Pharmaceutical Quality Management Systems Market Size - By Solution Type (Regulatory & Compliance Management, Document Management, Audit Management), Deployment Model (Cloud-based), Enterprise Size (Large Enterprise), Global Forecast, 2023 - 2032

Pharmaceutical Quality Management Systems  Market Size

Pharmaceutical Quality Management Systems Market size accounted for USD 1.4 billion in 2022 and is estimated to grow at 13.1% to reach USD 4.5 billion by 2032 due to the increasing cost of drugs manufacturing.
 

With the growing demand for high-quality drugs and an increasing awareness pertaining to the importance of quality in healthcare, pharmaceutical companies are prioritizing quality management systems to ensure patient safety and maintain high standards. Also, in the face of increasing cost pressures, quality management systems present pharmaceutical companies with a valuable solution for enhancing operational efficiency and decreasing expenses.
 

Pharmaceutical quality management systems (QMS) refer to a set of processes, procedures, and resources implemented by pharmaceutical companies to ensure the quality, safety, and efficacy of their products. These systems are designed to comply with regulatory requirements and industry standards throughout the entire product lifecycle, from research and development to manufacturing, distribution, and post-market surveillance.
 

COVID-19 Impact

The COVID-19 pandemic had a positive impact on the pharmaceutical quality management systems (QMS) market. As the global healthcare industry faced unprecedented challenges, pharmaceutical manufacturers increasingly recognized the significance of maintaining high-quality standards. This led to a heightened demand for robust QMS solutions to ensure the safety, efficacy, and quality of drugs and medical products. Furthermore, the adoption of quality management systems helped companies to enhance their quality management processes, implement risk mitigation strategies, and ensure compliance with rapidly changing regulations.
 

Pharmaceutical Quality Management Systems Market Trends

Increasing demand to comply with regulatory requirements is one of the significant progression drivers for the market. Pharmaceutical industries are subject to strict regulations, owing to the direct impact of drugs, medical devices, and medications on consumer health. Moreover, small, and mid-sized pharmaceutical businesses are concentrating on following laws to produce better products and maintain their competitiveness in the business.
 

Pharmaceutical Quality Management Systems Restraint

High implementation and maintenance costs may hamper the pharmaceutical quality management systems market development. Implementing a QMS solution involves expenses related to software licensing, customization, training, and integration with existing infrastructure. Additionally, ongoing maintenance costs include system upgrades, technical support, and regular updates to comply with evolving regulatory requirements. These costs can be burdensome for smaller pharmaceutical companies or those with limited budgets.
 

Pharmaceutical Quality Management Systems Solution Type Segmentation

By solution type, the pharmaceutical quality management systems market is classified into regulatory & compliance management, document management, supplier quality management, corrective action preventive action (CAPA) management, audit management, change management, training management, complaints management, non-conformances handling, inspection management, and other solution types. The regulatory & compliance management segment accounted for 18.7% of the market share in 2022. The regulatory & compliance management solutions empower pharmaceutical companies to streamline their regulatory processes, enhance data integrity, and minimize the possibility of non-compliance. Also, these solutions offer a centralized platform for efficiently managing tasks associated with regulatory and compliance requirements, including activities such as change management, document control, audit management, and deviation management.
 

Pharmaceutical Quality Management Systems Market Analysis

Based on deployment model, the pharmaceutical quality management systems market is segmented into cloud-based and on-premise. The cloud-based segment is expected to register around USD 2 billion by 2032. The cloud-based deployment model provides considerable advantages compared to traditional on-premises software or paper-based systems. The cloud-based technology simplifies the transition to an electronic QMS and enables remote access within a highly secure environment. Additionally, the model offers easy scalability, allowing businesses to increase the number of users and storage in response to changing business requirements.
 

Based on enterprise size, the pharmaceutical quality management systems market is segmented into large enterprise and small & medium enterprise (SME). The large enterprise segment accounted for 62% of the market share in 2022. Extensive operations, complex supply chains, and stringent compliance requirements in large enterprises will contribute to the industry gains. Furthermore, large enterprises often operate globally, making it crucial to have comprehensive quality management systems in place to ensure compliance across multiple jurisdictions.
 

North America pharmaceutical quality management systems market accounted for 42.3% market share in 2022. The region's well-established pharmaceutical industry, rigorous regulatory framework, and emphasis on quality standards will drive the demand for pharmaceutical quality management systems. For instance, in January 2021, Arena Solutions, Inc. partnered with Rimsys Inc., a developer of regulatory information management (RIM) software platforms to offer an end-to-end quality and product-centric regulatory solution. This partnership helped the company to expand its product offering.
 

Pharmaceutical Quality Management Systems Market Share

Major market players operating in the pharmaceutical quality management systems market include :

• ANTARES VISION S.p.A
• AssurX Inc.
• AXSource
• ComplianceQuest, ETQ, LLC
• Sparta Systems, Inc.
   

Pharmaceutical Quality Management Systems Industry News:

• In January 2023, Palantir Technologies Inc., one of the leading builders of operating systems for organizations across the healthcare sector, launched a fit-for-purpose quality management system. This system helps its life sciences customers to meet GxP requirements. This strategy helped the company to expand its product portfolio and customer base.
   
• In May 2020, ComplianceQuest acquired LifeGuard Solutions, a salesforce native environmental, health & safety (EHS) solution provider. Through this acquisition, ComplianceQuest expanded its product portfolio to include a fully integrated EHS solution to help companies achieve compliance, improve quality and risk management, maximize health and safety in the workplace. This strategy helped the company to expand and grow.
   

The pharmaceutical quality management systems market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Solution Type

• Regulatory and Compliance Management
• Document Management
• Supplier Quality Management
• Corrective Action Preventive Action (CAPA) Management
• Audit Management
• Change Management
• Training Management
• Complaints Management
• Non-conformances Handling
• Inspection Management
• Other Solution Types

By Deployment Model

• Cloud-based
• On-premise 

By Enterprise Size

• Small and Medium Enterprise (SME)
• Large Enterprise

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East & Africa