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    US Rapid Diagnostics Market

    ID: MRFR/MED/15211-HCR
    200 Pages
    Rahul Gotadki
    September 2025

    US Rapid Diagnostics Market Research Report By Application (Blood Glucose Testing, Infectious Disease Testing, Cardiometabolic Testing, Pregnancy & Fertility Testing, Fecal Occult Blood Testing, Coagulation Testing, Toxicology Testing) and By Product Type (Over the Counter (OTC) Kits, Professional Kits) - Forecast to 2035

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    US Rapid Diagnostics Market Summary

    The US Rapid Diagnostics market is projected to grow from 5.2 USD Billion in 2024 to 12.5 USD Billion by 2035, indicating a robust expansion trajectory.

    Key Market Trends & Highlights

    US Rapid Diagnostics Key Trends and Highlights

    • The market is anticipated to experience a compound annual growth rate of 8.3 percent from 2025 to 2035.
    • By 2035, the market valuation is expected to reach 12.5 USD Billion, reflecting substantial growth potential.
    • In 2024, the market is valued at 5.2 USD Billion, laying a strong foundation for future expansion.
    • Growing adoption of rapid testing technologies due to increasing demand for timely diagnostics is a major market driver.

    Market Size & Forecast

    2024 Market Size 5.2 (USD Billion)
    2035 Market Size 12.5 (USD Billion)
    CAGR (2025-2035) 8.3%

    Major Players

    Danaher Corporation, Quidel Corporation, Hologic, bioMerieux, Roche Diagnostics, Abbott Laboratories, BD (Becton, Dickinson and Company), PerkinElmer, Thermo Fisher Scientific, Cepheid, TestAmericas, Siemens Healthineers, Arbor Vita Corporation, OraSure Technologies

    US Rapid Diagnostics Market Trends

    The US Rapid Diagnostics Market is being shaped by several noteworthy trends that reflect advancements in technology and shifts in healthcare practices. A significant trend is the increasing demand for rapid testing solutions that can provide immediate results, driven by a need for faster clinical decision-making.

    The COVID-19 pandemic has significantly accelerated the adoption of rapid diagnostics, especially for infectious diseases like influenza and strep throat, fueling interest from both healthcare providers and consumers. This urgent need for timely diagnoses emphasizes the importance of rapid tests in public health systems, showcased by initiatives from the Centers for Disease Control and Prevention (CDC).

    Key market drivers include the growing awareness about early disease detection and the need for home-based diagnostic solutions, which have been further promoted by healthcare policies aiming to improve accessibility and affordability. Regulatory approvals have streamlined the process for new rapid diagnostic tests, encouraging innovation in product development.

    Additionally, the push for personalized medicine and point-of-care testing has created opportunities for manufacturers to explore novel methodologies. Emerging opportunities lie in the expansion of rapid diagnostic applications beyond infectious diseases, such as chronic disease management and personalized healthcare.

    Manufacturers can also capture opportunities by integrating digital health technologies, allowing for better data management and patient engagement. Trends such as increased partnerships between technology firms and healthcare organizations can enhance the reach of rapid diagnostics, supporting advancements in telehealth and remote monitoring.

    Ultimately, these trends signal a transformative period for the US Rapid Diagnostics Market, aligning with healthcare's broader goals of efficiency and effectiveness in patient care.

    Market Segment Insights

    Rapid Diagnostics Market Application Insights

    The Application segment of the US Rapid Diagnostics Market plays a crucial role in enhancing healthcare outcomes through timely and accurate testing solutions. This segment includes various applications such as Blood Glucose Testing, Infectious Disease Testing, Cardiometabolic Testing, Pregnancy and Fertility Testing, Fecal Occult Blood Testing, Coagulation Testing, and Toxicology Testing.

    Blood Glucose Testing is particularly significant due to the increasing prevalence of diabetes in the US, which necessitates regular monitoring and has created demand for user-friendly and reliable testing devices. Infectious Disease Testing remains a priority, especially in light of global health challenges, driving innovations in point-of-care testing and rapid results that significantly enhance patient management.

    Cardiometabolic Testing is gaining traction as more emphasis is placed on heart health and the increased incidence of cardiovascular diseases, promoting preventive care and early intervention strategies. Pregnancy and Fertility Testing solutions are critical for family planning, with advancements in at-home testing contributing to their popularity, allowing individuals to track health status with ease.

    Fecal Occult Blood Testing is vital for early detection of colorectal cancer, influencing screening practices and impacting overall public health initiatives aimed at reducing cancer mortality rates. In addition, Coagulation Testing is essential for monitoring patients on anticoagulants, ensuring safety and efficacy in treatment, while Toxicology Testing plays an increasingly important role in substance abuse screening and workplace health assessments.

