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Global Healthcare Regulatory Affairs Outsourcing Market: By Services: Regulatory Writing and Publishing, Regulatory Submissions, Others; By Stage; By End Use; Regional Analysis; Historical Market and Forecast (2018-2028); Market Dynamics: SWOT Analysis; Value Chain Analysis; Competitive Landscape; Industry Events and Developments
Global Healthcare Regulatory Affairs Outsourcing Market Outlook
The global market for healthcare regulatory affairs outsourcing is expected to grow at a CAGR of about 9.10% in the forecast period of 2023-2028, owing to the rising prevalence of several chronic diseases.
North America and Asia Pacific to be Among the Significant Regional Markets for Healthcare Regulatory Affairs Outsourcing
North America is expected to be one of the dominant regions in the global healthcare regulatory affairs outsourcing market due to the increasing presence of the major international regulatory agencies in the region. The region has a significant presence of multinational biotech and pharma companies that carry out many clinical trials and have a well-developed and advanced healthcare infrastructure. The growth can also be attributed to the increased focus on reducing investment costs and capitalising on the availability of cheap labour, rising concentration on the optimum utilisation of resources, and changing regulatory scenarios across the region.
During the forecast period, Asia Pacific is expected to grow significantly due to the increasingly low cost of labour and increased availability of skilled labour, along with the increase in the number of clinical trials and firms attempting to penetrate markets in countries such as India and China.
Europe Expected to Witness Considerable Growth in the Coming Years
Europe is likely to be a key market for healthcare regulatory affairs outsourcing owing to the presence of a significant international regulatory agency, the European Medicines Agency (EMA). The presence of established pharmaceutical and medical device players is one of the key factors driving the market growth in the region. Moreover, many pharma and biotech companies have started outsourcing their drug development services to countries like Italy, Germany, and France, further augmenting the market growth for the healthcare regulatory affairs outsourcing market.
Market Segmentations
Healthcare regulatory affairs outsourcing refers to regulatory rules implemented to guarantee that organisations adhere to operational requirements. In general, these policies strive to protect public health and welfare by ensuring the safety of pharmaceutical and healthcare products. Medical writing and publishing regulatory paperwork given by expert medical writers, quality control, and publishers play a crucial role in creating high-quality documents for clinical research initiatives as part of healthcare regulatory affairs outsourcing.
The various services provided by the market are:
- Regulatory Writing and Publishing
- Regulatory Submissions
- Clinical Trial Applications and Services Registrations
- Regulatory Consulting and Legal Representation
- Others
Based on stage, the market is divided into:
- Preclinical
- Clinical
- PMA
The end-uses of the market are:
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
The regional markets for healthcare regulatory affairs outsourcing can be divided into North America, Europe, the Asia Pacific, Latin America, the Middle East and Africa.
Rising Cases of Chronic Ailments Propelling the Market Growth
The rapidly rising cases of various chronic diseases and high expenses connected with research and development operations are the primary drivers fuelling the global healthcare regulatory affairs outsourcing market. Cancer and other infectious diseases encourage biopharmaceutical companies to develop many new products, which is vital in escalating the market growth. Besides this, the rapid increase in clinical trial product development and research and development activities, clinical trial applications, product registration, and drug pipeline, a rising shift toward an outcome-based model, an increase in the use of generics, and an increase in demand for drugs and medical devices at a lower cost are the significant factors propelling the market growth of healthcare regulatory affairs outsourcing.
In addition, the strict government regulations imposed by the regulatory authorities to hire skilled regulatory professionals capable of handling evaluation, registration, and compilation of regulatory compliant documentation will propel the market growth. Rising demand for speedy product approval and increasing investments in the regulatory information system to automate activities like regulatory publishing and operations are expected to influence market growth.
Several companies in the healthcare regulatory affairs outsourcing market are expected to see significant growth during the projection period due to the extensive acceptance of the company's growth strategies such as collaboration, acquisition, and partnerships. For instance, in April 2020, Pfizer Inc. and ICON plc signed a three-year agreement. This agreement expands on the firms' current collaboration, in which ICON provides global expertise in clinical trial planning, execution, management, and execution, which will likely add growth to the market in the coming years.
