North America Regulatory Information Management System Market Size, Share & Trends Analysis Report By End User (Pharmaceutical Sector, Medical Device Sector, and Others), By Country and Growth Forecast, 2024 - 2031

The North America Regulatory Information Management System Market would witness market growth of 9.8% CAGR during the forecast period (2024-2031).

The US market dominated the North America Regulatory Information Management System Market by Country in 2023, and would continue to be a dominant market till 2031; thereby, achieving a market value of $1,203.8 Million by 2031. The Canada market is registering a CAGR of 12.3% during (2024 - 2031). Additionally, The Mexico market would showcase a CAGR of 11.3% during (2024 - 2031).



The drug development process in the pharmaceutical sector is highly complex and involves multiple stages, including preclinical research, clinical trials, regulatory submissions, and post-market surveillance. Managing regulatory submissions, clinical trial documentation, and approvals requires coordination across cross-functional teams, adherence to regulatory guidelines, and compliance with regulatory timelines. For example, as per Invest India, the pharmaceutical industry in India is anticipated to increase to $65 billion by 2024 and $130 billion by 2030. Regulatory information management systems provide document management, submission tracking, and compliance monitoring capabilities, enabling pharmaceutical companies to streamline regulatory processes and accelerate time-to-market for new drugs.

There is a growing preference for cloud-based RIMS solutions due to their scalability, flexibility, and cost-effectiveness. Cloud-based RIMS offers easier deployment, maintenance, and accessibility, allowing companies to access regulatory data and processes from anywhere, anytime. Integration of RIMS with other enterprise systems, such as Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), and Enterprise Resource Planning (ERP) systems, is gaining traction. Seamless integration streamlines data exchange improves workflow efficiency and enhances regulatory compliance across the organization.

Mexico's pharmaceutical manufacturing business has grown significantly in recent years, owing to increased healthcare spending, rising demand for pharmaceutical products, and government attempts to encourage domestic production and innovation. According to the Mexican government, the manufacturing sector's gross domestic product was $5.18 trillion MX in the fourth quarter of 2023. The pharmaceutical manufacturing sector in Mexico is increasingly adopting technology and automation to improve operational efficiency, enhance product quality, and ensure regulatory compliance in Mexico. Automation of regulatory compliance activities accelerates the product development lifecycle and enhances regulatory efficiency in Mexico's pharmaceutical industry. Hence, the factors mentioned above will drive the regional market growth.

Based on End User, the market is segmented into Pharmaceutical Sector, Medical Device Sector, and Others. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.

List of Key Companies Profiled

• Veeva Systems, Inc.
• Korber AG (Optel Group)
• ArisGlobal LLC (Nordic Capital Limited)
• Calyx
• Ennov SAS
• MasterControl, Inc.
• LORENZ Life Sciences Group
• AmpleLogic
• Cencora, Inc. (PharmaLex Holding GmbH)
• Ithos Global Inc. (Cordance Group)

Market Report Segmentation

By End User

• Pharmaceutical Sector
• Medical Device Sector
• Others

By Country

• US
• Canada
• Mexico
• Rest of North America