Point of Care Testing Market - Global Forecast 2025-2030

The Point of Care Testing Market size was estimated at USD 32.56 billion in 2024 and expected to reach USD 36.80 billion in 2025, at a CAGR 12.79% to reach USD 67.07 billion by 2030.

Point of care testing refers to the performance of diagnostic analyses at or near the site of patient care, enabling the delivery of rapid results that inform immediate clinical decision making. This shift from centralized laboratory testing toward decentralized models has been propelled by advancements in miniaturized analytical devices and the growing demand for streamlined workflows. By eliminating the delays inherent to sample transport and laboratory processing, point of care diagnostics accelerate time to diagnosis, improving patient throughput and reducing the risk of adverse events associated with delayed treatment. These devices range from handheld glucose meters to sophisticated molecular platforms, each designed to deliver accuracy, reliability, and ease of use at the patient’s side. citeturn0search12turn0search0

The landscape of point of care testing is being reshaped by a confluence of technological breakthroughs, regulatory reforms, and shifting care models. The integration of digital diagnostics, which marries data analytics with traditional in vitro testing, is unlocking new avenues for clinical decision support and remote patient monitoring. Manufacturers are embedding connectivity features into portable devices to enable seamless data sharing with electronic medical records, fostering interoperability across care settings and reducing administrative burdens. Simultaneously, regulatory bodies have adapted frameworks to accelerate the authorization of innovative point of care platforms-most notably through programs such as the FDA’s Diagnostic Data Program and the NIH’s RADx initiative-expediting the deployment of tests during public health emergencies. At the same time, patient-centric care models, from virtual visits to home health services, are driving demand for tests that can be performed without specialized training or laboratory infrastructure. As these trends converge, stakeholders across the healthcare ecosystem must navigate a landscape defined by agile innovation and an expanded regulatory scope. citeturn1search0turn0search4

The imposition of U.S. tariffs on imported medical devices and related components has introduced a layer of complexity for point of care testing manufacturers and distributors. Under Section 301, duties on Chinese-origin items such as biosensors, microfluidics cartridges, test strips, and reagents have risen to 25–50 percent, with additional levies applied to syringes, needles, masks, and gloves reaching up to 100 percent in 2026. These measures have elevated input costs, disrupted established sourcing relationships, and prompted industry calls for exclusion requests and temporary waivers. Beyond individual product lines, the tariffs have strained global supply chains, as critical subcomponents often require specialized manufacturing processes with limited domestic alternatives. Meanwhile, derivative steel and aluminum tariffs have further increased costs for diagnostic housings and instrument enclosures. In response, companies are evaluating nearshoring options, dual sourcing strategies, and tariff classification reviews to mitigate risk. The cumulative effect through 2025 underscores the need for comprehensive tariff management plans that align procurement, regulatory, and compliance functions to maintain continuity of diagnostic availability. citeturn2news12turn2search0

Insight into market dynamics emerges from examining product portfolios that span blood glucose monitoring, where continuous diabetes management remains foundational; cardiac marker testing, crucial for rapid myocardial infarction assessment; coagulation testing to guide anticoagulant therapy; and drug abuse testing, which supports both clinical and forensic applications. Hematology testing platforms offer near-patient complete blood counts, while infectious disease testing has seen unprecedented demand through lateral flow rapid antigen tests for respiratory pathogens. Pregnancy and fertility testing and urinalysis kits complete the suite of offerings that address both chronic and acute care needs. Underlying these applications are core technologies such as biosensor platforms delivering electrochemical readouts, lateral flow immunoassays offering visual or instrument-read results in minutes, and emerging microfluidics systems that enable multiplexed analyses on chip-scale devices. Performance across these technologies is evaluated on parameters of sensitivity, specificity, and ease of use for whole blood, saliva, or urine samples. The end user landscape spans ambulatory care centers and clinics to high-throughput diagnostic laboratories, home care settings where self-testing drives patient empowerment, and hospitals seeking rapid turnaround in critical care. Distribution channels range from direct sales contracts with large health systems to distributor networks serving smaller facilities, and ecommerce platforms providing convenient access to over-the-counter tests. Through this multi-dimensional lens, companies can uncover targeted growth pockets and prioritize investments aligned with evolving clinical needs.

