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    US Biomarker Test Market

    ID: MRFR/LS/11961-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US Biomarker Test Market Research Report: By Application (Oncology, Cardiovascular, Neurology, Infectious Diseases, Metabolic Diseases), By Type of Test (Genetic Tests, Proteomic Tests, Metabolomic Tests, Microbiomic Tests), By Technology (Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, Next-Generation Sequencing) and By End Use (Hospitals, Clinical Laboratories, Research Institutions, Pharmaceutical Companies) - Forecast to 2035

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    US Biomarker Test Market Infographic
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    US Biomarker Test Market Summary

    The United States biomarker test market is projected to grow from 8.77 USD billion in 2024 to 14.5 USD billion by 2035, reflecting a robust CAGR of 4.68%.

    Key Market Trends & Highlights

    US Biomarker Test Key Trends and Highlights

    • The market valuation for biomarker tests in the United States is expected to reach 14.5 USD billion by 2035.
    • From 2025 to 2035, the biomarker test market is anticipated to grow at a compound annual growth rate of 4.68%.
    • In 2024, the market is valued at 8.77 USD billion, indicating a strong foundation for future growth.
    • Growing adoption of biomarker tests due to increasing demand for personalized medicine is a major market driver.

    Market Size & Forecast

    2024 Market Size 8.77 (USD Billion)
    2035 Market Size 14.5 (USD Billion)
    CAGR (2025-2035) 4.68%

    Major Players

    Illumina, Exact Sciences, Bristol Myers Squibb, Sensei Health, Roche Diagnostics, Genomic Health, Myriad Genetics, Abbott Laboratories, PerkinElmer, NeoGenomics, Thermo Fisher Scientific, Agilent Technologies, Invitae, Labcorp, Qiagen

    US Biomarker Test Market Trends

    The US Biomarker Test Market has seen significant growth driven by several key market drivers. Increasing demand for personalized medicine is reshaping healthcare, as clinicians seek more precise and effective treatment options for patients. Advances in technology, such as next-generation sequencing and improved bioinformatics tools, have made it easier to identify and validate biomarkers, facilitating their integration into clinical practice.

    Additionally, as healthcare regulations evolve, there is a greater emphasis on early disease detection and management, leading to an expanding role for biomarker tests in routine diagnostics. Opportunities to be explored in the US market include the potential for developing novel biomarkers for complex diseases such as cancer, cardiovascular diseases, and neurodegenerative disorders.

    The growing trend of companion diagnostics is creating synergies between biomarker tests and targeted therapies, improving patient outcomes. Moreover, a shift toward digital health solutions and telemedicine offers new avenues for integrating biomarker testing into patient care through remote monitoring and data collection. Recent trends indicate a rise in collaboration between academic institutions, biotechnology companies, and healthcare providers to expedite the discovery and development of biomarkers.

    Increased funding for research and clinical trials also contributes to innovation in this space. Regulatory bodies in the US, such as the FDA and CMS, are focusing on streamlining approval processes for biomarker tests, which may enhance market accessibility and encourage faster adoption among healthcare providers.Overall, the US Biomarker Test Market is evolving with advancements in technology, regulatory support, and a growing emphasis on personalized healthcare solutions.

    Market Segment Insights

    Biomarker Test Market Application Insights

    The Application segment of the US Biomarker Test Market encompasses a variety of critical areas, including Oncology, Cardiovascular, Neurology, Infectious Diseases, and Metabolic Diseases. As the market continues to evolve, Oncology remains a prominent focus within the industry, significantly driven by the rising incidence of cancer and advancements in personalized medicine. The ability to target treatments more effectively creates a profound impact in how therapies are developed and administered, making this segment particularly significant in the US healthcare landscape.

