Healthcare Regulatory Affairs Outsourcing Market - Global Industry Analysis

Healthcare Regulatory Affairs Outsourcing Market- By Services (Regulatory Writing & Publishing, Clinical Trial Applications & Services Registrations, Regulatory Consulting & Legal Representation, and Regulatory Submissions), By End-User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, and Food & Beverage Companies), And By Region- Global Industry Perspective, Comprehensive Analysis, and Forecast, 2021 – 2028

Published Date: 29-Dec-2021 Category: Pharmaceutical Report Format : PDF Pages: 193 Report Code: ZMR-3369 Status : Published

The global Healthcare Regulatory Affairs Outsourcing Market accrued earnings worth approximately 5.23 (USD Billion) in 2020 and is predicted to gain revenue of about 12.14 (USD Billion) by 2028, is set to record a CAGR of nearly 11.7% over the period from 2021 to 2028.

Description

The global Healthcare Regulatory Affairs Outsourcing Market accrued earnings worth approximately 5.23 (USD Billion) in 2020 and is predicted to gain revenue of about 12.14 (USD Billion) by 2028, is set to record a CAGR of nearly 11.7% over the period from 2021 to 2028. The report offers assessment and analysis of the Healthcare Regulatory Affairs Outsourcing Market on a global and regional level. The study offers a comprehensive assessment of the market competition, constraints, revenue estimates, opportunities, evolving trends, and industry-validated data. The report provides historical data from 2018 to 2020 along with a forecast from 2021 to 2028 based on revenue (USD Billion).

Healthcare Regulatory Affairs Outsourcing Market: Overview

Emerging biotech & pharmacy markets across globe has resulted into necessity for healthcare regulatory affairs outsourcing activities. Moreover, pharmacy firms are working with contract research organizations for new drug development. Surge in incidences of chronic disorders will generate new growth avenues for healthcare regulatory affairs outsourcing industry in coming years. Apparently, period of drug approval is very expensive and time-consuming and requires tedious process of documentation. However, to prevent these issues firms are entering into alliances with firms in business of healthcare regulatory affairs outsourcing for quick documentation & drug approval. This has translated into humungous demand for healthcare regulatory affairs outsourcing activities.

Global Healthcare Regulatory Affairs Outsourcing Market

Healthcare Regulatory Affairs Outsourcing Market: Growth Drivers

Constant surge in compliance measures, strict legislations governing drug development & approvals, and high proportion of medicine withdrawals has compelled biotech, pharm, and life science firms to outsource healthcare regulatory affairs activities with a view to reduce operating costs. This, in turn, will enlarge scope of growth of healthcare regulatory affairs outsourcing industry over forecasting period. In addition to this, regulatory support is necessary for large number of processes in clinical studies including manufacturing & controls methods, healthcare report writing, data management processes, regulatory chemistry procedures, and labeling & liaison methods. This will proliferate size of healthcare regulatory affairs outsourcing industry over assessment period. Moreover, outsourcing of non-core activities will help firms concentrate on various research & development activities.

In addition to this, outsourcing of healthcare regulatory affairs is predicted to assist firms in focusing on core competencies, minimizing service delivery period, and enhance competitive edge for firms. This will create new growth avenues for healthcare regulatory affairs outsourcing market over forecasting timespan. Nevertheless, huge risks related to data security issues in firms can pose a threat to expansion of healthcare regulatory affairs outsourcing industry in foreseeable future.

Report Scope:

Report Attribute Details
Base Year 2020
Historic Years 2016 - 2020
Forecast Years 2021 - 2028
Segments Covered By Product Type, By Application, and By End Use
Forecast Units Value (USD Billion), and Volume (Units)
Quantitative Units Revenue in USD million/billion and CAGR from 2021 to 2028
Regions Covered North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, and Rest of World
Countries Covered U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Argentina, GCC Countries, and South Africa, among others
Number of Companies Covered 10 companies with scope for including additional 15 companies upon request
Report Coverage Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, market attractiveness analysis by segments and region, company market share analysis, and COVID-19 impact analysis.
Customization Scope Avail customized purchase options to meet your exact research needs.