    Overall, these applications represent a dynamic and evolving facet of the US Rapid Diagnostics Market, addressing diverse healthcare needs and contributing to improved patient outcomes through accessible diagnostics.

    Rapid Diagnostics Market Product Type Insights

    The US Rapid Diagnostics Market exhibits significant growth within its Product Type segment, primarily driven by the increasing demand for efficient and timely diagnostic solutions. Over the Counter (OTC) Kits have emerged as a crucial component in this landscape, enabling consumers to perform tests in the comfort of their homes, thus enhancing accessibility and convenience in healthcare.

    This trend reflects a growing consumer preference for self-diagnosis and proactive health management. Conversely, Professional Kits, utilized predominantly in clinical settings, remain essential for healthcare professionals who require accurate and rapid test results to inform patient care.

    These professional solutions often dominate in terms of reliability and comprehensive testing capabilities, catering to a wide spectrum of applications, including infectious diseases and chronic conditions. As a result, the US Rapid Diagnostics Market segmentation highlights diverse opportunities and growth drivers, including technological advancements in testing methodologies, increased public health awareness, and a focus on preventive care.

    Moreover, the ongoing challenges posed by emerging health threats underscore the necessity for rapid diagnostic solutions in both home and professional environments, thereby strengthening the market's trajectory.

    Get more detailed insights about US Rapid Diagnostics Market Research Report- Forecast to 2035

    Key Players and Competitive Insights

    The US Rapid Diagnostics Market is characterized by a dynamic competitive landscape, driven by a growing demand for quick and reliable diagnostic tests across various healthcare settings. The market has seen significant advancements in technology, with many players developing innovative solutions to improve speed, accuracy, and efficiency in diagnostics.

    As healthcare systems increasingly prioritize rapid results to enhance patient outcomes, the competition among manufacturers intensifies. Industry leaders are engaged in continuous research and development initiatives, aiming to expand their product portfolios and capitalize on emerging trends such as point-of-care testing and at-home diagnostics.

    The increasing prevalence of infectious diseases and the recent global health crises have further catalyzed the demand for rapid diagnostic solutions, prompting companies to enhance their capabilities and market reach.

    Danaher Corporation has established a strong presence in the US Rapid Diagnostics Market, attributed to its diversified portfolio of advanced diagnostics technologies and platforms that cater to various applications. The company's focus on innovation has enabled it to maintain a competitive edge, as it consistently invests in research and development to enhance its offerings.

    Through strategic collaborations and partnerships, Danaher has expanded its market footprint, allowing it to deliver integrated solutions that meet the evolving needs of healthcare providers. Its commitment to quality and efficiency in product development, along with a strong brand reputation, has positioned Danaher favorably within the competitive landscape.

    The company's strengths lie in its exceptional technical expertise and ability to adapt to changing market dynamics, ensuring sustained growth and relevance in the rapidly evolving diagnostics sector.

    Quidel Corporation displays a formidable presence in the US Rapid Diagnostics Market, particularly known for its advancements in point-of-care rapid testing solutions. The company’s portfolio features a range of key products, including rapid immunoassays and molecular diagnostics tailored to infectious disease testing.

    Quidel's extensive market presence is reinforced by its focus on developing innovative tests that provide quick and accurate results, contributing to timely patient care. The firm has successfully capitalized on opportunities through strategic mergers and acquisitions, enhancing its product offerings and expanding its operational capabilities.

    Quidel’s strengths include its commitment to high-quality testing solutions, strong distribution networks, and the ability to respond swiftly to public health needs, which has proven particularly vital in addressing outbreaks and urgent health concerns within the US market. Its dedication to research and continuous product innovation positions Quidel as a key player in the competitive landscape of rapid diagnostics.

    Key Companies in the US Rapid Diagnostics Market market include

    Industry Developments

    In recent months, the US Rapid Diagnostics Market has experienced notable advancements and developments. Danaher Corporation has expanded its portfolio by enhancing diagnostic capabilities through strategic partnerships and innovative product launches. Quidel Corporation has introduced new rapid test kits for infectious diseases, reflecting an increasing demand for quick testing solutions post-pandemic.

    Hologic continues to innovate in women's health diagnostics, while bioMerieux has strengthened its position with new offerings in infectious disease testing. Roche Diagnostics and Abbott Laboratories have also contributed to market growth with novel diagnostic tools. In terms of mergers and acquisitions, BD (Becton, Dickinson and Company) announced its acquisition of a diagnostics company in July 2023, further solidifying its role in the market.

    Recent financial reports indicate substantial growth in market valuation among leading companies, positively impacting overall industry dynamics. Over the past two to three years, the market has seen significant technological progress and an increasing shift towards decentralized testing solutions, with companies like Cepheid and Thermo Fisher Scientific leading the trend.

