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Regulatory Information Management System (RIMS) Market Growth Analysis & Forecast (2024-2032)
The Regulatory Information Management System (RIMS) Market encompasses the global market for managing and automating regulation across multiple sectors with regards to software and services.
IMR Group
Description
Regulatory Information Management System (RIMS) Market Synopsis:
Regulatory Information Management System (RIMS) Market Size Was Valued at USD 2.5 Billion in 2023, and is Projected to Reach USD 6.2 Billion by 2032, Growing at a CAGR of 10.7% From 2024-2032.
The Regulatory Information Management System (RIMS) Market encompasses the global market for managing and automating regulation across multiple sectors with regards to software and services. It also assists in managing regulatory submission and compliance, record management and tracking, allowing organizations to manage the challenging and often unique, regional compliance requirements effectively.
The RIMS market is growing due to pressing requirements that diverse industries need to manage rising and complicated regulatory environments globally. The traditional products of this market include solutions designed to support businesses in their compliance with regional and global regulations like the FDA and the EMA. Originally used only in pharmaceutical and biotech industries, RIMS has grown to other segments of healthcare including; Medical device companies, healthcare providers and CROs.
RIMS has benefitted from emergent technologies such as cloud computing, artificial intelligence, and data analytics as it supports real time tracking of regulations, analytics, and management of global submission. These solutions are central to eliminating errors, facilitating accelerated approval of regulations, and enhancing clarity in those processes. In addition, an increased use of digital solutions and the transition to a paperless environment have become the drivers of the RIMS market.
Subsequently, as regulatory environment becomes complex, firms are outsourcing RIMS services to specific retailers that can offer solutions that meet the ‘organisation’s needs with concerns to compliance. The linkage between RIMS and ERP as well as other management systems takes the efficiency of the operation to another level. Regional Wise, North America dominate the market due to high regulatory support and the high presence of technology and other developing countries in the Asia-Pacific region are experiencing a high growth rate in the market.
Regulatory Information Management System (RIMS) Market Trend Analysis
Integration of AI and Machine Learning in RIMS
The application of ‘Big data, ‘Artificial intelligence’ and ‘Machine learning’ in RIMS are one of the progressive changes being adopted to revolutionize the industry. These technologies improve the system capability in terms of its foresight of regulatory adjustments, documents categorization, and submission procedures. RIMS solutions can then use the algorithm to scan through regulatory data histories; this greatly assists in the formulation of compliance strategies and the minimization of rejected submissions.
Furthermore, the task of identifying and assessing regulation risks is being made by applying ML algorithms to the goal to optimize the distribution of resources. It also greatly benefits the company both in achieving faster time to market for products as well as reducing costs associated with compliance. As AI & ML continue to progress, so too will their application to improving RIMS with solutions for smarter regulation, adding value to organizations in the increasingly competitive regulatory landscape.
Growing Demand in Emerging Markets
New opportunities for RIMS growth are also observed in the APAC and Latin America emerging markets. The growth rate of pharmaceutical and biotechnology enterprises, advanced medical device enterprises in these areas require efficient regulatory management. These governments are applying superior policies in aspects of product quality and performance so as to force companies to deal with enhanced RIMS solutions.
However, with the shifts from traditional on-premises solutions to cloud offerings, RIMS is now much more affordable for SMEs in emerging markets. As a result of this democratization of regulatory technology, organizations ranging from small to large are able to gain compliance when it comes to international standards and while making them trustworthy and accessible for markets around the world.
Regulatory Information Management System (RIMS) Market Segment Analysis:
Regulatory Information Management System (RIMS) Market is Segmented on the basis of Component, Deployment Mode, Enterprise Size, Industry Vertical, and Region.
By Component, Software segment is expected to dominate the market during the forecast period
RIMS being an integrated market has two principal segments comprising RIMS software and RIMS services. Software solutions occupy a large market share because they can rationally organize regulatory work. Some of the elements available in these platforms include; regulatory monitoring, submission management, and compliance reporting making it crucial platforms particularly for big organizations that operating in an environment with a high compliance standard. With the advent of cloud hosted software solutions, these benefits have also been taken up a notch.
