The global regulatory affairs market size is expected to reach USD 27.0 billion by 2030, registering a CAGR of 8.7% over the forecast years, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market. The global market showed lucrative growth during the COVID-19 pandemic.
The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against COVID-19. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices, are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs are projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services in this segment.
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The regulatory writing & publishing segment dominated the market in 2021 due to an increase in the outsourcing of these services by large- and mid-size medical device and biopharmaceutical companies
Based on indications, the oncology segment accounted for the largest revenue share in 2021. The segment share is attributed to the high prevalence of cancer, which is creating the need for safe and effective treatments
Based on end-uses, the pharmaceutical companies segment accounted for the largest market share in 2021. A rise in the number of approved pharmaceutical products is the key factor responsible for the segment’s growth
Asia Pacific is projected to witness the fastest growth rate during the forecast period on account of the improved regulatory landscape and growing venture activities by biopharmaceutical companies
Grand View Research has segmented the global regulatory affairs market based on services, category, indication, product stage, service provider, company size, end-use, and region
Regulatory Affairs Services Outlook (Revenue, USD Million, 2018 - 2030)
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Writing
Publishing
Product Registration & Clinical Trial Applications
Other Services
Regulatory Affairs Category Outlook (Revenue, USD Million, 2018 - 2030)
Drugs
Innovator
Preclinical
Clinical
Post Market
Generics
Preclinical
Clinical
Post Market
Biologics
Biotech
Preclinical
Clinical
Post Market
ATMP
Preclinical
Clinical
Post Market
Biosimilars
Preclinical
Clinical
Post Market
Medical Devices
Diagnostics
Preclinical
Clinical
Post Market
Therapeutics
Preclinical
Clinical
Post Market
Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
Neurology
Cardiology
Immunology
Others
Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018 - 2030)
Preclinical
Clinical studies
PMA
Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2018 - 2030)
In-house
Outsourced
Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018 - 2030)
Small
Medium
Large
Regulatory Affairs End-use Outlook (Revenue, USD Million, 2018 - 2030)
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies
Regulatory Affairs Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
U.K.
Germany
France
Italy
Spain
Russia
Turkey
The Netherlands
Switzerland
Sweden
Asia Pacific
Japan
China
India
Australia
South Korea
Indonesia
Malaysia
Singapore
Thailand
Taiwan
Latin America
Brazil
Mexico
Argentina
Colombia
Chile
Middle East & Africa
South Africa
Saudi Arabia
UAE
Egypt
Israel
List of Kay Players of Regulatory Affairs Market
Accell Clinical Research, LLC
Genpact
Criterium, Inc.
PRA Health Sciences
Promedica International
WuXi AppTec, Inc.
Medpace
Charles River Laboratories International, Inc.
ICON plc
Covance, Inc.
PAREXEL International Corp., Inc.
Freyr
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