Product Code: GVR-4-68040-491-8
Life Sciences Quality Management Software Market Growth & Trends:
The global life sciences quality management software market size is anticipated to reach USD 6.72 billion by 2030 and is projected to grow at a CAGR of 12.99% from 2025 to 2030, according to a new report by Grand View Research, Inc. Key factor contributing to the market growth is the increasing use of quality management software (QMS) in the life sciences supply chain to ensure product quality and safety. Moreover, the growing need to comply with regulatory guidelines and technological advancements in the life science industry is expected to drive market growth.
The increasing use of QMS in life sciences supply chains is essential for ensuring product quality and safety. As the industry faces stringent regulatory requirements, adopting QMS frameworks helps organizations maintain compliance, enhance operational efficiency, and improve continuously. QMS are comprehensive frameworks that document processes, procedures, and responsibilities essential for meeting regulatory standards. They are designed to ensure safe, effective, and high-quality products throughout their lifecycle.
The growing trend toward digitalization within the industry, with many companies adopting eQMS. These systems facilitate better data management, streamline processes, and enhance compliance through automated workflows & real-time monitoring. For instance, in January 2023, Palantir launched a fit-for-purpose QMS integrated with its Foundry platform. This system is designed to help life sciences companies meet Good Practice (GxP) requirements and streamline critical workflows, including clinical data analysis.
Integrating digital tools into QMS has transformed how life sciences organizations manage quality. Technologies such as predictive analytics and digital twins allow companies to anticipate challenges before they arise, representing the principle of "Quality by Design" (QbD). This proactive approach minimizes recalls and enhances trust in product integrity by ensuring that quality considerations are embedded in every product development and distribution stage.
Life Sciences Quality Management Software Market Report Highlights:
- Based on application, the data management segment led the market with the largest revenue share of 17.51% in 2024. The rising volume of data generated by the life science industry necessitates the need for effective data quality management, thereby increasing the demand for quality management software.
- Based on deployment mode, the cloud & web-based segment led the market with the largest revenue share of 77.02% in 2024, and is expected to register at the fastest CAGR over the forecast period, as companies are shifting from traditional paper-based systems to digital platforms, allow for secure, traceable, and readily accessible documentation.
- Based on end use, the pharmaceutical firms segment accounted for the largest revenue share of 57.28% in 2024. This growth is attributed to the growing use of digital technology in the pharmaceutical sector, the growing need to comply with regulatory guidelines, and the increasing complexity of supply chains.
- North America dominated the market with the largest revenue share of 39.97% in 2024, attributed to the robust presence of life science companies and rising R&D expenditure in the region. In addition, companies are engaged in new product launches and merger and acquisition activities, thereby driving market growth.
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
- 1.6. Information or Data Analysis
- 1.7. Market Formulation & Validation
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. Total Market: CAGR Calculation
- 1.10. Objectives
- 1.10.1. Objective 1
- 1.10.2. Objective 2
- 1.10.3. Objective 3
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. Porter's Five Forces Analysis
- 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, 2018 to 2030 (USD Million)
- 4.4. Data Management
- 4.4.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.5. Training Management
- 4.5.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.6. Supplier Management
- 4.6.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.7. Regulatory and Compliance Management
- 4.7.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.8. Corrective Action Preventive Action (CAPA) Management
- 4.8.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.9. Audit Management
- 4.9.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.10. Change Management
- 4.10.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.11. Non-conformances Management
- 4.11.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.12. Inspection Management
- 4.12.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.13. Risk Management
- 4.13.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 4.14. Others
- 4.14.1. Market estimates and forecasts, 2018 to 2030 (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, 2018 to 2030 (USD Million)
- 5.4. Cloud & Web-based
- 5.4.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 5.5. On-premises
- 5.5.1. Market estimates and forecasts, 2018 to 2030 (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, 2018 to 2030 (USD Million)
- 6.4. Pharmaceutical Firms
- 6.4.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 6.5. Biotech Firms
- 6.5.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
- 6.6. CROs/CDMOs
- 6.6.1. Market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 7. Life Sciences Quality Management Software Market: Regional Estimates & Trend Analysis
- 7.1. Regional Market Share Analysis, 2024 & 2030
- 7.2. Regional Market Dashboard
- 7.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
- 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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (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, 2018 to 2030 (USD Million)
Chapter 8. Competitive Landscape
- 8.1. Company/Competition Categorization
- 8.2. Strategy Mapping
- 8.2.1. Partnerships & collaborations
- 8.2.2. Mergers & acquisitions
- 8.2.3. New product launches
- 8.2.4. Expansions
- 8.2.5. Others
- 8.3. Company Market Position Analysis
- 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