Regulatory Affairs Outsourcing Market, by Service Type, by Application, and by Region - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2028

Regulatory affairs outsourcing market has grown significantly over the last decade. Increasing research and development expenditure in healthcare sector and increasing adoption of various growth strategies has boosted demand for regulatory outsourcing services in recent years. These services are majorly offered in the pharmaceutical and medical devices segment. Rising number of clinical trials is expected to fuel the Regulatory affairs outsourcing market growth over the forecast period.

Market Dynamics

Increasing number of clinical trials and research and development expenditure in the healthcare sector is expected to drive the market growth. According to Clinical Trials.gov, the number of clinical studies registered in 50 states and 209 countries in 2018 and around 293,353 and 262,371 in 2017.

Companies engaged in the Regulatory affairs outsourcing market are expected to generate significant return-on-investment (ROI) over the forecast period owing to the increasing adoption of business growth strategies such as partnership, acquisition by the market players. For instance, in June 2018, Medpace, Inc. and International Health Management Associates, Inc. announced collaboration for offering clinical trials in the infectious diseases domain. Similarly, in August 2018, Synchrogenix, subsidiary of Certara, L.P., announced partnership with PleaseTech Ltd., a review specialist and provider of document redaction services

Key players in the market are focused on facility expansions in order to enhance their share in potential markets, which, in turn, is expected to propel the market growth over the forecast period. For instance, in July 2021, Health Advances LLC, a healthcare consulting and subsidiary of Parexel International Corporation, launched Health Advances Asia Limited and extended its offering in drug development and commercialization services to the Asia Pacific region.

Key features of the study:

• This report provides in-depth analysis of the Regulatory affairs outsourcing market and provides market size (US$ million) and Compound Annual Growth Rate (CAGR %) for the forecast period (2022-2028), considering 2021 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategy adopted by key players
• It profiles key players in the global Regulatory affairs outsourcing market based on the following parameters - company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
• Key companies covered as a part of this study include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics.
• The global Regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
• Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the regulatory outsourcing market

Detailed Segmentation:

• Global Regulatory Affairs Outsourcing Market, By Service Type:
  • Regulatory Consulting and Legal Representation
  • Product Registration and Clinical Trial Applications
  • Regulatory Writing and Publishing
  • Regulatory Submission
  • Others
• Global Regulatory Affairs Outsourcing Market, By Application:
  • Pharma and Biotech Products
  • Medical Devices
• Global Regulatory Affairs Outsourcing Market, By Geography/Region:
  • North America
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Application:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • U.S.
    • Canada
  • Latin America
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Application:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
  • Europe
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Application:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Applications:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Application:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
    • By Application:
    • Pharma and Biotech Products
    • Medical Devices
    • By Country:
    • South Africa
    • Central Africa
    • North Africa
• Company Profiles
  • WuXi AppTec Co., Ltd.*
    • Company Overview
    • Product Portfolio
    • Financial Performance
    • Key Highlights
    • Market Strategies
  • Charles River Laboratories, Inc.
  • Accell Clinical Research, LLC
  • PRA Health Sciences, Inc.
  • Parexel International Corporation
  • Clinilabs Inc.
  • Criterium Inc.
  • IQVIA Holdings Inc.
  • Medpace Inc.
  • Certara, L.P.

"*" marked represents similar segmentation in other categories in the respective section.