Quality management systems play a crucial role in the Class II medical device industry, particularly in the pharmaceutical sector. They ensure quality assurance throughout the product lifecycle, effective issue management, and optimal employee training. They also help companies comply with various regulatory requirements and standards.

Although quality management software (QMS) is used in various industrial segments, its adoption is gradual in the pharmaceutical industry. According to market research conducted by BIS Research, the global pharmaceutical quality management software market is expected to grow with a CAGR of 22.91% in terms of market value during the forecast period 2021-2030. With increasing technology adoption in the pharmaceutical industry, small-scale pharmaceutical companies are expected to adopt software technology before beginning the manufacturing process. Furthermore, the COVID-19 pandemic also had a positive impact on software growth. This is attributed to government-imposed restrictions during the lockdown and the shift toward working remotely. The ongoing digital transformation of the pharmaceutical industry is one of the key factors driving the growth of the global pharmaceutical quality management software market.

On the regional level, North America and Europe are projected to have maximum growth owing to the factors such as increasing technology integration in healthcare extending to the pharmaceutical industry and high cost of drug manufacturing.

The latest market study by BIS Research, titled “Global Pharmaceutical Quality Management Software Market,” focuses on assessing the market potential for the period 2021-2030. The market study offers an in-depth analysis of competitive assessment, COVID-19 impact, key trends, potential market dynamics, and many other aspects.

During the report development process, analysts worked with various stakeholders to better understand the technical aspects of various applications within the pharmaceutical quality management software market. The following is an excerpt from a conversation between Purvi Bhasin, Research Analyst at BIS Research, and Yuanfeng Vice President of Operations:

Q: Could you highlight the key challenges for the pharmaceutical quality management software adoption?

Richard: The main hold up for adopting an electronic quality management system (eQMS) has been the comfort associated with the paper-based, status quo approaches to quality management as well as the high cost and resource needs associated with large, established eQMS players. The pandemic and a pressing need to accelerate the availability of life-saving products has forced quality management teams that had not already adopted an eQMS to move quickly from paper to the cloud in order to maintain performance in a remote working environment.

Additionally, since 2010, organizations such as Qualio have come to market with a purpose-built solution to support emerging life sciences companies with a cost-effective and easy-to-use eQMS.

Q: Some companies, such as Novartis, have developed an in-house QMS system that is not for sale. If the pharmaceutical companies continue to develop in-house QMS, wouldn’t it affect the companies making the software for pharmaceutical companies and clients?

Richard: Yes, Novartis and many other major pharmaceutical companies have built their QMS mostly due to a lack of vendors that can meet their needs in the market. Most of our customers are emerging pharmaceutical companies (most have less than 1,000 employees but are growing fast) and medical device, biotechnology, and contract service providers. Qualio customers include notable organizations such as Medable, 4G Clinical, Proscia, and Ginkgo Bioworks. These types of companies are often more inclined to purchase an eQMS and related services instead of developing an internal QMS team.

Q: Is it safe to assume that the COVID-19 pandemic did not have any impact on the market, or was it a positive one?

Richard: Overall, the pandemic had a strong impact on overall digital transformation, including the adoption of eQMS software such as Qualio. Over the last year, we experienced unprecedented customer demand, including more than 260 percent revenue growth year-over-year.

We also tripled the size of our team in 2020 to meet the growing demand for our software and services.

Q: Do you feel there is regional competition in Nordic countries, France, and Australia, among others?

Richard: I think most of the providers of QMS solutions are consultants who are most likely potential partners rather than competitors. 30% of our revenue comes from Europe, 65% from the U.S. and Canada, and 5% in Asia. We partner with quality and regulatory consultants to deliver standard operating procedures (SOPs) and guidance to a larger number of clients, while Yuanfeng serves as the platform to provide their services.