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The market is growing due to technological advancements such as AI-powered analytics, blockchain for data management, and cloud-based platforms for integration.
Key players in the industry include AmpleLogic, ArisGlobal, Calyx, Dassault Systemes, DDi, DXC Technology, Ennov, Ithos Global (Cordance Group), Kalypso (Rockwell Automation), and Korber.
The U.S. regulatory information management system market recorded USD 747.7 million in 2024 and is projected to witness substantial growth over the forecast period, driven by strict compliance standards imposed by the U.S. Food and Drug Administration (FDA).
The software segment dominated the market with a revenue of USD 1.5 billion in 2024 and is expected to grow significantly over the forecast period due to its critical role in streamlining complex regulatory processes.
The regulatory information management system industry was valued at approximately USD 2.2 billion in 2024 and is estimated to grow at a 10.9% CAGR from 2025 to 2034, driven by the increasing complexity of regulatory requirements and the rising volume of regulatory data.