Healthcare Regulatory Affairs Outsourcing Market: Regional Landscape

North America To Account Majorly Towards Overall Market Size By 2028

Growth of healthcare regulatory affairs outsourcing market in North America over assessment period can be due to surge in number of copyright expiries and focus on new product launches in countries such as the U.S. and Canada. Apart from this, need for quick drug approvals to gain competitive advantage over business rivals and acquire major industry share has resulted in healthcare firms outsource healthcare regulatory affairs activities in countries such as the U.S. This has translated into humungous growth of regional market.

Competitive Landscape

Key players profiled in study and influencing market growth are Accell Clinical Research, LLC, Medpace, Inc., Wuxi AppTec, Promedica International, PARAXEL International Corporation, PRA Health Sciences, Inc., Labcorp Drug Development, Freyr Solutions, Criterium, Inc., and Quintiles IMS Holdings, Inc.

The global Healthcare Regulatory Affairs Outsourcing Market is segmented as follows:

By Services

  • Regulatory Writing &  Publishing
  • Regulatory Submissions
  • Clinical Trial Applications & Services Registrations
  • Regulatory Consulting & Legal Representation

By End-User

  • Mid-Size Pharmaceutical Companies
  • Large Pharmaceutical Companies  
  • Biotechnology Companies
  • Medical Device Companies
  • Food & Beverage Companies

By Region

  • North America
    • The U.S.
    • Canada
  • Europe
    • France
    • The UK
    • Spain
    • Germany
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Southeast Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

