Global Healthcare Regulatory Affairs Outsourcing Market Size, Trends & Growth Opportunity, By Service (Regulatory Consulting, Legal Representation, and Other Services), By Company Size (Small, Medium, and Large), By Stage (Preclinical, Clinical, and PMA), By End-user (Medical Devices, Pharmaceutical, and Biotechnology Companies), and By Region and Forecast till 2027.
Report ID : QR1001347 | Industries : Healthcare | Published On :January 2022 | Page Count : 232Global Healthcare Regulatory Affairs Outsourcing Market
Manufacturing and controls (CMC), medial report writing, regulatory chemistry, data management, country regulatory affairs, regulatory strategy, and labelling and liaison are just a few of the processes that are regulated. Healthcare organisations can focus on marketing and research and development by outsourcing these non-core activities to experts. Product approvals, optimised reimbursements, and increased productivity can all benefit businesses in the long run.
Drivers: In addition, the rising prevalence of several chronic diseases, such as cancer and other infectious diseases, has prompted biopharmaceutical companies to develop a slew of new products. As the number of products in clinical trials grows, so does the demand for clinical trial applications and product registration services, propelling this market forward.
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Restraints: Life sciences companies are under a lot of pressure to cut costs. Market growth is expected to be hampered in the forecasting period due to a loss of control and technological advancements leading to price fluctuations.
Impact of Covid-19
The COVID-19 pandemic has caused delays in drug development, manufacturing, supply chain, and almost all other aspects of the process. Furthermore, market participants face particular challenges such as tight deadlines and round-the-clock staff availability. However, the clinical trial service segment is growing due to a large number of ongoing clinical trials in response to the COVID-19 pandemic. Communication with regulatory bodies has become unpredictably unpredictable, with long wait times for responses from review teams or agencies that are critical to moving the development process forward. Furthermore, market participants must contend with time constraints and personnel availability 24 hours a day, seven days a week.
Segmentation By Service: Global Healthcare Regulatory Affairs Outsourcing Market is classified on the basis of Service into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services.
Segmentation By Company Size: Global Healthcare Regulatory Affairs Outsourcing Market is classified on the basis of Company Size into Small, Medium, and Large.
Segmentation By Stage: Global Healthcare Regulatory Affairs Outsourcing Market is classified on the basis of Stage into Preclinical, Clinical, and PMA (Post Market Authorization).
Segmentation By End-User: Global Healthcare Regulatory Affairs Outsourcing Market is classified on the basis of End-User into Medical Device Companies, Pharmaceutical Companies, and Biotechnology Companies.
Segmentation By Region: Global Healthcare Regulatory Affairs Outsourcing Market is classified on the basis of Region into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
Competitive Landscape: The key players of Global Healthcare Regulatory Affairs Outsourcing Market are Covance Inc, Cardinal Health, Paraxel and Kyoto University Hospital, IQVIA, KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, and Asphalion S.L.
Industrial Development
- In April of this year, Cardinal Health acquired mscripts. This acquisition will enhance the company's capabilities for customers while also strengthening the relationship between payers, pharmacies, and patients.
- In October 2021, Paraxel and Kyoto University Hospital announced a strategic partnership aimed at expanding clinical research opportunities and improving clinical study support.
- IQVIA announced in April 2021 that it had acquired a minority stake in Q2 Solutions, a central laboratory services joint venture, from Quest Diagnostics.
Market Taxonomy
By Service
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
By Company Size
- Small
- Medium
- Large
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 & Africa
Key Questions Addressed by the Report
- What are the Key Opportunities in Global Healthcare Regulatory Affairs Outsourcing Market?
- What will be the growth rate from 2020 to 2027?
- Which segment/region will have highest growth?
- What are the factors that will impact/drive the Market?
- What is the competitive Landscape in the Industry?
- What is the role of key players in the value chain?
