Regulatory Affairs Outsourcing Market

The latest report by IMARC Group, titled “Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026,” finds that the global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Regulatory affairs outsourcing refers to the process of hiring third-party services to ensure public health and safety. It is increasingly employed by government bodies as well as private organizations to analyze and monitor the safety and efficacy of products, including pharmaceuticals, medical devices, agrochemicals, pesticides, cosmetics, and veterinary and complementary medicines. It helps achieve regulatory requirements for generic drugs, innovator drugs, biologics, and biosimilars. It also provides services including regulatory consultant, regulatory writing and publishing, product registration and clinical trial applications, and legal representation.

We are regularly tracking the direct effect of COVID-19 on the market, along with the indirect influence of associated industries. These observations will be integrated into the report.

Global Regulatory Affairs Outsourcing Market Trends:

The market is primarily driven by the increasing number of clinical trials, coupled with the development of life science industries, especially in the areas of personalized medicine and orphan drugs. As a result, life science organizations are outsourcing non-core functions and regulatory services to enhance their operational efficiencies. Moreover, the rapid growth of the pharmaceutical and biotechnological industries is another major growth-inducing factor. Besides this, the rising in-house resources for healthcare regulatory affairs are also fueling the market growth. In addition to this, various companies are under constant pressure to procure timely clinical approvals from regulators in different regions. Consequently, an increase in the geographical expansion activities by companies that aim for quick approvals in local markets has resulted in the adoption of outsourcing models for regulatory services. Furthermore, the extensive investment in research and development (R&D) activities for the production of biosimilars and generic drugs are creating a positive outlook for the market. Looking forward, the market is expected to exhibit strong growth during the forecast period (2021-2026).

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