Pharmaceutical Quality Management Systems Market Size, Share, Forecast, & Trends Analysis by Solution Type (Deviation, CAPA, Audit, Risk & Compliance, Inspection, Change, Training) Deployment Mode (Cloud, On-premise) End User - Global Forecast to 2031

Pharmaceutical Quality Management Systems Market Size & Forecast

The Pharmaceutical Quality Management Systems Market is expected to reach $4.59 billion by 2031, at a CAGR of 15.6% from 2024 to 2031. A pharmaceutical quality management system comprises procedures, processes, and policies aimed at ensuring high product quality in pharmaceutical manufacturing. These systems are tailored to meet the specific needs of the company and comply with regulatory standards. Regulatory requirements pertaining to product quality assist pharmaceutical companies in managing risks, enhancing customer satisfaction, and optimizing the quality control process. Pharmaceutical quality management systems enable document management, change control, training management, audit management, and deviation management.

Rising drug manufacturing costs, stringent regulatory standards for pharmaceutical production, rapid growth of the pharmaceutical industry, and the advantages of software-based quality management systems drive the growth of this market. However, the high costs of deploying pharmaceutical quality management systems restrain the growth of this market.

The increasing demand for generic drugs & biopharmaceuticals and the rising preference for platform-as-a-service solutions among pharmaceutical companies are expected to create market growth opportunities. However, security concerns associated with on-cloud deployments pose a significant challenge to the market’s growth.

Pharmaceutical Quality Management Systems Market Growth Drivers

Stringent Regulatory Standards for Pharmaceutical Production

Pharmaceutical products directly impact consumer health and well-being, making them subject to rigorous regulations. Manufacturers must adhere to strict safety and quality standards to bring their products to market. With the pharma sector expanding rapidly, companies are prioritizing compliance with regulations and investing in research and development to deliver superior products and maintain competitiveness. Many companies based in developing countries like India and China export to the U.S., where the FDA regulates products. To ensure product safety, the FDA conducts inspections of facilities and procedures of all pharmaceutical manufacturers, both domestic and international, that sell products in the U.S. Therefore, these companies must be FDA registered and comply with current good manufacturing practices (cGMP).

Additionally, manufacturers must adhere to guidelines such as ICH Guideline Q10, 21 CFR Part 211, and International Organization for Standardization (ISO) guidelines to produce and market their products. The rising regulatory requirements and expanding international markets have increased the demand for quality management systems among pharmaceutical manufacturers.

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Advantages of Software-based Quality Management Systems

Manufacturers in the pharmaceutical industry encounter challenges due to evolving regulations, shifting market demands, and supply chain disruptions. Traditional systems often create gaps between quality management and manufacturing, resulting in difficulties in adapting to regulatory changes and delays in bringing drugs to market.

The adoption of software-based quality management systems addresses these challenges by enhancing product quality and ensuring patient safety. Pharmaceutical QMS software enables companies to comply with evolving global regulatory landscapes. As global trials and cross-border drug launches become more prevalent, this software facilitates regulatory compliance in each region, thereby reducing the risk of drug failures and accelerating time-to-market.

In addition to regulatory compliance, pharmaceutical QMS software offers streamlined operations, robust risk management and mitigation, enhanced consumer confidence, improved supply chain efficiency, increased process efficiency, and minimized drug wastage.

Pharmaceutical Quality Management Systems Market Trends

Integration of Artificial Intelligence Into Quality Management Systems

The integration of Artificial Intelligence (AI) into quality management systems offers numerous benefits. It enables the accurate and swift analysis of vast amounts of data, which can be a challenge if done manually. AI-powered systems enable efficient analyses, leading to improved decision-making, faster problem-solving, and enhanced quality control. Regulatory compliance is critical in the pharmaceutical industry, and AI integration into QMS can assist companies in automating compliance operations and providing real-time alerts when issues arise. AI can also automatically update QMS in response to legislative changes, ensuring compliance.

Artificial intelligence can analyze data from quality management systems to identify potential compliance issues early on. Major industry players are increasingly adopting AI-based pharmaceutical QMS solutions. For instance, in April 2023, Dot Compliance (U.S.) launched an AI-powered electronic quality management system designed for the life sciences sector. This system incorporates proprietary algorithms and utilizes ChatGPT to enhance compliance efforts within pharmaceutical organizations.

Pharmaceutical Quality Management Systems Market Opportunities

Increasing Demand for Generic Drugs & Biopharmaceuticals

The adoption of biopharmaceuticals is outpacing that of conventional synthetic drugs due to their benefits, including specific molecule targetting, low side effects, and high activity and specificity. Biopharmaceuticals are increasingly utilized in the treatment of immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and cancer.

Quality management systems play a crucial role in the biopharmaceutical industry by ensuring standardized and high-quality products. These systems enable biopharmaceutical firms to consistently adhere to quality standards, comply with regulations, and continuously improve organizational processes. Quality management systems enable pharmaceutical and biopharmaceutical companies to enhance overall customer satisfaction, minimize the risk of product recalls, and improve product quality.

