생명과학 품질 관리 소프트웨어 시장 규모, 점유율, 동향 분석 보고서 : 용도별, 도입 형태별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Life Sciences Quality Management Software Market Summary

The global life sciences quality management software market size was estimated at USD 3.27 billion in 2024 and is projected to reach USD 9.47 billion by 2033, growing at a CAGR of 12.65% from 2025 to 2033. Technological advancements and the growing need to comply with regulatory guidelines are factors driving market growth.

In addition, the market is expected to expand due to the growing use of smart devices and the internet of things (IoT). The incorporation of the Six Sigma approach into life sciences Quality Management Software (QMS) is anticipated to open new opportunities for industrial expansion.

The increasing demand for compliance with regulatory guidelines significantly drives the adoption of QMS in the life sciences industry. This shift is influenced by the need to ensure product safety, efficacy, and adherence to stringent regulations imposed by authorities, such as the FDA and ISO standards. The life sciences sector is highly regulated, requiring companies to maintain high-quality and safety standards. A robust QMS helps organizations meet these regulatory demands efficiently, ensuring that products are safe for public use and comply with necessary guidelines.

In addition, technological advancements are also a significant factor in harnessing the adoption of QMS in the life sciences industry. This transformation is largely due to the increasing need for compliance, efficiency, and innovation within a highly regulated environment. The life sciences sector is transitioning from traditional, paper-based QMS to digital Enterprise Quality Management Software (eQMS). This shift allows organizations to harmonize policies, processes, and documentation, ensuring that quality is integrated into every operational step. Digital systems facilitate real-time data access, enhancing decision-making and operational efficiency.

Global Life Sciences Quality Management Software Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global life sciences quality management software market report based on application, deployment method, end use, and region:

• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Data Management
• Training management
• Supplier management
• Regulatory and Compliance Management
• Corrective Action Preventive Action (CAPA) Management
• Audit Management
• Change Management
• Non-Conformances Management
• Inspection Management
• Risk Management
• Others
• Deployment Mode Outlook (Revenue, USD Million, 2021 - 2033)
• Cloud & Web based
• On-premises
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Pharmaceutical Firms
• Biotech Firms
• CROs/CDMOs
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• MEA
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Application Segment
  • 1.2.2. Deployment Mode
  • 1.2.3. End Use Segment
• 1.3. Information analysis
  • 1.3.1. Market formulation & data visualization
• 1.4. Data validation & publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Total Market: CAGR Calculation
• 1.10. Objectives
  • 1.10.1. Objective 1
  • 1.10.2. Objective 2

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Insights Landscape

Chapter 3. Life Sciences Quality Management Software Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Technological advancements in the life science industry
    • 3.2.1.2. Growing need to comply with regulatory guidelines
    • 3.2.1.3. Increasing use of quality management software (QMS) in the life sciences supply chain to ensure product quality and safety
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Security concerns with cloud deployment
    • 3.2.2.2. A shortage of skilled professionals
• 3.3. Life Sciences Quality Management Software Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Technological landscape
    • 3.3.2.3. Economic landscape
    • 3.3.2.4. Environmental Landscape
    • 3.3.2.5. Legal Landscape
    • 3.3.2.6. Social Landscape

