Pharmaceutical Quality Management Systems Markets: Deviation, CAPA, Audit, Risk & Compliance, Inspection, Document, Change, Training Management - Global Forecast to 2030

Dublin, March 01, 2024 (GLOBE NEWSWIRE) -- The "Pharmaceutical Quality Management Systems Market by Solution Type (Deviation, CAPA, Audit, Risk & Compliance, Inspection, Document, Change, Training Management), Deployment Mode (Cloud, On-premise), and End User (Pharmaceutical, CDMO/CRO) - Global Forecast to 2030" report has been added to's offering.

The pharmaceutical quality management systems market is expected to reach $3.97 billion by 2030, at a CAGR of 15.6% from 2023 to 2030

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.

Additionally, the growing generic drugs & and 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, the high costs of deploying pharmaceutical quality management systems restrain the growth of this market. Security concerns related to on-cloud deployments among pharmaceutical organizations are a major challenge for market growth.

Asia-Pacific is slated to register with the highest CAGR during the forecast period. The healthcare needs of people in Asia-Pacific countries are progressively increasing due to the rising burden of chronic diseases. A large population pool and government initiatives to improve healthcare facilities and services in these countries are the key factors supporting the growth of the Asia-Pacific market. These countries have also been identified as low-cost destinations for pharmaceutical manufacturers for a long time, which further supports the growth of this market in Asia-Pacific.

The CAPA management segment is expected to grow at the highest CAGR during the forecast period. The need for Corrective and Preventive Action (CAPA) management in the pharmaceutical industry is driven by several factors that ensure product quality, patient safety, and regulatory compliance. CAPA management is essential for addressing issues and preventing their recurrence, further contributing to the overall integrity of pharmaceutical operations.

In 2023, the cloud/web-based segment is expected to account for the largest share of the pharmaceutical quality management systems market. The largest share of this segment is attributed to several advantages offered by cloud/web-based deployments over on-premise deployments, such as cost minimization, easy accessibility, adjustability, and updated cloud systems. Another major advantage of web-based deployments is the lower risk of data loss through better encryption and data backup.

The pharmaceutical and biotechnology companies segment is expected to grow at the highest CAGR during the forecast period. The highest CAGR of the segment is attributed to increasing R&D investments by pharmaceutical & biotechnology companies, widespread utilization of quality management systems to ensure product quality, and a growing emphasis on personalized medicine research.

Market Insights

Factors Affecting Market Growth

  • Pharmaceutical Companies' Growing Need to Comply with Regulatory Requirements Driving the Adoption of Pharmaceutical Quality Management Systems
  • High Costs of Deploying Pharmaceutical Quality Management Systems Limiting their Adoption
  • Growing Generic Drugs & Biopharmaceuticals Markets Generating Growth Opportunities for Market Players
  • Security Concerns Related to On-cloud Deployments Impacting the Implementation of Pharmaceutical QMS
  • Factor Analysis


  • Integration Of Artificial Intelligence & Machine Learning into Pharmaceutical Quality Management Systems
  • Increasing Inclination Toward Personalized Medicine

Pharmaceutical Quality Management Systems Market: Regulatory Analysis

  • Overview
  • International Organization for Standardization (ISO)
  • Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
  • ICH Guideline Q10
  • Current Good Manufacturing Practice (cGMP)

Pricing Analysis

Case Studies

Company Profiles

  • Honeywell International Inc. (U.S.)
  • IQVIA Holdings Inc. (U.S.)
  • ANTARES VISION S.p.A (Italy)
  • Dassault Systemes SE (France)
  • EtQ Management Consultants Inc. (U.S.)
  • Ideagen PLC (U.K.)
  • Korber AG (Germany)
  • LogicGate Inc. (U.S.)
  • ComplianceQuest Inc (U.S.)
  • AssurX Inc. (U.S.)
  • AXSource Consulting Inc. (U.S.)

Competition Analysis

  • Key Growth Strategies
  • Competitive Benchmarking
  • Competitive Dashboard
  • Industry Leaders
  • Market Differentiators
  • Vanguards
  • Emerging Companies
  • Market Players Ranking (2022)

Scope of the Report:

Pharmaceutical Quality Management Systems Market Assessment by Solution Type

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

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

Pharmaceutical Quality Management Systems Market Assessment, by Deployment Mode

  • Cloud/Web-based
  • On-Premise

Pharmaceutical Quality Management Systems Market Assessment, by End User

  • Pharmaceutical and Biotechnology Companies
  • Research Laboratories

Pharmaceutical Quality Management Systems Market Assessment, by Geography

  • North America
  • U.S.
  • Canada
  • Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Ireland
  • Belgium
  • Netherlands
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Singapore
  • Malaysia
  • Philippines
  • Vietnam
  • Rest of Asia-Pacific
  • Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
  • Middle East & Africa

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