Redding, California, Sept. 21, 2023 (GLOBE NEWSWIRE) -- According to a new market research report titled, ‘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,’ 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.
Pharmaceutical Quality Management Systems (QMS) are sets of procedures and practices that contribute to the quality of pharmaceutical products. Quality management systems reflect regulatory requirements relevant to industries and companies. ICH Q10 and ISO 9001:2015 are some of the most important quality standards and guidelines for the pharmaceutical industry. Quality Management systems have positively impacted the global pharmaceutical market and brought about significant changes in the pharmaceutical industry.
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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.
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.
Increasing Inclination Towards Personalized Medicine is Driving the Demand for Pharmaceutical Quality Management Systems
Advances in proteomic and genomic sciences have boosted the development of personalized therapies. Personalized medicine is an emerging approach in today’s healthcare systems. A wave of personalized medicines has entered mainstream clinical practices, changing the methods for identifying, classifying, and treating diseases. Personalized medicines are increasingly being recognized by policymakers, driving innovative approaches to develop and produce personalized therapies. Personalized therapies are designed according to patients’ unique requirements, which makes it difficult to manufacture them, maintain quality control, and guarantee consistency and repeatability. Patient information, such as genetic and clinical data, is crucial to developing personalized treatments. Large data volumes can be difficult to handle and analyze, necessitating powerful data management systems and analytical tools.
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As per a report by the Personalized Medicine Coalition, the number of personalized medicines on the market is growing rapidly. In the U.S., the number more than doubled during 2016–2020. Personalized medicines accounted for 39% of the U.S. FDA’s new drug approvals in 2020, increasing from 5% in 2005. Further, the use of biomarkers in clinical trials increased from 18% in 2000 to 61% in 2019, generating opportunities to produce personalized therapies and driving the demand for pharmaceutical QMS. In June 2020, Infosys Limited (India) launched a platform for personalized medicine based on its SCI platform, SAP S/4HANA, SAP Analytics Cloud solution, and SAP C/4HANA, to address regulatory compliance, patient management, and supply chain issues.
Some of 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.)
The global pharmaceutical quality management systems market is segmented by solution type, deployment mode, and end user. The study also evaluates industry competitors and analyzes their market share at global and regional levels.
Based on solution type, the pharmaceutical quality management systems market is segmented into 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. 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.
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Based on deployment mode, the global pharmaceutical quality management systems market is segmented into cloud/web-based and on-premise. 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 cloud/web-based deployments offer several advantages 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.
Based on end user, the global pharmaceutical quality management systems market is segmented into pharmaceutical and biotechnology companies, contract development and manufacturing organization/contract research organization, and research laboratories. 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.
In 2023, North America is expected to account for the largest share of the pharmaceutical quality management systems market. North America’s large market share is primarily attributed to the increasing use of advanced digital tools approved by regulatory authorities in the region’s pharmaceutical sector to improve overall development and manufacturing outcomes and the presence of major market players in the region.
The report also includes an extensive assessment of the key strategic developments of leading market participants in the industry over the past years (2020–2022). In the last couple of years, the global pharmaceutical quality management systems market witnessed several strategic developments.
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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 & 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
- CDMO/CRO
- 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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