Rising Demand for Non-Hospital-Based Point-of-Care Diagnostic Products Set to Drive Market Growth Through 2035

The global non-hospital-based point-of-care diagnostic products market is positioned for strong expansion over the next decade. Valued at USD 16.8 billion in 2025, the sector is projected to climb to USD 40.0 billion by 2035, recording a promising compound annual growth rate of 9.1%. The increasing preference for convenient, rapid, and affordable diagnostic solutions outside of traditional hospital environments has become a primary driver of this growth trajectory.

With health systems across the globe shifting toward decentralized care models, the reliance on homecare diagnostics and community-based solutions has intensified. From chronic disease management to infectious disease monitoring, patients and providers alike are recognizing the value of point-of-care diagnostic products that deliver accurate results in real time.

Key Trends Shaping Market Expansion

One of the most significant trends propelling the market is the rise in consumer awareness around preventive health and self-monitoring. Patients now seek the flexibility to test and monitor conditions at home, reducing the need for frequent hospital visits. This trend is further strengthened by the growing geriatric population, which requires frequent health monitoring, and by the rising incidence of conditions such as diabetes and cardiovascular diseases.

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Technological advancements have made diagnostic kits more reliable, portable, and user-friendly, allowing broader access to health monitoring tools. Additionally, the COVID-19 pandemic accelerated the adoption of rapid testing solutions, creating lasting changes in consumer behavior and healthcare infrastructure. These shifts are expected to continue fostering adoption in both developed and emerging economies.

Segmental Insights: Paper-Based Test Kits Lead the Market

By product type, the paper-based test kit segment is projected to hold 58.3% of the global market revenue in 2025, cementing its position as the dominant product category. Paper-based kits offer a simple yet powerful solution for rapid diagnostics, requiring no sophisticated equipment and minimal training for effective use. Their cost-effectiveness makes them especially valuable in emerging markets and remote areas where access to hospital laboratories is limited.

The eco-friendly, disposable nature of paper-based test kits also resonates with growing global demand for sustainable healthcare solutions. These attributes, combined with mass production capabilities, ensure that paper-based kits will remain at the forefront of non-hospital-based diagnostic solutions.

Homecare Settings Continue to Dominate End-User Demand

The homecare settings segment is expected to account for 46.9% of the market share in 2025. The appeal of at-home diagnostic solutions lies in their ability to empower patients to monitor their health conditions without needing to visit a hospital or clinic.

The rise of telehealth services has further reinforced the role of home-based diagnostics, as patients can now test themselves and share results with healthcare providers virtually. This synergy between self-testing kits and digital health platforms is revolutionizing patient care by offering timely interventions and reducing the burden on traditional healthcare facilities.

Hospitals and diagnostic clinics continue to play a crucial role, but the rising preference for homecare products underscores the growing patient demand for convenience, autonomy, and accessibility.

Regional Insights: North America and Europe Hold Strong Market Shares

North America is expected to dominate the global market with a 33.2% share between 2025 and 2035. The region’s strong healthcare infrastructure, widespread adoption of advanced technologies, and high prevalence of chronic and metabolic diseases contribute to this leadership position. Government initiatives supporting decentralized healthcare further boost the uptake of point-of-care diagnostics in this region.

Europe stands as the second-largest regional market, expected to account for 29.8% of the global share by 2035. Rising medical awareness, robust healthcare systems, and increasing per capita healthcare spending are contributing to this growth. Countries across Western and Eastern Europe are embracing decentralized care models, aligning with the region’s focus on early detection and preventive healthcare strategies.

Meanwhile, Asia-Pacific represents a rapidly expanding growth frontier. Improving healthcare access, rising disposable incomes, and government-driven initiatives to promote affordable healthcare solutions are expected to accelerate market growth in this region.

Factors Driving Market Adoption

The expanding geriatric population plays a pivotal role in shaping market dynamics. Older adults often require frequent testing for chronic diseases, making home-based and point-of-care diagnostic products an attractive solution. Similarly, the growing prevalence of diabetes worldwide has intensified the demand for glucose monitoring and lipid profile testing outside of hospital settings.

Technological advancements are another major growth driver. Innovations in biosensors, microfluidics, and bioanalytical platforms have significantly improved the performance and accuracy of diagnostic kits. Furthermore, increased awareness among consumers about the importance of early diagnosis and disease prevention has created fertile ground for market expansion.

Challenges to Market Growth

Despite strong prospects, the non-hospital-based point-of-care diagnostic products market faces certain challenges. Inadequate training for product use, inconsistent quality control, and improper maintenance of testing devices can compromise test accuracy. Additionally, while affordability has improved, some advanced diagnostic devices still remain out of reach for lower-income populations. Addressing these barriers will be essential for manufacturers and regulators seeking to expand adoption across diverse demographics.

Start-Up Ecosystem and Innovation Landscape

The start-up ecosystem in the sector is vibrant, with emerging companies focusing on cost-efficient supply chains, automated solutions, and consumer-centric product design. Start-ups are driving innovation in biosensors, assay formats, and complementary diagnostic technologies.

Biosensors, in particular, are playing an increasingly important role in enhancing the bioanalytical performance of diagnostic kits. Developments in surface plasmon resonance, spectroscopy, and microfluidics are transforming how non-hospital-based diagnostic products deliver results. These innovations will continue to push the boundaries of test accuracy, speed, and affordability.

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Competitive Landscape: Established and Emerging Players

The market is highly competitive, with global leaders and regional players shaping its growth trajectory. Established companies such as Abbott Laboratories, Siemens Healthcare, Bio-Rad Laboratories, Thermo Fisher Scientific, and Roche Diagnostics continue to dominate with their robust product portfolios and extensive distribution networks.

At the same time, newer entrants and specialized companies such as STD Rapid Test Kits are bringing innovation to underserved markets. By focusing on affordable, user-friendly solutions, these players are gaining traction in emerging economies. Strategic partnerships, acquisitions, and collaborations are becoming common strategies among both established and new entrants to expand their global footprint and meet growing consumer demand.

Recent Industry Developments

Collaborations between companies across geographies are accelerating innovation and market reach. For instance, in December 2020, Australia-based Anteo Diagnostics partnered with China’s GeneoDx Biotechnology to distribute point-of-care diagnostic products, expanding Anteo’s access to the Chinese market. Similarly, in October 2020, U.S.-based GenePeek entered an agreement with India’s CORE Diagnostics to issue advanced prenatal testing, showcasing the global appetite for cross-border collaborations in this sector.

These developments highlight how both established players and start-ups are leveraging partnerships to expand into new markets, strengthen distribution channels, and broaden their product offerings.

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