Japan In-Vitro Diagnostics (IVD) Market is expected to reach US$ 3.24 Billion by 2028, according to Renub Research. Japan medical device market is one of the largest in the world, and its In-Vitro Diagnostics (IVD) market includes a wide range of tests such as clinical chemistry, immunoassays, microbiology, molecular diagnostics, and point-of-care testing. The Pharmaceuticals and Medical Devices Agency oversees the regulation of IVD products in Japan.

Additionally, Japan is a leader in the global diagnostics imaging market and holds a strong position due to its advanced technology and expertise in the field. The aging population and increasing prevalence of neurological diseases, including Alzheimer’s disease, are driving the growth of the IVD market in Japan. In order to fulfill the increased need for better neurological healthcare, new IVD and high modalities are being created. Not only will these developments help the medical devices sector growth, but they also make it possible to provide patients with neurological illnesses with better treatment.


Japan IVD Market is estimated to grow at a CAGR of 3.54% between 2022 and 2028

The aging population and increasing prevalence of neurological diseases, including Alzheimer’s disease, are driving the growth of the Japan IVD market. In-vitro diagnostics has undergone significant changes with the adoption of advanced technologies like genetic testing, molecular diagnostics, PCR, and NGS. These technologies offer fast turnaround, reliability, user-friendliness, and predictability of predisposed diseases, which have made them popular offerings among diagnosis providers in Japan and worldwide.

The Japanese government consistently takes initiatives and makes policies to promote medical devices and healthcare projects, offering opportunities to both Japanese and foreign manufacturers. The FY 2022 budget declared by the Japanese government reflects a continued commitment to promoting the healthcare industry as an area of growth. Japanese In-Vitro Diagnostics Market Size was US$ 2.63 Billion in 2022. The Japanese in-vitro diagnostics industry is also confronted with significant problems, such as a lack of effective reimbursement systems, tight regulations, and the limited budgets of hospitals and laboratories in emerging nations.


Genetic Testing market will hold Largest Market Share in Japan IVD Market

The Japan IVD market is segmented into various categories, including Clinical Chemistry, Urine & Faces, SMBG, Hematology, Immunology, Tumor Marker, Infection, Microbiology, Genetic Testing, Pathology, and Others. The aging population in Japan has made genetic testing more important, and the government has launched initiatives to promote personalized medicine and genomics. The Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) regulate genetic testing. The Japan IVD market is expected to grow due to increasing demand for personalized medicine and precision medicine.

Japan has a highly advanced healthcare system that is a significant market for clinical chemistry products in the Asia-Pacific region. The demand for these products is propelled by various factors such as the prevalence of chronic diseases, rising healthcare expenditure, and an aging population. Although the market is projected to experience moderate growth, pricing pressures and reimbursement concerns could affect its growth.

Additionally, the Japan IVD market is highly competitive, with both domestic and international companies operating in the sector. Also, The Japan infection market is a significant segment of the in-vitro diagnostics market in Japan. The increasing prevalence of infectious diseases and the growing elderly population are the main factors contributing to the market’s growth. The market includes a wide range of diagnostic tests such as clinical chemistry, microbiology, molecular diagnostics, and point-of-care testing.

Japan’s population and high per capita income make it an attractive Japan IVD market for medical device manufacturers, particularly in the areas of high-tech products, self-care, preventative care, in-home care, health-IT devices, and advanced diagnostics that use AI. However, the presence of strong domestic companies in sectors such as home therapeutic equipment, diagnostic imaging equipment, dialyzers, endoscopes, and surgical equipment may pose challenges to foreign manufacturers.


Key Players

The Japan in-vitro diagnostics market is characterized by intense competition, as numerous domestic and international companies are actively involved in this space. Some of the major players operating in the Japan IVD market include Roche Diagnostics, Abbott Laboratories, Biomerieux, Danaher Corporation, Becton,Bio-Rad Laboratories, Inc.,Sysmex Corporation, and Thermo Fisher Scientific Inc.


Renub Research report titled “Japan In Vitro Diagnostics (IVD) Market, By segment (Urine & Faces, Hematology, Clinical Chemistry, SMBG, Tumor Marker, Immunology, Infection, Microbiology, Pathology, Genetic Testing, and Others), Companies (Abbott Laboratories, Danaher Corporation, Biomerieux, Roche Diagnostics, Becton, Sysmex Corporation, Bio-Rad Laboratories, Inc., and Thermo Fisher Scientific Inc.), Reimbursements, Porter’s Model)" provides a complete analysis of Japan In Vitro Diagnostics (IVD) Industry.


Segment – Japan IVD Market has been covered from 11 viewpoints

1. Urine & Faces Market
2. Hematology Market
3. Clinical Chemistry Market
4. SMBG Market
5. Tumor Marker Market
6. Immunology Market
7. Infection Market
8. Microbiology Market
9. Pathology Market
10. Genetic Testing Market
11. Others Market


All the Companies have been covered from

  • Overview
  • Recent Developments
  • Revenues




Company Analysis:

1. Abbott Laboratories
2. Danaher Corporation
3. Biomerieux
4. Roche Diagnostics
5. Becton
6. Sysmex Corporation
7. Bio–Rad Laboratories, Inc
8. Thermofisher Scientific Inc.