The healthcare regulatory affairs outsourcing market is expected to grow from USD 6.55 billion in 2019 to USD 16.57 billion by 2027, at a CAGR of 12.3% during the forecast period 2020-2027.
The healthcare regulatory affairs outsourcing includes medical writing and publishing the regulatory documentation offered by quality control, experienced medical writers, and publishers that play an important role in developing high-quality documents for clinical research projects. Further, regulatory submissions refer to the submission of any documentation on healthcare products to a regulatory agency to get reviewed. Healthcare regulatory affairs outsourcing services are in demand from mid-size pharma companies, large pharma companies, and various others.
The factors driving the market are rising investments in the healthcare sector in developed and developing countries, increasing R&D activities, and increasing collaboration between regulatory outsourcing and drug developers. The risk associated with data security, system access, and loss of control and technological advances leading to pricing fluctuations restrains the market growth. Adoption of regulatory affairs in developing economies provide market growth opportunities.
This study delivers a comprehensive analysis of services, end-user, and region. The services segment includes legal representation, regulatory consulting, regulatory writing and publishing, and product registration and clinical trial application. The regulatory writing and publishing segment holds the largest market share, owing to an increasing need for high-quality documents to support timely drug approval, increasing demand for regulatory writing and publishing services. The legal representation segment is expected to witness significant growth, owing to the increasing demand for legal representation. Based on end-user, the market is segmented into pharmaceutical, medical devices, food and beverages, and biotechnology. The pharmaceutical segment holds the largest market share, owing to rapid development in generic ANDA filings, personalised medicines, adaptive trial designs, companion diagnostics, and novel drug applications.
The market has been divided into North America, Europe, Asia-Pacific, Middle East & Africa, and South America. North America dominates the market, owing to changing regulatory scenarios across the region. In the region, the market is driven by the U.S., owing to the presence of large pharmaceutical and biotech companies to maintain workload management. The market in the Asia-Pacific region is expected to witness significant growth, owing to lower outsourcing costs, the availability of a skilled workforce, and the rapid expansion of healthcare companies. In the region, China and India influence market growth, owing to an increasing number of clinical trials.
Some of the notable players in the market are Parexel International Corporation, Covance Group Ltd., Quintiles Transnational Holdings, Inc., ICON Plc., Pharmaceutical Product Development, Charles River Laboratories International, Inc., Medpace, Inc., KAI Research, Inc., and Medelis, Inc. In April 2019, Citoxlab, a non-clinical contract research organization, was acquired by Charles River Laboratories International Inc. This acquisition was made to expand the product portfolio and strengthen its market position.
Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, Services
Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, End-User
Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, Region
Report Description:
