Pharmaceutical Quality Management Systems Market
Number of pages: 100 | Report Format: PDF | Published date: April 18, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 1.48 billion |
|
Market Size Value in 2031 |
US$ 4.44 billion |
|
CAGR |
10.5% |
|
Base Year For Estimation |
2022 |
|
Forecast Period |
2023 to 2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Deployment, Solution Type, End User, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global pharmaceutical quality management systems market was valued at US$ 1.48 billion in 2022 and is expected to register a revenue CAGR of 10.5% to reach US$ 4.44 billion by 2031.
Pharmaceutical Quality Management Systems Market Fundamentals
Pharmaceutical quality management systems (QMS) refer to integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured, and distributed in compliance with regulatory requirements and meet the desired quality standards. The purpose of QMS is to ensure that pharmaceutical products are safe, effective, and reliable and meet the needs of patients.
Pharmaceutical QMS encompasses several areas, including quality planning, quality assurance, quality control, and quality improvement. Quality planning involves defining quality objectives, setting quality standards, and establishing the necessary processes and resources to achieve them. Quality assurance involves monitoring and evaluating whether the operational processes and activities meet the defined quality standards. Quality control involves testing, inspecting, and validating the products to verify that they meet quality standards. Quality improvement includes identifying areas of non-conformance, inefficiencies, and opportunities for improvement in the quality management system technologies.
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Pharmaceutical Quality Management Systems Market Dynamics
With the increasing demand for high-quality drugs and a growing awareness of the importance of quality in healthcare, pharmaceutical companies prioritize quality management systems to maintain high standards and ensure patient safety, which is the primary driver of the global pharmaceutical quality management systems market revenue growth. The pharmaceutical industry is experiencing significant growth, driven by increased healthcare spending and the development of new drugs. This growth is driving the adoption of quality management systems to manage the difficulty of pharmaceutical manufacturing processes. Furthermore, the pharmaceutical industry is adopting new technologies to improve efficiency, reduce costs, and enhance quality. This includes automated quality management systems, digitalization of processes, and integration of data analytics, further fueling the revenue growth of the global pharmaceutical quality management systems market. Moreover, the pharmaceutical industry is becoming increasingly global, with companies operating in multiple countries and regions through subsidiaries and local manufacturing units. This is driving the adoption of global quality management systems to ensure consistency and compliance across different locations.
However, implementing and maintaining a pharmaceutical quality management system can be expensive, particularly for small to mid-sized companies. This may limit adoption, especially in developing countries or companies with limited budgets. Furthermore, implementing a quality management system can require significant changes to a company's processes and culture, which may be met with resistance from employees or management. Additionally, cybersecurity concerns, privacy considerations, and the complexity of regulatory compliance are some restraints impeding the overall market revenue growth.
Pharmaceutical Quality Management Systems Market Ecosystem
The global pharmaceutical quality management systems market is analyzed from four perspectives: deployment, solution type, end-user, and region.
Pharmaceutical Quality Management Systems Market by Deployment
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Based on the deployment, the global pharmaceutical quality management systems market is segmented into on-cloud, and on-premises.
The on-cloud segment dominated the market with the largest revenue share in 2022, attributed to the need for pharmaceutical companies to manage their quality processes more efficiently and effectively while reducing costs and increasing flexibility. The on-cloud deployment refers to cloud-based software solutions hosted on remote servers and accessed via the Internet. These solutions provide pharmaceutical companies with a flexible and scalable way to manage their quality processes without requiring extensive IT infrastructure or in-house technical expertise. Cloud-based solutions eliminate the need for on-premise servers and hardware, reducing IT infrastructure costs for pharmaceutical companies. They can be easily scaled up or down as per the business needs of pharmaceutical companies, allowing them to adapt to changing requirements without incurring additional costs. They can be accessed from anywhere with an internet connection, making it easier for pharmaceutical companies to manage their quality processes remotely or from multiple locations. Additionally, cloud-based solutions offer advanced security features such as data encryption, user authentication, and regular backups, ensuring that pharmaceutical companies' sensitive data is safe and secure. These features contribute to the dominance of the on-cloud pharmaceutical quality management systems market.
The on-premise segment accounts for the largest revenue share of the market. The on-premise deployment refers to software solutions installed and run on servers within a company's physical premises. On-premise solutions require companies to purchase, install, and maintain the hardware and software to run the system. With an on-premise solution, companies have complete control over their data and can ensure that it is stored securely and meets regulatory requirements. They can be customized to meet a company's specific needs, including integrating with existing systems or adapting to unique business processes. On-premise pharmaceutical quality management systems typically have higher uptime rates and fewer potential points of failure compared to cloud-based solutions, as the system is not dependent on an internet connection or a third-party provider.
