Global Healthcare Regulatory Affairs Outsourcing Market: Overview
Consistent evaluation of cost-saving options such as regulatory affairs outsourcing is carried out by several drug/device manufacturers in order to streamline their operations and ensure product safety and maintain public healthcare.\
The global health care regulatory affairs outsourcing market includes services like regulatory writing and publishing, clinical trial applications, etc. A new research report by Future Market Insights provides an in-depth analysis of the global regulatory affairs outsourcing market. This comprehensive research report is titled ‘Healthcare Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2022 – 2028’. It includes all the crucial numbers of the market along with the dynamics impacting it. According to this research report the global healthcare regulatory affairs outsourcing market is expected to reach a market revenue of over US$ 2,000 Mn by the end of 2025, growing at a stellar CAGR of 12.2% over the forecast period. The growth of the market is triggered largely by the increasing investments in the healthcare industry along with the increase in research and developments taking place. Also increasing focus on CMOs and CROs has been observed in the market. The reports also depicts that Asia Pacific is expected to lead the global healthcare regulatory affairs outsourcing market during 2017-2025. Low cost, fast turnaround time and easy availability of the skilled and trained professionals will further result in increased outsourcing in APAC countries.
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2012-2021 Healthcare Regulatory Affairs Outsourcing Market in Comparison to 2022-2028 Demand Outlook
Demand for healthcare regulatory affairs outsourcing is projected to increase at an impressive 13.5% CAGR, in comparison with the 10.8% CAGR registered between 2012 and 2021.
The expansion of the healthcare sector worldwide is compelling biotechnology and pharmaceutical companies to outsource regulatory affairs to save costs and leverage the expertise available with contract research organizations (CROs). This process allows companies to save time and improve their core competencies, which is a chief driver of the market.
Regulatory support is available for most of the processes across clinical trials, such as manufacturing and controls (CMC), medial report writing, regulatory chemistry, data management, country regulatory affairs, regulatory strategy, and labeling & liaison.
Outsourcing these non-core activities to experts enables healthcare organizations to focus on their marketing and research and development activities. In the long run, companies can benefit from product approvals, optimized reimbursements, and increased productivity.
Owing to these factors, the market is anticipated to witness an upward trajectory in growth over the forecast period, opines FMI.
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Global Healthcare Regulatory Affairs Outsourcing Market: Segmental Analysis
- Based on End Users, mid-size pharmaceutical companies leads the market with a high market size expected during the forecast period, growing at a CAGR of 13.8% during the forecast period. However Biotechnology companies are also progressing at a high rate and is expected to give a strong competition to mid-size pharma companies in terms of growth rate expected during the forecast period.
- On the basis of Services, regulatory writing and publishing service segment is expected to dominate the market with a market share of over US$ 800 Mn by the end of 2025. However the segment is much behind the other services in terms of growth rate. Regulatory consulting and legal representation is the service which is expected to register fastest growth at a CAGR of 14.3% during the forecast period.
- In terms of Region, Asia Pacific is expected to be the largest region with a high market valuation. However, North America is also expected to give tough competition to APAC. Both these regions are expected to reflect a valuation higher than US$ 720 Mn by 2025 end. However North America lags behind in the race with comparatively less CAGR expected during the forecast period. Whereas, Asia Pacific is expected to register the fastest growth rate of 13.2% CAGR during the forecast period.
Global Healthcare Regulatory Affairs Outsourcing Market: Competitive Landscape
The research report consists of a brief profile of all the major players leading in the industry. It also includes a SWOT analysis of these companies. The leading players mentioned in the report includes companies like Clinilabs, Inc., Accell Clinical Research, LLC., Freyr Solutions, The Weinberg Group Inc., Covance, Inc., (LabCorp), Pharmaceutical Product Development LLC, ICON plc., Sciformix Corporation etc.
- Regulatory Writing and Publishing
- Regulatory Submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
End User:
- Mid-Size Pharmaceutical Companies
- Large Pharmaceutical Companies
- Biotechnology Companies
- Medical Devices Manufacturer
- Food & Beverage Companies
Region
- North America
- Latin America
- Europe
- East Asia
- South Asia
- Oceania
- Middle East & Africa