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Global Regulatory Information Management System Market Share 2025, Forecast To 2034

4 Mar, 2025

What Fueled The Previous Growth In The Regulatory Information Management System Market?

The regulatory information management system market has seen considerable growth due to a variety of factors.
•Recent years have seen a rapid expansion in the size of the regulatory information management system market. The market's worth is projected to increase from $1.99 billion in 2024 to $2.22 billion in 2025, marking a compound annual growth rate (CAGR) of 11.7%.
Several factors including strict regulatory compliance prerequisites, growth of the pharmaceutical industry, expansion of global supply chains, a rise in regulatory data volume, and heightened focus on data security have contributed to this historic period of growth.

What Is The Expected Growth In The Regulatory Information Management System Market Size?

The regulatory information management system market is expected to maintain its strong growth trajectory in upcoming years.
• Anticipated to witness a rapid expansion in the coming years is the regulatory information management system market. Its worth is projected to reach $3.38 billion by 2029, progressing at a compound annual growth rate (CAGR) of 11.1%.
The projection factors for this growth during the forecast period include the implementation of artificial intelligence (AI), a more intricate regulatory landscape, expansion of RIMS in developing markets, higher demand for cloud-based solutions, and focus on real-time regulatory monitoring. Key trends identified for the forecast period are technological advancements, cooperation and integration with external partners, utilisation of blockchain technology for data integrity, mobile access and user-friendly interfaces, and platforms for cross-functional collaboration.

What Are the Critical Driver Fuelling the Regulatory Information Management System Market's Growth?

The upward trend in the number of clinical trials is notably impacting the evolution of the regulatory information management system market. Clinical trials, which involve the use of human subjects for the investigation of therapeutic, surgical, or behavioral interventions, increasingly rely on regulatory information management systems to oversee, control, and simplify the escalating regulatory requirements and complexities associated with their procedures. For example, in February 2023, the World Health Organization (WHO), a Switzerland-based intergovernmental authority in charge of international public health, reported an increase in the number of clinical trials in the Southeast Asia region, from 10,966 in 2021 to 11,030 in 2022. In light of this, the escalating number of clinical trials serves as a catalyst for the expansion of the regulatory information management system market.

How Is the Regulatory Information Management System Market segmented?

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 Subsegments:
1) By Solution: Regulatory Compliance Management Software, Document Management Systems, Data Management Solutions, Analytics And Reporting Tools
2) By Services: Consulting Services, Implementation Services, Support And Maintenance Services, Training And Education Services

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What New Trends Are Influencing the Regulatory Information Management System Market?

The primary trend escalating in the regulatory information management system market is the innovation of new products. The foremost companies in this market are introducing novel products to maintain their market status. For instance, in February 2023, ArisGlobal LLC, an American life sciences solutions provider, unveiled its Investigational Product Regulatory Information Management System (RIMS). This product was designed considering the specific requirements of life science and medical device corporations as they progress through the phases of drug development. The Investigational Product RIMS emerges as the perfect pre-validated, ready-made solution for burgeoning life science and medical device companies yet to gain marketing authorization for their products. It offers defining features like clinical trial authorization tracking for meeting regulatory time constraints and accelerating market entry, investigational submission and dossier planning with smart automation and activity stimuli to boost efficiency, and health authority commitment management for comprehensive planning and monitoring of interactions, commitments, and responsibilities.

Who Are the Key Players in the Regulatory Information Management System Market?

Major companies operating in the regulatory information management system market include:
• 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.

What Is The Most Dominant Region In The Regulatory Information Management System Market?

North America was the largest region in the regulatory information management system market in 2024. 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.