Regulatory Information Management System Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028
The Global Regulatory Information Management System Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to the growing prevalence of delivering effective applications and proper planning in the procedures. Additionally, the growing number of new players and rising adoption of the latest techniques to develop productivity demand for the Regulatory Information Management System Market across different parts of the globe. Additionally, increasing investments by public and private organizations and increasing support from the IT sector are further expected to increase the demand for regulatory information management systems, thereby fuelling market growth through 2028. In 2016, the U.S. spent $3,337 billion, or 17.9 percent of the gross domestic product (GDP), on national health expenditures, of which $329 billion was spent on prescription drugs. Similarly, the growing demand for real-time monitoring of regulations in the clinical trial sector is the major factor fuelling the growth of the market over the years.
Increasing Product Development
Rapidly evolving regulatory frameworks and changing product approval requisites continue to propel developers to stay abreast of the latest regulations and connect with market players to ensure software efficiency for error-free regulation compliance processes. Increasing transformations in regulation paradigms within pharmaceuticals, medical devices, and life science sectors are expected to boost the demand for regulatory information management systems during the forecast period. In the pharmaceutical sector, a regulatory information management system facilitates the robust application of planning, viewing, publishing, registration, and management of products throughout their life cycle. The software also allows effective, compliant management of regulations and regulatory information. Further, in April 2020, Oracle built and donated a COVID-19 Therapeutic Learning System to the U.S. government that allows physicians and patients to record the effectiveness of promising COVID-19 drug therapies.
Rising demand for Software-Based Work
Increasing the number of clinical trials demand for managing and controlling the processes of releasing new data and maintaining existingi8ng product data is the major factor expected to boost the market growth during the forecasting period. The rising need to reduce manual errors in regulatory processes and easy access is further anticipated to create a lucrative growth of Global Regulatory Information Management System Market during the forecast period. Furthermore, the increasing adoption of cloud-based regulatory information management systems among end users to prepare accurate data is an important factor that propels market growth during the forecast period. Due to manual error increasing demand for real-time monitoring of regulations in the clinical trial sector and automated management of the entire workflow of product process worldwide in further real-time fuel the market growth in the upcoming years. In the United States, the total amount of money spent on medicines reached approximately 574 billion U.S. dollars in 2021.
Market Segmentation
The global regulatory information management system market can be segmented by component, deployment mode, application, and by region. Based on components, the market can be divided into Solutions and Services. Based on deployment mode, the market can be divided into On-Premises and Cloud. Based on application, the market can be grouped into Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, and Others. Based on the end user, the market can be segmented into Pharmaceuticals, Medical Devices, and Others. Regionally, North America dominated the market among Asia Pacific, Europe, Middle East & Africa, and South America. Amongst different countries, the United States dominates The Global Regulatory Information Management System Market on account of the growing demand for error-free data.
Market Players
ArisGlobal LLC, Arivis AG, DDi, Inc., Ennov SA, Extedo Gmbh, Glemser Technologies Corporation, Instem Group, MasterControl, Inc., Parexel International Corporation, Samarind Ltd., Sparta Systems, Inc., Acuta LLC, Virtify, Inc., Amplexor International SA, Veeva Systems Inc. are some of the leading players operating in the Global Regulatory Information Management System Market.
Recent Development
- For instance, a provider such as Calyx reported on October 25, 2021, that one of the top ten pharmaceutical companies in the world had signed a contract to continue using the Calyx Regulatory Information Management (RIM) system for crucial submissions of clinical trial data to international regulators through 2026.
In this report, global regulatory information management system market has been segmented into the following categories, in addition to the industry trends, which have also been detailed below:
- Regulatory Information Management System Market, By Component:
- Solution
- Services
- Regulatory Information Management System Market, By Deployment Mode:
- On-Premises
- Cloud
- Regulatory Information Management System Market, By Application:
- Registration Management
- Regulatory Intelligence
- Labeling Management
- Submission Planning & Tracking Management
- Publishing
- Document Management
- Others
- Regulatory Information Management System Market, By End User:
- Pharmaceutical
- Medical Devices
- Others
- Regulatory Information Management System Market, By Region:
- North America
- United States
- Canada
- Mexico
- Europe
- France
- Germany
- United Kingdom
- Italy
- Spain
- Asia Pacific
- China
- India
- Japan
- South Korea
- Australia
- South America
- Brazil
- Argentina
- Colombia
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
Company Profiles: Detailed analysis of the major companies present in Global Regulatory Information Management System Market.
