DUBLIN, December 8, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/wnnm33/regulatory) has announced the addition of the "Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020" report to their offering.

     (Logo: http://photos.prnewswire.com/prnh/20130307/600769 )


Pharmaceutical companies are significantly changing their business models by outsourcing the regulatory support services due to growing regulatory pressures and threats of litigation over perceived drug side effects. Regulatory affairs outsourcing by biopharmaceutical companies have helped to minimize losses incurred from product approval delays or recalls. Furthermore, increasing drug development expenses and weak pipelines for novel drugs in many established firms are some of the important factors contributing to the growth of the global regulatory affairs outsourcing market. The growing need of pharmaceutical companies to shift their focus from ancillary to core business activities is also expected to augment the growth of the global regulatory affairs outsourcing market in the coming few years.

The global regulatory affairs outsourcing market is segmented by services into regulatory affairs; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others (post approval maintenance, reimbursement consulting etc.). Regulatory writing and publishing services accounted for the largest share of more than 40% of the overall regulatory affairs outsourcing market in 2013 and is expected to maintain its lead during the forecast period through 2014 to 2020. Factors that have contributed towards the large market size of the regulatory writing and publishing services are increasing need for user/reviewer friendly and complete drug application submissions, and sound knowledge for drug development services.

Additionally, a well-written clinical study report (CSR) can help in adding a lot of value in the final production of clinical trial documentation, thereby complying with stringent regulatory requirements of the drug development process. The regulatory consulting and legal representation services segment is also estimated to grow at an approximate CAGR of above 14%. The major driving factors for the rapid growth of this segment are growing demand of drug manufacturing companies for product safety and efficacy evaluations. Furthermore, the need of various pharmaceutical companies to minimize business impacts such as product recalls and loss of sales, and ensure global environmental compliance would also propel the growth of the regulatory consulting and legal representation services segment.

Currently, the regulatory affairs outsourcing market is fragmented due to the involvement of several established and emerging contract research organizations. Some of the major players operating in the global regulatory affairs outsourcing market are Charles River Laboratories International, Inc., Covance Group Ltd., Parexel International Corporation, WuXi AppTec, Quintiles Transnational Holdings, Inc., Medpace, Inc., Promedica International, Clinilabs, Inc., Accell Clinical Research, LLC, Criterium, Inc., ICON plc and Pharmaceutical Product Development.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Executive Summary

Chapter 3 Global Regulatory Affairs Outsourcing Market Overview

Chapter 4 Global Regulatory Affairs Outsourcing Market, by Services

Chapter 5 Global Regulatory Affairs Outsourcing Market, by Geography

Chapter 6 Recommendations

Chapter 7 Company Profiles


Companies Mentioned:

• Accell Clinical Research
• Charles River Laboratories International
• Clinilabs
• Covance
• Criterium
• ICON
• Medpace
• PAREXEL International Corporation
• PRA International, Inc.
• Pharmaceutical Product Development
• Promedica International
• Quintiles Transnational Corporation
• WuXi AppTec

For more information visit http://www.researchandmarkets.com/research/wnnm33/regulatory

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

SOURCE Research and Markets