GVR Report cover Pharmaceutical Quality Management Software Market Size, Share & Trends Report

Pharmaceutical Quality Management Software Market Size, Share & Trends Analysis Report By Application (Data Management, Risk Management), By Deployment Mode (Cloud & Web-based, On-premise), By Region, And Segment Forecasts, 2023 - 2030

  • Report ID: GVR-4-68040-130-9
  • Number of Pages: 180
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2021
  • Industry: Healthcare

Report Overview

The global pharmaceutical quality management software market size was estimated at USD 1.5 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 12.58% from 2023 to 2030. The growing use of digital technology in the pharmaceutical sector, the growing need to comply with regulatory guidelines, and the increasing complexity of supply chains areamong the key factors driving the market growth. Increasing expenses in drug manufacturing and the rising use of technology in the pharmaceutical industry are driving market growth. For instance, a 2021 report from the Congressional Budget Office estimated that developing a new drug, including both initial investment and expenses on unsuccessful drugs, can range from under USD 1 billion to over USD 2 billion.

U.S. Pharmaceutical Quality Management Software market size and growth rate, 2023 - 2030

Furthermore, a study by the London School of Hygiene & Tropical Medicine, published in the JAMA Journal in 2020, discovered that the typical cost of introducing a new medication to the market was USD 985 million, with an average cost of USD 1.3 billion. These significant financial challenges have led to the emergence of software-based quality management systems as a crucial solution for reducing drug development costs. Therefore, software-based quality management systems offer a promising market for pharmaceutical QMS. Furthermore, pharmaceutical enterprises globally are recognizing the strategic significance of implementing comprehensive QMS to enhance overall company performance and secure a competitive edge.

This has led to various market providers taking strategic steps to meet this growing demand. For instance, in 2022, ComplianceQuest partnered with EZEN, a company that offers digital transformation services to the life sciences and healthcare sectors. As the pharmaceutical industry prioritizes quality assurance, demand for innovative QMS solutions is expected to increase, driving market growth. The COVID-19 pandemic had a moderate effect on market growth. The market experienced a decline in growth as a result of financial constraints and a reluctance to invest in new technology. However, as the market recovered, industry organizations sought to adopt quality management systems to control and document their activities.

During the pandemic, the quality of products and services provided became increasingly important. This will result in the adoption of pharmaceutical quality management systems, propelling market growth in the forecast period. Technological advancements, such as cloud computing, analytics, and big data, have greatly enhanced Quality Management Systems (QMS) in terms of scalability, cost-effectiveness, flexibility, and platform independence. These innovations have significantly expanded QMS capabilities, making them more scalable, cost-efficient, adaptable, and platform-agnostic. As a result, the pharmaceutical sector is witnessing a rapid and widespread adoption of QMS solutions.

Application Insights

The data management segment held the largest market share of over 17% in 2022. The rising volume of inconsistent healthcare data and the increased demand from regulatory organizations for reports that adhere to exacting quality standards are the main factors influencing this growth. Big Data is frequently used by the pharmaceutical industry. These companies employ data for a variety of tasks, such as analyzing clinical findings and assessing the efficacy of medications, based on actual health outcomes. Big data is expected to become even more important to pharmaceutical organizations, therefore effective data quality management is expected to become even more crucial.

On the other hand, the regulatory and compliance management segment is anticipated to grow at the fastest CAGR during the forecast period due to factors, such as the increasing number of counterfeit drugs, the recall of drugs from the market, and an increased emphasis on product quality. Regulatory entities, such as government agencies and accrediting organizations, require pharmaceutical companies to submit comprehensive reports on a variety of quality metrics, such as safety measures, drug quality, and adherence to best practices.

Deployment Mode Insights

The cloud & web-based segment held the largest revenue share of over 75% in 2022 and is projected to experience the fastest growth during the forecast period. This is due to the adaptability of Cloud and Web-based solutions, which enable organizations to readily adapt their software usage to evolving regulatory requirements and operational requirements. In addition, Cloud and Web-based systems reduce initial expenditures, facilitate data sharing and collaboration, and offer remote accessibility. These characteristics are reshaping the quality management system and contributing to the segment's rapid expansion.

