監管資訊管理市場－全球產業規模、佔有率、趨勢、機會和預測（按組件、按部署模式、按應用、按最終用戶、按地區和競爭細分，2020 年至 2030 年）

2024 年全球監管資訊管理市場價值為 21.2 億美元，預計到 2030 年將達到 38.1 億美元，預測期內的複合年成長率為 10.41%。全球監管資訊管理 (RIM) 市場在幫助生命科學公司有效處理複雜的監管流程方面發揮關鍵作用。隨著各地區法規的發展和日益嚴格，製藥、生物技術和醫療器材領域的組織擴大投資於精簡的 RIM 系統，以管理合規性、降低風險並縮短產品上市時間。 RIM 涵蓋監管資料的收集、儲存和使用，包括提交、產品註冊、Kiyoclear 和與監管機構的通訊。公司依靠這些系統來維護關鍵資訊的集中儲存庫，以支援決策並確保遵守本地和全球監管要求。 RIM 市場成長的一個關鍵驅動力是數位轉型。基於雲端的平台和自動化工具正在取代傳統的手動方法，以便能夠更快、更準確地處理監管任務。這些現代系統提供即時協作、提高透明度和跨部門整合，幫助公司在不斷變化的監管環境中保持領先地位。

例如，2025年2月，電子品質管理系統 (eQMS) 的演進顯著提升了藥品臨床試驗監管資訊管理 (RIM) 的能力。現代 eQMS 平台現已支援即時資料擷取、集中文件儲存和自動化方案管理，並與監管合規要求無縫銜接。這些增強功能能夠更好地整合品質和監管流程，提高資料準確性、稽核準備度和提交時效。因此，eQMS 創新正成為強化全球 RIM 策略的關鍵推手。

關鍵市場促進因素

監理複雜性日益增加

主要市場挑戰

數據標準化與整合

主要市場趨勢

轉向基於雲端的 RIM 平台

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：全球監理資訊管理市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按組件（解決方案與服務）
  • 依部署模式（本機部署 vs. 雲端部署）
  • 按應用程式（註冊管理、監管情報、標籤管理、提交計劃和追蹤管理、出版、文件管理、其他）
  • 按最終用戶（製藥、醫療器材、其他）
  • 按地區
  • 按公司分類（2024）
• 市場地圖
  • 按組件
  • 按部署模式
  • 按應用
  • 按最終用戶
  • 按地區

第5章：北美監理資訊管理市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按組件
  • 按部署模式
  • 按應用
  • 按最終用戶
  • 按國家/地區
• 北美：國家分析
  • 美國
  • 加拿大
  • 墨西哥

第6章：歐洲監理資訊管理市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 法國
  • 德國
  • 英國
  • 義大利
  • 西班牙

第7章：亞太監管資訊管理市場展望

• 市場規模和預測
• 市場佔有率和預測
• 亞太地區：國家分析
  • 中國
  • 印度
  • 日本
  • 韓國
  • 澳洲

第8章：南美洲監理資訊管理市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 巴西
  • 阿根廷
  • 哥倫比亞

第9章：中東和非洲監理資訊管理市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第10章：市場動態

• 驅動程式
• 挑戰

第 11 章：市場趨勢與發展

第 12 章：競爭格局

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

第13章：戰略建議

第14章調查會社について,免責事項

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