Global Life Sciences Quality Management Software Market Size Study, By Application (Data Management, Regulatory and Compliance Management, Others), By Deployment Mode (Cloud & Web-Based, On-Premise), By End Use (Pharmaceutical Firms, Biotech Firms, CROs/C

Global Life Sciences Quality Management Software Market Size Study, By Application (Data Management, Regulatory and Compliance Management, Others), By Deployment Mode (Cloud & Web-Based, On-Premise), By End Use (Pharmaceutical Firms, Biotech Firms, CROs/CDMOs), and Regional Forecasts 2022-2032

The global life sciences quality management software market was valued at approximately USD 2.89 billion in 2023 and is projected to grow at a robust CAGR of 12.99% over the forecast period 2024-2032. The rising adoption of quality management software (QMS) in the life sciences industry is driven by the increasing need to comply with stringent regulatory guidelines established by agencies such as the FDA and ISO. The growing shift from traditional paper-based QMS to digital eQMS is revolutionizing the sector, enabling organizations to improve operational efficiency, ensure product safety, and enhance compliance.

Technological advancements, such as Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT), are transforming QMS by enabling predictive analytics and real-time data monitoring. These innovations streamline manufacturing processes, enhance decision-making, and help organizations maintain superior quality standards. For instance, the launch of AI-integrated solutions such as ComplianceQuest's Life Sciences Cloud and Dot Compliance's ChatGPT-enabled eQMS highlights the industry's move towards advanced technologies for quality assurance.

Key applications driving growth include data management, regulatory and compliance management, and risk management. The increasing complexity of regulatory requirements and the growing emphasis on patient safety have positioned QMS as a critical tool for life sciences companies. Additionally, deployment modes are shifting towards cloud-based solutions, which accounted for the largest market share in 2023, driven by their scalability, cost-effectiveness, and enhanced data accessibility.

Regionally, North America dominated the market in 2023 due to its stringent regulatory environment and well-established pharmaceutical and biotechnology sectors. However, Asia-Pacific is expected to exhibit the fastest growth, supported by the rise of contract research organizations (CROs) and contract manufacturing organizations (CMOs), alongside increasing investment in healthcare infrastructure in countries like China, Japan, and India.

Major market player included in this report are:
• Dassault Systèmes
• IQVIA (Pilgrim)
• MasterControl Solutions, Inc.
• AmpleLogic
• Qualio - QMS for Life Sciences
• QT9 Software
• Sparta Systems- TrackWise (Honeywell International Inc.)
• AssurX, Inc
• ETQ, LLC (Hexagon)
• Veeva Systems
• Qualityze
• Ideagen
• ComplianceQuest
• Dot Compliance
• AURA Quality Management

The detailed segments and sub-segment of the market are explained below:

By Application:
• Data Management
• Training Management
• Supplier Management
• Regulatory and Compliance Management
• Corrective Action Preventive Action (CAPA) Management
• Audit Management
• Change Management
• Non-Conformances Management
• Inspection Management
• Risk Management
• Others

By Deployment Mode:
• Cloud & Web-Based
• On-Premises

By End Use:
• Pharmaceutical Firms
• Biotech Firms
• CROs/CDMOs

By Region:

North America
• U.S.
• Canada
• Mexico

Europe
• Germany
• UK
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway

Asia-Pacific
• China
• Japan
• India
• South Korea
• Australia
• Thailand

Latin America
• Brazil
• Argentina

Middle East & Africa
• South Africa
• Saudi Arabia
• UAE
• Kuwait

Years considered for the study are as follows:
• Historical year – 2022
• Base year – 2023
• Forecast period – 2024 to 2032

Key Takeaways
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country-level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand-side and supply-side analysis of the market.

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