    Cardiovascular biomarkers also play a vital role in assessing risk and managing diseases, observing major growth due to increasing awareness regarding heart diseases and conditions. The integration of biomarkers in cardiovascular diagnostics aids in early detection and personalized treatment plans, yielding better patient outcomes. Neurology is another crucial segment, with biomarkers helping to identify neurodegenerative diseases such as Alzheimer's and Parkinson's more accurately, fostering innovations in therapeutic approaches that can change the management of these debilitating conditions.

    Infectious Diseases utilize biomarker testing for rapid diagnosis and monitoring treatment efficacy, driven by the increasing threat of emerging pathogens and antibiotic resistance, as seen in public health advisories. This area highlights the importance of timely testing and tailored treatment, which is essential for effective disease management in the US. The Metabolic Diseases category underscores a growing need for precision medicine and paternalistic healthcare models, as these conditions often lead to significant healthcare burdens.

    Biomarker testing aids in assessing patient risk profiles, enabling healthcare providers to implement preventive measures and effectively manage chronic conditions.Overall, the US Biomarker Test Market segmentation delineates diverse applications that are poised for growth due to technological advancements, improved understanding of disease mechanisms, and the implementation of precision medicine. These segments not only fill gaps in existing healthcare practices but also demonstrate the significant potential of biomarkers in enhancing patient outcomes, contributing to the overall dynamics of the industry.

    As public health demands evolve, the potential applications of biomarkers will likely expand, offering novel solutions to pressing health challenges faced in the US. The collective evolution of these segments points toward a rapidly advancing market landscape where biomarker tests are becoming indispensable tools in diagnosis and treatment across multifaceted health issues, thereby shaping the future of healthcare delivery.

    Biomarker Test Market Type of Test Insights

    The US Biomarker Test Market is experiencing steady expansion, driven by advancements in diagnostic technologies and increasing demand for personalized medicine. Within the Type of Test segment, Genetic Tests are particularly significant, playing a vital role in the early detection of diseases and enabling targeted therapies. Meanwhile, Proteomic Tests are gaining traction due to their ability to analyze protein expressions, which are crucial in understanding diseases and developing new treatments.

    Metabolomic Tests provide insights into metabolic changes in patients, facilitating more comprehensive disease assessments.Additionally, Microbiomic Tests are becoming increasingly important as they help identify the role of microbiota in various health conditions. The diversity in the Type of Test segment illustrates the growing awareness and utilization of biomarkers in healthcare, supporting the shift toward more precision-oriented therapies and improving patient outcomes.

    The insights derived from US Biomarker Test Market statistics suggest that these testing methodologies will continue to evolve, offering significant opportunities for innovation and growth within the industry.Each of these tests contributes uniquely to understanding complex biological systems, thereby underscoring their importance in modern medicine.

    Biomarker Test Market Technology Insights

    The Technology segment of the US Biomarker Test Market presents a diverse landscape with a variety of methods including Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, and Next-Generation Sequencing. Polymerase Chain Reaction has played a crucial role in amplifying DNA segments, enabling precise genetic analysis, which is foundational in both diagnostics and Research and Development.

    Meanwhile, Mass Spectrometry is significant for its ability to identify and quantify biomolecules with high accuracy, making it essential for clinical and pharmaceutical applications.Immunoassays, being widely used for their sensitivity and specificity, are pivotal in detecting diseases and monitoring therapeutic responses, showcasing their vital status in translational medicine.

    Next-Generation Sequencing stands out for its capacity to process large volumes of genetic information rapidly, thus transforming personalized medicine and genomics. As technology continues to advance, the interplay between these methodologies is expected to drive innovation within the US Biomarker Test Market, reflecting an industry that is adaptable to the evolving demands in healthcare and research settings..

    Biomarker Test Market End Use Insights

    The US Biomarker Test Market, categorized by End Use, plays a crucial role in the healthcare landscape, reflecting a growing reliance on biomarker analysis for disease diagnosis and treatment. Hospitals are increasingly adopting biomarker tests to enhance patient care and streamline treatment plans, thereby improving clinical outcomes.

