Malaysia Regulatory Affairs Outsourcing Market Size & Outlook
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Malaysia regulatory affairs outsourcing market highlights
- The Malaysia regulatory affairs outsourcing market generated a revenue of USD 58.1 million in 2023 and is expected to reach USD 113.9 million by 2030.
- The Malaysia market is expected to grow at a CAGR of 10.1% from 2024 to 2030.
- In terms of segment, product registration & clinical trial applications was the largest revenue generating service in 2023.
- Legal representation is the most lucrative service segment registering the fastest growth during the forecast period.
Regulatory affairs outsourcing market data book summary
| Market revenue in 2023 | USD 58.1 million |
| Market revenue in 2030 | USD 113.9 million |
| Growth rate | 10.1% (CAGR from 2023 to 2030) |
| Largest segment | Product registration & clinical trial applications |
| Fastest growing segment | Legal representation |
| Historical data | 2018 - 2022 |
| Base year | 2023 |
| Forecast period | 2024 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Regulatory consulting, Legal representation, Regulatory writing & publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services |
| Key market players worldwide | Genpact Ltd, Criterium Inc., Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Icon PLC, Labcorp Drug Development, FREYR Battery Inc, Cencora Inc, Pharmexon, QVigilance, BlueReg Group, ZEINCRO Group |
Other key industry trends
- In terms of revenue, Malaysia accounted for 0.9% of the global regulatory affairs outsourcing market in 2023.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In Asia Pacific, Japan regulatory affairs outsourcing 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 1,056.9 million by 2030.
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Regulatory Affairs Outsourcing Market Scope
Regulatory Affairs Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| ZEINCRO Group | View profile | 101-250 | Sofia, Grad Sofiya, Bulgaria, Europe | https://www.zeincro.com/ |
| 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 |
| Promedica International | View profile | 11-50 | Costa Mesa, California, United States, North America | https://promedica-intl.com |
| Labcorp Drug Development | View profile | 10001+ | Princeton, New Jersey, United States, North America | https://drugdevelopment.labcorp.com |
| Cencora Inc | View profile | 46000 | 1 West First Avenue, Conshohocken, PA, United States, 19428-1800 | https://www.cencora.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 |
| Charles River Laboratories International Inc | View profile | 21400 | 251 Ballardvale Street, Wilmington, MA, United States, 01887 | https://www.criver.com |
Malaysia regulatory affairs outsourcing 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 outsourcing market will help companies and investors design strategic landscapes.
Product registration & clinical trial applications was the largest segment with a revenue share of 25.99% in 2023. Horizon Databook has segmented the Malaysia regulatory affairs outsourcing market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, other services covering the revenue growth of each sub-segment from 2018 to 2030.
Malaysia is one of the fastest growing markets in Asia Pacific. The country’s exports of medical devices are significantly higher than the imports. The country possesses a strong manufacturing infrastructure for medical devices, which is one of the major reasons for the growth of medical device exports.
Singapore, Germany, and the U.S. are the largest suppliers of medical devices to Malaysia, with Singapore leading out of the three. The country imports only higher classification medical devices that are not manufactured within the country.
Major medical devices export destinations for the country includes the U.S., Belgium, Germany, and Japan. The aforementioned factors are anticipated to significantly boost market growth.
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Target buyers of Malaysia regulatory affairs outsourcing market databook
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Our clientele includes a mix of regulatory affairs outsourcing 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 Malaysia regulatory affairs outsourcing market , including forecasts for subscribers. This country databook contains high-level insights into Malaysia regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
Partial client list
Malaysia Regulatory Consulting - Regulatory Affairs Outsourcing Market, 2023 - 2030 (US$M)
Malaysia Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)
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