Global Medical Device Regulatory Affairs Market Size & Outlook
Global medical device regulatory affairs market, 2018-2030 (US$M)
Related Markets
Global medical device regulatory affairs market highlights
- The global medical device regulatory affairs market generated a revenue of USD 6,748.4 million in 2024 and is expected to reach USD 11,663.6 million by 2030.
- The market is expected to grow at a CAGR (2025 - 2030) of 9.5% by 2030.
- In terms of segment, outsource accounted for a revenue of USD 4,434.3 million in 2024.
- Outsource is the most lucrative service provider segment registering the fastest growth during the forecast period.
- In terms of region, Asia Pacific was the largest revenue generating market in 2024.
- Country-wise, India is expected to register the highest CAGR from 2025 to 2030.
Global data book summary
| Market revenue in 2024 | USD 6,748.4 million |
| Market revenue in 2030 | USD 11,663.6 million |
| Growth rate | 9.5% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| Historical data covered | 2018 - 2023 |
| Base year for estimation | 2024 |
| Forecast period covered | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsource |
Other key industry trends
- In terms of revenue, the North America accounted for 32.1% of the global medical device regulatory affairs market in 2024.
- By country, the U.S. is projected to lead the global market in terms of revenue in 2030.
- By country, India is the fastest growing regional market 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 |
|---|---|---|---|---|
| Laboratory Corporation of America Holdings | View profile | - | - | - |
| Emergo Group | View profile | 251-500 | Austin, Texas, United States, North America | https://www.emergobyul.com/ |
| Freyr Solutions | View profile | 1001-5000 | Princeton, New Jersey, United States, North America | http://www.freyrsolutions.com/ |
| Intertek Group PLC | View profile | 44000 | 33 Cavendish Square, London, United Kingdom, W1G 0PS | https://www.intertek.com |
| Promedica International | View profile | 11-50 | Costa Mesa, California, United States, North America | https://promedica-intl.com |
| SGS AG | View profile | 103193 | 1 Place des Alpes, P.O. Box 2152, Geneva, Switzerland, CH-1211 | https://www.sgs.com |
| IQVIA Holdings Inc | View profile | 87000 | 2400 Ellis Road, Durham, NC, United States, 27703 | https://www.iqvia.com |
| Medpace Holdings Inc | View profile | 5800 | 5375 Medpace Way, Cincinnati, OH, United States, 45227 | https://www.medpace.com |
| Icon PLC | View profile | 41150 | South County Business Park, Leopardstown, Dublin, Ireland, D18 X5R3 | https://www.iconplc.com |
| Integer Holdings Corp | View profile | 10500 | 5830 Granite Parkway, Suite 1150, Plano, TX, United States, 75024 | https://www.integer.net |
Global 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 65.71% in 2024. Horizon Databook has segmented the Global medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
- Global Medical Device Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2018-2030)
- Outsource
- In-house
- Global Medical Device Regulatory Affairs Service Outlook (Revenue, USD Million, 2018-2030)
- Regulatory Writing & Publishing
- Regulatory Consulting
- Legal Representation
- Other Services
- Product Registration & Clinical Trial Applications
- Global Medical Device Regulatory Affairs Type Outlook (Revenue, USD Million, 2018-2030)
- Therapeutics
- Diagnostics
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Target buyers of Global medical device regulatory affairs market databook
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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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30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
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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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The rest of the revenue is generated working with academic and research not-for-profit institutes. We do our bit of pro-bono by working with these institutions at subsidized rates.
Horizon Databook provides a detailed overview of global-level data and insights on the Global medical device regulatory affairs market , including forecasts for subscribers. This global databook contains high-level insights into Global medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
Partial client list
Global medical device regulatory affairs market size, by regions, 2018-2030 (US$M)
Top 10 countries: Medical device regulatory affairs market size, 2024 (US$M)
Global medical device regulatory affairs market share, by service, 2024 & 2030 (%, US$M)
Medical device regulatory affairs market: Opportunity assessment by country
Global medical device regulatory affairs market, by region, 2024 (US$M)
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