The global quality management software market size was valued at USD 11.71 billion in 2024 and is projected to reach from USD 12.93 billion in 2025 to USD 28.70 billion by 2033, growing at a CAGR of 10.48% during the forecast period (2025-2033).
The increasing functionality of quality management software (QMS) solutions and the integration of artificial intelligence and machine learning techniques are driving market expansion throughout the forecast period.
The QMS market is expected to grow significantly due to the rising demand for effective organizational process management and the requirement to match customer expectations in a highly competitive market.
Further, swift technological advancements in the IT and telecom sectors and the improved automation in the transportation and logistics industries add to market demand. Out-of-specification test findings, processing of non-conformances, calibration, assuring compliance, and a centralized system that ensures linkage to enterprises' ERP and CRM systems are all features of QMS software. These features, along with benefits, such as reduced operating costs and business process optimization, are expected to drive QMS adoption across a wide range of sectors.
In applications such as document control and non-conformance resolution, QMS provides greater flexibility and mobility. Demand for cloud-based QMS solutions across end-use industries is expected to drive market expansion due to indicated scalability and accessibility.
The healthcare quality management market is expanding steadily due to rising healthcare expenses, an increased volume of unstructured data, and a global aging population.
As new technology emerges, the cost of healthcare services rises, impacting the performance of healthcare providers in developing or undeveloped countries. Governments are making efforts to achieve a standard level of quality. Such government directives assist in the global expansion of the healthcare quality management industry. However, increased quality reporting system prices and data security risks connected with quality management software impede market expansion.
Quality management in healthcare strives to enhance treatment efficacy and patient satisfaction with the service. Quality management in health care is becoming more vital as the aging population and healthcare expenses rise. A health care system consists of small and big enterprises, such as pharmacies, medical clinics, and hospitals, and the components required to offer excellent service for the system to function correctly.
Study Period | 2021-2033 | CAGR | 10.48% |
Historical Period | 2021-2023 | Forecast Period | 2025-2033 |
Base Year | 2024 | Base Year Market Size | USD 11.71 Billion |
Forecast Year | 2033 | Forecast Year Market Size | USD 28.70 Billion |
Largest Market | North America | Fastest Growing Market | Asia Pacific |
In 2020, North America dominated the global market with a share of over 40%. In North America, the Patient Protection and Accountable Care Act (PPACA) of 2010 was enacted to provide excellent healthcare facilities and compel compliance with quality standards. Meanwhile, SaaS companies in Europe delivering solutions on cloud-based platforms must adhere to the European Data Protection Directive (Directive 95/46/EC) and the General Data Protection Regulation.
The European Union's Medical Device Regulation (EU MDR), which superseded the Medical Device Directive in 2020, requires medical organizations to meet standards such as device categorization and upgrading quality management systems (QMS). Over the projected period, these factors are expected to considerably enhance the QMS market growth in North America and Europe.
Asia-Pacific is expected to be the fastest-expanding regional market, owing to rising awareness of standards and quality in emerging markets such as China and India. Further, ISO 9000 registration has become a requirement for conducting business with firms and government agencies in the European Union, Asia-Pacific, the United States, and Canada.
We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports
The requirement for healthcare providers to decrease spiraling operational costs, increased demand for excellent healthcare, government policies to encourage value-based treatment, and an increasing number of claims denied by insurers all contribute to a large part of this market.
As healthcare data become more diverse by the day, business intelligence has a sturdy effect on quality management in healthcare. This problem of healthcare providers is addressed by business intelligence, which deals with massive amounts of data and makes it simpler for providers to manage such data.
The healthcare industry benefits from business intelligence (BI) by getting insights, lowering expenses, boosting revenue, and enhancing patient safety. By offering evidence-based clinical decision-making, BI may also aid in the improvement of patient care and outcomes. This assists clinicians in monitoring and predicting patient diagnoses. Due to continual development, evidence-based medications and appropriate data usage are influencing the quality of the healthcare industry.