This segment widens the offering from software products and services by delivering implementation, integration and support services. There is also an increasing interest in regulatory consulting services since organizations are in a constant search for professional advice to work through the complex rules governing various issues. The penetration of software and services promotes the overall approach to the management of regulatory information and fast-growing market demand.
By Industry Vertical, Pharmaceutical segment expected to held the largest share
Pharmaceuticals and biotechnology are the largest sectors using RIMS to meet the regulatory and compliance management requirements of the industry. These industries rely on RIMS to overcome such challenges in submission processes and conform to international practise. The medical devices segment is also growing at a fast pace and so is the regulatory pressure in this segment.
Other verticals which are adopting this in a big way are the healthcare providers and contract research organisations (CROs) who need RIMS for tracking clinical trials, patient data and other compliance documents. This increasing range of industry applications is indicative of the increasing relevance and flexibility of RIMS today.
Regulatory Information Management System (RIMS) Market Regional Insights:
North America is Expected to Dominate the Market Over the Forecast period
North America is the biggest RIMS market due to the region’s progressive laws and the widespread implementation of efficient approaches. Many large regulation agencies like the FDA are situated in this location and the compliance requirements are high which require better implementation of RIMS solutions. Further, the increased number of pharma and biotech industry players with their base in U.S and Canada and to maintain the compliance of regulatory management systems boost the demand.
The region’s technological advancement coupled with the huge investment in AI and cloud-based solutions cement its market.eu Leadership Add to that technological leadership, significant investment in AI and cloud-based platforms. The focus of North American business on innovation accompanied by compliance with international standards will preserve its leadership in the RIMS market.
Active Key Players in the Regulatory Information Management System (RIMS) Market
Amplexor Life Sciences (Belgium)
ArisGlobal (USA)
DXC Technology (USA)
Ennov (France)
EXTEDO (Germany)
IQVIA (USA)
MasterControl Inc. (USA)
Oracle Corporation (USA)
Parexel International Corporation (USA)
Phlexglobal (UK)
Sparta Systems (USA)
Veeva Systems (USA)
Other Active Players.
Key Industry Developments in the Regulatory Information Management System (RIMS) Market:
In May 2023, ArisGlobal acquired SPORIFY, a provider of Regulatory Data Solutions. The acquisition aims to enhance ArisGlobal LifeSphere Regulatory solutions with advanced data governance capabilities for its life sciences customers.
In April 2023, Ennov acquired Samarind, a provider of RIM solutions. The aim behind the acquisition was to strengthen its global position in the RIM software market.
In February 2023, ArisGlobal launched a new RIM solution named Investigational Product RIMS. The launch aims to cater to the increasing demands of the life sciences and medical device companies.
