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.

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.

 

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.

Key Questions Answered in the Global Pharmaceutical Quality Management Market Report

•    How did the COVID-19 pandemic impact the adoption of pharmaceutical quality management software by various pharmaceutical and life sciences companies?
•    What is the outlook for the global pharmaceutical quality management software market during the forecast period 2021-2030?
•    What are the key trends influencing the global pharmaceutical quality management software market? How will they influence the market in short-, mid-, and long-term duration?
•    What is the end user perception toward pharmaceutical quality management software?
•    How is the patent landscape for pharmaceutical quality software? Which country/cluster witnessed the highest patent filing from January 2014-June 2021?
•    What are the key factors impacting the global pharmaceutical quality management software market? What will be their impact in short-, mid-, and long-term duration?
•    What are the key opportunities areas in the global pharmaceutical quality management software market? What is their potential in short-, mid-, and long-term duration?
•    What are the key strategies adopted by companies in the global pharmaceutical quality management software market? 
•    What are the key application areas of the global pharmaceutical quality management software market? Which application is expected to hold the highest growth potential during the forecast period 2021-2030?
•    What is the preferred deployment model for the global pharmaceutical quality management software? What is the growth potential of various deployment models present in the market?
•    Who are the key end users of pharmaceutical quality software? What is their respective share in the global pharmaceutical quality management software market? 
•    Which regional market is expected to hold the highest growth potential in the global pharmaceutical quality management software market during the forecast period 2021-2030?
•    Which are the key players in the global pharmaceutical quality management software market?

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Who should buy this report and why?

Assuming that the reader is a developer of pharmaceutical quality management software, they will be able to do the following –

•    Understand their position as compared to some of the key players in the market
•    Stay updated with novel technology integration, features, and the latest developments in the market
•    Understand the impact of COVID-19 on the adoption of pharmaceutical QMS and the entry barriers as a result of it
•    Gain insights into which regions to target globally based on factors such as the technology adoption in the pharmaceutical industry and government established regulations
•    To gain insights into end-user perception with respect to the adoption of pharmaceutical QMS systems
•    Identify some of the key players in the market and understand their valuable contribution.

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