Published Year: 2021
Global AI in Healthcare Market: Analysis and Forecast, 2021-2030
The global AI in healthcare market is anticipated to reach $35,892.2 million by 2030,...
Market Research Report
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Report Summary
Global Pharmaceutical Quality Management Software Market Industry Overview
The manufacture of drugs and pharmaceutical products passes through various processing steps, each of which requires monitoring to ensure the safety, efficacy, and quality of the manufactured product. Traditional paper-based quality management systems are associated with various drawbacks that can be overcome by software-based quality management systems.
While the pharmaceutical quality management software market is still in its niche stage, the market is anticipated to grow rapidly owing to increasing technology adoption in the pharmaceutical industry, increasing cost of drug manufacturing, and evolving regulations. Currently, a few large pharmaceutical companies have adopted electronic quality management systems in order to automate their processes. With increasing technology adoption in the pharmaceutical industry, going forward, smaller companies are expected to implement software-based systems from the beginning itself.
The COVID-19 pandemic has further accelerated the digital transformation of the pharmaceutical industry. This positive impact is attributed to factors such as travel restrictions and the emerging concept of working and communicating remotely.
The global pharmaceutical quality management software market report highlights that the market was valued at $472.6 million in 2020 and is expected to reach $3,717.7 million by the end of 2030. The market is expected to grow at a CAGR of 22.91% during the forecast period from 2021 to 2030.
Figure: Global Pharmaceutical Quality Management Software Market, $Million, 2020 and 2030
Source: Expert Interviews and BIS Research Analysis
Global Pharmaceutical Quality Management Software Market Drivers
The factors driving the growth of the market include the increasing cost of drug manufacturing, constantly evolving regulations, and growing technology adoption in the pharmaceutical industry. Pharmaceutical companies spend up to billions of dollars in the manufacture of a new drug, thereby increasing the demand for automating manufacturing processes. The benefits associated with paper-based quality management systems are overcome by software-based quality management systems, presenting a lucrative market for pharmaceutical quality management software.
Furthermore, increasing demand by pharmaceutical companies to comply with regulatory requirements in order to compete with other players in the market is another factor driving the growth of the market.
Global Pharmaceutical Quality Management Software Market Challenges
The factors restraining the growth of the global pharmaceutical quality management software include security concerns pertaining to on-cloud deployment and the lack of well-established regulations governing pharmaceutical quality management software systems. Data breach incidents cause the pharmaceutical industry to suffer both monetary losses as well as breaches of customer trust. Additionally, while emerging economies in Asia-Pacific and Rest-of-the-World present a huge potential for growth of the pharmaceutical quality management software market, currently, market penetration in the region is challenging owing to factors such as lack of technology integration in the pharmaceutical industry and high upfront costs associated with the purchase of software.
However, the COVID-19 pandemic has countered these challenges and thus, positively impacted the digital transformation of the pharmaceutical industry.
Global Pharmaceutical Quality Management Software Market Opportunities
Synergies between pharmaceutical QMS developers and local end users and the development of solutions based on platform-as-a-service business model hold immense potential for the growth of the global pharmaceutical quality management software market.
The development of solutions based on the platform-as-a-service model is a novel model for running applications such as quality management software wherein a third party maintains the hardware and software infrastructure and delivers it to users over the internet. The software developers are adopting the PaaS solutions due to their simplicity, scalability, and reliability.
Impact of COVID-19 on the Global Pharmaceutical Quality Management Software Market
A paradigm shift in consumer preference from a paper-based management system to a digital cloud-based system has been witnessed in the past decade. The pandemic had a positive impact on the global pharmaceutical quality management software market. This is attributed to government-imposed restrictions during the lockdown and the shift towards working remotely. The realized benefits are expected to influence user perception post-COVID as well. Some of these benefits include:
• Time saving due to systematic categorization and storage of documentation
• Convenient approach to storage, manage and make sense of large amounts of data
• Higher revenue stream, in the long run, owing to cost savings
• Cost savings are realized in areas such as non-conformity and complaints
• Streamlined workflow enabling more efficient communication and collaboration within the organization as well as with clients
Market Segmentation
Global Pharmaceutical Quality Management Software Market (by Deployment Model)
The global pharmaceutical quality management software market has been segmented on the basis of deployment model into three broad categories, namely, on-cloud, web-based, and on-premises.