    Clinical laboratories serve as vital hubs for testing, contributing significantly to the accuracy and efficiency of diagnostics through advanced biomarker profiling. Research institutions leverage these tests for innovative studies, pushing the boundaries of medical science and enabling breakthroughs in personalized medicine.

    Pharmaceutical companies utilize biomarker tests in drug development and clinical trials, significantly impacting how new therapies are evaluated and validated. The shift towards precision medicine underscores the importance of each segment as they collectively drive the market's growth, supported by advances in technology and increasing demand for tailored treatment options in the US.

    As a result, this sector not only enhances patient care but also fuels significant innovations and collaborations among healthcare stakeholders. Overall, the End Use segmentation highlights critical areas of growth and opportunity within the broader US Biomarker Test Market.

    Get more detailed insights about US Biomarker Test Market

    Key Players and Competitive Insights

    The US Biomarker Test Market is characterized by its rapid evolution and significant expansion, driven by advancements in technology, increased focus on personalized medicine, and a growing understanding of disease mechanisms. This market encompasses a wide range of testing modalities, including genomic, proteomic, and metabolomic tests that facilitate disease diagnosis, prognosis, and treatment decisions.

    Competition within this landscape is fierce, with numerous players striving to establish their dominance through innovative products, strategic partnerships, and enhancing their service offerings. A broad array of applications for biomarker tests, from oncology to infectious diseases, has also encouraged the entry of both established firms and new entrants seeking to capture a share of this lucrative market.

    As regulatory frameworks evolve and reimbursement policies adapt to support biomarker utilization, the competitive dynamics are likely to shift, creating opportunities and challenges for market participants.Illumina stands out prominently in the US Biomarker Test Market, given its robust portfolio of next-generation sequencing technologies that enable comprehensive genomic profiling.

    Focused on innovation, Illumina has consistently delivered high-quality products that support both research and clinical applications, reinforcing its position as a market leader. The company's strength lies in its ability to provide scalable and cost-effective sequencing solutions, which have gained widespread adoption among laboratories and healthcare providers across the United States.

    Illumina's collaborations with academic and clinical institutions further enhance its market presence and facilitate the development of tailored biomarker tests for various diseases. The integration of its technologies into clinical workflows has streamlined the process of biomarker discovery, positioning Illumina favorably within the competitive landscape of the biomarker testing arena.

    Exact Sciences is another key player in the US Biomarker Test Market, primarily known for its focus on cancer diagnostics. The company offers a suite of innovative tests, most notably in colorectal cancer screening, utilizing advanced molecular techniques for accurate detection. Exact Sciences' strength lies in its commitment to improving patient outcomes through early detection and intervention.

    With a strong presence in the US, the company has forged strategic partnerships and acquisitions to expand its test menu and enhance its capabilities. These mergers and acquisitions have not only bolstered its technological expertise but have also allowed Exact Sciences to leverage synergies that can lead to the development of novel biomarker tests. Their continual investment in research and development positions them well to capitalize on emerging trends in the biomarker testing landscape, solidifying their role as a competitive force within the market.

    Key Companies in the US Biomarker Test Market market include

    Industry Developments

    The US Biomarker Test Market has seen significant developments, particularly in the areas of product innovation and corporate activities. Illumina announced advancements in gene sequencing technology in September 2023, improving accuracy and accessibility for clinical applications. Exact Sciences launched a new colorectal cancer screening test in August 2023, aimed at enhancing early detection.

    Current affairs highlight ongoing collaborations, such as Bristol Myers Squibb's partnership with Sensei Health to integrate AI in oncology, which is enhancing the personalization of treatment. In terms of mergers and acquisitions, Roche Diagnostics completed its acquisition of GenMark Diagnostics in May 2021, enhancing its molecular testing capabilities.

