Pharmaceutical Quality Management Software Market Size, Share & Trends Analysis Report By Application (Data Management, Risk Management, Audit Management), By Deployment Mode (Cloud & Web-based, On-premise), By Region, And Segment Forecasts, 2025 - 2030

Pharmaceutical Quality Management Software Market Growth & Trends

The global pharmaceutical quality management software market size is expected to reach USD 3.85 billion by 2030, registering a CAGR of 12.99% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market growth is being propelled by the increasing expenses associated with drug manufacturing, the ever-evolving regulatory landscape, and the expanding integration of technology within the pharmaceutical sector. A quality management system ensures that a company's products meet market expectations and industry standards. Quality assurance methods are employed to ensure there are no defects, and all actions taken to address issues are well-documented.

A robust pharmaceutical quality management system (QMS) offers several advantages to businesses, including ensuring product integrity, expediting the introduction of new products to the market, reducing the time and cost associated with document management, aiding in the identification and resolution of issues, verifying the quality of supplier processes, and enabling employee skill enhancement through effective training. The COVID-19 pandemic positively affected the market. It led pharmaceutical manufacturers to recognize the significance of maintaining stringent quality standards amidst unprecedented challenges in the global healthcare industry.

This heightened awareness drove a surge in demand for efficient QMS solutions to guarantee the effectiveness, quality, and safety of pharmaceuticals and medical products. In addition, the adoption of quality management systems aided businesses in enhancing their quality management procedures, implementing risk mitigation strategies, and ensuring adherence to regulatory requirements. Furthermore, the various strategies employed by the key market competitors over the next few years are likely to drive market expansion.

For instance, in 2021, Arena Solutions, Inc., partnered with Rimsys Inc., a company that offers regulatory information management (RIM) software systems, to create a comprehensive quality and product-focused regulatory solution. This collaboration allowed the organization to expand its product offerings. In addition, in April 2021, Medidata, a company under Dassault Systèmes, introduced Medidata Risk Management, a new addition to its Risk-Based Quality Management (RBQM) suite, which comprises a wide range of solutions aimed at speeding up the adoption of proactive oversight activities in clinical operations

Pharmaceutical Quality Management Software Market Report Highlights

• Based on applications, the data management segment dominated the market in 2024 and accounted for the largest revenue share of 17.52%. Furthermore, the regulatory and compliance management segment is expected to grow at the fastest CAGR from 2025 to 2030.
• Based on deployment mode, the cloud & web-based segment held the largest market share of 77.02% in 2024 and is expected to register growth at the fastest CAGR during the forecast period. On-premises software accounted for a significant revenue share in 2024.
• North America pharmaceutical quality management software market dominated with the largest revenue share of 38.63% in 2024. Pharmaceutical quality management software market in the U.S. is experiencing significant growth, driven by an increasing emphasis on regulatory compliance and the need for enhanced operational efficiency within the pharmaceutical and biopharmaceutical industry.
• Pharmaceutical quality management software market in Asia Pacific is poised to grow at the fastest CAGR from 2025 to 2030 due to the increasing regulatory requirements imposed by health authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and local regulatory agencies.