Healthcare Regulatory Affairs Outsourcing Market Research Report - Forecast till 2027

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

Please note that the assessment period of report has been updated from 2018-2023 to 2020-2027. Cordially fill the sample form for updated data.

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 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

  • 2017: USD 3,120.4 Million
  • 2027: Significant Value
  •   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

  • Increasing number of patent expirations
  • Growing research and development activities
  •   Key Market Drivers

  • Rising development of products in clinical trials
  • The demand for clinical trial applications


  • 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.