Japan Medical Device Regulatory Affairs Market Size & Outlook
Japan medical device regulatory affairs market, 2018-2030 (US$M)
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Japan medical device regulatory affairs market highlights
- The Japan medical device regulatory affairs market generated a revenue of USD 795.7 million in 2024 and is expected to reach USD 1,429.1 million by 2030.
- The Japan market is expected to grow at a CAGR of 10.2% from 2025 to 2030.
- In terms of segment, outsource was the largest revenue generating service provider in 2024.
- Outsource is the most lucrative service provider segment registering the fastest growth during the forecast period.
Medical device regulatory affairs market data book summary
| Market revenue in 2024 | USD 795.7 million |
| Market revenue in 2030 | USD 1,429.1 million |
| Growth rate | 10.2% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsource |
Other key industry trends
- In terms of revenue, Japan accounted for 11.8% of the global medical device regulatory affairs market in 2024.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In Asia Pacific, Japan medical device regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
- India is the fastest growing regional market in Asia Pacific and is projected to reach USD 964.9 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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Japan medical device regulatory affairs market outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to medical device regulatory affairs market will help companies and investors design strategic landscapes.
Outsource was the largest segment with a revenue share of 66.19% in 2024. Horizon Databook has segmented the Japan medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
Japan has the most modern medical devices in its health sector. The government is continuously promoting technological updates and innovations in the country. Medical device manufacturers residing in the country are engaged in producing modern technological medical devices. As the production of medical devices increases, the demand for medical device regulatory affairs also grows.
This is expected to increase the presence of a greater number of regulatory affairs companies in the region. In addition, the trend of replacing medical devices with modern technology drives the regional market growth. In addition, the initiative to maintain standards in the manufacturing process is expected to drive market growth.
Various initiatives being undertaken by the government and healthcare associations to restrict the production of toxic and harmful devices are boosting the market growth. This increases the need for clinical test applications, regulatory writing, and publishing
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Our clientele includes a mix of medical device regulatory affairs market companies, investment firms, advisory firms & academic institutions.
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Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
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Horizon Databook provides a detailed overview of country-level data and insights on the Japan medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Japan medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Japan medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
Japan Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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