Overview

Regulatory Affairs Outsourcing Market is poised to value USD 11806.16 million by 2028 end at a CAGR of 8.9% during the forecast period 2022 to 2028. 

FutureWise Market Research has instantiated a report that provides an intricate analysis of Regulatory Affairs Outsourcing Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.

According to the research study conducted by FutureWise research analysts, the Regulatory Affairs Outsourcing Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business Indication.

Major players included in the Regulatory Affairs Outsourcing Market:
• Accell Clinical Research, LLC
• GenPact Ltd
• Criterium
• PRA Health Sciences
• Promedica International
• WuXiAppTec, Inc
• Medpace
• Pharmaceutical Product Development, LLC (PPD)
• Charles River Laboratories International, Inc.
• ICON plc
• Covance
• Parexel International Corporation; Inc
• Freyr
• Clinilabs Inc.
• IQVIA Holdings Inc.
• Certara, L.P.
(Note: The list of the major players will be updated with the latest market scenario and trends)

Regulatory Affairs Outsourcing Market Segmentation:
By Services
• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
• Product Registration & Clinical Trial Applications
• Other Services

By Company Size
• Small
• Medium
• Large

By Category
• Drugs
   o Generics
   o Innovators
• Biologics
   o Biotech
   o ATMPs
• Medical devices
   o Therapeutic
   o Diagnostic

By Indication
• Oncology
• Neurology
• Cardiology
• Immunology
• Others

By Stage
• Preclinical
• Clinical
• PMA (Post Market Authorization)

By End-user
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

By Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

Competitive Landscape:
• Tier 1 players- established companies in the market with a major market share
• Tier 2 players
• Emerging players which are growing rapidly
• New Entrants

FutureWise Key Takeaways:
• Growth prospects
• SWOT analysis
• Key trends
• Key data-points affecting market growth

Objectives of the Study:
• To provide with an exhaustive analysis on the Regulatory Affairs Outsourcing Market By Services, By Company Size, By Category, By Indication, By Stage, By End-user and By Region.
• To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
• To evaluate and forecast micro-markets and the overall market
• To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
• To record and evaluate competitive landscape mapping- Services launches, technological advancements, mergers and expansions

Flexible Delivery Model:
• We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
• The customization Mobility Care offered are free of charge with purchase of any license of the report
• You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents

1. Market Introduction
  1.1 Objectives of the Study
  1.2 Market Definition
  1.3 Market Scope
      1.3.1 Years Considered for the Study
      1.3.2 Market Covered
  1.4 Currency
  1.5 Limitations
  1.6 Stakeholders

2. Research Company Sizeology
   2.1 Research Data
       2.1.1 Secondary Data
             2.1.1.1 Key Data from Secondary Sources
       2.1.2 Primary Data
             2.1.2.1 Key Data from Primary Sources
   2.2 Market Size Estimation
   2.3 Market Breakdown and Data Triangulation
   2.4 Assumptions for the Study  

3. Executive Summary
  3.1 Market Outlook
  3.2 Segment Outlook
  3.3 Competitive Insights

4. Regulatory Affairs Outsourcing Market Variables, Trends & Scope
  4.1. Market Lineage Outlook
  4.2. Penetration and Growth Prospect Mapping
  4.3. Industry Value Chain Analysis
  4.4. Cost Analysis Breakdown
  4.5. Technology Overview
  4.6. Regulatory Framework
       4.6.1. Reimbursement Framework
       4.6.2. Standards and Compliances

5. Market Overview
  5.1. Market Dynamics
       5.1.1. Market Driver Analysis
              5.1.1.1. Increasing focus of Regulatory Affairs Outsourcing Companies on Brand Protection
              5.1.1.2. Untapped Opportunities in Emerging Regions
       5.1.2. Market Restraint Analysis
              5.1.2.1. High Cost Associated with Implementation of Predictive Analysis
       5.1.3. Industry Challenges
              5.1.3.1. Presence of Ambiguous Regulatory Framework

6. Regulatory Affairs Outsourcing Market Analysis Tools
  6.1. Industry Analysis - Porter’s
       6.1.1. Supplier Power
       6.1.2. Buyer Power
       6.1.3. Substitution Threat
       6.1.4. Threat from New Entrants
       6.1.5. Competitive Rivalry
  6.2. Pestel Analysis
       6.2.1. Political Landscape
       6.2.2. Environmental Landscape
       6.2.3. Social Landscape
       6.2.4. Technology Landscape
       6.2.5. Legal Landscape
  6.3. Major Deals And Strategic Alliances Analysis
       6.3.1. Joint Ventures
       6.3.2. Mergers and Acquisitions
       6.3.3. Licensing and Partnership
       6.3.4. Technology Collaborations
       6.3.5. Strategic Divestments
  6.4. Market Entry Strategies
  6.5. Case Studies

