Australia Medical Device Regulatory Affairs Market Size & Outlook
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Australia medical device regulatory affairs market highlights
- The Australia medical device regulatory affairs market generated a revenue of USD 101.8 million in 2024 and is expected to reach USD 171.2 million by 2030.
- The Australia market is expected to grow at a CAGR of 9.1% from 2025 to 2030.
- In terms of segment, outsource was the largest revenue generating service provider in 2024.
- Outsource is the most lucrative service provider segment registering the fastest growth during the forecast period.
Medical device regulatory affairs market data book summary
| Market revenue in 2024 | USD 101.8 million |
| Market revenue in 2030 | USD 171.2 million |
| Growth rate | 9.1% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsource |
| Key market players worldwide | Icon PLC, Emergo Group, Freyr Solutions, Laboratory Corporation of America Holdings, IQVIA Holdings Inc, Intertek Group PLC, SGS AG, Promedica International, Integer Holdings Corp, Medpace Holdings Inc |
Other key industry trends
- In terms of revenue, Australia accounted for 1.5% of the global medical device regulatory affairs market in 2024.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In Asia Pacific, Japan medical device 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 964.9 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| Laboratory Corporation of America Holdings | View profile | - | - | - |
| Emergo Group | View profile | 251-500 | Austin, Texas, United States, North America | https://www.emergobyul.com/ |
| Freyr Solutions | View profile | 1001-5000 | Princeton, New Jersey, United States, North America | http://www.freyrsolutions.com/ |
| Intertek Group PLC | View profile | 44000 | 33 Cavendish Square, London, United Kingdom, W1G 0PS | https://www.intertek.com |
| Promedica International | View profile | 11-50 | Costa Mesa, California, United States, North America | https://promedica-intl.com |
| SGS AG | View profile | 103193 | 1 Place des Alpes, P.O. Box 2152, Geneva, Switzerland, CH-1211 | https://www.sgs.com |
| IQVIA Holdings Inc | View profile | 87000 | 2400 Ellis Road, Durham, NC, United States, 27703 | https://www.iqvia.com |
| Medpace Holdings Inc | View profile | 5800 | 5375 Medpace Way, Cincinnati, OH, United States, 45227 | https://www.medpace.com |
| Icon PLC | View profile | 41150 | South County Business Park, Leopardstown, Dublin, Ireland, D18 X5R3 | https://www.iconplc.com |
| Integer Holdings Corp | View profile | 10500 | 5830 Granite Parkway, Suite 1150, Plano, TX, United States, 75024 | https://www.integer.net |
Australia medical device 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 medical device regulatory affairs market will help companies and investors design strategic landscapes.
Outsource was the largest segment with a revenue share of 65.32% in 2024. Horizon Databook has segmented the Australia medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
There is a high demand for a wide range of medical equipment in Australia. The market is very competitive and mature. The country's population expects superior-quality medical treatments, and there is a constant need for state-of-the-art medical products. The demand for medical products and other healthcare services is projected to increase, owing to continuous technological developments, rapidly aging population, increasing burden of chronic diseases, and growing individual income.
Australia has one of the longest life expectancies across the globe & the demand for medical devices is expected to grow with an increase in the geriatric population. Opportunities exist for products that can provide a significant improvement in clinical outcomes.
There is also growing demand for products that aid faster recovery, reduce hospitalization & rehabilitation costs, and manage chronic diseases. These factors are anticipated to boost the demand for regulatory affairs services for medical devices in Australia, which is expected to make the market in Australia competitive.
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Target buyers of Australia medical device regulatory affairs market databook
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Our clientele includes a mix of medical device regulatory affairs 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 medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Australia medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Australia medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
Australia Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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