监管资讯管理系统市场机会、成长动力、产业趋势分析与预测 2025 - 2034

2024 年全球监管资讯管理系统( RIMS) 市场价值为 22 亿美元，预计 2025 年至 2034 年期间将以 10.9% 的强劲复合年增长率增长。随着全球市场联繫日益紧密，法规发展速度也比以往任何时候都快，企业被迫采用先进的解决方案来帮助它们始终领先于合规要求。对准确性、透明度和营运效率的需求从未如此重要，因此，组织正在转向尖端的 RIMS 来简化流程、增强资料处理并即时保持法规遵循。预计各行各业，特别是製药、医疗保健和製造业，将越来越依赖这些技术来应对复杂的监管环境。

市场分为软体和服务，其中软体领域处于领先地位。 2024 年，软体部门创造的收入为 15 亿美元，预计在预测期内将显着成长。软体解决方案占据主导地位，因为它们能够简化监管流程、最大限度地减少人工错误并加强合规管理。这些工具旨在随着业务成长而扩展，使其成为各种规模公司的理想选择。随着监管需求变得越来越动态和复杂，软体解决方案可协助组织简化提交、追踪合规更新并减少营运效率低下。

在部署方面，市场分为基于云端的解决方案和内部部署的解决方案。基于云端的系统已获得广泛关注，预计到 2034 年该领域的规模将达到 39 亿美元。这些系统在监管环境中尤其有价值，因为企业需要即时更新和无缝整合以保持灵活性和合规性。透过利用云端技术，公司可以确保掌握不断变化的法规，同时最大限度地降低合规失败的风险。

从地区来看，2024 年美国监管资讯管理系统市场价值为 7.477 亿美元。美国仍然是製药和医疗器材等行业的中心，高效处理监管资料、提交和批准至关重要。随着这些行业的公司寻求在多个司法管辖区保持合规的方法，美国越来越广泛地采用 RIMS 解决方案的趋势继续推动市场成长。

目录

第 1 章：方法论与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 监管要求日益复杂
    • 监管资料量不断增加
    • 技术进步
    • 临床试验和药物审批的成长
  • 产业陷阱与挑战
    • 实施成本高
• 成长潜力分析
• 监管格局
  • 我们
  • 欧洲
• 技术格局
• 未来市场趋势
• 定价分析
• 差距分析
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第 5 章：市场估计与预测：按组件，2021 年至 2034 年

• 主要趋势
• 软体
• 服务

第 6 章：市场估计与预测：按部署类型，2021 年至 2034 年

• 主要趋势
• 基于云端
• 本地

第 7 章：市场估计与预测：按应用，2021 年至 2034 年

• 主要趋势
• 登记
• 提交
• 出版
• 其他应用

第 8 章：市场估计与预测：依最终用途，2021 年至 2034 年

• 主要趋势
• 製药业
• 医疗器材领域
• 其他最终用户

第 9 章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：公司简介

• AmpleLogic
• ArisGlobal
• Calyx
• Dassault Systemes
• DDi
• DXC Technology
• Ennov
• Ithos Global (Cordance Group)
• Kalypso (Rockwell Automation)
• Korber
• LORENZ Life Sciences Group
• MasterControl
• PhlexGlobal
• Rimsys
• Veeva Systems

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