Pharmaceutical Quality Management Systems Market Worth $3.97 Billion by 2030 – Exclusive Report by Meticulous Research®

Redding, California, Feb. 01, 2023 (GLOBE NEWSWIRE) — According to a new market research report titled, ‘Pharmaceutical Quality Management Systems Market by Solution (Deviation, CAPA, Audit, Inspection, Document, Supplier, Risk, Training, Change Management), Deployment Mode (On-Premises, Web/Cloud), End User (Pharmaceutical, CRO) – Global Forecast to 2030’, published by Meticulous Research^®, the pharmaceutical quality management systems market is projected to reach $3.97 billion by 2030, at a CAGR of 15.6% from 2023 to 2030.

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Pharmaceutical quality management systems help coordinate and direct an organization’s activities to meet regulatory and customer requirements. The systems also help to improve efficiency and effectiveness at all levels of the process. The constant pressure on pharmaceutical companies to increase production capacities with adherence to regulatory rules has increased the need for pharmaceutical quality management systems.

Standard organizations and regulatory authorities that expanded the use of remote audits during the COVID-19 pandemic:

• ISO standards: ISO 19011:2018 guidelines for auditing management systems allow for remote QMS audits.
• EU Medical Device Regulation (MDR): The European Commission’s Medical Device Coordination Group (MDCG) clarified in guidance that remote EU MDR audits may be conducted in certain situations during the pandemic period.
• Medical Device Single Audit Program (MDSAP): A December 2020 transmittal from MDSAP assessment program managers (APMs) specifies the expanded ways for in-person audits under MDSAP.
• Pharmaceuticals and Medical Devices Agency (PMDA): Japan’s PMDA released its procedure for remote inspections in November, which it uses in certain situations.

All these factors resulted in a surge of demand for the systems, creating opportunities for quality management systems vendors systems in the market during the pandemic.

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The global pharmaceutical quality management systems market is segmented by solution type, deployment mode, end user, and geography.

Based on solution type, in 2023, the non-conformance/deviation management segment is expected to hold the largest share of the pharmaceutical quality management systems market. Key factors such as the increasing importance of deviations and non-conformance from the regulatory point of view and the increasing emphasis of the FDA to deliver regulatory-compliant products are contributing to the large market share of this segment. Pharmaceutical plants approved by FDA and European Medicines Agency (EMA) need to comply with their set regulations. Among them, deviations and non conformance are critical as they indicate the quality of the manufacturing process. Thus many pharmaceutical players adopt quality management systems to record and improve the deviations during the process.

Based on deployment mode, the on-cloud segment is projected to record the fastest growth rate during the forecast period. The rapid shift from on-premise to cloud-based systems in pharma businesses due to benefits such as quick and easy scalability, increased flexibility, and reduced IT costs have primarily contributed to the segment’s fast growth.

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Based on end user, in 2023, the pharmaceutical, life sciences, and biotechnology companies segment is expected to account for the largest share of the pharmaceutical quality management systems market. The large market share of this segment is attributed to the growing importance of quality management during drug manufacturing. Critical process parameters in the biological drug manufacturing process are difficult to manage with paper-based documentation and may impact product release during audits. Moreover, mounting pressures to increase production capacity require streamlining process controls. Thus, strongly supporting the adoption of quality management systems in pharmaceutical and biopharmaceutical companies.

Based on geography, Asia-Pacific is projected to register the highest CAGR during the forecast period. The growth of this market is attributed to the well-developed pharmaceutical sector, a large number of FDA-approved facilities, increasing automation in the drug manufacturing process, increasing numbers of contract research laboratories, and increasing adoption of quality management systems by major pharma players.

The report also includes an extensive assessment of the key strategic developments of leading market participants in the industry over the last four years (2020–2023), such as product launches, collaborations, agreements, and expansions.

Some of the key players operating in the global pharmaceutical quality management systems market are ANTARES VISION SpA (Italy), AssurX Inc.(U.S.), AXSource (U.S.), CLARIVATE PLC (U.K.), ComplianceQuest (U.S.), Dassault Systemes (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.).

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Scope of the Report:

Pharmaceutical Quality Management Systems Market, by Solution Type

• Non-conformance/Deviation management
• CAPA Management
• Audit Management
• Risk & Compliance
• Suppliers & Materials Management
• Inspection Management
• Document Management
• Change Management
• Training Management
• Other Solution Types

Note: Other solution types include complaint management, out-of-specification, release management, incidents & occurrence management, post-market surveillance, design control, and asset management.

Pharmaceutical Quality Management Systems Market, by Deployment Mode

• Cloud/Web-based
• On-Premises

Pharmaceutical Quality Management Systems Market, by End User

• Pharmaceutical, Life Sciences, and Biotechnology Companies
• Contract Research Organizations
• Others

Note: Other end users include research labs and contract drug manufacturers

Pharmaceutical Quality Management Systems Market, by Geography

• North America
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • China
  • Japan
  • India
  • Rest of APAC (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America (RoLATM)
  • Middle East & Africa

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About Meticulous Research®

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