Pharmaceutical Quality Management Systems Market by Solution Type
Based on the solution types, the global pharmaceutical quality management systems market is segmented into corrective action preventive action (CAPA) management, audit management, document management, change management, training management, complaints management, regulatory and compliance management, non-conformances handling, supplier quality management, inspection management, and others.
The regulatory and compliance management segment dominated the market with the largest revenue share in 2022. Regulatory and compliance management solutions refer to software solutions that help pharmaceutical companies comply with regulatory requirements and guidelines, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), as well as other industry-specific regulations and standards. Regulatory and compliance management solutions enable pharmaceutical companies to streamline their regulatory processes, improve data integrity, and reduce non-compliance risk. These solutions provide a centralized platform for managing regulatory and compliance-related tasks, such as document control, change management, audit management, and deviation management. These solutions also provide a centralized repository for managing documents related to regulatory compliance, such as standard operating procedures (SOPs), work instructions, and policies. Furthermore, they enable pharmaceutical companies to manage deviations from established quality processes, ensuring that deviations are properly investigated, documented, and addressed. These overall influences contribute to the revenue growth of the regulatory and compliance management segment.
The corrective action preventive action (CAPA) management segment also accounted for a notable pharmaceutical quality management systems market revenue share, owing to the growing need of pharmaceutical companies to maintain high product quality and ensure compliance with regulatory requirements. CAPA management solutions are software solutions that help pharmaceutical companies identify and address quality issues and implement preventive measures to avoid similar issues in the future. CAPA management solutions enable pharmaceutical companies to manage their quality processes in a structured and systematic manner, ensuring that quality issues are properly investigated, documented, and addressed. These solutions provide a centralized platform for managing CAPA-related tasks, such as root cause analysis, corrective actions, preventive actions, and effectiveness checks. They enable pharmaceutical companies to conduct a systematic investigation to identify the root cause of quality issues, helping to address the underlying cause of the problem. Additionally, they provide a platform for monitoring and tracking the effectiveness of CAPA-related actions, ensuring that the implemented solutions are effective in addressing the identified quality issues. These aspects contribute to the revenue growth of the corrective action preventive action management segment.
Pharmaceutical Quality Management Systems Market by End User
Based on the end user, the global pharmaceutical quality management systems market is segmented into pharmaceutical companies and contract research organizations (CROs).
The pharmaceutical companies segment accounts for the largest revenue share in the pharmaceutical quality management systems market with the largest revenue share in 2022, attributed to the need to maintain high-quality standards, comply with regulatory requirements, and ensure the safety and efficacy of pharmaceutical products. Pharmaceutical companies have a strong incentive to maintain high-quality standards to ensure the safety and efficacy of their products, comply with regulatory requirements, and maintain public trust. Quality management software solutions can help pharmaceutical companies achieve these goals by providing tools for managing and tracking quality processes, identifying and addressing quality issues, and maintaining compliance with regulatory requirements. These factors contribute to the revenue growth of the pharmaceutical companies segment.
Pharmaceutical Quality Management Systems Market by Region
Based on region, the global pharmaceutical quality management systems market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominated the global pharmaceutical quality management systems market with the largest revenue share in 2022, attributed to the widespread usage of advanced digital technologies permitted by regulatory bodies in the pharmaceutical sector to improve overall process results. Additionally, companies across the region are continuously involved in launching new and improved products, which are also expected to improve the pharmaceutical quality management systems market outlook. For instance, in January 2023, Palantir Technologies Inc., a leading provider of operating systems for healthcare organizations, announced the release of a purpose-built Quality Management System to assist its life sciences clients utilizing the Foundry platform in meeting GxP standards. Palantir Foundry is intended to assist enterprises in improving their operations by establishing a centralized operating system for their data, resulting in better data-driven decision-making. Life sciences customers can benefit from the same power and flexibility of Foundry while remaining in compliance with 21 CFR Part 11 requirements thanks to Palantir's GxP certification package.
Pharmaceutical Quality Management Systems Market Competitive Landscape
The prominent players operating in the global pharmaceutical quality management systems market are:
Pharmaceutical Quality Management Systems Market Strategic Developments
Pharmaceutical Quality Management Systems (QMS) is a set of integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured, and distributed in compliance with regulatory requirements and meet the required quality standards.
The expected size of the global pharmaceutical quality management systems market in 2031 is US$ 4.44 billion.
The revenue CAGR of the global pharmaceutical quality management systems market during the forecast period will be 10.5% from 2023 to 2031.
Cybersecurity concerns, privacy concerns, and the complexity of regulatory compliance are factors restricting the global pharmaceutical quality management systems market revenue growth to its full potential.
Some prominent players operating in the global pharmaceutical quality management systems market are Dassault Systemes, Honeywell International Inc., Qualio — QMS for Life Sciences, Veeva Systems Inc., and AXSource, AssurX Inc.
*Insights on financial performance are subject to the availability of information in the public domain