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

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

  • November 2021 •
  • 149 pages •
  • Report ID: 6185560 •
  • Format: PDF
The global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020.

Looking forward, the analyst 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 analyst 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?