Market Overview

The market size of point-of-care testing (POCT) in Japan (as a total of ten major segments) declined to 172,500 million yen in FY2024, representing 63.0% of the size of the previous fiscal year.

The domestic POCT market has experienced notable volatility in recent years. Driven by a pandemic-fueled surge in demand for antigen test kits and genetic POCT products, the market peaked at the 300 billion yen level in FY2022. However, momentum shifted in FY2023 following the reclassification of COVID-19 to a Category 5 infectious disease. By FY2024, the market faced a sharp correction as the "special demand" concluded—marked by the end of government subsidies and local government stockpiling initiatives.

Meanwhile, demand for COVID-19 test kits remains stable among medical institutions. Growing demand for the diagnosis of respiratory infectious diseases in clinical settings—particularly the identification of influenza viruses and other respiratory pathogens—is contributing to the expansion of the POCT market.

Noteworthy Topics

Stable Demand for Multiplex CoV-Flu Rapid Tests at Medical Institutions

Immunochromatography test kits (lateral flow tests) are one of the key segments in the Japanese POCT market. During the surge of COVID-19, the demand for COVID-19 antigen test kits propelled the market growth significantly. However, following the end of government subsidies and local government stockpiling initiatives, manufacturers faced the needs to adjust directions.

Still, the demand for COVID-19 test kits at medical institutions remain robust. In conjunction with the simultaneous outbreak of influenza and COVID-19 in FY2024, multiplex CoV-Flu rapid test kits have taken root in clinical field as tool to determine pathogen for primary diagnosis of patients with high fever.

Since COVID-19, influenza, and RSV often present with nearly identical symptoms, such as high fever and respiratory distress, accurately distinguishing among these highly transmissible viruses is essential for prescribing appropriate antiviral treatments and implementing isolation protocols. In response, POCT kit manufacturers are increasingly focusing on expanding and enhancing their product portfolios, including multiplex COVID-19/influenza rapid test kits as well as single-target test kits for various respiratory infectious diseases. Going forward, POCT kit suppliers will be expected to determine which products are most suitable for specific situations, taking into account factors such as the scale of an outbreak and the capacity of the clinical setting.

Future Outlook

The POCT market is poised to grow as specimen testing continues to migrate from centralized laboratories to point-of-care settings. Traditionally, testing has been performed using large-scale analyzers located in hospital laboratories or external clinical testing centers; however, a growing share of diagnostic testing is expected to be conducted directly within clinical settings. Consequently, clinics (independent physicians) are likely to become increasingly important users of POCT. This transition will be driven by four major shifts in the market landscape: Stronger partnerships between clinics and pharmaceutical wholesalers; the evolution of regulatory requirements for testing quality assurance and medical device management; a more clearly defined division of responsibilities between centralized laboratory testing and POCT; and greater standardization of POCT protocols in clinical settings.

Furthermore, the use of point-of-care testing in clinical settings is expected to expand beyond infectious diseases to support the diagnosis, treatment, and preventive management of chronic conditions such as diabetes, heart failure, and chronic kidney disease. Significant opportunities remain to increase the adoption of POCTs, including biomarker-based tests, as routine tools for physicians to aid diagnosis, assess patient status, and guide clinical decision-making.

Although demand for SARS-CoV-2 antigen test kits has plateaued below pandemic-era levels, it maintains a stable baseline within respiratory diagnostic protocols. The clinical necessity for early detection is intensifying, precipitated by recurring COVID-19 resurgences after the Category 5 reclassification, as well as seasonal outbreaks of influenza, streptococcal infections, adenovirus, RSV, and Mycoplasma pneumonia. High-sensitivity detection and multi-disease screening reduce burdens of patients and shorten consultation times. Developing new multi-parameter testing kits for screening multiple pathogens, beyond COVID/Flu combo kits, will be essential for future market growth.

Research Outline