Overview and Scope
The regulatory affairs outsourcing refers to external services utilized by the pharmaceutical, biotech and medical devices manufacturing companies to gain fast regulatory approvals from various organizations. These include pharmaceutical regulations, quality, safety, and efficacy criteria, as well as the attitudes and requirements of health authorities.
Sizing and Forecast
The regulatory affairs outsourcing market size has grown rapidly in recent years. It will grow from $7.6 billion in 2023 to $8.49 billion in 2024 at a compound annual growth rate (CAGR) of 11.6%. The growth in the historic period can be attributed to globalization of regulatory standards, evolving regulatory landscape, industry-specific regulations, cost containment strategies, focus on core competencies.
The regulatory affairs outsourcing market size is expected to see rapid growth in the next few years. It will grow to $13.83 billion in 2028 at a compound annual growth rate (CAGR) of 13.0%. The growth in the forecast period can be attributed to increasing complexity of submissions, digital transformation in regulatory processes, emphasis on compliance and risk management, shift in product development trends, growing complexity in submissions. Major trends in the forecast period include expansion of life sciences industry, sustainability and environmental regulations, demand for strategic guidance, utilization of advanced analytics, enhanced risk management.
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Segmentation & Regional Insights
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
Top 5 Major Players:
- Thermo Fisher Scientific Inc. (PPD),
- IQVIA, ICON PLC,
- Eurofins Scientific,
- WuXi App Tec,
- Syneos Health,
North America was the largest region in the regulatory affairs outsourcing market in 2023. 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.
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Major Driver Impacting Market Growth
The growth in R&D activities for new vaccines, therapeutics, and medical devices is expected to propel the growth of the regulatory affairs outsourcing market. The companies operating in the medical device, pharmaceutical, and biotechnological sectors are increasingly investing in R&D activities to develop innovative products and expand their business across the globe. Additionally, these companies are inkling toward outsourcing regulatory affairs to reduce the operational costs and increase the speed of the regulatory process by utilizing professionals involved in it. For instance, in March 2022, according to National Health Expenditures (NHE) report, prepared by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS) suggests that the annual growth in national health spending is expected to average 5.1% over 2021-2030, and to reach nearly $6.8 trillion by 2030. Therefore, the growth in R&D activities for new vaccines, therapeutics, and medical devices is expected to drive the growth of the regulatory affairs outsourcing market.
Key Industry Players
Major companies operating in the regulatory affairs outsourcing market report are Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON plc, Eurofins Scientific, 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, Consumer Product Testing Co, Promedica International, Clinilabs Inc., CliniExperts Pvt Ltd., Covance Inc, Global Regulatory Services (GRS), Pharma Design Limited, PharmaLex, Hiray Pharma Solutions, LGM Pharma, BlueReg Group, EPiC Auditors Ltd.
The regulatory affairs outsourcing market report table of contents includes:
1. Executive Summary
2. Regulatory Affairs Outsourcing Market Characteristics
3. Regulatory Affairs Outsourcing Market Trends And Strategies
4. Regulatory Affairs Outsourcing Market – Macro Economic Scenario
5. Global Regulatory Affairs Outsourcing Market Size and Growth
….
32. Global Regulatory Affairs Outsourcing Market Competitive Benchmarking
33. Global Regulatory Affairs Outsourcing Market Competitive Dashboard
34. Key Mergers And Acquisitions In The Regulatory Affairs Outsourcing Market
35. Regulatory Affairs Outsourcing Market Future Outlook and Potential Analysis
36. Appendix
List Of Tables:
Table 1: Global Historic Market Growth, 2018-2023, $ Billion
Table 2: Global Forecast Market Growth, 2023-2028F, 2033F, $ Billion
Table 3: Global Regulatory Affairs Outsourcing Market, Segmentation By Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
Table 4: Global Regulatory Affairs Outsourcing Market, Segmentation By Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
Table 5: Global Regulatory Affairs Outsourcing Market, Segmentation By Category, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
….
Table 76: Thermo Fisher Scientific Inc. (PPD) Financial Performance
Table 77: IQVIA Financial Performance
Table 78: ICON plc Financial Performance
Table 79: Eurofins Scientific Financial Performance
Table 80: WuXi App Tec Financial Performance
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