Table Of Content

  • Chapter 1. Preface
    • 1.1. Report Description and Scope
    • 1.2. Research Scope
    • 1.3. Research Methodulogy
      • 1.3.1. Market Research Type
      • 1.3.2. Market Research Methodulogy
  • Chapter 2. Executive Summary
    • 2.1. Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
    • 2.2. Healthcare Regulatory Affairs Outsourcing Market: Snapshot
  • Chapter 3. Global Healthcare Regulatory Affairs Outsourcing Market– Industry Analysis
    • 3.1. Healthcare Regulatory Affairs Outsourcing Market: Market Dynamics
    • 3.2. Market Drivers
      • 3.2.1. Offshoring of non-core activities will help healthcare firms focus on various research & development activities, thereby driving growth of healthcare regulatory affairs outsourcing market.
      • 3.2.2. Regulatory support is required for large number of processes in clinical studies including manufacturing & contruls methods, healthcare report writing, data management processes, regulatory chemistry procedures, and labeling & liaison methods. This will enlarge scope of healthcare regulatory affairs outsourcing industry growth over projected timeframe.
    • 3.3. Porter’s Five Forces Analysis
    • 3.4. Market Attractiveness Analysis
      • 3.4.1. Market attractiveness analysis By Services
      • 3.4.2. Market attractiveness analysis By End-User
  • Chapter 4. Global Healthcare Regulatory Affairs Outsourcing Market– Competitive Landscape
    • 4.1. Company market share analysis
      • 4.1.1. Global Healthcare Regulatory Affairs Outsourcing Market: company market share, 2019
    • 4.2. Strategic development
      • 4.2.1. Acquisitions & mergers
      • 4.2.2. New Service launches
      • 4.2.3. Agreements, partnerships, cullaborations, and joint ventures
      • 4.2.4. Research and development and Regional expansion
    • 4.3. Price trend analysis
  • Chapter 5. Global Healthcare Regulatory Affairs Outsourcing Market– Services Analysis
    • 5.1. Global Healthcare Regulatory Affairs Outsourcing Market overview: By Services
      • 5.1.1. Global Healthcare Regulatory Affairs Outsourcing Market share, By Services, 2020 and 2028
    • 5.2. Regulatory Writing & Publishing
      • 5.2.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Writing & Publishing, 2018–2028(USD Billion)
    • 5.3. Regulatory Submissions
      • 5.3.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Submissions, 2018–2028(USD Billion)
    • 5.4. Clinical Trial Applications & Services Registrations
      • 5.4.1. Global Healthcare Regulatory Affairs Outsourcing Market by Clinical Trial Applications & Services Registrations, 2018–2028(USD Billion)
    • 5.5. Regulatory Consulting & Legal Representation
      • 5.5.1. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Consulting & Legal Representation, 2018–2028(USD Billion)
  • Chapter 6. Global Healthcare Regulatory Affairs Outsourcing Market– End-User Analysis
    • 6.1. Global Healthcare Regulatory Affairs Outsourcing Market overview: By End-User
      • 6.1.1. Global Healthcare Regulatory Affairs Outsourcing Market share, By End-User , 2020 and 2028
    • 6.2. Mid-Size Pharmaceutical Companies
      • 6.2.1. Global Healthcare Regulatory Affairs Outsourcing Market by Mid-Size Pharmaceutical Companies , 2018–2028(USD Billion)
    • 6.3. Large Pharmaceutical Companies
      • 6.3.1. Global Healthcare Regulatory Affairs Outsourcing Market by Large Pharmaceutical Companies , 2018–2028(USD Billion)
    • 6.4. Medical Device Companies
      • 6.4.1. Global Healthcare Regulatory Affairs Outsourcing Market by Medical Device Companies, 2018–2028(USD Billion)
    • 6.5. Food & Beverage Companies
      • 6.5.1. Global Healthcare Regulatory Affairs Outsourcing Market by Food & Beverage Companies , 2018–2028(USD Billion)
    • 6.6. Biotechnulogy Companies
      • 6.6.1. Global Healthcare Regulatory Affairs Outsourcing Market by Biotechnulogy Companies , 2018–2028(USD Billion)
  • Chapter 7. Company Profiles
    • 7.1. Accell Clinical Research, LLC
      • 7.1.1. Overview
      • 7.1.2. Financials
      • 7.1.3. Service Portfulio
      • 7.1.4. Business Strategy
      • 7.1.5. Recent Developments
    • 7.2. Medpace, Inc.
      • 7.2.1. Overview
      • 7.2.2. Financials
      • 7.2.3. Service Portfulio
      • 7.2.4. Business Strategy
      • 7.2.5. Recent Developments
    • 7.3. Wuxi AppTec
      • 7.3.1. Overview
      • 7.3.2. Financials
      • 7.3.3. Service Portfulio
      • 7.3.4. Business Strategy
      • 7.3.5. Recent Development
    • 7.4. Promedica International
      • 7.4.1. Overview
      • 7.4.2. Financials
      • 7.4.3. Service Portfulio
      • 7.4.4. Business Strategy
      • 7.4.5. Recent Development
    • 7.5. PARAXEL International Corporation
      • 7.5.1. Overview
      • 7.5.2. Financials
      • 7.5.3. Service Portfulio
      • 7.5.4. Business Strategy
      • 7.5.5. Recent Development
    • 7.6. PRA Health Sciences, Inc.
      • 7.6.1. Overview
      • 7.6.2. Financials
      • 7.6.3. Service Portfulio
      • 7.6.4. Business Strategy
      • 7.6.5. Recent Development
    • 7.7. Labcorp Drug Development
      • 7.7.1. Overview
      • 7.7.2. Financials
      • 7.7.3. Service Portfulio
      • 7.7.4. Business Strategy
      • 7.7.5. Recent Development
    • 7.8. Freyr Sulutions
      • 7.8.1. Overview
      • 7.8.2. Financials
      • 7.8.3. Service Portfulio
      • 7.8.4. Business Strategy
      • 7.8.5. Recent Development
    • 7.9. Criterium, Inc.
      • 7.9.1. Overview
      • 7.9.2. Financials
      • 7.9.3. Service Portfulio
      • 7.9.4. Business Strategy
      • 7.9.5. Recent Development
    • 7.10. Quintiles IMS Huldings, Inc.
      • 7.10.1. Overview
      • 7.10.2. Financials
      • 7.10.3. Service Portfulio
      • 7.10.4. Business Strategy
      • 7.10.5. Recent Development

