Healthcare Regulatory Affairs Outsourcing Market Trends, Application And Growth Analysis By Service (Regulatory Writing And Publishing & Regulatory Submissions) And End User (Mid-Size Pharmaceutical Companies & Biotechnology Companies) - Forecast Till 2027
ID: MRFR/HC/6334-HCR | February 2021 | Region: Global | 90 pages
Healthcare Regulatory Affairs Outsourcing Market Scenario
The Healthcare Regulatory Affairs Outsourcing Market is expected to grow significantly over the forecast period. The market held a market value of USD 3,120.4 million in 2017 and is projected to grow at a CAGR of 9.4% over the forecast period. The regulatory affairs and operations processes that are outsourced include submission planning and publishing, local regulatory affairs, medical writing, regulatory data, and information management, labeling, agency liaison, regulatory strategy, translation, administrative documents, dossier conversion, and literature searches. The factors such as an increasing number of patent expirations, growing research and development activities are anticipated to boost the growth of the healthcare regulatory affairs outsourcing market over the forecast period.
Moreover, the growing prevalence of several chronic diseases such as cancer and other infectious diseases have encouraged biopharmaceutical companies to develop a large number of new products. With the rising development of products in clinical trials, the demand for clinical trial applications and product registration services is increasing, thus driving the growth of this market. For instance, according to a recent survey, the pharmaceutical and biotechnology industry in the US spent a total of USD 102 billion on research and development in 2015. Additionally, according to the International Federation of Pharmaceutical Manufacturers & Associations in 2015, 56 new pharmaceuticals were launched, out of more than 7,000 compounds that were in development. However, the risk associated with data security and lack of standardization may hamper the market growth during the assessment period.
Segmentation
The global healthcare regulatory affairs outsourcing market has been segmented into services, and end user.
By services, the market has been segmented into regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, regulatory consulting and legal representation and other regulatory affairs.
On the basis of end user, the market has been segmented into mid-size pharmaceutical companies, large pharmaceutical companies, biotechnology companies, medical device companies, and food and beverage companies.
The global healthcare regulatory affairs outsourcing market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The healthcare regulatory affairs outsourcing market in the Americas has further been segmented into North America and Latin America, with the North American market divided into the US and Canada.
The European healthcare regulatory affairs outsourcing market has been segmented into Western Europe and Eastern Europe. The Western Europe healthcare regulatory affairs outsourcing market has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.
The healthcare regulatory affairs outsourcing market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The healthcare regulatory affairs outsourcing market in the Middle East & Africa has been segmented into the Middle East and Africa.
Key players
Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Criterium Inc., ICON plc, Covance, Inc., Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, WuXi App Tec and others are some of the prominent players in the global healthcare regulatory affairs outsourcing market.
Regional Market Summary
Global Healthcare Regulatory Affairs Outsourcing Market Share (%), by Region, 2017 
Geographically, the Americas is anticipated to dominate the global healthcare regulatory affairs outsourcing market owing to the increasing prevalence of chronic diseases. The rising prevalence of cancer and other chronic diseases demands the discovery of newer and effective drugs which is anticipated to fuel the market growth in this region. For instance, according to the Centers for Disease Control and Prevention, in 2014, 9,421 new cases of tuberculosis were registered in the US. Moreover, according to the National Cancer Institute, in 2016, around 1,685,210 new cases of cancer had been diagnosed in the US.
Europe is expected to hold the second largest position in the global healthcare regulatory affairs outsourcing market. The market growth in this region is attributed to the growing research and development activities in the European countries. For instance, according to the National Institute for Health Research, the Association of the British Pharmaceutical Industry (ABPI) invested over Euro 4.1 billion just in the UK on R&D, looking for breakthroughs for conditions such as cancer, dementia, and rare genetic diseases.
The healthcare regulatory affairs outsourcing market in Asia-Pacific region consists of countries namely China, Japan, Republic of Korea, India, Australia and Rest of Asia-Pacific. The Asia-Pacific region is expected to be the fastest growing region owing to the increasing number of biopharmaceutical companies and high growth opportunities for major key players for setting up their regional headquarters and manufacturing plants in this region.
The Middle East & Africa is expected to hold the lowest share of the global healthcare regulatory affairs outsourcing market. Majority of the market of the region is anticipated to be held by the Middle East region owing to the growing government initiatives for the healthcare sector.
