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    US HIV Diagnostics Market

    ID: MRFR/Pharma/15130-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US HIV Diagnostics Market Research Report By Test Type (Antibody Tests, Antigen Tests, Nucleic Acid Tests), By End User (Hospitals, Diagnostic Laboratories, Home Care Settings), By Product Type (Tests Kits, Instruments, Software) and By Technology (Elisa, Rapid Testing, Polymerase Chain Reaction) - Forecast to 2035

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    US HIV Diagnostics Market Infographic
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    US HIV Diagnostics Market Summary

    The US HIV Diagnostics market is projected to grow from 774.2 million USD in 2024 to 1249.5 million USD by 2035.

    Key Market Trends & Highlights

    US HIV Diagnostics Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate of 4.45 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 1249.5 million USD, indicating robust growth.
    • In 2024, the market is valued at 774.2 million USD, reflecting a strong foundation for future expansion.
    • Growing adoption of advanced diagnostic technologies due to increasing awareness and early detection initiatives is a major market driver.

    Market Size & Forecast

    2024 Market Size 774.2 (USD Million)
    2035 Market Size 1249.5 (USD Million)
    CAGR (2025-2035) 4.45%

    Major Players

    Diagnostics for All, Hologic, Quidel Corporation, BioRad Laboratories, Roche Holding, Grifols, Abbott Laboratories, Snap Diagnostics, Beckman Coulter, Thermo Fisher Scientific, Cepheid, Siemens Healthineers, Ortho Clinical Diagnostics, Becton Dickinson

    Market Segment Insights

    HIV Diagnostics Market Test Type Insights

    The US HIV Diagnostics Market, particularly focusing on the Test Type segment, plays a critical role in the healthcare landscape. The market is primarily characterized by three main testing methodologies Antibody Tests, Antigen Tests, and Nucleic Acid Tests. Each of these tests has unique functionality and significance in diagnosing HIV, shaping the diagnostic landscape.

    Antibody Tests are widely utilized, as they measure the body's immune response to HIV, showcasing their importance in large-scale screening programs due to their ease of use and cost-effectiveness, thus facilitating early diagnosis. On the other hand, Antigen Tests provide the advantage of detecting viral proteins in the early stages of HIV infection, making them vital in acute diagnosis.

    They are increasingly gaining traction among healthcare providers aiming for prompt treatment initiation. Nucleic Acid Tests stand out for their ability to identify HIV at very low levels, proving significant, especially in high-risk populations where early interventions can dramatically improve health outcomes. This Test Type segmentation reflects a variety of healthcare needs, driven by factors such as rising infection rates and the push for widespread testing.

    The importance of early detection is amplified by the Centers for Disease Control and Prevention statistics showing that about 1.2 million people in the U.S. are living with HIV, with nearly 13% unaware of their infection. This highlights a crucial opportunity for enhancing testing methods and accessibility across diverse populations. Consequently, the overall growth in the US HIV Diagnostics Market is driven by the demand for accurate and timely diagnostic tests that cater to a variety of clinical scenarios and patient needs, fostering a comprehensive approach to HIV management and care.

    With ongoing advancements in technology and increasing public health awareness, the Test Type segment is projected to continue evolving, making significant contributions to the overall efficacy of HIV diagnosis in the United States.

    HIV Diagnostics Market End User Insights

    The End User segment of the US HIV Diagnostics Market plays a crucial role in the delivery of essential healthcare services. Hospitals are significant players, providing comprehensive HIV testing and management services, which are vital for early diagnosis and treatment. These facilities possess the necessary infrastructure, trained personnel, and state-of-the-art technology to support accurate testing and patient care.

    Diagnostic Laboratories also hold a considerable position in the US HIV Diagnostics Market, as they specialize in performing a wide range of laboratory tests, enhancing the efficiency and accuracy of HIV diagnostics. Their ability to provide rapid testing solutions meets the increasing demand for timely results. Furthermore, Home Care Settings are gaining traction, particularly in the wake of the COVID-19 pandemic, as they provide a convenient and accessible means for individuals to receive testing in the comfort of their homes.