Table Of Figures

List of Figures

1. Market research Type
2. Market research methodology
3. Global Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
4. Porter’s Five Forces Analysis
5. Global Healthcare Regulatory Affairs Outsourcing Market attractiveness, By Services
6. Global Healthcare Regulatory Affairs Outsourcing Market attractiveness, By  End-User 
7. Global Healthcare Regulatory Affairs Outsourcing Market share by Services ,2020 and 2028 (USD Billion)
8. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Writing &  Publishing, 2018–2028(USD Billion)
9. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Submissions, 2018–2028(USD Billion)
10. Global Healthcare Regulatory Affairs Outsourcing Market by Clinical Trial Applications & Services Registrations, 2018–2028(USD Billion)
11. Global Healthcare Regulatory Affairs Outsourcing Market by Regulatory Consulting & Legal Representation, 2018–2028(USD Billion)
12. Global Healthcare Regulatory Affairs Outsourcing Market share by  End-User ,2020 and 2028 (USD Billion)
13. Global Healthcare Regulatory Affairs Outsourcing Market by Mid-Size Pharmaceutical Companies , 2018–2028(USD Billion)
14. Global Healthcare Regulatory Affairs Outsourcing Market by Large Pharmaceutical Companies , 2018–2028(USD Billion)
15. Global Healthcare Regulatory Affairs Outsourcing Market by Biotechnology Companies , 2018–2028(USD Billion)
16. Global Healthcare Regulatory Affairs Outsourcing Market by Medical Device Companies, 2018–2028(USD Billion)
17. Global Healthcare Regulatory Affairs Outsourcing Market by Food & Beverage Companies, 2018–2028(USD Billion)
18. Global Healthcare Regulatory Affairs Outsourcing Market share, by Region, 2020 and 2028
19. North America Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
20. Europe Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
21. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
22. Latin America Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
23. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market, 2018–2028(USD Billion)
 


Table Of Tables

List of Tables

1. Global Healthcare Regulatory Affairs Outsourcing Market: snapshot
2. Drivers of the Healthcare Regulatory Affairs Outsourcing Market: impact analysis
3. North America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
4. North America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
5. The U.S. Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
6. The U.S. Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
7. Rest of North America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
8. Rest of North America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
9. Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
10. Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
11. UK Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
12. UK Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
13. France Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
14. France Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
15. Germany Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
16. Germany Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
17. Rest of Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
18. Rest of Europe Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
19. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
20. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
21. China Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
22. China Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
23. Japan Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
24. Japan Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
25. India Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
26. India Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
27. Rest of Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
28. Rest of Asia Pacific Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
29. Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
30. Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
31. Brazil Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
32. Brazil Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
33. Rest of Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
34. Rest of Latin America Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
35. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
36. The Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
37. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
38. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
39. South Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
40. South Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)
41. Rest of the Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By Services  ,2018–2028(USD Billion)
42. Rest of the Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market revenue, By  End-User  ,2018–2028(USD Billion)

 

Methodology

Free Analysis

With the rising demand for various services, the market for healthcare regulatory affairs outsourcing is at upsurge. It includes writing and publishing of medical regulatory documentation which is offered by experienced quality control publishers and auditors and medical writers, who play an important role in the development of high-quality documents for clinical research projects. Regulatory submissions refer to submission of any information or documentation related to healthcare products to a regulatory body in order to get it reviewed. There are also other outsourcing services like regulatory consulting, legal representations, and clinical trial applications. All these services are in high demand from all the end-user companies ranging from pharma to food and beverages.

Many countries are increasing their investments in the research and development activities which have triggered the development and launch of new products in the market. With the rising guidelines by the regulatory authorities all over the world, there has been a growing alliance between the drug developers, CRO’s and CMO’s to mitigate risks. Since CMO’s and CRO’s help the companies in these risks, companies are able to focus on their core businesses. Therefore, patent expirations, along with increasing R&D activities have been identified as the major factors fueling the growth of the healthcare regulatory affairs outsourcing market. The rise in demand for services offered by healthcare regulatory affairs outsourcing market has also resulted in increasing documentation during device and drug manufacturing. Thus the small and mid-sized pharmaceutical companies are facing problems of extensive documentation. Due to the stringent policies, the regulatory authorities demand skilled and trained regulatory professionals who are capable of handling registration, evaluation, and compilation of data efficiently. Consequently, the biotechnology and pharmaceutical companies are seeking help from the regulatory service providers, thus boosting the market growth for healthcare regulatory affairs outsourcing. 

