• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor
    Hero Background

    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

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    US Point of Care Molecular Diagnostics Market Infographic
    Purchase Options

    US Point of Care Molecular Diagnostics Market Summary

    As per MRFR analysis, the US point-of-care molecular diagnostics market size was estimated at 1312.04 USD Million in 2024. The US point of-care-molecular-diagnostics market is projected to grow from 1420.67 USD Million in 2025 to 3145.99 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 8.28% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US point-of-care molecular diagnostics market is poised for substantial growth driven by technological advancements and increasing demand for rapid testing.

    • Technological advancements are enhancing the accuracy and speed of point-of-care molecular diagnostics.
    • The largest segment in this market is the infectious disease testing segment, which continues to dominate due to rising health concerns.
    • The fastest-growing segment is personalized medicine, reflecting a shift towards tailored healthcare solutions.
    • Key market drivers include the rising prevalence of infectious diseases and a growing focus on preventive healthcare.

    Market Size & Forecast

    2024 Market Size 1312.04 (USD Million)
    2035 Market Size 3145.99 (USD Million)

    Major Players

    Abbott (US), Roche (CH), Cepheid (US), Thermo Fisher Scientific (US), Hologic (US), Qiagen (DE), BD (US), Luminex (US), GenMark Diagnostics (US)

    US Point of Care Molecular Diagnostics Market Trends

    The point of-care-molecular-diagnostics market is currently experiencing a notable transformation, driven by advancements in technology and an increasing demand for rapid testing solutions. This market is characterized by the development of innovative diagnostic tools that provide immediate results, thereby enhancing patient management and treatment decisions. The integration of molecular techniques into point-of-care settings appears to be a response to the growing need for efficient healthcare delivery, particularly in remote or underserved areas. Furthermore, the emphasis on personalized medicine is likely to propel the adoption of these diagnostic solutions, as they enable tailored treatment approaches based on individual patient profiles. In addition, regulatory support and funding initiatives from government bodies are fostering growth within the point of-care-molecular-diagnostics market. These efforts aim to streamline the approval processes for new diagnostic devices, ensuring that they meet safety and efficacy standards. As a result, manufacturers are encouraged to innovate and expand their product offerings. The convergence of technology, regulatory support, and market demand suggests a promising future for the point-of-care-molecular-diagnostics market, with potential for significant advancements in healthcare outcomes and accessibility.

    Technological Advancements

    The point of-care-molecular-diagnostics market is witnessing rapid technological innovations that enhance the accuracy and speed of diagnostic tests. New platforms are emerging that utilize advanced molecular techniques, enabling healthcare providers to obtain results in real-time. This trend is likely to improve patient outcomes by facilitating timely interventions.

    Regulatory Support

    Regulatory bodies are increasingly providing support for the development and approval of point-of-care molecular diagnostics. Streamlined processes and funding initiatives are encouraging manufacturers to bring new products to market. This trend may lead to a wider array of diagnostic options available to healthcare providers.

    Increased Demand for Rapid Testing

    There is a growing demand for rapid testing solutions within the point-of-care-molecular-diagnostics market. Healthcare providers are seeking efficient methods to diagnose conditions quickly, particularly in emergency and primary care settings. This trend indicates a shift towards more accessible and immediate healthcare solutions.

    US Point of Care Molecular Diagnostics Market Drivers

    Shift Towards Personalized Medicine

    The movement towards personalized medicine is reshaping the landscape of the point of-care-molecular-diagnostics market. As healthcare providers increasingly recognize the importance of tailoring treatments to individual patient profiles, molecular diagnostics play a crucial role in identifying specific biomarkers. This shift is supported by the growing body of evidence suggesting that personalized approaches can enhance treatment efficacy and reduce adverse effects. The market is projected to expand as more healthcare facilities adopt molecular diagnostic tools to facilitate personalized treatment plans. Furthermore, the potential for improved patient outcomes may lead to a reduction in overall healthcare costs, making this an attractive proposition for stakeholders in the point of-care-molecular-diagnostics market.

    Expansion of Home Healthcare Services

    The expansion of home healthcare services is emerging as a key driver for the point of-care-molecular-diagnostics market. With an increasing number of patients preferring to receive care in the comfort of their homes, there is a growing need for portable and user-friendly diagnostic tools. The home healthcare market in the US is projected to reach $173 billion by 2026, indicating a robust demand for point-of-care solutions. This trend suggests that the point of-care-molecular-diagnostics market will likely see increased adoption as healthcare providers develop strategies to deliver effective diagnostics outside traditional clinical settings, thereby enhancing patient convenience and accessibility.