Chapter 4. Life Sciences Quality Management Software Market: Application Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Life Sciences Quality Management Software Market Application Movement Analysis
• 4.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 4.4. Data Management
  • 4.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.5. Training Management
  • 4.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.6. Supplier Management
  • 4.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.7. Regulatory and Compliance Management
  • 4.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.8. Corrective Action Preventive Action (CAPA) Management
  • 4.8.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.9. Audit Management
  • 4.9.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.10. Change Management
  • 4.10.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.11. Non-conformances Management
  • 4.11.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.12. Inspection Management
  • 4.12.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.13. Risk Management
  • 4.13.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.14. Others
  • 4.14.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 5. Life Sciences Quality Management Software Market: Deployment Mode Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Life Sciences Quality Management Software Market Deployment Mode Movement Analysis
• 5.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by Deployment Mode, 2021 to 2033 (USD Million)
• 5.4. Cloud & Web-based
  • 5.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 5.5. On-premises
  • 5.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 6. Life Sciences Quality Management Software Market: End Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Life Sciences Quality Management Software Market End Use Movement Analysis
• 6.3. Global Life Sciences Quality Management Software Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
• 6.4. Pharmaceutical Firms
  • 6.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 6.5. Biotech Firms
  • 6.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
• 6.6. CROs/CDMOs
  • 6.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 7. Life Sciences Quality Management Software Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2033
• 7.2. Regional Market Dashboard
• 7.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 7.4. North America
  • 7.4.1. U.S.
    • 7.4.1.1. Key country dynamics
    • 7.4.1.2. Regulatory framework
    • 7.4.1.3. Competitive scenario
    • 7.4.1.4. U.S. market estimates and forecasts 2021 - 2033 (USD Million)
  • 7.4.2. Canada
    • 7.4.2.1. Key country dynamics
    • 7.4.2.2. Regulatory framework
    • 7.4.2.3. Competitive scenario
    • 7.4.2.4. Canada market estimates and forecasts 2021 - 2033 (USD Million)
  • 7.4.3. Mexico
    • 7.4.3.1. Key country dynamics
    • 7.4.3.2. Regulatory framework
    • 7.4.3.3. Competitive scenario
    • 7.4.3.4. Mexico market estimates and forecasts 2021 - 2033 (USD Million)
• 7.5. Europe
  • 7.5.1. UK
    • 7.5.1.1. Key country dynamics
    • 7.5.1.2. Regulatory framework
    • 7.5.1.3. Competitive scenario
    • 7.5.1.4. UK market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. Germany
    • 7.5.2.1. Key country dynamics
    • 7.5.2.2. Regulatory framework
    • 7.5.2.3. Competitive scenario
    • 7.5.2.4. Germany market estimates and forecasts 2021 - 2033 (USD Million)
  • 7.5.3. France
    • 7.5.3.1. Key country dynamics
    • 7.5.3.2. Regulatory framework
    • 7.5.3.3. Competitive scenario
    • 7.5.3.4. France market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. Italy
    • 7.5.4.1. Key country dynamics
    • 7.5.4.2. Regulatory framework
    • 7.5.4.3. Competitive scenario
    • 7.5.4.4. Italy market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. Spain
    • 7.5.5.1. Key country dynamics
    • 7.5.5.2. Regulatory framework
    • 7.5.5.3. Competitive scenario
    • 7.5.5.4. Spain market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Norway
    • 7.5.6.1. Key country dynamics
    • 7.5.6.2. Regulatory framework
    • 7.5.6.3. Competitive scenario
    • 7.5.6.4. Norway market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Sweden
    • 7.5.7.1. Key country dynamics
    • 7.5.7.2. Regulatory framework
    • 7.5.7.3. Competitive scenario
    • 7.5.7.4. Sweden market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.8. Denmark
    • 7.5.8.1. Key country dynamics
    • 7.5.8.2. Regulatory framework
    • 7.5.8.3. Competitive scenario
    • 7.5.8.4. Denmark market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Japan
