의약품 품질관리 소프트웨어 시장 보고서 : 솔루션 유형, 도입 모델, 기업 규모, 최종사용자, 지역별(2025-2033년)

The global pharmaceutical quality management software market size reached USD 1.4 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 2.9 Billion by 2033, exhibiting a growth rate (CAGR) of 8.9% during 2025-2033. The increasing digitization in the pharmaceutical sector and the growing requirement to comply with regulatory guidelines are stimulating the market.

Pharmaceutical quality management software is a software system that is designed to manage and maintain the quality of pharmaceutical products throughout the entire product lifecycle. It is a comprehensive system that helps pharmaceutical companies to ensure that their products meet the highest standards of quality and safety, and comply with regulatory requirements. It assists in managing the creation, revision, and distribution of documents related to quality management processes, such as standard operating procedures (SOPs), work instructions, and policies. It also tracks employee training and certification, ensuring that all personnel are trained and qualified to perform their assigned tasks. In addition, it manages non-conformances, deviations, and incidents that may arise during the manufacturing processes and corrective and preventive actions (CAPAs) that are required to address non-conformances and prevent their recurrence. Owing to these properties, various companies are adopting pharmaceutical quality management software to streamline their quality management processes, reduce errors and inconsistencies, and improve compliance with regulatory requirements.

Pharmaceutical Quality Management Software Market Trends:

The market is primarily driven by the rising digitization in the pharmaceutical industry. Nowadays, companies are using advanced technologies, such as cloud computing, artificial intelligence (AI), and machine learning, to automate tasks, improve data analytics, and enhance collaboration and communication across the organization. In addition, the surging need to comply with regulatory requirements represents another major growth-inducing factor. The pharmaceutical industry is subject to strict regulatory requirements and standards, such as good manufacturing practice (GMP) and good laboratory practice (GLP), which require companies to maintain a high level of quality in their products and processes. Pharmaceutical quality management software helps companies to comply with these requirements and demonstrate their commitment to quality. Besides this, the pharmaceutical industry has a complex supply chain, involving multiple suppliers, manufacturers, and distributors. Pharmaceutical quality management software helps companies to manage this complexity and ensure that all parties involved in the supply chain meet the required quality standards. Moreover, the escalating demand for high-quality and safe pharmaceutical products is escalating the demand for pharmaceutical quality management software that enables companies to ensure that their products meet the highest standards of quality and safety, reducing the risk of product recalls, adverse events, and reputational damage. On account of these factors, the market is expected to witness positive growth in the coming years.

Global Pharmaceutical Quality Management Software Industry Segmentation:

Solution Type Insights:

• Corrective Action Preventive Action (CAPA) Management
• Audit Management
• Document Management
• Change Management
• Training Management
• Risk Management
• Complaints Management
• Regulatory and Compliance Management
• Non-Conformances Handling
• Supplier Quality Management
• Inspection Management
• Equipment Management
• Others

Deployment Model Insights:

• On-Cloud
• Web-Based
• On-Premises

Enterprise Size Insights:

• Small and Medium-sized Enterprises
• Large Enterprises

End User Insights:

• Pharmaceutical, Life Sciences, and Biotechnology Companies
• Contract Research Organizations
• Others

Regional Insights:

• North America
• United States
• Canada
• Europe
• Germany
• France
• United Kingdom
• Italy
• Spain
• Russia
• Others
• Asia Pacific
• China
• Japan
• India
• South Korea
• Australia
• Indonesia
• Others
• Latin America
• Brazil
• Mexico
• Others
• Middle East and Africa
• The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America was the largest market for pharmaceutical quality management software. Some of the factors driving the North America pharmaceutical quality management software market include increasing regulatory compliance requirements, growing complexity of pharmaceutical supply chains, and escalating demand for automation and digitization.

Competitive Landscape:

• The report has also provided a comprehensive analysis of the competitive landscape in the global pharmaceutical quality management software market. Detailed profiles of all major companies have also been provided. Some of the companies covered include AssurX Inc., ComplianceQuest, Dassault Systemes SE (Dassault Group), ETQ LLC (Hexagon AB), Ideagen, IQVIA Inc., Mastercontrol Inc., Qualio, Veeva Systems Inc, etc. Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Questions Answered in This Report:

• How has the global pharmaceutical quality management software market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global pharmaceutical quality management software market?
• What is the impact of each driver, restraint, and opportunity on the global pharmaceutical quality management software market?
• What are the key regional markets?
• Which countries represent the most attractive pharmaceutical quality management software market?
• What is the breakup of the market based on the solution type?
• Which is the most attractive solution type in the pharmaceutical quality management software market?
• What is the breakup of the market based on the deployment model?
• Which is the most attractive deployment model in the pharmaceutical quality management software market?
• What is the breakup of the market based on enterprise size?
• Which is the most attractive enterprise size in the pharmaceutical quality management software market?
• What is the breakup of the market based on the end user?
• Which is the most attractive end user in the pharmaceutical quality management software market?
• What is the competitive structure of the global pharmaceutical quality management software market?
• Who are the key players/companies in the global pharmaceutical quality management software market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Pharmaceutical Quality Management Software Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Solution Type

