IMARC Group’s report titled “Pharmaceutical Quality Management Software Market Report by Solution Type (Corrective Action Preventive Action (CAPA) Management, Audit Management, Document Management, Change Management, Training Management, Risk Management, Complaints Management, Regulatory and Compliance Management, Non-Conformances Handling, Supplier Quality Management, Inspection Management, Equipment Management, and Others), Deployment Model (On-Cloud, Web-Based, On-Premises), Enterprise Size (Small and Medium-sized Enterprises, Large Enterprises), End User (Pharmaceutical, Life Sciences, and Biotechnology Companies, Contract Research Organizations, and Others), and Region 2025-2033”, The global pharmaceutical quality management software market size reached USD 1.4 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 2.9 Billion by 2033, exhibiting a growth rate (CAGR) of 8.9% during 2025-2033.
Factors Affecting the Growth of the Pharmaceutical Quality Management Software Industry:
Stricter Rules Driving Growth:
The pharmaceutical quality management software (PQMS) market is growing fast due to stricter rules from health authorities like the FDA and EMA. These rules require drug companies to ensure safety, quality, and proper record-keeping. By 2024, more companies will use PQMS to stay compliant and improve their quality processes. Modern software with features like automated audits, risk management, and real-time monitoring is becoming essential. As drug production and supply chains get more complex, companies need better systems to track quality at every stage, making PQMS a key tool for efficiency and meeting regulations.
Focus on Digital Tools and Accurate Data:
Pharma companies are moving toward digital systems to handle data better and ensure accuracy. This shift is crucial for meeting rules and building trust with customers and regulators. By 2024, many companies will use PQMS powered by technologies like cloud computing, artificial intelligence, and machine learning. These tools help automate data collection, improve accuracy, and provide real-time insights, making decision-making faster and better. Remote work has also made cloud-based software popular because it allows teams in different locations to work together easily. These digital tools are helping companies improve operations and respond to changing rules more effectively.
Demand for All-in-One Solutions:
Pharma companies are looking for quality management systems that connect all parts of their operations. Traditional systems often worked separately, leading to inefficiencies. By 2024, integrated PQMS that cover everything—from development to manufacturing and distribution—will become more common. These systems allow teams to find and fix quality issues faster, reducing risks like product recalls. Many companies are also connecting PQMS with other systems, such as lab management tools, to streamline workflows and improve data sharing. This unified approach helps companies maintain high-quality standards and work more efficiently.
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Leading Companies Operating in the Pharmaceutical Quality Management Software Industry:
AssurX Inc.
ComplianceQuest
Dassault Systèmes SE (Dassault Group)
ETQ LLC (Hexagon AB)
Ideagen
IQVIA Inc.
Mastercontrol Inc.
Qualio
Veeva Systems Inc
Pharmaceutical Quality Management Software Market Report Segmentation:
Breakup By Solution Type:
Corrective Action Preventive Action (CAPA) Management
Audit Management
Document Management
Change Management
Training Management
Risk Management
Complaints Management
Regulatory and Compliance Management
Non-Conformances Handling
Supplier Quality Management
Inspection Management
Equipment Management
Others
Breakup By Deployment Mode:
On-Cloud
Web-Based
On-Premises
Breakup By Enterprise Size:
Small and Medium-sized Enterprises
Large Enterprises
Breakup By End User:
Pharmaceutical, Life Sciences, and Biotechnology Companies
Contract Research Organizations
Others
Regional Insights:
North America (United States, Canada)
Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
Latin America (Brazil, Mexico, Others)
Middle East and Africa
Pharmaceutical Quality Management Software Market Trends:
The Pharmaceutical Quality Management Software market is changing as technology advances. Artificial intelligence and machine learning are becoming important for automating quality checks, spotting problems early, and managing risks better. By 2024, these smart systems will help companies make faster, data-driven decisions. Cloud-based solutions are also growing in popularity because they’re flexible and allow remote access. This is especially helpful as remote work becomes more common. These trends show that PQMS is becoming a must-have for companies aiming to meet stricter rules, work more efficiently, and ensure high product quality.
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IMARC Group is a global management consulting firm that helps the world’s most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.
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