Healthcare Regulatory Affairs Outsourcing Market, by Service
- Regulatory Writing and Publishing
- Regulatory Submissions
- Clinical Trial Applications sand Services Registrations
- Regulatory Consulting and Legal Representation
- Other Regulatory Affairs
Healthcare Regulatory Affairs Outsourcing Market, by End User
- Mid-Size Pharmaceutical Companies
- Large Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
- Food and Beverage Companies
Healthcare Regulatory Affairs Outsourcing Market, by Region
- AmericasNorth America
- US
- Canada
- Latin America
- Europe
- Western Europe
- Germany
- France
- Italy
- Spain
- UK
- Rest of Western Europe
- Eastern Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Middle East & Africa
- Middle East
- Africa
Company Profiles
- Accell Clinical Research, LLC
- Charles River Laboratories International, Inc.
- Clinilabs, Inc.
- Covance, Inc.
- Criterium, Inc.
- ICON plc
- Medpace, Inc.
- PAREXEL International Corporation
- Pharmaceutical Product Development, (PPD) LLC
- Promedica International
- Quintiles Transnational Corporation
- WuXi App Tec
- Others
Intended Audience
- Traders, Distributors, and Suppliers
- Manufacturers
- Hospitals
- Government and Regional Agencies and Research Organizations
- Consultants
- Distributors
Report Scope:
| Report Attribute/Metric | Details |
|---|---|
| Market Size |
|
| CAGR | 9.4% (2018-2023) |
| Base Year | 2019 |
| Forecast Period | 2020-2027 |
| Historical Data | 2018 |
| Forecast Units | Value (USD Million) |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Services and End user |
| Geographies Covered | North America, Europe, Asia-Pacific, and Rest of the World (RoW) |
| Key Vendors | Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Criterium Inc., ICON plc, Covance, Inc., Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, WuXi App Tec |
| Key Market Opportunities |
|
| Key Market Drivers |
|
Frequently Asked Questions (FAQ) :
The market was valued at more than USD 3.1 billion in 2017.
The market is expected to exhibit a strong 9.4% CAGR over the forecast period from 2018 to 2023.
The growing prevalence of chronic diseases such as cancer is the major driver for the market.
The risk of data breach and lack of standardization are the key restraints on the global healthcare regulatory affairs outsourcing market.
The Americas, followed by Europe, hold the largest share in the market.
Table of Content:
