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    US Point of Care Molecular Diagnostics Market

    ID: MRFR/MED/15131-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US Point of Care Molecular Diagnostics Market Research Report By Product Type (PCR Tests, Nucleic Acid Amplification Tests, Microarray, Next-Generation Sequencing, Other Genetic Tests), By Application (Infectious Diseases, Genetic Testing, Cancer Diagnosis, Metabolic Disorders), By End Use (Hospitals, Diagnostic Laboratories, Home Care Settings, Outpatient Clinics) and By Technology (Isothermal Amplification, Polymerase Chain Reaction, Sanger Sequencing, CRISPR Technology) - Forecast to 2035

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    US Point of Care Molecular Diagnostics Market Infographic
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    US Point of Care Molecular Diagnostics Market Summary

    The US Point of Care Molecular Diagnostics market is projected to grow from 1.75 USD Billion in 2024 to 4.25 USD Billion by 2035.

    Key Market Trends & Highlights

    US Point of Care Molecular Diagnostics Key Trends and Highlights

    • The market is expected to witness a compound annual growth rate of 8.4 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 4.25 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 1.75 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of molecular diagnostics due to the increasing demand for rapid and accurate testing is a major market driver.

    Market Size & Forecast

    2024 Market Size 1.75 (USD Billion)
    2035 Market Size 4.25 (USD Billion)
    CAGR (2025-2035) 8.4%

    Major Players

    LabCorp, BioRad Laboratories, Roche Diagnostics, Point of Care Diagnostics, GenMark Diagnostics, Mayo Clinic Laboratories, Abbott Laboratories, Horizon Discovery, Thermo Fisher Scientific, Cepheid, Premier Medical Corporation, Siemens Healthineers, Quest Diagnostics, NantHealth, BD

    Market Segment Insights

    Point of Care Molecular Diagnostics Market Product Type Insights

    The 'US Point of Care Molecular Diagnostics Market' features a diverse range of product types that play crucial roles in the rapid diagnosis and management of various health conditions. Among these, PCR Tests are particularly significant due to their ability to amplify DNA and detect the presence of pathogens, making them invaluable for infectious disease diagnosis.

    Nucleic Acid Amplification Tests extend the capabilities of traditional testing by offering enhancements in sensitivity and specificity, thus increasingly becoming vital tools in clinical settings for the detection of a variety of genetic disorders and infections. Meanwhile, Microarray technology offers a high-throughput option for simultaneous analysis of thousands of genetic variants, which is particularly advantageous in research and diagnostics for complex conditions, allowing for personalized medicine approaches.

    Next-Generation Sequencing stands out given its capability to sequence entire genomes quickly and affordably, paving the way for comprehensive genetic testing and analysis. Other Genetic Tests contribute diversity to the market by addressing specific diseases or conditions that require tailored testing solutions.

    The segmentation within the 'US Point of Care Molecular Diagnostics Market' reflects both a response to technological advancements and an increasing demand for rapid, accurate, and precise diagnostic tools, ultimately enhancing patient care and health outcomes across various medical disciplines. This growth is driven by the ongoing focus on early disease detection and the necessity for targeted therapies, aligning well with trends in healthcare towards precision medicine and patient-centered approaches.

    Additionally, regulatory support and innovation in molecular diagnostic technologies are helping to propel advances within these product types, ensuring that the US remains at the forefront of this evolving industry.

    Point of Care Molecular Diagnostics Market Application Insights

    Point of Care Molecular Diagnostics Market Application Insights

    The US Point of Care Molecular Diagnostics Market is witnessing robust growth, particularly within the Application segment, which encompasses various critical areas, including Infectious Diseases, Genetic Testing, Cancer Diagnosis, and Metabolic Disorders. The rising prevalence of infectious diseases has led to a significant demand for rapid and accurate diagnostic tests, making this category a key focus in the market.

    Genetic testing is gaining importance as it enables personalized medicine approaches, crucial for effective treatment strategies in chronic conditions. Cancer diagnosis through point-of-care technologies allows for timely interventions, which is vital given the increasing cancer incidence rates in the US. Furthermore, metabolic disorders are being increasingly addressed with molecular diagnostics, as early detection can lead to better management and outcomes.

    With the growing emphasis on decentralized healthcare and the need for timely medical responses, these applications are pivotal in advancing the overall efficiency of healthcare delivery in the US. The market growth is driven not only by technological advancements but also by an increasing awareness of preventive healthcare measures and the potential for improved patient outcomes through early diagnosis.

