监管资讯管理市场－全球产业规模、份额、趋势、机会和预测（按组件、按部署模式、按应用、按最终用户、按地区和竞争细分，2020 年至 2030 年）

2024 年全球监管资讯管理市场价值为 21.2 亿美元，预计到 2030 年将达到 38.1 亿美元，预测期内的复合年增长率为 10.41%。全球监管资讯管理 (RIM) 市场在帮助生命科学公司有效处理复杂的监管流程方面发挥关键作用。随着各地区法规的发展和日益严格，製药、生物技术和医疗器材领域的组织越来越多地投资于精简的 RIM 系统，以管理合规性、降低风险并缩短产品上市时间。 RIM 涵盖监管资料的收集、储存和使用，包括提交、产品註册、Kiyoclear 和与监管机构的通讯。公司依靠这些系统来维护关键资讯的集中储存库，以支援决策并确保遵守本地和全球监管要求。 RIM 市场成长的一个关键驱动力是数位转型。基于云端的平台和自动化工具正在取代传统的手动方法，以便能够更快、更准确地处理监管任务。这些现代系统提供即时协作、提高透明度和跨部门集成，帮助公司在不断变化的监管环境中保持领先地位。

例如，2025年2月，电子品质管理系统 (eQMS) 的演进显着提升了药品临床试验监管资讯管理 (RIM) 的能力。现代 eQMS 平台现已支援即时资料撷取、集中文件储存和自动化方案管理，并与监管合规要求无缝衔接。这些增强功能能够更好地整合品质和监管流程，提高资料准确性、稽核准备度和提交时效。因此，eQMS 创新正成为强化全球 RIM 策略的关键推手。

关键市场驱动因素

监理复杂性日益增加

主要市场挑战

数据标准化与集成

主要市场趋势

转向基于云端的 RIM 平台

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：全球监理资讯管理市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按组件（解决方案与服务）
  • 依部署模式（本机部署 vs. 云端部署）
  • 按应用程式（註册管理、监管情报、标籤管理、提交计划和追踪管理、出版、文件管理、其他）
  • 按最终用户（製药、医疗器材、其他）
  • 按地区
  • 按公司分类（2024）
• 市场地图
  • 按组件
  • 按部署模式
  • 按应用
  • 按最终用户
  • 按地区

第五章：北美监理资讯管理市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按组件
  • 按部署模式
  • 按应用
  • 按最终用户
  • 按国家/地区
• 北美：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第六章：欧洲监理资讯管理市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 义大利
  • 西班牙

第七章：亚太监管资讯管理市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第八章：南美洲监理资讯管理市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第九章：中东和非洲监理资讯管理市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：市场动态

• 驱动程式
• 挑战

第 11 章：市场趋势与发展

第 12 章：竞争格局

• ArisGlobal LLC
• Arivis AG
• DDi, Inc.
• Ennov SA
• Extedo Gmbh
• Glemser Technologies Corporation
• Instem Group
• MasterControl, Inc.
• Parexel International Corporation
• Samarind Ltd.

第十三章：战略建议

第14章调查会社について・免责事项

Global Regulatory Information Management Market was valued at USD 2.12 billion in 2024 and is expected to reach USD 3.81 billion by 2030 with a CAGR of 10.41% during the forecast period. The Global Regulatory Information Management (RIM) market plays a pivotal role in helping life sciences companies efficiently handle complex regulatory processes. As regulations evolve and become more stringent across regions, organizations in the pharmaceutical, biotechnology, and medical device sectors are increasingly investing in streamlined RIM systems to manage compliance, reduce risk, and improve time-to-market. RIM encompasses the collection, storage, and use of regulatory data, including submissions, product registrations, Kiyoclear, and correspondence with regulatory authorities. Companies rely on these systems to maintain a centralized repository of critical information that supports decision-making and ensures adherence to local and global regulatory requirements. A key driver of growth in the RIM market is digital transformation. Cloud-based platforms and automation tools are replacing traditional manual methods, enabling faster, more accurate handling of regulatory tasks. These modern systems offer real-time collaboration, improved transparency, and integration across departments, helping companies stay ahead of shifting regulatory landscapes.

For instance, in Feb 2025, the evolution of electronic Quality Management Systems (eQMS) is significantly advancing the capabilities of Regulatory Information Management (RIM) in pharmaceutical clinical trials. Modern eQMS platforms now support real-time data capture, centralized document storage, and automated protocol management, aligning seamlessly with regulatory compliance requirements. These enhancements enable better integration of quality and regulatory processes, improving data accuracy, audit readiness, and submission timelines. As a result, eQMS innovation is becoming a key enabler in strengthening global RIM strategies.

Key Market Drivers

Increasing Regulatory Complexity

Increasing regulatory complexity is one of the most significant drivers shaping the Global Regulatory Information Management (RIM) market. Across the pharmaceutical, biotechnology, and medical device industries, companies are facing a rapidly evolving landscape of compliance requirements imposed by national and international regulatory bodies. Health authorities such as the U.S. FDA, the European Medicines Agency (EMA), and regulatory agencies in Asia and Latin America are frequently updating their guidelines, introducing new formats for submissions, and enforcing stricter requirements around data integrity, traceability, and transparency. This growing complexity places immense pressure on regulatory affairs teams to stay current with the latest regulatory changes while managing a rising volume of product data, documentation, and submission timelines. Each country or region often maintains distinct and detailed expectations for product approval, post-market surveillance, and lifecycle management. As companies expand into global markets, the need to navigate overlapping and sometimes contradictory regulations becomes more pronounced.

