생명과학 품질관리 소프트웨어 시장 규모, 점유율, 동향 분석 : 용도별, 도입 모드별, 최종 용도별, 지역별, 전망과 예측(2024-2031년)

The Global Life Sciences Quality Management Software Market size is expected to reach $7.17 billion by 2031, rising at a market growth of 12.6% CAGR during the forecast period.

The North America region witnessed 38% revenue share in the market in 2023. This significant share is attributed to North America's well-established life sciences industry, which includes numerous pharmaceutical and biotech firms that require advanced quality management solutions to comply with stringent regulatory standards set by agencies such as the FDA. The presence of major market players and continuous technological advancements further bolster the adoption of quality management software in this region.

The life sciences industry has embraced cloud-based technologies as they provide a flexible and scalable approach to managing quality management systems (QMS). Cloud solutions enable life sciences organizations to securely store vast amounts of data and access them from anywhere, facilitating real-time collaboration and decision-making. This has led to a growing shift from traditional on-premise solutions to cloud-based platforms, as they reduce the need for heavy infrastructure investments and maintenance. Thus, cloud-based life sciences quality management software offers scalability, flexibility, and compliance advantages that are pivotal in meeting the industry's evolving needs.

Additionally, Patient safety and product quality are at the core of the life sciences industry, especially as companies are tasked with meeting stringent regulatory standards and maintaining public trust. As the demand for new medications, medical devices, and treatments increases, ensuring these products meet the highest quality standards is critical. This software is key in monitoring and improving product quality, from development to post-market surveillance. Therefore, the growing focus on patient safety and product quality drives the need for sophisticated quality management systems that ensure compliance and efficacy across life sciences industries.

However, One of the main challenges life sciences organizations face when adopting quality management software is the significant upfront costs associated with software implementation. Implementing a new QMS often involves substantial expenditures on software licenses, hardware infrastructure, and training. Many life sciences companies, particularly small and mid-sized organizations, may struggle with the financial burden of these initial investments, especially when they need to prioritize other operational costs. In conclusion, this software's high implementation and maintenance costs pose a significant challenge to organizations, particularly those with limited budgets.

Moreover, Many life sciences companies postponed or cancelled their Quality Management Software implementation projects due to budget constraints and shifting priorities during the pandemic. Budgets for new software purchases and upgrades were reduced as companies diverted funds to immediate pandemic-related needs and emergency measures. Disruptions in global supply chains affected the availability of hardware and support services required for deploying and maintaining QMS. Thus, the COVID-19 pandemic had a negative impact on the market.

Application Outlook

Based on application, the market is divided into data management, regulatory & compliance management, corrective action preventive action (CAPA) management, change management, audit management, risk management, non-conformances management, supplier management, training management, inspection management, and others. The regulatory & compliance management segment procured 15% revenue share in the market in 2023. This segment is crucial in helping life sciences companies adhere to stringent regulatory requirements and industry standards. The increasing complexity of regulations and the need for automated systems to manage compliance processes efficiently are significant drivers for this segment.

Deployment Mode Outlook

On the basis of deployment mode, this market is segmented into cloud & web-based and on-premises. In 2023, the on-premises segment attained 25% revenue share in the market. Concerns over data security, regulatory compliance, and the need for complete control over IT environments often drive this preference. Large organizations particularly favor on-premises solutions with established IT infrastructures and highly sensitive data requiring stringent security measures.

End Use Outlook

By end use, this market is divided into pharmaceutical firms, biotech firms, and CROs/CDMOs. The biotech firms segment procured 31% revenue share in the market in 2023. Biotech firms, which are heavily involved in innovative research and development activities, utilize quality management software to streamline their operations and maintain compliance with regulatory requirements. These software solutions support biotech companies in managing quality throughout the product development lifecycle, from early-stage research to clinical trials and commercialization.

Regional Outlook

Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The Asia Pacific region generated 30% revenue share in the market in 2023. This notable share highlights the region's rapid growth and increasing adoption of quality management solutions in the life sciences sector. Factors contributing to this growth include the expanding pharmaceutical and biotechnology industries, increasing clinical trials, and rising investments in healthcare infrastructure.

List of Key Companies Profiled

• AmpleLogic
• Hexagon AB
• Qualityze Inc.
• Veeva Systems, Inc.
• SimplerQMS
• Dassault Systemes SE
• MasterControl Solutions Inc.
• Ideagen Plc
• IQVIA Holdings, Inc.
• Honeywell International Inc.

Global Life Sciences Quality Management Software Market Report Segmentation

By Application

• Data Management
• Regulatory & Compliance Management
• Corrective Action Preventive Action (CAPA) Management
• Change Management
• Audit Management
• Risk Management
• Non-Conformances Management
• Supplier Management
• Training Management
• Inspection Management
• Other Application

By Deployment Mode

• Cloud & Web-based
• On-premises

By End Use

• Pharmaceutical Firms
• Biotech Firms
• CROs/CDMOs

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
  • Singapore
  • 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 Life Sciences Quality Management Software Market, by Application
  • 1.4.2 Global Life Sciences Quality Management Software Market, by Deployment Mode
  • 1.4.3 Global Life Sciences Quality Management Software Market, by End Use
  • 1.4.4 Global Life Sciences Quality Management Software 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

Chapter 4. Competition Analysis - Global

• 4.1 Market Share Analysis, 2023
• 4.2 Porter Five Forces Analysis

Chapter 5. Global Life Sciences Quality Management Software Market by Application

• 5.1 Global Data Management Market by Region
• 5.2 Global Regulatory & Compliance Management Market by Region
• 5.3 Global Corrective Action Preventive Action (CAPA) Management Market by Region
• 5.4 Global Change Management Market by Region
• 5.5 Global Audit Management Market by Region
• 5.6 Global Risk Management Market by Region
• 5.7 Global Non-Conformances Management Market by Region
• 5.8 Global Supplier Management Market by Region
• 5.9 Global Training Management Market by Region
• 5.1 Global Inspection Management Market by Region
• 5.11 Global Other Application Market by Region

Chapter 6. Global Life Sciences Quality Management Software Market by Deployment Mode

• 6.1 Global Cloud & Web-based Market by Region
• 6.2 Global On-premises Market by Region

Chapter 7. Global Life Sciences Quality Management Software Market by End Use

• 7.1 Global Pharmaceutical Firms Market by Region
• 7.2 Global Biotech Firms Market by Region
• 7.3 Global CROs/CDMOs Market by Region

Chapter 8. Global Life Sciences Quality Management Software Market by Region

• 8.1 North America Life Sciences Quality Management Software Market
  • 8.1.1 North America Life Sciences Quality Management Software Market by Application
    • 8.1.1.1 North America Data Management Market by Country
    • 8.1.1.2 North America Regulatory & Compliance Management Market by Country
    • 8.1.1.3 North America Corrective Action Preventive Action (CAPA) Management Market by Country
    • 8.1.1.4 North America Change Management Market by Country
    • 8.1.1.5 North America Audit Management Market by Country
    • 8.1.1.6 North America Risk Management Market by Country
    • 8.1.1.7 North America Non-Conformances Management Market by Country
    • 8.1.1.8 North America Supplier Management Market by Country
    • 8.1.1.9 North America Training Management Market by Country
    • 8.1.1.10 North America Inspection Management Market by Country
    • 8.1.1.11 North America Other Application Market by Country
  • 8.1.2 North America Life Sciences Quality Management Software Market by Deployment Mode
    • 8.1.2.1 North America Cloud & Web-based Market by Country
    • 8.1.2.2 North America On-premises Market by Country
  • 8.1.3 North America Life Sciences Quality Management Software Market by End Use
    • 8.1.3.1 North America Pharmaceutical Firms Market by Country
    • 8.1.3.2 North America Biotech Firms Market by Country
    • 8.1.3.3 North America CROs/CDMOs Market by Country
  • 8.1.4 North America Life Sciences Quality Management Software Market by Country
    • 8.1.4.1 US Life Sciences Quality Management Software Market
      • 8.1.4.1.1 US Life Sciences Quality Management Software Market by Application
      • 8.1.4.1.2 US Life Sciences Quality Management Software Market by Deployment Mode
      • 8.1.4.1.3 US Life Sciences Quality Management Software Market by End Use
    • 8.1.4.2 Canada Life Sciences Quality Management Software Market
      • 8.1.4.2.1 Canada Life Sciences Quality Management Software Market by Application
      • 8.1.4.2.2 Canada Life Sciences Quality Management Software Market by Deployment Mode
      • 8.1.4.2.3 Canada Life Sciences Quality Management Software Market by End Use
    • 8.1.4.3 Mexico Life Sciences Quality Management Software Market
      • 8.1.4.3.1 Mexico Life Sciences Quality Management Software Market by Application
      • 8.1.4.3.2 Mexico Life Sciences Quality Management Software Market by Deployment Mode
      • 8.1.4.3.3 Mexico Life Sciences Quality Management Software Market by End Use
    • 8.1.4.4 Rest of North America Life Sciences Quality Management Software Market
      • 8.1.4.4.1 Rest of North America Life Sciences Quality Management Software Market by Application
      • 8.1.4.4.2 Rest of North America Life Sciences Quality Management Software Market by Deployment Mode
      • 8.1.4.4.3 Rest of North America Life Sciences Quality Management Software Market by End Use
• 8.2 Europe Life Sciences Quality Management Software Market
  • 8.2.1 Europe Life Sciences Quality Management Software Market by Application
    • 8.2.1.1 Europe Data Management Market by Country
    • 8.2.1.2 Europe Regulatory & Compliance Management Market by Country
    • 8.2.1.3 Europe Corrective Action Preventive Action (CAPA) Management Market by Country
    • 8.2.1.4 Europe Change Management Market by Country
    • 8.2.1.5 Europe Audit Management Market by Country
    • 8.2.1.6 Europe Risk Management Market by Country
    • 8.2.1.7 Europe Non-Conformances Management Market by Country
    • 8.2.1.8 Europe Supplier Management Market by Country
    • 8.2.1.9 Europe Training Management Market by Country
    • 8.2.1.10 Europe Inspection Management Market by Country
    • 8.2.1.11 Europe Other Application Market by Country
  • 8.2.2 Europe Life Sciences Quality Management Software Market by Deployment Mode
    • 8.2.2.1 Europe Cloud & Web-based Market by Country
    • 8.2.2.2 Europe On-premises Market by Country
  • 8.2.3 Europe Life Sciences Quality Management Software Market by End Use
    • 8.2.3.1 Europe Pharmaceutical Firms Market by Country
    • 8.2.3.2 Europe Biotech Firms Market by Country
    • 8.2.3.3 Europe CROs/CDMOs Market by Country
  • 8.2.4 Europe Life Sciences Quality Management Software Market by Country
    • 8.2.4.1 Germany Life Sciences Quality Management Software Market
      • 8.2.4.1.1 Germany Life Sciences Quality Management Software Market by Application
      • 8.2.4.1.2 Germany Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.1.3 Germany Life Sciences Quality Management Software Market by End Use
    • 8.2.4.2 UK Life Sciences Quality Management Software Market
      • 8.2.4.2.1 UK Life Sciences Quality Management Software Market by Application
      • 8.2.4.2.2 UK Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.2.3 UK Life Sciences Quality Management Software Market by End Use
    • 8.2.4.3 France Life Sciences Quality Management Software Market
      • 8.2.4.3.1 France Life Sciences Quality Management Software Market by Application
      • 8.2.4.3.2 France Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.3.3 France Life Sciences Quality Management Software Market by End Use
    • 8.2.4.4 Russia Life Sciences Quality Management Software Market
      • 8.2.4.4.1 Russia Life Sciences Quality Management Software Market by Application
      • 8.2.4.4.2 Russia Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.4.3 Russia Life Sciences Quality Management Software Market by End Use
    • 8.2.4.5 Spain Life Sciences Quality Management Software Market
      • 8.2.4.5.1 Spain Life Sciences Quality Management Software Market by Application
      • 8.2.4.5.2 Spain Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.5.3 Spain Life Sciences Quality Management Software Market by End Use
    • 8.2.4.6 Italy Life Sciences Quality Management Software Market
      • 8.2.4.6.1 Italy Life Sciences Quality Management Software Market by Application
      • 8.2.4.6.2 Italy Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.6.3 Italy Life Sciences Quality Management Software Market by End Use
    • 8.2.4.7 Rest of Europe Life Sciences Quality Management Software Market
      • 8.2.4.7.1 Rest of Europe Life Sciences Quality Management Software Market by Application
      • 8.2.4.7.2 Rest of Europe Life Sciences Quality Management Software Market by Deployment Mode
      • 8.2.4.7.3 Rest of Europe Life Sciences Quality Management Software Market by End Use
• 8.3 Asia Pacific Life Sciences Quality Management Software Market
  • 8.3.1 Asia Pacific Life Sciences Quality Management Software Market by Application
    • 8.3.1.1 Asia Pacific Data Management Market by Country
    • 8.3.1.2 Asia Pacific Regulatory & Compliance Management Market by Country
    • 8.3.1.3 Asia Pacific Corrective Action Preventive Action (CAPA) Management Market by Country
    • 8.3.1.4 Asia Pacific Change Management Market by Country
    • 8.3.1.5 Asia Pacific Audit Management Market by Country
    • 8.3.1.6 Asia Pacific Risk Management Market by Country
    • 8.3.1.7 Asia Pacific Non-Conformances Management Market by Country
    • 8.3.1.8 Asia Pacific Supplier Management Market by Country
    • 8.3.1.9 Asia Pacific Training Management Market by Country
    • 8.3.1.10 Asia Pacific Inspection Management Market by Country
    • 8.3.1.11 Asia Pacific Other Application Market by Country
  • 8.3.2 Asia Pacific Life Sciences Quality Management Software Market by Deployment Mode
    • 8.3.2.1 Asia Pacific Cloud & Web-based Market by Country
    • 8.3.2.2 Asia Pacific On-premises Market by Country
  • 8.3.3 Asia Pacific Life Sciences Quality Management Software Market by End Use
    • 8.3.3.1 Asia Pacific Pharmaceutical Firms Market by Country
    • 8.3.3.2 Asia Pacific Biotech Firms Market by Country
    • 8.3.3.3 Asia Pacific CROs/CDMOs Market by Country
  • 8.3.4 Asia Pacific Life Sciences Quality Management Software Market by Country
    • 8.3.4.1 China Life Sciences Quality Management Software Market
      • 8.3.4.1.1 China Life Sciences Quality Management Software Market by Application
      • 8.3.4.1.2 China Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.1.3 China Life Sciences Quality Management Software Market by End Use
    • 8.3.4.2 Japan Life Sciences Quality Management Software Market
      • 8.3.4.2.1 Japan Life Sciences Quality Management Software Market by Application
      • 8.3.4.2.2 Japan Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.2.3 Japan Life Sciences Quality Management Software Market by End Use
    • 8.3.4.3 India Life Sciences Quality Management Software Market
      • 8.3.4.3.1 India Life Sciences Quality Management Software Market by Application
      • 8.3.4.3.2 India Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.3.3 India Life Sciences Quality Management Software Market by End Use
    • 8.3.4.4 South Korea Life Sciences Quality Management Software Market
      • 8.3.4.4.1 South Korea Life Sciences Quality Management Software Market by Application
      • 8.3.4.4.2 South Korea Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.4.3 South Korea Life Sciences Quality Management Software Market by End Use
    • 8.3.4.5 Singapore Life Sciences Quality Management Software Market
      • 8.3.4.5.1 Singapore Life Sciences Quality Management Software Market by Application
      • 8.3.4.5.2 Singapore Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.5.3 Singapore Life Sciences Quality Management Software Market by End Use
    • 8.3.4.6 Malaysia Life Sciences Quality Management Software Market
      • 8.3.4.6.1 Malaysia Life Sciences Quality Management Software Market by Application
      • 8.3.4.6.2 Malaysia Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.6.3 Malaysia Life Sciences Quality Management Software Market by End Use
    • 8.3.4.7 Rest of Asia Pacific Life Sciences Quality Management Software Market
      • 8.3.4.7.1 Rest of Asia Pacific Life Sciences Quality Management Software Market by Application
      • 8.3.4.7.2 Rest of Asia Pacific Life Sciences Quality Management Software Market by Deployment Mode
      • 8.3.4.7.3 Rest of Asia Pacific Life Sciences Quality Management Software Market by End Use
• 8.4 LAMEA Life Sciences Quality Management Software Market
  • 8.4.1 LAMEA Life Sciences Quality Management Software Market by Application
    • 8.4.1.1 LAMEA Data Management Market by Country
    • 8.4.1.2 LAMEA Regulatory & Compliance Management Market by Country
    • 8.4.1.3 LAMEA Corrective Action Preventive Action (CAPA) Management Market by Country
    • 8.4.1.4 LAMEA Change Management Market by Country
    • 8.4.1.5 LAMEA Audit Management Market by Country
    • 8.4.1.6 LAMEA Risk Management Market by Country
    • 8.4.1.7 LAMEA Non-Conformances Management Market by Country
    • 8.4.1.8 LAMEA Supplier Management Market by Country
    • 8.4.1.9 LAMEA Training Management Market by Country
    • 8.4.1.10 LAMEA Inspection Management Market by Country
    • 8.4.1.11 LAMEA Other Application Market by Country
  • 8.4.2 LAMEA Life Sciences Quality Management Software Market by Deployment Mode
    • 8.4.2.1 LAMEA Cloud & Web-based Market by Country
    • 8.4.2.2 LAMEA On-premises Market by Country
  • 8.4.3 LAMEA Life Sciences Quality Management Software Market by End Use
    • 8.4.3.1 LAMEA Pharmaceutical Firms Market by Country
    • 8.4.3.2 LAMEA Biotech Firms Market by Country
    • 8.4.3.3 LAMEA CROs/CDMOs Market by Country
  • 8.4.4 LAMEA Life Sciences Quality Management Software Market by Country
    • 8.4.4.1 Brazil Life Sciences Quality Management Software Market
      • 8.4.4.1.1 Brazil Life Sciences Quality Management Software Market by Application
      • 8.4.4.1.2 Brazil Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.1.3 Brazil Life Sciences Quality Management Software Market by End Use
    • 8.4.4.2 Argentina Life Sciences Quality Management Software Market
      • 8.4.4.2.1 Argentina Life Sciences Quality Management Software Market by Application
      • 8.4.4.2.2 Argentina Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.2.3 Argentina Life Sciences Quality Management Software Market by End Use
    • 8.4.4.3 UAE Life Sciences Quality Management Software Market
      • 8.4.4.3.1 UAE Life Sciences Quality Management Software Market by Application
      • 8.4.4.3.2 UAE Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.3.3 UAE Life Sciences Quality Management Software Market by End Use
    • 8.4.4.4 Saudi Arabia Life Sciences Quality Management Software Market
      • 8.4.4.4.1 Saudi Arabia Life Sciences Quality Management Software Market by Application
      • 8.4.4.4.2 Saudi Arabia Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.4.3 Saudi Arabia Life Sciences Quality Management Software Market by End Use
    • 8.4.4.5 South Africa Life Sciences Quality Management Software Market
      • 8.4.4.5.1 South Africa Life Sciences Quality Management Software Market by Application
      • 8.4.4.5.2 South Africa Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.5.3 South Africa Life Sciences Quality Management Software Market by End Use
    • 8.4.4.6 Nigeria Life Sciences Quality Management Software Market
      • 8.4.4.6.1 Nigeria Life Sciences Quality Management Software Market by Application
      • 8.4.4.6.2 Nigeria Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.6.3 Nigeria Life Sciences Quality Management Software Market by End Use
    • 8.4.4.7 Rest of LAMEA Life Sciences Quality Management Software Market
      • 8.4.4.7.1 Rest of LAMEA Life Sciences Quality Management Software Market by Application
      • 8.4.4.7.2 Rest of LAMEA Life Sciences Quality Management Software Market by Deployment Mode
      • 8.4.4.7.3 Rest of LAMEA Life Sciences Quality Management Software Market by End Use

Chapter 9. Company Profiles

• 9.1 AmpleLogic
  • 9.1.1 Company Overview
  • 9.1.1 SWOT Analysis
• 9.2 Hexagon AB
  • 9.2.1 Company Overview
  • 9.2.2 Financial Analysis
  • 9.2.3 Regional & Segmental Analysis
  • 9.2.4 Research & Development Expenses
  • 9.2.5 Recent strategies and developments:
    • 9.2.5.1 Acquisition and Mergers:
  • 9.2.6 SWOT Analysis
• 9.3 Qualityze Inc.
  • 9.3.1 Company Overview
• 9.4 Veeva Systems, Inc.
  • 9.4.1 Company Overview
  • 9.4.2 Financial Analysis
  • 9.4.3 Regional Analysis
  • 9.4.4 Research & Development Expenses
  • 9.4.5 SWOT Analysis
• 9.5 SimplerQMS
  • 9.5.1 Company Overview
• 9.6 Dassault Systemes SE
  • 9.6.1 Company Overview
  • 9.6.2 Financial Analysis
  • 9.6.3 Regional Analysis
  • 9.6.4 Research & Development Expense
  • 9.6.5 SWOT Analysis
• 9.7 MasterControl Solutions Inc.
  • 9.7.1 Company Overview
• 9.8 Ideagen Plc
  • 9.8.1 Company Overview
• 9.9 IQVIA Holdings, Inc.
  • 9.9.1 Company Overview
  • 9.9.2 Financial Analysis
  • 9.9.3 Segmental and Regional Analysis
  • 9.9.4 Recent strategies and developments:
    • 9.9.4.1 Partnerships, Collaborations, and Agreements:
  • 9.9.5 SWOT Analysis
• 9.10. Honeywell International, Inc.
  • 9.10.1 Company Overview
  • 9.10.2 Financial Analysis
  • 9.10.3 Segmental and Regional Analysis
  • 9.10.4 Research & Development Expenses
  • 9.10.5 Recent strategies and developments:
    • 9.10.5.1 Partnerships, Collaborations, and Agreements:
    • 9.10.5.2 Product Launches and Product Expansions:
  • 9.10.6 SWOT Analysis

Chapter 10. Winning Imperatives of Life Sciences Quality Management Software Market