    Growing Focus on Preventive Healthcare

    The increasing emphasis on preventive healthcare is influencing the point of-care-molecular-diagnostics market. As healthcare systems shift from reactive to proactive approaches, there is a heightened demand for diagnostic tools that can identify health issues before they escalate. This trend is reflected in the rising investments in preventive care initiatives, with the US government allocating over $1 billion annually to support preventive health programs. The point of-care-molecular-diagnostics market stands to gain from this focus, as rapid and accurate diagnostics enable early detection and intervention, ultimately leading to better health outcomes and reduced healthcare costs.

    Technological Integration in Healthcare

    The integration of advanced technologies into healthcare systems is a significant driver for the point of-care-molecular-diagnostics market. Innovations such as artificial intelligence (AI) and machine learning are enhancing the capabilities of diagnostic tools, enabling faster and more accurate results. The US healthcare sector is increasingly investing in these technologies, with expenditures on health IT projected to reach $280 billion by 2025. This technological evolution not only improves diagnostic accuracy but also streamlines workflows in clinical settings. As healthcare providers seek to optimize their operations and enhance patient care, the point of-care-molecular-diagnostics market is likely to experience substantial growth driven by these technological advancements.

    Rising Prevalence of Infectious Diseases

    The increasing incidence of infectious diseases in the US is a primary driver for the point of-care-molecular-diagnostics market. As healthcare providers seek rapid and accurate diagnostic solutions, the demand for molecular diagnostics is expected to rise. According to the Centers for Disease Control and Prevention (CDC), infectious diseases account for a significant portion of healthcare expenditures, with costs exceeding $120 billion annually. This trend indicates a growing need for effective diagnostic tools that can provide timely results, thereby facilitating prompt treatment decisions. The point of-care-molecular-diagnostics market is likely to benefit from this rising prevalence, as healthcare systems prioritize the implementation of advanced diagnostic technologies to improve patient outcomes.

    Market Segment Insights

    By Type: PCR Tests (Largest) vs. Nucleic Acid Amplification Tests (Fastest-Growing)

    In the US point-of-care-molecular-diagnostics market, PCR Tests hold the largest market share, reflecting their established presence in various medical applications. With a robust demand driven by the need for accurate disease detection, PCR Tests continue to dominate the market landscape, capturing the attention of healthcare providers and patients alike. On the other hand, Nucleic Acid Amplification Tests, though smaller in proportion, are witnessing rapid growth, showcasing an increasing acceptance among clinicians due to their versatility in diagnosing different pathogens. The growth trends in this segment are propelled by technological advancements and expanded applications of molecular diagnostics in infectious diseases, oncology, and genetic testing. The surge in demand for rapid testing solutions, combined with the need for precise and swift analysis, has positioned Nucleic Acid Amplification Tests as a crucial player for the future. Additionally, the ongoing research and innovations in molecular techniques are expected to further enhance the efficacy and reach of both PCR Tests and Nucleic Acid Amplification Tests in the evolving healthcare landscape.

    Testing: PCR (Dominant) vs. Microarray (Emerging)

    PCR Tests are characterized by their proven efficiency in amplifying DNA segments, making them vital in the diagnosis of infectious diseases and genetic disorders. Their long-standing presence establishes them as a trusted option among healthcare providers, thus maintaining a dominant position in the market. In contrast, Microarray technology, as an emerging solution, offers broader applications in genomics and personalized medicine, allowing for simultaneous analysis of multiple genetic sequences, which is becoming increasingly valued in modern diagnostics. The flexibility and capability of Microarray tests to provide comprehensive insights into genetic information make them a promising area for growth in the US point-of-care-molecular-diagnostics market.

