Global Regulatory Affairs Outsourcing Market to Reach USD 16.0 Billion by 2033, Propelled by the Exponential Growth in the Biotechnological and Pharmaceutical Industries

January 03, 2025 | Healthcare

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The latest report by IMARC, titled “Regulatory Affairs Outsourcing Market Report by Services (Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration and Clinical Trial Applications, and Others), Company Size (Small, Medium, Large), Category (Generic Drugs, Innovator Drugs, Biologic Drugs, Biosimilars, Medical Devices, and Others), Indication (Oncology, Neurology, Cardiology, Immunology, and Others), Stage (Preclinical, Clinical, PMA (Post Market Authorization)), End User (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), and Region 2025-2033”, finds that the global regulatory affairs outsourcing market size reached USD 8.3 Billion in 2024. Regulatory affairs outsourcing refers to the hiring process of third-party services by private organizations and government bodies in order to ensure public health and safety. These services include managing regulatory requirements for innovator drugs, generic drugs, biosimilars, biologics, and others. Outsourcing organizations ensure the safety and efficacy of the products while ensuring they are safe for consumption. These services are used for regulatory writing and publishing, clinical trial and patent application, legal representation, and product registration. In recent years, regulatory affairs outsourcing has gained momentum due to its adoption in pharmaceutical companies for achieving speedy government approvals.

Global Regulatory Affairs Outsourcing Market Trends:

One of the primary factors driving the market is the exponential growth in the biotechnological and pharmaceutical industries. Additionally, the increasing focus of pharmaceutical industries on expanding their supplies and operations in developing economies is creating a positive market outlook. Other than this, regulatory affairs outsourcing services are employed to produce orphan, biosimilar, and generic drugs. Besides this, these services reduce the costs of managing in-house resources, including training, facilities, technology, specialized knowledge, and geographic regulations. This, along with the increasing number of trials, is boosting the demand for regulatory affairs outsourcing. Furthermore, extensive research and development (R&D) activities, improvements in the healthcare industry, and a rise in the number of FDA-approved manufacturing plants are catalyzing the market growth. Looking forward, IMARC Group expects the market size to reach USD 16.0 Billion by 2033, expanding at a CAGR of 7.22% during the forecast period (2025-2033).

Market Summary

Based on the services, the market has been divided into regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial applications, and others.
On the basis of the company size, the market has been segmented into small, medium, and large.
Based on the category, the market has been segregated into generic drugs, innovator drugs, biologic drugs, biosimilars, medical devices (therapeutic and diagnostic), and others.
On the basis of the indication, the market has been categorized into oncology, neurology, cardiology, immunology, and others.
Based on the stage, the market has been divided into preclinical, clinical, and post market authorization (PMA).
On the basis of the end user, the market has been segregated into medical device, pharmaceutical, and biotechnology companies.
Region-wise, the market has been classified into North America (the United States and Canada), Asia-Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others), Latin America (Brazil, Mexico, and others), and Middle East and Africa.
The competitive landscape of the market has also been analyzed, with some 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.

Report Coverage:

Report Features	Details
Base Year of the Analysis	2024
Historical Period	2019-2024
Forecast Period	2025-2033
Units	Billion USD
Segment Coverage	Services, Company Size, Category, Indication, Stage, End User, Region
Region Covered	Asia Pacific, Europe, North America, Latin America, Middle East and Africa
Countries Covered	United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico
Companies Covered	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.
Customization Scope	10% Free Customization
Post-Sale Analyst Support	10-12 Weeks
Delivery Format	PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)

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Global Regulatory Affairs Outsourcing Market to Reach USD 16.0 Billion by 2033, Propelled by the Exponential Growth in the Biotechnological and Pharmaceutical Industries

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