Pharmaceutical Quality Management Systems Market Analysis: Key Findings

By Solution Type: In 2024, the Non-conformance/Deviation Management Segment to Dominate the Pharmaceutical Quality Management Systems Market

Based on solution type, the pharmaceutical quality management systems market is segmented into non-conformance/deviation management, document management, CAPA management, risk & compliance, inspection management, audit management, suppliers & materials management, training management, change management, and other solution types. In 2024, the non-conformance/deviation management segment is expected to account for the largest share of 18.1% of the pharmaceutical quality management systems market. This segment’s large market share can be attributed to the growing adoption of non-conformance/deviation management to mitigate risks related to inadequate control over quality management systems, thereby enhancing efficiency across all business operations. Additionally, non-conformance management aids pharmaceutical manufacturers in detecting process and product defects early and anticipating potential future issues.

However, the CAPA management segment is projected to witness the highest growth rate of 17.3% during the forecast period of 2024–2031. This segment’s growth can be attributed to the increasing demand for Corrective and Preventive Action (CAPA) management in the pharmaceutical industry, driven by the need to ensure product quality, patient safety, and regulatory compliance. CAPA management is essential for identifying and addressing issues that could pose risks to patient safety, encompassing concerns related to product quality, manufacturing processes, labeling, and packaging.

By Deployment Mode: In 2024, the Non-conformance/Deviation Management Segment to Dominate the Pharmaceutical Quality Management Systems Market

Based on deployment mode, the pharmaceutical quality management systems market is segmented into cloud/web-based and on-premise. In 2024, the cloud/web-based segment is expected to account for the largest share of 79.4% of the pharmaceutical quality management systems market. The large market share of this segment is attributed to the benefits offered by cloud/web-based deployments, such as cost-effectiveness, real-time analysis capabilities, easy access to data, internal and external data sharing, flexibility, and scalability.

Cloud/web-based models are gaining rapid popularity in the pharmaceutical quality management systems market. These systems eliminate the need for hardware installation and maintenance costs, as well as the requirement for in-house IT maintenance and support teams. Therefore, the cost-effectiveness of cloud-based deployment makes it a viable option, even for small and medium-sized research laboratories.

By End User: In 2024, the Pharmaceutical and Biotechnology Companies Segment to Dominate the Pharmaceutical Quality Management Systems Market

Based on end user, the pharmaceutical quality management systems market is segmented into pharmaceutical and biotechnology companies, contract research organizations (CROS)/ contract development manufacturing organizations (CDMOs), and research laboratories. In 2024, the pharmaceutical and biotechnology companies segment is expected to account for the largest share of the pharmaceutical quality management systems market. This segment’s large market share can be attributed to frequent changes in manufacturing processes, stringent regulatory requirements, the growing need to increase production capacity, and the rising costs of drug manufacturing.

The pharmaceutical and biopharmaceutical sectors have witnessed significant growth in recent years due to the increasing demand for pharmaceutical products, growing adoption of single-use products, growing incidences and prevalence of various chronic diseases, and rising need to address unmet medical requirements for rare and chronic diseases. Additionally, governments of various countries are taking initiatives by making investments and providing grants and funds to pharmaceutical and biotechnology companies for the manufacture and R&D of biopharmaceuticals. For instance, in November 2021, Medical Research Agency (Poland) announced government funding of USD 73.3 million (PLN 300 million) for producing vaccines based on mRNA technology in Poland.

Geographical Analysis

In 2024, North America to Dominate the Market

In 2024, North America is expected to account for the largest share of the 38.4% of pharmaceutical quality management systems market. North America’s large market share can be attributed to the increasing use of advanced digital tools approved by regulatory authorities in the region’s pharmaceutical sector to improve overall development & manufacturing outcomes and the presence of major market players in the region. Additionally, the strong financial capabilities of small and mid-sized organizations drive the adoption of quality management systems in the region.

However, the market in Asia-Pacific is projected to register the highest CAGR of 16.8% during the forecast period. The growth of this regional market is driven by the large population base and government initiatives aimed at enhancing healthcare facilities and services in the region. Additionally, these countries have long been recognized as low-cost destinations for pharmaceutical manufacturing. As a result, major international companies are expanding their operations there to leverage these cost advantages and tap into the growing market opportunities in Asia-Pacific.

Pharmaceutical Quality Management Systems Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the leading players’ product portfolios and geographic presence and the key growth strategies adopted by them over the past few years. The key players profiled in the pharmaceutical quality management systems market are Honeywell International Inc. (U.S.), IQVIA Holdings Inc. (U.S.), ANTARES VISION S.p.A (Italy), Dassault Systèmes SE (France), EtQ Management Consultants, Inc. (U.S.), Ideagen PLC (U.K.), Körber AG (Germany), LogicGate, Inc. (U.S.), ComplianceQuest, Inc (U.S.), AssurX, Inc. (U.S.), and AXSource Consulting, Inc. (U.S.).

Pharmaceutical Quality Management Systems Market Overview: Latest Developments from Key Industry Players

• In July 2023, Ideagen (U.K.) enhanced its internal audit and risk management solutions with the addition of enterprise risk management and internal audit capabilities.

• In April 2023, ANTARES Vision (Italy) acquired Smart Point Technologies Ltd. (India) through its subsidiary rfXcel. Smart Point, a software development company, will significantly bolster ANTARES Vision's presence in the pharmaceutical Track & Trace sector.

• In February 2023, LogicGate (U.S.) partnered with Climb Channel Solutions (U.S.), an international specialty technology distributor and a subsidiary of Climb Global Solutions, Inc. (U.S.). This partnership was aimed at expanding the company’s presence in Europe, the Middle East, and Africa.

Pharmaceutical Quality Management Systems Market Research Summary

Key questions answered in the pharmaceutical quality management systems market report: