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The latest report by IMARC, titled “ RegulatoryAffairsOutsourcingMarket: Global IndustryTrends,Share,Size,Growth,Opportunitya ndForecast 2022-2027
”, finds that the global regulatory affairs market size reached US$ 6.43 Billion in 2021.
Regulatory affairs outsourcing refers to the hiring process of third-party services by private organizations and government bodies in order to ensure public health and safety. These services include managing regulatory requirements for innovator drugs, generic drugs, biosimilars, biologics, and others. Outsourcing organizations ensure the safety and efficacy of the products while ensuring they are safe for consumption. These services are used for regulatory writing and publishing, clinical trial and patent application, legal representation, and product registration. In recent years, regulatory affairs outsourcing has gained momentum due to its adoption in pharmaceutical companies for achieving speedy government approvals. We are regularly tracking the direct effect of COVID-19 on the market, along with the indirect influence of the associated industries. These observations will be further integrated into the report.
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One of the primary factors driving the market is the exponential growth in the biotechnological and pharmaceutical industries. Additionally, the increasing focus of pharmaceutical industries on expanding their supplies and operations in developing economies is creating a positive market outlook. Other than this, regulatory affairs outsourcing services are employed to produce orphan, biosimilar, and generic drugs.
Besides this, these services reduce the costs of managing in-house resources, including training, facilities, technology, specialized knowledge, and geographic regulations. This, along with the increasing number of trials, is boosting the demand for regulatory affairs outsourcing. Furthermore, extensive research and development (R&D) activities, improvements in the healthcare industry, and a rise in the number of FDA-approved manufacturing plants are catalyzing the market growth.
Looking forward, IMARC Group expects the market size to reach US$ 10.76 Billion by 2017, expandingataCAGRof8.88%duringtheforecast period(2022-2027). View Report TOC, Figures and Tables: https://www.imarcgroup.com/regulatory-affairs-outsourcing-market
Key Market Segmentation
The research report includes the following segments:
Breakup by Services:
• Regulatory Consulting
• Legal Representation
• Regulatory Writing and Publishing
• Product Registration and Clinical Trial Applications
• Others
Breakup by Company Size:
• Small
• Medium
• Large
Breakup by Stage:
• Preclinical
• Clinical
• PMA (Post Market Authorization)
Breakup by Category:
• Generic Drugs
• Innovator Drugs
• Biologic Drugs
• Biosimilars
• Medical Devices
o Therapeutic
o Diagnostic
• Others
Breakup by Indication:
• Oncology
• Neurology
• Cardiology
• Immunology
• Others
Breakup by End User:
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies
Breakup by Region:
• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa
Competitive Landscape:
• Charles River Laboratories International Inc.
• Covance Inc (Laboratory Corporation of America Holdings)
• Freyr
• ICON Plc
• Medpace Holdings Inc.
• Parexel International Corporation
• Pharmaceutical Product Development LLC
• Promedica International- A California Corporation
• Wuxi AppTec Co.Ltd.
1. Howhastheglobalregulatoryaffairsoutsourcingmarketperformedsofarandhowwill it performinthecomingyears?
2. WhathasbeentheimpactofCOVID-19ontheglobalregulatoryaffairsoutsourcingmarket?
3. Whatarethekeyregional markets?
4. Whatisthebreakupofthemarketbasedontheservices?
5. Whatisthebreakupofthemarketbasedonthecompanysize?
6. Whatisthebreakupofthemarketbasedonthecategory?
7. Whatisthebreakupofthemarketbasedontheindication?
8. Whatisthebreakupofthemarketbasedonthestage?
9. Whatisthebreakupofthemarketbasedontheenduser?
10. Whatarethevariousstagesinthevaluechainoftheindustry?
11. Whatarethekeydrivingfactorsandchallengesintheindustry?
12. Whatisthestructureoftheglobal regulatoryaffairsoutsourcingmarket andwho arethekey players?
13. Whatisthedegreeofcompetitionintheindustry?
Clickhereto visitthecompletetableofcontentwithlist offiguresandtables: https://www.imarcgroup.com/regulatory-affairs-outsourcing-market/toc
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