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Redding, California - July 10, 2024

Pharmaceutical Quality Management Systems Market to be Worth $4.59 Billion by 2031

Pharmaceutical Quality Management Systems Market Size, Share, Forecast, & Trends Analysis by Solution Type (Deviation, CAPA, Audit, Risk & Compliance, Inspection, Change, Training) Deployment Mode (Cloud, On-premise) End User - Global Forecast to 2031


Meticulous Research®—a leading global market research company, published a research report titled, Pharmaceutical Quality Management Systems Market Size, Share, Forecast, & Trends Analysis by Solution Type (Deviation, CAPA, Audit, Risk & Compliance, Inspection, Change, Training) Deployment Mode (Cloud, On-premise) End User - Global Forecast to 2031.’

According to this latest publication from Meticulous Research®, the global pharmaceutical quality management systems market is projected to reach $4.59 billion by 2031 at a CAGR of 15.6%. Rising drug manufacturing costs, stringent regulatory standards for pharmaceutical production, rapid growth of the pharmaceutical industry, and the advantages of software-based quality management systems drive the growth of this market. However, the high costs of deploying pharmaceutical quality management systems restrain the growth of this market.

The increasing demand for generic drugs & biopharmaceuticals and the rising preference for platform-as-a-service solutions among pharmaceutical companies are expected to create market growth opportunities. However, security concerns associated with on-cloud deployments pose a significant challenge to the market’s 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 the solution types covered in this report, in 2024, the non-conformance/deviation management segment is expected to account for the largest share of 18.1% 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 the deployment modes covered in this report, the cloud/web-based segment is projected to register the highest CAGR of 16.3% during the forecast period. This segment’s growth can be attributed to the benefits offered by 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 the end users covered in this report, in 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the pharmaceutical quality management systems market. This segment’s large market share can be attributed to the increasing demand for new drugs and therapies, leading to extensive research and development activities, rising funding and investments in the pharmaceutical & biotech industry, and supportive government initiatives for pharmaceutical and biotechnology companies aimed at promoting the manufacture and R&D of biopharmaceuticals.

This research report analyzes major geographies and provides a comprehensive analysis of the market in 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 Rest of Asia-Pacific), Latin America (Brazil, Mexico, and the Rest of Latin America), and the Middle East & Africa.

Among the regions covered in this report, Asia-Pacific is projected to register the highest CAGR of 16.8% during the forecast period. The growth of this regional market is driven by advancements in healthcare infrastructure, development in the R&D sector, a large population pool, and government initiatives aimed at improving healthcare facilities.

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Key Questions Answered in the Report:

  • Which are the high-growth market segments in terms of solution type, deployment mode, end user, and regions/countries?
  • What was the historical market for pharmaceutical quality management systems across the globe?
  • What are the market forecasts and estimates for 2024–2031?
  • What are the major drivers, restraints, challenges, opportunities, and trends in the global pharmaceutical quality management systems market?
  • Who are the major players in the global pharmaceutical quality management systems market?
  • What is the competitive landscape like?
  • What are the recent developments in the pharmaceutical quality management systems market?
  • What strategies are adopted by the major players in the pharmaceutical quality management systems market?
  • What are the geographical trends and high-growth regions/countries?

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