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According to Coherent Market Insights, the global regulatory affairs outsourcing Market was valued at US$ 3,683.7 million in 2019, and is projected to exhibit a CAGR of 12.0% over the forecast period (2019 – 2027).
Key Trends and Analysis of the Regulatory Affairs Outsourcing Market:
Key trends in the market are increasing research and development expenditure in the healthcare sector, rising number of clinical trials, high complexity in research and development, and stringent government regulations.
Increasing research and development expenditure in the healthcare sector is the major factor that is expected to bolster the market growth. For instance, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), 2016, pharmaceutical and biotechnology companies invested an estimated US$ 58.8 billion in research and development in 2015, which was majority of all biopharmaceutical R&D spending in the U.S.
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The pharmaceutical and biotechnology companies are actively adopting outsourcing services in order to expand their presence and product offerings in the global market. For instance, in May 2017, Rich Pharma, Inc., a developer of oncology therapies, selected IND 2 Results, LLC as a CRO to provide protocol development, medical writing, and regulatory consulting services for its clinical trials on treatment of Hodgkin’s Lymphoma and Acute Myelocytic Leukemia.
Furthermore, key players operating in the market are focused on adopting acquisition and collaboration strategies in order to expand their offerings in potential markets. For instance, in April 2019, Charles River Laboratories International, Inc. acquired Citoxlab, a non-clinical Contract Research Organization (CRO) offering regulated safety assessment services, medical device testing, and other services. The acquisition has expanded Charles’ offerings and strengthened its market position as a CRO.
However, price fluctuation and hidden cost of regulatory affairs outsourcing services are some of the major factors hindering the market growth. Use of technological platforms, which includes software for clinical data management, database, document management, and other technology enhances the overall process and provides quality data, however, it increases the cost of outsourcing services, which can hamper demand for regulatory affairs outsourcing services.
Key Market Takeaways:
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