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1037112

Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026

Published: | IMARC Services Private Limited | 149 Pages | Delivery time: 2-3 business days

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Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026
Published: November 10, 2021
IMARC Services Private Limited
Content info: 149 Pages
Delivery time: 2-3 business days
  • Description
  • Table of Contents

The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, IMARC Group expects the market to exhibit strong growth during 2021-2026. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor.

Regulatory affairs outsourcing refers to the hiring of third-party services by the government bodies and private organizations to ensure public health and safety. The services include managing regulatory requirements for generic drugs, innovator drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the products and ensure that they are safe for consumption. These services are required for clinical trial and patent application, regulatory writing and publishing, product registration and legal representation. Pharmaceutical organizations also opt for these services to seek speedy government approvals in various regions.

Significant growth in the pharmaceutical and biotechnological industries across the globe represents one of the key factors creating a positive outlook for the market. Furthermore, the increasing emphasis of pharmaceutical organizations to expand their operations and supplies in the emerging economies is also driving the market growth. Outsourcing regulatory affairs also aid in minimizing the costs associated with managing in-house resources, such as facilities, training, technology, specialized knowledge and geographic regulations. Additionally, regulatory affairs outsourcing services are also widely used for the development of biosimilar, orphan and generic drugs, which is acting as another major growth-inducing factor. Life science organizations are increasingly outsourcing non-core functions and regulatory services and increase their overall operational efficiencies, which, in turn, is contributing to the market growth. Other factors, including significant improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are anticipated to drive the market further.

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global regulatory affairs outsourcing market, along with forecasts at the global, regional and country level from 2021-2026. Our report has categorized the market based on services, company size, category, indication, stage and end user.

Breakup by Services:

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing and Publishing
  • Product Registration and Clinical Trial Applications
  • Others

Breakup by Company Size:

  • Small
  • Medium
  • Large

Breakup by Category:

  • Generic Drugs
  • Innovator Drugs
  • Biologic Drugs
  • Biosimilars
  • Medical Devices
  • Therapeutic
  • Diagnostic
  • Others

Breakup by Indication:

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

Breakup by Stage:

  • Preclinical
  • Clinical
  • PMA (Post Market Authorization)

Breakup by End User:

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Charles River Laboratories International, Inc., Covance Inc (Laboratory Corporation of America Holdings), Freyr, ICON Plc, Medpace Holdings Inc., Parexel International Corporation, Pharmaceutical Product Development LLC, Promedica International- A California Corporation and Wuxi AppTec Co. Ltd.

Key Questions Answered in This Report:

  • How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global regulatory affairs outsourcing market?
  • What are the key regional markets?
  • What is the breakup of the market based on the services?
  • What is the breakup of the market based on the company size?
  • What is the breakup of the market based on the category?
  • What is the breakup of the market based on the indication?
  • What is the breakup of the market based on the stage?
  • What is the breakup of the market based on the end user?
  • What are the various stages in the value chain of the industry?
  • What are the key driving factors and challenges in the industry?
  • What is the structure of the global regulatory affairs outsourcing market and who are the key players?
  • What is the degree of competition in the industry?
Product Code: SR1020G132_Report

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Regulatory Affairs Outsourcing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Services

  • 6.1 Regulatory Consulting
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Legal Representation
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Regulatory Writing and Publishing
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Product Registration and Clinical Trial Applications
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast
  • 6.5 Others
    • 6.5.1 Market Trends
    • 6.5.2 Market Forecast

7 Market Breakup by Company Size

  • 7.1 Small
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Medium
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Large
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast

8 Market Breakup by Category

  • 8.1 Generic Drugs
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Innovator Drugs
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Biologic Drugs
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Biosimilars
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Medical Devices
    • 8.5.1 Market Trends
    • 8.5.2 Major Types
      • 8.5.2.1 Therapeutic
      • 8.5.2.2 Diagnostic
    • 8.5.3 Market Forecast
  • 8.6 Others
    • 8.6.1 Market Trends
    • 8.6.2 Market Forecast

9 Market Breakup by Indication

  • 9.1 Oncology
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Neurology
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Cardiology
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast
  • 9.4 Immunology
    • 9.4.1 Market Trends
    • 9.4.2 Market Forecast
  • 9.5 Others
    • 9.5.1 Market Trends
    • 9.5.2 Market Forecast

10 Market Breakup by Stage

  • 10.1 Preclinical
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Clinical
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 PMA (Post Market Authorization)
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast

11 Market Breakup by End User

  • 11.1 Medical Device Companies
    • 11.1.1 Market Trends
    • 11.1.2 Market Forecast
  • 11.2 Pharmaceutical Companies
    • 11.2.1 Market Trends
    • 11.2.2 Market Forecast
  • 11.3 Biotechnology Companies
    • 11.3.1 Market Trends
    • 11.3.2 Market Forecast

