CHAPTER 1. Industry Overview of Regulatory Affairs Outsourcing Market
1.1. Definition and Scope
1.1.1. Definition of Regulatory Affairs Outsourcing
1.1.2. Market Segmentation
1.1.3. Years Considered for the Study
1.1.4. Assumptions and Acronyms Used
1.1.4.1. Market Assumptions and Market Forecast
1.1.4.2. Acronyms Used in Global Regulatory Affairs Outsourcing Market
1.2. Summary
1.2.1. Executive Summary
1.2.2. Regulatory Affairs Outsourcing Market By Service
1.2.3. Regulatory Affairs Outsourcing Market By End-user
1.2.4. Regulatory Affairs Outsourcing Market By Region
CHAPTER 2. Research Approach
2.1. Methodology
2.1.1. Research Programs
2.1.2. Market Size Estimation
2.1.3. Market Breakdown and Data Triangulation
2.2. Data Source
2.2.1. Secondary Sources
2.2.2. Primary Sources
CHAPTER 3. Market Dynamics And Competition Analysis
3.1. Market Drivers
3.1.1. Driver 1
3.1.2. Driver 2
3.2. Restraints and Challenges
3.2.1. Restraint 1
3.2.2. Restraint 2
3.3. Growth Opportunities
3.3.1. Opportunity 1
3.3.2. Opportunity 2
3.4. Porter’s Five Forces Analysis
3.4.1. Bargaining Power of Suppliers
3.4.2. Bargaining Power of Buyers
3.4.3. Threat of Substitute
3.4.4. Threat of New Entrants
3.4.5. Degree of Competition
3.5. Market Concentration Ratio and Market Maturity Analysis of Regulatory Affairs Outsourcing Market
3.5.1. Go To Market Strategy
3.5.1.1. Introduction
3.5.1.2. Growth
3.5.1.3. Maturity
3.5.1.4. Saturation
3.5.1.5. Possible Development
3.6. Technological Roadmap for Regulatory Affairs Outsourcing Market
3.7. Value Chain Analysis
3.7.1. List of Key Manufacturers
3.7.2. List of Customers
3.7.3. Level of Integration
3.8. Regulatory Compliance
3.9. Competitive Landscape, 2021
3.9.1. Player Positioning Analysis
3.9.2. Key Strategies Adopted By Leading Players
CHAPTER 4. Regulatory Affairs Outsourcing Market By Service
4.1. Introduction
4.2. Regulatory Affairs Outsourcing Revenue By Service
4.2.1. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast, By Service, 2018-2030
4.2.2. Regulatory Consulting
4.2.2.1. Regulatory Consulting Market Revenue (USD Million) and Growth Rate (%), 2018-2030
4.2.3. Legal Representation
4.2.3.1. Legal Representation Market Revenue (USD Million) and Growth Rate (%), 2018-2030
4.2.4. Product Registration And Clinical Trial Application
4.2.4.1. Product Registration And Clinical Trial Application Market Revenue (USD Million) and Growth Rate (%), 2018-2030
4.2.5. Regulatory Writing And Publishing
4.2.5.1. Regulatory Writing And Publishing Market Revenue (USD Million) and Growth Rate (%), 2018-2030
4.2.6. Other Regulatory Service
4.2.6.1. Other Regulatory Service Market Revenue (USD Million) and Growth Rate (%), 2018-2030
CHAPTER 5. Regulatory Affairs Outsourcing Market By End-user
5.1. Introduction
5.2. Regulatory Affairs Outsourcing Revenue By End-user
5.2.1. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast, By End-user, 2018-2030