Key Players in the Global Market for Healthcare Regulatory Affairs Outsourcing
The report gives a detailed analysis of the following key players in the global healthcare regulatory affairs outsourcing market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:
- WuXi AppTec
- Freyr
- Parexel International Corporation
- Medpace, Inc.
- ICON plc
- IQVIA Inc.
- Labcorp Drug Development
- Others
The comprehensive EMR report provides an in-depth assessment of the market based on the Porter's five forces model along with giving a SWOT analysis.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
|---|---|
| Base Year | 2022 |
| Historical Period | 2018-2022 |
| Forecast Period | 2023-2028 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|
| Breakup by Services |
|
| Breakup by Stage |
|
| Breakup by End Use |
|
| Breakup by Region |
|
| Market Dynamics |
|
| Competitive Landscape |
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| Companies Covered |
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| Report Price and Purchase Option | Explore our purchase options that are best suited to your resources and industry needs. |
| Delivery Format | Delivered as an attached PDF and Excel through email, with an option of receiving an editable PPT, according to the purchase option. |
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
2 Report Coverage – Key Segmentation and Scope
3 Report Description
3.1 Market Definition and Outlook
3.2 Properties and Applications
3.3 Market Analysis
3.4 Key Players
4 Key Assumptions
5 Executive Summary
5.1 Overview
5.2 Key Drivers
5.3 Key Developments
5.4 Competitive Structure
5.5 Key Industrial Trends
6 Market Snapshot
6.1 Global
6.2 Region
7 Opportunities and Challenges in the Market
8 Global Healthcare Regulatory Affairs Outsourcing Market Analysis
8.1 Key Industry Highlights
8.2 Global Healthcare Regulatory Affairs Outsourcing Historical Market (2018-2022)
8.3 Global Healthcare Regulatory Affairs Outsourcing Market Forecast (2023-2028)
8.4 Global Healthcare Regulatory Affairs Outsourcing Market by Services
8.4.1 Regulatory Writing and Publishing
8.4.1.1 Market Share
8.4.1.2 Historical Trend (2018-2022)
8.4.1.3 Forecast Trend (2023-2028)
8.4.2 Regulatory Submissions
8.4.2.1 Market Share
8.4.2.2 Historical Trend (2018-2022)
8.4.2.3 Forecast Trend (2023-2028)
8.4.3 Clinical Trial Applications and Services Registrations
8.4.3.1 Market Share
8.4.3.2 Historical Trend (2018-2022)
8.4.3.3 Forecast Trend (2023-2028)
8.4.4 Regulatory Consulting and Legal Representation
8.4.4.1 Market Share
8.4.4.2 Historical Trend (2018-2022)
8.4.4.3 Forecast Trend (2023-2028)
8.4.5 Others
8.5 Global Healthcare Regulatory Affairs Outsourcing Market by Stage
8.5.1 Preclinical
8.5.1.1 Market Share
8.5.1.2 Historical Trend (2018-2022)
8.5.1.3 Forecast Trend (2023-2028)
8.5.2 Clinical
8.5.2.1 Market Share
8.5.2.2 Historical Trend (2018-2022)
8.5.2.3 Forecast Trend (2023-2028)
8.5.3 PMA
8.5.3.1 Market Share
8.5.3.2 Historical Trend (2018-2022)
8.5.3.3 Forecast Trend (2023-2028)
8.6 Global Healthcare Regulatory Affairs Outsourcing Market by End Use
8.6.1 Pharmaceutical Companies
8.6.1.1 Market Share
8.6.1.2 Historical Trend (2018-2022)
8.6.1.3 Forecast Trend (2023-2028)
8.6.2 Biotechnology Companies
8.6.2.1 Market Share
8.6.2.2 Historical Trend (2018-2022)
8.6.2.3 Forecast Trend (2023-2028)
8.6.3 Medical Device Companies
8.6.3.1 Market Share
8.6.3.2 Historical Trend (2018-2022)
8.6.3.3 Forecast Trend (2023-2028)
8.7 Global Healthcare Regulatory Affairs Outsourcing Market by Region
8.7.1 North America
8.7.1.1 Market Share
8.7.1.2 Historical Trend (2018-2022)
8.7.1.3 Forecast Trend (2023-2028)
8.7.2 Europe
8.7.2.1 Market Share
8.7.2.2 Historical Trend (2018-2022)
8.7.2.3 Forecast Trend (2023-2028)
8.7.3 Asia Pacific
8.7.3.1 Market Share
8.7.3.2 Historical Trend (2018-2022)
8.7.3.3 Forecast Trend (2023-2028)
8.7.4 Latin America
8.7.4.1 Market Share
8.7.4.2 Historical Trend (2018-2022)
8.7.4.3 Forecast Trend (2023-2028)
8.7.5 Middle East and Africa
8.7.5.1 Market Share
8.7.5.2 Historical Trend (2018-2022)
8.7.5.3 Forecast Trend (2023-2028)
9 North America Healthcare Regulatory Affairs Outsourcing Market Analysis
9.1 United States of America
9.1.1 Market Share
9.1.2 Historical Trend (2018-2022)
9.1.3 Forecast Trend (2023-2028)
9.2 Canada
9.2.1 Market Share
9.2.2 Historical Trend (2018-2022)
9.2.3 Forecast Trend (2023-2028)
10 Europe Healthcare Regulatory Affairs Outsourcing Market Analysis
10.1 United Kingdom
10.1.1 Market Share
10.1.2 Historical Trend (2018-2022)
10.1.3 Forecast Trend (2023-2028)
10.2 Germany
10.2.1 Market Share
10.2.2 Historical Trend (2018-2022)
10.2.3 Forecast Trend (2023-2028)
10.3 France
10.3.1 Market Share
10.3.2 Historical Trend (2018-2022)
10.3.3 Forecast Trend (2023-2028)
10.4 Italy
10.4.1 Market Share
10.4.2 Historical Trend (2018-2022)
10.4.3 Forecast Trend (2023-2028)
10.5 Others
11 Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Analysis
11.1 China
11.1.1 Market Share
11.1.2 Historical Trend (2018-2022)
11.1.3 Forecast Trend (2023-2028)
11.2 Japan
11.2.1 Market Share
11.2.2 Historical Trend (2018-2022)
11.2.3 Forecast Trend (2023-2028)
11.3 India
11.3.1 Market Share
11.3.2 Historical Trend (2018-2022)
11.3.3 Forecast Trend (2023-2028)
11.4 ASEAN
11.4.1 Market Share
11.4.2 Historical Trend (2018-2022)
11.4.3 Forecast Trend (2023-2028)
11.5 Australia
11.5.1 Market Share
11.5.2 Historical Trend (2018-2022)
11.5.3 Forecast Trend (2023-2028)
11.6 Others
12 Latin America Healthcare Regulatory Affairs Outsourcing Market Analysis
12.1 Brazil
12.1.1 Market Share
12.1.2 Historical Trend (2018-2022)
12.1.3 Forecast Trend (2023-2028)
12.2 Argentina
12.2.1 Market Share
12.2.2 Historical Trend (2018-2022)
12.2.3 Forecast Trend (2023-2028)
12.3 Mexico
12.3.1 Market Share
12.3.2 Historical Trend (2018-2022)
12.3.3 Forecast Trend (2023-2028)
12.4 Others
13 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Analysis
13.1 Saudi Arabia
13.1.1 Market Share
13.1.2 Historical Trend (2018-2022)
13.1.3 Forecast Trend (2023-2028)
13.2 United Arab Emirates
13.2.1 Market Share
13.2.2 Historical Trend (2018-2022)
13.2.3 Forecast Trend (2023-2028)
13.3 Nigeria
13.3.1 Market Share
13.3.2 Historical Trend (2018-2022)
13.3.3 Forecast Trend (2023-2028)
13.4 South Africa
13.4.1 Market Share
13.4.2 Historical Trend (2018-2022)
13.4.3 Forecast Trend (2023-2028)
13.5 Others
14 Market Dynamics
14.1 SWOT Analysis
14.1.1 Strengths
14.1.2 Weaknesses
14.1.3 Opportunities
14.1.4 Threats
14.2 Porter’s Five Forces Analysis
14.2.1 Supplier’s Power
14.2.2 Buyer’s Power
14.2.3 Threat of New Entrants
14.2.4 Degree of Rivalry
14.2.5 Threat of Substitutes
14.3 Key Indicators for Demand
14.4 Key Indicators for Price
15 Competitive Landscape
15.1 Market Structure
15.2 Company Profiles
15.2.1 WuXi AppTec
15.2.1.1 Company Overview
15.2.1.2 Product Portfolio
15.2.1.3 Demographic Reach and Achievements
15.2.1.4 Certifications
15.2.2 Freyr
15.2.2.1 Company Overview
15.2.2.2 Product Portfolio
15.2.2.3 Demographic Reach and Achievements
15.2.2.4 Certifications
15.2.3 Parexel International Corporation
15.2.3.1 Company Overview
15.2.3.2 Product Portfolio
15.2.3.3 Demographic Reach and Achievements
15.2.3.4 Certifications
15.2.4 Medpace, Inc.
15.2.4.1 Company Overview
15.2.4.2 Product Portfolio
15.2.4.3 Demographic Reach and Achievements
15.2.4.4 Certifications
15.2.5 ICON plc
15.2.5.1 Company Overview
15.2.5.2 Product Portfolio
15.2.5.3 Demographic Reach and Achievements
15.2.5.4 Certifications
15.2.6 IQVIA Inc.
15.2.6.1 Company Overview
15.2.6.2 Product Portfolio
15.2.6.3 Demographic Reach and Achievements
15.2.6.4 Certifications
15.2.7 Labcorp Drug Development
15.2.7.1 Company Overview
15.2.7.2 Product Portfolio
15.2.7.3 Demographic Reach and Achievements
15.2.7.4 Certifications
15.2.8 Others
16 Key Trends and Developments in the Market
List of Key Figures and Tables
1. Global Healthcare Regulatory Affairs Outsourcing Market: Key Industry Highlights, 2018 and 2028
2. Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Services (USD Billion), 2018-2022
3. Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Services (USD Billion), 2023-2028
4. Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Stage (USD Billion), 2018-2022
5. Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Stage (USD Billion), 2023-2028
6. Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by End Use (USD Billion), 2018-2022
7. Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by End Use (USD Billion), 2023-2028
8. Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Region (USD Billion), 2018-2022
9. Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Region (USD Billion), 2023-2028
10. North America Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
11. North America Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
12. Europe Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
13. Europe Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
14. Asia Pacific Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
15. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
16. Latin America Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
17. Latin America Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
18. Middle East and Africa Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2018-2022
19. Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2023-2028
20. Global Healthcare Regulatory Affairs Outsourcing Market Structure.
Key Questions Answered in the Report
The global healthcare regulatory affairs outsourcing market is projected to grow at a CAGR of 9.10% between 2023 and 2028.
The major drivers of the market include the increase in clinical trial product development, increase in the use of generics, increase in demand for drugs and medical devices at a lower cost, strict government regulations to hire skilled regulatory professionals capable, rising demand for speedy product approval and increasing investments in the regulatory information system.
Rising cases of chronic diseases and increased research and development activities are the key industry trends propelling the market's growth.
The major regions in the industry are North America, Latin America, the Middle East and Africa, Europe, and the Asia Pacific.
The various services provided by the market include regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, and regulatory consulting and legal representation, among others.
Based on stage, the market is divided into preclinical, clinical, and PMA.
The end-use sectors are pharmaceutical, biotechnology, and medical device companies.
The major players in the industry include WuXi AppTec, Freyr, Parexel International Corporation, Medpace, Inc., ICON plc, IQVIA Inc., and Labcorp Drug Development, among others.
Analyst Review
The rising cases of chronic diseases drove the global healthcare regulatory affairs outsourcing market in the historical period. Aided by the increase in demand for drugs and medical devices at a lower cost and increase in research and development activities, the market is expected to grow at a CAGR of 9.10% in the forecast period of 2023-2028.
EMR’s meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. The various services the market provides are regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, and regulatory consulting and legal representation, among others. Based on stage, the market is divided into preclinical, clinical, and PMA. The market's end-uses are pharmaceutical, biotechnology, and medical device companies. The major regional markets for healthcare regulatory affairs outsourcing are North America, Europe, the Asia Pacific, Latin America, the Middle East and Africa. The key players in the above market are WuXi AppTec, Freyr, Parexel International Corporation, Medpace, Inc., ICON plc, IQVIA Inc., and Labcorp Drug Development, among others.
EMR’s research methodology uses a combination of cutting-edge analytical tools and the expertise of their highly accomplished team, thus, providing their customers with market insights that are accurate, actionable, and help them remain ahead of their competition.
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