    Point of Care Molecular Diagnostics Market End Use Insights

    The US Point of Care Molecular Diagnostics Market is experiencing substantial growth across various end-use settings, highlighting the shifting landscape in healthcare delivery. Hospitals are increasingly adopting point of care molecular diagnostics for rapid result turnaround, which is critical for timely decision-making in patient care.

    Diagnostic laboratories also play a pivotal role by integrating advanced molecular diagnostic technologies to enhance accuracy and expand testing capabilities. Home care settings have witnessed growing demand as patients prefer easy access to testing in their own environments, which fosters independence and improves monitoring of chronic conditions.

    Outpatient clinics are becoming significant players as well, utilizing point of care diagnostics to facilitate immediate patient management, reducing the need for hospital visits. This transition is driven by the increasing prevalence of infectious diseases and the rising focus on preventive healthcare practices.

    The continuous advancements in technology, coupled with a growing emphasis on value-based care, support the expansion of these settings, providing numerous opportunities for innovation and enhancing patient satisfaction within the US healthcare landscape. The increasing emphasis on personalized medicine further contributes to the sector's developmental dynamics, making these end-use categories vital in shaping the future of the US Point of Care Molecular Diagnostics Market.

    Point of Care Molecular Diagnostics Market Technology Insights

    The Technology segment of the US Point of Care Molecular Diagnostics Market plays a crucial role in shaping the healthcare landscape by offering a diverse range of innovative diagnostic solutions. Isothermal Amplification is gaining traction due to its simplicity and rapid results, making it particularly valuable in remote settings.

    Polymerase Chain Reaction (PCR) remains a cornerstone technology, well-regarded for its sensitivity and specificity, thus making it widely utilized in various clinical applications. Sanger Sequencing, though established, maintains relevance for its accuracy, particularly in research and genetic testing.

    Additionally, CRISPR Technology is emerging as a transformative tool, enabling precise editing and detection of genetic material, which carries significant implications in personalized medicine. Together, these technologies foster rapid advancements in the molecular diagnostics arena, addressing the growing demand for quick and accurate testing in the US healthcare system, responding to public health needs, and paving the way for improved patient outcomes.

    Get more detailed insights about US Point of Care Molecular Diagnostics Market

    Key Players and Competitive Insights

    The US Point of Care Molecular Diagnostics Market is characterized by a dynamic competitive landscape that is continually evolving with advancements in technology, regulatory changes, and shifts in consumer demands. As healthcare providers increasingly seek rapid and accurate diagnostic solutions to enhance patient care, leading players in the market are adapting their strategies to maintain a competitive edge.

    This market is marked by innovation, with companies investing heavily in research and development to introduce cutting-edge products that meet diverse clinical needs. With a focus on providing accessible testing solutions, players are expanding their distribution networks and collaborating with healthcare facilities to boost their market presence. Furthermore, strategic partnerships and acquisitions among key players are reshaping the competitive framework, enabling companies to leverage synergies and broaden their portfolios.

    LabCorp stands as a significant entity within the US Point of Care Molecular Diagnostics Market, boasting a formidable presence through its extensive network of laboratories and clinical facilities. The company's strengths lie in its comprehensive range of diagnostic testing services, which leverage advanced molecular technologies to deliver timely results.

    LabCorp has made substantial investments in point-of-care testing, ensuring that healthcare providers can access critical diagnostic information rapidly at the site of patient care. By focusing on quality and reliability, LabCorp maintains a strong reputation among healthcare professionals, contributing to its competitive advantage. The company’s commitment to innovation positions it favorably in the ever-evolving landscape of molecular diagnostics, allowing it to adapt to emerging trends and patient demands efficiently.

    BioRad Laboratories has established itself as a prominent player within the US Point of Care Molecular Diagnostics Market, particularly known for its innovative product offerings that include PCR testing solutions and molecular assays. The company's strengths are evident through its extensive product portfolio that caters to various healthcare settings, from hospitals to outpatient clinics.

    BioRad's emphasis on quality control and regulatory compliance enhances its reputation for reliability in diagnostic testing. The company also actively engages in strategic mergers and acquisitions, ensuring that it remains at the forefront of technological advancements and market trends. With a focus on research and development, BioRad continuously expands its capabilities, enhancing its competitive position in the U.S. market. By offering solutions that support accurate diagnostics and improve patient care, BioRad solidifies its integral role in the evolving landscape of point of care molecular diagnostics.

    Key Companies in the US Point of Care Molecular Diagnostics Market market include

    Industry Developments

    Recent developments in the US Point of Care Molecular Diagnostics Market have been significant, particularly due to the ongoing demand for rapid testing solutions amid the public health landscape. Companies such as LabCorp, Roche Diagnostics, and Abbott Laboratories have enhanced their product offerings to meet the increased need for timely diagnostic solutions.