    This shift is driven by an increase in awareness and acceptance of HIV testing, underscoring the importance of these settings in promoting public health. Overall, the US HIV Diagnostics Market segmentation illustrates a multi-faceted approach to addressing HIV testing needs across diverse environments, encouraging early detection and reducing transmission rates.

    HIV Diagnostics Market Product Type Insights

    The US HIV Diagnostics Market, particularly in the realm of Product Type, comprises critical components such as Test Kits, Instruments, and Software, each holding significant importance in the ongoing battle against HIV. Test Kits dominate the landscape due to their wide application in both professional and at-home testing, facilitating early diagnosis and timely treatment.

    Instruments play a vital role in enhancing the accuracy and efficiency of diagnostic procedures, contributing to the reliability of results in clinical settings. Meanwhile, Software is increasingly pivotal in streamlining data management, ensuring compliance, and enabling integration with health information systems, which is essential for tracking and reporting HIV-related data effectively.

    The ongoing trend emphasizing preventive healthcare and rapid testing solutions further fuels the demand across these product types, allowing for improved patient outcomes and public health strategies. The market is influenced by growth drivers including increasing healthcare awareness and rising government initiatives aimed at reducing HIV transmission rates in the US.

    Challenges such as regulatory hurdles and the need for continuous innovation in testing methodologies remain prevalent, but the evolution toward more advanced diagnostic technologies offers numerous opportunities to innovate within the market.

    HIV Diagnostics Market Technology Insights

    The Technology segment of the US HIV Diagnostics Market plays a critical role in enhancing the accuracy and speed of HIV detection. Among its components, Enzyme-Linked Immunosorbent Assay (ELISA) serves as a foundational method for diagnosing HIV infections, primarily due to its high sensitivity and reliability, establishing it as a key player in routine screenings.

    Rapid Testing, on the other hand, has gained substantial importance in the US healthcare system as it allows for immediate results and facilitates timely treatment decisions, which is essential in controlling the spread of HIV. Moreover, Polymerase Chain Reaction (PCR) technology is significant for its capacity to detect viral RNA, making it indispensable in monitoring viral loads and diagnosing acute infections.

    These advancements contribute to ongoing initiatives aimed at increasing testing accessibility across diverse populations in the US, addressing both public health needs and the growing demand for innovative diagnostic solutions. Notably, the integration of these technologies is essential in facilitating early HIV detection and treatment engagement, ultimately aiming to reduce transmission rates and improve health outcomes in affected communities.

    Get more detailed insights about US HIV Diagnostics Market

    Key Players and Competitive Insights

    The competitive landscape of the US HIV diagnostics market is marked by continuous innovation and strategic developments aimed at improving detection, monitoring, and prevention of HIV. With increasing awareness about HIV testing and diagnosis, a variety of diagnostic methods have been introduced, including rapid tests, viral load assays, and point-of-care testing solutions.

    As market players strive for a competitive edge, factors such as accuracy, reliability, speed of results, and ease of use play a significant role in influencing physician and patient choices. The emphasis on early diagnosis and access to treatment has pushed companies to invest in advanced technologies, enhancing the capabilities of diagnostic solutions tailored to meet the unique needs of healthcare providers and patients alike.

    Diagnostics for All is recognized as a player actively seeking to establish a strong presence within the US HIV diagnostics market through its innovative and accessible solutions. The company focuses on developing diagnostics that not only provide accurate results but are also cost-effective and easy to use in various healthcare settings.

    Their strengths lie in their commitment to making diagnostic testing available to underserved populations, thereby contributing to increased testing rates and improved health outcomes. By being dedicated to research and development, Diagnostics for All has built a reputation for enhancing public health awareness about HIV, driving awareness for the importance of regular testing, and aligning with initiatives aiming for the elimination of HIV transmission in the longer term.

    Hologic stands out in the US HIV diagnostics market with a comprehensive portfolio that includes leading-edge technologies for HIV diagnostics. Hologic's key products and services encompass a range of molecular and immunoassay testing solutions designed for accurate detection of HIV infections. Their robust market presence is complemented by strategic partnerships, mergers, and acquisitions aimed at expanding their technological capabilities and market reach.

    Through these efforts, Hologic has fortified its standing in the industry, leveraging advanced platforms and strong distribution networks to broaden their accessibility in both clinical and laboratory settings. The company's focus on innovation supports their goal of improving patient care and outcomes, solidifying their role as a significant contributor to the ongoing fight against HIV in the United States.