Chapter 1: Introduction
1.1 Scope and Coverage
Chapter 2:Executive Summary
Chapter 3: Market Landscape
3.1 Market Dynamics
3.1.1 Drivers
3.1.2 Restraints
3.1.3 Opportunities
3.1.4 Challenges
3.2 Market Trend Analysis
3.3 PESTLE Analysis
3.4 Porter’s Five Forces Analysis
3.5 Industry Value Chain Analysis
3.6 Ecosystem
3.7 Regulatory Landscape
3.8 Price Trend Analysis
3.9 Patent Analysis
3.10 Technology Evolution
3.11 Investment Pockets
3.12 Import-Export Analysis
Chapter 4: Regulatory Information Management System (RIMS) Market by Deployment Type
4.1 Regulatory Information Management System (RIMS) Market Snapshot and Growth Engine
4.2 Regulatory Information Management System (RIMS) Market Overview
4.3 On-Premises
4.3.1 Introduction and Market Overview
4.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
4.3.3 Key Market Trends, Growth Factors and Opportunities
4.3.4 On-Premises: Geographic Segmentation Analysis
4.4 Cloud-Based
4.4.1 Introduction and Market Overview
4.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
4.4.3 Key Market Trends, Growth Factors and Opportunities
4.4.4 Cloud-Based: Geographic Segmentation Analysis
Chapter 5: Regulatory Information Management System (RIMS) Market by Organization Size
5.1 Regulatory Information Management System (RIMS) Market Snapshot and Growth Engine
5.2 Regulatory Information Management System (RIMS) Market Overview
5.3 Small and Medium-Sized Enterprises (SMEs
5.3.1 Introduction and Market Overview
5.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.3.3 Key Market Trends, Growth Factors and Opportunities
5.3.4 Small and Medium-Sized Enterprises (SMEs: Geographic Segmentation Analysis
5.4 Large Enterprises
5.4.1 Introduction and Market Overview
5.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.4.3 Key Market Trends, Growth Factors and Opportunities
5.4.4 Large Enterprises: Geographic Segmentation Analysis
Chapter 6: Regulatory Information Management System (RIMS) Market by Industry Vertical
6.1 Regulatory Information Management System (RIMS) Market Snapshot and Growth Engine
6.2 Regulatory Information Management System (RIMS) Market Overview
6.3 Banking
6.3.1 Introduction and Market Overview
6.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.3.3 Key Market Trends, Growth Factors and Opportunities
6.3.4 Banking: Geographic Segmentation Analysis
6.4 Financial Services
6.4.1 Introduction and Market Overview
6.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.4.3 Key Market Trends, Growth Factors and Opportunities
6.4.4 Financial Services: Geographic Segmentation Analysis
6.5 and Insurance (BFSI
6.5.1 Introduction and Market Overview
6.5.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.5.3 Key Market Trends, Growth Factors and Opportunities
6.5.4 and Insurance (BFSI: Geographic Segmentation Analysis
6.6 Healthcare
6.6.1 Introduction and Market Overview
6.6.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.6.3 Key Market Trends, Growth Factors and Opportunities
6.6.4 Healthcare : Geographic Segmentation Analysis
6.7 Retail
6.7.1 Introduction and Market Overview
6.7.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.7.3 Key Market Trends, Growth Factors and Opportunities
6.7.4 Retail: Geographic Segmentation Analysis
6.8 IT and Telecommunications
6.8.1 Introduction and Market Overview
6.8.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.8.3 Key Market Trends, Growth Factors and Opportunities
6.8.4 IT and Telecommunications: Geographic Segmentation Analysis
6.9 Manufacturing
6.9.1 Introduction and Market Overview
