Pharmaceutical-grade Quality Management Systems Market

Report Description

Pharmaceutical-grade Quality Management Systems Market Outlook 

The global pharmaceutical-grade quality management systems market size was USD 1.7 Billion in 2023 and is likely to reach USD 5.7 Billion by 2032, expanding at a CAGR of 14.2% during 2024–2032. The market growth is attributed to the growing requirement to streamline the quality management process by reducing human errors and increasing operational efficiency.

Global industry compliance is constantly evolving with new regulations and reference documents being published every 25 minutes, which means 58 a day and 21,000 per year. Maintaining compliance requires diligent efforts to track, review, and evaluate these documents. Quality management systems (QMS) adapt to these changes, especially when systems become digitally transformed. Quality management teams are embracing technologies to drive innovation and eliminate error-prone, labor-intensive paper-based systems, or standalone solutions.

Quality management is crucial in the pharmaceutical industry, ensuring the safety, effectiveness, and reliability of medicines for human consumption. It is also crucial in meeting regulatory requirements, as poor practices affect patient safety, which leads to product recalls and damages the reputation of the company. The emergence of software-based quality management systems is expected to fuel the market in the coming years.

Quality management systems detect inefficiencies, mistakes, and flaws and provide a framework for ongoing improvements. Pharmaceutical firms are expected to increase their bottom line while upholding high standards of quality by cutting waste and streamlining operations.

In the pharmaceutical industry, establishing and operating under the quality management system (QMS) is mandatory. The pharmaceutical industry is required to establish a QMS that is compliant with the regulations that apply to it. The industry bears the responsibility for adhering to the applicable norms and standards, which are contingent upon several aspects, such as product type and geographic area. Some of the most common standards and regulations applicable to the pharmaceutical QMS include the International Organization for Standardization (ISO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), ICH Guideline Q10, and Current Good Manufacturing Practice (cGMP).

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Impact of AI on the Pharmaceutical-grade Quality Management Systems Market

Artificial intelligence (AI) has a significant impact on the pharmaceutical-grade quality management systems (PQMS) market, bringing transformative advancements and potential challenges. AI enhances data analysis and risk management by analyzing vast amounts of quality data from various sources, enabling predictive quality management and proactive measures to mitigate risks.

AI-powered systems automate several tasks, such as document review, audit trail management, and data analysis, ensuring compliance with regulatory requirements and reducing human error. They generate regulatory reports and facilitate communication with regulatory agencies. AI streamlines workflows, increasing efficiency and predicts potential equipment malfunctions or quality deviations. This enables preventive maintenance and real-time quality control, improving overall product quality and reducing production downtime.

Pharmaceutical-grade Quality Management Systems Market Dynamics

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Major Drivers

Increasing drug manufacturing is expected to drive the market in the coming years. However, the drug manufacturing process requires QMS to streamline the process. These systems eliminate human errors and enable real-time data analysis, thereby driving the market.

Rising technological advancements in the pharmaceutical industry influence research and development activities to advance existing products, which help pharmaceutical firms optimize huge processes and critical data, thereby boosting the global market. Additionally, the emergence of software-based quality management systems boosts the market, as it helps to reduce drug development costs.

Rising importance of quality pharmaceutical products is expected to propel the market during the projection period. Moreover, the cost-effectiveness, scalability, and data accessibility of QMS are expected to fuel the market during the forecast period.

Existing Restraints

Growing concerns about the data security of cloud-based QMS are restraining the market. Moreover, the lack of regulatory policies for quality management software is also hindering the market.

Issues related to the integration of quality management software with other systems, such as enterprise resource planning, cause compatibility issues, which hinder the market. Additionally, high cost associated with these systems is expected to hamper the market during the forecast period.

Emerging Opportunities

Increasing adoption of cloud-based technologies is creating immense opportunities in the market. The scalability, flexibility, and affordability of cloud-based solutions attract pharmaceutical organizations seeking to improve their quality management procedures.

Development of mobile applications for pharma quality management systems and access to the on-the-go management tools are expected to propel the global market during the forecast period. The real-time collaborations and data collection of mobile apps offer user friendliness and efficient solutions.

Scope of the Pharmaceutical-grade Quality Management Systems Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Application Segment Analysis

Based on application, the market is bifurcated into data management and risk management. The data management segment is expected to expand at a significant growth rate during the projection period. The segment growth is attributed to the rising usage of big data in the pharmaceutical industry for effective data management. Moreover, the increasing demand for adhering to quality standards and analyzing the efficacy of the medication is boosting the segment.  

Large volumes of data about drugs manufacturing, raw materials, and product testing are organized and analyzed efficiently by QMS. It improves decision-making and enables prompt reactions to deviations or quality issues by centralizing data and increasing transparency and traceability. The QMS enables smooth data management that boosts productivity and offers a strong base for upholding strict quality requirements, which are crucial in the production of pharmaceuticals.

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Deployment Mode Segment Analysis

On the basis of deployment mode, the global pharmaceutical-grade quality management systems market is segregated into cloud & web-based and on-premise. The cloud & web-based segment registered a 75% CAGR in 2023 and is expected to grow significantly during the forecast period, due to the high scalability and flexibility of cloud-based solutions. These solutions enable the pharmaceutical industry to access quality management tools and data from any place with internet availability.

Cloud-based QMS solutions free up resources by managing IT infrastructure, saving money on operations, and allowing businesses to concentrate on their core skills. These solutions are scalable, which allows pharmaceutical firms to readily adapt their resources to meet demand. This feature makes them the perfect option for organizations seeking to grow quickly and expand internationally.

End-user Segment Analysis

On the basis of end-user, the market is segmented into pharmaceutical and CDMO/CRO. The pharmaceutical segment is expected to register a robust growth rate during the forecast period due to the high adoption of pharmaceutical-grade QMS in the pharmaceutical industry as compared to CDMO/CRO. Moreover, strict regulations imposed by several agencies, such as the FDA and EMA, for ensuring the quality of pharmaceuticals boost the adoption of these QMS. 

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Regional Analysis

In terms of region, the global pharmaceutical-grade quality management systems market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America held a large market share in 2023 and is expected to dominate the market during the projection period. The market growth in the region is attributed to the high adoption of technologically advanced systems, high disposable income, and advanced healthcare infrastructure. Additionally, the increasing focus on drug safety, stringent regulatory requirements, and quality enhancement within pharmaceutical organizations is anticipated to boost the market during the forecast period.   

The market in Asia Pacific is expected to grow at a significant pace in the coming years, due to the rapid expansion of the pharmaceutical industry in the region, especially in countries such as China, India, and Japan. The demand for QMS in the region is driven by factors such as the huge patient population, rising healthcare costs, and growing awareness of healthcare standards.

Several government and non-government pharmaceutical firms in this region are investing in quality management software to improve the quality of their products, adhere to international standards, and obtain a competitive advantage in the worldwide market. Furthermore, rising partnerships between domestic and foreign pharmaceutical companies encourage the use of QMS, thereby propelling the market.

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