Pharmaceutical Quality Management Systems Market to be Worth $3.97 Billion by 2030 ​

According to this latest publication from Meticulous Research^®, the global pharmaceutical quality management systems market is projected to reach $3.97 billion by 2030 at a CAGR of 15.6%. The growth of this market is driven by the increasing costs of drug manufacturing, pharmaceutical companies’ growing need to comply with regulatory requirements, the rapid growth of the pharmaceutical industry, and the benefits of software-based quality management systems. However, the high costs of deploying pharmaceutical quality management systems restrain the growth of this market.

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The growing generic drugs & biopharmaceuticals markets and pharmaceutical companies’ increasing preference for platform-as-a-service solutions are expected to generate growth opportunities for the players in this market. However, security concerns related to on-cloud deployments among pharmaceutical organizations are a major challenge for market growth.

Key Players

The key players operating in the global pharmaceutical quality management systems market are ANTARES VISION SpA (Italy), AssurX Inc. (U.S.), AXSource Consulting Inc. (U.S.), Körber AG (Germany), ComplianceQuest, Inc. (U.S.), Dassault Systèmes SE (France), EtQ Management Consultants Inc.(U.S.), Honeywell  International Inc. (U.S.), Ideagen PLC (U.K.), IQVIA HOLDINGS INC. (U.S), LogicGate Inc. (U.S.), and MasterControl,  Inc. (U.S.)

Pharmaceutical Quality Management Systems Assays Market: Future Outlook

The global pharmaceutical quality management systems market is segmented by  Solution Type (Non-conformance/Deviation Management, CAPA Management, Audit Management, Risk & Compliance Management, Suppliers & Materials Management, Inspection Management, Document Management, Change Management, Training Management, and Other Solution Types), Deployment Mode (Cloud/Web-Based and On-Premise), End User (pharmaceutical and biotechnology companies, contract development manufacturing organizations (CDMOs)/ contract research organizations (CROS)/, and research laboratories ) and Geography. The study also evaluates industry competitors and analyzes their market share at global and regional levels.

Among all solution types studied in this report, in 2023, the non-conformance/deviation management segment is expected to account for the largest share of the pharmaceutical quality management systems market. The importance of managing non-conformance and deviations is emphasized by several industry standards, such as the ISO 9001:2015 Quality Management System Standard (QMS). By implementing these controls, organizations can identify quality-related issues early and address them quickly with minimal disruption to operations. Additionally, the increasing importance of preventing deviations and non-conformance from a regulatory perspective contributes to the segment’s large share.

Among all deployment modes studied in this report, the cloud/web-based segment is expected to grow at the highest CAGR during the forecast period. The segment’s highest growth is attributed to the benefits of cloud/web-based QMS, such as cost-effectiveness, real-time analysis, easy access to data, internal and external data sharing, flexibility, and scalability. Additionally, private cloud deployment offers reliability, security, privacy, and customization.

Among all end users studied in this report, the pharmaceutical and biotechnology companies segment is expected to account for the largest pharmaceutical quality management systems market share. The largest share of this segment is attributed to the increasing demand for new drugs and therapies, leading to extensive research and development activities, rising funding and investments in the pharmaceutical and biotech industry, and governments of various countries investing in and providing grants and funds to pharmaceutical and biotechnology companies for the manufacture and R&D of biopharmaceuticals.

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Geographic Review

This research report analyzes major geographies and provides a comprehensive analysis of North America (U.S. and Canada), Europe (Germany, France, U.K., Italy, Spain, Ireland, Belgium, Netherlands, and the Rest of Europe), Asia-Pacific (China, Japan, India, Malaysia, Philippines, Vietnam, Singapore, and the Rest of Asia-Pacific), Latin America (Brazil, Mexico, and the Rest of Latin America), and the Middle East & Africa.

Among all regions studied in this report, Asia-Pacific is expected to grow at the highest CAGR during the forecast period. The highest CAGR of the region is attributed to advancements in healthcare infrastructure, development in the R&D sector, a large population pool, and government initiatives to improve healthcare facilities.

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