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Published Date: 2016-04-08Number of Pages: 76

Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023

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.

Clinical Trial Application and Product Registration Services to be Key Enabler of Growth

Of the key regulatory affair services outsourced by life sciences companies, regulatory writing and publishing is presently the largest market segment, accounting for a share of more than 40% across the global market in 2014. Owing to the diverse and continuously changing regulations across local, regional, national, and international markets, companies spend a vast share in their overall regulatory investments for timely updating data such as regulatory submissions and standard operating procedures. It is owing to this fact that the segment of regulatory writing and publishing leads the regulatory affairs outsourcing 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.

 

regulatory-affairs-outsourcing-market

 

Low-cost Clinical Trial Centers in Emerging Economies to be Key Enabler of Growth

In the years to come, regulatory affairs service providers in emerging economies across regions such as Latin America and Asia Pacific are expected to bag the most numbers of outsourcing projects across the globe. An increased number of biopharmaceutical companies are using emerging economies as a launch pad for their venture in larger markets such as North America and Europe.

Product development, research, and commercialization units are being set up at an increased rate across emerging economies owing to cheap resources and raw material costs. The vast population base of Asia Pacific also makes it a lucrative regional market for the medical industry. These factors are acting in favor of the regulatory affairs outsourcing markets in these regions and will help strengthen the market’s foothold in the next few years. As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market. The market is expected to expand at a 15.8% CAGR in Asia Pacific and 11.1% CAGR across Latin America from 2015 to 2023.


1. Preface

2. Executive Summary
    2.1. Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014-2023 (US $ Mn)
    2.2. Global Regulatory Affairs Outsourcing Market, by Services, 2014 (US$ Mn)
    2.3. Global Regulatory Affairs Outsourcing: Market Snapshot

3. Industry Analysis: Global Regulatory Affairs Outsourcing Market 
    3.1. Introduction
    3.2. Market Drivers
           3.2.1. Driver 1: Increasing research and development activities across the world
           3.2.2. Driver 2: Increasing cost efficiencies
           3.2.3. Driver 3: Extensive documentation during drug/device manufacturing
    3.3. Market Restraints
           3.3.1. Restraint 1: Risk associated with data security, system access and loss of control
           3.3.2. Restraint 2: Technological advances leading to rapid pricing fluctuations
    3.4. Market Opportunities
           3.4.1. Opportunity 1: Emerging economies to offer lucrative growth opportunities
    3.5. Porter’s Five Forces Analysis
    3.6. Value Chain Analysis: Global Regulatory Affairs Outsourcing Market 
    3.7. Market Attractiveness Analysis– Regulatory Affairs Outsourcing Market, by Geography (2014) (%) 
    3.8. Competitive Landscape- Regulatory Affairs Outsourcing Market, by Key Players (2014) (%) 

4. Global Regulatory Affairs Outsourcing Market Segmentation – by Services
    4.1. Introduction
    4.2. Global Regulatory Affairs Outsourcing Market Revenue, by Services 2013–2023 (US$ Mn)
    4.3. Global Regulatory Submissions Market Revenue, 2013–2023, (US$ Mn)
    4.4. Global Clinical Trial Application and Product Registration Market Revenue, 2013–2023, (US$ Mn)
    4.5. Global Regulatory Writing and Publishing Market Revenue, 2013–2023, (US$ Mn)
    4.6. Global Regulatory Consultation and legal Representation Market Revenue, 2013–2023, (US$ Mn)
    4.7. Global Others Regulatory Affairs Market Revenue, 2013–2023, (US$ Mn)

5. Global Regulatory Affairs Outsourcing Market Segmentation – by Geography
    5.1. Introduction
    5.2. Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013–2023 (US$ Mn)
    5.3. North America Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.3.1. U.S. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
           5.3.2. Canada Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
    5.4. Europe Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.4.1. U.K. Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
           5.4.2. Germany Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
           5.4.3. Rest of Europe Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$Mn)
    5.5. Asia Pacific (APAC) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.5.1. India Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.5.2. China Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.5.3. Japan Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.5.4. Rest of APAC Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
    5.6. Latin America (LATAM) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.6.1. Brazil Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
           5.6.2. Mexico Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
           5.6.3. Rest of LATAM Regulatory Affairs Outsourcing Market Revenue, 2013-2023 (US$ Mn)
    5.7. Middle East and Africa (MEA) Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.7.1. South Africa Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)
           5.7.2. Rest of MEA Regulatory Affairs Outsourcing Market Revenue, 2013–2023 (US$ Mn)