12 Market Breakup by Region

  • 12.1 North America
    • 12.1.1 United States
      • 12.1.1.1 Market Trends
      • 12.1.1.2 Market Forecast
    • 12.1.2 Canada
      • 12.1.2.1 Market Trends
      • 12.1.2.2 Market Forecast
  • 12.2 Asia-Pacific
    • 12.2.1 China
      • 12.2.1.1 Market Trends
      • 12.2.1.2 Market Forecast
    • 12.2.2 Japan
      • 12.2.2.1 Market Trends
      • 12.2.2.2 Market Forecast
    • 12.2.3 India
      • 12.2.3.1 Market Trends
      • 12.2.3.2 Market Forecast
    • 12.2.4 South Korea
      • 12.2.4.1 Market Trends
      • 12.2.4.2 Market Forecast
    • 12.2.5 Australia
      • 12.2.5.1 Market Trends
      • 12.2.5.2 Market Forecast
    • 12.2.6 Indonesia
      • 12.2.6.1 Market Trends
      • 12.2.6.2 Market Forecast
    • 12.2.7 Others
      • 12.2.7.1 Market Trends
      • 12.2.7.2 Market Forecast
  • 12.3 Europe
    • 12.3.1 Germany
      • 12.3.1.1 Market Trends
      • 12.3.1.2 Market Forecast
    • 12.3.2 France
      • 12.3.2.1 Market Trends
      • 12.3.2.2 Market Forecast
    • 12.3.3 United Kingdom
      • 12.3.3.1 Market Trends
      • 12.3.3.2 Market Forecast
    • 12.3.4 Italy
      • 12.3.4.1 Market Trends
      • 12.3.4.2 Market Forecast
    • 12.3.5 Spain
      • 12.3.5.1 Market Trends
      • 12.3.5.2 Market Forecast
    • 12.3.6 Russia
      • 12.3.6.1 Market Trends
      • 12.3.6.2 Market Forecast
    • 12.3.7 Others
      • 12.3.7.1 Market Trends
      • 12.3.7.2 Market Forecast
  • 12.4 Latin America
    • 12.4.1 Brazil
      • 12.4.1.1 Market Trends
      • 12.4.1.2 Market Forecast
    • 12.4.2 Mexico
      • 12.4.2.1 Market Trends
      • 12.4.2.2 Market Forecast
    • 12.4.3 Others
      • 12.4.3.1 Market Trends
      • 12.4.3.2 Market Forecast
  • 12.5 Middle East and Africa
    • 12.5.1 Market Trends
    • 12.5.2 Market Breakup by Country
    • 12.5.3 Market Forecast

13 SWOT Analysis

  • 13.1 Overview
  • 13.2 Strengths
  • 13.3 Weaknesses
  • 13.4 Opportunities
  • 13.5 Threats

14 Value Chain Analysis

15 Porters Five Forces Analysis

  • 15.1 Overview
  • 15.2 Bargaining Power of Buyers
  • 15.3 Bargaining Power of Suppliers
  • 15.4 Degree of Competition
  • 15.5 Threat of New Entrants
  • 15.6 Threat of Substitutes

16 Price Analysis

17 Competitive Landscape

  • 17.1 Market Structure
  • 17.2 Key Players
  • 17.3 Profiles of Key Players
    • 17.3.1 Charles River Laboratories International Inc.
      • 17.3.1.1 Company Overview
      • 17.3.1.2 Product Portfolio
      • 17.3.1.3 Financials
      • 17.3.1.4 SWOT Analysis
    • 17.3.2 Covance Inc (Laboratory Corporation of America Holdings)
      • 17.3.2.1 Company Overview
      • 17.3.2.2 Product Portfolio
      • 17.3.2.3 SWOT Analysis
    • 17.3.3 Freyr
      • 17.3.3.1 Company Overview
      • 17.3.3.2 Product Portfolio
    • 17.3.4 ICON Plc
      • 17.3.4.1 Company Overview
      • 17.3.4.2 Product Portfolio
      • 17.3.4.3 Financials
      • 17.3.4.4 SWOT Analysis
    • 17.3.5 Medpace Holdings Inc
      • 17.3.5.1 Company Overview
      • 17.3.5.2 Product Portfolio
      • 17.3.5.3 Financials
      • 17.3.5.4 SWOT Analysis
    • 17.3.6 Parexel International Corporation
      • 17.3.6.1 Company Overview
      • 17.3.6.2 Product Portfolio
      • 17.3.6.3 SWOT Analysis
    • 17.3.7 Pharmaceutical Product Development LLC
      • 17.3.7.1 Company Overview
      • 17.3.7.2 Product Portfolio
      • 17.3.7.3 Financials
      • 17.3.7.4 SWOT Analysis
    • 17.3.8 Promedica International- A California Corporation
      • 17.3.8.1 Company Overview
      • 17.3.8.2 Product Portfolio
    • 17.3.9 Wuxi AppTec Co. Ltd.
      • 17.3.9.1 Company Overview
      • 17.3.9.2 Product Portfolio