Regulatory Information Management System Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Component (Solution v/s Services), By Deployment Mode (On-Premises v/s Cloud), By Application (Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, and Others), By End User (Pharmaceutical, Medical Devices, and Others), By Region and Competition
Market Report I 2023-04-01 I 114 Pages I TechSci Research
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.
Report Scope:
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:
o Solution
o Services
- Regulatory Information Management System Market, By Deployment Mode:
o On-Premises
o Cloud
- Regulatory Information Management System Market, By Application:
o Registration Management
o Regulatory Intelligence
o Labeling Management
o Submission Planning & Tracking Management
o Publishing
o Document Management
o Others
- Regulatory Information Management System Market, By End User:
o Pharmaceutical
o Medical Devices
o Others
- Regulatory Information Management System Market, By Region:
o North America
- United States
- Canada
- Mexico
o Europe
- France
- Germany
- United Kingdom
- Italy
- Spain
o Asia Pacific
- China
- India
- Japan
- South Korea
- Australia
o South America
- Brazil
- Argentina
- Colombia
o Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in Global Regulatory Information Management System Market.
Available Customizations:
With the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
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
Content is provided by our partners and every effort is made to make Market Report details as clear as possible. If you are not sure the exact content you require is included in this study you can Contact us to double check. To do this you can:
Use the ‘? ASK A QUESTION’ below the license / prices and to the right of this box. This will come directly to our team who will work on dealing with your request as soon as possible.
Write to directly on support@scotts-international.com with details. Please include as much information as possible including the name of report or link so our staff will be able to work on you request.
Telephone us directly on 0048 603 394 346 and an experienced member of team will be on hand to answer.
With the vast majority of our partners we can obtain Sample Pages to support your decision. This is something we can arrange without revealing your personal details.
It is important to note that we will not be able to provide you the exact data or statistics such as Market Size and Forecasts. Sample pages usually confirm the layout or the Categories included in Charts and Graphs, excluding specific data.
To ask for Sample Pages by contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
Whilst we try to make our online platform as easy to use as possible there is always the possibility that a better alternative has not been found in your search.
To avoid this possibility Contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346 and a Senior Team Member can review your requirements and send a list of possibilities with opinions and recommendations.
All prices are set by our partners and should be exactly the same as those listed on their own websites. We work on a Revenue share basis ensuring that you never pay more than what is offered elsewhere.
Should you find the price cheaper on another platform we recommend you to Contact us as we should be able to match this price. You can Contact us though through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
As we work in close partnership with our Partners from time to time we can secure discounts and assist with negotiations, this is part of our personalised service to you.
Discounts can sometimes be arranged for speedily placed orders; multiple report purchases or Higher License purchases.
To check if a Discount is possible please Contact our experienced team through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
Most Market Reports on our platform are listed in USD or EURO based on the wishes of our Partners. To avoid currency fluctuations and potential price differentiations we do not offer the possibility to change the currency online.
Should you wish to pay in a different currency to that advertised online we do accept payments in USD, EURO, GBP and PLN. The price will be calculated based on the relevant exchange rate taken from our National Bank.
To pay in a different above currency to that advertised online please Contact our team and a quotation will be sent within a couple of hours with payment details.
License options vary from Partner to Partner as is usually based on the number of Users that will benefitting from the report. It is very important that License ordered is not breached as this could have potential negative consequences for you individually or your employer.
If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.
The Global Site License is the most comprehensive license available. By selecting this license, the Market Report can be shared with other ‘Allowed Users’ and any other member of staff from the same organisation regardless of geographic location.
It is important to note that this may exclude Parent Companies or Subsidiaries.
If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.
The most common format is PDF, however in certain circumstances data may be present in Excel format or Online, especially in the case of Database or Directories. In addition, for certain higher license options a CD may also be provided.
If you have questions or need clarification about the specific formats we recommend you to Contact us and a detailed explanation will be provided.
Delivery is fulfilled by our partners directly. Once an order has been placed we inform the partner by sharing the delivery email details given in the order process.
Delivery is usually made within 24 hours of an order being placed, however it may take longer should your order be placed prior to the weekend or if otherwise specified on the Market Report details page. Additionally, if details have been not fully completed in the Order process a delay in delivery is possible.
If a delay in delivery is expected you will be informed about it immediately.
As most Market Reports are delivered in PDF format we almost never have to add additional Shipping Charges. If, however you are ordering a Higher License service or a specific delivery format (e.g. CD version) charges may apply.
If you are concerned about additional Shipping Charges we recommend you to Contact us to double check.
We work in Partnership with PayU to ensure payments are made securely in a fast and effortless way. PayU is the e-payments division of Naspers.
Naspers operates in over 133 International Markets and ranks 3rd Globally in terms of the number of e-commerce customers served.
For more information on PayU please visit: https://www.payu.pl/en/about-us
If you require an invoice prior to payment, this is possible. To ensure a speedy delivery of the Market Report we require all relevant company details and you agree to maximum payment terms of 30 days from receipt of order.
With our regular clients deliver of the Market Report can be made prior to receiving payment, however in some circumstances we may ask for payment to be received before arranging for the Market Report to be delivered.
We have specifically partnered with leading International companies to protect your privacy by using different technologies and processes to ensure security.
Everything submitted to Scotts International is encrypted via SSL (Secure Socket Layer) and all personal information provided to Scotts International is stored on computer systems with limited access in controlled environments.
We partner with PayU (https://www.payu.pl/en/about-us) to ensure all credit card payments are made securely in a fast and effortless way.
PayU offers 250+ various payment channels and eWallet services across 4 continents allowing buyers to pay electronically, whether on a computer or a mobile device.