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    US COVID 19 Diagnostics Market

    ID: MRFR/MED/13097-HCR
    200 Pages
    Rahul Gotadki
    October 2025

    US COVID-19 Diagnostics Market Research Report By Test Type (PCR Tests, Antigen Tests, Antibody Tests, CRISPR Tests), By End User (Hospitals, Clinics, Laboratories, Home Care), By Sample Type (Nasopharyngeal Swabs, Oropharyngeal Swabs, Saliva, Serum) and By Distribution Channel (Direct Sales, Retail Pharmacies, Online Sales) - Forecast to 2035

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    US COVID 19 Diagnostics Market Infographic
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    US COVID 19 Diagnostics Market Summary

    As per MRFR analysis, the US The COVID-19 diagnostics market size was estimated at $1940.0 million in 2024. The US covid 19-diagnostics market is projected to grow from 2015.27 $ Million in 2025 to 2950.0 $ Million by 2035, exhibiting a compound annual growth rate (CAGR) of 3.88% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US The COVID-19 diagnostics market is experiencing a transformative shift towards rapid and accessible testing solutions.

    • The rise of Point-of-Care Testing is reshaping the landscape of diagnostics, enhancing accessibility and speed.
    • Integration of Digital Health Technologies is becoming increasingly prevalent, facilitating remote monitoring and data management.
    • Regulatory adaptation is a focal point, ensuring that diagnostic solutions meet evolving public health needs.
    • Increased demand for rapid testing and government initiatives are driving market growth, particularly in the largest segment of molecular diagnostics.

    Market Size & Forecast

    2024 Market Size 1940.0 (USD Million)
    2035 Market Size 2950.0 (USD Million)

    Major Players

    Abbott Laboratories (US), Roche Diagnostics (CH), Thermo Fisher Scientific (US), Siemens Healthineers (DE), BD (Becton, Dickinson and Company) (US), Cepheid (US), Hologic (US), PerkinElmer (US)

    US COVID 19 Diagnostics Market Trends

    The COVID-19 diagnostics market is currently experiencing a dynamic evolution, driven by advancements in technology and an increasing emphasis on rapid testing solutions. The ongoing demand for efficient and accurate diagnostic tools reflects a broader trend towards personalized healthcare. As healthcare providers and patients alike seek timely results, the market is witnessing a shift towards point-of-care testing, which offers convenience and speed. This trend is likely to enhance patient outcomes and streamline healthcare processes, indicating a significant transformation in how diagnostics are approached. Moreover, the regulatory landscape is adapting to facilitate innovation within the covid 19-diagnostics market. Regulatory bodies are increasingly prioritizing the approval of novel testing methods, which may lead to a wider array of options for healthcare professionals. This evolving framework appears to support the introduction of more sophisticated technologies, such as molecular diagnostics and next-generation sequencing. As these advancements unfold, they could potentially reshape the diagnostic landscape, making it more responsive to emerging health challenges and patient needs.

    Rise of Point-of-Care Testing

    The COVID-19 diagnostics market is witnessing a notable shift towards point-of-care testing solutions. These tests provide immediate results, allowing for quicker decision-making in clinical settings. This trend is particularly relevant in emergency situations, where timely diagnosis can significantly impact patient management and treatment outcomes.

    Integration of Digital Health Technologies

    There is a growing integration of digital health technologies within the covid 19-diagnostics market. Telehealth platforms and mobile applications are being utilized to enhance patient engagement and streamline the testing process. This integration may improve accessibility to diagnostic services, particularly in remote or underserved areas.

    Focus on Regulatory Adaptation

    The regulatory environment surrounding the covid 19-diagnostics market is evolving to accommodate innovative testing solutions. Regulatory agencies are expediting the approval processes for new diagnostic methods, which may lead to a broader range of available tests. This focus on adaptation could foster a more responsive market, better equipped to address public health needs.

