Press release
Quality Management Software Market Set for Strong Growth to USD 20.7 Billion by 2030, Led by North America's 40% Market Share | DataM Intelligence
The Global Quality Management Software Market reached USD 8.5 billion in 2022 and is expected to reach USD 20.7 billion by 2030, growing with a CAGR of 11.6% during the forecast period 2024-2031.Market growth is driven by increasing regulatory compliance demands across industries, rising adoption of digital transformation initiatives, and the need for enhanced operational efficiency in manufacturing and supply chains. Advancements in AI-integrated QMS platforms, growing emphasis on quality assurance in pharmaceuticals and healthcare, expanding cloud-based solutions, and heightened focus on sustainability and risk management are further accelerating market expansion.
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United States: Key Industry Developments
✅ December 2025: MasterControl released an AI-enhanced Quality Management Software (QMS) platform upgrade, integrating predictive analytics for real-time compliance monitoring and defect prevention in manufacturing sectors.
✅ November 2025: IQMS (Dassault Systèmes) launched a cloud-native QMS module tailored for US healthcare firms, featuring automated audit trails and ESG reporting to streamline FDA regulations.
✅ October 2025: ETQ launched Reliance QMS 2025, introducing blockchain-based traceability for supply chain quality assurance, adopted widely by automotive leaders like Ford.
Asia Pacific / Japan: Key Industry Developments
✅ November 2025: NEC Corporation unveiled an AI-driven Supplier Quality Management application in Japan, boosting digitalization with 9.8% H2 CAGR growth through cloud audits and risk assessment.
✅ October 2025: SAP expanded its Asia Pacific QMS suite with machine learning for predictive quality control, targeting SMEs in electronics and automotive with regulatory compliance tools.
✅ September 2025: Siemens introduced advanced QMS software in Japan, emphasizing Industry 4.0 integration for manufacturing, amid rising cloud adoption and sustainability mandates.
Key Mergers and Acquisitions(2025 - 26):
✅ Major enterprise software company acquired a specialized QMS provider in November 2025, expanding integrated quality and compliance solutions for regulated industries.
✅ Investor consortium acquired a cloud-native QMS startup in June 2025, accelerating digital compliance and quality operations tools across regions.
✅ IQMS, an HCL Technologies company, secured significant investment in October 2024 to fuel growth in quality management software development and market expansion.
Market Segmentation Analysis:
-By Solution: Audit Management Leads Compliance Focus
Audit Management dominates with 25% share in 2025, streamlining regulatory inspections and risk assessments across industries.
Non-conformances/Corrective and Preventative holds 20%, enabling root-cause analysis and CAPA processes for quality improvement.
Supplier Quality Management claims 15%, optimizing vendor performance and supply chain compliance. Document Control, Complaint Handling, Employee Training, Calibration Management, and Change Management split the rest at 10%, 8%, 7%, 8%, and 7%, supporting core documentation, customer feedback, workforce upskilling, equipment accuracy, and process updates.
-By Deployment: Cloud Surges on Scalability
Cloud leads at 60% share, offering flexible, cost-efficient access with real-time updates and remote collaboration.
On-premise takes 40%, preferred by regulated sectors for data control and customization despite higher upkeep.
-By Enterprise: Large Enterprises Command Scale
Large Enterprises hold 70% share, leveraging robust systems for complex global operations and compliance.
Small & Medium Enterprises (SMEs) capture 30%, adopting affordable tools for agile quality control.
-By End-User: Manufacturing Drives Volume
Manufacturing tops at 30% share, powering production quality and defect reduction in high-volume lines.
Healthcare follows at 20%, ensuring patient safety and regulatory adherence. IT & Telecom, Consumer Goods & Retail, Transportation & Logistics, Defense & Aerospace, and Others divide the rest at 15%, 12%, 10%, 8%, and 5%, addressing sector-specific compliance and efficiency needs.
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Growth Drivers:
-Stringent Regulatory Compliance: Industries face increasing pressure from standards like ISO 9001 and FDA guidelines, driving adoption of QMS to ensure adherence and avoid penalties.
-Customer Satisfaction Focus: Emphasis on high-quality products reduces recalls and builds loyalty, boosting demand for software that maintains consistent standards.
-Digital Transformation: Cloud, AI, IoT, and automation integration enable real-time monitoring, predictive analytics, and efficiency gains across operations.
-Lean and Six Sigma Adoption: Widespread use of quality methodologies requires advanced tools to optimize processes and minimize defects.
-Operational Efficiency Gains: Automation streamlines quality control and documentation, cutting costs and enhancing productivity in complex supply chains.
Regional Insights:
-North America holds the largest share of the global Quality Management Software market (approximately 40% of revenue) due to advanced regulatory frameworks, mature digital infrastructure, and high adoption in industries like manufacturing, healthcare, and aerospace. The United States leads regional dominance with strong FDA oversight driving demand for compliant eQMS systems.
-Europe accounts for around 28% of the global market, supported by stringent standards like ISO and GDPR, alongside robust manufacturing bases. Germany, France, and the UK are key contributors, with growing cloud QMS uptake in automotive and pharmaceuticals.
-Asia Pacific represents about 20% of the market and is the fastest-growing region, fueled by manufacturing expansion in China, India, and South Korea, plus regulatory alignment with global norms. Local production booms and SME cloud adoption accelerate demand.
-Latin America holds roughly 6% of the global share but shows steady growth potential, led by Brazil and Mexico in pharmaceuticals and food processing. Cloud solutions gain traction amid improving regulations and cost pressures.
-Middle East & Africa captures the remaining 5%, with emerging adoption in UAE, Saudi Arabia, and South Africa driven by diversification into manufacturing and healthcare infrastructure.
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Key Players:
Arena Solutions, Inc. | Cority Software Inc. | Dassault Systemes SE | EtQ Management Consultants, Inc. | Ideagen Plc. | Intelex Technologies | MasterControl, Inc. | MetricStream, Inc. | Microsoft Corporation | Oracle Corporation
Key Highlights (Top 5 Key Players) for Quality Management Software Market:
-Microsoft Corporation provides Dynamics 365 Quality Management module, enabling automated compliance tracking, audit management, and real-time defect analysis integrated with its broader ERP ecosystem.
-Oracle Corporation offers Oracle Quality Management Cloud, streamlining supplier quality controls, CAPA processes, and non-conformance reporting through AI-driven predictive analytics.
-Dassault Systemes SE delivers 3DEXPERIENCE Quality platform, supporting collaborative risk management, FMEA workflows, and regulatory compliance for manufacturing and aerospace industries.
-MasterControl, Inc. specializes in cloud-based QMS solutions for life sciences, automating document control, training management, and validation to ensure FDA and ISO adherence.
-Intelex Technologies provides EHSQ software with customizable modules for incident management, audit tracking, and continuous improvement, serving heavy industry and sustainability-focused sectors.
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