    Key Companies in the US HIV Diagnostics Market market include

    Industry Developments

    The US HIV Diagnostics Market has witnessed various developments recently, with companies like Abbott Laboratories and Roche Holding focusing on enhancing testing technologies and ensuring broader accessibility. Notably, Abbott Laboratories launched its new HIV test in September 2023, designed to increase diagnosis rates, particularly among underserved populations. In addition, BioRad Laboratories has been working on innovative solutions to improve laboratory testing efficiency.

    The market has experienced significant growth, with valuations of enterprises like Hologic and Quidel Corporation showing robust upward trends due to increased federal funding for HIV testing initiatives. There were no recent mergers or acquisitions reported among key players in the US HIV Diagnostics Market.

    In the last two to three years, significant advancements, such as the FDA's approval of rapid testing devices, have shaped the market dynamics, encouraging competitive innovation among major players like Grifols and Siemens Healthineers. As the government continues to emphasize HIV awareness and testing, the overall landscape remains optimistic, reflecting an ongoing commitment to eradicating the epidemic by improving diagnostic capabilities across the United States.

    Market Segmentation

    HIV Diagnostics Market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Home Care Settings

    HIV Diagnostics Market Test Type Outlook

    • Antibody Tests
    • Antigen Tests
    • Nucleic Acid Tests

    HIV Diagnostics Market Technology Outlook

    • Elisa
    • Rapid Testing
    • Polymerase Chain Reaction

    HIV Diagnostics Market Product Type Outlook

    • Tests Kits
    • Instruments
    • Software

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 744.06(USD Million)
    MARKET SIZE 2024 774.2(USD Million)
    MARKET SIZE 2035 1249.5(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 4.448% (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 Million
    KEY COMPANIES PROFILED Diagnostics for All, Hologic, Quidel Corporation, BioRad Laboratories, Roche Holding, Grifols, Abbott Laboratories, Snap Diagnostics, Beckman Coulter, Thermo Fisher Scientific, Cepheid, Siemens Healthineers, Ortho Clinical Diagnostics, Becton Dickinson
    SEGMENTS COVERED Test Type, End User, Product Type, Technology
    KEY MARKET OPPORTUNITIES Point-of-care testing advancements, Increased telehealth integration, Emerging self-testing kits, Focus on preventive diagnostics, Enhanced partnerships with community organizations
    KEY MARKET DYNAMICS Growing prevalence of HIV, Advancements in diagnostic technologies, Increased funding for HIV programs, Rising demand for rapid testing, Government initiatives for early detection
    COUNTRIES COVERED US

    FAQs

    What is the projected market size of the US HIV Diagnostics Market in 2024?

    The US HIV Diagnostics Market is projected to be valued at 774.2 million USD in 2024.

    What is the expected market size in 2035?

    By 2035, the US HIV Diagnostics Market is expected to reach a valuation of 1249.5 million USD.

    What is the expected CAGR for the US HIV Diagnostics Market from 2025 to 2035?

    The expected CAGR for the US HIV Diagnostics Market from 2025 to 2035 is 4.448%.

    Which test type segment is projected to have the highest market value in 2035?

    The Antibody Tests segment is projected to be valued at 400.0 million USD in 2035.

    What is the expected market value for Nucleic Acid Tests in 2024?

    In 2024, the market value for Nucleic Acid Tests is expected to be 284.2 million USD.

    Who are the major players in the US HIV Diagnostics Market?

    Some of the major players include Abbott Laboratories, Roche Holding, and Hologic.

    What is the projected market value for Antigen Tests in 2035?

    The projected market value for Antigen Tests in 2035 is 400.0 million USD.

    How much is the Antibody Tests segment valued at in 2024?

    The Antibody Tests segment is valued at 250.0 million USD in 2024.

    What challenges are currently faced by the US HIV Diagnostics Market?

    Current challenges include regulatory hurdles and the need for extensive awareness and education.

    What growth opportunities exist within the US HIV Diagnostics Market?

    Growth opportunities are present in technological advancements and increasing demand for rapid and accurate diagnostics.

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