    US COVID 19 Diagnostics Market Drivers

    Emergence of New Variants

    The emergence of new variants of the virus continues to influence the covid 19-diagnostics market. As variants evolve, the need for effective diagnostic tools that can accurately detect these changes becomes increasingly critical. The US has witnessed several variants that have demonstrated varying degrees of transmissibility and resistance to existing tests. This dynamic landscape necessitates the development of updated diagnostic solutions, which could lead to a market expansion. Analysts suggest that the market may grow by approximately 10% annually as manufacturers adapt their products to meet the challenges posed by new variants, ensuring that testing remains effective and reliable.

    Public Awareness and Education

    Public awareness regarding the importance of testing has significantly impacted the covid 19-diagnostics market. Educational campaigns aimed at informing the population about the benefits of regular testing have led to increased participation in testing programs. In the US, surveys indicate that over 70% of individuals recognize the importance of testing in controlling the spread of the virus. This heightened awareness has resulted in a greater demand for diagnostic services, particularly in community settings. Consequently, the market is likely to experience growth as more individuals seek testing, driven by a better understanding of its role in public health.

    Government Initiatives and Funding

    Government initiatives play a pivotal role in shaping the covid 19-diagnostics market. In the US, substantial funding has been allocated to enhance testing capabilities and improve access to diagnostics. Programs aimed at increasing testing availability in underserved communities have emerged, reflecting a commitment to equitable healthcare. The federal government has invested over $10 billion in testing infrastructure, which has bolstered the market's growth. These initiatives not only support the development of innovative diagnostic technologies but also ensure that testing remains accessible to the population. As a result, the market is likely to see sustained growth driven by ongoing government support.

    Increased Demand for Rapid Testing

    The COVID-19 diagnostics market experiences heightened demand for rapid testing solutions, driven by the need for quick results in various settings, including hospitals, clinics, and workplaces. Rapid tests enable timely decision-making, which is crucial for controlling outbreaks. In the US, the market for rapid antigen tests has surged, with estimates indicating that these tests account for a substantial portion of the overall diagnostics market. The convenience and speed of these tests appeal to both healthcare providers and patients, leading to a projected growth rate of approximately 15% annually in this segment. This trend underscores the importance of rapid testing in the ongoing management of public health and safety.

    Technological Advancements in Diagnostics

    Technological advancements are reshaping the covid 19-diagnostics market, with innovations enhancing the accuracy and efficiency of testing methods. The integration of artificial intelligence and machine learning in diagnostic processes is becoming more prevalent, allowing for faster analysis and improved result interpretation. In the US, companies are investing heavily in research and development to create next-generation diagnostic tools that can provide real-time results. This trend is expected to drive market growth, with projections indicating a potential increase of 12% annually as new technologies are adopted. The continuous evolution of diagnostic capabilities is crucial for addressing the ongoing challenges posed by the pandemic.

    Market Segment Insights

    By Test Type: PCR Tests (Largest) vs. Antigen Tests (Fastest-Growing)

    In the US covid 19-diagnostics market, PCR Tests maintain the largest market share due to their reliability and accuracy in detecting the virus. They are widely used across healthcare settings, contributing significantly to the overall market dynamics. In contrast, Antigen Tests are gaining traction and are becoming more popular among consumers for their rapid results, appealing to those seeking convenience and speed in diagnosis. The growth trends in this segment reveal a shift towards more accessible testing options. The demand for Antigen Tests is rising sharply as they offer faster testing solutions, making them particularly attractive during high transmission periods. By offering an easy-to-use format, manufacturers are capitalizing on this trend, which is expected to drive further innovation and adoption in the coming years.

    PCR Tests (Dominant) vs. CRISPR Tests (Emerging)

    PCR Tests are recognized as the dominant testing solution in the US covid 19-diagnostics market, due to their established presence and trust within the medical community. Their sensitivity and specificity make them the preferred choice for accurate diagnosis, especially in clinical settings. On the other hand, CRISPR Tests are emerging with novel technology that promises faster and more efficient results. While still in the early adoption phase, CRISPR technology’s potential in diagnostics could revolutionize testing by reducing the time and cost associated with traditional methods. As developers continue to refine these tests, CRISPR may soon play a more significant role in the landscape of covid diagnostics.

