Regulatory Affairs Outsourcing Market: Comprehensive Analysis and Forecast -2028
In 2020, the global market was valued at US$ 4.5 billion, with an estimated Compound Annual Growth Rate (CAGR) of 19% projected from 2021 to 2028. By the end of 2028, it is expected to reach US$ 17.3 billion.
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Transparency Market Research's latest report on the global regulatory affairs outsourcing market highlights the increase in research & development activities in the life science industry worldwide, driving the market during the forecast period.
The market growth is fueled by an upsurge in clinical trials, expansion of the life sciences industry, and advancements in biosimilars, personalized medicine, and orphan pharmaceuticals. Increased investments in research & development for biosimilar, orphan, and generic drugs, along with a focus on product development, contribute to market expansion. The COVID-19 pandemic, while placing pressure on regulatory and outsourcing teams, has boosted demand for R&D activities and regulatory affairs assistance.
Investments in Research & Development:
Key players like Bayer AG are investing in research to introduce new therapies and medicines, driving market growth. For instance, Bayer AG's pharmaceutical division launched a cell and gene therapy platform in December 2020, enhancing its market position.
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Risks associated with outsourcing and data sharing pose challenges to market growth. Concerns about data security and access to sensitive information by outsourcing partners are expected to hinder market expansion.
The market is highly fragmented, with international and regional players dominating. Major players include Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Covance, Inc., ICON plc, Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development (PPD) LLC, Promedica International, Quintiles Transnational Corporation, WuXi App Tec, among others.
Market players are engaged in regulatory approvals, technological advancements, and strategic collaborations to fuel market growth. For instance, Parexel International Corporation expanded its regulatory services by offering medical writing in 2018.
The market is segmented by service (Regulatory Affairs, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation, Others) and region, providing comprehensive insights into industry dynamics and trends.
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