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(Medical-NewsWire.com, May 05, 2016 ) 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 2015 to 2023 are provided for all the segments, considering 2014 as the base year.
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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.
The report also profiles major players in the XPS 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 Quintiles Transnational Corporation, Covance, Inc.(LabCorp), PAREXEL International Corporation, Pharmaceutical Product Development, LLC, ICON plc, and WuXi Apptec
The global regulatory affairs outsourcing market is segmented into the following categories:
Global Regulatory Affairs Outsourcing Market, by Services
Regulatory Submissions
Clinical Trial Applications and Product Registrations
Regulatory Writing and Publishing
Regulatory Consulting and Legal Representation
Other Regulatory Affairs
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Global Regulatory Affairs Outsourcing Market, by Geography
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 Of Content
1. Preface
2. Executive Summary
2.1. Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014-2023 (US $ Mn)
2.2. Global Regulatory Affairs Outsourcing Market, by Services, 2014 (US$ Mn)
2.3. Global Regulatory Affairs Outsourcing: Market Snapshot
3. Industry Analysis: Global Regulatory Affairs Outsourcing Market
3.1. Introduction
3.2. Market Drivers
3.2.1. Driver 1: Increasing research and development activities across the world
3.2.2. Driver 2: Increasing cost efficiencies
3.2.3. Driver 3: Extensive documentation during drug/device manufacturing
3.3. Market Restraints
3.3.1. Restraint 1: Risk associated with data security, system access and loss of control
3.3.2. Restraint 2: Technological advances leading to rapid pricing fluctuations
3.4. Market Opportunities
3.4.1. Opportunity 1: Emerging economies to offer lucrative growth opportunities
3.5. Porter’s Five Forces Analysis
3.6. Value Chain Analysis: Global Regulatory Affairs Outsourcing Market
3.7. Market Attractiveness Analysis– Regulatory Affairs Outsourcing Market, by Geography (2014) (%)
3.8. Competitive Landscape- Regulatory Affairs Outsourcing Market, by Key Players (2014) (%)
4. Global Regulatory Affairs Outsourcing Market Segmentation – by Services
4.1. Introduction
4.2. Global Regulatory Affairs Outsourcing Market Revenue, by Services 2013–2023 (US$ Mn)
4.3. Global Regulatory Submissions Market Revenue, 2013–2023, (US$ Mn)
4.4. Global Clinical Trial Application and Product Registration Market Revenue, 2013–2023, (US$ Mn)
4.5. Global Regulatory Writing and Publishing Market Revenue, 2013–2023, (US$ Mn)
4.6. Global Regulatory Consultation and legal Representation Market Revenue, 2013–2023, (US$ Mn)
4.7. Global Others Regulatory Affairs Market Revenue, 2013–2023, (US$ Mn)
5. Global Regulatory Affairs Outsourcing Market Segmentation – by Geography
5.1. Introduction
5.2. Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013–2023 (US$ Mn)
5.3. North America Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.3.1. U.S. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
5.3.2. Canada Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
5.4. Europe Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.4.1. U.K. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
5.4.2. Germany Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
5.4.3. Rest of Europe Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
5.5. Asia Pacific (APAC) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.5.1. India Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.5.2. China Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.5.3. Japan Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.5.4. Rest of APAC Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.6. Latin America (LATAM) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.6.1. Brazil Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
5.6.2. Mexico Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
5.6.3. Rest of LATAM Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
5.7. Middle East and Africa (MEA) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.7.1. South Africa Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
5.7.2. Rest of MEA Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
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