세계의 규제 정보 관리 시스템 시장 규모, 점유율, 동향 분석 보고서 : 최종 사용자별, 지역별 전망 및 예측(2024-2031년)

The Global Regulatory Information Management System Market size is expected to reach $4.7 billion by 2031, rising at a market growth of 10.5% CAGR during the forecast period.

The Asia Pacific region is home to rapidly growing pharmaceutical and healthcare industries. Thus, the Asia Pacific region acquired $579.5 million revenue in 2023. As the pharmaceutical sector expands, the complexity of regulatory compliance requirements also increases, driving the demand for robust regulatory information management systems to ensure compliance with regulatory standards, streamline regulatory processes, and accelerate product approvals in China.

Quality management is paramount in the pharmaceutical and healthcare industries to ensure that products meet safety and efficacy standards. RIMS solutions integrate with Quality Management Systems (QMS) to support quality management processes such as document control, deviation management, corrective and preventive actions (CAPA), and audit management. Therefore, the market is expanding significantly due to the rising focus on patient safety and product quality.

Additionally, RIMS solutions facilitate collaboration among cross-functional teams involved in regulatory processes, including regulatory affairs, quality assurance, clinical research, and product development. RIMS enables teams to collaborate effectively, streamline communication, and coordinate efforts to achieve regulatory objectives by providing a centralized platform for sharing regulatory information, documents, and submissions. Thus, because of the enhanced collaboration and interoperability, the market is anticipated to increase significantly.

However, SMEs often operate with tighter budgets compared to larger corporations. The high upfront costs associated with implementing RIMS solutions may deter SMEs from investing in these systems, limiting their ability to enhance regulatory compliance, streamline processes, and compete effectively in regulated markets. Thus, high implementation costs can slow down the growth of the market.

By End User Analysis

By end user, the market is categorized into pharmaceutical sector, medical device sector, and others. In 2023, the pharmaceutical sector segment held a 44.3% revenue share in the market. Pharmaceutical companies must submit various regulatory documents to health authorities for drug approval and marketing authorization.

By Regional Analysis

Region-wise, the market is analysed across North America, Europe, Asia Pacific, and LAMEA. In 2023, the North America region led the market by generating the highest 40% revenue share. Regulatory agencies in North America prioritize patient safety and product quality in approving and overseeing pharmaceuticals, medical devices, and healthcare products.

Recent Strategies Deployed in the Market

• 2024-Feb: LORENZ Life Sciences Group came into partnership with DNAnexus, Inc., a company that specializes in cloud-based solutions for genomic data analysis and management. Under this collaboration, LORENZ would be providing Trusted Regulatory Spaces-secure, cloud-native environments enhancing the submission validation process and facilitating sponsor-reviewer communication for human drug and biologics applications to health authorities.
• 2023-Dec: Korber AG signed a partnership with Franz Ziel GmbH, a German engineering company specializing in precision machinery and automation solutions. Through this partnership, Korber would strategically broaden its product range in a key area to better serve our customers.
• 2023-Aug: Veeva Systems, Inc. acquired Learnaboutgmp, an online platform offering comprehensive training and resources for Good Manufacturing Practice (GMP) compliance. Through this acquisition, Veeva would be able to assist clients in fostering more strategic training initiatives, enhancing job competency, and ensuring compliance.
• 2023-May: Veeva Systems, Inc. signed a partnership with Lotus Clinical Research, a leading clinical research organization specializing in conducting trials for pharmaceutical and biotechnology companies. Under this partnership, Veeva would help Lotus to enhance trial efficiency through streamlined collaboration, leveraging user-friendly clinical applications to expand disease expertise and bolster site interactions for enhanced patient recruitment.
• 2023-Apr: Ennov SAS took over Samarind, a company that offers Regulatory Information Management ("RIM") software (known as Samarind RMS) and related services tailored for the life sciences industry. This acquisition would enhance Ennov's standing in the Regulatory Information Management (RIM) software market, particularly within the Medical Device sector.

