunoassays are expected to dominate the market by technology due to their high sensitivity, specificity, and broad application in disease diagnostics, especially in oncology and infectious diseases. Widely used in clinical settings, they support rapid biomarker detection and monitoring. Although NGS and PCR are growing rapidly, immunoassays continue to hold the largest share due to scalability and proven clinical utility.
The Northeast region is likely to dominate the market due to its strong presence of academic research institutions, biotech hubs, and public-private collaborations. For instance, in March 2025, Enigma Biomedical USA, Inc. began a partnership with Boston University’s CTE Center and the Concussion Legacy Foundation to advance 4R Tau PET biomarkers for diagnosing chronic traumatic encephalopathy (CTE). Such initiatives reinforce the Northeast’s innovation leadership, outpacing other regions like the Midwest, South, and West in biomarker discovery and validation.
The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Roche, a global leader in diagnostics and pharmaceuticals, plays a pivotal role in the U.S. biomarkers market through innovative diagnostic solutions. In February 2025, Roche partnered exclusively with PathAI to co-develop AI-powered digital pathology algorithms for companion diagnostics. This move strengthens Roche’s position in precision medicine by enhancing biomarker identification capabilities, accelerating targeted therapy development, and advancing diagnostic accuracy across disease areas.
In March 2024, Boston Consulting Group (BCG) and Merck initiated a strategic collaboration to apply AI and GenAI for drug target discovery. Through BCG X, the partnership aims to develop algorithms that mine omics data to uncover relationships between biomarkers and disease biology. This positions Merck as a pivotal enabler of biomarker-driven drug development in the evolving U.S. biomarkers market.
Thermo Fisher Scientific Inc. is a global leader in life sciences, offering a wide range of laboratory products and technologies. In November 2024, it entered a collaboration with Mainz Biomed N.V. to develop and commercialize the company's next-generation colorectal cancer (CRC) screening product. Thermo Fisher will contribute its expertise in mRNA-based assays and life sciences technologies, advancing early cancer detection. This partnership positions Thermo Fisher at the forefront of innovative diagnostic solutions in the U.S. biomarkers market.
QIAGEN, a global leader in molecular diagnostics, plays a key role in the United States biomarkers market by advancing companion diagnostics (CDx). In August 2024, QIAGEN expanded its collaboration with AstraZeneca to develop CDx for chronic disease therapies. QIAGEN will leverage its QIAstat-Dx platform for genotyping assays, allowing for rapid patient evaluation, enhancing precision medicine by enabling timely treatment decisions with genomically targeted therapies.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Abbott, Agilent Technologies, Inc., Revvity, Charles River Laboratories, Bio-Rad Labroatories, Inc., and Eurofins Scientific.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product |
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| Breakup by Type |
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| Breakup by Application |
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| Breakup by Technology |
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| Breakup by Disease Indication |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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