Report Highlights
Global Regulatory Affairs Outsourcing Market: Overview
This research study analyzes the market for regulatory affairs outsourcing services in terms of revenue (US$ Mn). The stakeholders of this report comprises the clinical research organizations. The global regulatory affairs outsourcing market has been broadly segmented on the basis of services (Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation and others regulatory affairs, and Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa).
Each geographic region is further analyzed at the country level for regulatory affairs outsourcing market. The market for each of these segment has been analyzed on the basis of various market dynamics such as technological advances, its advantages and increasing use of outsourcing by leading pharmaceutical and biotechnology companies. Market revenue in terms of US$ Mn for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2017 to 2023 are provided for all the segments, considering 2016 as the base year.
Global Regulatory Affairs Outsourcing Market: Key Research Aspects
The regulatory affairs outsourcing market report comprises an elaborate executive summary, which includes a market snapshot that provides information about various segments and sub-segments of the market. The market overview section of the report explores market dynamics such as drivers, restraints, and opportunities affecting the demand and acceptance of outsourcing regulatory affairs activities across the globe. The report provides a detailed industry analysis of the global regulatory affairs outsourcing market with the help of Porter’s Five Forces model which pose an impact on the sustainability of the companies and value chain analysis.
The forces analyzed are bargaining power of buyers, bargaining power of suppliers, threat of new entrants, threat of substitutes, and degree of competition. The market attractiveness analysis has been provided in the market overview section in order to elucidate the intensity of competition in the market in different regions across the globe. The competitive scenario between different market players is evaluated through market share analysis in the competitive landscape section of the report. All these factors would help the market players to take strategic decisions in order to strengthen their positions and expand their shares worldwide.
A list of recommendations has been provided for new entrants as well as existing market players to assist them in taking strategic initiatives to establish a strong presence in the market.
Global Regulatory Affairs Outsourcing Market: Company Profiles
The report also profiles major players in the this market on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Key players in the global regulatory affairs outsourcing market are Criterium, Inc., Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., and Accell Clinical Research, LLC.
The global regulatory affairs outsourcing market is segmented into the following categories:
By Services
Regulatory Submissions
Clinical Trial Applications and Product Registrations
Regulatory Writing and Publishing
Regulatory Consulting and Legal Representation
Other Regulatory Affairs
By Region
North America
U.S.
Canada
Europe
U.K.
Germany
Rest of Europe
Asia Pacific (APAC)
India
China
Japan
Rest of APAC
Latin America (LATAM)
Brazil
Mexico
Rest of LATAM
Middle East and Africa (MEA)
South Africa
Rest of MEA
- Table 1 : Market Snapshot: Global Regulatory Affairs Outsourcing Market, 2014 and 2023
- Table 2 : Percentage of Registered Studies by Location
- Table 3 : Share of Total Global R&D Spending
- Table 4 : Global Regulatory Affairs Outsourcing Market Revenue, by Services, 2013 – 2023 (US$ Mn)
- Table 5 : Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013 – 2023 (US$ Mn)
- Table 6 : North America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
- Table 7 : Europe Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
- Table 8 : Asia Pacific Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
- Table 9 : Latin America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
- Table 10 : Middle East and Africa Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
- Figure 1 : Market Segmentation: Regulatory Affairs Outsourcing Market
- Figure 2 : Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014 and 2023 (Value %)
- Figure 3 : Global Regulatory Affairs Outsourcing Market, by Services, (US$ Mn) 2014
- Figure 4 : Porter’s Five Forces Analysis: Regulatory Affairs Outsourcing Market
- Figure 5 : Value Chain Analysis: Regulatory Affairs Outsourcing Market
- Figure 6 : Market Attractiveness Analysis: Regulatory Affairs Outsourcing Market
- Figure 7 : Competitive Landscape: Regulatory Affairs Outsourcing Market
- Figure 8 : Global Outsourcing of Regulatory Submissions Market Revenue, 2013 – 2023 (US$ Mn)
- Figure 9 : Global Outsourcing of Clinical Trial Application & Product Registration Market Revenue, 2013 – 2023 (US$ Mn)
- Figure 10 : Global Outsourcing of Regulatory Writing and Publishing Market Revenue, 2013 – 2023 (US$ Mn)
- Figure 11 : Global Outsourcing of Regulatory Consulting & Legal Representation Market Revenue, 2013 – 2023 (US$ Mn)
- Figure 12 : Global Outsourcing of Other Regulatory Affairs Services Market Revenue, 2013 – 2023 (US$ Mn)
- Figure 13 : Charles River Laboratories International, Inc.: Financial Overview, 2012 – 2014 (US$ Mn)
- Figure 14 : Covance, Inc.: Financial Overview, 2012 – 2014 (US$ Mn)
- Figure 15 : ICON plc: Financial Overview, 2012 – 2014 (US$ Mn)
- Figure 16 : PAREXEL International Corporation: Financial Overview, 2013 – 2015 (US$ Mn)
- Figure 17 : Quintiles Transnational Corporation: Financial Overview, 2012 – 2014 (US$ Mn)
- Figure 18 : Wuxi AppTec: Financial Overview, 2011 – 2013 (US$ Mn)
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