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Regulatory Affairs Outsourcing Market Analysis By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Application), And Segment Forecasts, 2014 - 2025

Regulatory Affairs Outsourcing Market Analysis By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Application), And Segment Forecasts, 2014 - 2025

The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025, according to a new report by Grand View Research, Inc. Outsourcing of regulatory affairs functions to CROs or other individual service providers offers life science companies the benefit to achieve cost efficiency and reduce the overall approval process time by eliminating delays associated with regulatory submission requirements. These benefits are primarily driving the outsourcing trend and hence impacting the market over the forecast period.

The augmenting disease prevalence in Asia Pacific and MEA regions and increasing number of clinical trials being conducted is stimulating life science companies to expand into these regions thereby increasing the demand of these services. Changing regulatory landscape especially in developing regions and stringent directive requirements in developed regions such as North America and Europe are driving the adoption of outsourcing trend in regulatory affairs function. Growth in emerging areas such as biosimilars and orphan drug is expected to stimulate the demand for regulatory expertise thereby contributing to the growth of regulatory affairs outsourcing market.

Further Key Findings From The Study Suggest:

  • Based on product, legal representation is expected to witness lucrative growth during the forecast period owing to healthcare reforms especially in emerging regions such as India and China. Also, rising demand of legal representation in regions such as Europe for gaining market authorization for companies who do not have an established base in the region. For instance, small or mid-size biopharmaceutical companies having domestic only, requires legal representative if they want to expand their presence in European countries such as UK and Germany. Regulatory writing and publishing is expected to be the leading segment during the forecast period.
  • Few of the industry players for the regulatory affairs outsourcing market are Clinical Research, Clinilabs Inc., Criterium Inc., PRA International, Promedica International, Wuxi AppTec, Medpace Inc.The other major players include Pharmaceutical Product Development(PPD), PAREXEL International Corporation, Charles River Laboratories International Inc., and Covance Inc.
  • There has been a trend of strategic partnership between services providers for increasing service portfolio or expanding regional presence. For instance, PPD formed a joint venture with Shin Nippon Biomedical Laboratories Ltd. (SNBL), leading provider of development services to biopharmaceuticals, to provide clinical development services in Japan including function based services such as regulatory and pharmacovigilance.