7. Regulatory Affairs Outsourcing Market, By Services Historical Analysis and Forecast 2022-2028 (USD Million)
  7.1. Regulatory Consulting
  7.2. Legal Representation
  7.3. Regulatory Writing & Publishing
  7.4. Product Registration & Clinical Trial Applications
  7.5. Other Services

8. Regulatory Affairs Outsourcing Market, By Company Size Historical Analysis and Forecast 2022-2028 (USD Million)  
  8.1. Small
  8.2. Medium
  8.3. Large

9. Regulatory Affairs Outsourcing Market, By Category Historical Analysis and Forecast 2022-2028 (USD Million)  
  9.1. Drugs
        9.1.1. Generics
        9.1.2. Innovators
  9.2. Biologics
        9.2.1. Biotech
        9.2.2. ATMPs
  9.3. Medical devices
        9.3.1. Therapeutic
        9.3.2. Diagnostic

10. Regulatory Affairs Outsourcing Market, By Indication Historical Analysis and Forecast 2022-2028 (USD Million)  
   10.1. Oncology
   10.2. Neurology
   10.3. Cardiology
   10.4. Immunology
   10.5. Others

11. Regulatory Affairs Outsourcing Market, By Stage Historical Analysis and Forecast 2022-2028 (USD Million)  
   11.1. Preclinical
   11.2. Clinical
   11.3. PMA (Post Market Authorization)

12. Regulatory Affairs Outsourcing Market, By End-user Historical Analysis and Forecast 2022-2028 (USD Million)  
   12.1. Medical Device Companies
   12.2. Pharmaceutical Companies
   12.3. Pharmaceutical Companies

13. North America Regulatory Affairs Outsourcing Market Analysis 2016–2020 and Forecast 2022–2028 (USD Million)
  13.1. Introduction
  13.2. Historical Market Size (USD Million) Analysis By Country, 2016-2020
       13.2.1. U.S.A
       13.2.2. Canada
       13.2.3. Mexico
  13.3. Market Size (USD Million) Forecast for North America 2022-2028

14. Latin America Regulatory Affairs Outsourcing Market Analysis 2016–2020 and Forecast 2022–2028 (USD Million)
   14.1. Introduction
   14.2. Historical Market Size (USD Million) Analysis By Country, 2016-2020
         14.2.1. Brazil
         14.2.2. Venezuela
         14.2.3. Argentina
         14.2.4. Rest of Latin America
   14.3. Market Size (USD Million) Forecast for Latin America 2022-2028

15. Europe Regulatory Affairs Outsourcing Market Analysis 2016–2020 and Forecast 2022–2028 (USD Million)
   15.1. Introduction
   15.2. Historical Market Size (USD Million) Analysis By Country, 2016-2020
         15.2.1. Germany
         15.2.2. U.K        
         15.2.3. France
         15.2.4. Italy
         15.2.5. Spain
         15.2.6. Russia
         15.2.7. Poland
         15.2.8. Rest of Europe
   15.3. Market Size (USD Million) Forecast for Europe 2022-2028

16. Asia Pacific Regulatory Affairs Outsourcing Market Analysis 2016–2020 and Forecast 2022–2028 (USD Million)
   16.1. Introduction
   16.2. Historical Market Size (USD Million) Analysis By Country, 2016-2020
         16.2.1. Japan
         16.2.2. China
         16.2.3. India
         16.2.4. Australia and New Zealand
         16.2.5. ASEAN
         16.2.6. Rest of Asia Pacific
   16.3. Market Size (USD Million) Forecast for Asia Pacific 2022-2028  

17. Middle East and Africa Market Analysis 2016–2020 and Forecast 2022–2028 (USD Million)
   17.1. Introduction
   17.2. Historical Market Size (USD Million) Analysis By Country, 2016-2020
         17.2.1. GCC
         17.2.2. Israel
         17.2.3. South Africa
         17.2.4. Rest of MEA
   17.3. Market Size (USD Million) Forecast for MEA 2022-2028

