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
REPORT HIGHLIGHT
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%.
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
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 America’s 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
TARGET AUDIENCE
- Traders, Distributors, and Suppliers
- Manufacturers
- Hospitals
- Government and Regional Agencies and Research Organizations
- Consultants
- Distributors
SCOPE OF THE REPORT
The scope of this report covers the market by its major segments, which include as follows:
MARKET, BY SERVICE
- Regulatory Writing & Publishing
- Regulatory Consulting
- Clinical Trial & Product Registration
- Legal Representation
- Others
MARKET, BY REGION
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- Rest of Europe
- Asia Pacific
- India
- China
- Rest of APAC
- Rest of the World
- Middle East and Africa
- Latin America
TABLE OF CONTENT
1. REGULATORY AFFAIRS OUTSOURCING MARKET OVERVIEW
1.1. Study Scope
1.2. Assumption and Methodology
2. EXECUTIVE SUMMARY
2.1. Key Market Facts
2.2. Geographical Scenario
2.3. Companies in the Market
3. REGULATORY AFFAIRS OUTSOURCING KEY MARKET TRENDS
3.1. Market Drivers
3.1.1. Impact Analysis of Market Drivers
3.2. Market Restraints
3.2.1. Impact Analysis of Market Restraints
3.3. Market Opportunities
3.4. Market Future Trends
4. REGULATORY AFFAIRS OUTSOURCING INDUSTRY STUDY
4.1. Porter’s Analysis
4.2. Market Attractiveness Analysis
4.3. Regulatory Framework Analysis
5. REGULATORY AFFAIRS OUTSOURCING MARKET LANDSCAPE
5.1. Market Share Analysis
6. REGULATORY AFFAIRS OUTSOURCING MARKET – BY SERVICE
6.1. Overview
6.2. Regulatory Writing & Publishing
6.2.1. Overview
6.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.3. Regulatory Consulting
6.3.1. Overview
6.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.4. Clinical Trial & Product Registration
6.4.1. Overview
6.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.5. Legal Representation
6.5.1. Overview
6.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.6. Others
6.6.1. Overview
6.6.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7. REGULATORY AFFAIRS OUTSOURCING MARKET– BY GEOGRAPHY
7.1. Introduction
7.2. North America
7.2.1. Overview
7.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.2.3. U.S.
7.2.3.1. Overview
7.2.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.2.4. Canada
7.2.4.1. Overview
7.2.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3. Europe
7.3.1. Overview
7.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.3. France
7.3.3.1. Overview
7.3.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.4. Germany
7.3.4.1. Overview
7.3.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.5. Rest of Europe
7.3.5.1. Overview
7.3.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4. Asia Pacific (APAC)
7.4.1. Overview
7.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.3. China
7.4.3.1. Overview
7.4.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.4. India
7.4.4.1. Overview
7.4.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.5. Rest of APAC
7.4.5.1. Overview
7.4.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5. Rest of the World
7.5.1. Overview
7.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5.3. Latin America
7.5.3.1. Overview
7.5.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5.4. Middle East and Africa
7.5.4.1. Overview
7.5.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
8. KEY VENDOR ANALYSIS
8.1. Quintiles Transnational
8.1.1. Company Overview
8.1.2. SWOT Analysis
8.1.3. Key Developments
8.2. ICON plc
8.2.1. Company Overview
8.2.2. SWOT Analysis
8.2.3. Key Developments
8.3. Pharmaceutical Product Development
8.3.1. Company Overview
8.3.2. SWOT Analysis
8.3.3. Key Developments
8.4. PAREXEL International
8.4.1. Company Overview
8.4.2. SWOT Analysis
8.4.3. Key Developments
8.5. Covance, Inc.
8.5.1. Company Overview
8.5.2. SWOT Analysis
8.5.3. Key Developments
*Client can request additional company profiling as per specific requirements
9. 360 DEGREE ANALYSTVIEW
10. APPENDIX
10.1. Research Methodology
10.2. Abbreviations
10.3. Disclaimer
10.4. Contact Us
List of Tables
Table 1 List of Acronyms
Table 2 Key Market Facts, 2014 – 2025
Table 3 Market Drivers: Impact Analysis
Table 4 Market Restraint: Impact Analysis
Table 5 Market Opportunity: Impact Analysis
Table 6 PEST Analysis
Table 7 Porter’s Five Forces Analysis
Table 8 Company Market Share Analysis
Table 9 Global Regulatory Affairs Outsourcing Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
Table 10 Regulatory Affairs Outsourcing Market, by Service, 2014 – 2025 (USD Billion)
Table 11 Regulatory Affairs Outsourcing Market, by Geography, 2014 – 2025 (USD Billion)
Table 12 North America Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 13 U.S. Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 14 Canada Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 15 Europe Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 16 France Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 17 Germany Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 18 Asia Pacific Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 19 China Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 20 India Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 21 Latin America Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 22 MEA Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
List of Figures
Figure 1 Research Methodology
Figure 2 Research Process Flow Chart
Figure 3 Comparative Analysis, by Geography, 2016-2025 (Value %)
Figure 4 Regulatory Framework Analysis
Figure 5 Regulatory Affairs Outsourcing Market, by Service, 2014 – 2025 (USD Billion)
Figure 6 Regulatory Affairs Outsourcing Market, by Geography, 2014 – 2025 (USD Billion)