Company Information
- Detailed analysis and profiling of additional market players (up to five).
- 1. Product Overview
- 1.1. Market Definition
- 1.2. Scope of the Market
- 1.2.1. Markets Covered
- 1.2.2. Years Considered for Study
- 1.2.3. Key Market Segmentations
- 2. Research Methodology
- 2.1. Objective of the Study
- 2.2. Baseline Methodology
- 2.3. Key Industry Partners
- 2.4. Major Association and Secondary Sources
- 2.5. Forecasting Methodology
- 2.6. Data Triangulation & Validation
- 2.7. Assumptions and Limitations
- 3. Executive Summary
- 3.1. Overview of the Market
- 3.2. Overview of Key Market Segmentations
- 3.3. Overview of Key Market Players
- 3.4. Overview of Key Regions/Countries
- 3.5. Overview of Market Drivers, Challenges, Trends
- 4. Global Regulatory Information Management System Market Outlook
- 4.1. Market Size & Forecast
- 4.1.1. By Value
- 4.2. Market Share & Forecast
- 4.2.1. By Component (Solution v/s Services)
- 4.2.2. By Deployment Mode (On-Premises v/s Cloud)
- 4.2.3. By Application (Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, Others)
- 4.2.4. By End User (Pharmaceutical, Medical Devices, Others)
- 4.2.5. By Region
- 4.2.6. By Company (2022)
- 4.3. Market Map
- 4.3.1. By Component
- 4.3.2. By Deployment Mode
- 4.3.3. By Application
- 4.3.4. By End User
- 4.3.5. By Region
- 5. North America Regulatory Information Management System Market Outlook
- 5.1. Market Size & Forecast
- 5.1.1. By Value
- 5.2. Market Share & Forecast
- 5.2.1. By Component
- 5.2.2. By Deployment Mode
- 5.2.3. By Application
- 5.2.4. By End User
- 5.2.5. By Country
- 5.3. North America: Country Analysis
- 5.3.1. United States Regulatory Information Management System Market Outlook
- 5.3.1.1. Market Size & Forecast
- 5.3.1.1.1. By Value
- 5.3.1.2. Market Share & Forecast
- 5.3.1.2.1. By Component
- 5.3.1.2.2. By Deployment Mode
- 5.3.1.2.3. By Application
- 5.3.1.2.4. By End User
- 5.3.2. Canada Regulatory Information Management System Market Outlook
- 5.3.2.1. Market Size & Forecast
- 5.3.2.1.1. By Value
- 5.3.2.2. Market Share & Forecast
- 5.3.2.2.1. By Component
- 5.3.2.2.2. By Deployment Mode
- 5.3.2.2.3. By Application
- 5.3.2.2.4. By End User
- 5.3.3. Mexico Regulatory Information Management System Market Outlook
- 5.3.3.1. Market Size & Forecast
- 5.3.3.1.1. By Value
- 5.3.3.2. Market Share & Forecast
- 5.3.3.2.1. By Component
- 5.3.3.2.2. By Deployment Mode
- 5.3.3.2.3. By Application
- 5.3.3.2.4. By End User
- 6. Europe Regulatory Information Management System Market Outlook
- 6.1. Market Size & Forecast
- 6.1.1. By Value
- 6.2. Market Share & Forecast
- 6.2.1. By Component
- 6.2.2. By Deployment Mode
- 6.2.3. By Application
- 6.2.4. By End User
- 6.2.5. By Country
- 6.3. Europe: Country Analysis
- 6.3.1. France Regulatory Information Management System Market Outlook
- 6.3.1.1. Market Size & Forecast
- 6.3.1.1.1. By Value
- 6.3.1.2. Market Share & Forecast
- 6.3.1.2.1. By Component