Regional analysis reveals that the Americas continue to lead in adoption, driven by established reimbursement pathways, robust healthcare infrastructure, and early uptake of digital integration initiatives. In the United States, reimbursement policies for waived and moderate‐complexity tests have supported widespread deployment in both clinical and consumer settings, while federal programs have funded mobile testing initiatives in underserved communities. Europe, the Middle East & Africa display a heterogeneous mosaic of regulatory harmonization under the IVDR and localized health system structures; here, accelerated approval pathways and public–private partnerships have propelled adoption in hospitals and decentralized care facilities, particularly for infectious disease surveillance. In Asia-Pacific, markets are experiencing the fastest expansion rates, as governments invest in rural healthcare infrastructure and preventive screening programs. Nations across the region are deploying point of care platforms in primary care clinics to tackle infectious diseases endemic to the area and to bridge diagnostic gaps in remote communities. The cumulative impact of these regional drivers underscores the necessity of tailoring market entry and product strategies to local regulatory landscapes, reimbursement environments, and healthcare delivery models. citeturn5search4

Leading players within the point of care testing sector are advancing their market positions through strategic collaborations, technology acquisitions, and expanded service offerings. Abbott Laboratories leverages its global footprint and strong portfolio in blood glucose and cardiac markers to cross-sell diagnostic solutions, while Roche Diagnostics deepens its molecular testing capabilities through partnerships that integrate sample preparation and data analytics. Danaher Corporation, through brands such as Cepheid, continues to enhance its cartridge-based platforms with new assays for multiplexed pathogen detection. Siemens Healthineers is exploring partnerships with digital health providers to embed artificial intelligence–driven decision support into its point of care solutions. Smaller innovators such as Quidel and Becton Dickinson focus on rapid immunoassay development and novel reagent formats, capitalizing on the learnings from pandemic-era test authorizations. Meanwhile, startups are attracting investment in microfluidic and biosensor technologies, aiming to disrupt traditional platforms with wearable or disposable formats. Across this landscape, the interplay of scale, innovation agility, and channel reach defines competitive advantage, encouraging ongoing alliances and portfolio diversification to meet heterogeneous customer needs.

To capitalize on the shift toward decentralized diagnostics, industry leaders should prioritize seamless integration of point of care devices into electronic health record workflows, ensuring that test data is transmitted securely and in real time to clinicians. Building resilience against tariff volatility requires establishing diversified supply chains, including nearshore manufacturing and dual sourcing agreements, while actively engaging with trade authorities to seek exclusions or tariff relief for critical components. Strengthening regulatory engagement through collaborative pilot programs and pre-submission consultations can expedite market entry for novel platforms and support adaptive pathways for emerging technologies. Additionally, companies must deepen their focus on user experience by co-designing solutions with end users to reduce complexity and training needs, thereby enhancing adoption in non‐laboratory settings. By aligning strategic initiatives across these four pillars-digital integration, supply chain resilience, regulatory collaboration, and user-centric design-organizations will be better positioned to deliver timely, accurate diagnostics that drive improved patient outcomes and sustainable growth.

This research integrates both secondary and primary methodologies to ensure rigorous and validated insights. Initially, secondary data were gathered from peer-reviewed journals, regulatory filings, government publications, and reputable industry analyses. These insights established a foundational understanding of technology trends, tariff policies, and competitive landscapes. To complement the desk research, primary interviews were conducted with key opinion leaders, including clinical laboratory directors, procurement officers in health systems, and regulatory experts, to capture nuanced perspectives on adoption barriers and future priorities. Quantitative data were triangulated using a bottom-up approach, cross-referencing production volumes, company disclosures, and customs data to map supply chain impacts. Qualitative findings were validated through interactive workshops with sector specialists to refine strategic recommendations. This multi-layered methodology ensures that the analysis reflects both macro-level market forces and ground-level operational realities, providing a robust framework for informed decision making.

Point of care testing has evolved from a niche convenience offering into a cornerstone of modern healthcare delivery, enabling rapid, on‐site diagnostics that support timely clinical decisions. Technological advancements in biosensors, lateral flow devices, and microfluidics are expanding the scope of tests available near the patient, while digital connectivity is transforming raw data into actionable insights. Nevertheless, external factors such as shifting tariff regimes and diverse regional reimbursement landscapes necessitate strategic adaptation by manufacturers and distributors. As stakeholders navigate these complexities, the focus must remain on delivering accurate, user-friendly solutions that enhance patient outcomes and optimize care pathways. The ability to anticipate regulatory shifts, diversify supply networks, and cultivate collaborative partnerships will determine which organizations maintain market leadership in this dynamic environment. Ultimately, point of care testing is poised to redefine diagnostic paradigms, offering a future where immediate, decentralized testing is integral to proactive, precision medicine.

For a comprehensive exploration of the point of care testing landscape and tailored insights, contact Ketan Rohom, Associate Director of Sales & Marketing. Connect directly to discuss customized research solutions that address your strategic priorities, from supply chain resilience and regulatory strategies to technology integration and market expansion. Secure your market intelligence package today and empower your organization with actionable data and expert guidance to thrive in a rapidly evolving diagnostics environment.