Global Regulatory Affairs Outsourcing Market: Overview



The report on the global regulatory affairs outsourcing market provides analysis for the period between 2016 and 2026, wherein 2017 is the base year, and 2018 to 2026 is the forecast period. Data for 2016 has been included to provide historical information. The study provides a comprehensive analysis of the expansion of the market during the forecast period, in terms of revenue estimates (in US$ Mn), across different geographies. The report covers market dynamics including drivers, restraints, opportunities, and trends expected to influence the expansion of the global regulatory affairs outsourcing market during the said period. Technologies that are playing a major role in driving the market have also been considered in the study.



The report also covers key industry developments, and Porter’s Five Force analysis which identifies bargaining power of suppliers, bargaining power of buyers, threat from new entrants, threat from substitutes, and degree of competition in the regulatory affairs outsourcing market. Ecosystem analysis which identifies key stakeholders in the regulatory affairs outsourcing market is covered in the report.



Global Regulatory Affairs Outsourcing Market: Scope of the Report



The regulatory affairs outsourcing market has been segmented based on services and region. By services, the market is segmented into regulatory submissions; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others. Geographically, the report classifies the global regulatory affairs outsourcing market into North America, Europe, Asia Pacific (APAC), Middle East & Africa (MEA), and South America; the regions are analyzed in terms of revenue generation. Furthermore, region-wise prominent countries covered in the report include the U.S, Canada, U.K., Germany, France, Japan, China, India, GCC countries, South Africa, and Brazil.



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Global trends have also been included in the regulatory affairs outsourcing study. Additionally, the report covers segment-wise comparison matrix, market attractiveness analysis, and market positioning of key players for all regions covered in the scope of study.

Comparison matrix includes segment growth matrix, 2016– 2026 (%), segment revenue contribution, 2016 - 2026 (%), and segment compound annual growth rate (CAGR %). Market attractiveness identifies and compares market attractiveness of segments based on CAGR and market share index across North America, Europe, Asia Pacific, Middle East & Africa (MEA), and South America.

Global Regulatory Affairs Outsourcing Market: Research Methodology

Secondary research sources typically include, but are not limited to company websites, annual reports, financial reports, broker reports, investor presentations, and SEC filings, internal and external proprietary databases, and relevant patent and regulatory databases, national government documents, vendors whitepapers, statistical databases, and market reports, news articles, press releases, and webcasts specific to companies operating in the market.

Primary research involves e-mail interactions, telephonic interviews, and face-to-face interviews for each market, category, segment, and sub-segment across geographies. We conduct primary interviews on an ongoing basis with industry participants and commentators in order to validate the data and analysis. Primary interviews provide first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook, etc. These help us to validate and strengthen secondary research findings. These also help develop the analysis team’s market expertise and understanding.

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Global Regulatory Affairs Outsourcing Market: Competitive Dynamics

The report includes competition landscape which comprises market share analysis, market positioning of major players in the regulatory affairs outsourcing market based on their 2017 revenues, and profiles of major players. Competition matrix benchmarks leading players on the basis of their capabilities and potential to grow. Factors including market position, offerings, and R&D focus are attributed to a company’s capabilities. Factors including top line growth, market share, segment growth, infrastructure facilities, and future outlook are attributed to a company’s potential to grow. This section also identifies and includes various recent developments carried out by the leading players of the regulatory affairs outsourcing market.