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Point Of Care Infectious Disease Testing Market Size Analysis, 2025-2034 | 4.2% Global CAGR


Point Of Care Infectious Disease Testing Market size is forecast to grow from USD 11.84 billion to USD 17.87 billion between 2025 and 2034, marking a CAGR of more than 4.2%. The expected industry revenue in 2025 is USD 12.3 billion.

 

Growth Drivers & Challenge

The Point of Care (POC) infectious disease testing market is being significantly propelled by the rising demand for rapid diagnostics, particularly in emergency and remote settings. The ability to deliver accurate results in a short time at the patient's side has been instrumental in improving treatment outcomes and reducing the burden on centralized laboratories. This is especially crucial in managing diseases with high transmission rates such as influenza, COVID-19, and HIV, where early detection can significantly alter the course of treatment and curb the spread. Furthermore, increasing investments by both governments and private players in healthcare infrastructure, including POC diagnostics, are driving market growth. Initiatives like mobile testing labs, funding for rapid test development, and greater availability of miniaturized and automated diagnostic devices are contributing to the expansion of this sector.


Another major growth driver is the growing prevalence of infectious diseases across the globe, combined with an aging population that is more susceptible to infections. With antimicrobial resistance on the rise and newer pathogens emerging, there is a heightened need for early and precise diagnostic tools that can be deployed at the site of care. This need has also encouraged innovation in molecular diagnostic platforms and microfluidic technologies, helping companies provide portable, multiplexed, and easy-to-use test kits suitable for use in both clinical and homecare settings.


However, the market is not without challenges. One of the key barriers is the regulatory complexity and variability across different regions. Obtaining approvals from governing bodies like the FDA, CE, or WHO can be time-consuming and costly, especially for small and medium enterprises. Additionally, in low- and middle-income countries, limited infrastructure, lack of skilled professionals, and inconsistent quality control practices can hinder widespread adoption of POC diagnostic solutions.


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Regional Analysis


In North America, the market for point of care infectious disease testing is witnessing robust growth driven by advanced healthcare systems, strong reimbursement policies, and continuous technological innovation. The region benefits from a well-established diagnostic industry and a high level of awareness among healthcare professionals and patients. The COVID-19 pandemic further accelerated the deployment of POC diagnostics in both clinical and home settings, strengthening market penetration. In the U.S., initiatives by the CDC and HHS to enhance preparedness for future pandemics are likely to sustain investment in this area.


Europe represents another prominent market with high adoption rates of POC testing, especially in countries like Germany, the UK, and France. The region’s focus on decentralizing healthcare and expanding access to diagnostics in community settings has promoted the use of rapid tests. Additionally, the strong presence of established diagnostic companies and collaboration between public health authorities and research institutions are fueling market advancements. However, regulatory hurdles under the new In Vitro Diagnostic Regulation (IVDR) could pose short-term constraints on market expansion.


Asia Pacific is expected to be the fastest-growing regional market, supported by a high burden of infectious diseases and improving healthcare access. Emerging economies such as China and India are witnessing growing government initiatives aimed at disease surveillance and timely diagnostics, especially in rural areas. Increased investments in healthcare infrastructure and partnerships with global diagnostic players are catalyzing the development of localized POC solutions. Moreover, the rise of urban populations and improved literacy about infectious diseases are boosting the adoption of diagnostic kits at pharmacies and primary health centers.


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Segmentation Analysis


Based on technology, the market is segmented into lateral flow assays, molecular diagnostics, immunoassays, and others. Lateral flow assays dominate due to their affordability, ease of use, and widespread use in detecting diseases like malaria and COVID-19. Molecular diagnostics, however, are gaining traction due to their higher sensitivity and specificity, especially for detecting bacterial and viral pathogens such as HIV and tuberculosis. Continuous R&D efforts to miniaturize and automate molecular platforms are likely to enhance their market share in the coming years.


When segmented by disease, the market includes respiratory infections, sexually transmitted infections (STIs), tropical diseases, gastrointestinal infections, and others. Respiratory infections, including COVID-19 and influenza, account for the largest share, given their high transmission rates and the global pandemic's impact. The STI segment, particularly for HIV and syphilis, is also significant due to increasing awareness and global efforts to eliminate mother-to-child transmission. Tropical diseases like dengue and malaria are primarily driving demand in developing regions, where early diagnosis through POC testing is crucial for timely treatment.


By end-use, the market is categorized into hospitals and clinics, diagnostic laboratories, homecare settings, and others. Hospitals and clinics remain the dominant segment due to the high volume of patient visits and access to a broad range of diagnostic tools. However, homecare settings are rapidly gaining momentum, especially with the growth of self-testing kits for conditions like COVID-19, HIV, and influenza. The convenience of testing at home, coupled with the availability of telehealth support, is reshaping consumer behavior and expanding the market's reach beyond traditional clinical environments.


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About Fundamental Business Insights:


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Email:  sales@fundamentalbusinessinsights.com

 

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