6. Recommendations

7. Company Profiles
    7.1. Accell Clinical Research, LLC
           7.1.1. Company Overview
           7.1.2. Financial Overview
           7.1.3. Product Portfolio
           7.1.4. Business Strategies
           7.1.5. Recent Developments
    7.2. Charles River Laboratories International, Inc.
           7.2.1. Company Overview
           7.2.2. Financial Overview
           7.2.3. Product Portfolio
           7.2.4. Business Strategies
           7.2.5. Recent Developments
    7.3. Clinilabs, Inc.
           7.3.1. Company Overview
           7.3.2. Financial Overview
           7.3.3. Product Portfolio
           7.3.4. Business Strategies
           7.3.5. Recent Developments
    7.4. Covance, Inc. 
           7.4.1. Company Overview
           7.4.2. Financial Overview
           7.4.3. Product Portfolio
           7.4.4. Business Strategies
           7.4.5. Recent Developments
    7.5. Criterium, Inc.
           7.5.1. Company Overview
           7.5.2. Financial Overview
           7.5.3. Product Portfolio
           7.5.4. Business Strategies
           7.5.5. Recent Developments
    7.6. ICON plc
           7.6.1. Company Overview
           7.6.2. Financial Overview
           7.6.3. Product Portfolio
           7.6.4. Business Strategies
           7.6.5. Recent Developments
    7.7. Medpace, Inc.
           7.7.1. Company Overview
           7.7.2. Financial Overview
           7.7.3. Product Portfolio
           7.7.4. Business Strategies
           7.7.5. Recent Developments
    7.8. PAREXEL International Corporation
           7.8.1. Company Overview
           7.8.2. Financial Overview
           7.8.3. Product Portfolio
           7.8.4. Business Strategies
           7.8.5. Recent Developments
    7.9. Pharmaceutical Product Development, (PPD) LLC 
           7.9.1. Company Overview
           7.9.2. Financial Overview
           7.9.3. Product Portfolio
           7.9.4. Business Strategies
           7.9.5. Recent Developments
    7.10. Promedica International
           7.10.1. Company Overview
           7.10.2. Financial Overview
           7.10.3. Product Portfolio
           7.10.4. Business Strategies
           7.10.5. Recent Developments
    7.11. Quintiles Transnational Corporation
           7.11.1. Company Overview
           7.11.2. Financial Overview
           7.11.3. Product Portfolio
           7.11.4. Business Strategies
           7.11.5. Recent Developments
    7.12. WuXi App Tec
           7.12.1. Company Overview
           7.12.2. Financial Overview
           7.12.3. Product Portfolio
           7.12.4. Business Strategies
           7.12.5. Recent Developments

 

List of Figures

FIGURE 1 Market Segmentation: Regulatory Affairs Outsourcing Market
FIGURE 2 Global Regulatory Affairs Outsourcing Market Share, by Geography, 2014 and 2023 (Value %)
FIGURE 3 Global Regulatory Affairs Outsourcing Market, by Services, (US$ Mn) 2014
FIGURE 4 Porter’s Five Forces Analysis: Regulatory Affairs Outsourcing Market
FIGURE 5 Value Chain Analysis: Regulatory Affairs Outsourcing Market
FIGURE 6 Market Attractiveness Analysis: Regulatory Affairs Outsourcing Market
FIGURE 7 Competitive Landscape: Regulatory Affairs Outsourcing Market
FIGURE 8 Global Outsourcing of Regulatory Submissions Market Revenue, 2013 – 2023 (US$ Mn)
FIGURE 9 Global Outsourcing of Clinical Trial Application & Product Registration Market Revenue, 2013 – 2023 (US$ Mn)
FIGURE 10 Global Outsourcing of Regulatory Writing and Publishing Market Revenue, 2013 – 2023 (US$ Mn)
FIGURE 11 Global Outsourcing of Regulatory Consulting & Legal Representation Market Revenue, 2013 – 2023 (US$ Mn)
FIGURE 12 Global Outsourcing of Other Regulatory Affairs Services Market Revenue, 2013 – 2023 (US$ Mn)
FIGURE 13 Charles River Laboratories International, Inc.: Financial Overview, 2012 – 2014 (US$ Mn)
FIGURE 14 Covance, Inc.: Financial Overview, 2012 – 2014 (US$ Mn)
FIGURE 15 ICON plc: Financial Overview, 2012 – 2014 (US$ Mn)
FIGURE 16 PAREXEL International Corporation: Financial Overview, 2013 – 2015 (US$ Mn)    
FIGURE 17 Quintiles Transnational Corporation: Financial Overview, 2012 – 2014 (US$ Mn)
FIGURE 18 Wuxi AppTec: Financial Overview, 2011 – 2013 (US$ Mn)

 

List of Tables

TABLE 1 Market Snapshot: Global Regulatory Affairs Outsourcing Market, 2014 and 2023
TABLE 2 Percentage of Registered Studies by Location 
TABLE 3 Share of Total Global R&D Spending
TABLE 4 Global Regulatory Affairs Outsourcing Market Revenue, by Services, 2013 – 2023 (US$ Mn)
TABLE 5 Global Regulatory Affairs Outsourcing Market Revenue, by Geography, 2013 – 2023 (US$ Mn)
TABLE 6 North America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
TABLE 7 Europe Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
TABLE 8 Asia Pacific Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
TABLE 9 Latin America Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn)
TABLE 10 Middle East and Africa Regulatory Affairs Outsourcing Market Revenue, by Country, 2013 – 2023 (US$ Mn) 

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. 

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. 

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.

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 

The global regulatory affairs outsourcing market is segmented into the following categories:

  • Global Regulatory Affairs Outsourcing Market, by Services
    • Regulatory Submissions
    • Clinical Trial Applications and Product Registrations
    • Regulatory Writing and Publishing
    • Regulatory Consulting and Legal Representation
    • Other Regulatory Affairs
  • Global Regulatory Affairs Outsourcing Market, by Geography
    • North America
      • U.S.
      • Canada
    • Europe
      • U.K.
      • Germany
      • Rest of Europe
    • Asia Pacific (APAC)
      • India
      • China
      • Japan
      • Rest of APAC
    • Latin America (LATAM)
      • Brazil
      • Mexico
      • Rest of LATAM
    • Middle East and Africa (MEA)
      • South Africa
      • Rest of MEA 


 
 
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