Global Healthcare Regulatory Affairs Outsourcing Market

The healthcare regulatory affairs outsourcing market is segmented based on services and end-user. Based on services, the market is segmented into regulatory writing and publishing, regulatory submissions, legal representation, and regulatory consulting, clinical trial applications and services registrations, and other regulatory affairs. The end-user segment is divided into biotechnology companies, mid-size pharmaceutical companies, medical device companies, large pharmaceutical companies, and food and beverage companies.

North America and Europe hold the largest share in the healthcare regulatory affairs outsourcing market. This growth is mainly attributed to the huge number of R&D activities in the field of drug discovery carried out in these two regions. These regions also have a large presence of multinational biotech and pharma companies which carry out a large number of clinical trials and also have well developed and advanced healthcare infrastructure. Due to high healthcare investment and rising government funding Europe also holds a maximum share of the market followed by North America. Asia Pacific region is also witnessing significant growth rate owing to the unmet health care needs and raised government funding towards research activities. Also, many biotech and pharma companies have started outsourcing their drug development services to various developing countries like China, Malaysia, India, and Singapore which is further boosting the market growth for healthcare regulatory affairs outsourcing market.

Some of the leading players in healthcare regulatory affairs outsourcing market include Medpace, Inc., Promedica International, PARAXEL International Corporation, Covance, Inc., Freyr Solutions, Criterium, Inc., Accell Clinical Research, PRA Health Sciences, Inc., Wuxi AppTec and Quintiles IMS Holdings, Inc. There has been a trend of a strategic partnership between services providers for increasing service portfolio to expand regional presence. For instance, Shin Nippon Biomedical Laboratories Ltd. (SNBL), leading provider of development services to biopharmaceuticals, formed a joint venture with PPD to provide clinical development services in Japan which includes function-based services such as pharmacovigilance.

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FrequentlyAsked Questions

Constant surge in compliance measures, strict legislations governing drug development & approvals, and high proportion of medicine withdrawals has compelled biotech, pharm, and life science firms to outsource healthcare regulatory affairs activities with a view to reduce operating costs. This, in turn, will enlarge scope of growth of healthcare regulatory affairs outsourcing industry over forecasting period. In addition to this, regulatory support is necessary for large number of processes in clinical studies including manufacturing & controls methods, healthcare report writing, data management processes, regulatory chemistry procedures, and labeling & liaison methods. This will proliferate size of healthcare regulatory affairs outsourcing industry over assessment period. Moreover, outsourcing of non-core activities will help firms concentrate on various research & development activities.

In addition to this, outsourcing of healthcare regulatory affairs is predicted to assist firms in focusing on core competencies, minimizing service delivery period, and enhance competitive edge for firms. This will create new growth avenues for healthcare regulatory affairs outsourcing market over forecasting timespan.

According to Zion market research report, the global Healthcare Regulatory Affairs Outsourcing Market accrued earnings worth approximately 5.23 (USD Billion) in 2020 and is predicted to gain revenue of about 12.14 (USD Billion) by 2028, is set to record a CAGR of nearly 11.7% over the period from 2021 to 2028.

North America will contribute lucratively towards the global market earnings over the projected timeline. The regional market surge is subject to surge in number of copyright expiries and focus on new product launches in countries such as the U.S. and Canada. Apart from this, need for quick drug approvals to gain competitive advantage over business rivals and acquire major industry share has resulted in healthcare firms outsource healthcare regulatory affairs activities in countries such as the U.S. This has translated into humungous growth of regional market. 

The key market participants include Accell Clinical Research, LLC, Medpace, Inc., Wuxi AppTec, Promedica International, PARAXEL International Corporation, PRA Health Sciences, Inc., Labcorp Drug Development, Freyr Solutions, Criterium, Inc., and Quintiles IMS Holdings, Inc.

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