In 2020, the complaint handling segment held a market share of over 15%. Effective complaint handling serves to anticipate client expectations and boost brand equity. In order to address consumer complaints more effectively and efficiently, businesses use standard complaint handling tools and processes. These elements are estimated to be noteworthy drivers of category growth.
For regulated life science and high-tech environments, a calibration management system connects associated maintenance duties and extra quality procedures. By minimizing the number of recalled items, such solutions assist in extending the life of machinery while also saving the firm money. According to Beamex Inc., a calibration software firm, over 75% of organizations in the pharmaceutical sector perform more than 2,000 calibrations every year. Calibration management systems from QMS may assist enterprises in managing instrument calibration operations and associated paperwork, allowing them to be more productive and efficient.
In 2020, the on-premise segment held a market share of over 60%. Due to the sheer emergence of digitization, many large organizations are migrating from pen and paper-based systems to automated systems, increasing demand for on-premise QMS. On-premise QMS is preferred because it is more secure and enables easy customization to meet the business objectives. Thus, it is extensively used by businesses that require high levels of data protection.
Further, increased concerns about data theft and the lack of essential company information on cloud-based systems are driving demand for on-premise QMS. Over the forecast period, the cloud segment is expected to be the fastest-growing. Cloud technology's increased scalability and flexibility, security concerns, and control over the computer system are some of the primary drivers expected to drive cloud sector growth. In terms of security, data encryption techniques are used to avoid the leak of sensitive QMS data. These encryption techniques are beneficial during data transfer and are expected to boost cloud segment growth throughout the forecast period.
In 2020, the large enterprise segment held a market share of over 60%. The significant purpose for large companies to implement QMS is to save money. Many QMS manufacturers offer separate software packages for large enterprises and medium-sized enterprises. These suites are adapted as per the clients' needs and thus, play a vital role in the selection process.
The mobility and flexibility provided by QMS are increasing its demand among major organizations, resulting in the software's continual development of new functions. Organizations worldwide employ a variety of software and systems to generate massive amounts of data. With ever-increasing data and the increasing need for technologies such as artificial intelligence and machine learning, QMS solutions are expected to meet businesses' growing demands for increased efficiency and productivity in their operations.
In 2020, the manufacturing segment held a market share of over 20%. This expansion is due to strict laws, excessive paperwork, and linked business systems. QMS solutions help manufacturing sectors improve quality via continuous improvement to prevent or swiftly respond to problems such as product recalls and maintain certification compliance. Furthermore, they assist in the prioritization of process improvement initiatives, the comparison of production line capabilities, and the assurance of product conformance. Such elements are expected to be primary drivers of segment growth throughout the forecast period.
Thus, QMS has become increasingly crucial among businesses for accomplishing goals, such as compliance with industry rules, avoiding potential product liability litigation, and retaining customers. For example, QMS assists telecom service providers in supporting their communication strategy by ensuring that telecom goods and services meet the highest quality standards, including TL9000 criteria. Further, vendors are considering the requirements of the Quality Excellence for Suppliers of Telecommunications Forum (QuEST), which supports ongoing improvements in the quality and dependability of telecom goods and services.
Many countries are suffering due to the pandemic; its adverse effects on businesses, individuals, governments, and preventive measures, have significantly affected financial markets, broader economies, and the overall demand for market products.
However, COVID-19 has accelerated health and fitness app adoption into traditional healthcare by integrating wearable technology. The forced lockdowns and remote work has increased awareness of personal health and wellness, and wearable healthcare devices are helping consumers take precautions to prevent infection.
Competitive players focus on acquisitions and mergers, the supply of customized solutions, and the development of businesses into unexplored commercial areas. Additionally, as part of a commercialization plan, corporations are investing heavily in developing new products and platforms with upgraded and better capabilities.
Further, product differentiation and improvements are expected to pave the way for the market development of organizations. For example, MasterControl, Inc. introduced MasterControl Manufacturing Excellence in August 2020 to improve manufacturing processes by improving efficiency and quality. Manufacturers would be able to use the new technology to develop dynamic linkages across corporate systems, processes, data sources, and people to gain a comprehensive perspective on production and quality data.