Italy Medical Device Regulatory Affairs Market Size & Outlook
Italy medical device regulatory affairs market, 2018-2030 (US$M)
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Italy medical device regulatory affairs market highlights
- The Italy medical device regulatory affairs market generated a revenue of USD 171.8 million in 2024 and is expected to reach USD 286.8 million by 2030.
- The Italy market is expected to grow at a CAGR of 8.9% 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 171.8 million |
| Market revenue in 2030 | USD 286.8 million |
| Growth rate | 8.9% (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, Italy accounted for 2.5% 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 Europe, UK medical device regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
- UK is the fastest growing regional market in Europe and is projected to reach USD 478.4 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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Italy 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 65.25% in 2024. Horizon Databook has segmented the Italy medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
Italy is considered the fourth-largest medical devices market in Europe, with many experienced workers and medical device manufacturers residing there. According to the data published by the International Trade Administration in November 2022, Italy has 4,500 companies dealing in medical equipment. Of these, 53% are manufacturers and 5% are service providers.
Due to advancements and transitions in patient care, clinical trial applications are growing in the regional market. This is expected to boost the medical devices regulatory affairs market in Italy. In addition, the efforts to innovate minimally invasive medical technology are propelling demand for the medical device regulatory affairs market.
Moreover, the investment of large medical device manufacturers such as Medtronic, Johnson and Johnson Services, Inc., and Stryker is fueling the market growth. However, the possibility of loss to the medical device manufacturers due to the delay in the approval of medical devices may lead to less production, reducing the number of clinical trial applications, document processes, etc.
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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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Horizon Databook provides a detailed overview of country-level data and insights on the Italy medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Italy medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Italy medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
Italy Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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