Dublin, Dec. 15, 2021 (GLOBE NEWSWIRE) -- The "Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.
The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Looking forward, the publisher 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:
The publisher 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?
Key Topics Covered:
1 Preface
2 Scope and 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
13 SWOT Analysis
14 Value Chain Analysis
15 Porters Five Forces Analysis
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
For more information about this report visit https://www.researchandmarkets.com/r/nq7kpo
