New

Healthcare Regulatory Affairs Outsourcing Market

2021

Healthcare Regulatory Affairs Outsourcing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications, Product Registrations, Regulatory Consulting and Legal Representation, Regularly Affairs, Regulatory Labelling, Regularity Artwork Services); End User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Medical Device Companies, Biotechnology Companies) and Geography

| Report Code: TIPRE00007611 | No. of Pages: 150 | Category: Healthcare IT | Status: Upcoming

Market Insights

Healthcare Regulatory Affairs Outsourcing Market 2028 By Type, End User and Geography | The Insight Partners

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MARKET OVERVIEW

Healthcare regulatory affairs mainly deals with the safety and efficacy of the product and other pharmaceutical agents. Medical writing and publishing of regulatory documentation prepared by experienced medical writers, quality control (QC) auditors, and publishers to develop high-quality documents for research projects regulatory submissions are among the services offered by healthcare regulatory affairs outsourcing. In addition other regulatory outsourcing services include, regulatory consulting, clinical trial applications, legal formalities and guidelines along with quality assurance and compliance.

MARKET SCOPE

The Global Healthcare Regulatory Affairs Outsourcing Market Analysis to 2028 is a specialized and in-depth study of the healthcare industry with a special focus on the global market trend analysis. The report aims to provide an overview of the healthcare regulatory affairs outsourcing market with detailed market segmentation by type and end user. The report provides key statistics on the market status of the leading healthcare regulatory affairs outsourcing market players and offers key trends and opportunities in the market.

MARKET SEGMENTATION

  •   Based on type the market is segmented as, regulatory writing and publishing, regulatory submissions, clinical trial applications, product registrations and regulatory consulting and legal representation, regulatory affairs, regulatory labelling.
  •   Based on end user the market is segmenetd as, mid-size pharmaceutical, large pharmaceutical companies, medical device companies and biotechnology companies.

MARKET DYNAMICS
Drivers:

  •   Increasing investment in healthcare sector is the key driving factor for the market growth.
  •   Growing collaborations between drug companies and regulatory affairs outsourcing companies is expected to create significant growth opportunities for the market.
  •   Rising R&D activities, coupled with patent expirations provide an impetus to the market growth.
  •   Globally, growing regulatory pressure on documentation related to drug and device manufacturing is fueling the demand for healthcare regulatory affairs outsourcing in upcoming years.

Restraints:

  •   However, high cost associated with outsourcing activities is expected to restrain market growth during the forecast period.



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REGIONAL FRAMEWORK


The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides an overview and forecast of the global market based on various segments. It also provides market size and forecast estimates from the year 2019 to 2028 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), the Middle East and Africa (MEA), and South America. The healthcare regulatory affairs outsourcing market by each region is later sub-segmented by respective countries and segments. The report covers the analysis and forecast of 18 countries globally along with the current trend and opportunities prevailing in the region.

The report analyzes factors affecting the market from both demand and supply side and further evaluates market dynamics affecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA, and South America after evaluating political, economic, social and technological factors affecting the healthcare regulatory affairs outsourcing market in these regions.

IMPACT OF COVID-19 ON HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET

COVID-19 first began in Wuhan (China) during December 2019 and since then it has spread at a fast pace across the globe. The US, India, Brazil, Russia, France, the UK, Turkey, Italy, and Spain are some of the worst affected countries in terms confirmed cases and reported deaths. The COVID-19 has been affecting economies and industries in various countries due to lockdowns, travel bans, and business shutdowns. Shutdown of various plants and factories has affected the global supply chains and negatively impacted the manufacturing, delivery schedules, and sales of products in global market. Few companies have already announced possible delays in product deliveries and slump in future sales of their products. According to the current market situation, the report further assesses the present and future effects of the COVID-19 pandemic on the overall market, giving more reliable and authentic projections In addition to this, the global travel bans imposed by countries in Europe, Asia-Pacific, and North America are affecting the business collaborations and partnerships opportunities.



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MARKET PLAYERS


The report covers key developments in the healthcare regulatory affairs outsourcing market as organic and inorganic growth strategies. Various companies are focusing on organic growth strategies such as product launches, product approvals and others such as patents and events. Inorganic growth strategies activities witnessed in the marketwere acquisitions, and partnership & collaborations. These activities have paved way for the expansion of business and customer base of market players. The market payers from healthcare regulatory affairs outsourcing market are anticipated to lucrative growth opportunities in the future with the rising demand for healthcare regulatory affairs outsourcing in the global market.

