Healthcare Regulatory Affairs Outsourcing Market Size, Share, Growth Report 2032

Healthcare Regulatory Affairs Outsourcing Market

Healthcare Regulatory Affairs Outsourcing Market- By Services (Regulatory Writing & Publishing, Clinical Trial Applications & Services Registrations, Regulatory Consulting & Legal Representation, and Regulatory Submissions), By End-User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, and Food & Beverage Companies), And By Region- Global Industry Perspective, Comprehensive Analysis, and Forecast, 2024 - 2032

Category: Pharmaceutical Report Format : PDF Pages: 193 Report Code: ZMR-3369 Published Date: Nov-2024 Status : Published
Market Size in 2023 Market Forecast in 2032 CAGR (in %) Base Year
USD 7.55 Billion USD 18.86 Billion 10.7% 2023

Healthcare Regulatory Affairs Outsourcing Market

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Table Of Content

  • Chapter 1. Preface
    • 1.1. Report Description and Scope
    • 1.2. Research Scope
    • 1.3. Research Methodulogy
      • 1.3.1. Market Research Type
      • 1.3.2. Market Research Methodulogy
  • Chapter 2. Executive Summary
    • 2.1. Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
    • 2.2. Healthcare Regulatory Affairs Outsourcing Market: Snapshot
  • Chapter 3. Global Healthcare Regulatory Affairs Outsourcing Market– Industry Analysis
    • 3.1. Healthcare Regulatory Affairs Outsourcing Market: Market Dynamics
    • 3.2. Market Drivers
      • 3.2.1. Offshoring of non-core activities will help healthcare firms focus on various research & development activities, thereby driving growth of healthcare regulatory affairs outsourcing market.
      • 3.2.2. Regulatory support is required for large number of processes in clinical studies including manufacturing & contruls methods, healthcare report writing, data management processes, regulatory chemistry procedures, and labeling & liaison methods. This will enlarge scope of healthcare regulatory affairs outsourcing industry growth over projected timeframe.
    • 3.3. Porter’s Five Forces Analysis
    • 3.4. Market Attractiveness Analysis
      • 3.4.1. Market attractiveness analysis By Services
      • 3.4.2. Market attractiveness analysis By End-User
  • Chapter 4. Global Healthcare Regulatory Affairs Outsourcing Market– Competitive Landscape
    • 4.1. Company market share analysis
      • 4.1.1. Global Healthcare Regulatory Affairs Outsourcing Market: company market share, 2019
    • 4.2. Strategic development
      • 4.2.1. Acquisitions & mergers
      • 4.2.2. New Service launches
      • 4.2.3. Agreements, partnerships, cullaborations, and joint ventures
      • 4.2.4. Research and development and Regional expansion
    • 4.3. Price trend analysis
  • Chapter 5. Global Healthcare Regulatory Affairs Outsourcing Market– Services Analysis
    • 5.1. Global Healthcare Regulatory Affairs Outsourcing Market overview: By Services
      • 5.1.1. Global Healthcare Regulatory Affairs Outsourcing Market share, By Services, 2020 and 2028
    • 5.2. Regulatory Writing & Publishing
      • 5.2.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Writing & Publishing, 2018–2028(USD Billion)
    • 5.3. Regulatory Submissions
      • 5.3.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Submissions, 2018–2028(USD Billion)