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

    In the US covid 19-diagnostics market, hospitals hold the largest share among the end user segments, attributing to their critical role in managing patient care during the pandemic. Clinics and laboratories also contribute significantly, given their function in testing and analysis. Home care has gained notable traction as a response to increasing demand for remote diagnostics, reflecting a shift in patient preferences towards convenience and accessibility. The growth trends in this segment are driven by the escalating incidence of covid 19 cases and the need for expedited diagnostic solutions. Innovations in testing methodologies, coupled with regulatory support for at-home testing kits, are contributing to the rapid expansion of the home care segment, making it the fastest-growing area in the market. The focus on decentralized healthcare is reshaping the dynamics of diagnostic accessibility across the board.

    Hospitals (Dominant) vs. Home Care (Emerging)

    Hospitals remain the dominant force in the US covid 19-diagnostics market due to their extensive resources and ability to conduct large volumes of tests. They are equipped with advanced technology and skilled professionals, allowing them to provide rapid and accurate results. Conversely, home care is emerging as a compelling segment facilitated by innovations in diagnostic tools that support at-home testing. This segment appeals to patients seeking convenience and reducing exposure risks. With growing consumer acceptance and the availability of user-friendly kits, home care diagnostics are rapidly becoming an integral part of the market, indicative of shifting preferences toward more personalized and accessible healthcare solutions.

    By Sample Type: Nasopharyngeal Swabs (Largest) vs. Saliva (Fastest-Growing)

    In the US covid 19-diagnostics market, the sample type segment shows diverse usage patterns. Nasopharyngeal swabs hold the largest share due to their long-standing efficacy in detecting the virus, while oropharyngeal swabs and saliva methods are gaining traction, reflecting evolving diagnostic practices. Serum samples are used less frequently but play a crucial role in certain testing modalities. The growth trends within this segment reveal strong demand for non-invasive testing methods, especially saliva samples, which have emerged as the fastest-growing option in recent years. The convenience and comfort associated with saliva collection appeal to a broader audience, driving its acceptance amidst ongoing pandemic scenarios. Innovations in swab technologies also contribute to reshaping this landscape.

    Nasopharyngeal Swabs (Dominant) vs. Saliva (Emerging)

    Nasopharyngeal swabs are the dominant sample type in the US covid 19-diagnostics market, known for their robust accuracy and reliability in viral detection. Their established usage in clinical settings provides a significant competitive advantage, maintaining a strong foothold among healthcare providers. On the other hand, saliva represents an emerging sample type, offering a more user-friendly approach to testing. Saliva collection is less invasive and more accessible, enabling easier sample collection at scale. As public health strategies evolve, saliva testing continues to gain ground, supported by technological advancements that enhance its reliability and integration into existing diagnostic workflows.

    By Distribution Channel: Direct Sales (Largest) vs. Online Sales (Fastest-Growing)

    In the US covid 19-diagnostics market, distribution channels exhibit significant variance in market share. Direct Sales dominate the sector, commanding a substantial share due to established relationships with healthcare providers and institutions. Retail Pharmacies also occupy a notable share, providing convenient access for consumers, but have been somewhat overshadowed by the rapid ascent of Online Sales. The latter channel is witnessing increasing importance as consumers opt for more convenient purchasing methods, contributing to changing market dynamics. Growth trends indicate that Online Sales are the fastest-growing distribution channel, propelled by the rise of e-commerce and shifting consumer preferences. Meanwhile, Direct Sales remain robust due to steadfast demand from clinical settings and direct relationships with healthcare professionals. The COVID-19 pandemic has further accelerated the need for accessible testing solutions, placing significant emphasis on effective distribution strategies across all channels.

    Direct Sales (Dominant) vs. Online Sales (Emerging)

    Direct Sales stand as the dominant distribution channel in the US covid 19-diagnostics market, primarily serving healthcare facilities, hospitals, and laboratories with consistent demand. This channel benefits from established networks and trust built over time, ensuring reliable delivery of diagnostic solutions. In contrast, Online Sales represent an emerging segment, gaining traction as consumers seek convenience and immediate access to testing kits from home. With increased digital engagement during the pandemic, online platforms are facilitating swift and straightforward purchasing processes. Both channels play pivotal roles in addressing the urgent need for diagnostics, however, Online Sales are expected to continue evolving rapidly due to technological advancements and changing consumer habits.

