市场调查报告书
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1451761
2024-2032 年按解决方案类型、部署模型、企业规模、最终用户和区域分類的药品品质管理软体市场报告Pharmaceutical Quality Management Software Market Report by Solution Type, Deployment Model, Enterprise Size, End User, and Region 2024-2032 |
2023年全球药品品质管理软体市场规模达12亿美元。展望未来, IMARC Group预计到2032年市场规模将达到28亿美元,2024-2032年复合年增长率(CAGR)为9.17%。整个製药行业数位化程度的不断提高、遵守监管指南的需求不断增加以及供应链日益复杂,是推动市场发展的一些关键因素。
药品品质管理软体是一种旨在管理和维护药品整个产品生命週期品质的软体系统。它是一个全面的系统,可帮助製药公司确保其产品符合最高的品质和安全标准,并符合监管要求。它有助于管理与品质管理流程相关的文件的创建、修订和分发,例如标准作业程序 (SOP)、工作指示和政策。它还追踪员工培训和认证,确保所有人员都经过培训并有资格执行分配的任务。此外,它还管理製造过程中可能出现的不合格情况、偏差和事件,以及解决不合格情况并防止其再次发生所需的纠正和预防措施 (CAPA)。由于这些特性,许多公司正在采用药品品质管理软体来简化其品质管理流程,减少错误和不一致,并提高对监管要求的合规性。
该市场主要是由製药业数位化的不断发展所推动的。如今,公司正在使用云端运算、人工智慧 (AI) 和机器学习等先进技术来自动化任务、改进资料分析并增强整个组织的协作和沟通。此外,遵守监管要求的需求激增是另一个主要的成长诱导因素。製药业受到严格的监管要求和标准的约束,例如良好生产规范 (GMP) 和良好实验室规范 (GLP),这要求公司在其产品和製程中保持高水准的品质。药品品质管理软体可帮助公司遵守这些要求并展示其对品质的承诺。除此之外,製药业拥有复杂的供应链,涉及多个供应商、製造商和分销商。药品品质管理软体可以帮助公司管理这种复杂性,并确保供应链中涉及的所有各方都符合所需的品质标准。此外,对高品质和安全药品的需求不断增长,对药品品质管理软体的需求也在增加,该软体使公司能够确保其产品符合最高的品质和安全标准,降低产品召回、不良事件和风险的风险。名誉损害。考虑到这些因素,预计未来几年市场将出现积极成长。
The global pharmaceutical quality management software market size reached US$ 1.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 2.8 Billion by 2032, exhibiting a growth rate (CAGR) of 9.17% during 2024-2032. The rising digitization across the pharmaceutical industry, the surging need to comply with regulatory guidelines, and the increasing complexity of supply chains represent some of the key factors driving the market.
Pharmaceutical quality management software is a software system that is designed to manage and maintain the quality of pharmaceutical products throughout the entire product lifecycle. It is a comprehensive system that helps pharmaceutical companies to ensure that their products meet the highest standards of quality and safety, and comply with regulatory requirements. It assists in managing the creation, revision, and distribution of documents related to quality management processes, such as standard operating procedures (SOPs), work instructions, and policies. It also tracks employee training and certification, ensuring that all personnel are trained and qualified to perform their assigned tasks. In addition, it manages non-conformances, deviations, and incidents that may arise during the manufacturing processes and corrective and preventive actions (CAPAs) that are required to address non-conformances and prevent their recurrence. Owing to these properties, various companies are adopting pharmaceutical quality management software to streamline their quality management processes, reduce errors and inconsistencies, and improve compliance with regulatory requirements.
The market is primarily driven by the rising digitization in the pharmaceutical industry. Nowadays, companies are using advanced technologies, such as cloud computing, artificial intelligence (AI), and machine learning, to automate tasks, improve data analytics, and enhance collaboration and communication across the organization. In addition, the surging need to comply with regulatory requirements represents another major growth-inducing factor. The pharmaceutical industry is subject to strict regulatory requirements and standards, such as good manufacturing practice (GMP) and good laboratory practice (GLP), which require companies to maintain a high level of quality in their products and processes. Pharmaceutical quality management software helps companies to comply with these requirements and demonstrate their commitment to quality. Besides this, the pharmaceutical industry has a complex supply chain, involving multiple suppliers, manufacturers, and distributors. Pharmaceutical quality management software helps companies to manage this complexity and ensure that all parties involved in the supply chain meet the required quality standards. Moreover, the escalating demand for high-quality and safe pharmaceutical products is escalating the demand for pharmaceutical quality management software that enables companies to ensure that their products meet the highest standards of quality and safety, reducing the risk of product recalls, adverse events, and reputational damage. On account of these factors, the market is expected to witness positive growth in the coming years.
IMARC Group provides an analysis of the key trends in each segment of the global pharmaceutical quality management software market, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on solution type, deployment model, enterprise size, and end user.
Corrective Action Preventive Action (CAPA) Management
Audit Management
Document Management
Change Management
Training Management
Risk Management
Complaints Management
Regulatory and Compliance Management
Non-Conformances Handling
Supplier Quality Management
Inspection Management
Equipment Management
Others
The report has provided a detailed breakup and analysis of the pharmaceutical quality management software market based on the solution type. This includes corrective action preventive action (CAPA) management, audit management, document management, change management, training management, risk management, complaints management, regulatory and compliance management, non-conformances handling, supplier quality management, inspection management, equipment management, and others.
On-Cloud
Web-Based
On-Premises
A detailed breakup and analysis of the pharmaceutical quality management software market based on the deployment model has also been provided in the report. This includes on-cloud, web-based, and on-premises.
Small and Medium-sized Enterprises
Large Enterprises
The report has provided a detailed breakup and analysis of the pharmaceutical quality management software market based on the enterprise size. This includes small and medium-sized enterprises, and large enterprises.
Pharmaceutical, Life Sciences, and Biotechnology Companies
Contract Research Organizations
Others
A detailed breakup and analysis of the pharmaceutical quality management software market based on the end user has also been provided in the report. This includes pharmaceutical, life sciences, and biotechnology companies, contract research organizations, and others. According to the report, pharmaceutical, life sciences, and biotechnology companies accounted for the largest market share.
North America
United States
Canada
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America was the largest market for pharmaceutical quality management software. Some of the factors driving the North America pharmaceutical quality management software market include increasing regulatory compliance requirements, growing complexity of pharmaceutical supply chains, and escalating demand for automation and digitization.
The report has also provided a comprehensive analysis of the competitive landscape in the global pharmaceutical quality management software market. Detailed profiles of all major companies have also been provided. Some of the companies covered include AssurX Inc., ComplianceQuest, Dassault Systemes SE (Dassault Group), ETQ LLC (Hexagon AB), Ideagen, IQVIA Inc., Mastercontrol Inc., Qualio, Veeva Systems Inc, etc. Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.