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Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report by Service (Legal Representation, Regulatory Consulting), by End Use (Medical Device Companies, Pharmaceutical Companies), by Region, and Segment Forecasts, 2020 - 2027

  • ID: 4761223
  • Report
  • March 2020
  • Region: Global
  • 100 pages
  • Grand View Research

FEATURED COMPANIES

  • Boston Analytical
  • Covance
  • Criterium, Inc.
  • Freyr
  • GenPact Ltd.
  • ICON plc
  • MORE
The global regulatory affairs outsourcing market size is expected to reach USD 15.6 billion by 2027, expanding at a CAGR of 11.9%. The entry of life sciences companies in global markets and the evolution of new areas such as orphan drugs, biosimilars, and personalized medicine are propelling market growth.

A significant increase in the fixed costs of in-house resources for healthcare regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities are driving life science firms to outsource these functions. Also, the rising number of clinical trials is expected to boost the demand for the services such as clinical trial applications and product registration in these regions.

Product specific clinical advice and strategy along with healthcare regulatory compliance at the early stages of product development can be critical for the product approval. Failure to address the compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the regulatory requirements.

Addressing local governing challenges and constant changes in the regulations of the major markets such as U.S., Europe, and Asia is creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay current with developments around the world. Amendments to current regulations are likely to complicate the governing pathway for the industry. This, in turn, is anticipated to drive the market for healthcare regulatory affairs outsourcing over the forecast period.

Further key findings from the report suggest:
  • The regulatory writing and publishing segment dominated the regulatory affairs outsourcing market in 2019 with a share of around 35.6% as they are offered from early stages of development to post-marketing authorization phase and is vital for success of a product
  • The legal representation segment is anticipated to register the fastest growth of 12.8% over the forecast period
  • Asia Pacific held the maximum share of the global market for regulatory affairs outsourcing, accounting for 43.0% of the market share in 2019. This can be attributed to the relatively lower cost for outsourcing, skilled workforce with technical expertise, and expansion of life sciences companies in countries such as India and China
  • Some of the players operating in the market are Accell Clinical Research, LLC., GenPact Ltd., Criterium, Inc., PRA Health Sciences, Promedica International, WuXi AppTec, Inc., Medpace, Pharmaceutical Product Development, LLC (PPD), Charles River Laboratories International, Inc., ICON plc, Covance, Parexel International Corporation, Inc., and Freyr.
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Boston Analytical
  • Covance
  • Criterium, Inc.
  • Freyr
  • GenPact Ltd.
  • ICON plc
  • MORE
Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Service
1.1.2. End-use
1.1.3. Regional scope
1.1.4. Estimates and forecast timeline
1.2. Research Methodology
1.3. Information Procurement
1.3.1. Purchased database
1.3.2. Internal database
1.3.3. Secondary sources
1.3.4. Primary research
1.4. Information or Data Analysis
1.4.1. Data analysis models
1.5. Market Formulation & Validation
1.6. Model Details
1.6.1. Commodity flow analysis (Model 1)
1.6.1.1. Approach 1: Commodity flow approach
1.6.2. Volume price analysis (Model 2)
1.6.2.1. Approach 2: Volume price analysis
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
1.9.1. Objective 1: Understanding the market dynamics
1.9.2. Objective 2: Understanding the market estimates and forecasts
1.9.3. Objective 3: Understanding the attributes such as strategy framework, competitor categorization
1.9.4. Objective 4: Understanding the key product and application scopes to conclude on the market size

Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights

Chapter 3. Regulatory Affairs Outsourcing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Penetration & Growth Prospect Mapping
3.3. Market Dynamics
3.3.1. Market Driver Analysis
3.3.1.1. Changing regulatory landscape
3.3.1.2. Entry of companies in the global market
3.3.1.3. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.3.1.4. Demand for faster approval process for breakthrough drugs and devices
3.3.1.5. Economic and competitive pressures
3.3.1.6. Life science companies focusing on their core competencies
3.3.2. Market Restraint Analysis
3.3.2.1. Data insecurity
3.3.2.2. Monitoring issues and lack of standardization
3.3.3. Industry Challenges
3.4. Regulatory Affairs Outsourcing: Market Analysis Tools
3.4.1. Industry Analysis - Porter’s
3.4.1.1. Supplier Power
3.4.1.2. Buyer Power
3.4.1.3. Substitution Threat
3.4.1.4. Threat from new entrant
3.4.1.5. Competitive rivalry
3.4.2. PESTEL Analysis
3.4.2.1. Political Landscape
3.4.2.2. Environmental Landscape
3.4.2.3. Social Landscape
3.4.2.4. Technology Landscape
3.4.2.5. Legal Landscape
3.4.3. Major Deals & Strategic Alliances Analysis

Chapter 4. Regulatory Affairs Outsourcing Market: Segment Analysis, by Service, 2016 - 2027 (USD Million)
4.1. Segment Dashboard
4.2. Definitions & Scope
4.3. Service Market Share Analysis, 2019 & 2027
4.4. Global Regulatory Affairs Outsourcing Market, By Service, 2016 to 2027
4.5. Market Size & Forecasts And Trend Analysis, 2016 to 2027 for the following
4.5.1. Regulatory consulting
4.5.2. Legal representation
4.5.3. Regulatory writing and publishing
4.5.4. Product registration and clinical trial application
4.5.5. Other regulatory services

Chapter 5. Regulatory Affairs Outsourcing Market: Segment Analysis, by End Use, 2016 - 2027 (USD Million)
5.1. Segment Dashboard
5.2. Definitions & Scope
5.3. Service Market Share Analysis, 2019 & 2027
5.4. Global Regulatory Affairs Outsourcing Market, By End Use, 2016 to 2027
5.5. Market Size & Forecasts And Trend Analysis, 2016 to 2027 for the following
5.5.1. Medical device companies
5.5.2. Pharmaceutical companies
5.5.3. Biotechnology companies

Chapter 6. Regulatory Affairs Outsourcing Market: Regional Market Analysis, by Service, 2016 - 2027 (USD Million)
6.1. Regional Market Dashboard
6.2. Regional Market Share Analysis, 2019 & 2027
6.3. Market Size, & Forecasts, And Trend Analysis, 2016 to 2027:
6.4. North America
6.4.1. Market estimates and forecast, by country, 2016 - 2027 (USD Million)
6.4.2. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.4.3. Market estimates and forecast, by end use, 2016 - 2027 (USD Million
6.4.4. U.S.
6.4.4.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.4.4.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.4.5. Canada
6.4.5.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.4.5.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5. Europe
6.5.1. Market estimates and forecast, by country, 2016 - 2027 (USD Million)
6.5.2. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.3. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.4. U.K.
6.5.4.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.4.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.5. Germany
6.5.5.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.5.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.6. France
6.5.6.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.6.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.7. Italy
6.5.7.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.7.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.8. Spain
6.5.8.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.8.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.9. Russia
6.5.9.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.9.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.10. Turkey
6.5.10.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.10.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.11. Netherlands
6.5.11.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.11.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.12. Switzerland
6.5.12.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.12.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.5.13. Sweden
6.5.13.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.5.13.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6. Asia Pacific
6.6.1. Market estimates and forecast, by country, 2016 - 2027 (USD Million)
6.6.2. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.3. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.4. China
6.6.4.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.4.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.5. Japan
6.6.5.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.5.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.6. India
6.6.6.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.6.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.7. Australia
6.6.7.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.7.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.8. South Korea
6.6.8.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.8.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.9. Indonesia
6.6.9.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.9.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.10. Malaysia
6.6.10.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.10.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.11. Singapore
6.6.11.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.11.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.12. Thailand
6.6.12.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.12.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.6.13. Taiwan
6.6.13.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.6.13.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7. Latin America
6.7.1. Market estimates and forecast, by country, 2016 - 2027 (USD Million)
6.7.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7.3. Brazil
6.7.3.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.7.3.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7.4. Mexico
6.7.4.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.7.4.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7.5. Argentina
6.7.5.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.7.5.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7.6. Colombia
6.7.6.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.7.6.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.7.7. Chile
6.7.7.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.7.7.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8. Middle East and Africa
6.8.1. Market estimates and forecast, by country, 2016 - 2027 (USD Million)
6.8.2. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.3. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8.4. South Africa
6.8.4.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.4.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8.5. Saudi Arabia
6.8.5.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.5.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8.6. UAE
6.8.6.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.6.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8.7. Egypt
6.8.7.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.7.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)
6.8.8. Israel
6.8.8.1. Market estimates and forecast, by service, 2016 - 2027 (USD Million)
6.8.8.2. Market estimates and forecast, by end use, 2016 - 2027 (USD Million)