    Get more detailed insights about US COVID 19 Diagnostics Market

    Key Players and Competitive Insights

    The covid 19-diagnostics market is currently characterized by a dynamic competitive landscape, driven by the ongoing demand for rapid and accurate testing solutions. Key players such as Abbott Laboratories (US), Roche Diagnostics (CH), and Thermo Fisher Scientific (US) are at the forefront, each adopting distinct strategies to enhance their market positioning. Abbott Laboratories (US) focuses on innovation, particularly in point-of-care testing, which allows for rapid results in various settings. Roche Diagnostics (CH) emphasizes its extensive portfolio of diagnostic solutions, leveraging its strong research capabilities to develop advanced testing technologies. Meanwhile, Thermo Fisher Scientific (US) is concentrating on expanding its manufacturing capabilities to meet the increasing demand for diagnostic kits, thereby solidifying its market presence. Collectively, these strategies contribute to a competitive environment that is increasingly reliant on technological advancements and operational efficiency.

    In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance responsiveness to market needs. The market structure appears moderately fragmented, with several key players exerting influence while also facing competition from emerging firms. This fragmentation allows for a diverse range of products and services, catering to various segments of the healthcare system. The collective influence of these major players shapes the market dynamics, as they continuously adapt to evolving consumer demands and regulatory requirements.

    In October 2025, Abbott Laboratories (US) announced the launch of a new rapid antigen test designed for home use, which is expected to significantly increase accessibility to testing. This strategic move not only aligns with the growing trend towards at-home diagnostics but also positions Abbott as a leader in consumer-friendly testing solutions. The introduction of this product could potentially enhance Abbott's market share by catering to a broader audience seeking convenient testing options.

    In September 2025, Roche Diagnostics (CH) expanded its partnership with a leading telehealth provider to integrate its diagnostic solutions into virtual care platforms. This collaboration is strategically important as it reflects the increasing convergence of telehealth and diagnostics, enabling healthcare providers to offer comprehensive care remotely. By enhancing its digital capabilities, Roche is likely to improve patient engagement and streamline testing processes, thereby reinforcing its competitive edge.

    In August 2025, Thermo Fisher Scientific (US) completed the acquisition of a biotech firm specializing in molecular diagnostics. This acquisition is indicative of Thermo Fisher's commitment to expanding its product offerings and enhancing its technological capabilities. By integrating advanced molecular diagnostic technologies, the company is poised to strengthen its position in the market and respond more effectively to the evolving needs of healthcare providers.

    As of November 2025, current competitive trends in the covid 19-diagnostics market include a pronounced focus on digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are increasingly shaping the landscape, as companies recognize the value of collaboration in driving innovation and improving operational efficiencies. Looking ahead, competitive differentiation is likely to evolve, shifting from price-based competition to a focus on innovation, technological advancements, and supply chain reliability. This transition suggests that companies that prioritize these aspects will be better positioned to thrive in an increasingly complex market.

    Key Companies in the US COVID 19 Diagnostics Market market include

    Industry Developments

    The US COVID-19 Diagnostics Market has seen significant developments recently, especially with respect to innovations and partnerships aimed at improving testing capabilities. Companies such as Abbott Laboratories and Thermo Fisher Scientific have introduced advanced testing solutions to meet the ongoing demand for rapid and accurate diagnostics. 

    Additionally, Quest Diagnostics has expanded its testing footprint by introducing at-home collection solutions, making access more convenient for patients. In terms of mergers and acquisitions, PerkinElmer announced in September 2023 its acquisition of a smaller diagnostic firm to enhance its portfolio of COVID-19 testing technologies, while Hologic has made strides in expanding its molecular diagnostics offerings through strategic alliances in the same period. The market is currently witnessing substantial growth in valuations, driven by the increasing focus on health surveillance and the development of new variants. 

