South Korea Medical Device Regulatory Affairs Market Size & Outlook
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South Korea medical device regulatory affairs market highlights
- The South Korea medical device regulatory affairs market generated a revenue of USD 127.4 million in 2024 and is expected to reach USD 195.1 million by 2030.
- The South Korea market is expected to grow at a CAGR of 7.3% 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 127.4 million |
| Market revenue in 2030 | USD 195.1 million |
| Growth rate | 7.3% (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 |
| Key market players worldwide | Icon PLC, Emergo Group, Freyr Solutions, Laboratory Corporation of America Holdings, IQVIA Holdings Inc, Intertek Group PLC, SGS AG, Promedica International, Integer Holdings Corp, Medpace Holdings Inc |
Other key industry trends
- In terms of revenue, South Korea accounted for 1.9% 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 |
|---|---|---|---|---|
| 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 |
South Korea 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 64.36% in 2024. Horizon Databook has segmented the South Korea medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
The country has several high-tech manufacturing facilities as well as research infrastructure. The cost of manufacturing and development of medical devices is quite low in the country as compared to developed economies. This is expected to boost the demand for the manufacturing and development of medical devices in South Korea.
The country's geriatric population is growing. For instance, according to World Bank, the geriatric population accounted for over 14% of the total population in 2018, and by 2021, this number increased to 17%. Such a rise in the geriatric population is expected to lead to an increase in the manufacturing of medical devices in the country, thus creating opportunities for market players in South Korea.
South Korea is a prominent destination for clinical trials in Asia, with its superior medical infrastructure and a highly educated, relatively healthy & wealthy population. The government support in the country for developing a robust clinical trial environment is anticipated to contribute to the demand for clinical trial application services, thereby contributing to market growth.
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Target buyers of South Korea 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 country-level data and insights on the South Korea medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into South Korea medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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South Korea medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
South Korea Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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