    This evolving landscape is shaping the future of rapid diagnostics, meeting the urgent needs of healthcare providers and patients across the United States.

    Market Segmentation

    Rapid Diagnostics Market Application Outlook

    • Blood Glucose Testing
    • Infectious Disease Testing
    • Cardiometabolic Testing
    • Pregnancy & Fertility Testing
    • Fecal Occult Blood Testing
    • Coagulation Testing
    • Toxicology Testing

    Rapid Diagnostics Market Product Type Outlook

    • Over the Counter (OTC) Kits
    • Professional Kits

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 4.62(USD Billion)
    MARKET SIZE 2024 5.2(USD Billion)
    MARKET SIZE 2035 12.5(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 8.3% (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 Danaher Corporation, Quidel Corporation, Hologic, bioMerieux, Roche Diagnostics, Abbott Laboratories, BD (Becton, Dickinson and Company), PerkinElmer, Thermo Fisher Scientific, Cepheid, TestAmericas, Siemens Healthineers, Arbor Vita Corporation, OraSure Technologies
    SEGMENTS COVERED Application, Product Type
    KEY MARKET OPPORTUNITIES Point-of-care testing expansion, Telehealth integration for diagnostics, Increased demand for home testing, Growing chronic disease management, Biodefense and infectious disease focus
    KEY MARKET DYNAMICS Growing demand for point-of-care testing, Increasing prevalence of infectious diseases, Advancements in diagnostic technologies, Rising healthcare expenditure, Regulatory approvals and compliance challenges
    COUNTRIES COVERED US

    FAQs

    What was the market size of the US Rapid Diagnostics Market in 2024?

    The US Rapid Diagnostics Market was valued at 5.02 billion USD in 2024.

    What is the expected market value of the US Rapid Diagnostics Market by 2035?

    By 2035, the US Rapid Diagnostics Market is anticipated to reach a valuation of 12.5 billion USD.

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

    The expected CAGR for the US Rapid Diagnostics Market from 2025 to 2035 is 8.639%.

    Which application in the US Rapid Diagnostics Market has the highest projected value in 2024?

    In 2024, Blood Glucose Testing is projected to have the highest market value at 1.2 billion USD.

    What will be the market size of Infectious Disease Testing in the US Rapid Diagnostics Market by 2035?

    Infectious Disease Testing is expected to grow to 4.5 billion USD by 2035.

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

    Major players include Mylan, Roche Diagnostics, Abbott Laboratories, and Thermo Fisher Scientific, among others.

    What is the expected market size for Pregnancy Fertility Testing in 2024?

    Pregnancy Fertility Testing is expected to be valued at 0.7 billion USD in 2024.

    What challenges does the US Rapid Diagnostics Market face?

    Challenges include the need for continuous innovation and navigating regulatory approvals in rapid diagnostics.

    What growth drivers are influencing the US Rapid Diagnostics Market?

    Key growth drivers include the increasing prevalence of chronic diseases and a growing demand for timely diagnostic results.

    What is the market value of Cardiometabolic Testing in 2035?

    Cardiometabolic Testing is expected to reach a market size of 2.5 billion USD by 2035.

    What is the expected market size of the US Rapid Diagnostics Market in 2024?

    The US Rapid Diagnostics Market is expected to be valued at 5.2 billion USD in 2024.

    What is the projected value of the US Rapid Diagnostics Market by 2035?

    By 2035, the US Rapid Diagnostics Market is projected to be valued at 12.5 billion USD.

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

    The expected CAGR for the US Rapid Diagnostics Market from 2025 to 2035 is 8.3%.

    Which application segment is expected to hold the largest market share in 2024?

    In 2024, the Blood Glucose Testing segment is expected to hold the largest market share valued at 1.4 billion USD.

    What market value is projected for the Infectious Disease Testing application by 2035?

    The Infectious Disease Testing application is projected to have a market value of 3.9 billion USD by 2035.

    What is the estimated market value for Cardiometabolic Testing in 2024?

    The Cardiometabolic Testing segment is estimated to have a market value of 1.2 billion USD in 2024.

    How much is the Pregnancy & Fertility Testing application expected to grow by 2035?

    The Pregnancy & Fertility Testing application is expected to grow to a market value of 1.9 billion USD by 2035.

    What are some key growth drivers for the US Rapid Diagnostics Market?

    Key growth drivers for the US Rapid Diagnostics Market include increasing demand for timely diagnostics and advancements in technology.

    What is the projected value for Fecal Occult Blood Testing in 2035?

    The Fecal Occult Blood Testing application is projected to have a market value of 1.4 billion USD by 2035.

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    Customer Strories

    “I am very pleased with how market segments have been defined in a relevant way for my purposes (such as "Portable Freezers & refrigerators" and "last-mile"). In general the report is well structured. Thanks very much for your efforts.”

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