South Korea Regulatory Affairs Market Size & Outlook

The regulatory affairs market in South Korea is expected to reach a projected revenue of US$ 454.5 million by 2030. A compound annual growth rate of 6.6% is expected of South Korea regulatory affairs market from 2025 to 2030.
Revenue, 2024 (US$M)
$310.1
Forecast, 2030 (US$M)
$454.5
CAGR, 2025 - 2030
6.6%
Report Coverage
South Korea

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South Korea regulatory affairs market, 2018-2030 (US$M)

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Related Markets

South Korea regulatory affairs market highlights

  • The South Korea regulatory affairs market generated a revenue of USD 310.1 million in 2024 and is expected to reach USD 454.5 million by 2030.
  • The South Korea market is expected to grow at a CAGR of 6.6% from 2025 to 2030.
  • In terms of segment, outsourcing was the largest revenue generating type in 2024.
  • Outsourcing is the most lucrative type segment registering the fastest growth during the forecast period.


Regulatory affairs market data book summary

Market revenue in 2024USD 310.1 million
Market revenue in 2030USD 454.5 million
Growth rate6.6% (CAGR from 2025 to 2030)
Largest segmentOutsourcing
Fastest growing segmentOutsourcing
Historical data2018 - 2023
Base year2024
Forecast period2025 - 2030
Quantitative unitsRevenue in USD million
Market segmentationIn-house, Outsourcing
Key market players worldwideGenpact Ltd, Criterium Inc., Icon PLC, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Labcorp Holdings Inc, FREYR Battery Inc, Pharmexon, Cambridge Design Partnership, Voisin Consulting Life Sciences, Accell, PAREXEL, Promedica International, PharmaLex, NDA Regulatory Service GmbH, QVigilance, BlueReg Group


Other key industry trends

  • In terms of revenue, South Korea accounted for 1.9% of the global 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 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 2,248.1 million by 2030.

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Regulatory Affairs Market Companies

Name Profile # Employees HQ Website
BlueReg Group View profile 101-250 Paris, Ile-de-France, France, Europe https://blue-reg.com
QVigilance View profile 11-50 Hitchin, Hertford, United Kingdom, Europe https://www.qvigilance.com
NDA Regulatory Service GmbH View profile 101-250 München, Bayern, Germany, Europe http://www.ndareg.com/
PharmaLex View profile 1001-5000 Friedrichsdorf, Hessen, Germany, Europe http://www.pharmalex.com/
Promedica International View profile 11-50 Costa Mesa, California, United States, North America https://promedica-intl.com
PAREXEL View profile 10001+ Waltham, Massachusetts, United States, North America http://www.parexel.com
Accell View profile 11-50 Warrenton, Virginia, United States, North America https://accellclinical.com/
Voisin Consulting Life Sciences View profile 251-500 San Francisco, California, United States, North America http://voisinconsulting.com/
Pharmexon View profile 11-50 Prague, Hlavni mesto Praha, Czech Republic, Europe https://pharmexon.com
FREYR Battery Inc View profile 212 Boulevard Royal, 22-24, Level 2449, Luxembourg, Luxembourg, L-2449 https://www.freyrbattery.com
Medpace Holdings Inc View profile 5800 5375 Medpace Way, Cincinnati, OH, United States, 45227 https://www.medpace.com
Wuxi AppTec Co Ltd View profile 41116 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, People's Republic of, 200131 https://www.wuxiapptec.com
Icon PLC View profile 41150 South County Business Park, Leopardstown, Dublin, Ireland, D18 X5R3 https://www.iconplc.com
Criterium Inc. View profile 101-250 Saratoga Springs, New York, United States, North America http://criteriuminc.com
Genpact Ltd View profile 131000 22 Victoria Street, Canon's Court, Hamilton, Bermuda, HM 12 https://www.genpact.com
Cambridge Design Partnership View profile 251-500 Bourn, Cambridgeshire, United Kingdom, Europe https://www.cambridge-design.com/
Labcorp Holdings Inc View profile 67000 358 South Main Street, Burlington, NC, United States, 27215 https://www.labcorp.com
Charles River Laboratories International Inc View profile 21400 251 Ballardvale Street, Wilmington, MA, United States, 01887 https://www.criver.com

South Korea 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 regulatory affairs market will help companies and investors design strategic landscapes.


Outsourcing was the largest segment with a revenue share of 63.79% in 2024. Horizon Databook has segmented the South Korea regulatory affairs market based on in-house, outsourcing covering the revenue growth of each sub-segment from 2018 to 2030.


South Korea is one of the largest markets in Asia Pacific along with Japan, China, and India. The medical device market is dependent on imports as low-end medical devices are manufactured in the country.

High-end medical devices are imported from North America, Asia, and Europe. The medical equipment imports from these three regions account for 60.0% of the total market demand, with the U.S. holding the largest share among the three.

Companies exporting med-tech equipment to South Korea require appointment of a representative or an importer to ensure regulatory compliance & gain medical device approval. The demand for legal representation services is expected to increase owing to growing import of medical devices.

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Horizon Databook provides a detailed overview of country-level data and insights on the South Korea regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into South Korea regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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South Korea regulatory affairs market size, by type, 2018-2030 (US$M)

South Korea Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)

South Korea regulatory affairs market size, by type, 2018-2030 (US$M)

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