Pharmaceutical Quality Management Software Market - Growth, Trends, and Forecasts (2022 - 2027)

The pharmaceutical quality management software market is expected to register a CAGR of 9.9% during the forecast period (2022-2027).

In the last decade, there has been a shift in consumer preference from a paper-based management system to a digital cloud-based system. The global pharmaceutical quality management software market benefited from the pandemic. This is due to government restrictions imposed during the lockdown, as well as a shift toward working remotely. A market player Assurx said that in June 2020, When COVID-19 rolled around 2020, businesses all over the world found themselves at the mercy of processes designed for a different era of manufacturing. As entire industries were upended by broken supply chains, changing production lines and processes, and a shift to remote work, cloud QMS (Quality Management Software) became a priority consideration. Thus, COVID-19 significantly impacted the pharmaceutical quality management software market.

The rising cost of drug manufacturing, constantly changing regulations, and growing technology adoption in the pharmaceutical industry are all factors driving the market growth. Pharmaceutical companies can spend billions of dollars developing a new drug, which drives up demand for automated manufacturing processes. For instance, according to the London School of Hygiene & Tropical Medicine and KU Leuven in March 2021 estimates, the average cost of bringing a new drug to market is USD 1.3 billion, and the median cost is USD 985 million. Thus, software-based quality management systems lower the cost of drug development and present a lucrative market for pharmaceutical quality management software.

Another factor driving the market's growth is pharmaceutical companies' increasing demand to comply with regulatory requirements to compete with other market players. Quality management standards and international technical specifications such as IATF 16949, AS9100 Rev.D, and ISO 9001 are expected to increase the use of QMS across end-use industries.

With the increasing adoption of technology in the pharmaceutical industry, smaller companies are expected to implement software-based systems from the start. Cloud computing, analytics, and big data, among other technological advancements, have enhanced QMS's existing capabilities in terms of scalability, cost-efficiency, flexibility, and platform independence. As a result, end-use industries such as life sciences, manufacturing, pharmaceuticals, and biotechnology are embracing QMS solutions at a rapid pace.

However, various strategies adopted by the key market players are anticipated to drive market growth over the forecast period. In July 2021, LogicGate raised USD 113 million in a Series C funding round. These funds will be used to support all aspects of the company's operations, including significant product advancements, the expansion of the partner ecosystem, international presence, and security posture.

Thus, all the aforementioned factors are expected to boost the market over the forecast period. However, security concerns pertaining to on-cloud deployment and lack of regulations for pharmaceutical quality management software are the major restraining factors for the market growth.

Key Market Trends

Calibration Management Segment is Expected to Hold Significant Market Share in the Process Component Segment

Calibration management software (CMS) is software designed to schedule the calibration of instrumentation and maintenance requirements in all types of industrial settings. As one type of enterprise asset management software, CMS handles maintenance and repair operations.

A calibration management solution connects related maintenance tasks and additional quality processes in regulated life science and high-tech environments. Such solutions help to extend the life of machinery and save the company millions of dollars by reducing the number of recalled products. The calibration management solutions offered by QMS can assist organizations in better managing instrument calibration processes and associated documentation, resulting in increased productivity and efficiency.

Furthermore, major players are employing a variety of strategies to grow their customer base, including expanding their services, launching new products, collaborating, partnering, and merging. For Instance, in January 2021, Beamex LOGiCAL is a modern subscription-based (SaaS) calibration software solution that helps companies streamline and digitize their calibration processes. The software works with Beamex documenting calibrators and is compatible with the Beamex bMobile calibration app. LOGiCAL is the culmination of Beamex's 40 years of calibration software development experience.

Thus, all aforementioned factors are expected to boost the segment over the forecast period.

North America Holds a Significant Share in the Market and Expected to do Same Over the Forecast Period

The major factors driving the market growth are an increase in demand for improved production and quality management standards. Furthermore, the market grows as the need to improve customer satisfaction grows. Also, the market is expected to benefit from the adoption of cloud-based solutions and QMS software by various market players in the region.

Strategic mergers and acquisitions, as well as partnerships, are thought to be the most efficient ways for market players to enter emerging markets quickly. in May 2020, ComplianceQuest acquired LifeGuard Solutions, a Salesforce-native EHS solution provider, as a natural extension of leading quality management system.

Furthermore, product differentiation and upgrades are expected to facilitate the growth of businesses in the market. For instance, in August 2020, MasterControl Manufacturing Excellence is a new solution from MasterControl Inc. that aims to boost manufacturing productivity and quality. The new solution would allow manufacturers to create dynamic connections among enterprise systems, processes, data sources, and people to get a holistic view of production and quality data.

Thus, owing to the abovementioned factors, the market is expected to show growth over the forecast period.

Competitive Landscape

The Pharmaceutical Quality Management Software market is fragmented with the presence of players such as ANTARES VISION S.p., AssurX Inc., a source, CLARIVATE PLC, ComplianceQuest, and Dassault Systemes. Quality management software is growing at a very fast pace. In addition, the market is very competitive, so prominent players are adopting different strategies such as an expansion of their services, new product launches, collaborations, partnerships, and mergers to increase their customer base.

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