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Regulatory Information Management System Market Size, Share & Trends Analysis Report By End User (Pharmaceutical Sector, Medical Device Sector, and Others), By Regional Outlook and Forecast, 2024 - 2031

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    Report

  • 147 Pages
  • April 2024
  • Region: Global
  • Marqual IT Solutions Pvt. Ltd (KBV Research)
  • ID: 5967278
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.

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)

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
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 Global Regulatory Information Management System Market, by End User
1.4.2 Global Regulatory Information Management System Market, by Geography
1.5 Methodology for the research
Chapter 2. Market at a Glance
2.1 Key Highlights
Chapter 3. Market Overview
3.1 Introduction
3.1.1 Overview
3.1.1.1 Market Composition and Scenario
3.2 Key Factors Impacting the Market
3.2.1 Market Drivers
3.2.2 Market Restraints
3.2.3 Market Opportunities
3.2.4 Market Challenges
3.3 Porter’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
5.1 Global Pharmaceutical Sector Market by Region
5.2 Global Medical Device Sector Market by Region
5.3 Global Others Market by Region
Chapter 6. Global Regulatory Information Management System Market by Region
6.1 North America Regulatory Information Management System Market
6.1.1 North America Regulatory Information Management System Market by End User
6.1.1.1 North America Pharmaceutical Sector Market by Country
6.1.1.2 North America Medical Device Sector Market by Country
6.1.1.3 North America Others Market by Country
6.1.2 North America Regulatory Information Management System Market by Country
6.1.2.1 US Regulatory Information Management System Market
6.1.2.1.1 US Regulatory Information Management System Market by End User
6.1.2.2 Canada Regulatory Information Management System Market
6.1.2.2.1 Canada Regulatory Information Management System Market by End User
6.1.2.3 Mexico Regulatory Information Management System Market
6.1.2.3.1 Mexico Regulatory Information Management System Market by End User
6.1.2.4 Rest of North America Regulatory Information Management System Market
6.1.2.4.1 Rest of North America Regulatory Information Management System Market by End User
6.2 Europe Regulatory Information Management System Market
6.2.1 Europe Regulatory Information Management System Market by End User
6.2.1.1 Europe Pharmaceutical Sector Market by Country
6.2.1.2 Europe Medical Device Sector Market by Country
6.2.1.3 Europe Others Market by Country
6.2.2 Europe Regulatory Information Management System Market by Country
6.2.2.1 Germany Regulatory Information Management System Market
6.2.2.1.1 Germany Regulatory Information Management System Market by End User
6.2.2.2 UK Regulatory Information Management System Market
6.2.2.2.1 UK Regulatory Information Management System Market by End User
6.2.2.3 France Regulatory Information Management System Market
6.2.2.3.1 France Regulatory Information Management System Market by End User
6.2.2.4 Russia Regulatory Information Management System Market
6.2.2.4.1 Russia Regulatory Information Management System Market by End User
6.2.2.5 Spain Regulatory Information Management System Market
6.2.2.5.1 Spain Regulatory Information Management System Market by End User
6.2.2.6 Italy Regulatory Information Management System Market
6.2.2.6.1 Italy Regulatory Information Management System Market by End User
6.2.2.7 Rest of Europe Regulatory Information Management System Market
6.2.2.7.1 Rest of Europe Regulatory Information Management System Market by End User
6.3 Asia Pacific Regulatory Information Management System Market
6.3.1 Asia Pacific Regulatory Information Management System Market by End User
6.3.1.1 Asia Pacific Pharmaceutical Sector Market by Country
6.3.1.2 Asia Pacific Medical Device Sector Market by Country
6.3.1.3 Asia Pacific Others Market by Country
6.3.2 Asia Pacific Regulatory Information Management System Market by Country
