Regulatory Affairs Outsourcing Market Analysis By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Application), And Segment Forecasts, 2018 - 2025

Industry Insights

The global regulatory affairs outsourcing market size was valued at USD 4.53 billion in 2016 and is expected to grow at a CAGR of 11.9% over the forecast period. Expansion of life science companies into global space and companies focusing on their core R&D functions is expected to be the major contributor to the growth of market. Regional expansion of these service providers and changing regulatory landscape is also expected to contribute to the market growth.

Rising R&D cost and pressure to curtail cost is stimulating the outsourcing trend of regulatory affair functions which is helping biopharmaceutical companies by reducing cost of these function. Life science companies are adopting different operating models for outsourcing their regulatory affair function to service providers depending upon the type and size of the company. 

U.S. regulatory affairs outsourcing market revenue, by service, 2014 - 2025 (USD Million)

Demand for regulatory services is also expected to increase from small or mid size life science companies who do not have an established regulatory affairs department and are expanding in different regions. Growth in emerging areas such as biosmiliars, personalized medicine and orphan drugs is further expected to contribute to the demand of these services in these areas. Growth in Information technology (IT) infrastructure in emerging regions and rise in quality of service provided by Contract Research Organization (CRO) and other service providers are also expected to boost the market growth.

Service Insights

Based on the type of service used by life science companies, the regulatory affairs outsourcing market is segmented into regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial application and other services.

As of 2016, regulatory writing and publishing held the largest share and is expected to dominate over the forecast period owing to rising trend of outsourcing non-core function by life science companies. Regulatory writing and publishing is expected to account for over 35.0% of market share by 2025.

Legal representation is expected to be the fastest growing segment over the forecast period owing to rising demand of legal representative in regions such as Europe for gaining market authorization for companies who do not have an established base in the region. Globalization of clinical trials especially in regions such as Asia pacific and Latin America is expected to boost demand for product registration and clinical trial application services thereby contributing to the growth of regulatory affairs outsourcing market

Global Regulatory Affairs Outsourcing Market, by Service, 2016 (%)

Regional Insights

Asia Pacific is expected to be the dominating and the fastest growing region in regulatory affairs outsourcing industry owing to cost efficiency and availability of skilled workforce within the region at a lower cost compared to the U.S. large and diverse population is a major driver for expansion of life science companies into the region thereby increasing the demand of these services.

North America and Europe are also expected to be significant contributor to the global market due to presence of global regulators such as the FDA and European Medicines Agency (EMA) in the region leading stringent follows ups of the authoritarian requirements. These regions together contribute about 57.0% of global pharmaceutical sales. Furthermore, presence of a large number of service provider or CROs in the region is also expected to boost the growth. Higher service cost compared to Asia Pacific and Latin America, is a major challenge affecting the growth of the market in the region.

Competitive Insights

Key players of the industry include Accell Clinical Research, Clinilabs Inc., Criterium Inc., PRA International, Promedica International, Wuxi AppTec, Medpace Inc., Pharmaceutical Product Development(PPD), PAREXEL International Corporation, Charles River Laboratories International Inc., ICON plc, Quintiles Transnational Holdings, and Covance Inc.

Over the forecast period, it may be predicted that the market is dominated by major international CROs like PRA International, PPD., Quintiles, Covance Inc. However, the may witness aggressive competition from various small and medium size CROs, service providers and independent consultants that offer these affairs services to life science companies in every stage of drug development process.

There has been a trend of strategic acquisition by major CROs, as companies are trying to strengthen their product portfolio and increase regional expansion. For instance, Paraxel acquired The Medical Affairs Company (TMAC), a leader in providing medical affairs services to biopharmaceutical companies.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the latest trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the regulatory affairs outsourcing market on the basis of services, and region:

• Service Outlook, 2014 - 2025 (USD Million)

  • Regulatory consulting

  • Legal representation

  • Regulatory writing and publishing

  • Product registration and clinical trial application

  • Other regulatory service

• Regional Outlook (USD Million), 2014 - 2025

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • MEA

    • South Africa

    • Saudi Arabia