List of Key Companies Profiled

• Veeva Systems, Inc.
• Korber AG (Optel Group)
• ArisGlobal LLC (Nordic Capital Limited)
• Calyx
• Ennov SAS
• MasterControl, Inc.
• LORENZ Life Sciences Group
• AmpleLogic
• Cencora, Inc. (PharmaLex Holding GmbH)
• Ithos Global Inc. (Cordance Group)

Global Regulatory Information Management System Market Report Segmentation

By End User

• Pharmaceutical Sector
• Medical Device Sector
• Others

By Geography

• North America
  • US
  • Canada
  • Mexico
  • Rest of North America
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Malaysia
  • Rest of Asia Pacific
• LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA

Table of Contents

Chapter 1.Market Scope & Methodology

• 1.1Market Definition
• 1.2Objectives
• 1.3Market Scope
• 1.4Segmentation
  • 1.4.1Global Regulatory Information Management System Market, by End User
  • 1.4.2Global Regulatory Information Management System Market, by Geography
• 1.5Methodology for the research

Chapter 2.Market at a Glance

• 2.1Key Highlights

Chapter 3.Market Overview

• 3.1Introduction
  • 3.1.1Overview
    • 3.1.1.1Market Composition and Scenario
• 3.2Key Factors Impacting the Market
  • 3.2.1Market Drivers
  • 3.2.2Market Restraints
  • 3.2.3Market Opportunities
  • 3.2.4Market Challenges
• 3.3Porter's Five Forces Analysis

Chapter 4.Strategies Deployed in Regulatory Information Management System Market

Chapter 5.Global Regulatory Information Management System Market by End User

• 5.1Global Pharmaceutical Sector Market by Region
• 5.2Global Medical Device Sector Market by Region
• 5.3Global Others Market by Region

Chapter 6.Global Regulatory Information Management System Market by Region

• 6.1North America Regulatory Information Management System Market
  • 6.1.1North America Regulatory Information Management System Market by End User
    • 6.1.1.1North America Pharmaceutical Sector Market by Country
    • 6.1.1.2North America Medical Device Sector Market by Country
    • 6.1.1.3North America Others Market by Country
  • 6.1.2North America Regulatory Information Management System Market by Country
    • 6.1.2.1US Regulatory Information Management System Market
      • 6.1.2.1.1US Regulatory Information Management System Market by End User
    • 6.1.2.2Canada Regulatory Information Management System Market
      • 6.1.2.2.1Canada Regulatory Information Management System Market by End User
    • 6.1.2.3Mexico Regulatory Information Management System Market
      • 6.1.2.3.1Mexico Regulatory Information Management System Market by End User
    • 6.1.2.4Rest of North America Regulatory Information Management System Market
      • 6.1.2.4.1Rest of North America Regulatory Information Management System Market by End User
• 6.2Europe Regulatory Information Management System Market
  • 6.2.1Europe Regulatory Information Management System Market by End User
    • 6.2.1.1Europe Pharmaceutical Sector Market by Country
    • 6.2.1.2Europe Medical Device Sector Market by Country
    • 6.2.1.3Europe Others Market by Country
  • 6.2.2Europe Regulatory Information Management System Market by Country
    • 6.2.2.1Germany Regulatory Information Management System Market
      • 6.2.2.1.1Germany Regulatory Information Management System Market by End User
    • 6.2.2.2UK Regulatory Information Management System Market
      • 6.2.2.2.1UK Regulatory Information Management System Market by End User
    • 6.2.2.3France Regulatory Information Management System Market
      • 6.2.2.3.1France Regulatory Information Management System Market by End User
    • 6.2.2.4Russia Regulatory Information Management System Market
      • 6.2.2.4.1Russia Regulatory Information Management System Market by End User
    • 6.2.2.5Spain Regulatory Information Management System Market
      • 6.2.2.5.1Spain Regulatory Information Management System Market by End User
    • 6.2.2.6Italy Regulatory Information Management System Market
      • 6.2.2.6.1Italy Regulatory Information Management System Market by End User
    • 6.2.2.7Rest of Europe Regulatory Information Management System Market
      • 6.2.2.7.1Rest of Europe Regulatory Information Management System Market by End User
• 6.3Asia Pacific Regulatory Information Management System Market
  • 6.3.1Asia Pacific Regulatory Information Management System Market by End User
    • 6.3.1.1Asia Pacific Pharmaceutical Sector Market by Country
    • 6.3.1.2Asia Pacific Medical Device Sector Market by Country
    • 6.3.1.3Asia Pacific Others Market by Country
  • 6.3.2Asia Pacific Regulatory Information Management System Market by Country
    • 6.3.2.1China Regulatory Information Management System Market
      • 6.3.2.1.1China Regulatory Information Management System Market by End User
    • 6.3.2.2Japan Regulatory Information Management System Market
      • 6.3.2.2.1Japan Regulatory Information Management System Market by End User
    • 6.3.2.3India Regulatory Information Management System Market
      • 6.3.2.3.1India Regulatory Information Management System Market by End User
    • 6.3.2.4South Korea Regulatory Information Management System Market
      • 6.3.2.4.1South Korea Regulatory Information Management System Market by End User
    • 6.3.2.5Australia Regulatory Information Management System Market
      • 6.3.2.5.1Australia Regulatory Information Management System Market by End User
    • 6.3.2.6Malaysia Regulatory Information Management System Market
      • 6.3.2.6.1Malaysia Regulatory Information Management System Market by End User
    • 6.3.2.7Rest of Asia Pacific Regulatory Information Management System Market
      • 6.3.2.7.1Rest of Asia Pacific Regulatory Information Management System Market by End User
• 6.4LAMEA Regulatory Information Management System Market
  • 6.4.1LAMEA Regulatory Information Management System Market by End User
    • 6.4.1.1LAMEA Pharmaceutical Sector Market by Country
    • 6.4.1.2LAMEA Medical Device Sector Market by Country
    • 6.4.1.3LAMEA Others Market by Country
  • 6.4.2LAMEA Regulatory Information Management System Market by Country
    • 6.4.2.1Brazil Regulatory Information Management System Market
      • 6.4.2.1.1Brazil Regulatory Information Management System Market by End User
    • 6.4.2.2Argentina Regulatory Information Management System Market
      • 6.4.2.2.1Argentina Regulatory Information Management System Market by End User
    • 6.4.2.3UAE Regulatory Information Management System Market
      • 6.4.2.3.1UAE Regulatory Information Management System Market by End User
    • 6.4.2.4Saudi Arabia Regulatory Information Management System Market
      • 6.4.2.4.1Saudi Arabia Regulatory Information Management System Market by End User
    • 6.4.2.5South Africa Regulatory Information Management System Market
      • 6.4.2.5.1South Africa Regulatory Information Management System Market by End User
    • 6.4.2.6Nigeria Regulatory Information Management System Market
      • 6.4.2.6.1Nigeria Regulatory Information Management System Market by End User
    • 6.4.2.7Rest of LAMEA Regulatory Information Management System Market
      • 6.4.2.7.1Rest of LAMEA Regulatory Information Management System Market by End User

