Global Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services(Regulatory consulting, regulatory writing & publishing), By Company size (Small, medium), By Category(Drugs, biologics), By Indication(Oncology, cardiology neurology), By Stage(Preclinical, clinical), By End-user(Medical device companies, pharmaceutical companies) - Industry Forecast 2024-2031

Report ID: SQMIG35D2051 | Region: Global | Published Date: February, 2024
Pages: 157 | Tables: 174 | Figures: 79

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FAQs

Regulatory Affairs Outsourcing Market size was valued at USD 6.48 billion in 2019 and is poised to grow from USD 7 billion in 2023 to USD 13.99 billion by 2031, growing at a CAGR of 8% in the forecast period (2024-2031).

regulatory affairs outsourcing market is highly competitive and somewhat fragmented. To maintain a competitive edge, the major industry participants are continually implementing various growth strategies. Innovations, mergers, and acquisitions, collaborations and partnerships are adopted by these players to thrive in the competitive market. In order to provide industries with the most effective and economical solutions, the major market players are also continually concentrating on R&D. 'IQVIA', 'PAREXEL International Corporation', 'Covance Inc.', 'Charles River Laboratories International Inc.', 'PRA Health Sciences Inc.', 'ICON plc', 'Syneos Health Inc.', 'Wuxi AppTec Inc.', 'FMD K&L Inc.', 'Clinilabs Drug Development Corporation', 'Premier Research', 'Medpace Holdings Inc.', 'Novotech Pty Ltd', 'Rho Inc.', 'Accell Clinical Research LLC', 'Genpact Limited', 'PharPoint Research Inc.', 'Catalyst Clinical Research LLC', 'MakroCare', 'Criterium Inc.'

The increasing number of chronic illness cases, patent expirations of prescription biologics, brand extensions, immediate access to OTC drugs across various platforms, economic and social factors, increasing healthcare expenditures, and advancements in regulatory affairs outsourcing are the factors increasing the demand for these services during the forecast period.

Increasing R&D investment to produce orphan, biosimilar, and generic drugs, as well as increased investment in clinical research, stringent government regulation, and an increased focus on product development to strengthen supply, are all making a significant contribution to the growth of the regulatory affairs outsourcing market.

In 2021, the Asia Pacific region accounted for more than 38% of revenue, and is further expected to have the significant market share during the forecast period due to an increase in clinical trials coupled with a spike in the proportion of companies trying to break into markets in emerging economies such as India and China. Furthermore, the availability of a qualified manpower in the region at lower costs than in the US is expected to drive regional market growth.

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