South Africa Regulatory Affairs Outsourcing Market Size & Outlook
South Africa regulatory affairs outsourcing market, 2018-2030 (US$M)
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South Africa regulatory affairs outsourcing market highlights
- The South Africa regulatory affairs outsourcing market generated a revenue of USD 80.8 million in 2023 and is expected to reach USD 103.0 million by 2030.
- The South Africa market is expected to grow at a CAGR of 3.5% 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 80.8 million |
| Market revenue in 2030 | USD 103.0 million |
| Growth rate | 3.5% (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, South Africa accounted for 1.2% 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 Middle East & Africa, South Africa regulatory affairs outsourcing market is projected to lead the regional market in terms of revenue in 2030.
- South Africa is the fastest growing regional market in Middle East & Africa and is projected to reach USD 103.0 million by 2030.
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Regulatory Affairs Outsourcing Market Scope
Regulatory Affairs Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
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South Africa 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 25.87% in 2023. Horizon Databook has segmented the South Africa 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.
South Africa is the largest market for pharmaceuticals in Sub-Saharan Africa region and has one of the most developed infrastructure and manufacturing facilities in the world. In addition, local presence of significant number of life sciences companies such as Adcock Ingram, Aspen Holdings, and Genius Biotherapeutics is anticipated to propel growth.
The government is planning to initiate new industrialization programs and policies such as the Ketlaphela project, which are likely to attract biopharmaceutical companies to this region, thereby contributing to the increasing demand for regulatory services.
Currently, Medicines Control Council (MCC) is the primary regulatory agency and one of the major challenges faced is regulatory approval process, which takes very long time. The 2015 Amendment has made a provision for the replacement of MCC by South African Health Product Regulatory Agency (SAHPRA), which will handle the regulatory approval processes related to the life sciences sector.
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Target buyers of South Africa 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 South Africa regulatory affairs outsourcing market , including forecasts for subscribers. This country databook contains high-level insights into South Africa regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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South Africa regulatory affairs outsourcing market size, by service, 2018-2030 (US$M)
South Africa Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)
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