    • 5.4. Clinical Trial Applications & Services Registrations
      • 5.4.1. Global Healthcare Regulatory Affairs Outsourcing Market by Clinical Trial Applications & Services Registrations, 2018–2028(USD Billion)
    • 5.5. Regulatory Consulting & Legal Representation
      • 5.5.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Consulting & Legal Representation, 2018–2028(USD Billion)
  • Chapter 6. Global Healthcare Regulatory Affairs Outsourcing Market– End-User Analysis
    • 6.1. Global Healthcare Regulatory Affairs Outsourcing Market overview: By End-User
      • 6.1.1. Global Healthcare Regulatory Affairs Outsourcing Market share, By End-User , 2020 and 2028
    • 6.2. Mid-Size Pharmaceutical Companies
      • 6.2.1. Global Healthcare Regulatory Affairs Outsourcing Market by Mid-Size Pharmaceutical Companies , 2018–2028(USD Billion)
    • 6.3. Large Pharmaceutical Companies
      • 6.3.1. Global Healthcare Regulatory Affairs Outsourcing Market by Large Pharmaceutical Companies , 2018–2028(USD Billion)
    • 6.4. Medical Device Companies
      • 6.4.1. Global Healthcare Regulatory Affairs Outsourcing Market by Medical Device Companies, 2018–2028(USD Billion)
    • 6.5. Food & Beverage Companies
      • 6.5.1. Global Healthcare Regulatory Affairs Outsourcing Market by Food & Beverage Companies , 2018–2028(USD Billion)
    • 6.6. Biotechnulogy Companies
      • 6.6.1. Global Healthcare Regulatory Affairs Outsourcing Market by Biotechnulogy Companies , 2018–2028(USD Billion)
  • Chapter 7. Company Profiles
    • 7.1. Accell Clinical Research, LLC
      • 7.1.1. Overview
      • 7.1.2. Financials
      • 7.1.3. Service Portfulio
      • 7.1.4. Business Strategy
      • 7.1.5. Recent Developments
    • 7.2. Medpace, Inc.
      • 7.2.1. Overview
      • 7.2.2. Financials
      • 7.2.3. Service Portfulio
      • 7.2.4. Business Strategy
      • 7.2.5. Recent Developments
    • 7.3. Wuxi AppTec
      • 7.3.1. Overview
      • 7.3.2. Financials
      • 7.3.3. Service Portfulio
      • 7.3.4. Business Strategy
      • 7.3.5. Recent Development
    • 7.4. Promedica International
      • 7.4.1. Overview
      • 7.4.2. Financials
      • 7.4.3. Service Portfulio
      • 7.4.4. Business Strategy
      • 7.4.5. Recent Development
    • 7.5. PARAXEL International Corporation
      • 7.5.1. Overview
      • 7.5.2. Financials
      • 7.5.3. Service Portfulio
      • 7.5.4. Business Strategy
      • 7.5.5. Recent Development
    • 7.6. PRA Health Sciences, Inc.
      • 7.6.1. Overview
      • 7.6.2. Financials
      • 7.6.3. Service Portfulio
      • 7.6.4. Business Strategy
      • 7.6.5. Recent Development
    • 7.7. Labcorp Drug Development
      • 7.7.1. Overview
      • 7.7.2. Financials
      • 7.7.3. Service Portfulio
      • 7.7.4. Business Strategy
      • 7.7.5. Recent Development
    • 7.8. Freyr Sulutions
      • 7.8.1. Overview
      • 7.8.2. Financials
      • 7.8.3. Service Portfulio
      • 7.8.4. Business Strategy
      • 7.8.5. Recent Development
    • 7.9. Criterium, Inc.
      • 7.9.1. Overview
      • 7.9.2. Financials
      • 7.9.3. Service Portfulio
      • 7.9.4. Business Strategy
      • 7.9.5. Recent Development
    • 7.10. Quintiles IMS Huldings, Inc.
      • 7.10.1. Overview
      • 7.10.2. Financials
      • 7.10.3. Service Portfulio
      • 7.10.4. Business Strategy
      • 7.10.5. Recent Development

