Australia Regulatory Affairs Outsourcing Market Size & Outlook
Australia regulatory affairs outsourcing market, 2018-2030 (US$M)
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Australia regulatory affairs outsourcing market highlights
- The Australia regulatory affairs outsourcing market generated a revenue of USD 105.8 million in 2023 and is expected to reach USD 187.0 million by 2030.
- The Australia market is expected to grow at a CAGR of 8.5% 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 105.8 million |
| Market revenue in 2030 | USD 187.0 million |
| Growth rate | 8.5% (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, Australia accounted for 1.6% 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 |
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Australia 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 Australia 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.
In Australia, there are nearly 400 domestic biotechnology, 500 MedTech, and 50 multinational companies operating as subsidiaries, such as Pfizer, GSK, Bristol-Myers Squibb, Merck, & Novartis.
The presence of several local and foreign companies is anticipated to boost demand for various regulatory services, thereby fueling the market growth.
Furthermore, aligning of Good Manufacturing Practices across various jurisdictions in the country owing to regulatory agreements between the Therapeutic Goods Administration (TGA) in Australia, the U.S. FDA, and the European Medicines Agency is anticipated to facilitate market entry of U.S. & European firms, which is likely to facilitate market growth.
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Target buyers of Australia 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 Australia regulatory affairs outsourcing market , including forecasts for subscribers. This country databook contains high-level insights into Australia regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Australia regulatory affairs outsourcing market size, by service, 2018-2030 (US$M)
Australia Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)
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