Regulatory Affairs Outsourcing Market Size Is Expected To Reach USD 14.9 Billion by 2028

 Regulatory Affairs Outsourcing Market Growth & Trends

The global regulatory affairs outsourcing market size is expected to reach USD 14.9 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 11.9% from 2021 to 2028. A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities, like training, technology, specialized knowledge, and facilities, is driving the outsourcing of regulatory affairs functions.

Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, are creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but, in turn, complicate the operation for healthcare product manufacturing companies. Thus, leading to the regulatory affairs outsourcing to service providers.

Moreover, due to the COVID-19, various healthcare companies are likely to opt for more regulatory advice in the recovery phase – on remote monitoring, telemedicine, data privacy, and more. Furthermore, as companies push to speed up the product development and approvals in therapies, vaccines, and devices for COVID-19, they are likely to engage even more intensively with the regulatory agencies.

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Regulatory Affairs Outsourcing Market Report Highlights

• The regulatory writing and publishing services dominated the market with a share of 36.7% in 2020 as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product
• In terms of company size, the large size companies are projected to expand at the fastest CAGR of 12.3% during the forecast period. Goodwill and resource abundance are the two key factors promoting their selection by end users
• By stage, the clinical segment accounted for the largest share of 46.7% in 2020 due to the increasing demand for clinical trials in developing countries
• Based on end user, the pharmaceutical companies are anticipated to register the fastest growth rate over the forecast period. This may be due to evolving areas such as orphan drugs and adaptive trial designs
• The Asia Pacific held the largest share of 37.9% in 2020 owing to higher offshoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India and China

Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global regulatory affairs outsourcing market based on service, company size, category, indication, stage, end-user, and region:

Regulatory Affairs Outsourcing Service Outlook (Revenue, USD Million, 2016 - 2028)

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
• Product Registration & Clinical Trial Applications
• Other Services

Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2016 - 2028)

• Small
• Medium
• Large

Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2016 - 2028)

• Drugs
  • Generics
  • Innovators
• Biologics
  • Biotech
  • ATMPs
  • Biosimilars
• Medical devices
  • Therapeutic
  • Diagnostic

Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2016 - 2028)

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2016 - 2028)

• Preclinical
• Clinical
• PMA (Post Market Authorization)

Regulatory Affairs Outsourcing End-user Outlook (Revenue, USD Million, 2016 - 2028)

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million, 2016 - 2028)

• North America
  • US.
  • Canada
• Europe
  • UK.
  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Turkey
  • Netherlands
  • Switzerland
  • Sweden
  • Azerbaijan
  • Belarus
  • Kazakhstan
  • Moldova
  • Georgia
  • Ukraine
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Indonesia
  • Malaysia
  • Singapore
  • Thailand
  • Taiwan
  • Armenia
  • Kyrgyzstan
  • Tajikistan
  • Uzbekistan
  • Turkmenistan
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Chile
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Egypt
  • Israel

List of Key Players of Regulatory Affairs Outsourcing Market

• Accell Clinical Research, LLC
• Genpact Ltd.
• Criterium, Inc.
• PRA Health Sciences
• Promedica International
• Medpace
• Charles River Laboratories International, Inc.
• ICON plc
• Covance
• Parexel International Corporation, Inc.
• Freyr

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.