Quality Management Software Market To Reach $22.1 Billion by 2035

Quality management software market is projected to grow from $8.2 billion in 2025 to $22.1 billion by 2035, expanding at a CAGR of 10.4% during the forecast period (2026–2035). The market growth is strongly driven by the rising need for regulatory compliance, digital transformation across industries, and increasing complexity in global supply chains.

Browse the full report description of “Quality Management Software Market Size, Share & Trends Analysis Report, By Deployment Model (Cloud-Based QMS, On-Premises QMS), By Solution Type (Document Control Management, CAPA Management, Audit Management, Supplier Quality Management, Complaint Handling, Training Management, Risk Management), By Industry Vertical (Life Sciences, Medical Devices, Food & Beverage, Manufacturing, Automotive, IT & Telecom, Consumer Goods, Others), By End-User Role (Quality Managers & Compliance Officers, Production & Operations Teams, Supplier & Vendor Networks, Executives & Decision Makers), Forecast Period (2026-2035)” at https://www.omrglobal.com/industry-reports/quality-management-software-market

A key macro driver accelerating market growth is the rapid digitalization of industries and increasing regulatory oversight. According to the International Telecommunication Union (ITU), over 67% of the global population (5.4 billion people) were using the internet in 2023, reflecting a sharp rise in digital adoption across enterprises. This surge in digital transformation has led organizations to adopt advanced software systems such as QMS to manage compliance, streamline workflows, and ensure product quality.

Additionally, regulatory pressure is intensifying across sectors such as pharmaceuticals and medical devices. The U.S. Food and Drug Administration (FDA) reported over 1,200 warning letters issued in 2023 related to quality and compliance violations, highlighting the growing importance of structured quality systems. Similarly, the European Commission continues to enforce stringent Good Manufacturing Practices (GMP) across industries, further driving QMS adoption. These regulatory frameworks are compelling organizations to implement automated quality management systems to avoid penalties, recalls, and reputational damage.

From an end-user perspective, the life sciences and manufacturing sectors are witnessing significant adoption. According to OECD data, manufacturing contributes to approximately 16% of global GDP, with increasing emphasis on quality assurance and operational efficiency. Furthermore, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) highlights that global pharmaceutical R&D spending exceeded $200 billion annually, necessitating robust QMS platforms for compliance, documentation, and risk management.

Among segments, Cloud-Based QMS (SaaS) is emerging as the fastest-growing segment due to its scalability, cost-effectiveness, and remote accessibility. Organizations are increasingly shifting from legacy on-premises systems to cloud-based platforms to support global operations and real-time quality monitoring.

Recent Developments

• In February 2025, MasterControl announced the general availability of its AI-powered Document Summarizer, enhancing its quality management software capabilities for life sciences organizations. The solution enables automated summarization of SOPs, work instructions, and document changes, improving document control, compliance readiness, and operational efficiency. As part of its broader AI suite, the tool supports translation and training workflows, reflecting the growing adoption of AI-driven automation in quality management systems across regulated industries.
• In September 2024, Veeva Systems announced the expansion of its Veeva Vault QMS with new capabilities for managing medtech field actions and product recalls. The update enhances end-to-end visibility and control across critical quality processes, including issue identification, evaluation, execution, and closure, while integrating seamlessly with complaint handling, CAPA, risk management, and change control. This development strengthens QMS efficiency by reducing manual processes, improving accuracy, and supporting better compliance and patient safety outcomes in the medical technology sector.

These developments highlight the increasing focus on cloud adoption, AI integration, and industry-specific customization, which are expected to drive long-term market growth.

Market Coverage

• The market number available for – 2025-2035
• Base year- 2025
• Forecast period- 2026-2035
• Segment Covered-
  • By Deployment Model
  • By Solution Type
  • By Industrial Vertical
  • By End Users' Role
• Regions Covered-
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Competitive Landscape – Master Control, Sparta Systems(Honeywell), Veeva Systems, Dassault Systèmes, Siemens Digital Industries software, among others.

Key questions addressed by the report.

• What is the market growth rate?
• Which segment and region dominate the market in the base year?
• Which segment and region will project the fastest growth in the market?
• Who is the leader in the market?
• How are players addressing challenges to sustain growth?
• Where is the investment opportunity?

Global Quality Management Software Market Report Segment

By Deployment Model

• Cloud-Based QMS (SaaS)
• On-Premises QMS

By Solution Type

• Document Control Management
• Corrective & Preventive Action (CAPA) Management
• Audit Management
• Supplier Quality Management (SQM)
• Complaint Handling
• Training Management
• Risk Management

By Industry Vertical

• Life Sciences
• Medical Devices
• Food & Beverage
• Manufacturing
• Automotive
• IT & Telecom
• Consumer Goods
• Others

By End-User Role

• Quality Managers & Compliance Officers
• Production & Operations Teams
• Supplier & Vendor Networks
• Executives & Decision Makers

Global Quality Management Software Market Report Segment by Region

North America

• United States
• Canada

Europe

• UK
• Germany
• Italy
• Spain
• France
• Russia
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia and New Zealand
• ASEAN Economies
• Rest of Asia-Pacific

Rest of the World

• Latin America
• Middle East & Africa

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