Chapter 7. Regulatory Affairs Outsourcing Market - Competitive Analysis
7.1. Key companies profiled
7.1.1. Accell Clinical Research, LLC.
7.1.1.1. Company overview
7.1.1.2. Financial performance
7.1.1.3. Product benchmarking
7.1.1.4. Strategic initiatives
7.1.2. GenPact Ltd.
7.1.2.1. Company overview
7.1.2.2. Financial performance
7.1.2.3. Product benchmarking
7.1.2.4. Strategic initiatives
7.1.3. Criterium, Inc.
7.1.3.1. Company overview
7.1.3.2. Financial performance
7.1.3.3. Product benchmarking
7.1.3.4. Strategic initiatives
7.1.4. PRA Health Sciences
7.1.4.1. Company overview
7.1.4.2. Financial performance
7.1.4.3. Product benchmarking
7.1.4.4. Strategic initiatives
7.1.5. Promedica International
7.1.5.1. Company overview
7.1.5.2. Financial performance
7.1.5.3. Product benchmarking
7.1.5.4. Strategic initiatives
7.1.6. WuXi AppTec, Inc.
7.1.6.1. Company overview
7.1.6.2. Financial performance
7.1.6.3. Product benchmarking
7.1.6.4. Strategic initiatives
7.1.7. Medpace
7.1.7.1. Company overview
7.1.7.2. Financial performance
7.1.7.3. Product benchmarking
7.1.7.4. Strategic initiatives
7.1.8. Boston Analytical
7.1.8.1. Company overview
7.1.8.2. Financial performance
7.1.8.3. Product benchmarking
7.1.8.4. Strategic initiatives
7.1.9. Charles River Laboratories International, Inc.
7.1.9.1. Company overview
7.1.9.2. Financial performance
7.1.9.3. Product benchmarking
7.1.9.4. Strategic initiatives
7.1.10. ICON plc
7.1.10.1. Company overview
7.1.10.2. Financial performance
7.1.10.3. Product benchmarking
7.1.10.4. Strategic initiatives
7.1.11. Covance
7.1.11.1. Company overview
7.1.11.2. Financial performance
7.1.11.3. Product benchmarking
7.1.11.4. Strategic initiatives
7.1.12. Parexel International Corporation, Inc.
7.1.12.1. Company overview
7.1.12.2. Financial performance
7.1.12.3. Product benchmarking
7.1.12.4. Strategic initiatives
7.1.13. Freyr
7.1.13.1. Company overview
7.1.13.2. Financial performance
7.1.13.3. Product benchmarking
7.1.13.4. Strategic initiatives
Note: Product cover images may vary from those shown
  • Accell Clinical Research, LLC.
  • GenPact Ltd.
  • Criterium, Inc.
  • PRA Health Sciences
  • Promedica International
  • WuXi AppTec, Inc.
  • Medpace
  • Boston Analytical
  • Charles River Laboratories International, Inc.
  • ICON plc
  • Covance
  • Parexel International Corporation, Inc.
  • Freyr
Note: Product cover images may vary from those shown

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