세계의 규제 정보 관리 시스템 시장 : 기회, 성장 촉진요인, 산업 동향 분석, 예측(2025-2034년)

The Global Regulatory Information Management System (RIMS) Market was valued at USD 2.2 billion in 2024 and is forecasted to grow at a robust CAGR of 10.9% from 2025 to 2034. This growth is largely driven by the increasing complexity of regulatory frameworks, the rising volume of compliance data, and the pressure on organizations to adopt more efficient management systems. With global markets becoming more interconnected and regulations evolving faster than ever, businesses are being compelled to adopt advanced solutions that help them stay ahead of compliance requirements. The need for accuracy, transparency, and operational efficiency has never been more critical, and as a result, organizations are turning to cutting-edge RIMS to streamline processes, enhance data handling, and maintain regulatory compliance in real-time. Industries across the board, especially those dealing with pharmaceuticals, healthcare, and manufacturing, are expected to increasingly rely on these technologies to navigate the intricate regulatory landscape.

The market is segmented into software and services, with the software segment leading the charge. In 2024, the software segment generated USD 1.5 billion in revenue and is expected to see significant growth over the forecast period. Software solutions dominate due to their ability to streamline regulatory processes, minimize manual errors, and enhance compliance management. These tools are designed to scale with business growth, making them ideal for companies of various sizes. As regulatory demands grow more dynamic and complex, software solutions help organizations simplify submissions, track compliance updates, and reduce operational inefficiencies.

In terms of deployment, the market is divided into cloud-based and on-premises solutions. Cloud-based systems have gained substantial traction, with the sector projected to reach USD 3.9 billion by 2034. The popularity of cloud-based solutions stems from their scalability, cost-effectiveness, and the flexibility they offer for remote access and collaboration. These systems are particularly valuable in a regulatory environment where businesses need real-time updates and seamless integration to maintain agility and compliance. By leveraging cloud technologies, companies can ensure they stay on top of constantly changing regulations while minimizing the risk of compliance failures.

Regionally, the U.S. regulatory information management system market was valued at USD 747.7 million in 2024. The country's stringent regulatory environment, driven by federal agencies enforcing rigorous compliance standards, has led to an increased demand for advanced management systems. The U.S. remains a hub for industries such as pharmaceuticals and medical devices, where the efficient handling of regulatory data, submissions, and approvals is critical. This trend toward greater adoption of RIMS solutions in the U.S. continues to fuel market growth as companies in these sectors look for ways to stay compliant across multiple jurisdictions.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing complexity of regulatory requirements
    • 3.2.1.2 Rising volume of regulatory data
    • 3.2.1.3 Technological advancements
    • 3.2.1.4 Growth in clinical trials and drug approvals
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High implementation cost
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 U.S.
  • 3.4.2 Europe
• 3.5 Technology landscape
• 3.6 Future market trends
• 3.7 Pricing analysis
• 3.8 Gap analysis
• 3.9 Porter’s analysis
• 3.10 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Component, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Software
• 5.3 Services

Chapter 6 Market Estimates and Forecast, By Deployment Type, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Cloud-based
• 6.3 On-premises

Chapter 7 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Registration
• 7.3 Submission
• 7.4 Publishing
• 7.5 Other applications

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Pharmaceutical sector
• 8.3 Medical device sector
• 8.4 Other end-users

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 AmpleLogic
• 10.2 ArisGlobal
• 10.3 Calyx
• 10.4 Dassault Systemes
• 10.5 DDi
• 10.6 DXC Technology
• 10.7 Ennov
• 10.8 Ithos Global (Cordance Group)
• 10.9 Kalypso (Rockwell Automation)
• 10.10 Korber
• 10.11 LORENZ Life Sciences Group
• 10.12 MasterControl
• 10.13 PhlexGlobal
• 10.14 Rimsys
• 10.15 Veeva Systems