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The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, IMARC Group expects the market to exhibit strong growth during 2021-2026. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.
Regulatory affairs outsourcing refers to the hiring of third-party services by the government bodies and private organizations to ensure public health and safety. The services include managing regulatory requirements for generic drugs, innovator drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the products and ensure that they are safe for consumption. These services are required for clinical trial and patent application, regulatory writing and publishing, product registration and legal representation. Pharmaceutical organizations also opt for these services to seek speedy government approvals in various regions.
Significant growth in the pharmaceutical and biotechnological industries across the globe represents one of the key factors creating a positive outlook for the market. Furthermore, the increasing emphasis of pharmaceutical organizations to expand their operations and supplies in the emerging economies is also driving the market growth. Outsourcing regulatory affairs also aid in minimizing the costs associated with managing in-house resources, such as facilities, training, technology, specialized knowledge and geographic regulations. Additionally, regulatory affairs outsourcing services are also widely used for the development of biosimilar, orphan and generic drugs, which is acting as another major growth-inducing factor. Life science organizations are increasingly outsourcing non-core functions and regulatory services and increase their overall operational efficiencies, which, in turn, is contributing to the market growth. Other factors, including significant improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are anticipated to drive the market further.
IMARC Group provides an analysis of the key trends in each sub-segment of the global regulatory affairs outsourcing market, along with forecasts at the global, regional and country level from 2021-2026. Our report has categorized the market based on services, company size, category, indication, stage and end user.
Breakup by Services:
Breakup by Company Size:
Breakup by Category:
Breakup by Indication:
Breakup by Stage:
Breakup by End User:
Breakup by Region:
The competitive landscape of the industry has also been examined along with the profiles of the key players being 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 and Wuxi AppTec Co. Ltd.
|Base Year of the Analysis||2020|
|Segment Coverage||Services, Company Size, Category, Indication, Stage, End User, Region|
|Region Covered||Asia Pacific, Europe, North America, Latin America, Middle East and Africa|
|Countries Covered||United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico|
|Companies Covered||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 and Wuxi AppTec Co. Ltd.|
|Customization Scope||10% Free Customization|
|Report Price and Purchase Option||Single User License: US$ 2299
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Corporate License: US$ 4499
|Post-Sale Analyst Support||10-12 Weeks|
|Delivery Format||PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)|
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