Global Regulatory Affairs Outsourcing Market
Regulatory affairs outsourcing are the services utilized by companies that manufacture pharmaceutical, biotech and medical devices, with the purpose of gaining fast approvals from various regulatory authorities.
The global regulatory affairs outsourcing market was valued at US$ 3,683.7 million in 2019, and is expected to exhibit a robust CAGR of 12.0% throughout the forecast period (2019-2027).
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Figure 1. Global Regulatory Affairs Outsourcing Market Value (US$ Mn), by Region, 2019
Source: Coherent Market Insights Analysis (2019)
Global Regulatory Affairs Outsourcing Market Insights
Rising incidence of refractive disorders is expected to propel the growth of the global regulatory affairs outsourcing market. Increasing research & development expenditure in the healthcare sector is another major growth propeller for this market. According to the National Bureau of Statistics, in February 2018, China’s expenditure on healthcare research & development programs increased by 11.6%, from 10.6% in 2016, and reaching US$ 280 million in 2017.
Owing to their huge expertise in the field of regulatory affairs, the companies offering outsourcing services have a higher product approval potential, in comparison to other pharmaceuticals or biotechnology companies. For instance, ProEd Regulatory, a subsidiary of Health Consultancy Group, stated that the company witnesses an 80% success rate, and takes around eight to ten drugs through a regulatory process each year to receive approval.
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However, several risks associated with data sharing and outsourcing are believed to hamper the global regulatory outsourcing market growth in the near future. Moreover, many outsourcing partners have access to the sensitive data of several pharmaceutical companies, which may also pose a threat to their security and data sharing.
Figure 2. Global Regulatory Affairs Outsourcing Market Share (%), by Therapeutic Applications, 2019 and 2027
Source: Coherent Market Insights Analysis (2019)
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Rising implementation of acquisition strategies in North America to bolster market growth
North America holds a dominant position in the global regulatory affairs outsourcing market, owing to increasing merger and acquisition strategies adopted by market players. For instance, in 2015, BioClinica, Inc. acquired Synowledge in a bid to expand its product offering in the drug safety and regulatory business process outsourcing market. Synowledge, for the record, specializes in regulatory affairs and information technology services for biopharmaceutical companies. Similarly, in 2014, Certara, a technology-enabled drug development and drug safety consultancy, announced the acquisition of specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to leading pharmaceutical, biotechnology, and medical device manufacturers worldwide.
Moreover, increasing research & development expenditure is a major factor bolstering market growth in North America. According to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceuticals industry invested an estimated US$ 90 billion in research & development activities in the U.S.
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Key Market Players
The major players operating in the global regulatory affairs outsourcing market include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.
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