- 6.3.1.2.2. By Deployment Mode
- 6.3.1.2.3. By Application
- 6.3.1.2.4. By End User
- 6.3.2. Germany Regulatory Information Management System Market Outlook
- 6.3.2.1. Market Size & Forecast
- 6.3.2.1.1. By Value
- 6.3.2.2. Market Share & Forecast
- 6.3.2.2.1. By Component
- 6.3.2.2.2. By Deployment Mode
- 6.3.2.2.3. By Application
- 6.3.2.2.4. By End User
- 6.3.3. United Kingdom Regulatory Information Management System Market Outlook
- 6.3.3.1. Market Size & Forecast
- 6.3.3.1.1. By Value
- 6.3.3.2. Market Share & Forecast
- 6.3.3.2.1. By Component
- 6.3.3.2.2. By Deployment Mode
- 6.3.3.2.3. By Application
- 6.3.3.2.4. By End User
- 6.3.4. Italy Regulatory Information Management System Market Outlook
- 6.3.4.1. Market Size & Forecast
- 6.3.4.1.1. By Value
- 6.3.4.2. Market Share & Forecast
- 6.3.4.2.1. By Component
- 6.3.4.2.2. By Deployment Mode
- 6.3.4.2.3. By Application
- 6.3.4.2.4. By End User
- 6.3.5. Spain Regulatory Information Management System Market Outlook
- 6.3.5.1. Market Size & Forecast
- 6.3.5.1.1. By Value
- 6.3.5.2. Market Share & Forecast
- 6.3.5.2.1. By Component
- 6.3.5.2.2. By Deployment Mode
- 6.3.5.2.3. By Application
- 6.3.5.2.4. By End User
- 7. Asia-Pacific Regulatory Information Management System Market Outlook
- 7.1. Market Size & Forecast
- 7.1.1. By Value
- 7.2. Market Share & Forecast
- 7.2.1. By Component
- 7.2.2. By Deployment Mode
- 7.2.3. By Application
- 7.2.4. By End User
- 7.2.5. By Country
- 7.3. Asia-Pacific: Country Analysis
- 7.3.1. China Regulatory Information Management System Market Outlook
- 7.3.1.1. Market Size & Forecast
- 7.3.1.1.1. By Value
- 7.3.1.2. Market Share & Forecast
- 7.3.1.2.1. By Component
- 7.3.1.2.2. By Deployment Mode
- 7.3.1.2.3. By Application
- 7.3.1.2.4. By End User
- 7.3.2. India Regulatory Information Management System Market Outlook
- 7.3.2.1. Market Size & Forecast
- 7.3.2.1.1. By Value
- 7.3.2.2. Market Share & Forecast
- 7.3.2.2.1. By Component
- 7.3.2.2.2. By Deployment Mode
- 7.3.2.2.3. By Application
- 7.3.2.2.4. By End User
- 7.3.3. Japan Regulatory Information Management System Market Outlook
- 7.3.3.1. Market Size & Forecast
- 7.3.3.1.1. By Value
- 7.3.3.2. Market Share & Forecast
- 7.3.3.2.1. By Component
- 7.3.3.2.2. By Deployment Mode
- 7.3.3.2.3. By Application
- 7.3.3.2.4. By End User
- 7.3.4. South Korea Regulatory Information Management System Market Outlook
- 7.3.4.1. Market Size & Forecast
- 7.3.4.1.1. By Value
- 7.3.4.2. Market Share & Forecast
- 7.3.4.2.1. By Component
- 7.3.4.2.2. By Deployment Mode
- 7.3.4.2.3. By Application
- 7.3.4.2.4. By End User
- 7.3.5. Australia Regulatory Information Management System Market Outlook
- 7.3.5.1. Market Size & Forecast
- 7.3.5.1.1. By Value
- 7.3.5.2. Market Share & Forecast
- 7.3.5.2.1. By Component
- 7.3.5.2.2. By Deployment Mode
- 7.3.5.2.3. By Application
- 7.3.5.2.4. By End User
- 8. South America Regulatory Information Management System Market Outlook
- 8.1. Market Size & Forecast
