North America Life Sciences Quality Management Software Market Size, Share & Trends Analysis Report By Application, By Deployment Mode (Cloud & Web-based and On-premises), By End Use, By Country and Growth Forecast, 2024 - 2031

North America Life Sciences Quality Management Software Market Size, Share & Trends Analysis Report By Application, By Deployment Mode (Cloud & Web-based and On-premises), By End Use, By Country and Growth Forecast, 2024 - 2031


The North America Life Sciences Quality Management Software Market would witness market growth of 12.1% CAGR during the forecast period (2024-2031).

The US market dominated the North America Life Sciences Quality Management Software Market by Country in 2023, and would continue to be a dominant market till 2031; thereby, achieving a market value of $1,867.5 million by 2031. The Canada market is experiencing a CAGR of 14.4% during (2024 - 2031). Additionally, The Mexico market would exhibit a CAGR of 13.5% during (2024 - 2031).

This market is evolving rapidly as the life sciences industry undergoes significant transformation driven by regulatory changes, technological advancements, and increasing competition. The life sciences sector, including pharmaceuticals, biotechnology, medical devices, and clinical research, demands high precision, compliance, and operational efficiency.

Life sciences QMS software has applications in various processes across the life sciences industry. The primary purpose of this software is to ensure that products meet the highest standards of quality, comply with international regulations, and are produced and distributed safely. Document control is a crucial aspect of quality management, especially in the highly regulated life sciences industry.

This market in Canada is set to see significant growth, driven by the country’s substantial investments in healthcare and a national commitment to improving health services. As outlined in the 2023 budget, the Government of Canada has allocated $196.1 billion over ten years to enhance healthcare services across provinces and territories, with an additional $46.2 billion in new funding to bolster healthcare infrastructure. For instance, Mexico’s government has been investing in public health initiatives, such as the IMSS (Instituto Mexicano del Seguro Social) and INSABI (Instituto de Salud para el Bienestar) programs, to enhance the quality and accessibility of healthcare services across the country. The government’s focus on improving healthcare for all, including its efforts to increase access to medical services in rural and underserved areas, is leading to modernizing healthcare facilities and systems. In conclusion, both Mexico's and Canada’s healthcare investments are driving a strong demand for life sciences quality management software to ensure quality and compliance.

Based on Application, the market is segmented 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 Other Application. Based on Deployment Mode, the market is segmented into Cloud & Web-based and On-premises. Based on End Use, the market is segmented into Pharmaceutical Firms, Biotech Firms, and CROs/CDMOs. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.

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.
North America 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 Country
  • US
  • Canada
  • Mexico
  • Rest of North America


Chapter 1. Market Scope & Methodology
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 North America Life Sciences Quality Management Software Market, by Application
1.4.2 North America Life Sciences Quality Management Software Market, by Deployment Mode
1.4.3 North America Life Sciences Quality Management Software Market, by End Use
1.4.4 North America Life Sciences Quality Management Software Market, by Country
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. North America Life Sciences Quality Management Software Market by Application
5.1 North America Data Management Market by Country
5.2 North America Regulatory & Compliance Management Market by Country
5.3 North America Corrective Action Preventive Action (CAPA) Management Market by Country
5.4 North America Change Management Market by Country
5.5 North America Audit Management Market by Country
5.6 North America Risk Management Market by Country
5.7 North America Non-Conformances Management Market by Country
5.8 North America Supplier Management Market by Country
5.9 North America Training Management Market by Country
5.1 North America Inspection Management Market by Country
5.11 North America Other Application Market by Country
Chapter 6. North America Life Sciences Quality Management Software Market by Deployment Mode
6.1 North America Cloud & Web-based Market by Country
6.2 North America On-premises Market by Country
Chapter 7. North America Life Sciences Quality Management Software Market by End Use
7.1 North America Pharmaceutical Firms Market by Country
7.2 North America Biotech Firms Market by Country
7.3 North America CROs/CDMOs Market by Country
Chapter 8. North America Life Sciences Quality Management Software Market by Country
8.1 US Life Sciences Quality Management Software Market
8.1.1 US Life Sciences Quality Management Software Market by Application
8.1.2 US Life Sciences Quality Management Software Market by Deployment Mode
8.1.3 US Life Sciences Quality Management Software Market by End Use
8.2 Canada Life Sciences Quality Management Software Market
8.2.1 Canada Life Sciences Quality Management Software Market by Application
8.2.2 Canada Life Sciences Quality Management Software Market by Deployment Mode
8.2.3 Canada Life Sciences Quality Management Software Market by End Use
8.3 Mexico Life Sciences Quality Management Software Market
8.3.1 Mexico Life Sciences Quality Management Software Market by Application
8.3.2 Mexico Life Sciences Quality Management Software Market by Deployment Mode
8.3.3 Mexico Life Sciences Quality Management Software Market by End Use
8.4 Rest of North America Life Sciences Quality Management Software Market
8.4.1 Rest of North America Life Sciences Quality Management Software Market by Application
8.4.2 Rest of North America Life Sciences Quality Management Software Market by Deployment Mode
8.4.3 Rest of North America 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

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