Healthcare Regulatory Affairs Outsourcing Market TOC
1 Introduction
1.1 Objective of the Study
1.2 Market definition
1.3 Market Scope
2 Research Methodology
2.1 Data Mining
2.2 Validation
2.3 Primary Interviews
2.4 List of Data Sources
3 Executive Summary
4 Global Healthcare Regulatory Affairs Outsourcing Market Outlook
4.1 Overview
4.2 Market Dynamics
4.2.1 Drivers
4.2.2 Restraints
4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis
5. Global Healthcare Regulatory Affairs Outsourcing Market, By Service
5.1 Y-o-Y Growth Comparison, By Service
5.2 Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
5.3 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Service
5.3.1 Regulatory Consulting
5.3.2 Legal Representation
5.3.3 Regulatory Writing & Publishing
5.3.4 Product Registration & Clinical Trial Company Sizes
5.3.5 Other Services
6. Global Healthcare Regulatory Affairs Outsourcing Market, By Company Size
6.1 Y-o-Y Growth Comparison, By Company Size
6.2 Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Company Size
6.3 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
6.3.1 Small
6.3.2 Medium
6.3.3 Large
7. Global Healthcare Regulatory Affairs Outsourcing Market, By Stage
7.1 Y-o-Y Growth Comparison, By Stage
7.2 Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Stage
7.3 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
7.3.1 Preclinical
7.3.2 Clinical
7.3.3 PMA (Post Market Authorization)
8. Global Healthcare Regulatory Affairs Outsourcing Market, By End-User
8.1 Y-o-Y Growth Comparison, By End-User
8. Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By End-User
8.3 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
8.3.1 Medical Device Companies
8.3.2 Pharmaceutical Companies
8.3.3 Biotechnology Companies
9. Global Healthcare Regulatory Affairs Outsourcing Market, By Region
9.1 Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Region
9.2 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Region
9.3 Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Region
10. North America Healthcare Regulatory Affairs Outsourcing Analysis and Forecast (2021-2027)
10.1 Introduction
10.2 North America Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
10.3 North America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
10.4 North America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
10.5 North America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
10.6 North America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Country
10.6.1 US
10.6.2 Canada
11. Europe Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast (2021-2027)
11.1 Introduction
11.2 Europe Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
11.3 Europe Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
11.4 Europe Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
11.5 Europe Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
11.6 Europe Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Country
11.6.1 UK
11.6.2 Germany
11.6.3 France
11.6.4 Italy
11.6.5 Spain
11.6.6 Netherland
12. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast (2021-2027)
12.1 Introduction
12.2 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
12.3 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
12.4 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
12.5 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
12.6 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Country
12.6.1 China
12.6.2 Japan
12.6.3 India
12.6.4 Australia
13. Latin America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast (2021-2027)
13.1 Introduction
13.2 Latin America Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
13.3 Latin America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
13.4 Latin America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
13.5 Latin America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
13.6 Latin America Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Country
13.6.1 Brazil
13.6.2 Rest of Latin America
14 Middle East Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast (2021-2027)
14.1 Introduction
14.2 Middle East Healthcare Regulatory Affairs Outsourcing Market Share Analysis, By Service
14.3 Middle East Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Company Size
14.4 Middle East Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Stage
14.5 Middle East Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By End-User
14.6 Middle East Healthcare Regulatory Affairs Outsourcing Market Size and Forecast, By Country
14.6.1 Saudi Arabia
14.6.2 UAE
14.6.3. Egypt
14.6.4. Kuwait
14.6.5. South Africa
15 Competitive Analysis
15.1 Competition Dashboard
15.2 Market share Analysis of Top Vendors
15.3 Key Development Strategies
16. Company Profiles
16.1 Covance Inc
16.1.1 Overview
16.1.2 Offerings
16.1.3 Key Financials
16.1.4 Business Segment & Geographic Overview
16.1.5 Key Market Developments
16.1.6 Key Strategies
16.2 Cardinal Health
16.2.1 Overview
16.2.2 Offerings
16.2.3 Key Financials
16.2.4 Business Segment & Geographic Overview
16.2.5 Key Market Developments
16.2.6 Key Strategies
16.3 Paraxel and Kyoto University Hospital
16.3.1 Overview
16.3.2 Offerings
16.3.3 Key Financials
16.3.4 Business Segment & Geographic Overview
16.3.5 Key Market Developments
16.3.6 Key Strategies
16.4 IQVIA
16.4.1 Overview
16.4.2 Offerings
16.4.3 Key Financials
16.4.4 Business Segment & Geographic Overview
16.4.5 Key Market Developments
16.4.6 Key Strategies
16.5 KLIFO
16.5.1 Overview
16.5.2 Offerings
16.5.3 Key Financials
16.5.4 Business Segment & Geographic Overview
16.5.5 Key Market Developments
16.5.6 Key Strategies
16.6 ProPharma Group
16.6.1 Overview
16.6.2 Offerings
16.6.3 Key Financials
16.6.4 Business Segment & Geographic Overview
16.6.5 Key Market Developments
16.6.6 Key Strategies
16.7 Arriello Ireland Ltd
16.7.1 Overview
16.7.2 Offerings
16.7.3 Key Financials
16.7.4 Business Segment & Geographic Overview
16.7.5 Key Market Developments
16.7.6 Key Strategies
16.8 DRA CONSULTING OY
16.8.1 Overview
16.8.2 Offerings
16.8.3 Key Financials
16.8.4 Business Segment & Geographic Overview
16.8.5 Key Market Developments
16.8.6 Key Strategies
16.9 Asphalion S.L
16.9.1 Overview
16.9.2 Offerings
16.9.3 Key Financials
16.9.4 Business Segment & Geographic Overview
16.9.5 Key Market Developments
16.9.6 Key Strategies