What Transformation Has the Regulatory Affairs Outsourcing Market Undergone?
The regulatory affairs outsourcing market has seen considerable growth due to a variety of factors.
• The expansion of the regulatory affairs outsourcing market has been swift in the past few years. Its size 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 growth experienced in the historic period can be associated with the internationalization of regulatory standards, changes in the regulatory environment, regulations specific to certain industries, strategies for containing costs, and an emphasis on core competencies.
What Is The Expected Growth In The Regulatory Affairs Outsourcing Market Size?
The regulatory affairs outsourcing market is expected to maintain its strong growth trajectory in upcoming years.
• The market size for regulatory affairs outsourcing is anticipated to experience accelerated expansion in the coming years, with an expected worth of $15.93 billion in 2029, maintaining a compound annual growth rate (CAGR) of 14.0%.
Factors contributing to this growth during the forecast period include the rising intricacy of submissions as well as digital advancement in regulatory procedures, focus on compliance and risk management, and change in product development trends. The forecast period will also witness specific trends such as growth in life sciences industry, sustainability and environmental norms, increased need for strategic advice, incorporation of superior analytics and improved risk administration.
What Main Forces Are Fueling Expansion In The Regulatory Affairs Outsourcing Market?
The expansion of the regulatory affairs outsourcing market is likely to be fueled by increased R&D activities aimed at creating new vaccines, therapeutic solutions, and medical equipment. Medical device, pharmaceutical, and biotechnological firms are stepping up their investment in R&D to invent innovative products and broaden their global footprint. To cut operational expenses and speed up the regulatory process, these firms are leaning towards outsourcing regulatory affairs to experts in the field. For instance, the National Health Expenditures (NHE) report from March 2022, penned by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS), predicted that annual national health spending is set to average a growth of 5.1% from 2021 to 2030, amounting to an impressive nearly $6.8 trillion by 2030. Thus, escalated R&D activities for new vaccines, therapies, and medical devices will likely stimulate the growth of the regulatory affairs outsourcing market.
What Are The Primary Segments In The Global 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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Which Key Trends Are Driving Changes In The Regulatory Affairs Outsourcing Market?
The emergence of software for efficient regulatory affairs record maintenance is shaping the trend in the regulatory affairs outsourcing market. Major market players are concentrating on the design of proficient software to maintain regulatory affairs records. To illustrate, Rimsys, an American software firm, introduced the beta version of its community-driven regulatory intelligence system named Rimsys Intel in May 2024. This global regulatory intelligence hub is community-driven, cost-free, and designed exclusively for the medical technology sector. Its goal is to facilitate accessibility to critical information for the medtech community.
Who Are the Key Players 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
What Is The Most Dominant Region In 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.