1. Introduction
1.1. Objectives of the Study
1.2. Market Definition
1.3. Research Scope
1.4. Currency
1.5. Key Target Audience
2. Research Methodology and Assumptions
3. Executive Summary
4. Premium Insights
4.1. Porter’s Five Forces Analysis
4.2. Value Chain Analysis
4.3. Top Investment Pockets
4.3.1. Market Attractiveness Analysis By Services
4.3.2. Market Attractiveness Analysis By End-User
4.3.3. Market Attractiveness Analysis By Region
4.4. Industry Trends
5. Market Dynamics
5.1. Market Evaluation
5.2. Drivers
5.2.1. Rising investments in the healthcare sector in developed and developing countries
5.2.2. Increasing R & D activities
5.3. Restraints
5.3.1. Risk associated with data security
5.4. Opportunities
5.4.1. Adoption of regulatory affairs in developing economies
6. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services
6.1. Segment Overview
6.2. Legal Representation
6.3. Regulatory Consulting
6.4. Regulatory Writing and Publishing
6.5. Product Registration and Clinical Trial Application
7. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End-User
7.1. Segment Overview
7.2. Pharmaceutical
7.3. Medical Device
7.4. Food and Beverages
7.5. Biotechnology
8. Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Regional Analysis
8.1. Segment Overview
8.2. North America
8.2.1. U.S.
8.2.2. Canada
8.2.3. Mexico
8.3. Europe
8.3.1. Germany
8.3.2. France
8.3.3. U.K.
8.3.4. Italy
8.3.5. Spain
8.4. Asia-Pacific
8.4.1. Japan
8.4.2. China
8.4.3. India
8.5. South America
8.5.1. Brazil
8.6. Middle East and Africa
8.6.1. UAE
8.6.2. South Africa
9. Global Healthcare Regulatory Affairs Outsourcing Market-Competitive Landscape
9.1. Overview
9.2. Market Share of Key Players in Global Healthcare Regulatory Affairs Outsourcing Market
9.2.1. Global Company Market Share
9.2.2. North America Company Market Share
9.2.3. Europe Company Market Share
9.2.4. APAC Company Market Share
9.3. Competitive Situations and Trends
9.3.1. Services Launches and Developments
9.3.2. Partnerships, Collaborations, and Agreements
9.3.3. Mergers & Acquisitions
9.3.4. Expansions
10. Company Profiles
10.1. Parexel International Corporation
10.1.1. Business Overview
10.1.2. Company Snapshot
10.1.3. Company Market Share Analysis
10.1.4. Company Services Portfolio
10.1.5. Recent Developments
10.1.6. SWOT Analysis
10.2. Covance Group Ltd.
10.2.1. Business Overview
10.2.2. Company Snapshot
10.2.3. Company Market Share Analysis
10.2.4. Company Services Portfolio
10.2.5. Recent Developments
10.2.6. SWOT Analysis
10.3. Quintiles Transnational Holdings, Inc.
10.3.1. Business Overview
10.3.2. Company Snapshot
10.3.3. Company Market Share Analysis
10.3.4. Company Services Portfolio
10.3.5. Recent Developments
10.3.6. SWOT Analysis
10.4. ICON Plc.
10.4.1. Business Overview
10.4.2. Company Snapshot
10.4.3. Company Market Share Analysis
10.4.4. Company Services Portfolio
10.4.5. Recent Developments
10.4.6. SWOT Analysis
10.5. Pharmaceutical Product Development
10.5.1. Business Overview
10.5.2. Company Snapshot
10.5.3. Company Market Share Analysis
10.5.4. Company Services Portfolio
10.5.5. Recent Developments
10.5.6. SWOT Analysis
10.6. Charles River Laboratories International, Inc.
10.6.1. Business Overview
10.6.2. Company Snapshot
10.6.3. Company Market Share Analysis
10.6.4. Company Services Portfolio
10.6.5. Recent Developments
10.6.6. SWOT Analysis
10.7. Medpace, Inc.
10.7.1. Business Overview
10.7.2. Company Snapshot
10.7.3. Company Market Share Analysis
10.7.4. Company Services Portfolio
10.7.5. Recent Developments
10.7.6. SWOT Analysis
10.8. KAI Research, Inc.
10.8.1. Business Overview
10.8.2. Company Snapshot
10.8.3. Company Market Share Analysis
10.8.4. Company Services Portfolio
10.8.5. Recent Developments
10.8.6. SWOT Analysis
10.9. Medelis, Inc.
10.9.1. Business Overview
10.9.2. Company Snapshot
10.9.3. Company Market Share Analysis
10.9.4. Company Services Portfolio
10.9.5. Recent Developments
10.9.6. SWOT Analysis
List of Table
1. Global Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
2. Global Legal Representation, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
3. Global Regulatory Consulting, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
4. Global Regulatory Writing and Publishing, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
5. Global Product Registration and Clinical Trial Application, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
6. Global Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
7. Global Pharmaceutical, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
8. Global Medical Device, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
9. Global Food and Beverage, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
10. Global Biotechnology, Healthcare Regulatory Affairs Outsourcing Market, By Region, 2019-2027 (USD Billion)
11. North America Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
12. North America Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
13. U.S. Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
14. U.S. Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
15. Canada Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
16. Canada Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
17. Mexico Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
18. Mexico Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
19. Europe Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
20. Europe Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
21. Germany Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
22. Germany Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
23. France Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
24. France Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
25. U.K. Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
26. U.K. Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
27. Italy Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
28. Italy Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
29. Spain Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
30. Spain Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
31. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
32. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
33. Japan Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
34. Japan Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
35. China Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
36. China Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
37. India Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
38. India Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
39. South America Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
40. South America Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
41. Brazil Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
42. Brazil Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
43. Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
44. Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
45. UAE Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
46. UAE Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
47. South Africa Healthcare Regulatory Affairs Outsourcing Market, By Services, 2019-2027 (USD Billion)
48. South Africa Healthcare Regulatory Affairs Outsourcing Market, By End-User, 2019-2027 (USD Billion)
List of Figures
1. Global Healthcare Regulatory Affairs Outsourcing Market Segmentation
2. Global Healthcare Regulatory Affairs Outsourcing Market: Research Methodology
3. Market Size Estimation Methodology: Bottom-Up Approach
4. Market Size Estimation Methodology: Top-Down Approach
5. Data Triangulation
6. Porter’s Five Forces Analysis
7. Value Chain Analysis
8. Global Healthcare Regulatory Affairs Outsourcing Market Attractiveness Analysis By Services
9. Global Healthcare Regulatory Affairs Outsourcing Market Attractiveness Analysis By End-User
10. Global Healthcare Regulatory Affairs Outsourcing Market Attractiveness Analysis By Region
11. Global Healthcare Regulatory Affairs Outsourcing Market: Dynamics
12. Global Healthcare Regulatory Affairs Outsourcing Market Share by Services (2020 & 2027)
13. Global Healthcare Regulatory Affairs Outsourcing Market Share by End-User (2020 & 2027)
14. Global Healthcare Regulatory Affairs Outsourcing Market Share by Regions (2020 & 2027)
15. Global Healthcare Regulatory Affairs Outsourcing Market Share by Company (2019)
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