規制情報管理市場 - 世界の産業規模、シェア、動向、機会、予測：コンポーネント別、展開モード別、用途別、エンドユーザー別、地域別、競合別、2020年～2030年

規制情報管理の世界市場規模は2024年に21億2,000万米ドル、予測期間中のCAGRは10.41%で2030年には38億1,000万米ドルに達すると予測されています。

世界の規制情報管理（RIM）市場は、ライフサイエンス企業が複雑な規制プロセスを効率的に処理する上で極めて重要な役割を果たしています。規制が進化し、地域によって厳しくなるにつれて、製薬、バイオテクノロジー、医療機器分野の企業は、コンプライアンスを管理し、リスクを低減し、市場投入までの時間を改善するために、合理化されたRIMシステムへの投資を増やしています。RIMは、申請、製品登録、Kiyoclear、規制当局とのやり取りを含む規制データの収集、保管、使用を包括します。企業は、意思決定を支援し、ローカルおよび世界な規制要件の遵守を保証する重要な情報の一元化されたリポジトリを維持するために、これらのシステムに依存しています。RIM市場の成長促進要因のひとつは、デジタルトランスフォーメーションです。クラウドベースのプラットフォームと自動化ツールは、従来の手作業に取って代わり、より迅速で正確な規制業務の処理を可能にしています。これらの最新システムは、リアルタイムのコラボレーション、透明性の向上、部門間の統合を提供し、企業が変化する規制状況の先取りを支援します。

例えば2025年2月には、電子品質管理システム（eQMS）の進化により、医薬品臨床試験における規制情報管理（RIM）の機能が大幅に向上しています。最新のeQMSプラットフォームは、リアルタイムデータキャプチャ、一元化された文書保管、自動化されたプロトコール管理をサポートし、規制コンプライアンス要件とシームレスに連携しています。これらの機能強化により、品質と薬事プロセスのより良い統合が可能になり、データの正確性、監査準備、および申請スケジュールが改善されます。その結果、eQMSの革新は世界なRIM戦略を強化する上で重要なイネーブラーになりつつあります。

市場促進要因

規制の複雑化

主な市場課題

データの標準化と統合

主な市場動向

クラウドベースのRIMプラットフォームへのシフト

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 世界の規制情報管理市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • コンポーネント別（ソリューション、サービス）
  • 導入モード別（オンプレミス、クラウド）
  • 用途別（登録管理、規制情報、ラベリング管理、申請計画および追跡管理、出版、文書管理、その他）
  • エンドユーザー別（医薬品、医療機器、その他）
  • 地域別
  • 企業別（2024）
• 市場マップ
  • コンポーネント別
  • 展開モード別
  • 用途別
  • エンドユーザー別
  • 地域別

第5章 北米の規制情報管理市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • コンポーネント別
  • 展開モード別
  • 用途別
  • エンドユーザー別
  • 国別
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第6章 欧州の規制情報管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第7章 アジア太平洋地域の規制情報管理市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 日本
  • 韓国
  • オーストラリア

第8章 南米の規制情報管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第9章 中東・アフリカの規制情報管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第10章 市場力学

• 促進要因
• 課題

第11章 市場動向と発展

第12章 競合情勢

• 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 戦略的提言

第14章 調査会社について・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