• 6.1 Corrective Action Preventive Action (CAPA) Management
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Audit Management
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Document Management
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast
• 6.4 Change Management
  • 6.4.1 Market Trends
  • 6.4.2 Market Forecast
• 6.5 Training Management
  • 6.5.1 Market Trends
  • 6.5.2 Market Forecast
• 6.6 Risk Management
  • 6.6.1 Market Trends
  • 6.6.2 Market Forecast
• 6.7 Complaints Management
  • 6.7.1 Market Trends
  • 6.7.2 Market Forecast
• 6.8 Regulatory and Compliance Management
  • 6.8.1 Market Trends
  • 6.8.2 Market Forecast
• 6.9 Non-Conformances Handling
  • 6.9.1 Market Trends
  • 6.9.2 Market Forecast
• 6.10 Supplier Quality Management
  • 6.10.1 Market Trends
  • 6.10.2 Market Forecast
• 6.11 Inspection Management
  • 6.11.1 Market Trends
  • 6.11.2 Market Forecast
• 6.12 Equipment Management
  • 6.12.1 Market Trends
  • 6.12.2 Market Forecast
• 6.13 Others
  • 6.13.1 Market Trends
  • 6.13.2 Market Forecast

7 Market Breakup by Deployment Model

• 7.1 On-Cloud
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Web-Based
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 On-Premises
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast

8 Market Breakup by Enterprise Size

• 8.1 Small and Medium-sized Enterprises
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Large Enterprise
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast

9 Market Breakup by End User

• 9.1 Pharmaceutical, Life Sciences, and Biotechnology Companies
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Contract Research Organizations
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Others
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast

10 Market Breakup by Region

• 10.1 North America
  • 10.1.1 United States
    • 10.1.1.1 Market Trends
    • 10.1.1.2 Market Forecast
  • 10.1.2 Canada
    • 10.1.2.1 Market Trends
    • 10.1.2.2 Market Forecast
• 10.2 Asia-Pacific
  • 10.2.1 China
    • 10.2.1.1 Market Trends
    • 10.2.1.2 Market Forecast
  • 10.2.2 Japan
    • 10.2.2.1 Market Trends
    • 10.2.2.2 Market Forecast
  • 10.2.3 India
    • 10.2.3.1 Market Trends
    • 10.2.3.2 Market Forecast
  • 10.2.4 South Korea
    • 10.2.4.1 Market Trends
    • 10.2.4.2 Market Forecast
  • 10.2.5 Australia
    • 10.2.5.1 Market Trends
    • 10.2.5.2 Market Forecast
  • 10.2.6 Indonesia
    • 10.2.6.1 Market Trends
    • 10.2.6.2 Market Forecast
  • 10.2.7 Others
    • 10.2.7.1 Market Trends
    • 10.2.7.2 Market Forecast
• 10.3 Europe
  • 10.3.1 Germany
    • 10.3.1.1 Market Trends
    • 10.3.1.2 Market Forecast
  • 10.3.2 France
    • 10.3.2.1 Market Trends
    • 10.3.2.2 Market Forecast
  • 10.3.3 United Kingdom
    • 10.3.3.1 Market Trends
    • 10.3.3.2 Market Forecast
  • 10.3.4 Italy
    • 10.3.4.1 Market Trends
    • 10.3.4.2 Market Forecast
  • 10.3.5 Spain
    • 10.3.5.1 Market Trends
    • 10.3.5.2 Market Forecast
  • 10.3.6 Russia
    • 10.3.6.1 Market Trends
    • 10.3.6.2 Market Forecast
  • 10.3.7 Others
    • 10.3.7.1 Market Trends
    • 10.3.7.2 Market Forecast
• 10.4 Latin America
  • 10.4.1 Brazil
    • 10.4.1.1 Market Trends
    • 10.4.1.2 Market Forecast
  • 10.4.2 Mexico
    • 10.4.2.1 Market Trends
    • 10.4.2.2 Market Forecast
  • 10.4.3 Others
    • 10.4.3.1 Market Trends
    • 10.4.3.2 Market Forecast
• 10.5 Middle East and Africa
  • 10.5.1 Market Trends
  • 10.5.2 Market Breakup by Country
  • 10.5.3 Market Forecast

11 Drivers, Restraints, and Opportunities

• 11.1 Overview
• 11.2 Drivers
• 11.3 Restraints
• 11.4 Opportunities

12 Value Chain Analysis

13 Porters Five Forces Analysis

• 13.1 Overview
• 13.2 Bargaining Power of Buyers
• 13.3 Bargaining Power of Suppliers
• 13.4 Degree of Competition
• 13.5 Threat of New Entrants
• 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

• 15.1 Market Structure
• 15.2 Key Players
• 15.3 Profiles of Key Players
  • 15.3.1 AssurX Inc.
    • 15.3.1.1 Company Overview
    • 15.3.1.2 Product Portfolio
  • 15.3.2 ComplianceQuest
    • 15.3.2.1 Company Overview
    • 15.3.2.2 Product Portfolio
  • 15.3.3 Dassault Systemes SE (Dassault Group)
    • 15.3.3.1 Company Overview
    • 15.3.3.2 Product Portfolio
    • 15.3.3.3 Financials
    • 15.3.3.4 SWOT Analysis
  • 15.3.4 ETQ LLC (Hexagon AB)
    • 15.3.4.1 Company Overview
    • 15.3.4.2 Product Portfolio
  • 15.3.5 Ideagen
    • 15.3.5.1 Company Overview
    • 15.3.5.2 Product Portfolio
  • 15.3.6 IQVIA Inc.
    • 15.3.6.1 Company Overview
    • 15.3.6.2 Product Portfolio
  • 15.3.7 Mastercontrol Inc.
    • 15.3.7.1 Company Overview
    • 15.3.7.2 Product Portfolio
  • 15.3.8 Qualio
    • 15.3.8.1 Company Overview
    • 15.3.8.2 Product Portfolio
  • 15.3.9 Veeva Systems Inc.
    • 15.3.9.1 Company Overview
    • 15.3.9.2 Product Portfolio
    • 15.3.9.3 Financials
    • 15.3.9.4 SWOT Analysis

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.