Chapter 7.Company Profiles

• 7.1Veeva Systems, Inc.
  • 7.1.1Company Overview
  • 7.1.2Financial Analysis
  • 7.1.3Regional Analysis
  • 7.1.4Research & Development Expenses
  • 7.1.5Recent strategies and developments:
    • 7.1.5.1Partnerships, Collaborations, and Agreements:
    • 7.1.5.2Acquisition and Mergers:
  • 7.1.6SWOT Analysis
• 7.2Korber AG
  • 7.2.1Company Overview
  • 7.2.2Recent strategies and developments:
    • 7.2.2.1Partnerships, Collaborations, and Agreements:
    • 7.2.2.2Acquisition and Mergers:
  • 7.2.3SWOT Analysis
• 7.3ArisGlobal LLC (Nordic Capital Limited)
  • 7.3.1Company Overview
  • 7.3.2Recent strategies and developments:
    • 7.3.2.1Product Launches and Product Expansions:
    • 7.3.2.2Acquisition and Mergers:
  • 7.3.3SWOT Analysis
• 7.4Calyx
  • 7.4.1Company Overview
  • 7.4.2SWOT Analysis
• 7.5Ennov SAS
  • 7.5.1Company Overview
  • 7.5.2Recent strategies and developments:
    • 7.5.2.1Acquisition and Mergers:
  • 7.5.3SWOT Analysis
• 7.6MasterControl, Inc.
  • 7.6.1Company Overview
  • 7.6.2SWOT Analysis
• 7.7LORENZ Life Sciences Group
  • 7.7.1Company Overview
  • 7.7.2Recent strategies and developments:
    • 7.7.2.1Partnerships, Collaborations, and Agreements:
  • 7.7.3SWOT Analysis
• 7.8AmpleLogic
  • 7.8.1Company Overview
  • 7.8.2SWOT Analysis
• 7.9Cencora, Inc. (PharmaLex Holding GmbH)
  • 7.9.1Company Overview
  • 7.9.2Financial Analysis
  • 7.9.3Segmental Analysis
  • 7.9.4SWOT Analysis
• 7.10.Ithos Global Inc. (Cordance Group)
  • 7.10.1Company Overview
  • 7.10.2SWOT Analysis

Chapter 8.Winning imperatives of Regulatory Information Management System Market