PUBLISHER: KBV Research | PRODUCT CODE: 1473153
PUBLISHER: KBV Research | PRODUCT CODE: 1473153
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)
North America Regulatory Information Management System Market Report Segmentation
By End User
- Pharmaceutical Sector
- Medical Device Sector
- Others
By Country
- US
- Canada
- Mexico
- Rest of North America
Table of Contents
Chapter 1.Market Scope & Methodology
- 1.1Market Definition
- 1.2Objectives
- 1.3Market Scope
- 1.4Segmentation
- 1.4.1North America Regulatory Information Management System Market, by End User
- 1.4.2North America Regulatory Information Management System Market, by Country
- 1.5Methodology for the research
Chapter 2.Market at a Glance
- 2.1Key Highlights
Chapter 3.Market Overview
- 3.1Introduction
- 3.1.1Overview
- 3.1.1.1Market Composition and Scenario
- 3.1.1Overview
- 3.2Key Factors Impacting the Market
- 3.2.1Market Drivers
- 3.2.2Market Restraints
- 3.2.3Market Opportunities
- 3.2.4Market Challenges
- 3.3Porter's Five Forces Analysis
Chapter 4.Strategies Deployed in Regulatory Information Management System Market
Chapter 5.North America Regulatory Information Management System Market by End User
- 5.1North America Pharmaceutical Sector Market by Country
- 5.2North America Medical Device Sector Market by Country
- 5.3North America Others Market by Country
Chapter 6.North America Regulatory Information Management System Market by Country
- 6.1US Regulatory Information Management System Market
- 6.1.1US Regulatory Information Management System Market by End User
- 6.2Canada Regulatory Information Management System Market
- 6.2.1Canada Regulatory Information Management System Market by End User
- 6.3Mexico Regulatory Information Management System Market
- 6.3.1Mexico Regulatory Information Management System Market by End User
- 6.4Rest of North America Regulatory Information Management System Market
- 6.4.1Rest of North America Regulatory Information Management System Market by End User
Chapter 7.Company Profiles
- 7.1Veeva Systems, Inc.
- 7.1.1Company Overview
- 7.1.2Financial Analysis
- 7.1.3Regional Analysis
- 7.1.4Research & Development Expenses
- 7.1.5Recent strategies and developments:
- 7.1.5.1Partnerships, Collaborations, and Agreements:
- 7.1.5.2Acquisition and Mergers:
- 7.1.6SWOT Analysis
- 7.2Korber AG
- 7.2.1Company Overview
- 7.2.2Recent strategies and developments:
- 7.2.2.1Partnerships, Collaborations, and Agreements:
- 7.2.2.2Acquisition and Mergers:
- 7.2.3SWOT Analysis
- 7.3ArisGlobal LLC (Nordic Capital Limited)
- 7.3.1Company Overview
- 7.3.2Recent strategies and developments:
- 7.3.2.1Product Launches and Product Expansions:
- 7.3.2.2Acquisition and Mergers:
- 7.3.3SWOT Analysis
- 7.4Calyx
- 7.4.1Company Overview
- 7.4.2SWOT Analysis
- 7.5Ennov SAS
- 7.5.1Company Overview
- 7.5.2Recent strategies and developments:
- 7.5.2.1Acquisition and Mergers:
- 7.5.3SWOT Analysis
- 7.6MasterControl, Inc.
- 7.6.1Company Overview
- 7.6.2SWOT Analysis
- 7.7LORENZ Life Sciences Group
- 7.7.1Company Overview
- 7.7.2Recent strategies and developments:
- 7.7.2.1Partnerships, Collaborations, and Agreements:
- 7.7.3SWOT Analysis
- 7.8AmpleLogic
- 7.8.1Company Overview
- 7.8.2SWOT Analysis
- 7.9Cencora, Inc. (PharmaLex Holding GmbH)
- 7.9.1Company Overview
- 7.9.2Financial Analysis
- 7.9.3Segmental Analysis
- 7.9.4SWOT Analysis
- 7.10.Ithos Global Inc. (Cordance Group)
- 7.10.1Company Overview
- 7.10.2SWOT Analysis
LIST OF TABLES
- TABLE 1North America Regulatory Information Management System Market, 2020 - 2023, USD Million
- TABLE 2North America Regulatory Information Management System Market, 2024 - 2031, USD Million
- TABLE 3North America Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
- TABLE 4North America Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
- TABLE 5North America Pharmaceutical Sector Market by Country, 2020 - 2023, USD Million
- TABLE 6North America Pharmaceutical Sector Market by Country, 2024 - 2031, USD Million
- TABLE 7North America Medical Device Sector Market by Country, 2020 - 2023, USD Million
- TABLE 8North America Medical Device Sector Market by Country, 2024 - 2031, USD Million
- TABLE 9North America Others Market by Country, 2020 - 2023, USD Million
- TABLE 10North America Others Market by Country, 2024 - 2031, USD Million
- TABLE 11North America Regulatory Information Management System Market by Country, 2020 - 2023, USD Million
- TABLE 12North America Regulatory Information Management System Market by Country, 2024 - 2031, USD Million
- TABLE 13US Regulatory Information Management System Market, 2020 - 2023, USD Million
- TABLE 14US Regulatory Information Management System Market, 2024 - 2031, USD Million
- TABLE 15US Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
- TABLE 16US Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
- TABLE 17Canada Regulatory Information Management System Market, 2020 - 2023, USD Million
- TABLE 18Canada Regulatory Information Management System Market, 2024 - 2031, USD Million
- TABLE 19Canada Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
- TABLE 20Canada Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
- TABLE 21Mexico Regulatory Information Management System Market, 2020 - 2023, USD Million
- TABLE 22Mexico Regulatory Information Management System Market, 2024 - 2031, USD Million
- TABLE 23Mexico Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
- TABLE 24Mexico Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
- TABLE 25Rest of North America Regulatory Information Management System Market, 2020 - 2023, USD Million
- TABLE 26Rest of North America Regulatory Information Management System Market, 2024 - 2031, USD Million
- TABLE 27Rest of North America Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
- TABLE 28Rest of North America Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
- TABLE 29Key Information - Veeva Systems, Inc.
- TABLE 30Key Information - Korber AG
- TABLE 31Key Information - ArisGlobal LLC
- TABLE 32Key Information - Calyx
- TABLE 33Key Information - Ennov SAS
- TABLE 34key information - MasterControl, Inc.
- TABLE 35Key Information - LORENZ Life Sciences Group
- TABLE 36Key Information - AmpleLogic
- TABLE 37Key Information - Cencora, Inc.
- TABLE 38Key Information - Ithos Global Inc.