    • 7.6.1.1. Key country dynamics
    • 7.6.1.2. Regulatory framework
    • 7.6.1.3. Competitive scenario
    • 7.6.1.4. Japan market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. China
    • 7.6.2.1. Key country dynamics
    • 7.6.2.2. Regulatory framework
    • 7.6.2.3. Competitive scenario
    • 7.6.2.4. China market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. India
    • 7.6.3.1. Key country dynamics
    • 7.6.3.2. Regulatory framework
    • 7.6.3.3. Competitive scenario
    • 7.6.3.4. India market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.4. Australia
    • 7.6.4.1. Key country dynamics
    • 7.6.4.2. Regulatory framework
    • 7.6.4.3. Competitive scenario
    • 7.6.4.4. Australia market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.5. South Korea
    • 7.6.5.1. Key country dynamics
    • 7.6.5.2. Regulatory framework
    • 7.6.5.3. Competitive scenario
    • 7.6.5.4. South Korea market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.6. Thailand
    • 7.6.6.1. Key country dynamics
    • 7.6.6.2. Regulatory framework
    • 7.6.6.3. Competitive scenario
    • 7.6.6.4. Thailand market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.7. Latin America
  • 7.7.1. Brazil
    • 7.7.1.1. Key country dynamics
    • 7.7.1.2. Regulatory framework
    • 7.7.1.3. Competitive scenario
    • 7.7.1.4. Brazil market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. Argentina
    • 7.7.2.1. Key country dynamics
    • 7.7.2.2. Regulatory framework
    • 7.7.2.3. Competitive scenario
    • 7.7.2.4. Argentina market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.8. MEA
  • 7.8.1. South Africa
    • 7.8.1.1. Key country dynamics
    • 7.8.1.2. Regulatory framework
    • 7.8.1.3. Competitive scenario
    • 7.8.1.4. South Africa market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.8.2. Saudi Arabia
    • 7.8.2.1. Key country dynamics
    • 7.8.2.2. Regulatory framework
    • 7.8.2.3. Competitive scenario
    • 7.8.2.4. Saudi Arabia market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.8.3. UAE
    • 7.8.3.1. Key country dynamics
    • 7.8.3.2. Regulatory framework
    • 7.8.3.3. Competitive scenario
    • 7.8.3.4. UAE market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.8.4. Kuwait
    • 7.8.4.1. Key country dynamics
    • 7.8.4.2. Regulatory framework
    • 7.8.4.3. Competitive scenario
    • 7.8.4.4. Kuwait market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company/Competition Categorization
• 8.2. Strategy Mapping
• 8.3. Company Market Position Analysis, 2024
• 8.4. Company Profiles/Listing
  • 8.4.1. Dassault Systemes
    • 8.4.1.1. Company overview
    • 8.4.1.2. Financial performance
    • 8.4.1.3. Product benchmarking
    • 8.4.1.4. Strategic initiatives
  • 8.4.2. IQVIA (Pilgrim)
    • 8.4.2.1. Company overview
    • 8.4.2.2. Financial performance
    • 8.4.2.3. Product benchmarking
    • 8.4.2.4. Strategic initiatives
  • 8.4.3. MasterControl Solutions, Inc.
    • 8.4.3.1. Company overview
    • 8.4.3.2. Financial performance
    • 8.4.3.3. Product benchmarking
    • 8.4.3.4. Strategic initiatives
  • 8.4.4. AmpleLogic
    • 8.4.4.1. Company overview
    • 8.4.4.2. Financial performance
    • 8.4.4.3. Product benchmarking
    • 8.4.4.4. Strategic initiatives
  • 8.4.5. Qualio - QMS for Life Sciences
    • 8.4.5.1. Company overview
    • 8.4.5.2. Financial performance
    • 8.4.5.3. Product benchmarking
    • 8.4.5.4. Strategic initiatives
  • 8.4.6. QT9 Software
    • 8.4.6.1. Company overview
    • 8.4.6.2. Financial performance
    • 8.4.6.3. Product benchmarking
    • 8.4.6.4. Strategic initiatives
  • 8.4.7. Sparta Systems- TrackWise (Honeywell International Inc.)
    • 8.4.7.1. Company overview
    • 8.4.7.2. Financial performance
    • 8.4.7.3. Product benchmarking
    • 8.4.7.4. Strategic initiatives
  • 8.4.8. AssurX, Inc
    • 8.4.8.1. Company overview
    • 8.4.8.2. Financial performance
    • 8.4.8.3. Product benchmarking
    • 8.4.8.4. Strategic initiatives
  • 8.4.9. ETQ, LLC (Hexagon)
    • 8.4.9.1. Company overview
    • 8.4.9.2. Financial performance
    • 8.4.9.3. Product benchmarking
    • 8.4.9.4. Strategic initiatives
  • 8.4.10. Veeva Systems
    • 8.4.10.1. Company overview
    • 8.4.10.2. Financial performance
    • 8.4.10.3. Product benchmarking
    • 8.4.10.4. Strategic initiatives
  • 8.4.11. Qualityze
    • 8.4.11.1. Company overview
    • 8.4.11.2. Financial performance
    • 8.4.11.3. Product benchmarking
    • 8.4.11.4. Strategic initiatives
  • 8.4.12. Ideagen
    • 8.4.12.1. Company overview
    • 8.4.12.2. Financial performance
    • 8.4.12.3. Product benchmarking
    • 8.4.12.4. Strategic initiatives