6.3.2.1 China Regulatory Information Management System Market
6.3.2.1.1 China Regulatory Information Management System Market by End User
6.3.2.2 Japan Regulatory Information Management System Market
6.3.2.2.1 Japan Regulatory Information Management System Market by End User
6.3.2.3 India Regulatory Information Management System Market
6.3.2.3.1 India Regulatory Information Management System Market by End User
6.3.2.4 South Korea Regulatory Information Management System Market
6.3.2.4.1 South Korea Regulatory Information Management System Market by End User
6.3.2.5 Australia Regulatory Information Management System Market
6.3.2.5.1 Australia Regulatory Information Management System Market by End User
6.3.2.6 Malaysia Regulatory Information Management System Market
6.3.2.6.1 Malaysia Regulatory Information Management System Market by End User
6.3.2.7 Rest of Asia Pacific Regulatory Information Management System Market
6.3.2.7.1 Rest of Asia Pacific Regulatory Information Management System Market by End User
6.4 LAMEA Regulatory Information Management System Market
6.4.1 LAMEA Regulatory Information Management System Market by End User
6.4.1.1 LAMEA Pharmaceutical Sector Market by Country
6.4.1.2 LAMEA Medical Device Sector Market by Country
6.4.1.3 LAMEA Others Market by Country
6.4.2 LAMEA Regulatory Information Management System Market by Country
6.4.2.1 Brazil Regulatory Information Management System Market
6.4.2.1.1 Brazil Regulatory Information Management System Market by End User
6.4.2.2 Argentina Regulatory Information Management System Market
6.4.2.2.1 Argentina Regulatory Information Management System Market by End User
6.4.2.3 UAE Regulatory Information Management System Market
6.4.2.3.1 UAE Regulatory Information Management System Market by End User
6.4.2.4 Saudi Arabia Regulatory Information Management System Market
6.4.2.4.1 Saudi Arabia Regulatory Information Management System Market by End User
6.4.2.5 South Africa Regulatory Information Management System Market
6.4.2.5.1 South Africa Regulatory Information Management System Market by End User
6.4.2.6 Nigeria Regulatory Information Management System Market
6.4.2.6.1 Nigeria Regulatory Information Management System Market by End User
6.4.2.7 Rest of LAMEA Regulatory Information Management System Market
6.4.2.7.1 Rest of LAMEA Regulatory Information Management System Market by End User
Chapter 7. Company Profiles
7.1 Veeva Systems, Inc.
7.1.1 Company Overview
7.1.2 Financial Analysis
7.1.3 Regional Analysis
7.1.4 Research & Development Expenses
7.1.5 Recent strategies and developments:
7.1.5.1 Partnerships, Collaborations, and Agreements:
7.1.5.2 Acquisition and Mergers:
7.1.6 SWOT Analysis
7.2 Korber AG
7.2.1 Company Overview
7.2.2 Recent strategies and developments:
7.2.2.1 Partnerships, Collaborations, and Agreements:
7.2.2.2 Acquisition and Mergers:
7.2.3 SWOT Analysis
7.3 ArisGlobal LLC (Nordic Capital Limited)
7.3.1 Company Overview
7.3.2 Recent strategies and developments:
7.3.2.1 Product Launches and Product Expansions:
7.3.2.2 Acquisition and Mergers:
7.3.3 SWOT Analysis
7.4 Calyx
7.4.1 Company Overview
7.4.2 SWOT Analysis
7.5 Ennov SAS
7.5.1 Company Overview
7.5.2 Recent strategies and developments:
7.5.2.1 Acquisition and Mergers:
7.5.3 SWOT Analysis
7.6 MasterControl, Inc.
7.6.1 Company Overview
7.6.2 SWOT Analysis
7.7 LORENZ Life Sciences Group
7.7.1 Company Overview
7.7.2 Recent strategies and developments:
7.7.2.1 Partnerships, Collaborations, and Agreements:
7.7.3 SWOT Analysis
7.8 AmpleLogic
7.8.1 Company Overview
7.8.2 SWOT Analysis
7.9 Cencora, Inc. (PharmaLex Holding GmbH)
7.9.1 Company Overview
7.9.2 Financial Analysis
7.9.3 Segmental Analysis
7.9.4 SWOT Analysis
7.10. Ithos Global Inc. (Cordance Group)
7.10.1 Company Overview
7.10.2 SWOT Analysis
Chapter 8. Winning imperatives of Regulatory Information Management System Market

Companies Mentioned

  • 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)

Methodology

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