Rising regulatory compliance requirements, rapid digital transformation in pharmaceutical manufacturing, and increasing focus on patient safety are driving the pharmaceutical quality management software market’s growth.
Austin, Texas, Jan. 30, 2026 (GLOBE NEWSWIRE) — Pharmaceutical Quality Management Software Market Size & Growth Analysis:
According to SNS Insider, The Pharmaceutical Quality Management Software Market is valued at USD 1.85 billion in 2025 and is expected to reach USD 6.48 billion by 2035, growing at a CAGR of 13.37% over 2026-2035. Owing to the growing complexity of pharmaceutical and biotech manufacturing as well as the growing regulatory compliance requirements, the pharmaceutical quality management software (PQMS) market is expected to increase dramatically.
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Market Size and Forecast
- Market Size in 2025: USD 1.85 Billion
- Market Size by 2035: USD 6.48 Billion
- CAGR: 13.37 % from 2026 to 2035
- Base Year: 2025
- Forecast Period: 2026–2035
- Historical Data: 2022–2024
U.S. Pharmaceutical Quality Management Software Market is valued at USD 0.56 billion in 2025 and is expected to reach USD 1.91 billion by 2035, growing at a CAGR of 13.15% during 2026-2035. The necessity for effective quality management in pharmaceutical and biotech manufacturing, as well as the increased regulatory compliance requirements, are driving growth in the U.S. pharmaceutical quality management software market.
Increasing Regulatory Compliance Requirements from FDA, EMA, and Other Authorities to Propel Growth Globally
Pharmaceutical firms must maintain accurate documentation, traceability, and real-time monitoring of quality procedures in order to comply with strict international requirements, such as FDA 21 CFR Part 11 and Good Manufacturing Practices (GMP). PQMS assists businesses in tracking remedial actions, managing deviations, automating compliance operations, and guaranteeing audit readiness. Pharmaceutical companies are investing in PQMS to lower compliance risks, minimize fines, and uphold high standards as regulatory scrutiny grows globally. Adoption is particularly high among mid-to-large businesses looking to guarantee safe, reliable product manufacture and expedite regulatory reporting.
High Implementation Costs and Complex Integration with Existing IT Systems May Limit Market Growth
For small and mid-sized pharmaceutical companies, the substantial software, hardware, and staff training costs associated with PQMS implementation may be unaffordable. Technical difficulties can result in delays and higher expenses when integrating with industrial or outdated ERP systems. The cost is further increased by continuing upkeep, updates, and compliance verification. Adoption may be slowed by these issues in developing nations or among smaller businesses with tighter finances. Consequently, the high total cost of ownership and intricate IT requirements serve as major obstacles to the global adoption of PQMS.
Major Pharmaceutical Quality Management Software Market Companies Analysis Listed in the Report are
- Veeva Systems Inc.
- MasterControl Solutions Inc.
- Honeywell International Inc.
- IQVIA Holdings Inc.
- Dassault Systèmes SE
- ComplianceQuest Inc.
- Qualio Inc.
- ETQ LLC
- AssurX Inc.
- QT9 Software Inc.
- Oracle Corporation
- SAP SE
- Siemens AG
- Ideagen Ltd.
- SoftExpert Inc.
- Instem PLC
- Intelex Technologies Inc.
- Intellect Inc.
- AmpleLogic Inc.
- Pilgrim Quality Solutions
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Segmentation Analysis:
By Function
PC‑Based dominates with 70% of the pharmaceutical quality management software market due to their widespread adoption across large enterprises and regulatory-driven industries. Camera‑Based fastest growing at 30% driven by the need for automation in quality inspection and real-time defect detection.
By Solution Type
CAPA Management dominates with 30% market share as they are central to ensuring compliance with regulatory standards and continuous quality improvement. Supplier Quality Management fastest growing at 20% due to globalization and complex supply chains in pharmaceuticals.
By Application
Predictive Maintenance dominates and fastest growing at 40% due to its integration with AI and IoT technologies. By analyzing machine data, predictive maintenance systems can forecast equipment failures, optimize maintenance schedules, and prevent production downtime.
By End‑Use
Pharmaceuticals & Chemicals dominates with 40% share due to the sector’s stringent regulatory requirements and critical focus on product quality. Food & Beverage / Logistics fastest growing at 12% CAGR due to increasing regulatory oversight, consumer safety concerns, and adoption of digital quality management solutions.
Regional Insights:
North America dominated the Pharmaceutical Quality Management Software Market with a 40.00% share in 2025 due to the presence of leading pharmaceutical companies, stringent regulatory compliance requirements, and high adoption of digital quality management solutions.
Asia Pacific is expected to grow at the fastest CAGR of about 15.05% from 2026–2035, driven by rapid expansion of pharmaceutical manufacturing, increasing regulatory focus on quality compliance, and growing adoption of cloud-based and automated QMS solutions.
Recent Developments:
- May 2024, Veeva launched QualityOne with AI-Powered CAPA Intelligence, a next-generation cloud-native Quality Management System (QMS) built on its Vault platform.
- October 2023, IQVIA expanded its Quality & Compliance Cloud to include risk-based quality management (RBQM) for both manufacturing and clinical operations.
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Exclusive Sections of the Report (The USPs):
- REGULATORY COMPLIANCE METRICS – helps you track adoption driven by FDA, EMA, WHO mandates, GxP compliance, audit reduction, and faster reporting.
- OPERATIONAL EFFICIENCY & PROCESS IMPROVEMENT – helps you evaluate reductions in deviations, CAPA incidents, batch release times, and standardized processes across sites.
- QUALITY IMPROVEMENT & RISK REDUCTION – helps you assess prevention of product recalls, proactive quality incident management, supplier compliance, and reduced OOS events.
- TECHNOLOGICAL ADOPTION RATE – helps identify penetration of PQMS across multiple manufacturing sites and uncover opportunities for digital transformation.
- SUPPLY CHAIN & CHANGE CONTROL EFFICIENCY – helps monitor error reduction in supplier quality management, change control, and cross-site process standardization.
- COMPETITIVE LANDSCAPE – helps gauge strength of key players via market reach, product offerings, recent developments, and growth projections.
Pharmaceutical Quality Management Software Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 1.85 Billion |
| Market Size by 2035 | USD 6.48 Billion |
| CAGR | CAGR of 13.37% From 2026 to 2035 |
| Base Year | 2025 |
| Forecast Period | 2026-2035 |
| Historical Data | 2022-2024 |
| Key Segments | • By Product (PC Based, Smart Camera Based) • By Solution Type (Document Control, Audit Management, Corrective & Preventive Action (CAPA), Change Management, Training Management, Supplier Quality Management) • By Application (Quality Assurance and Inspection, Positioning and Guidance, Measurement, Identification, Predictive Maintenance) • By End-use (Automotive, Pharmaceuticals & Chemicals, Electronics & Semiconductor, Pulp & Paper, Printing & Labeling, Food & Beverage (Packaging and Bottling), Glass & Metal, Postal & Logistics, Others) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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