The report also includes the profiles of key companies along with their SWOT analysis and market strategies in the healthcare regulatory affairs outsourcing market. In addition, the report focuses on leading industry players with information such as company profiles, components, and services offered, financial information of the last 3 years, the key development in the past five years.

  •   Accell Clinical Research, LLC
  •   Charles River Laboratories
  •   Clinilabs Inc
  •   Labcorp Drug Development
  •   Freyr
  •   ICON plc
  •   PPD Inc
  •   IQVIA
  •   Parexel International Corporation
  •   Medpace
The Insight Partner's dedicated research and analysis team consist of experienced professionals with advanced statistical expertise and offer various customization options in the existing study.


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TABLE OF CONTENTS

1. INTRODUCTION
1.1. SCOPE OF THE STUDY
1.2. THE INSIGHT PARTNERS RESEARCH REPORT GUIDANCE
1.3. MARKET SEGMENTATION
1.3.1 Healthcare Regulatory Affairs Outsourcing Market - By Type
1.3.2 Healthcare Regulatory Affairs Outsourcing Market - By End User
1.3.3 Healthcare Regulatory Affairs Outsourcing Market - By Region
1.3.3.1 By Country

2. KEY TAKEAWAYS

3. RESEARCH METHODOLOGY

4. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET LANDSCAPE
4.1. OVERVIEW
4.2. PORTER'S FIVE FORCES ANALYSIS
4.2.1 Bargaining Power of Buyers
4.2.1 Bargaining Power of Suppliers
4.2.1 Threat of Substitute
4.2.1 Threat of New Entrants
4.2.1 Competitive Rivalry
4.3. EXPERT OPINIONS

5. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET - KEY MARKET DYNAMICS
5.1. KEY MARKET DRIVERS
5.2. KEY MARKET RESTRAINTS
5.3. KEY MARKET OPPORTUNITIES
5.4. FUTURE TRENDS
5.5. IMPACT ANALYSIS OF DRIVERS AND RESTRAINTS

6. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET - GLOBAL MARKET ANALYSIS
6.1. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING - GLOBAL MARKET OVERVIEW
6.2. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING - GLOBAL MARKET AND FORECAST TO 2028
6.3. MARKET POSITIONING/MARKET SHARE

7. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET - REVENUE AND FORECASTS TO 2028 - TYPE
7.1. OVERVIEW
7.2. TYPE MARKET FORECASTS AND ANALYSIS
7.3. REGULATORY WRITING AND PUBLISHING
7.3.1. Overview
7.3.2. Regulatory Writing and Publishing Market Forecast and Analysis
7.4. REGULATORY SUBMISSIONS
7.4.1. Overview
7.4.2. Regulatory Submissions Market Forecast and Analysis
7.5. CLINICAL TRIAL APPLICATIONS
7.5.1. Overview
7.5.2. Clinical Trial Applications Market Forecast and Analysis
7.6. PRODUCT REGISTRATIONS
7.6.1. Overview
7.6.2. Product Registrations Market Forecast and Analysis
7.7. REGULATORY CONSULTING AND LEGAL REPRESENTATION
7.7.1. Overview
7.7.2. Regulatory Consulting and Legal Representation Market Forecast and Analysis
7.8. REGULARLY AFFAIRS
7.8.1. Overview
7.8.2. Regularly Affairs Market Forecast and Analysis
7.9. REGULATORY LABELLING
7.9.1. Overview
7.9.2. Regulatory Labelling Market Forecast and Analysis
7.10. REGULARITY ARTWORK SERVICES
7.10.1. Overview
7.10.2. Regularity Artwork Services Market Forecast and Analysis
8. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET - REVENUE AND FORECASTS TO 2028 - END USER
8.1. OVERVIEW
8.2. END USER MARKET FORECASTS AND ANALYSIS
8.3. MID-SIZE PHARMACEUTICAL COMPANIES
8.3.1. Overview
8.3.2. Mid-Size Pharmaceutical Companies Market Forecast and Analysis
8.4. LARGE PHARMACEUTICAL COMPANIES
8.4.1. Overview
8.4.2. Large Pharmaceutical Companies Market Forecast and Analysis
8.5. MEDICAL DEVICE COMPANIES
8.5.1. Overview
8.5.2. Medical Device Companies Market Forecast and Analysis
8.6. BIOTECHNOLOGY COMPANIES
8.6.1. Overview
8.6.2. Biotechnology Companies Market Forecast and Analysis

9. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET REVENUE AND FORECASTS TO 2028 - GEOGRAPHICAL ANALYSIS
9.1. NORTH AMERICA
9.1.1 North America Healthcare Regulatory Affairs Outsourcing Market Overview
9.1.2 North America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis
9.1.3 North America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Type
9.1.4 North America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By End User
9.1.5 North America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Countries
9.1.5.1 United States Healthcare Regulatory Affairs Outsourcing Market
9.1.5.1.1 United States Healthcare Regulatory Affairs Outsourcing Market by Type
9.1.5.1.2 United States Healthcare Regulatory Affairs Outsourcing Market by End User
9.1.5.2 Canada Healthcare Regulatory Affairs Outsourcing Market
9.1.5.2.1 Canada Healthcare Regulatory Affairs Outsourcing Market by Type
9.1.5.2.2 Canada Healthcare Regulatory Affairs Outsourcing Market by End User
9.1.5.3 Mexico Healthcare Regulatory Affairs Outsourcing Market
9.1.5.3.1 Mexico Healthcare Regulatory Affairs Outsourcing Market by Type
9.1.5.3.2 Mexico Healthcare Regulatory Affairs Outsourcing Market by End User
9.2. EUROPE
9.2.1 Europe Healthcare Regulatory Affairs Outsourcing Market Overview
9.2.2 Europe Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis
9.2.3 Europe Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Type
9.2.4 Europe Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By End User
9.2.5 Europe Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Countries
9.2.5.1 Germany Healthcare Regulatory Affairs Outsourcing Market
9.2.5.1.1 Germany Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.1.2 Germany Healthcare Regulatory Affairs Outsourcing Market by End User
9.2.5.2 France Healthcare Regulatory Affairs Outsourcing Market
9.2.5.2.1 France Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.2.2 France Healthcare Regulatory Affairs Outsourcing Market by End User
9.2.5.3 Italy Healthcare Regulatory Affairs Outsourcing Market
9.2.5.3.1 Italy Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.3.2 Italy Healthcare Regulatory Affairs Outsourcing Market by End User
9.2.5.4 Spain Healthcare Regulatory Affairs Outsourcing Market
9.2.5.4.1 Spain Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.4.2 Spain Healthcare Regulatory Affairs Outsourcing Market by End User
9.2.5.5 United Kingdom Healthcare Regulatory Affairs Outsourcing Market
9.2.5.5.1 United Kingdom Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.5.2 United Kingdom Healthcare Regulatory Affairs Outsourcing Market by End User
9.2.5.6 Rest of Europe Healthcare Regulatory Affairs Outsourcing Market
9.2.5.6.1 Rest of Europe Healthcare Regulatory Affairs Outsourcing Market by Type
9.2.5.6.2 Rest of Europe Healthcare Regulatory Affairs Outsourcing Market by End User
9.3. ASIA-PACIFIC
9.3.1 Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market Overview
9.3.2 Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis
9.3.3 Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Type
9.3.4 Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By End User
9.3.5 Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Countries
9.3.5.1 Australia Healthcare Regulatory Affairs Outsourcing Market
9.3.5.1.1 Australia Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.1.2 Australia Healthcare Regulatory Affairs Outsourcing Market by End User
9.3.5.2 China Healthcare Regulatory Affairs Outsourcing Market
9.3.5.2.1 China Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.2.2 China Healthcare Regulatory Affairs Outsourcing Market by End User
9.3.5.3 India Healthcare Regulatory Affairs Outsourcing Market
9.3.5.3.1 India Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.3.2 India Healthcare Regulatory Affairs Outsourcing Market by End User
9.3.5.4 Japan Healthcare Regulatory Affairs Outsourcing Market
9.3.5.4.1 Japan Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.4.2 Japan Healthcare Regulatory Affairs Outsourcing Market by End User
9.3.5.5 South Korea Healthcare Regulatory Affairs Outsourcing Market
9.3.5.5.1 South Korea Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.5.2 South Korea Healthcare Regulatory Affairs Outsourcing Market by End User
9.3.5.6 Rest of Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market
9.3.5.6.1 Rest of Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market by Type
9.3.5.6.2 Rest of Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market by End User
9.4. MIDDLE EAST AND AFRICA
9.4.1 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Overview
9.4.2 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis
9.4.3 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Type
9.4.4 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By End User
9.4.5 Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Countries
9.4.5.1 South Africa Healthcare Regulatory Affairs Outsourcing Market
9.4.5.1.1 South Africa Healthcare Regulatory Affairs Outsourcing Market by Type
9.4.5.1.2 South Africa Healthcare Regulatory Affairs Outsourcing Market by End User
9.4.5.2 Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market
9.4.5.2.1 Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market by Type
9.4.5.2.2 Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market by End User
9.4.5.3 U.A.E Healthcare Regulatory Affairs Outsourcing Market
9.4.5.3.1 U.A.E Healthcare Regulatory Affairs Outsourcing Market by Type
9.4.5.3.2 U.A.E Healthcare Regulatory Affairs Outsourcing Market by End User
9.4.5.4 Rest of Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market
9.4.5.4.1 Rest of Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market by Type
9.4.5.4.2 Rest of Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market by End User
9.5. SOUTH AND CENTRAL AMERICA
9.5.1 South and Central America Healthcare Regulatory Affairs Outsourcing Market Overview
9.5.2 South and Central America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis
9.5.3 South and Central America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Type
9.5.4 South and Central America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By End User
9.5.5 South and Central America Healthcare Regulatory Affairs Outsourcing Market Forecasts and Analysis - By Countries
9.5.5.1 Brazil Healthcare Regulatory Affairs Outsourcing Market
9.5.5.1.1 Brazil Healthcare Regulatory Affairs Outsourcing Market by Type
9.5.5.1.2 Brazil Healthcare Regulatory Affairs Outsourcing Market by End User
9.5.5.2 Argentina Healthcare Regulatory Affairs Outsourcing Market
9.5.5.2.1 Argentina Healthcare Regulatory Affairs Outsourcing Market by Type
9.5.5.2.2 Argentina Healthcare Regulatory Affairs Outsourcing Market by End User
9.5.5.3 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market
9.5.5.3.1 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market by Type
9.5.5.3.2 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market by End User

