Regulatory Affairs Outsourcing Market Worth $13.9 Billion By 2030: Grand View Research, Inc.

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Sep 08, 2022, 10:00 ET

SAN FRANCISCO, Sept. 8, 2022 /PRNewswire/ -- The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these 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.

Key Industry Insights & Findings from the report:

The regulatory writing & publishing services segment dominated the market with the maximum revenue share in 2021as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product.
The large companies segment is projected to witness the fastest CAGR during the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment growth.
The clinical studies stage segment accounted for the largest market share in 2021 due to the increasing demand for clinical trials in developing countries.
The pharmaceutical companies end-use segment is anticipated to witness the fastest growth rate over the forecast period due to evolving areas, such as orphan drugs and personalized therapies.
Asia Pacific held the maximum revenue share of the global market in 2021 owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & China.

Read 180 page market research report, "Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Biologics, Medical Devices), By Company Size (Medium, Large), By Indication, By Stage, By Services, By End Use, And Segment Forecasts, 2022 - 2030", published by Grand View Research.

Regulatory Affairs Outsourcing Market Growth & Trends

The market witnessed a significant decline in 2020 due to the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial activities including regulatory updates. Disruption in the supply chain and closure of R&D sites resulted in a significant loss of revenues in 2020 across the industry. However, due to the pandemic, various healthcare companies are opting for more regulatory advice, as companies push to speed up the product development & approvals in therapies, vaccines, & devices for COVID-19. Owing to the urgent need for medical devices and therapies for COVID-19, regulatory authorities are providing emergency use authorization for the majority of products. Such actions have further promoted the demand for these services post 2020 and the positive rebound of sales across the industry can be witnessed from 2021.

Regulatory Affairs Outsourcing Market Segmentation

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

Regulatory Affairs Outsourcing Market - Services Outlook (Revenue, USD Million, 2018 - 2030)

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

Regulatory Affairs Outsourcing Market - Company Size Outlook (Revenue, USD Million, 2018 - 2030)

Small
Medium
Large

Regulatory Affairs Outsourcing Market - Category Outlook (Revenue, USD Million, 2018 - 2030)

Drugs

Generics
Innovators

Biologics

Biotech
ATMPs
Biosimilars

Medical Devices

Therapeutic
Diagnostic

Regulatory Affairs Outsourcing Market - Stage Outlook (Revenue, USD Million, 2018 - 2030)

Preclinical
Clinical
PMA (Post Market Authorization)

Regulatory Affairs Outsourcing Market - Indication Outlook (Revenue, USD Million, 2018 - 2030)

Oncology
Neurology
Cardiology
Immunology
Others

Regulatory Affairs Outsourcing Market - End-use Outlook (Revenue, USD Million, 2018 - 2030)

Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies

Regulatory Affairs Outsourcing Market - 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
Europe CIS Countries

Asia Pacific

Japan
China
India
Australia
South Korea
Indonesia
Malaysia
Singapore
Thailand
Taiwan
Asia Pacific CIS Countries

Latin America

Brazil
Mexico
Argentina
Colombia
Chile

Middle East & Africa

South Africa
Saudi Arabia
UAE
Egypt
Israel

List of Key Players of the Regulatory Affairs Outsourcing Market

Accell Clinical Research, LLC
GenPact Ltd.
Criterium, Inc.
PRA Health Sciences
Promedica International
Dr.Regenold GmbH
BioMapas
Zeincro Group
Medpace
ICON plc
Covance
Parexel International Corp.
Freyr

Check out more related studies published by Grand View Research:

Medical Device Regulatory Affairs Market - The global medical device regulatory affairs market size is expected to reach USD 8.6 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 8.6% from 2021 to 2028. Technological advancements in medical devices such as AI/Machine learning, increasing trends of portable and smaller devices, and government regulations are driving the market.
Nordic Regulatory Affairs Market - The Nordic regulatory affairs market size is expected to reach USD 272.7 million by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 7.5% from 2021 to 2028. An increase in R&D activities in countries such as Denmark and Norway, drug pipeline, and clinical trial applications are some of the key factors expected to drive the market.
Medical Device Complaint Management Market - The global medical device complaint management market size is expected to reach USD 13.4 billion by 2030, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 8.5% from 2022 to 2030. Increasing utilization of software aiding in the overall complaint management process is expected to increase the market growth. The growing adoption of the digital system over paper-based work for tracking medical complaints is further boosting the market growth.

Browse through Grand View Research's Medical Devices Industry Research Reports.

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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