Italy Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs market in Italy is expected to reach a projected revenue of US$ 378.3 million by 2030. A compound annual growth rate of 9.5% is expected of Italy medical device regulatory affairs market from 2024 to 2030.
Revenue, 2023 (US$M)
$200.4
Forecast, 2030 (US$M)
$378.3
CAGR, 2024 - 2030
9.5%
Report Coverage
Italy

Italy medical device regulatory affairs market, 2018-2030 (US$M)

Italy

Related Markets

Italy medical device regulatory affairs market highlights

  • The Italy medical device regulatory affairs market generated a revenue of USD 200.4 million in 2023 and is expected to reach USD 378.3 million by 2030.
  • The Italy market is expected to grow at a CAGR of 9.5% from 2024 to 2030.
  • In terms of segment, regulatory writing & publishing was the largest revenue generating services in 2023.
  • Regulatory Consulting is the most lucrative services segment registering the fastest growth during the forecast period.


Medical device regulatory affairs market data book summary

Market revenue in 2023USD 200.4 million
Market revenue in 2030USD 378.3 million
Growth rate9.5% (CAGR from 2023 to 2030)
Largest segmentRegulatory writing & publishing
Fastest growing segmentRegulatory Consulting
Historical data2018 - 2022
Base year2023
Forecast period2024 - 2030
Quantitative unitsRevenue in USD million
Market segmentationRegulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services
Key market players worldwideLabcorp Holdings Inc, Icon PLC, IQVIA Holdings Inc, Intertek Group PLC, SGS AG, Promedica International, Integer Holdings Corp, Medpace Holdings Inc, Emergo Group, Freyr Solutions


Other key industry trends

  • In terms of revenue, Italy accounted for 3.0% of the global medical device regulatory affairs market in 2023.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
  • In Europe, Germany 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 658.3 million by 2030.

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Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

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.


Regulatory writing & publishing was the largest segment with a revenue share of 53.29% in 2023. Horizon Databook has segmented the Italy medical device regulatory affairs market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, other services 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.

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.

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.
  • 30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
  • 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 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 services, 2018-2030 (US$M)

Italy Medical Device Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)

Italy medical device regulatory affairs market size, by services, 2018-2030 (US$M)

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