Press release
Regulatory Affairs Outsourcing Market Forecasts to 2025: $9.42 Billion Opportunity Driven by Globalization, Technology, and Focus on Core Competency
"The explosive evolution of regulatory standards and the increasing complexity and globalization of the medical landscape accelerate the growth of the regulatory affairs outsourcing market in the coming years.
What Is The Projected Market Size Of The Regulatory Affairs Outsourcing Global Market And Its Growth Rate?
• The regulatory affairs outsourcing market size has grown exponentially in recent times and is projected to grow from $8.44 billion in 2024 to $9.42 billion in 2025 at a Compound Annual Growth Rate (CAGR) of 11.6%.
• The swift growth during the historic period is mostly attributed to the globalization of regulatory standards, evolving regulatory landscape, industry-specific regulations, cost containment strategies, and focus on core competencies.
• Moreover, the regulatory affairs outsourcing market is set to witness a surge in the market size reaching approximately $15.93 billion in 2029 at a compound annual growth rate (CAGR) of 14.0%.
• The steep growth in the forecast period can be credited to the increasing complexity of submissions, digital switches in regulatory processes, emphasis on compliance and risk management, alteration in product development trends, and rising complexity in submissions.
What Is Driving The Growth In The Regulatory Affairs Outsourcing Global Market?
The escalation in Research & Development activities for new vaccines, therapeutics, and medical devices is forecasted to spur the growth of the regulatory affairs outsourcing market. The medical device, pharmaceutical, and biotechnological sectors are consistently investing in R&D to develop innovative products and expand their businesses globally. To reduce operational costs and speed up the regulatory process, these companies are outsourcing regulatory affairs to professionals within this scope. For instance, in March 2022, the National Health Expenditures (NHE) reported that the annual growth in national health spending is predicted to average 5.1% over 2021-2030 and reach nearly $6.8 trillion by 2030. Consequently, the rise in R&D activities for new vaccines, therapeutics, and medical devices is expected to push the growth of the regulatory affairs outsourcing market further.
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Who Are the Key Players Driving Regulatory Affairs Outsourcing Global Market Growth?
• 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 Key Trends In The Regulatory Affairs Outsourcing Global Market?
Key trends in the regulatory affairs outsourcing market include:
• Expansion of the life sciences industry
• Sustainability and environmental regulations
• Demand for strategic guidance
• Utilization of advanced analytics
• Enhanced risk management
What Are The Segments Of The Global Regulatory Affairs Outsourcing Global Market?
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
4. By Company Size: Small, Medium, Large
5. By End User: Medical Device Company, Biotechnology Company, Pharmaceutical Company
Which Region Leads The Regulatory Affairs Outsourcing Global Market?
In 2024, North America dominated the regulatory affairs outsourcing market. However, Asia-Pacific is expected to be the fastest-growing region in the forecast period. Apart from these, the regulatory affairs outsourcing market report covers other regions such as Western Europe, Eastern Europe, South America, Middle East, and Africa.
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What Is Covered In The Regulatory Affairs Outsourcing Global Market Report 2025 Global Market Report?
- Market Size Analysis: Analyze the Regulatory Affairs Outsourcing Global Market Report 2025 size by key regions, countries, product types, and applications.
- Market Segmentation Analysis: Identify various subsegments within the Regulatory Affairs Outsourcing Global Market Report 2025 for effective categorization.
- Key Player Focus: Focus on key players to define their market value, share, and competitive landscape.
- Growth Trends Analysis: Examine individual growth trends and prospects in the Market.
- Market Contribution: Evaluate contributions of different segments to the overall Regulatory Affairs Outsourcing Global Market Report 2025 growth.
- Growth Drivers: Detail key factors influencing market growth, including opportunities and drivers.
- Industry Challenges: Analyze challenges and risks affecting the Regulatory Affairs Outsourcing Global Market Report 2025.
- Competitive Developments: Analyze competitive developments, such as expansions, agreements, and new product launches in the market.
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