    Myriad Genetics acquired the assets of a small diagnostics company in April 2023, broadening its genetic testing offerings. Growth in the market valuation of key players like Thermo Fisher Scientific and Labcorp has been noteworthy, with a reported increase in demand for comprehensive biomarker tests, spurred by rising investments in Research and Development. Collectively, these developments indicate a robust US Biomarker Test Market, characterized by innovation and strategic business maneuvers, driving the future of precision medicine.

    Market Segmentation

    Biomarker Test Market End Use Outlook

    • Hospitals
    • Clinical Laboratories
    • Research Institutions
    • Pharmaceutical Companies

    Biomarker Test Market Technology Outlook

    • Polymerase Chain Reaction
    • Mass Spectrometry
    • Immunoassays
    • Next-Generation Sequencing

    Biomarker Test Market Application Outlook

    • Oncology
    • Cardiovascular
    • Neurology
    • Infectious Diseases
    • Metabolic Diseases

    Biomarker Test Market Type of Test Outlook

    • Genetic Tests
    • Proteomic Tests
    • Metabolomic Tests
    • Microbiomic Tests

    Report Scope

    Report Scope:
    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 8.4(USD Billion)
    MARKET SIZE 2024 8.77(USD Billion)
    MARKET SIZE 2035 14.5(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 4.677% (2025 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    MARKET FORECAST PERIOD 2025 - 2035
    HISTORICAL DATA 2019 - 2024
    MARKET FORECAST UNITS USD Billion
    KEY COMPANIES PROFILED Illumina, Exact Sciences, Bristol Myers Squibb, Sensei Health, Roche Diagnostics, Genomic Health, Myriad Genetics, Abbott Laboratories, PerkinElmer, NeoGenomics, Thermo Fisher Scientific, Agilent Technologies, Invitae, Labcorp, Qiagen
    SEGMENTS COVERED Application, Type of Test, Technology, End Use
    KEY MARKET OPPORTUNITIES Personalized medicine advancements, Increased cancer diagnosis demand, Rising awareness of preventive healthcare, Growth of liquid biopsy technology, Expansion of companion diagnostics usage
    KEY MARKET DYNAMICS Rising prevalence of chronic diseases, Advancements in precision medicine, Growing investment in R&D, Increasing collaboration among stakeholders, Regulatory support for innovation
    COUNTRIES COVERED US

    FAQs

    What is the expected market size of the US Biomarker Test Market in 2024?

    The US Biomarker Test Market is expected to be valued at 8.77 billion USD in 2024.

    What will be the market value of the US Biomarker Test Market by 2035?

    By 2035, the US Biomarker Test Market is projected to reach a value of 14.5 billion USD.

    What is the anticipated compound annual growth rate (CAGR) for the US Biomarker Test Market from 2025 to 2035?

    The expected CAGR for the US Biomarker Test Market from 2025 to 2035 is 4.677%.

    Which application segment will dominate the US Biomarker Test Market in 2024?

    The Oncology application segment is expected to dominate the market, valued at 3.5 billion USD in 2024.

    What will be the value of the Cardiovascular application segment by 2035?

    The Cardiovascular application segment is projected to be valued at 3.5 billion USD by 2035.

    Who are the key players in the US Biomarker Test Market?

    Major players in the market include Illumina, Exact Sciences, Bristol Myers Squibb, and Roche Diagnostics.

    How much is the Neurology application segment expected to grow by 2035?

    The Neurology application segment is anticipated to grow to 2.5 billion USD by 2035.

    What is the projected market size for the Infectious Diseases application in 2024?

    The market size for the Infectious Diseases application is expected to be 1.2 billion USD in 2024.

    What challenges or opportunities might influence the US Biomarker Test Market?

    Emerging trends, technological advances, and a focus on personalized medicine may present both challenges and opportunities in the market.

    What is the expected market value of Metabolic Diseases segment by 2035?

    The Metabolic Diseases segment is projected to reach a value of 1.1 billion USD by 2035.

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