18. Market Share Analysis and Competitive Landscape  
   18.1. Global Landscape - Key Players, Revenue and Presence
   18.2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
   18.3. Global Emerging Companies
   18.4.  North America - Market Share Analysis and Key Regional Players
   18.5.  Europe - Market Share Analysis and Key Regional Players
   18.6.  Asia Pacific - Market Share Analysis and Key Regional Players
   18.7.  Global Key Player - Growth Matrix

19. Company Profiles (Competition Dashboard, Competitors Deep Dive, Servicess Offered and Financial Layouts)
   19.1. Accell Clinical Research, LLC
         19.1.1. Company Overview
         19.1.2. Product Portfolio
         19.1.3. SWOT Analysis
         19.1.4. Financial Overview
         19.1.5. Strategic Overview
   19.2. GenPact Ltd
         19.2.1. Company Overview
         19.2.2. Product Portfolio
         19.2.3. SWOT Analysis
         19.2.4. Financial Overview
         19.2.5. Strategic Overview
   19.3. Criterium
         19.3.1. Company Overview
         19.3.2. Product Portfolio
         19.3.3. SWOT Analysis
         19.3.4. Financial Overview
         19.3.5. Strategic Overview
   19.4. PRA Health Sciences
         19.4.1. Company Overview
         19.4.2. Product Portfolio
         19.4.3. SWOT Analysis
         19.4.4. Financial Overview
         19.4.5. Strategic Overview
   19.5. Promedica International
         19.5.1. Company Overview
         19.5.2. Product Portfolio
         19.5.3. SWOT Analysis
         19.5.4. Financial Overview
         19.5.5. Strategic Overview          
   19.6. WuXiAppTec, Inc
         19.6.1. Company Overview
         19.6.2. Product Portfolio
         19.6.3. SWOT Analysis
         19.6.4. Financial Overview
         19.6.5. Strategic Overview      
   19.7. Medpace
         19.7.1. Company Overview
         19.7.2. Product Portfolio
         19.7.3. SWOT Analysis
         19.7.4. Financial Overview
         19.7.5. Strategic Overview
   19.8. Pharmaceutical Product Development, LLC (PPD)
         19.8.1. Company Overview
         19.8.2. Product Portfolio
         19.8.3. SWOT Analysis
         19.8.4. Financial Overview
         19.8.5. Strategic Overview
   19.9. Charles River Laboratories International, Inc.
         19.9.1. Company Overview
         19.9.2. Product Portfolio
         19.9.3. SWOT Analysis
         19.9.4. Financial Overview
         19.9.5. Strategic Overview
   19.10.ICON plc
         19.10.1. Company Overview
         19.10.2. Product Portfolio
         19.10.3. SWOT Analysis
         19.10.4. Financial Overview
         19.10.5. Strategic Overview
   19.11.Covance
         19.11.1. Company Overview
         19.11.2. Product Portfolio
         19.11.3. SWOT Analysis
         19.11.4. Financial Overview
         19.11.5. Strategic Overview
   19.12.Parexel International Corporation; Inc
         19.12.1. Company Overview
         19.12.2. Product Portfolio
         19.12.3. SWOT Analysis
         19.12.4. Financial Overview
         19.12.5. Strategic Overview
   19.13.Freyr
         19.13.1. Company Overview
         19.13.2. Product Portfolio
         19.13.3. SWOT Analysis
         19.13.4. Financial Overview
         19.13.5. Strategic Overview
   19.14.Clinilabs Inc.
         19.14.1. Company Overview
         19.14.2. Product Portfolio
         19.14.3. SWOT Analysis
         19.14.4. Financial Overview
         19.14.5. Strategic Overview
   19.15.IQVIA Holdings Inc.
         19.15.1. Company Overview
         19.15.2. Product Portfolio
         19.15.3. SWOT Analysis
         19.15.4. Financial Overview
         19.15.5. Strategic Overview
   19.16.Certara, L.P.
         19.16.1. Company Overview
         19.16.2. Product Portfolio
         19.16.3. SWOT Analysis
         19.16.4. Financial Overview
         19.16.5. Strategic Overview
 
20 Pre and Post COVID-19 Impact
   20.1. Positive influence on the healthcare industry
   20.2. The financial disruption of the manufacturing sector
   20.3. Impact of COVID-19 on emerging companies
   20.4. Significant mandates in the healthcare regulations initiated by administrations
   20.5. The overall economic slowdown of the developing and developed nations

21. FutureWise SME Key Takeaway Points for Client

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