The introduction of initiatives like Identification of Medicinal Products (IDMP), electronic Common Technical Document (eCTD) requirements, and increased scrutiny over pharmacovigilance reporting have added new layers of data governance obligations. Companies must not only prepare documentation accurately but also ensure that all regulatory content is consistent, traceable, and compliant across different jurisdictions. Errors or delays in regulatory submissions can result in significant business consequences, including product launch delays, market withdrawals, or financial penalties. In response to this environment, organizations are turning to RIM solutions to gain control over their regulatory data, automate repetitive processes, and build a centralized framework that can adapt to changing global requirements. These systems provide structured workflows, version control, and real-time visibility into regulatory activities. By helping organizations stay ahead of evolving regulations, RIM platforms play a critical role in ensuring compliance, reducing risk, and maintaining business continuity in a complex regulatory ecosystem.

Key Market Challenges

Data Standardization and Integration

Data standardization and integration are critical challenges facing the Regulatory Information Management (RIM) market. In the life sciences industry, regulatory processes involve vast volumes of structured and unstructured data originating from multiple departments such as research and development, clinical trials, manufacturing, and quality assurance. Each department often uses its own systems and formats, leading to data silos, duplication, and inconsistencies. Without standardization, it becomes difficult to ensure the accuracy, traceability, and completeness of regulatory submissions. Inconsistent data formats and naming conventions can delay submission approvals, increase the risk of compliance errors, and reduce operational efficiency. For global organizations, this issue is magnified when dealing with multiple regulatory bodies, each with distinct requirements for data presentation and content structure. Standardizing data across internal systems helps establish a single source of truth, which is essential for preparing timely and compliant submissions.

Effective integration of RIM platforms with other enterprise systems-such as document management systems, enterprise resource planning (ERP), and clinical trial management systems-allows for seamless data exchange and end-to-end visibility. Without strong integration capabilities, companies struggle to keep regulatory information current and aligned across departments. Manual data reconciliation not only consumes time but also introduces a higher risk of human error. RIM solutions must be built to support interoperable, scalable data models that align with global standards such as IDMP and HL7. Ensuring proper data flow and connectivity across systems enables faster decision-making, better collaboration, and more proactive compliance management. In a complex regulatory environment, data standardization and integration form the foundation of a resilient and efficient RIM strategy.

Key Market Trends

Shift Toward Cloud-Based RIM Platforms

The shift toward cloud-based Regulatory Information Management (RIM) platforms is transforming how life sciences companies manage regulatory operations. As the industry faces increasing pressure to streamline global submissions, ensure compliance, and respond quickly to changing regulatory requirements, cloud-based systems offer a more agile and scalable approach compared to traditional on-premise solutions. These platforms provide centralized access to regulatory data, allowing teams across geographies to collaborate in real time and maintain a single source of truth. Cloud-based RIM solutions reduce the burden of maintaining infrastructure, enabling companies to allocate resources toward core regulatory tasks rather than IT management. System updates, data backups, and security protocols are handled by the vendor, ensuring the platform remains current with evolving standards and best practices. This model supports faster deployment and more predictable operational costs, which is particularly valuable for companies managing diverse product portfolios across multiple markets.

Remote access to regulatory data is increasingly essential as organizations embrace hybrid and distributed work models. Cloud platforms make it possible for regulatory affairs teams to access, review, and submit documents without being tied to a single location or network. This level of flexibility improves responsiveness and decision-making during time-sensitive regulatory events. Security and compliance capabilities built into cloud-based RIM systems have advanced significantly. These platforms now include robust encryption, audit trails, and role-based access controls to safeguard sensitive information. As regulatory landscapes grow more complex, cloud provides the flexibility and reliability that life sciences companies need to stay competitive, compliant, and efficient in managing global regulatory demands.

Key Market Players

• ArisGlobal LLC
• Arivis AG
• DDi, Inc.
• Ennov SA
• Extedo Gmbh
• Glemser Technologies Corporation
• Instem Group
• MasterControl, Inc.
• Parexel International Corporation
• Samarind Ltd.

Report Scope:

In this report, the Global Regulatory Information Management Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Regulatory Information Management Market, By Component:

• Solution
• Services

Regulatory Information Management Market, By Deployment Mode:

• On-Premises
• Cloud

Regulatory Information Management Market, By Application:

• Registration Management
• Regulatory Intelligence
• Labeling Management
• Submission Planning & Tracking Management
• Publishing
• Document Management
• Others

Regulatory Information Management Market, By End User:

• Pharmaceutical
• Medical Devices
• Others

Regulatory Information Management Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Information Management Market.

Available Customizations:

Global Regulatory Information Management Market report 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).

Table of Contents

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 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 (2024)
• 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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. ArisGlobal LLC
  • 12.1.1. Business Overview
  • 12.1.2. Product Offerings
  • 12.1.3. Recent Developments
  • 12.1.4. Financials (As Reported)
  • 12.1.5. Key Personnel
  • 12.1.6. SWOT Analysis
• 12.2. Arivis AG
• 12.3. DDi, Inc.
• 12.4. Ennov SA
• 12.5. Extedo Gmbh
• 12.6. Glemser Technologies Corporation
• 12.7. Instem Group
• 12.8. MasterControl, Inc.
• 12.9. Parexel International Corporation
• 12.10. Samarind Ltd.

13. Strategic Recommendations

14. About Us & Disclaimer