The Japan in vitro diagnostics market was valued at USD 4.22 Billion in 2025, driven by rising elderly population leading to greater diagnostic testing needs, and increasing demand for personalized medicine across the region. The market is anticipated to grow at a CAGR of 6.20% during the forecast period of 2026-2035, with the values likely to reach USD 7.70 Billion by 2035. The market benefits from advanced healthcare infrastructure and growing adoption of molecular diagnostics. Trends such as AI-integrated testing and home-based diagnostics are expected to accelerate growth during the forecast period.
Base Year
Historical Period
Forecast Period
In June 2023, Sysmex Corporation, Japan, launched a rapid AST system in Europe using proprietary microfluidics, showcasing Japan’s innovation in in vitro diagnostics and strengthening its position in combating antimicrobial resistance globally.
A key trend in Japan in vitro diagnostics market is a surge in strategic partnerships. For instance, in December 2024, Precision Biosensor partnered with NIPRO Corporation to introduce Atlyze, enhancing point-of-care diagnostics access nationwide.
The market is propelled by a growing elderly population, rising prevalence of chronic diseases, and technological advancements. Leading industry players are offering innovative molecular, immunoassay, and point-of-care diagnostic solutions.
Compound Annual Growth Rate
6.2%
Value in USD Billion
2026-2035
*this image is indicative*
In vitro diagnostics (IVD) are laboratory-based tests performed on biological samples such as blood, urine, or tissue to detect diseases, monitor health conditions, and guide treatment decisions. These diagnostics are vital in ensuring accurate, early diagnosis and personalized patient care. The in vitro diagnostics market in Japan is experiencing steady growth due to its aging population, rising chronic disease burden, and advancements in diagnostic technologies. Increased demand for point-of-care testing and government support further contribute to market expansion. The market is poised to grow at a CAGR of 6.20% during the forecast period of 2026–2035.
Innovative Diagnostic Launch to Augment Growth in In Vitro Diagnostics Market in Japan
A key growth driver in the market is the increasing emphasis on advanced diagnostic tools to combat antimicrobial resistance. In July 2024, Shionogi & Co., Ltd. announced the domestic launch of the “Shionogi MIC Dry Plate Cefiderocol,” designed to assess bacterial susceptibility to Fetroja, a treatment for Gram-negative infections. This innovation supports more targeted antibiotic use and strengthens the nation’s infectious disease diagnostics framework. Such advancements are expected to significantly propel market growth in the coming years.
The market is experiencing multiple trends, including an increase in regulatory approvals for novel cancer diagnostics, as well as a surge in innovation and strategic collaborations.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product & Services
Market Breakup by Technology
Market Breakup by Application
Market Breakup by End User
Segmentation Based on Application to Witness Substantial Growth
Among various application areas driving the market, infectious diseases emerge as the dominant segment due to their profound public health impact and escalating demand for accurate diagnostic solutions. According to the Tuberculosis in Japan Annual Report 2022, in 2021, a total of 11,519 new tuberculosis (TB) cases were reported, corresponding to a notification rate of 9.2 per 100,000 population. Among these cases, 73.0% were pulmonary TB (PTB), while extrapulmonary TB (EPTB) accounted for 27.0%. This significant disease burden fuels market growth, supported by government initiatives and rising public awareness, positioning infectious diseases as a key revenue driver in the forecast period.
The key features of the market report comprise funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
F. Hoffmann-La Roche Ltd., established in 1896 and is a global leader in diagnostic solutions. The company develops and manufactures in vitro diagnostic tests and instruments for diseases such as cancer, diabetes, and infectious conditions. Roche’s advanced diagnostic systems and test strips are widely used in Japan, supporting effective disease detection and treatment within clinical and laboratory settings.
Bio-Rad Laboratories is a prominent player in the in vitro diagnostics market. The company offers the QXDx product family, featuring advanced Droplet Digital PCR (ddPCR) systems and assay kits. These tools provide ultrasensitive and precise quantification for diagnostic applications, including chronic myeloid leukemia monitoring, and are gaining regulatory approvals for clinical use.
Established in 1963, bioMérieux SA develops innovative IVD solutions, including molecular biology, immunoassays, and microbiology products. bioMérieux actively supports compliance with the new In Vitro Diagnostic Regulations (IVDR), enhancing patient safety and product quality in the Japan IVD market.
Abbott, headquartered in Abbott Park, Illinois, is a key player in the in vitro diagnostics market. The company introduced the ARCHITECT i1000SR, a high-productivity immunoassay analyzer designed to deliver rapid, accurate results. This advanced system supports improved laboratory workflow and enhances diagnostic efficiency, reinforcing Abbott’s strong market presence.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Sysmex Corporation, Thermo Fisher Scientific Inc., QIAGEN, Quidel Corporation, and Danaher Corporation.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product & Services |
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| Breakup by Technology |
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| Breakup by Application |
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| Breakup by End User |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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