Regulatory Affairs Outsourcing Market Outlook 2028
- The globalregulatory affairs outsourcing market was valued at US$ 5 Bn in 2020
- It is estimated to expand at a CAGR of 19%from 2021 to 2028
- The globalregulatory affairs outsourcing market is expected to reach the value of US$ 3 Bn by the end of 2028
Regulatory Affairs Outsourcing Market: Overview
- According to Transparency Market Research’s latest report on the global regulatory affairs outsourcing market for the historical period 2017–2028 and forecast period 2021–2028, increase in research development activities in the life science industry across the world is projected to drive the global regulatory affairs outsourcing market during the forecast period
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Rise in Number of Clinical Trials and Growth of Life Science Industry: Key Drivers
- The global regulatory affairs outsourcing market is driven by increase in the number of clinical trials, growth of the life sciences industry, and advancements in biosimilars, personalized medicine, orphan pharmaceuticals
- Rise in investment in RD activities to develop biosimilar, orphan, and generic drugs, increase in investment in clinical research, surge in focus on product development to expand supply, strict government regulation, and rise in the number of FDA-approved manufacturing plants boost the growth of the global regulatory affairs outsourcing market
- The global regulatory affairs outsourcing market presents significant opportunities to global and mid-sized market players such as delivery of low-cost regulatory services and boosting marketing activities
- COVID-19 pandemic has placed many regulatory and outsourcing teams under pressure; however, it has also had a positive effect on the bio/pharmaceutical outsourcing industry, wherein the demand for RD activity is growing, leading to surge in regulatory affairs assistance
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Increase in Investments by Key Players in Research Development for Regulatory Affairs Outsourcing
- As new therapies and medicines are introduced to the market, the field of medicine continues to evolve. Several public-private institutes and businesses focus on research in order to discover novel medicines.
- Bayer AG's pharmaceutical division unveiled a cell and gene therapyplatform in December 2020. Moreover, expanding pharmaceutical and biotechnology product pipeline is expected to drive market during the forecast period.
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Risk Associated with Regulatory Affairs Outsourcing
- Risks associated with outsourcing and data sharing are expected to hamper the growth of the global regulatory outsourcing market during the forecast period. Several outsourcing partners have access to pharmaceutical and other industries sensitive data, which is likely to pose a threat to data sharing and security to the companies.
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Regulatory Affairs Outsourcing Market: Competition Landscape
- This report profiles major players in the global regulatory affairs outsourcing market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
- The global regulatory affairs outsourcing market is highly fragmented, with the presence of a number of international as well as regional players
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