6.9.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.9.3 Key Market Trends, Growth Factors and Opportunities
6.9.4 Manufacturing: Geographic Segmentation Analysis
6.10 Government
6.10.1 Introduction and Market Overview
6.10.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.10.3 Key Market Trends, Growth Factors and Opportunities
6.10.4 Government: Geographic Segmentation Analysis
6.11 Others
6.11.1 Introduction and Market Overview
6.11.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.11.3 Key Market Trends, Growth Factors and Opportunities
6.11.4 Others: Geographic Segmentation Analysis
Chapter 7: Regulatory Information Management System (RIMS) Market by Component
7.1 Regulatory Information Management System (RIMS) Market Snapshot and Growth Engine
7.2 Regulatory Information Management System (RIMS) Market Overview
7.3 Software
7.3.1 Introduction and Market Overview
7.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
7.3.3 Key Market Trends, Growth Factors and Opportunities
7.3.4 Software: Geographic Segmentation Analysis
7.4 Services
7.4.1 Introduction and Market Overview
7.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
7.4.3 Key Market Trends, Growth Factors and Opportunities
7.4.4 Services: Geographic Segmentation Analysis
Chapter 8: Company Profiles and Competitive Analysis
8.1 Competitive Landscape
8.1.1 Competitive Benchmarking
8.1.2 Regulatory Information Management System (RIMS) Market Share by Manufacturer (2023)
8.1.3 Industry BCG Matrix
8.1.4 Heat Map Analysis
8.1.5 Mergers and Acquisitions
8.2 VEEVA SYSTEMS (USA)
8.2.1 Company Overview
8.2.2 Key Executives
8.2.3 Company Snapshot
8.2.4 Role of the Company in the Market
8.2.5 Sustainability and Social Responsibility
8.2.6 Operating Business Segments
8.2.7 Product Portfolio
8.2.8 Business Performance
8.2.9 Key Strategic Moves and Recent Developments
8.2.10 SWOT Analysis
8.3 ORACLE CORPORATION (USA)
8.4 ARISGLOBAL (USA)
8.5 PAREXEL INTERNATIONAL CORPORATION (USA)
8.6 MASTERCONTROL INC. (USA)
8.7 SPARTA SYSTEMS (USA)
8.8 AMPLEXOR LIFE SCIENCES (BELGIUM)
8.9 DXC TECHNOLOGY (USA)
8.10 PHLEXGLOBAL (UK)
8.11 ENNOV (FRANCE)
8.12 IQVIA (USA)
8.13 EXTEDO (GERMANY)
8.14 OTHER ACTIVE PLAYERS
Chapter 9: Global Regulatory Information Management System (RIMS) Market By Region
9.1 Overview
9.2. North America Regulatory Information Management System (RIMS) Market
9.2.1 Key Market Trends, Growth Factors and Opportunities
9.2.2 Top Key Companies
9.2.3 Historic and Forecasted Market Size by Segments
9.2.4 Historic and Forecasted Market Size By Deployment Type
9.2.4.1 On-Premises
9.2.4.2 Cloud-Based
9.2.5 Historic and Forecasted Market Size By Organization Size
9.2.5.1 Small and Medium-Sized Enterprises (SMEs
9.2.5.2 Large Enterprises
9.2.6 Historic and Forecasted Market Size By Industry Vertical
9.2.6.1 Banking
9.2.6.2 Financial Services
9.2.6.3 and Insurance (BFSI
9.2.6.4 Healthcare
9.2.6.5 Retail
9.2.6.6 IT and Telecommunications
9.2.6.7 Manufacturing
9.2.6.8 Government
9.2.6.9 Others
9.2.7 Historic and Forecasted Market Size By Component
9.2.7.1 Software
9.2.7.2 Services
9.2.8 Historic and Forecast Market Size by Country
9.2.8.1 US
9.2.8.2 Canada
9.2.8.3 Mexico
9.3. Eastern Europe Regulatory Information Management System (RIMS) Market
9.3.1 Key Market Trends, Growth Factors and Opportunities
9.3.2 Top Key Companies
9.3.3 Historic and Forecasted Market Size by Segments
9.3.4 Historic and Forecasted Market Size By Deployment Type
9.3.4.1 On-Premises
9.3.4.2 Cloud-Based
9.3.5 Historic and Forecasted Market Size By Organization Size
9.3.5.1 Small and Medium-Sized Enterprises (SMEs
9.3.5.2 Large Enterprises