    Additionally, GenMark Diagnostics recently received emergency use authorization for its molecular test, underscoring the continuous innovation within the sector. Current affairs indicate a trend towards consolidation in the market, with the merger of Quest Diagnostics and Premier Medical Corporation announced in September 2023, aimed at expanding testing capabilities and improving patient access to advanced diagnostics.

    In the past few years, impactful changes have occurred, such as the FDA approval of various point of care tests that streamline laboratory workflows and provide near-instant results. The financial growth of companies, supported by significant R&D investments, is driving the overall market valuation, with Thermo Fisher Scientific and Cepheid showing particularly strong expansions. Moreover, the incorporation of digital technologies in diagnostics is becoming increasingly prevalent, aligning with broader healthcare trends focused on personalized medicine and patient-centered care.

    Market Segmentation

    Point of Care Molecular Diagnostics Market End Use Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Home Care Settings
    • Outpatient Clinics

    Point of Care Molecular Diagnostics Market Technology Outlook

    • Isothermal Amplification
    • Polymerase Chain Reaction
    • Sanger Sequencing
    • CRISPR Technology

    Point of Care Molecular Diagnostics Market Application Outlook

    • Infectious Diseases
    • Genetic Testing
    • Cancer Diagnosis
    • Metabolic Disorders

    Point of Care Molecular Diagnostics Market Product Type Outlook

    • PCR Tests
    • Nucleic Acid Amplification Tests
    • Microarray
    • Next-Generation Sequencing
    • Other Genetic Tests

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 1.41(USD Billion)
    MARKET SIZE 2024 1.75(USD Billion)
    MARKET SIZE 2035 4.25(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 8.401% (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 LabCorp, BioRad Laboratories, Roche Diagnostics, Point of Care Diagnostics, GenMark Diagnostics, Mayo Clinic Laboratories, Abbott Laboratories, Horizon Discovery, Thermo Fisher Scientific, Cepheid, Premier Medical Corporation, Siemens Healthineers, Quest Diagnostics, NantHealth, BD
    SEGMENTS COVERED Product Type, Application, End Use, Technology
    KEY MARKET OPPORTUNITIES Rapid test development for infectious diseases, Integration with telehealth services, Adoption of portable diagnostic devices, Increased demand due to aging population, Regulatory support for innovative diagnostics
    KEY MARKET DYNAMICS increasing prevalence of infectious diseases, rapid result delivery, investment in personalized medicine, technological advancements in diagnostics, growing focus on home healthcare
    COUNTRIES COVERED US

    FAQs

    What is the projected market size of the US Point of Care Molecular Diagnostics Market in 2024?

    The US Point of Care Molecular Diagnostics Market is projected to be valued at 1.75 billion USD in 2024.

    What is the expected market size of the US Point of Care Molecular Diagnostics Market by 2035?

    By 2035, the market is expected to grow to an estimated value of 4.25 billion USD.

    What is the expected compound annual growth rate (CAGR) for the US Point of Care Molecular Diagnostics Market from 2025 to 2035?

    The market is anticipated to grow at a CAGR of 8.401 percent from 2025 to 2035.

    Who are the key players in the US Point of Care Molecular Diagnostics Market?

    Key players include LabCorp, BioRad Laboratories, Roche Diagnostics, and Abbott Laboratories among others.

    Which product type in the US Point of Care Molecular Diagnostics Market holds the largest value in 2024?

    The largest product type by value in 2024 is PCR Tests, which is valued at 0.45 billion USD.

    What is the market value for Nucleic Acid Amplification Tests in 2024 within the US Point of Care Molecular Diagnostics Market?

    Nucleic Acid Amplification Tests are projected to have a market value of 0.4 billion USD in 2024.

    What is the value of the Microarray product type in the US Point of Care Molecular Diagnostics Market for 2024?

    The Microarray product type is expected to be valued at 0.25 billion USD in the year 2024.

    How much is the Other Genetic Tests segment expected to grow by 2035?

    The Other Genetic Tests segment is anticipated to grow to 1.538 billion USD by 2035 from 0.35 billion USD in 2024.

    What are the primary growth drivers for the US Point of Care Molecular Diagnostics Market?

    Primary growth drivers include increased demand for rapid testing and advancements in diagnostic technology.

    What impact do current global scenarios have on the US Point of Care Molecular Diagnostics Market?

    Current global scenarios are likely to accelerate the demand for Point of Care Molecular Diagnostics due to a focus on quick and accurate health solutions.

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