The Regulatory Affairs Outsourcing Market refers to the practise of hiring a third-party organisation to undertake numerous regulatory compliance activities for a single product or a portfolio of goods. This covers tasks including filing marketing authorization applications, negotiating with regulatory authorities, monitoring regulatory developments, producing and maintaining regulatory paperwork, and providing regulatory assistance for post-approval operations.
Because of increased regulatory complexity, worldwide market access requirements, and a growing need for more specialised and efficient regulatory services, the market for regulatory affairs outsourcing has risen dramatically in recent years. The pharmaceutical and biotechnology sectors have been early adopters of regulatory affairs outsourcing, but the practise is spreading to other industries such as medical devices, cosmetics, and food and beverage. The desire to decrease costs, enhance efficiency, and remain compliance with increasingly complex rules are driving the expansion of the regulatory affairs outsourcing industry. Furthermore, the market is developing as a result of the increasing globalisation of the pharmaceutical and biotechnology sectors, as well as the rising need for specialised regulatory services.
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Key Market Segments Covered in the Global Regulatory Affairs Outsourcing Market
- By Services
- Regulatory Consulting Outsourcing
- Legal Representation Outsourcing
- Regulatory Writing & Publishing Outsourcing
- Other Regulatory Affairs Outsourcing Services
- By Company Size
- Small Sized Companies
- Medium Sized Companies
- Large Sized Companies
- By Category
- Drugs
- Generics
- Innovators
- Biologics
- Biotech
- ATMPs
- Biosimilars
- Medical Devices
- Therapeutic
- Diagnostic
- Drugs
- By Indication
- Oncology
- Neurology
- Radiology
- Immunology
- Other Indications
- By Stage
- Pre-Clinical
- Clinical
- Post Market Authorization
- By End Use
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
- Regions
- North America
- MEA
- Latin America
- Europe
- Asia-Pacific
Key Takeaways from the Market Study
- The global regulatory affairs outsourcing market to value US$ 7 Bn in 2022
- From 2015-2021, regulatory affairs outsourcing demand flourished at a 6.5% CAGR
- APAC to garner a market share of 37% in 2022 with respect to regulatory affairs outsourcing
- Clinical studies segment procured the largest market share of 46% in 2021.
- Based on end-user segment, the pharmaceutical companies segment to secure the largest market share of 38% in 2022.
Key Players of the Global Cloud Computing Market
- Accell Clinical Research LLC
- GenPact Ltd.
- Criterium Inc.
- PRA Health Sciences
- Promedica International
- WuxI AppTec Inc.
- Medspace
- Charles River Laboratories International Inc.
- ICON Plc.
- Labcorp
Competitive Landscape
The players of the global regulatory affairs outsourcing market focus on expanding their global influence. Some of the adopted strategies are partnerships, collaborations, and acquisitions. Recent key developments among key players are:
- ProPharma Group, an Odyssey Investment Partners portfolio company, announced the acquisition of iSafety Systems in August 2021. Pharmacovigilance outsourcing company iSafety is based in India.
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ICON plc bought PRA Health Sciences, a CRO, in July 2021. The acquisition was made with the intention of expanding ICON plc’s offering of services. ICON will remain the company’s official name. The organization seeks to become the most advanced clinical research organization and healthcare intelligence by br