Medical QMS Software Market Size & Outlook, 2025-2033

Medical Qms Software Market Size

The global medical QMS software market size was valued at USD 587.99 billion in 2024 and is expected to grow from USD 702.66 billion in 2025 to reach USD 4117.56 billion by 2033, growing at a CAGR of 15% during the forecast period (2025-2033).

 Quality Management System (QMS) is a codified framework that documents processes, procedures, and responsibilities for accomplishing quality objectives and safety compliance in pharmaceutical and life science-related activities. These medical care and pharmaceutical ventures must follow strict guidelines as they are concerned with the patient's life and safety.

Subsequently, a QMS is essential to keep up with the updated databases, quality compliances, reduce overheads, enhance productivity, and manage the healthcare facility's daily operations. The global medical QMS software market is divided into solution types, deployment types, end-users, and regions.

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Medical Qms Software Market Growth Factors

A Need to Pare Medical Errors to Ascend the Demand for Qms

The medical QMS software is utilized in primary business operations and processes. QMS helps avoid senseless blunders, make process corrections, and improvise as per the feedback. The medical facilities cannot provide poor quality services as medical errors can cost a fortune. In the US, fatal incidents are often reported due to medical errors. 

QMS organizes various databases efficiently so that the concerned person can access the files timely and update any equal information. Virtual Reality and augmented reality show an incredible breadth in the headway of existing innovations in this field. These technologies are considered to be very expensive. However, the initial expenses of adopting these technologies will be comparatively lesser than the time and cash saved from their usage.

Expanded Risk of Data Security

Data breaches and critical data loss are significant limitations in this market. From 2009 to 2019, around 3000 data breaches were accounted for. This brought about the disclosure of 230,954,151 confidential medical service records. In 2018, an average of 1 data breach was accounted for per day, whereas in 2020, it went up to 1.76 per day. Thus, data security issues are rising day by day. These data breaches can lead to significant losses and harm the reputation of health care facilities. Hence, they need to be avoided at all costs. This large number of network safety weaknesses have hampered the development of the market. 

Technical Advances to Create Booming Interest in Qms

The utilization of trend-setting developments has given the medical QMS market many chances. The advancements in technologies have developed the security frameworks and security measures in medical care offices. The quality management software market is expected to observe massive development, given the rising interest for viable administration and operational efficiency in hospitals and other health care centers. 

The portability and adaptability presented by quality administration software drive the interest in QMS software. The rising demand for cloud-based QMS software due to versatility and openness is turning out to be a progressive way of managing healthcare facilities. Attributable to the strict guidelines, installed plans of action, and complex methods in the administration, logistics, and operations, collecting patient data, the execution of medical QMS has expanded worldwide.

Regional Analysis

Asia-Pacific: Dominant Region

North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are the market segments divided geographically. The regional analysis of the medical QMS software market has been directed based on a few essential perspectives, for example, regional market development drivers and restrictions, local market income, and development rate of the overall industry. 

Asia-Pacific is the leading market for medical QMS software and is predicted to grow because of recent product developments by major sector players. The growth of the Asia-Pacific medical QMS software market is determined by a few emerging economies, including India, China, and Japan. It is predicted to grow at an elevated CAGR of 14.35% by 2029. 

Europe: Growing Region

Europe and America are other significant markets for the QMS software and are expected to grow at a CAGR of 14.24 % and 14.13%, respectively. Also, ISO 9000 enrolment has turned into a requirement in the European Union, Asia-Pacific, the US, and Canada, increasing the demand for the QMS software market.

Solution Type Anlysis

The Audit Management segment dominates the medical QMS software market. Audit management software ensures compliance with regulatory standards by automating audit processes, managing audit trails, and facilitating internal and external audits. It is well-established due to the critical need for healthcare providers and manufacturers to adhere to stringent quality and safety regulations, thus preventing costly non-compliance penalties and enhancing operational efficiency. This widespread requirement for regulatory adherence drives the robust adoption of audit management solutions in the medical QMS sector.

Deployment Type Analysis

The cloud-based segment dominates the medical QMS software market due to its scalability, cost-effectiveness, and ease of access. Established through increasing demand for remote accessibility and real-time data sharing, cloud solutions offer enhanced collaboration and compliance features. This trend is driven by healthcare organizations seeking efficient, adaptable systems to streamline operations and improve patient outcomes.

End-Users Analysis

In the medical QMS software market, large enterprises dominate the segment. These companies, with extensive resources and complex regulatory requirements, prioritize robust quality management systems to ensure compliance and enhance operational efficiency. Large enterprises often have the budget and need for comprehensive QMS solutions, driving their adoption and establishment in the market. Their focus on maintaining high standards in product quality and patient safety reinforces their leading position in this segment.

Impact of Covid-19

The COVID-19 pandemic has created havoc in the entire world. All the sectors around the world were drastically affected. There was chaos in the healthcare sector due to the increasing number of patients worldwide. An automatic organization system had become a need for the hour in this situation. The world healthcare facilities were not prepared for this COVID-19 outbreak, and hence the demand for these systems quickly increased.

After the pandemic, the hospitals realized the need to have quality management systems for administration and overall operations. In such a difficult time, medical errors should be avoided as the number of fatal incidents was already surging in the second wave. It is also crucial for healthcare facilities to keep up with the regulatory landscape concerning the use of the software. Continuous training to understand these changes and requirements due to developing technologies has become necessary post-pandemic. Due to these reasons, the need for medical QMS software will rise in the forecast period. 

List of key players in Medical QMS Software Market

1. Almond,
2. Plex Systems Inc.,
3. PTC Inc.,
4. Greenlight Guru,
5. QAD Inc.,
6. Qualio,
7. Insilicotrials Technologies,
8. QMS Wrapper,
9. Sparta Systems,
10. Siemens AG,
11. Qualys,
12. among others. 

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Recent Developments

• June 2021– Rockwell Corporation acquired Plex Systems at USD 2.22 billion from Francisco Partners
• January 2021 – Greenlight Guru announced a strategic partnership with Nelson Labs.
• January 2021 – PTC Inc. had completed the acquisition of Arena Solutions, a market leader in SaaS and Product lifestyle management (PLM) solutions, thus expanding to the product development market further. The buyout cost USD 715 million.
• August 2021 – Qualio announced the launch of design controls for medical devices and software as a medical device (SaMD) company.
• March 2021 – Siemens Digital Industries Software has announced Teamcenter Quality Software, a new suite of solutions that provide a closed-loop approach for quality management from design to manufacturing on the shop floor and back again. 
• April 2021 – Plex Sytems, the leader in cloud-delivered manufacturing solutions, announced that Quality Management Systems (QMS) is available as a standalone offering. Plex QMS helps manufacturers adhere to industry compliance, regulations, and standards such as FMEA, PPAP, SQF, and BRC to avoid costly product recalls.