As per analysts at Zion Market Research, the global regulatory affairs outsourcing market is projected to grow at a CAGR of around 12.1% during the forecasted period 2019–2025. The rise in research & development activities, mainly in the life science industry for the decrease in overall authorization process by reducing interruptions in authoritarian filings and the improvement in the ROI (Return on Investment) & cost efficiency are predicted to drive the market growth. Furthermore, favorable authoritarian mandates are expected to boost the adoption over the forecasted period.
Some of the leading players in the market are PRA International; Accell Clinical Research; Quintiles Transnational Holdings; PAREXEL International Corporation; Clinilabs Inc.; Charles River Laboratories International Inc.; Wuxi AppTec; Criterium Inc.; and Medpace Inc.
Competitive Pressure For Product Launches & Approval To Boost The Global Regulatory Affairs Outsourcing Market
Regulatory work involves wide-ranging assessment of a particular product to safeguard the protection of public health, import & distribution, marketing authorization, and so to meet safety & efficacy of products, market players are ensuring the product meets all the legal requirements. The regulatory affair outsourcing firms are accountable for keeping track regarding the regulatory obligations specific to the regions for ensuring that company productively launches and sell pharmaceutical products, biologics, medical devices, and functional foods. If the product is unsuccessful in meeting the regulatory guidelines, the product can be dismissed resulting in the huge loss of revenue. Several small and large pharmaceutical & biopharmaceutical organizations are dependent on CRO’s (contract research organization) and other drug development activities for expanding their territories, which is believed to be a key driving factor for the expansion of the global regulatory affairs outsourcing market. Additionally, augmenting funding by leading market players in research & development activities—to advance biosimilar, orphan, and generic drugs—is expected to boost the global regulatory affairs outsourcing market during the forecasted period.
The global regulatory affairs outsourcing market is bifurcated on the basis of service and regional analysis. Based on the service, the market is divided into regulatory writing & publishing, clinical trial application, product registration, patent application, legal representation, and other regulatory affairs.
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North America & Asia Pacific To Register Massive Growth In The Global Regulatory Affairs Outsourcing Market
Based on geographical analysis, the global regulatory affairs outsourcing market is divided into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. The North America region is anticipated to be a major contributor to the development of the global market. The existence of global life sciences & pharmaceutical companies, strong regulators such as FDA (Food and Drug Administration) and the availability of talent pool are likely to contribute to the overall growth. The Asia Pacific region is anticipated to be the fastest-developing region in the upcoming years. By the end of 2025, the region will account for over 44.7% of the market share.
This review is based on a report by Zion Market Research, titled “Regulatory Affairs Outsourcing Market – Segmented By Service (Regulatory Writing & Publishing, Clinical Trial Application, Product Registration, Patent Application, Legal Representation, Other Regulatory Affairs), And Geography – Global Industry Perspective, Comprehensive Analysis, and Forecast, 2019 – 2025”