REDDING, Calif., July 15, 2024 /PRNewswire/ — According to a new market 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,’ published by Meticulous Research®, the pharmaceutical quality management systems market is projected to reach $4.59 billion by 2031 at a CAGR of 15.6% from 2024 to 2031.

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Pharmaceutical Quality Management Systems (QMS) are sets of procedures and practices that contribute to the quality of pharmaceutical products. Quality management systems facilitate 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.

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. 

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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. Policymakers are increasingly recognizing personalized medicines, 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.

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 increased by more than two-fold 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.

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.).

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The global pharmaceutical quality management systems market study presents historical market data in terms of values (2022 and 2023), estimated current data (2024), and forecasts for 2031. 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 the market at the regional and country 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. 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. However, the CAPA management segment is expected to register the highest CAGR during the forecast period. This segment’s growth can be attributed to the increasing demand for Corrective and Preventive Action (CAPA) management in the pharmaceutical industry, driven by the need to 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.

Based on deployment mode, the pharmaceutical quality management systems market is segmented into cloud/web-based and on-premise. In 2024, the cloud/web-based segment is expected to account for the largest share of 79.4% of the pharmaceutical quality management systems market. The large market share of this segment can be attributed to the advantages offered by cloud/web-based deployments over on-premise deployments, such as cost minimization, easy accessibility, adjustability, and updated cloud systems.

Based on end user, the pharmaceutical quality management systems market is segmented into pharmaceutical and biotechnology companies, contract development and manufacturing organizations/contract research organizations, and research laboratories. The pharmaceutical and biotechnology companies segment is expected to register the highest CAGR during the forecast period. The growth of this 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.

Geographically, in 2024, North America is expected to account for the largest share of 38.4% of the pharmaceutical quality management systems market. North America’s large market share can be attributed to the increasing use of advanced digital tools approved by regulatory authorities in the region’s pharmaceutical sector to improve overall development & manufacturing outcomes and the presence of major market players in the region.

The report also includes an extensive assessment of the key growth strategies adopted by leading market players over the past few years (2021–2024). 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 managementDocument ManagementCAPA ManagementRisk & Compliance ManagementInspection ManagementAudit ManagementSuppliers & Materials ManagementTraining ManagementChange ManagementOther 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-basedOn-Premise

Pharmaceutical Quality Management Systems Market Assessment—by End User

Pharmaceutical and Biotechnology CompaniesCDMO/CROResearch Laboratories

Pharmaceutical Quality Management Systems Market Assessment—by Geography

North AmericaU.S.CanadaEuropeGermanyFranceU.K.ItalySpainIrelandBelgiumNetherlandsRest of EuropeAsia-PacificChinaJapanIndiaSingaporeMalaysiaPhilippinesVietnamRest of Asia-PacificLatin AmericaBrazilMexicoRest of Latin AmericaMiddle East & Africa

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