Latin America Regulatory Affairs Outsourcing Market Size & Outlook

The regulatory affairs outsourcing market in Latin America is expected to reach a projected revenue of US$ 340.0 million by 2030. A compound annual growth rate of 3.8% is expected of Latin America regulatory affairs outsourcing market from 2024 to 2030.
Revenue, 2023 (US$M)
$262.4
Forecast, 2030 (US$M)
$340.0
CAGR, 2024 - 2030
3.8%
Report Coverage
Latin America

Latin America regulatory affairs outsourcing market, 2018-2030 (US$M)

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Latin America regulatory affairs outsourcing market highlights

  • The Latin America regulatory affairs outsourcing market generated a revenue of USD 262.4 million in 2023.
  • The market is expected to grow at a CAGR of 3.8% 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.
  • Country-wise, Chile is expected to register the highest CAGR from 2024 to 2030.


Latin America data book summary

Market revenue in 2023USD 262.4 million
Market revenue in 2030USD 340.0 million
Growth rate3.8% (CAGR from 2023 to 2030)
Largest segmentProduct registration & clinical trial applications
Fastest growing segmentLegal representation
Historical data covered2018 - 2022
Base year for estimation2023
Forecast period covered2024 - 2030
Quantitative unitsRevenue in USD million
Market segmentationRegulatory consulting, Legal representation, Regulatory writing & publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services
Key market players worldwideGenpact 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, Latin America region accounted for 4.0% of the global regulatory affairs outsourcing market in 2023.
  • Globally, Asia Pacific is projected to lead the regional market in terms of revenue in 2030.
  • Asia Pacific is the fastest growing regional market and is projected to reach USD 5,028.6 million by 2030.

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Regulatory Affairs Outsourcing Market Scope

Regulatory affairs outsourcing market segmentation & scope

Regulatory Affairs Outsourcing Market Companies

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Latin America 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 25.95% in 2023. Horizon Databook has segmented the Latin America 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.


Latin America is one of the fastest growing regions for Regulatory affairs outsourcing market after Asia Pacific owing to cost-effectiveness, increase in number of clinical trials, and rise in number of new entrants venturing into the pharmaceutical market within the region. 

Brazil, Mexico, Venezuela, and Argentina are driving the growth of life sciences market in Latin America. The market is expected to showcase significant growth during the forecast period owing to increase in number of biopharmaceutical companies venturing into this region, which is anticipated to drive the demand for regulatory services, thereby contributing to the growth of Regulatory affairs outsourcing market. 

In addition, its geographic placement, in being strategically close to the U.S. market, is another factor attracting outsourcing in this region. Presence of CROs and regulatory service providers is also expected to increase considerably, which is expected to further drive the growth of Regulatory affairs outsourcing market in the region.

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

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Latin America regulatory affairs outsourcing market size, by country, 2018-2030 (US$M)

Latin America Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)

Latin America regulatory affairs outsourcing market size, by country, 2018-2030 (US$M)

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