9.3.6 Historic and Forecasted Market Size By Industry Vertical
9.3.6.1 Banking
9.3.6.2 Financial Services
9.3.6.3 and Insurance (BFSI
9.3.6.4 Healthcare
9.3.6.5 Retail
9.3.6.6 IT and Telecommunications
9.3.6.7 Manufacturing
9.3.6.8 Government
9.3.6.9 Others
9.3.7 Historic and Forecasted Market Size By Component
9.3.7.1 Software
9.3.7.2 Services
9.3.8 Historic and Forecast Market Size by Country
9.3.8.1 Russia
9.3.8.2 Bulgaria
9.3.8.3 The Czech Republic
9.3.8.4 Hungary
9.3.8.5 Poland
9.3.8.6 Romania
9.3.8.7 Rest of Eastern Europe
9.4. Western Europe Regulatory Information Management System (RIMS) Market
9.4.1 Key Market Trends, Growth Factors and Opportunities
9.4.2 Top Key Companies
9.4.3 Historic and Forecasted Market Size by Segments
9.4.4 Historic and Forecasted Market Size By Deployment Type
9.4.4.1 On-Premises
9.4.4.2 Cloud-Based
9.4.5 Historic and Forecasted Market Size By Organization Size
9.4.5.1 Small and Medium-Sized Enterprises (SMEs
9.4.5.2 Large Enterprises
9.4.6 Historic and Forecasted Market Size By Industry Vertical
9.4.6.1 Banking
9.4.6.2 Financial Services
9.4.6.3 and Insurance (BFSI
9.4.6.4 Healthcare
9.4.6.5 Retail
9.4.6.6 IT and Telecommunications
9.4.6.7 Manufacturing
9.4.6.8 Government
9.4.6.9 Others
9.4.7 Historic and Forecasted Market Size By Component
9.4.7.1 Software
9.4.7.2 Services
9.4.8 Historic and Forecast Market Size by Country
9.4.8.1 Germany
9.4.8.2 UK
9.4.8.3 France
9.4.8.4 The Netherlands
9.4.8.5 Italy
9.4.8.6 Spain
9.4.8.7 Rest of Western Europe
9.5. Asia Pacific Regulatory Information Management System (RIMS) Market
9.5.1 Key Market Trends, Growth Factors and Opportunities
9.5.2 Top Key Companies
9.5.3 Historic and Forecasted Market Size by Segments
9.5.4 Historic and Forecasted Market Size By Deployment Type
9.5.4.1 On-Premises
9.5.4.2 Cloud-Based
9.5.5 Historic and Forecasted Market Size By Organization Size
9.5.5.1 Small and Medium-Sized Enterprises (SMEs
9.5.5.2 Large Enterprises
9.5.6 Historic and Forecasted Market Size By Industry Vertical
9.5.6.1 Banking
9.5.6.2 Financial Services
9.5.6.3 and Insurance (BFSI
9.5.6.4 Healthcare
9.5.6.5 Retail
9.5.6.6 IT and Telecommunications
9.5.6.7 Manufacturing
9.5.6.8 Government
9.5.6.9 Others
9.5.7 Historic and Forecasted Market Size By Component
9.5.7.1 Software
9.5.7.2 Services
9.5.8 Historic and Forecast Market Size by Country
9.5.8.1 China
9.5.8.2 India
9.5.8.3 Japan
9.5.8.4 South Korea
9.5.8.5 Malaysia
9.5.8.6 Thailand
9.5.8.7 Vietnam
9.5.8.8 The Philippines
9.5.8.9 Australia
9.5.8.10 New Zealand
9.5.8.11 Rest of APAC
9.6. Middle East & Africa Regulatory Information Management System (RIMS) Market
9.6.1 Key Market Trends, Growth Factors and Opportunities
9.6.2 Top Key Companies
9.6.3 Historic and Forecasted Market Size by Segments
9.6.4 Historic and Forecasted Market Size By Deployment Type
9.6.4.1 On-Premises
9.6.4.2 Cloud-Based
9.6.5 Historic and Forecasted Market Size By Organization Size
9.6.5.1 Small and Medium-Sized Enterprises (SMEs
9.6.5.2 Large Enterprises
9.6.6 Historic and Forecasted Market Size By Industry Vertical
9.6.6.1 Banking
9.6.6.2 Financial Services
9.6.6.3 and Insurance (BFSI
9.6.6.4 Healthcare
9.6.6.5 Retail
9.6.6.6 IT and Telecommunications
9.6.6.7 Manufacturing
9.6.6.8 Government
9.6.6.9 Others
9.6.7 Historic and Forecasted Market Size By Component
9.6.7.1 Software
9.6.7.2 Services
9.6.8 Historic and Forecast Market Size by Country
9.6.8.1 Turkiye
9.6.8.2 Bahrain
9.6.8.3 Kuwait
9.6.8.4 Saudi Arabia
9.6.8.5 Qatar
9.6.8.6 UAE
9.6.8.7 Israel
9.6.8.8 South Africa
9.7. South America Regulatory Information Management System (RIMS) Market