Chapter 1. Methodology and Scope
1.1. Information Procurement
1.1.1. Purchased database
1.1.2. GVR’s internal database
1.2. Data Analysis
1.3. Market Formulation & Validation
1.4. Approaches for Market Estimation
1.4.1. Approach 1: Commodity flow & bottom-up approach
1.4.2. Approach 2: Top-down and parent market analysis
Chapter 2. Executive Summary
2.1. Regulatory affairs outsourcing - Industry Snapshot and Key Buying Criteria, 2014 - 2025
Chapter 3. Regulatory Affairs Outsourcing Industry Outlook
3.1. Regulatory affairs outsourcing: Market segmentation
3.2. Regulatory affairs outsourcing market size and growth prospects
3.3. Regulatory affairs outsourcing: Market dynamics
3.3.1. Market driver analysis
3.3.2. Market restraint analysis
3.4. Key opportunities prioritized
3.5. Industry analysis - Porter's
3.6. Regulatory affairs outsourcing competitive landscape, 2014
3.6.1. Competitive landscape: Market position analysis (based on products, regional presence and strategic initiatives)
3.7. Regulatory affairs outsourcing market: PESTEL analysis, 2014
Chapter 4. Regulatory Affairs Outsourcing Service Outlook
4.1. Regulatory affairs outsourcing market share, by service, 2014 & 2025
4.2. Regulatory consulting
4.2.1. Regulatory consulting market estimates and forecasts, 2014 - 2025 (USD Million)
4.3. Legal Representation
4.3.1. Legal Representation market estimates and forecasts, 2014 - 2025 (USD Million)
4.4. Regulatory writing and publishing
4.4.1. Regulatory writing and publishing market estimates and forecasts, 2014 - 2025 (USD Million)
4.5. Product registration and clinical trial application
4.5.1. Product registration and clinical trial application market estimates and forecasts, 2014 - 2025 (USD Million)
4.6. Other regulatory affairs
4.6.1. Other regulatory affairs market estimates and forecasts, 2014 - 2025 (USD Million)
Chapter 5. Regulatory Affairs Outsourcing Regional Outlook
5.1. Regulatory affairs outsourcing market share, by region, 2014 & 2025
5.2. North America
5.2.1. North America Regulatory affairs outsourcing market estimates and forecasts, by service, Revenue, 2014 - 2025 (USD Million)
5.2.1.1. U.S. Regulatory affairs outsourcing market estimates and forecasts
5.2.1.2. Canada Regulatory affairs outsourcing market estimates and forecasts
5.3. Europe
5.3.1. Europe Regulatory affairs outsourcing market estimates and forecasts, by Service, 2014 - 2025 (USD Million)
5.3.1.1. UK Regulatory affairs outsourcing market estimates and forecasts
5.3.1.2. Germany Regulatory affairs outsourcing market estimates and forecasts
5.4. Asia Pacific
5.4.1. Asia Pacific Regulatory affairs outsourcing market estimates and forecasts, by service, 2014 - 2025 (USD Million)
5.4.1.1. Japan Regulatory affairs outsourcing market estimates and forecasts
5.4.1.2. China Regulatory affairs outsourcing market estimates and forecasts
5.4.1.2. India Regulatory affairs outsourcing market estimates and forecasts
5.5. Latin America
5.5.1. Latin America Regulatory affairs outsourcing market estimates and forecasts, by service, 2014 - 2025 (USD Million)
5.5.1.1. Brazil Regulatory affairs outsourcing market estimates and forecasts
5.5.1.2. Mexico Regulatory affairs outsourcing market estimates and forecasts
5.6. MEA
5.6.1. MEA Regulatory affairs outsourcing market estimates and forecasts, by product, 2014 - 2025 (USD Million)
5.6.1.1. South Africa Regulatory affairs outsourcing market estimates and forecasts
5.6.1.2. Saudi Arabia Regulatory affairs outsourcing market estimates and forecasts
Chapter 6 Competitive Landscape
6.1. Accell Clinical Research
6.1.1. Company Overview
6.1.2. Financial Performance
6.1.3. Product Benchmarking
6.1.4. Strategic Initiatives
6.2. Genpact Ltd
6.2.1. Company Overview
6.2.2. Financial Performance
6.2.3. Product Benchmarking
6.2.4. Strategic Initiatives
6.3. Criterium, Inc
6.3.1. Company Overview
6.3.2. Financial Performance
6.3.3. Product Benchmarking
6.3.4. Strategic Initiatives
6.4. PRA Health Sciences, Inc
6.4.1. Company Overview
6.4.2. Financial Performance
6.4.3. Product Benchmarking
6.4.4. Strategic Initiatives
6.5. Promedica International
6.5.1. Company Overview
6.5.2. Financial Performance
6.5.3. Product Benchmarking
6.5.4. Strategic Initiatives
6.6. Wuxi AppTec
6.6.1. Company Overview
6.6.2. Financial Performance
6.6.3. Product Benchmarking
6.6.4. Strategic Initiatives
6.7. Medpace, Inc
6.7.1. Company Overview
6.7.2. Financial Performance
6.7.3. Product Benchmarking
6.7.4. Strategic Initiatives
6.8. Pharmaceutical Product Development (PPD), LLC
6.8.1. Company Overview
6.8.2. Financial Performance
6.8.3. Product Benchmarking
6.8.4. Strategic Initiatives
6.9. PARAXEL International Corporation
6.9.1. Company Overview
6.9.2. Financial Performance
6.9.3. Product Benchmarking
6.9.4. Strategic Initiatives
