COVID-19 Detection PoC Kits Market - Global Forecast 2025-2030

The COVID-19 Detection PoC Kits Market size was estimated at USD 3.61 billion in 2024 and expected to reach USD 3.86 billion in 2025, at a CAGR 6.78% to reach USD 5.35 billion by 2030.

Point-of-care COVID-19 detection kits have emerged as indispensable tools in global health, delivering rapid, actionable insights that transcend the constraints of centralized laboratory testing. By enabling decentralized testing at clinics, pharmacies, and even homes, these kits have dramatically reduced turnaround times for diagnostic results from days to mere minutes. This acceleration in diagnostic workflows has not only alleviated pressure on hospital laboratories but has also empowered clinicians and public health officials to make timely decisions in outbreak containment and patient management. The reliability of these tests is underscored by comprehensive analyses indicating that molecular point-of-care assays authorized under FDA Emergency Use Authorization exhibit a pooled sensitivity of 0.94 and specificity of 1.00, reflecting near-laboratory accuracy in real-world settings.

Building on the foundations laid during the early pandemic response, self-administered antigen tests have become a mainstay in routine screening protocols. Data from community testing events demonstrate that antigen tests achieve sensitivity rates as high as 89% and specificity approaching 99.9% when administered under proper guidelines. Coupled with evolving public health strategies, these kits have been integrated into surveillance initiatives-ranging from congregate care to workplace screening-cementing their role in a holistic approach to managing the endemic phase of COVID-19. As testing paradigms continue to evolve, point-of-care kits remain central to ensuring healthcare resilience and preparedness for emergent respiratory threats.

The landscape of point-of-care COVID-19 diagnostics has undergone transformative shifts driven by regulatory evolution, technological breakthroughs, and changing user expectations. Regulatory agencies such as the FDA have tightened Emergency Use Authorization requirements, mandating sensitivity and specificity thresholds that align closely with reference molecular benchmarks, which in turn has elevated clinical confidence in decentralized testing solutions. Simultaneously, the European Union’s implementation of the In Vitro Diagnostic Regulation (IVDR) in 2022 has ushered in new post-market surveillance obligations, compelling manufacturers to maintain rigorous performance tracking and safety reporting across diverse populations, thereby enhancing the overall quality assurance framework in global markets.

Technological innovation has also played a pivotal role, with microfluidic immunofluorescence assays and loop-mediated isothermal amplification (LAMP) platforms emerging as high-sensitivity alternatives to traditional lateral flow devices. These advancements have facilitated rapid molecular testing with minimal operator training, broadening the scope of near-patient diagnostics beyond conventional settings. Moreover, integration of digital readers and smartphone connectivity has enabled semi-quantitative result interpretation and real-time data sharing, bolstering epidemiological surveillance and outbreak analytics across healthcare networks.

Concurrently, consumer behavior has shifted toward greater acceptance of self-testing and telemedicine-facilitated diagnostics. The transition from centralized laboratories to home-based and point-of-care applications reflects a broader trend in personalized healthcare, where patients demand rapid, convenient solutions without sacrificing accuracy. This shift has catalyzed the development of multiplex assays capable of concurrent detection of COVID-19, influenza, and RSV, addressing the complexity of co-circulating respiratory pathogens and reinforcing the essential role of point-of-care kits in a post-pandemic healthcare ecosystem.

The enactment of sweeping tariff measures in early 2025 has materially impacted the supply chain economics of COVID-19 point-of-care detection kits. Among the most significant changes was the imposition of a global 10% tariff on nearly all U.S. imports effective April 5, 2025, which encompasses critical medical supplies such as active pharmaceutical ingredients and diagnostic components. In parallel, specific increases targeting Chinese imports have introduced a 10% duty on all shipments from China beginning February 2025, further amplifying cost pressures for manufacturers dependent on established Asian supply chains.