- 8.1.1. By Value
- 8.2. Market Share & Forecast
- 8.2.1. By Component
- 8.2.2. By Deployment Mode
- 8.2.3. By Application
- 8.2.4. By End User
- 8.2.5. By Country
- 8.3. South America: Country Analysis
- 8.3.1. Brazil Regulatory Information Management System Market Outlook
- 8.3.1.1. Market Size & Forecast
- 8.3.1.1.1. By Value
- 8.3.1.2. Market Share & Forecast
- 8.3.1.2.1. By Component
- 8.3.1.2.2. By Deployment Mode
- 8.3.1.2.3. By Application
- 8.3.1.2.4. By End User
- 8.3.2. Argentina Regulatory Information Management System Market Outlook
- 8.3.2.1. Market Size & Forecast
- 8.3.2.1.1. By Value
- 8.3.2.2. Market Share & Forecast
- 8.3.2.2.1. By Component
- 8.3.2.2.2. By Deployment Mode
- 8.3.2.2.3. By Application
- 8.3.2.2.4. By End User
- 8.3.3. Colombia Regulatory Information Management System Market Outlook
- 8.3.3.1. Market Size & Forecast
- 8.3.3.1.1. By Value
- 8.3.3.2. Market Share & Forecast
- 8.3.3.2.1. By Component
- 8.3.3.2.2. By Deployment Mode
- 8.3.3.2.3. By Application
- 8.3.3.2.4. By End User
- 9. Middle East and Africa Regulatory Information Management System Market Outlook
- 9.1. Market Size & Forecast
- 9.1.1. By Value
- 9.2. Market Share & Forecast
- 9.2.1. By Component
- 9.2.2. By Deployment Mode
- 9.2.3. By Application
- 9.2.4. By End User
- 9.2.5. By Country
- 9.3. MEA: Country Analysis
- 9.3.1. South Africa Regulatory Information Management System Market Outlook
- 9.3.1.1. Market Size & Forecast
- 9.3.1.1.1. By Value
- 9.3.1.2. Market Share & Forecast
- 9.3.1.2.1. By Component
- 9.3.1.2.2. By Deployment Mode
- 9.3.1.2.3. By Application
- 9.3.1.2.4. By End User
- 9.3.2. Saudi Arabia Regulatory Information Management System Market Outlook
- 9.3.2.1. Market Size & Forecast
- 9.3.2.1.1. By Value
- 9.3.2.2. Market Share & Forecast
- 9.3.2.2.1. By Component
- 9.3.2.2.2. By Deployment Mode
- 9.3.2.2.3. By Application
- 9.3.2.2.4. By End User
- 9.3.3. UAE Regulatory Information Management System Market Outlook
- 9.3.3.1. Market Size & Forecast
- 9.3.3.1.1. By Value
- 9.3.3.2. Market Share & Forecast
- 9.3.3.2.1. By Component
- 9.3.3.2.2. By Deployment Mode
- 9.3.3.2.3. By Application
- 9.3.3.2.4. By End User
- 10. Market Dynamics
- 10.1. Drivers
- 10.2. Challenges
- 11. Market Trends & Developments
- 12. Competitive Landscape
- 12.1. Business Overview
- 12.2. Product Offerings
- 12.3. Recent Developments
- 12.4. Financials (As Reported)
- 12.5. Key Personnel
- 12.6. SWOT Analysis
- 12.6.1. ArisGlobal LLC
- 12.6.2. Arivis AG
- 12.6.3. DDi, Inc.
- 12.6.4. Ennov SA
- 12.6.5. Extedo Gmbh
- 12.6.6. Glemser Technologies Corporation
- 12.6.7. Instem Group
- 12.6.8. MasterControl, Inc.
- 12.6.9. Parexel International Corporation
- 12.6.10. Samarind Ltd.
- 12.6.11. Sparta Systems, Inc.
- 12.6.12. Acuta LLC
- 12.6.13. Virtify, Inc.
- 12.6.14. Amplexor International SA
- 12.6.15. Veeva Systems Inc.
- 13. Strategic Recommendations
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