    By Application: Infectious Diseases (Largest) vs. Genetic Testing (Fastest-Growing)

    In the US point of-care-molecular-diagnostics market, Infectious Diseases hold the largest share, proving essential in providing rapid and accurate diagnoses for various infections. This segment spans a wide array of tests catering to bacterial, viral, and parasitic diseases, making it a critical component of public health initiatives. Genetic Testing follows closely behind, emerging rapidly due to increased awareness and demand for personalized medicine. The segment is gaining traction in both clinical and home testing settings, highlighting a shift towards decentralized healthcare solutions. Growth trends in the US point of-care-molecular-diagnostics market are driven by technological advancements and the ongoing COVID-19 pandemic, which has accelerated the adoption of molecular diagnostics across all applications. Additionally, the rising prevalence of chronic diseases, coupled with a growing aging population, is propelling the demand for Cancer Diagnosis and Metabolic Disorders testing. Moreover, innovative product developments and strategic partnerships among key players are facilitating faster market entry and expansion in this dynamic landscape.

    Infectious Diseases (Dominant) vs. Genetic Testing (Emerging)

    Infectious Diseases represent a dominant segment within the US point of-care-molecular-diagnostics market, characterized by a diverse range of tests that provide immediate results for critical conditions. This segment benefits from high demand in both hospital settings and telehealth services due to the need for timely diagnosis and treatment of infections. Meanwhile, Genetic Testing is considered an emerging segment, rapidly evolving with advancements in genomics and biotechnology. It focuses on identifying genetic predispositions and is increasingly integrated into routine healthcare, fostering targeted therapies and preventive healthcare strategies. As these two segments evolve, they reflect the overall trend towards personalized, efficient, and accessible healthcare solutions.

    By End Use: Hospitals (Largest) vs. Home Care Settings (Fastest-Growing)

    The distribution of market share among the end-use segments reveals that hospitals currently hold the largest share, reflecting their significant role in patient care and diagnosis. Diagnostic laboratories also contribute substantially, benefitting from increased demands for accurate and timely diagnostics. Outpatient clinics, while smaller, are becoming more relevant as they adapt to emerging trends, though home care settings are rapidly gaining traction due to their rising preference among patients seeking convenience and immediate access to diagnostics. Growth trends in the US point of-care-molecular-diagnostics market indicate a strong shift towards home care settings. This is driven by advancements in technology and an increasing emphasis on personalized medicine. Additionally, the aging population and the desire for cost-effective healthcare solutions encourage the emergence of home care as a vital segment, with innovations in diagnostic tools enabling patients to obtain results quickly and accurately from the comfort of their homes.

    Hospitals (Dominant) vs. Home Care Settings (Emerging)

    Hospitals remain the dominant player in the end-use segment, characterized by their extensive infrastructure, access to advanced diagnostic technologies, and the ability to provide comprehensive patient care. They invest heavily in molecular diagnostics to enhance patient outcomes, driving high volumes of testing across various medical departments. In contrast, home care settings are emerging rapidly, appealing to patients who prefer at-home testing for convenience and safety reasons. The growth in this area is bolstered by technological advancements that have made home testing reliable and efficient. As home care settings evolve, they are expected to capture a larger share of the market, catering to the preferences of patients and healthcare providers alike.

    By Technology: Isothermal Amplification (Largest) vs. CRISPR Technology (Fastest-Growing)

    In the US point of-care-molecular-diagnostics market, Isothermal Amplification holds the largest share due to its rapid testing capabilities and ease of use, allowing for quick diagnosis without the complex setup of traditional methods. In contrast, CRISPR Technology, while currently a smaller segment, is gaining traction rapidly as it offers unprecedented precision and speed in diagnostics, appealing significantly to healthcare providers seeking innovative solutions. Growth trends in this market are being driven by increasing demand for rapid and accurate diagnostics, particularly in the context of infectious diseases. The shift towards personalized medicine and advancements in technology are further propelling the growth of segments like CRISPR, which is seen as a transformative approach in diagnostics. Additionally, rising investments in R&D are expected to enhance the capabilities of both Isothermal Amplification and CRISPR Technology, consolidating their positions in the market.

    Technology: Isothermal Amplification (Dominant) vs. CRISPR Technology (Emerging)

    Isothermal Amplification is the dominant technology in the US point of-care-molecular-diagnostics market, favored for its ability to deliver rapid results without the need for thermal cycling. Its user-friendliness and efficiency in various settings, including remote areas, make it an essential tool for clinicians. On the other hand, CRISPR Technology represents an emerging force with its precise gene editing capabilities, which are revolutionizing molecular diagnostics. The potential for CRISPR to enhance the specificity and sensitivity of tests is drawing significant interest and investment, positioning it as a game changer despite its current nascent stage in the market.