5.2.2. Pharmaceutical Companies
5.2.2.1. Pharmaceutical Companies Market Revenue (USD Million) and Growth Rate (%), 2018-2030
5.2.3. Medical Device Companies
5.2.3.1. Medical Device Companies Market Revenue (USD Million) and Growth Rate (%), 2018-2030
5.2.4. Biotechnology Companies
5.2.4.1. Biotechnology Companies Market Revenue (USD Million) and Growth Rate (%), 2018-2030
CHAPTER 6. North America Regulatory Affairs Outsourcing Market By Country
6.1. North America Regulatory Affairs Outsourcing Market Overview
6.2. U.S.
6.2.1. U.S. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
6.2.2. U.S. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
6.3. Canada
6.3.1. Canada Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
6.3.2. Canada Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
6.4. North America PEST Analysis
CHAPTER 7. Europe Regulatory Affairs Outsourcing Market By Country
7.1. Europe Regulatory Affairs Outsourcing Market Overview
7.2. U.K.
7.2.1. U.K. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
7.2.2. U.K. Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
7.3. Germany
7.3.1. Germany Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
7.3.2. Germany Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
France
7.3.3. France Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
7.3.4. France Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
7.4. Spain
7.4.1. Spain Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
7.4.2. Spain Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
7.5. Rest of Europe
7.5.1. Rest of Europe Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
7.5.2. Rest of Europe Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
7.6. Europe PEST Analysis
CHAPTER 8. Asia Pacific Regulatory Affairs Outsourcing Market By Country
8.1. Asia Pacific Regulatory Affairs Outsourcing Market Overview
8.2. China
8.2.1. China Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.2.2. China Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.3. Japan
8.3.1. Japan Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.3.2. Japan Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.4. India
8.4.1. India Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.4.2. India Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.5. Australia
8.5.1. Australia Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.5.2. Australia Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.6. South Korea
8.6.1. South Korea Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.6.2. South Korea Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.7. Rest of Asia-Pacific
8.7.1. Rest of Asia-Pacific Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
8.7.2. Rest of Asia-Pacific Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
8.8. Asia Pacific PEST Analysis
CHAPTER 9. Latin America Regulatory Affairs Outsourcing Market By Country
9.1. Latin America Regulatory Affairs Outsourcing Market Overview
9.2. Brazil
9.2.1. Brazil Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
9.2.2. Brazil Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
9.3. Mexico
9.3.1. Mexico Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
9.3.2. Mexico Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
9.4. Rest of Latin America
9.4.1. Rest of Latin America Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
9.4.2. Rest of Latin America Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
9.5. Latin America PEST Analysis
CHAPTER 10. Middle East & Africa Regulatory Affairs Outsourcing Market By Country
10.1. Middle East & Africa Regulatory Affairs Outsourcing Market Overview
10.2. GCC
10.2.1. GCC Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
10.2.2. GCC Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
10.3. South Africa
10.3.1. South Africa Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
10.3.2. South Africa Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
10.4. Rest of Middle East & Africa
10.4.1. Rest of Middle East & Africa Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By Service, 2018-2030
10.4.2. Rest of Middle East & Africa Regulatory Affairs Outsourcing Revenue (USD Million) and Forecast By End-user, 2018-2030
10.5. Middle East & Africa PEST Analysis
CHAPTER 11. Player Analysis Of Regulatory Affairs Outsourcing Market
11.1. Regulatory Affairs Outsourcing Market Company Share Analysis
11.2. Competition Matrix
11.2.1. Competitive Benchmarking of key players by price, presence, market share, and R&D investment
11.2.2. New Product Launches and Product Enhancements
11.2.3. Mergers And Acquisition In Global Regulatory Affairs Outsourcing Market
11.2.4. Partnership, Joint Ventures and Strategic Alliances/ Sales Agreements
CHAPTER 12. Company Profile
12.1. Medpace Inc.
12.1.1. Company Snapshot
12.1.2. Business Overview
12.1.3. Financial Overview
12.1.3.1. Revenue (USD Million), 2021
12.1.3.2. Medpace Inc. 2021 Regulatory Affairs Outsourcing Business Regional Distribution
12.1.4. Product/Service and Specification
12.1.5. Recent Developments & Business Strategy
12.2. Charles River Laboratories International Inc
12.3. Accell Clinical Research
12.4. PRA International
12.5. Wuxi AppTec
12.6. PAREXEL International Corporation
12.7. Criterium Inc.
12.8. Quintiles Transnational Holdings
12.9. Clinilabs Inc.
12.10. Dr. Regenold GmbH
PRA International
12.5. Wuxi AppTec
12.6. PAREXEL International Corporation
12.7. Criterium Inc.
12.8. Quintiles Transnational Holdings
12.9. Clinilabs Inc.
12.10. Dr. Regenold GmbH
The estimated value of global regulatory affairs outsourcing market in 2021 was accounted to be USD 6,921 Million.
The projected CAGR regulatory affairs outsourcing market during the analysis period of 2022 to 2030 is 10.4%.
The prominent players of the global regulatory affairs outsourcing market are Medpace Inc., Charles River Laboratories International Inc, Accell Clinical Research, PRA International, Wuxi AppTec, PAREXEL International Corporation, Criterium Inc., Quintiles Transnational Holdings, Clinilabs Inc., and Dr. Regenold GmbH.
Asia-Pacific held the dominating regulatory affairs outsourcing during the analysis period of 2022 to 2030.
Europe region exhibited fastest growing CAGR for regulatory affairs outsourcing during the analysis period of 2022 to 2030.
Changing regulatory environment and increasing demand for a faster clearance process for novel medicines and devices drives the growth of global regulatory affairs outsourcing market.
Based on service, regulatory writing and publishing segment is expected to hold the maximum share of the regulatory affairs outsourcing market.
Customer Satisfaction
Availability - we are always there when you need us
Fortune 50 Companies trust Acumen Research and Consulting
of our reports are exclusive and first in the industry
more data and analysis
reports published till date