9.7.1 Key Market Trends, Growth Factors and Opportunities
9.7.2 Top Key Companies
9.7.3 Historic and Forecasted Market Size by Segments
9.7.4 Historic and Forecasted Market Size By Deployment Type
9.7.4.1 On-Premises
9.7.4.2 Cloud-Based
9.7.5 Historic and Forecasted Market Size By Organization Size
9.7.5.1 Small and Medium-Sized Enterprises (SMEs
9.7.5.2 Large Enterprises
9.7.6 Historic and Forecasted Market Size By Industry Vertical
9.7.6.1 Banking
9.7.6.2 Financial Services
9.7.6.3 and Insurance (BFSI
9.7.6.4 Healthcare
9.7.6.5 Retail
9.7.6.6 IT and Telecommunications
9.7.6.7 Manufacturing
9.7.6.8 Government
9.7.6.9 Others
9.7.7 Historic and Forecasted Market Size By Component
9.7.7.1 Software
9.7.7.2 Services
9.7.8 Historic and Forecast Market Size by Country
9.7.8.1 Brazil
9.7.8.2 Argentina
9.7.8.3 Rest of SA
Chapter 10 Analyst Viewpoint and Conclusion
10.1 Recommendations and Concluding Analysis
10.2 Potential Market Strategies
Chapter 11 Research Methodology
11.1 Research Process
11.2 Primary Research
11.3 Secondary Research
Q1: What would be the forecast period in the Regulatory Information Management System (RIMS) Market research report?
A1: The forecast period in the Regulatory Information Management System (RIMS) Market research report is 2024-2032.
Q2: Who are the key players in the Regulatory Information Management System (RIMS) Market?
A2: Veeva Systems (USA), Oracle Corporation (USA), ArisGlobal (USA), Parexel International Corporation (USA), MasterControl Inc. (USA), Sparta Systems (USA), Amplexor Life Sciences (Belgium), DXC Technology (USA), and Other Active Players.
Q3: What are the segments of the Regulatory Information Management System (RIMS) Market?
A3: The Regulatory Information Management System (RIMS) Market is segmented into Component, Deployment Mode, Enterprise Size, Industry Vertical and region. By Component, the market is categorized into Software, Services. By Deployment Mode, the market is categorized into On-Premises, Cloud-Based. By Enterprise Size, the market is categorized into Small and Medium Enterprises (SMEs), Large Enterprises. By Industry Vertical, the market is categorized into Pharmaceutical, Biotechnology, Medical Devices, Healthcare Providers, Contract Research Organizations (CROs), Others. By region, it is analyzed across North America (U.S., Canada, Mexico), Eastern Europe (Russia, Bulgaria, The Czech Republic, Hungary, Poland, Romania, Rest of Eastern Europe), Western Europe (Germany, UK, France, The Netherlands, Italy, Russia, Spain, Rest of Western Europe), Asia Pacific (China, India, Japan, South Korea, Malaysia, Thailand, Vietnam, The Philippines, Australia, New-Zealand, Rest of APAC), Middle East & Africa (Turkiye, Bahrain, Kuwait, Saudi Arabia, Qatar, UAE, Israel, South Africa), South America (Brazil, Argentina, Rest of SA).
Q4: What is the Regulatory Information Management System (RIMS) Market?
A4: The Regulatory Information Management System (RIMS) Market encompasses the global market for managing and automating regulation across multiple sectors with regards to software and services. It also assists in managing regulatory submission and compliance, record management and tracking, allowing organizations to manage the challenging and often unique, regional compliance requirements effectively.
Q5: How big is the Regulatory Information Management System (RIMS) Market?
A5: Regulatory Information Management System (RIMS) Market Size Was Valued at USD 2.5 Billion in 2023, and is Projected to Reach USD 6.2 Billion by 2032, Growing at a CAGR of 10.7% From 2024-2032.
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