Global Pharmaceutical Quality Management Software market share and size, 2022

On-premises software accounted for a significant revenue share in 2022. This is primarily attributed to its capacity to deliver robust data security and control, rendering it an attractive option for healthcare entities that prioritize stringent compliance mandates associated with quality management systems. These healthcare organizations place a premium on preventing data breaches, and as such, on-premises software solutions have been favored for their ability to meet these stringent requirements.

Regional Insights

In 2022, North America held the largest market share of over 38% due to the growing need for better production and quality control standards, along with the increasing use of advanced technologies, cloud-based solutions, and quality management software in the pharmaceutical sector. Furthermore, with an advanced healthcare infrastructure, stringent regulatory requirements, and an increasing focus on drug safety, pharmaceutical companies in North America are seeking advanced solutions to enhance quality control and compliance.

Pharmaceutical Quality Management Software Market Trends, by Region, 2023 - 2030

This demand is expected to drive the adoption of quality management software, creating significant opportunities for software providers in the region and contributing to the market expansion. On the other hand, Asia Pacific is expected to be the fastest-growing regional market. The COVID-19 pandemic has compelled Asia Pacific countries to prioritize pharmaceutical manufacturing, transport, and logistics while maintaining high quality. As a result, demand for pharma QMS solutions is increasing, particularly in Asia Pacific's emerging economies.

Key Companies & Market Share Insights

The market is moderately competitive as participants continue to concentrate on providing customized solutions, acquisitions, mergers, and market expansion. Additionally, as part of their commercialization strategies, businesses are investing in the development of new products and platforms with enhanced capabilities. For instance, in January 2023, Palantir Technologies Inc., a prominent supplier of operating systems for healthcare organizations, introduced its Quality Management System to assist life sciences customers using the Foundry platform in meeting GxP standards. Many major pharmaceutical research organizations are currently adopting Palantir's QMS for certification purposes.Some of the key players in the global pharmaceutical quality management software market include:

  • MasterControl Solutions, Inc.

  • AmpleLogic

  • Qualio

  • Pilgrim (IQVIA)

  • QT9

  • Sparta Systems (TrackWise)

  • AssurX, Inc.

  • Dassault Systèmes

  • ETQ, LLC (Hexagon)

  • Veeva Systems

  • Qualityze Inc.

  • Ideagen

Pharmaceutical Quality Management Software Market Report Scope

Report Attribute


The market size value in 2023

USD 1.7 billion

The revenue forecast in 2030

USD 3.9 billion

Growth rate

CAGR of 12.58 % from 2023 to 2030

The base year for estimation


Historical data

2018 - 2021

Forecast period

2023 - 2030

Quantitative units

Revenue in USD million/billion and CAGR from 2023 to 2030

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Application, deployment mode, region

Regional Scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; UK; Germany; France; Italy; Spain; Sweden; Norway; Denmark; China; Japan; India; Australia; South Korea; Thailand; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait

Key companies profiled

MasterControl Solutions, Inc.; AmpleLogic; Qualio; Pilgrim (IQVIA); QT9; Sparta Systems (TrackWise); AssurX, Inc.; Dassault Systèmes; ETQ, LLC (Hexagon); Veeva Systems; Qualityze Inc.; Ideagen

Customization scope

Free report customization (equivalent to up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional, and segment scope

Pricing and purchase options

Avail of customized purchase options to meet your exact research needs. Explore purchase options.


Global Pharmaceutical Quality Management Software Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global pharmaceutical quality management software market based on application, deployment mode, and region:

Global Pharmaceutical Quality Management Software Market Report Segmentation

  • Application Outlook (Revenue, USD Million, 2018 - 2030)

    • Data Management

    • Training management

    • Supplier management

    • Regulatory and Compliance Management

    • Corrective Action Preventive Action (CAPA) Management

    • Audit Management

    • Change Management

    • Non-Conformances Management

    • Inspection Management

    • Risk Management

    • Others

  • Deployment Mode Outlook (Revenue, USD Million, 2018 - 2030)

    • Cloud-based & Web-Based

    • On-premises

  • Regional Outlook (Revenue, USD Million, 2018 - 2030)

    • North America

      • U.S.

      • Canada

    • Europe

      • UK

      • Germany

      • France

      • Italy

      • Spain

      • Denmark

      • Sweden

      • Norway

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

      • Thailand

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

      • Kuwait

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