Regulatory Affairs Outsourcing Market : Rising Awareness, Competition Significant Growth Factors & Industry Analysis By 2023

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.

Economic and competitive pressures in the healthcare industry continue to motivate life sciences companies to explore ways of cutting costs across operations and increase their focus on product innovations, research activities, and improved turnaround time of deliverables. Companies aspiring to widen their global reach are increasing investments on R&D activities and new products are entering clinical trials and the market at a rapid pace. Undertaking regulatory affairs and the maintenance of vast volumes data generated during the process can be a daunting task for companies having a vast product portfolio and operations spread across diverse regional markets.

These factors have encouraged an increased rate of outsourcing of regulatory affairs across life sciences industries in the past few years. Recent findings by Transparency Market Research state that the global regulatory affairs outsourcing market will exhibit a healthy 11.5% CAGR from 2015 to 2023. As a result, the market, which had a valuation of US$1.9 bn in 2014 will rise to US$5.7 bn by 2023.

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.

Over the next few years, however, the market for regulatory affairs outsourcing is witness the highest gains from the clinical trial applications and product registration segment. Factors such as patent expiries and the rising prevalence of a number of chronic, viral, and bacterial diseases have prompted biopharmaceutical companies in the development of a large number of new products. With the rising number of products in clinical trials, the demand for clinical trial application and product registration services is expected to substantially rise in the next few years.

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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

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