Component-level tariffs have been particularly pronounced for diagnostic kit materials. For instance, semiconductors essential to digital lateral flow readers now attract a 50% duty, while imports of disposable medical gloves face a 50% rate as of January 1, 2025; syringes and needles, critical for sample collection, incurred duties rising to 100% from September 2024. These escalations have contributed to heightened procurement costs for healthcare providers, with hospitals reporting medical supply expenses comprising over 10% of operational budgets and anticipating an incremental $6.6 billion increase in 2023–2024 alone. In response, leading stakeholders are accelerating localization strategies and seeking tariff exemptions for essential healthcare goods to mitigate near-term disruptions and sustain testing capacity at scale.

A granular view of the point-of-care COVID-19 detection market reveals distinct segments that collectively define product portfolios, use cases, and distribution strategies. Product type segmentation identifies core categories-consumables, instruments, and kits-that form the backbone of diagnostic workflows, each requiring specialized manufacturing and regulatory considerations. Application segmentation spans clinical testing environments, academic and pharmaceutical research settings, individual self-testing contexts, and broader public health surveillance initiatives, reflecting diverse end-user requirements.

Detection technology segmentation encompasses antibody-based lateral flow assays, antigen rapid tests, and isothermal amplification methods such as LAMP, each offering unique trade-offs in sensitivity, specificity, and operational complexity. Sample type segmentation underscores the predominance of nasopharyngeal and oropharyngeal swabs for professional testing, while saliva-based assays gain traction for user-friendly, at-home applications. End-user segmentation highlights diagnostic centers, home care providers, and hospital networks as primary channels driving kit utilization. Finally, distribution channel segmentation distinguishes hospital pharmacies, online retail platforms, and brick-and-mortar retail pharmacies as the conduits through which tests reach patients and clinicians. By weaving these dimensions together, stakeholders can target development and deployment strategies that resonate with specific market niches and user preferences.

Regional dynamics exert significant influence on the adoption and evolution of COVID-19 point-of-care diagnostics. In the Americas, the United States maintains robust support for at-home testing, exemplified by federal initiatives like the COVIDtests.gov program, which has distributed over two billion tests since January 2020, ensuring widespread access through mail-order portals and hotlines. U.S. clinical guidelines, anchored by sensitivity benchmarks exceeding 80% positive percent agreement and specificity above 96%, continue to guide procurement decisions and public health surveillance strategies across diverse care settings.

In Europe, Middle East & Africa, regulatory harmonization under the IVDR has elevated conformity assessments and post-market surveillance, prompting manufacturers to align product portfolios with rigorous CE marking requirements and ongoing performance reporting. While this environment fosters high-quality diagnostics, it also extends market entry timelines and increases compliance costs, particularly for smaller innovators. Region-specific reimbursement schemes further modulate adoption rates, with certain EU member states offering premium coverage for rapid antigen tests deployed in long-term care facilities.

Asia-Pacific is characterized by a strategic shift toward onshore manufacturing and supply chain resilience. Governments in China, India, and Indonesia are incentivizing local production through “Made in China 2025,” “Make in India,” and Production-Linked Incentive programs, respectively, buoying investments in medtech capacity and reinforcing procurement preferences for domestically produced kits. As a result, multinational companies are reevaluating their regional footprints to navigate evolving import regulations and capitalize on incentives that favor localized manufacturing and technology transfer.

Abbott’s diagnostics portfolio has witnessed a recalibration of COVID-19 testing revenue, with second-quarter 2025 sales of $55 million, down from $102 million year-over-year, reflecting both the maturation of pandemic-era demand and increased competition from multiplex and non-COVID applications. Despite a 1.4% organic decline in its core diagnostics business, the company reinforced its commitment to point-of-care innovation through targeted product enhancements and expansion of its rapid molecular assay pipeline.

Roche’s Diagnostics Division reported a 4% sales increase to CHF 14.3 billion in 2024, driven predominantly by immunodiagnostic and molecular lab solutions as COVID-19-related product sales declined from CHF 0.8 billion to CHF 0.2 billion year-over-year. Excluding pandemic-linked testing, the base business grew by 8%, underscoring the broad applicability of its diagnostic platforms in areas such as immunoassays, clinical chemistry, and near-patient care operations across hospital and ambulatory settings.