    The major companies involved in the diagnostics sector, such as Roche, Danaher Corporation, and Becton Dickinson, continue to invest heavily in Research and Development to remain competitive and address the evolving needs in the post-pandemic landscape. Recent trends indicate a sustained increase in testing demand, influenced by the regulatory environment and ongoing public health initiatives within the US.

    Future Outlook

    US COVID 19 Diagnostics Market Future Outlook

    The covid 19-diagnostics market is projected to grow at 3.88% CAGR from 2024 to 2035, driven by technological advancements, increased testing demand, and regulatory support.

    New opportunities lie in:

    • Development of mobile testing units for remote areas
    • Integration of AI for rapid diagnostic analysis
    • Expansion of home testing kits for consumer convenience

    By 2035, the market is expected to maintain robust growth and innovation.

    Market Segmentation

    US COVID 19 Diagnostics Market End User Outlook

    • Hospitals
    • Clinics
    • Laboratories
    • Home Care

    US COVID 19 Diagnostics Market Test Type Outlook

    • PCR Tests
    • Antigen Tests
    • Antibody Tests
    • CRISPR Tests

    US COVID 19 Diagnostics Market Sample Type Outlook

    • Nasopharyngeal Swabs
    • Oropharyngeal Swabs
    • Saliva
    • Serum

    US COVID 19 Diagnostics Market Distribution Channel Outlook

    • Direct Sales
    • Retail Pharmacies
    • Online Sales

    Report Scope

    MARKET SIZE 2024 1940.0(USD Million)
    MARKET SIZE 2025 2015.27(USD Million)
    MARKET SIZE 2035 2950.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 3.88% (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 Laboratories (US), Roche Diagnostics (CH), Thermo Fisher Scientific (US), Siemens Healthineers (DE), BD (Becton, Dickinson and Company) (US), Cepheid (US), Hologic (US), PerkinElmer (US)
    Segments Covered Test Type, End User, Sample Type, Distribution Channel
    Key Market Opportunities Integration of advanced molecular diagnostics technologies enhances rapid testing capabilities in the covid 19-diagnostics market.
    Key Market Dynamics Technological advancements and regulatory changes drive innovation in the covid 19-diagnostics market, enhancing testing capabilities.
    Countries Covered US

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    FAQs

    What is the expected market size of the US COVID-19 Diagnostics Market in 2024?

    In 2024, the US COVID-19 Diagnostics Market is expected to be valued at 2.5 billion USD.

    What is the projected market size for the US COVID-19 Diagnostics Market by 2035?

    The overall market is projected to grow to 4.5 billion USD by the year 2035.

    What is the expected compound annual growth rate (CAGR) for the US COVID-19 Diagnostics Market from 2025 to 2035?

    The market is expected to witness a CAGR of 5.489% from 2025 to 2035.

    Which test type holds the largest market share in the US COVID-19 Diagnostics Market in 2024?

    PCR Tests hold the largest market share, valued at 1.0 billion USD in 2024.

    What will be the market value of Antigen Tests in the US COVID-19 Diagnostics Market by 2035?

    Antigen Tests will have a market value of 1.5 billion USD by the year 2035.

    What is the market size of Antibody Tests in the US COVID-19 Diagnostics Market in 2024?

    Antibody Tests are valued at 0.5 billion USD in the year 2024.

    Who are the key players in the US COVID-19 Diagnostics Market as of 2025?

    Key players include Abbott Laboratories, Roche, and Thermo Fisher Scientific, among others.

    What will be the market value of CRISPR Tests in 2035?

    CRISPR Tests will be valued at 0.3 billion USD by the year 2035.

    How does the competitive landscape of the US COVID-19 Diagnostics Market look?

    The competitive landscape includes major players like Quest Diagnostics and Danaher Corporation.

    What are the expected growth drivers for the US COVID-19 Diagnostics Market from 2025 to 2035?

    Growth is expected to be driven by advancements in testing technologies and increasing healthcare demand.

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