10. INDUSTRY LANDSCAPE
10.1. MERGERS AND ACQUISITIONS
10.2. AGREEMENTS, COLLABORATIONS AND JOIN VENTURES
10.3. NEW PRODUCT LAUNCHES
10.4. EXPANSIONS AND OTHER STRATEGIC DEVELOPMENTS

11. HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET, KEY COMPANY PROFILES
11.1. ACCELL CLINICAL RESEARCH, LLC
11.1.1. Key Facts
11.1.2. Business Description
11.1.3. Products and Services
11.1.4. Financial Overview
11.1.5. SWOT Analysis
11.1.6. Key Developments
11.2. CHARLES RIVER LABORATORIES
11.2.1. Key Facts
11.2.2. Business Description
11.2.3. Products and Services
11.2.4. Financial Overview
11.2.5. SWOT Analysis
11.2.6. Key Developments
11.3. CLINILABS INC
11.3.1. Key Facts
11.3.2. Business Description
11.3.3. Products and Services
11.3.4. Financial Overview
11.3.5. SWOT Analysis
11.3.6. Key Developments
11.4. LABCORP DRUG DEVELOPMENT
11.4.1. Key Facts
11.4.2. Business Description
11.4.3. Products and Services
11.4.4. Financial Overview
11.4.5. SWOT Analysis
11.4.6. Key Developments
11.5. FREYR
11.5.1. Key Facts
11.5.2. Business Description
11.5.3. Products and Services
11.5.4. Financial Overview
11.5.5. SWOT Analysis
11.5.6. Key Developments
11.6. ICON PLC
11.6.1. Key Facts
11.6.2. Business Description
11.6.3. Products and Services
11.6.4. Financial Overview
11.6.5. SWOT Analysis
11.6.6. Key Developments
11.7. PPD INC
11.7.1. Key Facts
11.7.2. Business Description
11.7.3. Products and Services
11.7.4. Financial Overview
11.7.5. SWOT Analysis
11.7.6. Key Developments
11.8. IQVIA
11.8.1. Key Facts
11.8.2. Business Description
11.8.3. Products and Services
11.8.4. Financial Overview
11.8.5. SWOT Analysis
11.8.6. Key Developments
11.9. PAREXEL INTERNATIONAL CORPORATION
11.9.1. Key Facts
11.9.2. Business Description
11.9.3. Products and Services
11.9.4. Financial Overview
11.9.5. SWOT Analysis
11.9.6. Key Developments
11.10. MEDPACE
11.10.1. Key Facts
11.10.2. Business Description
11.10.3. Products and Services
11.10.4. Financial Overview
11.10.5. SWOT Analysis
11.10.6. Key Developments

12. APPENDIX
12.1. ABOUT THE INSIGHT PARTNERS
12.2. GLOSSARY OF TERMS
The List of Companies

1. Accell Clinical Research, LLC
2. Charles River Laboratories
3. Clinilabs Inc
4. Labcorp Drug Development
5. Freyr
6. ICON plc
7. PPD Inc
8. IQVIA
9. Parexel International Corporation
10. Medpace
11. WuXi AppTec
12. Genpact Ltd.
13. PRA Health Sciences
14. Promedica International"
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