Quidel experienced a 22% reduction in Point-of-Care revenues, which declined to $694.1 million in fiscal 2024, attributable primarily to waning government award volumes for QuickVue and Sofia antigen assays. In response, the company updated its package insert data to reflect a 96.7% positive percent agreement of the Sofia SARS Antigen FIA test against PCR, reinforcing clinical confidence and supporting renewed adoption in high-risk congregate settings such as nursing homes.

Becton Dickinson leveraged its extensive BD Veritor™ instrument installed base of over 25,000 units to introduce a portable, walk-away antigen test delivering 84% sensitivity and 100% specificity within 15 minutes. By ramping manufacturing to two million tests per week, the company has addressed acute demand among frontline healthcare workers while integrating digital reporting capabilities via its BD Synapsys™ informatics solution to streamline data capture for surveillance programs.

LumiraDx has distinguished itself with a microfluidic immunofluorescence antigen test demonstrating 97.6% sensitivity and 96.6% specificity within 12 minutes. The company’s expansion into a five-minute ultra assay-CE marked in 2022-underscores its commitment to enhancing throughput and connectivity on its multimodal platform, positioning the firm for growth in near-patient and decentralized care settings.

Industry leaders should prioritize diversification of supply chains to mitigate the impacts of tariff-induced cost inflation and geopolitical uncertainties. Strategic investments in regional manufacturing hubs, particularly within Asia-Pacific markets offering incentive schemes, can enhance production resilience and reduce exposure to import duties. Simultaneously, forging partnerships with contract development and manufacturing organizations (CDMOs) that possess localized expertise will streamline regulatory compliance and shorten lead times for component sourcing.

Furthermore, embracing digital integration through connected devices and data analytics platforms can unlock new value in surveillance and patient management. By embedding artificial intelligence–driven result interpretation and automated reporting functionalities, manufacturers can offer end users comprehensive solutions that transcend basic diagnostics. Collaboration with public health agencies to align on data-sharing protocols and interoperability standards will be critical to maximizing the utility of real-time test data for outbreak forecasting and resource allocation. Finally, continued investment in multiplex assay development and sustainable test materials will strengthen market differentiation and meet evolving demands for eco-friendly healthcare delivery.

This analysis synthesizes insights from a multifaceted research framework combining primary and secondary data sources. Primary research included interviews with key opinion leaders spanning laboratory directors, procurement executives, and public health officials, facilitating a nuanced understanding of operational challenges and adoption drivers. Secondary research encompassed a comprehensive review of regulatory documents, such as FDA Emergency Use Authorization guidelines and the European IVDR framework, alongside performance evaluations published in peer-reviewed journals and government databases.

Quantitative data points were validated through triangulation across multiple channels, including company financial disclosures, PubMed meta-analyses, and federal tariff schedules. Market dynamics and cost impact assessments leveraged official U.S. Trade Representative publications and American Hospital Association fact sheets. To ensure methodological rigor, diagnostic performance metrics were benchmarked against reference standards for sensitivity and specificity, while regional segmentation insights drew upon industry reports from L.E.K. Consulting and public health adoption trends documented by the CDC.

The point-of-care COVID-19 detection kit market stands at an inflection point where innovation, regulatory evolution, and geopolitical forces converge to define future trajectories. Rapid antigen and molecular platforms, once emergency measures, are now embedded within the broader diagnostic continuum, underscoring their enduring value in clinical decision-making and public health surveillance. As tariffs reshape supply chains and regional production gains prominence, manufacturers and policymakers must collaborate to safeguard testing capacity and affordability.

By harnessing advanced segmentation insights, tapping into diverse regional strategies, and leveraging robust partnerships, industry stakeholders can navigate market complexities while driving sustainable growth. The imperative for digital integration and multiplex capabilities remains clear, promising to elevate the standard of care through faster, more informative diagnostics. Ultimately, a coordinated approach that balances technological excellence with strategic supply chain management will be essential to maintaining preparedness for current and future public health challenges.

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