Global Regulatory Affairs Outsourcing Market - Snapshot

According to a new market report published by Transparency Market Research titled “Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026,” the global regulatory affairs outsourcing market is expected to reach US$ 12,806.9 Mn by 2026, expanding at a CAGR of 13.1% from 2018 to 2026. North America held a prominent share of the regulatory affairs outsourcing market in 2017 and is projected to be at the forefront of global demand. Also, the Asia Pacific regulatory affairs outsourcing market is expected to expand at a significant CAGR.

Regulatory affairs departments play a vital role in the life sciences industry. With the changing regulatory environment and requirements, various companies tend to outsource regulatory affairs as it is beneficial in terms of time and money. Though large pharmaceutical companies have their in-house regulatory affairs department, managing large regulatory departments can be very expensive and the scope of knowledge and expertise required to manage these regulatory departments is limited. Regulatory affairs and operations encompass a wide range of processes such as country-specific regulatory affairs, report publishing, submission planning, regulatory data management, regulatory strategy, dossier conversion, literature searches, and others. In addition, expensive clinical trials and demand for reduced time required for commercialization of new drugs will further support the growth of the regulatory affairs outsourcing market.

1global regulatory affairs outsourcing market

Regulatory consulting and legal representation segment to expand rapidly during the forecast period

The regulatory affairs outsourcing market can be segmented based on services and geography. Based on services, the market has been segmented into regulatory submissions; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others. The others segment includes maintenance and post-marketing surveillance. Regulatory writing and publishing segment holds the largest market share. This is attributed to the increased frequency of outsourcing medical writing, clinical trial summaries, drafting of informed consent forms and other services. Also, regulatory consulting and legal representation segment is expected to expand at the highest CAGR during the forecast period. This is due to the increasing need for the consultation specifically with respect to country wise filing strategies and for gap analysis.

North America is expected to hold a substantial share in the overall market

Based on geography, the global regulatory affairs outsourcing market has been divided into North America, South America, Europe, Asia Pacific, and Middle East & Africa. North America is expected to hold a prominent share and account for more than 40% of the global market in 2026, followed by Europe. The growth in the North America market is because majority of the large contract research organizations (CROs) are domiciled in this region. The U.S. regulatory affairs outsourcing market accounted for the largest share compared to the Canada market due to implementation of well-structured regulatory policies along with huge presence of leading pharmaceutical companies. As a part of the strategy, several service providers are investing in tools development specific to a particular application and are focused on new product developments, partnerships, and mergers and acquisitions in order to increase geographical reach in the global regulatory affairs outsourcing market.

Major players operating in the global regulatory affairs outsourcing market include PAREXEL International Corporation, WuXi AppTec, IQVIA Holdings Inc., Accell Clinical Research LLC, Clinilabs Inc., Criterium, Inc., Pharmaceutical Product Development, (PPD) LLC, Promedica International, Charles River Laboratories International, Inc., ICON plc., BlueReg Group, Covance, Inc., Dr. Regenold GmbH, FMD K&L, Genpact Limited, ProductLife Group S.A., Intertek Group plc,Kinapse Ltd, Medpace, Inc., Navitas Life Sciences, PharmaLex GmbH, PRA Health Sciences, Inc., Syneos Health, Inc., and Verisk 3E.

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. 

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.

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.

Company profiling includes company overview, major business strategies adopted, SWOT analysis, and market revenues between 2016 and 2018. The players profiled in the global regulatory affairs outsourcing market include PAREXEL International Corporation, WuXi AppTec, IQVIA Holdings Inc., Accell Clinical Research LLC, Clinilabs Inc., Criterium, Inc., Pharmaceutical Product Development, (PPD) LLC, Promedica International, Charles River Laboratories International, Inc., ICON plc., BlueReg Group, Covance, Inc., Dr. Regenold GmbH,FMD K&L, Genpact Limited, ProductLife Group S.A., Intertek Group plc,Kinapse Ltd, Medpace, Inc., Navitas Life Sciences, PharmaLex GmbH, PRA Health Sciences, Inc., Syneos Health, Inc., and Verisk 3E.

Market Segmentation

Regulatory Affairs Outsourcing Market Analysis, by Services

  • Regulatory Submissions 
  • Clinical Trial Applications and Product Registrations 
  • Regulatory Writing and Publishing 
  • Regulatory Consulting and Legal Representation 
  • Others

Additionally, the report provides cross-sectional analysis of the regulatory affairs outsourcing market with respect to the following geographical segments:

  • North America
    • U.S.
    • Canada
    • Rest of North America 
  • Europe
    • UK
    • Germany
    • Italy
    • Turkey
    • Russia
    • Rest of Europe
  • Asia Pacific 
    • Japan
    • China
    • India
    • South Korea
    • Indonesia
    • Rest of Asia Pacific
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Rest of South America
.