Table Of Figures

List of Figures

1. Market research Type
2. Market research methodology
3. Global Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
4. Porter’s Five Forces Analysis
5. Global Healthcare Regulatory Affairs Outsourcing Market attractiveness, By Services
6. Global Healthcare Regulatory Affairs Outsourcing Market attractiveness, By  End-User 
7. Global Healthcare Regulatory Affairs Outsourcing Market share by Services ,2020 and 2028 (USD Billion)
8. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Writing &  Publishing, 2018–2028(USD Billion)
9. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Submissions, 2018–2028(USD Billion)
10. Global Healthcare Regulatory Affairs Outsourcing Market by Clinical Trial Applications & Services Registrations, 2018–2028(USD Billion)
11. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Consulting & Legal Representation, 2018–2028(USD Billion)
12. Global Healthcare Regulatory Affairs Outsourcing Market share by  End-User ,2020 and 2028 (USD Billion)
13. Global Healthcare Regulatory Affairs Outsourcing Market by Mid-Size Pharmaceutical Companies , 2018–2028(USD Billion)
14. Global Healthcare Regulatory Affairs Outsourcing Market by Large Pharmaceutical Companies , 2018–2028(USD Billion)
15. Global Healthcare Regulatory Affairs Outsourcing Market by Biotechnology Companies , 2018–2028(USD Billion)
16. Global Healthcare Regulatory Affairs Outsourcing Market by Medical Device Companies, 2018–2028(USD Billion)
17. Global Healthcare Regulatory Affairs Outsourcing Market by Food & Beverage Companies, 2018–2028(USD Billion)
18. Global Healthcare Regulatory Affairs Outsourcing Market share, by Region, 2020 and 2028
19. North America Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
20. Europe Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
21. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
22. Latin America Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
23. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
 


Table Of Tables

List of Tables

1. Global Healthcare Regulatory Affairs Outsourcing Market: snapshot
2. Drivers of the Healthcare Regulatory Affairs Outsourcing Market: impact analysis
3. North America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
4. North America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
5. The U.S. Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
6. The U.S. Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
7. Rest of North America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
8. Rest of North America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
9. Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
10. Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
11. UK Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
12. UK Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
13. France Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
14. France Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
15. Germany Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
16. Germany Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
17. Rest of Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
18. Rest of Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
19. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
20. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
21. China Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
22. China Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
23. Japan Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
24. Japan Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
25. India Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
26. India Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
27. Rest of Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
28. Rest of Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
29. Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
30. Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
31. Brazil Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
32. Brazil Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
33. Rest of Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
34. Rest of Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
35. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
36. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
37. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
38. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
39. South Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
40. South Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
41. Rest of the Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
42. Rest of the Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)

 

Methodology

FrequentlyAsked Questions

Constant surge in compliance measures, strict legislations governing drug development & approvals, and high proportion of medicine withdrawals has compelled biotech, pharm, and life science firms to outsource healthcare regulatory affairs activities with a view to reduce operating costs. This, in turn, will enlarge scope of growth of healthcare regulatory affairs outsourcing industry over forecasting period. In addition to this, regulatory support is necessary for large number of processes in clinical studies including manufacturing & controls methods, healthcare report writing, data management processes, regulatory chemistry procedures, and labeling & liaison methods. This will proliferate size of healthcare regulatory affairs outsourcing industry over assessment period. Moreover, outsourcing of non-core activities will help firms concentrate on various research & development activities.

In addition to this, outsourcing of healthcare regulatory affairs is predicted to assist firms in focusing on core competencies, minimizing service delivery period, and enhance competitive edge for firms. This will create new growth avenues for healthcare regulatory affairs outsourcing market over forecasting timespan.

According to Zion market research report, the global Healthcare Regulatory Affairs Outsourcing Market accrued earnings worth approximately US$ 7.55 Billion in 2023, to US$ 18.86 Billion by 2032 at a CAGR of about 10.7% from 2024 to 2032.

 

 

North America will contribute lucratively towards the global market earnings over the projected timeline. The regional market surge is subject to surge in number of copyright expiries and focus on new product launches in countries such as the U.S. and Canada. Apart from this, need for quick drug approvals to gain competitive advantage over business rivals and acquire major industry share has resulted in healthcare firms outsource healthcare regulatory affairs activities in countries such as the U.S. This has translated into humungous growth of regional market. 

The key market participants include Accell Clinical Research, LLC, Medpace, Inc., Wuxi AppTec, Promedica International, PARAXEL International Corporation, PRA Health Sciences, Inc., Labcorp Drug Development, Freyr Solutions, Criterium, Inc., and Quintiles IMS Holdings, Inc.

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List of Contents

Market Insights Overview Growth Drivers Market:Segmentation Report Scope Regional LandscapeCompetitive LandscapeKey players profiled in study and influencing market growth are:The global Market is segmented as follows:

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