PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1364701
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1364701
Pharmaceutical Quality Management Software Market size was valued at USD 1,208.1 Million in 2022, expanding at a CAGR of 8.2% from 2023 to 2030.
Pharmaceutical Quality Management System (QMS) is a comprehensive collection of policies, processes, and procedures designed to ensure and maintain uniform and high quality in the production of pharmaceutical products. A robust Pharmaceutical Quality System (PQS) that reflects the applicable requirements can also help pharmaceutical companies to mitigate risks, improve customer satisfaction, and streamline quality processes. Establishing and working according to the Quality Management System (QMS) is a requirement in the pharmaceutical industry. To ensure uniform and high-quality products, companies need to implement a Quality Management Software that reflects the requirements applicable to them. The quality system uses monitoring methods such as Quality Assurance to prevent quality deviations and emphasizes quality system documentation to record all problems and their solutions.
The pharmaceutical industry differs from other industries in that digital transformation is critical for improved patient care, cost-effectiveness, greater transparency, production, and drug development. Many pharmaceutical companies appreciate the implementation of digital processes because the benefits far outweigh the costs. It also improves transparency and has the potential to mitigate the loss of data. The digital process needs to gain momentum in the pharmaceutical industry.
The pharmaceutical industry (PI) is one of the fastest-growing economic sectors with worldwide sales of more than USD1228.45 billion last years in 2020. Since 2017, the pharmaceutical market has grown at the rapid annual rate of 5.8%. Worldwide revenue in the pharmaceutical market was 1143 billion US dollars in the year of 2017 and it will cross 1462 billion US dollars in 2021, According to International Trade Administration (ITA). Furthermore, Growing Regulatory Analysis and The evolution of AI and machine learning provides growth opportunity for the market. Moreover, implementing quality management software necessitates a considerable upfront expenditure, which might hinder the growth of new companies.
The Global Pharmaceutical Quality Management Software Market is segmented on the basis of, Deployment Mode, Solution, and Region.
The market is divided into three categories based on deployment Mode: Cloud-based and On-premises. The On-premise segment is expected to dominate the market. Pharmaceutical Quality Management Software (QMS) on-premises provides a localized solution in which the software and accompanying data are stored on the company's own servers rather than on the cloud.
The market is divided into two categories based on Solution: Data Management, Training management, Supplier management, Regulatory and Compliance Management, Corrective Action Preventive Action (CAPA) Management, Audit Management, Change Management, Non-Conformances Management, Inspection Management, Risk Management and Others. The regulatory and Compliance Management sector dominates the market growth. Pharmaceutical Quality Management Software (QMS) designed for regulatory and compliance management is essential for businesses to ensure that their products meet worldwide quality standards and regulatory regulations.
Geographically, this market is widespread into the regions of North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further divided as per the nations bringing business. North America is projected to drive the growth of market, due to Increasing expenses in drug manufacturing and the rising use of technology in the pharmaceutical industry. North America, particularly the United States, has one of the highest drug development expenses in the world.
Companies in North America are frequently in the forefront of adopting new technologies such as AI, IoT, and advanced data analytics. This proclivity to incorporate technology can greatly assist quality management operations. Estimates, from multiple sources, of average R&D expenditures per new drug range from less than USD1 billion to more thanUSD2 billion. Europe is second largest market for Pharmaceutical Quality Management Software.
Pharmaceutical, biotech, and API producers are constantly under pressure to manage the rising complexity of their operations in the face of rigorous regulatory requirements and frequent modifications. To satisfy market demands, several firms recognized the need to improve the agility and flexibility of their Quality Management Systems (QMS). Some organizations prefer one QMS with the highest level of regulatory standards for all types of processes. However, this is effective as it ensures compliance of the entire organization but will increase the cost of quality and reduce flexibility. This will stop the product from entering into the market quickly. Furthermore, Pharma CEOs and COOs may need to make dramatic changes to their operations strategy as the industry navigates new difficulties in order to retain lucrative and sustainable operations. Many pharmaceutical businesses (pharmacies) have traditionally deprioritized operations strategies in the face of competing business pressures. This is beginning to change.
Factors such as the COVID-19 outbreak, geopolitics, inflation, new therapeutic modalities, and new methods of working necessitate pharmacies to carefully reconsider their long-term sourcing, manufacturing, and supply chain decisions. Increasing competition, changing regulatory requirements, disruptive technologies, and various other factors are pushing pharmaceutical manufacturers to fast-track innovation to boost their productivity and product quality. In 2018, for instance, members of the Pharmaceutical Research and Manufacturers of America (PhRMA) trade association spent a record-breaking USD79.6 billion on research and development. Improving processes and assets by taking advantage of manufacturing and control technology can help. An industrial software platform that can help companies track data, control processes and automate various functions, can be beneficial in this area.
On Dec. 14, 2020, PTC announced that it has signed a definitive agreement to acquire Arena Solutions, Inc. the industry's leading software as a service (SaaS) product lifecycle management (PLM) platform provider. The acquisition will further PTC's strategy to be the leader in the rapidly growing market for SaaS-based product development software, enabling the company to deliver a complete CAD + PLM SaaS solution.
The scope of this report covers the market by its major segments, which include as follows: