Pharmaceutical Quality Management Software Market worth $2.98 billion by 2030 with 13.3% CAGR | MarketsandMarkets™

DELRAY BEACH, Fla., Nov. 17, 2025 /PRNewswire/ -- The global Pharmaceutical Quality Management Software Market, valued at US$1.41 billion in 2024, stood at US$1.59 billion in 2025 and is projected to advance at a resilient CAGR of 13.3% from 2025 to 2030, culminating in a forecasted valuation of US$2.98 billion by the end of the period. The pharmaceutical quality management software market is experiencing rapid growth, driven by increasing regulatory demands, rising complexity in drug development and clinical trials, and the broader move toward digital transformation in the industry. Companies are adopting these solutions to streamline documentation, enhance compliance, and lower risks associated with manual processes. Cloud-based platforms are becoming more popular due to their flexibility, scalability, and lower initial costs compared to traditional systems, while advanced features like automation, analytics, and real-time dashboards are further boosting adoption. As pharmaceutical and biotech firms face pressure to speed up time-to-market while maintaining high quality and safety standards, the need for integrated quality management systems continues to grow across research, manufacturing, clinical, and regulatory areas.

Two key strategies are driving growth in the pharmaceutical quality management software market: ongoing technological advancements and strategic public-private partnerships. In terms of innovation, companies are improving AI-integrated solutions, automating predictive quality analytics, and enabling real-time issue detection. For example, in April 2024, Veeva Systems launched the Veeva AI Partner Program, which offers partners the advanced technology and support needed to seamlessly integrate Generative AI (GenAI) solutions with Veeva Vault applications. Regarding collaboration, pharmaceutical and biotechnology companies are increasingly partnering to expand pharmaceutical quality management software infrastructure and reach. A notable example is the July 2024 partnership between Neuraxpharm and Veeva to implement Vault QualityDocs and Vault Training, streamlining quality management and compliance across more than 100 CDMOs, allowing for standardized, efficient collaboration and high manufacturing quality.

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By enterprise size, large enterprises hold the largest share of the pharmaceutical quality management software market. This dominance is attributed to their extensive production volumes, complex operational structures, and stringent regulatory compliance requirements. Large pharmaceutical companies have the financial capability and technological infrastructure to implement comprehensive QMS solutions that integrate multiple quality processes across global facilities. These enterprises prioritize robust quality management systems to ensure product consistency, enhance traceability, and minimize the risk of non-compliance. Moreover, their focus on digital transformation, automation, and data-driven decision-making further drives the adoption of advanced QMS platforms within this segment..

By end user, pharmaceutical companies hold the largest share of the pharmaceutical quality management software market. This dominance is primarily due to the critical need for maintaining stringent quality standards throughout drug development, manufacturing, and distribution processes. Pharmaceutical companies face rigorous regulatory requirements from agencies such as the FDA and EMA, driving the adoption of advanced QMS solutions to ensure compliance, traceability, and product consistency. These systems help streamline quality processes, manage documentation, track deviations, and support continuous improvement initiatives.

By geography, In 2024, North America reinforced its position as a global leader in the pharmaceutical quality management software market. The region is characterized by a highly regulated pharmaceutical sector and the presence of complex, frequently updated FDA guidelines that necessitate rigorous compliance. Significant investments in digital transformation across pharmaceutical manufacturing and development further reinforce this position. The emphasis on product safety, risk mitigation, and standardized operational processes drives demand for integrated quality management software solutions that facilitate documentation management, streamline audits, automate corrective and preventive actions (CAPA), and oversee process deviations. Leading pharmaceutical companies in the US and Canada have increasingly adopted cloud-based platforms, AI-enabled analytics, and centralized quality oversight to address the growing complexity of clinical trials, supply chain networks, and decentralized manufacturing operations. Supported by a strong presence of global pharmaceutical leaders, advanced healthcare infrastructure, and sustained R&D investment.

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The key players functioning in the Pharmaceutical quality management software market include Veeva Systems Inc. (US), MasterControl Solutions, Inc. (US), Honeywell International Inc. (US), IQVIA (US), Qualio, Inc. (US), Hexagon AB (Sweden), AssurX, Inc. (US), QT9 Software (US), Dassault Systèmes (France), ComplianceQuest (US), Ideagen (UK), SoftExpert (Brazil), Instem (UK), Intelex Technologies (Canada), Intellect, Inc. (US), AmpleLogic (India).

Veeva Systems Inc.

Veeva Systems Inc. (Veeva) is a provider of cloud-based software solutions tailored to the global life sciences industry, focusing on pharmaceutical operations, including quality management systems (QMS). The company has served over 1,000 customers, including top pharmaceutical companies. Veeva addresses critical needs like CAPA, change control, and batch release, driving operational efficiency and regulatory compliance. Veeva's flagship offering in the pharmaceutical QMS market is Veeva Quality Cloud, a comprehensive suite built on the Vault Platform, designed to streamline and unify quality processes across the product lifecycle. This suite addresses the industry's stringent regulatory requirements, such as those from the FDA, EMA, and other global bodies, while enhancing collaboration and visibility across quality, manufacturing, and supply chain operations.

MasterControl Solutions, Inc.

Master Control provides a, cloud-based Quality Management System (QMS) specifically designed for the pharmaceutical industry, enabling companies to streamline compliance, improve product quality, and accelerate time-to-market. The platform integrates critical quality processes including document control, training management, quality event management, audit management, supplier management, and risk management, into a unified, closed-loop system. The AI-powered automation, MasterControl reduces manual tasks, predicts potential quality issues, and provides actionable insights, allowing teams to focus on innovation rather than paperwork. Its system ensures regulatory compliance with FDA and ISO standards, supports flexible workflows, and facilitates seamless collaboration across departments and suppliers.

Honeywell International Inc.

Honeywell International Inc. offers a comprehensive suite of Quality Management System (QMS) solutions specifically designed for the pharmaceutical industry, designed to enhance compliance, operational efficiency, and product quality throughout the manufacturing lifecycle. Its offerings include cloud-based platforms like TrackWise Digital for enterprise-wide quality management, TrackWise Manufacturing for AI-assisted integration of digital and physical manufacturing processes, Honeywell Forge Life Sciences for IoT-enabled operational optimization, and Honeywell Quality Management Review (HQMR) for consolidated, actionable insights across sites. These solutions support diverse pharmaceutical applications, including biotechnology, biopharma, medical devices, and cell and gene therapy, ensuring adherence to regulatory standards while streamlining complex workflows. The company provides pharma QMS solutions through industrial automation segment.

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