Pharmaceutical Quality Management Software Market Soars to USD 1.5 Billion in 2023, Set to Reach Dizzying Heights of USD 3.5 Billion by 2030 | MarketDigits

The Global Pharmaceutical Quality Management Software Market was valued USD 1.5 Billion in 2023 and projected to reach USD 3.5 Billion by 2030, growing at a CAGR of 12.8% during the forecast period of 2023-2030

Richmond, Feb. 06, 2024 (GLOBE NEWSWIRE) — According to a research report “Pharmaceutical Quality Management Software Market, by Offering (Solution {Document Management, Training management, Quality event management, Supplier management, Audit Management, Change Management, Risk Management, Others} and Service), Deployment (On-premises, Cloud-based and Web-based, Others), End User (Pharmaceutical, Biotech, Contract Research Organization (CRO), Medical Devices and Contract Development and Manufacturing Organization, Others) and Region – Global Forecast to 2030.

Global Pharmaceutical Quality Management Software Market Report Scope:

Report Details
Market size value in 2023 USD 1.5 Billion
Market size value in 2030 USD 3.5 Billion
CAGR (2023-2030) 12.8%
Forecast Period 2023–2030
Historic Data 2019
Forecast Units Value (USD Million/USD Billion)
Segments Covered Offering, Deployment, End User and Region
Geographies Covered North America, Europe, Asia Pacific, and RoW
  • AmpleLogic
  • AssurX, Inc
Sample of Companies Covered
  • Dassault Systèmes
  • ETQ, LLC
  • Honeywell International Inc.

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TOC Covers in Depth & Breath on Pharmaceutical Quality Management Software Market
170 – Market Data Tables
65 – List of Figures
225 – Pages

The report includes Vendor Assessment (Company Profiles, Market Positioning, Strategies, Recent Developments, Capabilities & Product Offerings / Mapping), Technology Assessment (Developments & Economic Impact), Partner & Customer Ecosystem (Product Services, Proposition & Key Features) Competitive Index & Regional FootPrint by MarketDigits.

Market Overview

Streamlining document management, training, and business processes poses a common challenge for pharmaceutical and biotech companies. The remedy comes in the form of pharmaceutical quality management software systems, which transform these challenges into manageable solutions. This software offers an organized platform that not only accelerates product time-to-market for pharmaceutical companies but also enhances compliance. Made specifically for the pharmaceutical industry, QMS software is skilled at efficiently handling document management and automating regulatory processes and training within a unified framework. In recent years, the global pharmaceutical market has undergone significant transformations, compelling companies to prioritize customer needs and internal efficiency to ensure quality and compliance throughout the pharmaceutical demand chain. Pharmaceutical quality experts face both challenges and opportunities to enhance quality and compliance. Factors such as complex supply chains, mergers and acquisitions, data integrity issues, and evolving regulations continually impact pharmaceutical quality strategies and processes. Regulatory bodies like the FDA, Good Manufacturing Practice, and Quality Management System emphasize not only the establishment of a culture of quality management but also strict compliance within the pharmaceutical industry. A significant component of any pharmaceutical quality management system is the meticulous management of documentation, including Standard Operating Procedures (SOPs), procedures, policies, and more. This control over documentation is instrumental in influencing product safety and quality.

Major Vendors in the Global Pharmaceutical Quality Management Software Market:

  • AmpleLogic
  • AssurX, Inc.
  • Dassault Systèmes
  • ETQ, LLC
  • Honeywell International Inc.
  • Ideagen
  • IQVIA Inc
  • MasterControl Solutions, Inc.
  • QT9 Software
  • Qualio
  • Qualityze
  • Veeva Systems

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The transition from a paper-based QMS to pharma QMS software

Many pharmaceutical companies currently service either a paper-based or partially electronic approach to manage operational processes, organizational priorities, and adherence to regulations. With regulatory bodies like the FDA tightening compliance rules, it has become imperative for pharmaceutical entities, irrespective of their size, to implement a systematic quality management approach. The traditional paper-based systems exhibit inefficiencies, human errors, and significant time consumption, rendering them outdated in today’s dynamic work environment characterized by complex supply chains, mergers and acquisitions, and increasingly stringent regulations. In response to these challenges, there is a growing necessity for pharmaceutical companies to transition to automated quality management systems. Such systems play a crucial role in accelerating and integrating various interconnected processes, including procurement, training, audits, deviation management, customer complaints, Corrective and Preventive Actions, and more. The FDA, a leading regulatory authority in the pharmaceutical industry, has been actively endorsing the adoption of technological innovations by drug manufacturers. The aim is to reduce production costs, enhance the availability of more cost-effective medications, and ultimately fortify public health.

Market Dynamics


  • Increasing cost of drugs and manufacturing
  • Technological adaption in companies
  • Government investment in pharmaceutical sectors
  • Transition from a paper-based QMS to pharma QMS software


  • Focus on the reduction of errors and increasing efficiency
  • Adoption of cloud base technology
  • Integration with existing system
  • Emergence of new technologies

Emergence of new technologies

Traditionally, new technologies are considered as disruptive, often facing challenges related to financial implications, operational adjustments, training requirements, and resistance during adoption. However, artificial intelligence (AI) stands out in this regard, being viewed as a catalyst for business growth rather than a financial burden, even in challenging economic times. Recent trends in the pharmaceutical industry underscore the increasing prominence of AI, with mentions in company filings experiencing a remarkable 105% surge between 2016 and 2021. The value of AI is exemplified by its role in expediting the development of safe and effective vaccines during the peak of the COVID-19 crisis. Notably, the time taken from identifying the coronavirus genome to initiating the first vaccine study was reduced to 300 days, a stark contrast to the average eight to 10 years previously required, as highlighted by Subroto Mukherjee, Head of Innovation and Emerging Technology, Americas at GlaxoSmithKline Consumer Healthcare.

North America dominates the market for Pharmaceutical Quality Management Software Market.

In the pharmaceutical quality management software sector, North America is positioned as a key player, driven by the significant presence of major pharmaceutical companies and a robust regulatory framework. The growth of quality management software in the pharmaceutical industry is fuelled by factors such as the industry’s expansion, a strong emphasis on quality assurance, and the widespread adoption of cutting-edge technologies. The market is expected to be dominated by companies specializing in pharmaceutical quality management solutions.

Furthermore, the Asia-Pacific region is experiencing noteworthy growth, attributed to the expanding pharmaceutical industry, increased investments in healthcare infrastructure, and a heightened focus on quality. Factors contributing to this growth include the surge in pharmaceutical manufacturing in emerging economies like China and India, presenting opportunities for the adoption of quality management software. Additionally, regulatory harmonization efforts contribute to the growth of this region. Both global and local players catering to the specific needs of the Asia-Pacific market are well-positioned to boom in this dynamic environment.

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The Cloud based Segment is anticipated to hold the Largest Market Share during the Forecast Period

The Pharmaceutical Quality Management Software Market is segmented based on deployment mode into cloud based and on-premises. Among them the cloud based segment dominated in terms of revenue share and is anticipated to witness the most rapid growth throughout the forecast period. This can be attributed to the flexibility of Cloud based solutions, allowing organizations to easily adjust their software usage to evolving regulatory and operational needs. Moreover, these systems minimize initial costs, promote data sharing and collaboration, and provide remote accessibility. These features are fundamentally transforming the quality management system, driving the swift expansion of this segment.

Segmentations Analysis of Pharmaceutical Quality Management Software Market:

  • By Offering
    • Solution
      • Document Management
      • Training management
      • Quality event management
      • Supplier management
      • Audit Management
      • Change Management
      • Risk Management
      • Others
    • Services
  • By Deployment
    • On-premises
    • Cloud-based
  • By End User
    • Pharmaceutical
    • Biotech
    • Contract Research Organization (CRO)
    • Medical Devices and Contract Development and Manufacturing Organization
    • Others
  • By Region
    • North America
    • Latin America
    • Europe
    • Asia Pacific
    • Middle East & Africa

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