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

    Key Players and Competitive Insights

    The point-of-care molecular diagnostics market is characterized by a dynamic competitive landscape, driven by technological advancements and an increasing demand for rapid diagnostic solutions. Key players such as Abbott (US), Roche (CH), and Cepheid (US) are strategically positioned to leverage innovation and partnerships to enhance their market presence. Abbott (US) focuses on expanding its product portfolio through continuous innovation, while Roche (CH) emphasizes strategic collaborations to enhance its diagnostic capabilities. Cepheid (US) is known for its rapid testing solutions, which are critical in addressing urgent healthcare needs, thereby shaping a competitive environment that prioritizes speed and accuracy in diagnostics.

    In terms of business tactics, companies are increasingly localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness to market demands. The market structure appears moderately fragmented, with several key players exerting influence through their innovative offerings and strategic initiatives. This fragmentation allows for a diverse range of products and services, catering to various healthcare settings and patient needs.

    In October 2025, Abbott (US) announced the launch of a new point-of-care molecular diagnostic device aimed at improving the detection of infectious diseases. This strategic move is significant as it not only expands Abbott's product line but also reinforces its commitment to providing timely diagnostic solutions in a rapidly evolving healthcare landscape. The introduction of this device is expected to enhance patient outcomes by facilitating quicker clinical decisions.

    In September 2025, Roche (CH) entered into a partnership with a leading telehealth provider to integrate its molecular diagnostic solutions into remote healthcare services. This collaboration is pivotal as it aligns with the growing trend of telemedicine, allowing Roche to reach a broader patient base and enhance accessibility to its diagnostic tools. The integration of molecular diagnostics into telehealth platforms may significantly improve patient management and monitoring.

    In August 2025, Cepheid (US) launched a new software update for its GeneXpert system, enhancing its data analytics capabilities. This update is crucial as it allows healthcare providers to better interpret diagnostic results and make informed decisions. The emphasis on data analytics reflects a broader trend in the industry towards leveraging technology to improve diagnostic accuracy and patient care.

    As of November 2025, current competitive trends in the point-of-care molecular diagnostics market include a strong focus on digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to drive innovation. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, innovative solutions, and reliable supply chains, underscoring the importance of agility and responsiveness in meeting healthcare demands.

    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.

    Future Outlook

    US Point of Care Molecular Diagnostics Market Future Outlook

    The point of-care-molecular-diagnostics market is projected to grow at 8.28% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for rapid testing, and rising healthcare expenditure.

    New opportunities lie in:

    • Development of portable diagnostic devices for remote patient testing.
    • Integration of AI algorithms for enhanced diagnostic accuracy.
    • Expansion of telehealth services incorporating molecular diagnostics.

    By 2035, the market is expected to achieve substantial growth, driven by innovation and increased accessibility.

    Market Segmentation

    US Point of Care Molecular Diagnostics Market Type Outlook

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

    US Point of Care Molecular Diagnostics Market End Use Outlook

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

    US Point of Care Molecular Diagnostics Market Technology Outlook

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

    US Point of Care Molecular Diagnostics Market Application Outlook

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

    Report Scope

    MARKET SIZE 2024 1312.04(USD Million)
    MARKET SIZE 2025 1420.67(USD Million)
    MARKET SIZE 2035 3145.99(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 8.28% (2024 - 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 Million
    Key Companies Profiled Abbott (US), Roche (CH), Cepheid (US), Thermo Fisher Scientific (US), Hologic (US), Qiagen (DE), BD (US), Luminex (US), GenMark Diagnostics (US)
    Segments Covered Type, Application, End Use, Technology
    Key Market Opportunities Integration of advanced technologies enhances rapid testing capabilities in the point of-care-molecular-diagnostics market.
    Key Market Dynamics Technological advancements drive rapid adoption of point-of-care molecular diagnostics, enhancing patient outcomes and healthcare efficiency.
    Countries Covered US

    Leave a Comment

    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.

    Download Free Sample

    Kindly complete the form below to receive a free sample of this Report

    Case Study
    Chemicals and Materials

    Compare Licence

    ×
    Features License Type
    Single User Multiuser License Enterprise User
    Price $4,950 $5,950 $7,250
    Maximum User Access Limit 1 User Upto 10 Users Unrestricted Access Throughout the Organization
    Free Customization
    Direct Access to Analyst
    Deliverable Format
    Platform Access
    Discount on Next Purchase 10% 15% 15%
    Printable Versions