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Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW)-Analysis, Share, Trends, Size, & Forecast From 2014-2025


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WMR-Western Market Research has recently published a comprehensive and exclusive research report, which is an intelligent study covering all key segments. This research report provides breakthrough inputs and insights on market related factors like size, competition, trends, analysis, forecasts etc. The study encompasses primary and secondary data sources along with quantitative and qualitative practices thus assuring data accuracy.

The regulatory affairs outsourcing market is estimated to represent a global market of USD 4.88 billion by 2017 with growth rate of 12.3%.

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Market Dynamics

Outsourcing is an integral part of any pharmaceutical and biotechnology companies value chain during the phase of research and development. A significant rise in clinical studies conducted in emerging economies has fueled the demand for outsourcing activities in regulatory services, providing a healthy platform for this industry growth. Regions such as Asia-Pacific offers a cost-effective environment for conducting drug development studies. For instance, countries such as China and India provide lower costs for clinical trials. Cost for conducting studies in these regions are 25% to 40% lower than that of the U.S. and European countries. Due to these facts, the trend of regulatory outsourcing has taken over the pharma and biotech companies operating in developed regions. In addition, a notable change in regulatory landscape coupled with the globalization of life-science organizations plays an important role in fostering the development of this industry. However, the risk associated with data security coupled with lack of standardization is a major challenge as organizations are outsourcing their clinical activities to offshore regions like the Asia Pacific and Latin America.

Service Takeaway

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In terms of services, the market is divided into Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, Legal Representation, and others. In 2017, regulatory writing and publishing segment captured the highest share, USD 1.6 billion during the same year. In addition, product registration segment is considered to show robust growth during the study period. Midsized and small-scale players are approaching clinical research organizations (CROs) for product registration and drug development needs since they do not have an established regulatory affairs department for international markets, driving this segment to great extent.

Regional Takeaway

Asia Pacific region is considered to be the fastest growing, at a 15.2% CAGR versus North Americas 10.8% from 2017 to 2025. This region is accounted for the largest share of the total market as it is well positioned to become a preferred destination for pharmaceutical studies. Attractive traits such as large patient pool, speedy recruitment, high-quality infrastructure and cost-effectiveness support the regional growth significantly. On contrary, North America captured 20.98% share of the overall market. Drug approval procedures are becoming more stringent and time-consuming in this regions. On other side, pharmaceutical industries are aimed to receive product approvals at the first attempt to gain higher shares. Thereby, companies are required to outsource their regulatory affairs in emerging regions which will pull back the growth of this industry in developed regions.

Key Vendor Takeaway

Key players such as Quintiles Transnational, ICON plc, Pharmaceutical Product Development, PAREXEL International, and Covance, Inc. are profiled extensively. Collectively, these players accounted for more than 50% share of the total market revenue. Global players have realized that timely marketing and clinical approvals from government bodies are the key parameters in drug development. Therefore, companies either strengthen their in-house regulatory department or outsource this process to the consulting firms. It has been noticed that industries are mainly focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency, supporting the industry growth.

The market size and forecast for each segment and sub-segments has been considered as below:

Historical Year-2014 & 2016
Base Year-2017
Estimated Year-2018
Projected Year-2025

Traders, Distributors, and Suppliers
Government and Regional Agencies and Research Organizations

The scope of this report covers the market by its major segments, which include as follows:


Regulatory Writing & Publishing
Regulatory Consulting
Clinical Trial & Product Registration
Legal Representation

North America
Rest of Europe
Asia Pacific
Rest of APAC
Rest of the World
Middle East and Africa
Latin America

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