Chapter 1. Report Prologue
Chapter 2. Market Introduction
2.1 Definition
2.2 Scope of the Study
2.2.1 Research Objective
2.2.2 Assumptions
2.2.3 Limitations
Chapter 3. Research Methodology
3.1 Introduction
3.2 Primary Research
3.3 Secondary Research
3.4 Market Size Estimation
Chapter 4. Market Dynamics
4.1 Drivers
4.2 Restraints
4.3 Opportunities
4.4 Challenges
4.5 Macroeconomic Indicators
4.6 Detection Technique Trends & Assessment
Chapter 5. Market Factor Analysis
5.1 Porter’s Five Forces Analysis
5.1.1 Bargaining Power of Suppliers
5.1.2 Bargaining Power of Buyers
5.1.3 Threat of New Entrants
5.1.4 Threat of Substitutes
5.1.5 Intensity of Rivalry
5.2 Value Chain Analysis
5.3 Investment Feasibility Analysis
5.4 Pricing Analysis
Chapter 6. Global Healthcare Regulatory Affairs Outsourcing Market, by Service
6.1 Introduction
6.2 Regulatory Writing and Publishing
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
6.3 Regulatory Submissions
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
6.4 Clinical Trial Applications and Service Registrations
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
6.5 Regulatory Consulting and Legal Representation
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
6.6 Other Regulatory Affairs
Chapter 7. Global Healthcare Regulatory Affairs Outsourcing Market, by End User
7.1 Introduction
7.2 Mid-Size Pharmaceutical Companies
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
7.3 Large Pharmaceutical Companies
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
7.4 Biotechnology Companies
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
7.5 Medical Device Companies
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
7.6 Food and Beverage Companies
Market Estimates & Forecast, by Region, 2020–2027
Market Estimates & Forecast, by Country, 2020–2027
Chapter 8. Global Healthcare Regulatory Affairs Outsourcing Market, by Region
8.1 Introduction
8.2 Americas
8.2.1 North America
8.2.1.1 US
8.2.1.2 Canada
8.2.2 Latin America
8.3 Europe
8.3.1 Western Europe
8.3.1.1 Germany
8.3.1.2 France
8.3.1.3 Italy
8.3.1.4 Spain
8.3.1.5 UK
8.3.1.6 Rest of Western Europe
8.3.2 Eastern Europe
8.4 Asia-Pacific
8.4.1 Japan
8.4.2 China
8.4.3 India
8.4.4 Australia
8.4.5 South Korea
8.4.6 Rest of Asia-Pacific
8.5 Middle East & Africa
8.5.1 Middle East
8.5.2 Africa
Chapter 9. Company Landscape
9.1 Introduction
9.2 Market Share Analysis
9.3 Key Development & Strategies
Chapter 10. Company Profiles
10.1 Accell Clinical Research, LLC
10.1.1 Company Overview
10.1.2 Treatment Overview
10.1.3 Financials Overview
10.1.4 Key Developments
10.1.5 SWOT Analysis
10.2 Charles River Laboratories International, Inc.
10.2.1 Company Overview
10.2.2 Treatment Overview
10.2.3 Financial Overview
10.2.4 Key Developments
10.2.5 SWOT Analysis
10.3 Clinilabs, Inc.
10.3.1 Company Overview
10.3.2 Treatment Overview
10.3.3 Financial Overview
10.3.4 Key Development
10.3.5 SWOT Analysis
10.4 Covance, Inc.
10.4.1 Company Overview
10.4.2 Treatment Overview
10.4.3 Financial Overview
10.4.4 Key Development
10.4.5 SWOT Analysis
10.5 Criterium, Inc.
10.5.1 Company Overview
10.5.2 Treatment Overview
10.5.3 Financial overview
10.5.4 Key Developments
10.5.5 SWOT Analysis
10.6 ICON plc
10.6.1 Company Overview
10.6.2 Treatment Overview
10.6.3 Financial Overview
10.6.4 Key Developments
10.6.5 SWOT Analysis
10.7 Medpace, Inc.
10.7.1 Overview
10.7.2 Treatment Overview
10.7.3 Financial Overview
10.7.4 Key Developments
10.7.5 SWOT Analysis
10.8 PAREXEL International Corporation
10.8.1 Overview
10.8.2 Treatment Overview
10.8.3 Financials
10.8.4 Key Developments
10.8.5 SWOT Analysis
10.9 Pharmaceutical Product Development, (PPD) LLC
10.9.1 Overview
10.9.2 Treatment Overview
10.9.3 Financials
10.9.4 Key Developments
10.9.5 SWOT Analysis
10.10 Promedica International
10.10.1 Overview
10.10.2 Treatment Overview
10.10.3 Financials
10.10.4 Key Developments
10.10.5 SWOT Analysis
10.11 Quintiles Transnational Corporation
10.11.1 Overview
10.11.2 Treatment Overview
10.11.3 Financials
10.11.4 Key Developments
10.11.5 SWOT Analysis
10.12 WuXi App Tec
10.12.1 Overview
10.12.2 Treatment Overview
10.12.3 Financials
10.12.4 Key Developments
10.12.5 SWOT Analysis
Chapter 11 MRFR Conclusion
11.1 Key Findings
11.1.1 From CEO’s Viewpoint
11.1.2 Unmet Needs of the Market
11.2 Key Companies to Watch
11.3 Predictions for the Regulatory Affairs Outsourcing Industry
Chapter 12. Appendix
LIST OF TABLES
Table 1 Global Healthcare Regulatory Affairs Outsourcing Market Synopsis, 2020–2027
Table 2 Global Healthcare Regulatory Affairs Outsourcing Market Estimates and Forecast, 2020–2027 (USD Million)
Table 3 Global Healthcare Regulatory Affairs Outsourcing Market, by Region, 2020–2027 (USD Million)
Table 4 Global Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD Million)