6.10. Charles River Laboratories International, Inc
6.10.1. Company Overview
6.10.2. Financial Performance
6.10.3. Product Benchmarking
6.10.4. Strategic Initiatives
6.11. ICON Plc
6.11.1. Company Overview
6.11.2. Financial Performance
6.11.3. Product Benchmarking
6.11.4. Strategic Initiatives
6.12. QuintilesIMS
6.12.1. Company Overview
6.12.2. Financial Performance
6.12.3. Product Benchmarking
6.12.4. Strategic Initiatives
6.13. Covance, Inc
6.13.1. Company Overview
6.13.2. Financial Performance
6.13.3. Product Benchmarking
6.13.4. Strategic Initiatives
List of Tables
TABLE 1 Regulatory affairs outsourcing‐ Global Market Current and Forecast by Region (2014 ‐ 2024) in (USD Million)
TABLE 2 North America Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Country, 2014 - 2025 (USD Million)
TABLE 3 North America Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million))
TABLE 4 U.S. Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 5 Canada Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 6 Europe Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Country, 2014 - 2025 (USD Million)
TABLE 7 Europe Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 8 UK Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 9 Germany Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 10 Asia Pacific Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Country, 2014 - 2025 (USD Million)
TABLE 11 Asia Pacific Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 12 Japan Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 13 China Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 14 Latin America Regulatory Affairs Outsourcing market estimates and forecasts, by Country, 2014 - 2025 (USD Million)
TABLE 15 Latin America Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 16 Brazil Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 17 Mexico Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 18 MEA Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Country, 2014 - 2025 (USD Million)
TABLE 19 MEA Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 20 South Africa Regulatory Affairs Outsourcing Market Estimates and Forecasts, by Service, 2014 - 2025 (USD Million)
TABLE 20 Saudi Arabia Regulatory Affairs Outsourcing Market Estimates and Forecasts, by End-Use, 2014 - 2025 (USD Million)
List of Figures
FIG. 1 Market research process
FIG. 2 Information procurement
FIG. 3 Primary research pattern
FIG. 4 Market research approaches
FIG. 5 Value chain based sizing & forecasting
FIG. 6 QFD modeling for market share assessment
FIG. 7 Market summary (Figures in USD Million, 2015)
FIG. 8 Market trends & outlook
FIG. 9 Regulatory affairs outsourcing market: Market Segmentation
FIG. 10 Regulatory affairs outsourcing market revenue, (USD Million), 2015-2025
FIG. 11 Market driver relevance analysis (Current & future impact)
FIG. 12 Market restraint relevance analysis (Current & future impact)
FIG. 13 Key Opportunities Prioritized
FIG. 14 Regulatory affairs outsourcing Porter’s analysis
FIG. 15 Regulatory affairs outsourcing PESTEL analysis
FIG. 16 Regulatory affairs outsourcing market product outlook key takeaways
FIG. 17 Regulatory affairs outsourcing market: Type movement analysis
FIG. 18 Regulatory consulting market, 2014 - 2025 (USD Million
FIG. 19 Referral Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 20 Individual and Referral CRM market, 2014 - 2025 (USD Million)
FIG. 21 Product registration and clinical trial application market, 2014 - 2025 (USD Million)
FIG. 22 Other regulatory service market, 2014 - 2025 (USD Million)
FIG. 23 Regional market place: Key takeaways
FIG. 24 Regional outlook, 2015 & 2025
FIG. 25 North America Regulatory affairs outsourcing market, 2013 - 2025 (USD Million)
FIG. 26 U.S. Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 27 Canada Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 28 Europe Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 29 UK Regulatory affairs outsourcing, 2014 - 2025 (USD Million)
FIG. 30 Germany Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 31 Asia Pacific Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 32 Japan Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 33 China Regulatory affairs outsourcing market, 2014 - 2025 (USD Million
FIG. 34 India Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 35 Latin America Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 36 Brazil Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 37 Mexico Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 38 MEA Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 39 South Africa Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 40 Saudi Arabia Regulatory affairs outsourcing market, 2014 - 2025 (USD Million)
FIG. 41 Strategy framework

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