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Regulatory Affairs Outsourcing Market Size Projected To Reach $15.93 Billion By 2034 With A Cagr Of 14%
Regulatory Affairs Outsourcing Market
What Is the Expected Regulatory Affairs Outsourcing Market Size During the Forecast Period?
The size of the market for outsourced regulatory affairs has seen a rapid growth over the last years. The projections indicate that it will increase from the $8.44 billion recorded in 2024 to reach $9.42 billion in 2025, with an 11.6% compound annual growth rate (CAGR). This significant increase during the past period can be credited to factors such as the globalization of regulatory norms, changes in the regulatory framework, regulations specific to certain industries, cost-cutting initiatives, and an emphasis on focal competencies.
The size of the regulatory affairs outsourcing market is predicted to surge significantly in the upcoming years. It's projected to expand to $15.93 billion by 2029, with a compound annual growth rate (CAGR) of 14.0%. The expected growth during this forecast period can be credited to factors such as the increased intricacy of submissions, the digital shift in regulatory procedures, a focus on compliance and risk management, changes in product development patterns, and a rise in submission complexities. Key trends projected for this period include the growth of the life sciences industry, sustainability and environmental directives, the need for strategic advice, the implementation of superior analytics, and improved risk management.
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What Are the High-Growth Segments in the Regulatory Affairs Outsourcing Market?
The regulatory affairs outsourcing market covered in this report is segmented -
1) By Service: Legal Representation, Regulatory Consulting, Product Registration & Clinical Trial Application, Regulatory Writing & Publication, Other Services
2) By Indication: Neurology, Oncology, Immunology, Cardiology, Other Indications
3) By Category: Biologics, Drugs, Medical Devices, By Company Size: Small, Medium, Large
4) By End User: Medical Device Company, Biotechnology Company, Pharmaceutical Company
Subsegments:
1) By Legal Representation: Compliance Support, Litigation Support, Intellectual Property Services
2) By Regulatory Consulting: Strategy Development, Risk Assessment, Regulatory Intelligence
3) By Product Registration And Clinical Trial Application: Dossier Preparation, Application Submission, Liaison With Regulatory Authorities
4) By Regulatory Writing And Publication: Clinical Study Reports, Regulatory Submission Documents, Scientific Publications
5) By Other Services: Training And Development, Pharmacovigilance, Quality Assurance And Auditing
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What Key Drivers Are Expected to Influence Future Regulatory Affairs Outsourcing Market Growth?
The surge in R&D endeavours for novel vaccines, treatments, and medical instruments should contribute substantially to the expansion of the regulatory affairs outsourcing market. Companies engaged in the medical device, pharmaceutical, and biotechnology industries are progressively investing in R&D initiatives to create innovative products and globally extend their businesses. Additionally, they show an increasing tendency to outsource regulatory affairs to diminish operating costs and accelerate the regulatory process by leveraging the skills of the individuals engaged in it. For example, as per the National Health Expenditures (NHE) report prepared by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) in March 2022, anticipated annual growth in national health expenditure is projected to average 5.1% between 2021 and 2030, reaching nearly $6.8 trillion by 2030. Consequently, the R&D growth in the development of new vaccines, treatments, and medical equipment is anticipated to stimulate the regulatory affairs outsourcing market.
Which Companies Hold the Largest Share Across Different Regulatory Affairs Outsourcing Market Segments?
Major companies operating in the regulatory affairs outsourcing market include Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON plc, WuXi App Tec, Syneos Health, Catalent Pharma Solutions, Charles River Laboratories International. Inc., Parexel International Corporation, Medpace, Curia, Certara L.P., Amicus GMP, Pace Life Sciences, CTI Clinical Trial & Consulting, Accell Clinical Research LLC, Promedica International, Clinilabs Inc., CliniExperts Pvt Ltd., Global Regulatory Services (GRS), Pharma Design Limited, PharmaLex, Hiray Pharma Solutions, LGM Pharma, BlueReg Group
What Are the Latest Developing Trends in the Regulatory Affairs Outsourcing Market?
The rise of effective software that maintains regulatory affairs records is a significant trend being observed in the regulatory affairs outsourcing market. Major players in the regulatory affairs outsourcing market are striving to develop efficient software that maintains regulatory affairs records. For instance, in May 2024, Rimsys, a software firm based in the US, launched the beta version of its user-supported regulatory intelligence platform, Rimsys Intel. This free, community-supported global regulatory intelligence hub is specifically designed for the medical technology sector and seeks to improve access to crucial information for the medtech community.
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What Are the Emerging Geographies for The Regulatory Affairs Outsourcing Market Growth?
North America was the largest region in the regulatory affairs outsourcing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the regulatory affairs outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
Frequently Asked Questions:
1. What Is the Market Size and Growth Rate of the Regulatory Affairs Outsourcing Market?
2. What is the CAGR expected in the Regulatory Affairs Outsourcing Market?
3. What Are the Key Innovations Transforming the Regulatory Affairs Outsourcing Industry?
4. Which Region Is Leading the Regulatory Affairs Outsourcing Market?
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