The on-cloud deployment model offers significant benefits over the traditional on-premises software or paper-based system. With the cloud-based system, it is easier to upgrade to the electronic QMS. The model can be accessed remotely in a highly secured environment. The model is also easily scalable, which allows clients to add more users and storage according to the business needs in the future.
Global Pharmaceutical Quality Management Software Market (by Application)
The global pharmaceutical quality management software market has been segmented on the basis of application into corrective action preventive action (CAPA) management, audit management, document management, change management, training management, risk management, complaints management, regulatory and compliance management, non-conformances handling, supplier quality management, inspection management, equipment management, and others.
Rising technology adoption in the pharmaceutical industry and increasing demand to automate processes to ensure regulatory compliance are major factors driving the growth of various quality management application areas.
Global Pharmaceutical Quality Management Software Market (by End User)
The global pharmaceutical quality management software market has been segmented on the basis of end users into three categories, namely, pharmaceutical, life sciences companies, and biotechnology companies, contract research organizations, and others.
Pharmaceutical, life sciences, and biotechnology companies are the major end users of the global pharmaceutical quality management software market. The adoption of quality management software is increasing in these industries due to the rapid growth of industries and ease of use. With the adoption of pharmaceutical QMS systems, the industries can better control, manage compliance, and assess the products for quality.
Contract research organizations (CRO) are the emerging end-user segment of the global pharmaceutical quality management software market. The trend is driven by both pharmaceutical and biotechnology companies outsourcing certain processes to CROs.
Global Pharmaceutical Quality Management Software Market (by Region)
The different regions covered under the global urgent care apps market include North America, Europe, Asia-Pacific, and Rest-of-the-World.
North America and Europe are two of the largest markets for pharmaceutical quality management software. This is attributed to increasing technology integration in the pharmaceutical industry. While developing countries such as those in Asia-Pacific and the Rest-of-the-World currently offer challenges to pharmaceutical QMS developers to enter the market in these regions, they are expected to register strong growth in the adoption of pharmaceutical quality management software in the near future.
Key Market Players and Competition Synopsis
Some of the key players operating in the market include ANTARES VISION S.p.A, AssurX, Inc., AXSource, CLARIVATE PLC., ComplianceQuest, Dassault Systèmes, EtQ Management Consultants, Inc., Honeywell International Inc., Ideagen Plc., IQVIA HOLDINGS INC., LogicGate, Inc, MasterControl, PTC Inc., Sarjen Systems Pvt. Ltd., Qualio, and Veeva Systems Inc.
In the past few years, the global pharmaceutical quality management software market has witnessed several strategic and technological developments undertaken by the different market players to attain their respective market shares in this emerging domain. Some of the strategies covered in this segment are funding activities, mergers and acquisitions (M&As), partnerships, alliances, and business expansion, regulatory and legal activities, and new offerings. The preferred strategy for companies has been partnerships followed by funding activities.
Pharmaceutical Quality Management Software Market - A Global and Regional Analysis
Focus on Deployment Models, Applications, End Users, and Country-Wise Analysis - Analysis and Forecast, 2021-2030
Some Faq's
Frequently Asked Questions
The global pharmaceutical quality management software market report highlights that the market was valued at $472.6 million in 2020 and is expected to reach $3,717.7 million by the end of 2030. The market is expected to grow at a CAGR of 22.91% during the forecast period from 2021 to 2030.
The key players are ANTARES VISION S.p.A, AssurX, Inc., AXSource, CLARIVATE PLC., ComplianceQuest, Dassault Systèmes, EtQ Management Consultants, Inc., Honeywell International Inc., Ideagen Plc., IQVIA HOLDINGS INC., LogicGate, Inc, MasterControl, PTC Inc., Sarjen Systems Pvt. Ltd., Qualio, and Veeva Systems Inc.
Synergies between pharmaceutical QMS developers and local end users and the development of solutions based on platform-as-a-service business model hold immense potential for the growth of the global pharmaceutical quality management software market.
The factors restraining the growth of the global pharmaceutical quality management software include security concerns pertaining to on-cloud deployment and the lack of well-established regulations governing pharmaceutical quality management software systems.
The factors driving the growth of the market include the increasing cost of drug manufacturing, constantly evolving regulations, and growing technology adoption in the pharmaceutical industry.
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