Australia Biopharmaceutical Regulatory Affairs Market Size & Outlook

The biopharmaceutical regulatory affairs market in Australia is expected to reach a projected revenue of US$ 94.0 million by 2030. A compound annual growth rate of 7.4% is expected of Australia biopharmaceutical regulatory affairs market from 2024 to 2030.
Revenue, 2023 (US$M)
$57.2
Forecast, 2030 (US$M)
$94.0
CAGR, 2024 - 2030
7.4%
Report Coverage
Australia

Australia biopharmaceutical regulatory affairs market, 2018-2030 (US$M)

Australia

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Australia biopharmaceutical regulatory affairs market highlights

  • The Australia biopharmaceutical regulatory affairs market generated a revenue of USD 57.2 million in 2023 and is expected to reach USD 94.0 million by 2030.
  • The Australia market is expected to grow at a CAGR of 7.4% from 2024 to 2030.
  • In terms of segment, regulatory writing & publishing was the largest revenue generating services in 2023.
  • Legal Representation is the most lucrative services segment registering the fastest growth during the forecast period.


Biopharmaceutical regulatory affairs market data book summary

Market revenue in 2023USD 57.2 million
Market revenue in 2030USD 94.0 million
Growth rate7.4% (CAGR from 2023 to 2030)
Largest segmentRegulatory writing & publishing
Fastest growing segmentLegal Representation
Historical data2018 - 2022
Base year2023
Forecast period2024 - 2030
Quantitative unitsRevenue in USD million
Market segmentationRegulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services
Key market players worldwideGenpact Ltd, Icon PLC, Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Labcorp Drug Development, Cencora Inc, Pharmexon, QVigilance, Voisin Consulting Life Sciences, Accell, Criterium Inc., Freyr Solutions, PharmaLex, NDA Regulatory Service GmbH, BlueReg Group, Cambridge Regulatory Services


Other key industry trends

  • In terms of revenue, Australia accounted for 1.5% of the global biopharmaceutical regulatory affairs market in 2023.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
  • In Asia Pacific, Japan biopharmaceutical 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 530.0 million by 2030.

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Biopharmaceutical Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

Australia biopharmaceutical 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 biopharmaceutical regulatory affairs market will help companies and investors design strategic landscapes.


Regulatory writing & publishing was the largest segment with a revenue share of 31.47% in 2023. Horizon Databook has segmented the Australia biopharmaceutical regulatory affairs market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, other services covering the revenue growth of each sub-segment from 2018 to 2030.


In Australia, nearly 400 domestic biotechnologies, 500 MedTech, and 50 multinational companies are operating as subsidiaries, such as Pfizer, GSK, Bristol-Myers Squibb, Merck, and Novartis. The presence of several local and foreign companies is anticipated to boost the demand for various regulatory services, fueling market growth.

Furthermore, aligning GMPs across various jurisdictions in the country owing to regulatory agreements between the TGA in Australia, the U.S. FDA, and EMA is anticipated to facilitate market entry of the firms in the U.S. and Europe, which is likely to facilitate market growth.

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

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Australia biopharmaceutical regulatory affairs market size, by services, 2018-2030 (US$M)

Australia Biopharmaceutical Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)

Australia biopharmaceutical regulatory affairs market size, by services, 2018-2030 (US$M)

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