Table 5 Global Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027 (USD Million)
Table 6 North America: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD
Million)
Table 7 North America: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027
(USD Million)
Table 8 US: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD Million)
Table 9 US: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027 (USD
Million)
Table 10 Canada: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD Million)
Table 11 Canada: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027 (USD
Million)
Table 12 Latin America: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD
Million)
Table 13 Latin America: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–
2027 (USD Million)
Table 14 Europe: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD Million)
Table 15 Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027 (USD
Million)
Table 16 Western Europe: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD
Million)
Table 17 Western Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–
2027 (USD Million)
Table 18 Eastern Europe: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD
Million)
Table 19 Eastern Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–
2027 (USD Million)
Table 20 Asia-Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD
Million)
Table 21 Asia-Pacific: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2020–2027 (USD Million)
Table 22 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Service, 2020–2027 (USD Million)
Table 23 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by End User,
2020–2027 (USD Million)
LIST OF FIGURES
Figure 1 Research Process
Figure 2 Segmentation for Global Healthcare Regulatory Affairs Outsourcing Market
Figure 3 Segmentation Market Dynamics for Global Healthcare Regulatory Affairs Outsourcing Market
Figure 4 Global Healthcare Regulatory Affairs Outsourcing Market Share, by Service, 2020
Figure 5 Global Healthcare Regulatory Affairs Outsourcing Market Share, by End User, 2020
Figure 6 Global Healthcare Regulatory Affairs Outsourcing Market Share, by Region, 2020
Figure 7 North America: Healthcare Regulatory Affairs Outsourcing Market Share, by Country, 2020
Figure 8 Europe: Healthcare Regulatory Affairs Outsourcing Market Share, by Country, 2020
Figure 9 Asia-Pacific: Healthcare Regulatory Affairs Outsourcing Market Share, by Country, 2020
Figure 10 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market Share, by Country, 2020
Figure 11 Global Healthcare Regulatory Affairs Outsourcing Market: Company Share Analysis, 2020 (%)
Figure 12 Accell Clinical Research, LLC: Key Financials
Figure 13 Accell Clinical Research, LLC: Segmental Revenue
Figure 14 Accell Clinical Research, LLC: Geographical Revenue
Figure 15 Charles River Laboratories International, Inc.: Key Financials
Figure 16 Charles River Laboratories International, Inc.: Segmental Revenue
Figure 17 Charles River Laboratories International, Inc.: Geographical Revenue
Figure 18 Clinilabs, Inc.: Key Financials
Figure 19 Clinilabs, Inc.: Segmental Revenue
Figure 20 Clinilabs, Inc.: Geographical Revenue
Figure 21 Covance, Inc.: Key Financials
Figure 22 Covance, Inc.: Segmental Revenue
Figure 23 Covance, Inc.: Geographical Revenue
Figure 24 Criterium, Inc.: Key Financials
Figure 25 Criterium, Inc.: Segmental Revenue
Figure 26 Criterium, Inc.: Geographical Revenue
Figure 27 ICON plc: Key Financials
Figure 28 ICON plc: Segmental Revenue
Figure 29 ICON plc: Geographical Revenue
Figure 30 Medpace, Inc.: Key Financials
Figure 31 Medpace, Inc.: Segmental Revenue
Figure 32 Medpace, Inc.: Geographical Revenue
Figure 33 PAREXEL International Corporation: Key Financials
Figure 34 PAREXEL International Corporation: Segmental Revenue
Figure 35 PAREXEL International Corporation: Geographical Revenue
Figure 36 Pharmaceutical Product Development, (PPD) LLC: Key Financials
Figure 37 Pharmaceutical Product Development, (PPD) LLC: Segmental Revenue
Figure 38 Pharmaceutical Product Development, (PPD) LLC: Geographical Revenue
Figure 39 Promedica International: Key Financials
Figure 40 Promedica International: Segmental Revenue
Figure 41 Promedica International: Geographical Revenue
Figure 42 Quintiles Transnational Corporation: Key Financials
Figure 43 Quintiles Transnational Corporation: Segmental Revenue
Figure 44 Quintiles Transnational Corporation: Geographical Revenue
Figure 45 WuXi App Tec: Key Financials
Figure 46 WuXi App Tec: Segmental Revenue
Figure 47 WuXi App Tec: Geographical Revenue
This table of content is tentative and subject to change as the research progresses.
Please Note: Financial details of company cannot be provided if the information of the company is not available in public domain and or reliable source.