Global Medical Device Regulatory Affairs Market Size & Outlook
Global medical device regulatory affairs market, 2018-2030 (US$M)
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Global medical device regulatory affairs market highlights
- The global medical device regulatory affairs market generated a revenue of USD 6,585.3 million in 2023 and is expected to reach USD 12,785.2 million by 2030.
- The market is expected to grow at a CAGR (2024 - 2030) of 9.9% by 2030.
- In terms of segment, regulatory writing & publishing accounted for a revenue of USD 3,147.6 million in 2023.
- Legal Representation is the most lucrative services segment registering the fastest growth during the forecast period.
- In terms of region, Asia Pacific was the largest revenue generating market in 2023.
- Country-wise, Kuwait is expected to register the highest CAGR from 2024 to 2030.
Global data book summary
| Market revenue in 2023 | USD 6,585.3 million |
| Market revenue in 2030 | USD 12,785.2 million |
| Growth rate | 9.9% (CAGR from 2023 to 2030) |
| Largest segment | Regulatory writing & publishing |
| Fastest growing segment | Legal Representation |
| Historical data covered | 2018 - 2022 |
| Base year for estimation | 2023 |
| Forecast period covered | 2024 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services |
Other key industry trends
- In terms of revenue, the North America accounted for 28.4% of the global medical device regulatory affairs market in 2023.
- By country, the U.S. is projected to lead the global market in terms of revenue in 2030.
- By country, Kuwait is the fastest growing regional market and is projected to reach USD 16.8 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|
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.
Regulatory writing & publishing was the largest segment with a revenue share of 47.8% in 2023. Horizon Databook has segmented the Global 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.
- Global Medical Device Regulatory Affairs Services Outlook (Revenue, USD Million, 2018-2030)
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Writing
- Publishing
- Product Registration & Clinical Trial Applications
- Other Services
- Global Medical Device Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018-2030)
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
- Global Medical Device Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Clinical studies
- PMA
- Global Medical Device Regulatory Affairs Service Provicer Outlook (Revenue, USD Million, 2018-2030)
- In-house
- Outsourcing
- Global Medical Device Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018-2030)
- Small
- Medium
- Large
- Global Medical Device Regulatory Affairs Device Type Outlook (Revenue, USD Million, 2018-2030)
- Diagnostics
- Therapeutics
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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.
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Global medical device regulatory affairs market size, by regions, 2018-2030 (US$M)
Top 10 countries: Medical device regulatory affairs market size, 2023 (US$M)
Global medical device regulatory affairs market share, by services, 2023 & 2030 (%, US$M)
Medical device regulatory affairs market: Opportunity assessment by country
Global medical device regulatory affairs market, by region, 2023 (US$M)
| Services | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | CAGR |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| North America | 1,186.9 | 1,296.9 | 1,419.2 | 1,555.3 | 1,705.5 | 1,871.2 | 2,052.1 | 2,251.6 | 2,472.4 | 2,716.6 | 2,987.4 | 3,287.7 | 3,621.0 | 9.9% |
| Europe | 941.7 | 1,027.7 | 1,123.2 | 1,229.4 | 1,346.5 | 1,475.4 | 1,616.1 | 1,770.9 | 1,942.1 | 2,131.2 | 2,340.5 | 2,572.5 | 2,829.7 | 9.8% |
| Asia Pacific | 1,607.4 | 1,765.0 | 1,940.9 | 2,137.4 | 2,355.3 | 2,596.6 | 2,861.4 | 3,154.4 | 3,480.1 | 3,841.9 | 4,244.0 | 4,692.3 | 5,191.6 | 10.4% |
| Latin America | 239.1 | 258.8 | 280.5 | 304.5 | 330.6 | 359.2 | 390.1 | 423.7 | 460.6 | 500.9 | 545.1 | 593.7 | 647.0 | 8.8% |
| MEA | 191.4 | 206.5 | 223.1 | 241.4 | 261.2 | 282.8 | 306.0 | 331.2 | 358.7 | 388.6 | 421.3 | 456.9 | 495.9 | 8.4% |
| Overall | 4,166.5 | 4,555.0 | 4,986.9 | 5,467.9 | 5,999.2 | 6,585.3 | 7,225.6 | 7,931.6 | 8,713.8 | 9,579.2 | 10,538.3 | 11,603.1 | 12,785.2 | 9.9% |
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