The Regulatory Affairs Outsourcing Global Market Report 2024 by The Business Research Company provides market overview across 60+ geographies in the seven regions – Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa, encompassing 27 major global industries. The report presents a comprehensive analysis over a ten-year historic period (2010-2021) and extends its insights into a ten-year forecast period (2023-2033).
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According to The Business Research Company’s Regulatory Affairs Outsourcing Global Market Report 2024, 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.
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.
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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
In July 2021, ICON, an Ireland-based drug and device development and commercialization services company, acquired PRA Health Sciences Inc. for approximately $12 billion. With this acquisition, ICON aims to enhance its consulting, clinical, and commercial services portfolio, geographic presence, therapeutic capabilities, and data-powered healthcare technology and to provide internationally scaled expertise and solutions. PRA Health Sciences Inc. is a US-based contract research organization (CRO) that offers advanced healthcare intelligence and affairs outsourcing services.
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
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26. South America Regulatory Affairs Outsourcing Market
27. Brazil Regulatory Affairs Outsourcing Market
28. Middle East Regulatory Affairs Outsourcing Market
29. Africa Regulatory Affairs Outsourcing Market
30. Regulatory Affairs Outsourcing Market Competitive Landscape And Company Profiles
Top Major Players:
- Thermo Fisher Scientific Inc.
- IQVIA
- ICON PLC
- Eurofins Scientific
- WuXi App Tec
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