Press release
Regulatory Affairs Outsourcing Market Poised for 14 % Growth, Set to Hit $32.84 Billion by 2029
Regulatory Affairs Outsourcing
Regulatory affairs outsourcing market's growth is anticipated to be fueled by the surge in R&D activities aimed at creating new vaccines, therapeutics, and medical equipment. Businesses in the medical device, pharmaceutical, and biotech industries are progressively investing in R&D endeavors to introduce groundbreaking products and broaden their global presence. Furthermore, these firms are leaning towards subcontracting regulatory affairs to cut operational expenses and expedite regulatory procedures through the use of industry professionals. For instance, the National Health Expenditures (NHE) report, produced by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) in March 2022, projected that national health spending will average a 5.1% annual increase from 2021 to 2030, eventually reaching nearly $6.8 trillion by 2030. Consequently, the expansion in R&D initiatives for novel vaccines, therapeutics, and medical devices is predicted to stimulate the growth of the regulatory affairs outsourcing market.
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What is the projected compound annual growth rate (CAGR) of the regulatory affairs outsourcing market from 2025 to 2034, and what factors influence it?
The size of the market for outsourcing regulatory affairs has seen significant expansion in the recent past. It is projected to rise from $8.44 billion in 2024 to $9.42 billion in 2025, marking a compound annual growth rate (CAGR) of 11.6%. The historic growth of this market can be linked to the internationalization of regulatory standards, transformations in the regulatory sphere, regulations specific to the industry, strategies to control costs, and a focus on core abilities.
The market for outsourcing in regulatory affairs is projected to experience significant expansion in the coming years, reaching a substantial $15.93 billion by 2029, growing at a compound annual growth rate (CAGR) of 14.0%. The expansion predicted over the forecast period can be linked to factors such as the increasing intricacy of submissions, the emergence of digital transformation in regulatory processes, a focus on compliance and risk management, and a shift in product development trends, alongside escalating complexity in submissions. Key trends anticipated during the forecast period encompass the growth of the life sciences industry, the impact of sustainability and environmental regulations, the need for strategic guidance, the employment of sophisticated analytics, and the improvement of risk management.
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How are the latest trends influencing the growth of the regulatory affairs outsourcing market?
A growing trend in the regulatory affairs outsourcing market is the emergence of effective software solutions for regulatory affairs recordkeeping. Top competitors in the market are concentrating on creating software that can efficiently manage regulatory affairs records. Take for instance, in May 2024, Rimsys, a software company based in the U.S., rolled out the beta version of its community-driven regulatory intelligence tool, Rimsys Intel. This free, global regulatory intelligence platform is specifically developed for the medical technology sector, with a goal of improving access to indispensable information for those in the medical technology community.
What are the major segments of the regulatory affairs outsourcing market and their role in driving growth?
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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Which regions are key players in the growth of the regulatory affairs outsourcing market?
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.
Who are the key firms paving the way for growth in the regulatory affairs outsourcing market?
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
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What Is Covered In The Regulatory Affairs Outsourcing Global Market Report?
•Market Size Forecast: Examine the regulatory affairs outsourcing market size across key regions, countries, product categories, and applications.
•Segmentation Insights: Identify and classify subsegments within the regulatory affairs outsourcing market for a structured understanding.
•Key Players Overview: Analyze major players in the regulatory affairs outsourcing market, including their market value, share, and competitive positioning.
•Growth Trends Exploration: Assess individual growth patterns and future opportunities in the regulatory affairs outsourcing market.
•Segment Contributions: Evaluate how different segments drive overall growth in the regulatory affairs outsourcing market.
•Growth Factors: Highlight key drivers and opportunities influencing the expansion of the regulatory affairs outsourcing market.
•Industry Challenges: Identify potential risks and obstacles affecting the regulatory affairs outsourcing market.
•Competitive Landscape: Review strategic developments in the regulatory affairs outsourcing market, including expansions, agreements, and new product launches.
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