Overview and Scope
A regulatory information management system refers to a centralized software platform that streamlines the tracking of product applications and registrations for the regulatory industry. It makes possible to trace and keep a record related to regulatory processes from beginning to end for a variety of segments, including pharmaceuticals, biologics, and cosmetics.
Sizing and Forecast
The regulatory information management system market size has grown rapidly in recent years. It will grow from $1.79 billion in 2023 to $2 billion in 2024 at a compound annual growth rate (CAGR) of 11.9%. The growth in the historic period can be attributed to stringent regulatory compliance requirements, pharmaceutical industry growth, globalization of supply chains, increasing volume of regulatory data, emphasis on data security.
The regulatory information management system market size is expected to see rapid growth in the next few years. It will grow to $3.01 billion in 2028 at a compound annual growth rate (CAGR) of 10.8%. The growth in the forecast period can be attributed to integration with artificial intelligence (ai), increased complexity of regulatory landscape, expansion of rims in emerging markets, demand for cloud-based solutions, focus on real-time regulatory monitoring. Major trends in the forecast period include advancements in technology, collaboration and integration with external partners, blockchain technology for data integrity, mobile access and user-friendly interfaces, cross-functional collaboration platforms.
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Segmentation & Regional Insights
The regulatory information management system market covered in this report is segmented –
1) By Component: Solution, Services
2) By Deployment: On-premise, Cloud
3)By Enterprise Size: Small And Medium Enterprises, Large Enterprises
4) By Application: Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning And Tracking Management, Publishing, Document Management, Other Applications
5) By End-Users: Pharmaceutical Sector, Medical Device Sector, Other End Users
North America was the largest region in the regulatory information management system market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the regulatory information management system 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 rising number of clinical trials is significantly contributing to the growth of the regulatory information management system market going forward. Clinical trials refer to studies in which people are used as test subjects for therapeutic, surgical, or behavioral interventions. The regulatory information management system is used for tracking, managing, and simplifying the growing regulatory requirements and complexities related to clinical trials. For instance, in February 2023, according to the World Health Organization (WHO), a Switzerland-based intergovernmental agency responsible for international public health, the number of clinical trials in the Southeast Asia region increased from 10,966 in 2021 to 11,030 in 2022. Further, according to the World Health Organization, the number of clinical trials in Africa increased from 905 in 2020 to 1,078 in 2021. Therefore, rising clinical trials will drive the regulatory information management system market.
Key Industry Players
Major companies operating in the regulatory information management system market report are Deloitte Touche Tohmatsu Limited, DXC Technology Company, IQVIA Inc., Wipro Ltd., Parexel International Corporation, Korber Pharma, Veeva Systems Inc., Dovel Technologies Inc., Calyx, ArisGlobal LLC, DDi Inc., NNIT A/S, Freyr Software Services Private Limite, Navitas Life Sciences, MasterControl Solutions Inc., Sparta Systems Inc., Instem PLC, Phlexglobal Ltd., Ennov SA, LORENZ Life Sciences Group, Extedo GmbH, Gimmal, Dot Compliance Ltd., Kalypso LP, Rimsys Inc., Virtify Inc., Glemser Technologies Corporation, RegDesk, AmpleLogic, Ithos Global Inc.
The regulatory information management system market report table of contents includes:
1. Executive Summary
2. Regulatory Information Management System Market Characteristics
3. Regulatory Information Management System Market Trends And Strategies
4. Regulatory Information Management System Market – Macro Economic Scenario
5. Global Regulatory Information Management System Market Size and Growth
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31. Regulatory Information Management System Market Other Major And Innovative Companies
32. Global Regulatory Information Management System Market Competitive Benchmarking
33. Global Regulatory Information Management System Market Competitive Dashboard
34. Key Mergers And Acquisitions In The Regulatory Information Management System Market
35. Regulatory Information Management System Market Future Outlook and Potential Analysis
36.Appendix
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