세계의 의약품 품질 관리 소프트웨어 시장 : 전개 형태별, 용도별, 최종사용자별, 지역별, 기회 및 예측(2018-2032년)

Global pharmaceutical quality management software market is projected to witness a CAGR of 9.43% during the forecast period 2025-2032, growing from USD 2.34 billion in 2024 to USD 4.81 billion in 2032. The pharmaceutical quality management software market is steadily growing, as companies within pharma, biotech, and medical devices transition from manual systems to automated solutions. These automated quality management solutions can manage quality tasks, including audits, CAPAs, training, and document control. These solutions enhance traceability, mitigate errors, and allow firms to have improved oversight of the quality management process. These software solutions allow for traceability and accuracy, as well as for firms to be able to manage improved oversight. Cloud-based platforms are allowing organizations to manage teams and processes regardless of the location. With real-time access, approvals may occur faster and be more productive.

Two main factors are driving this growth. First, cloud-based and artificial intelligence (AI) solutions offer automation and instant access to data. They cut down manual work and increase accuracy. Second, stricter regulations from organizations like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) push companies to maintain high-quality standards. Staying compliant and audit-ready is essential. Digital Pharmaceutical Quality Management Software makes this easier.

For instance, in April 2024, Clarivate Plc acquired Global QMS, Inc., a provider of cloud-based regulatory compliance software, to help life sciences companies better manage evolving global regulations.

Technological Advancement Driving Growth in the Pharmaceutical Quality Management Software Market

Technological advancement is a key factor driving growth in the pharmaceutical quality management software (PQMS) market. Modern solutions now integrate cloud computing, artificial intelligence (AI), and automation to improve quality processes. Use of cloud-based and AI-powered systems has been an essential part of pharmaceutical quality management software (PQMS) market. These technologies offer faster setup, better flexibility, and real-time access to data. Cloud solutions reduce the need for heavy IT infrastructure. They also support remote work and improve team collaboration. This is especially useful for global pharmaceutical companies. AI tools bring added benefits. It helps to automate routine quality checks and to detect problems early. This leads to quicker decision-making and fewer delays. AI also supports faster compliance with strict regulations. These tools can learn from data and improve over time. This makes the software smarter and more reliable. The combination of cloud and AI helps companies stay competitive. It improves overall efficiency and reduces risks. As regulations become stricter, companies need tools that adapt quickly. Cloud-based PQMS platforms meet this need. They are also easier to update and maintain. Many companies are now switching from old systems to modern, cloud-based solutions.

For instance, in February 2025, ComplianceQuest partnered with Salesforce Life Sciences Cloud to launch LifeQuest 360 an AI-powered, end-to-end life sciences platform designed to transform operations from R&D to commercialization and sustainability.

Rising Regulatory Compliance Demands are Driving the Adoption of Pharmaceutical Quality Management Software

Increased regulatory pressure is one of the main reasons pharmaceutical organizations choose to use new quality management software. The regulatory guidelines from the U.S. FDA, EMA, WHO, and other agencies continue to grow rapidly in complexity, and companies now have to demonstrate compliance at every stage of the product lifecycle. Manual systems often do not have the required accuracy and traceability and expose companies to risk during inspections and audits. Digital quality systems can offer a solution to this challenge of modernization. Digital quality systems automate several processes, including change management, document control, and audit preparedness; as well as allow real-time oversight of records and electronic documents. Companies can be more responsive to issues and avoid costly penalties. The level of human error diminishes due to automation which in turn improves data integrity. Cloud-based platforms allow for all stakeholders worldwide to collaborate more easily which is most important for organizations operating across borders. PQMS tools can offer compliant functionality with the standards such as FDA 21 CFR Part 11 and ISO 13485 proactively in their design. The obligation to remain compliant is a major motivation of organizations to deploy digital quality tools.

For instance, SimplerQMS, a cloud-based eQMS, enables life sciences firms to schedule audits, track outcomes, and manage supplier quality in one platform helping companies meet FDA 21 CFR Part 11 and EU Annex 11 standards with real-time data and streamlined workflows.

Cloud-based Deployment is the Dominant Segment in the Pharmaceutical Quality Management Software Market

The pharmaceutical quality management software (PQMS) market is mostly driven by cloud-based solutions. These offer flexibility, scalability, and lower costs compared to on-premises systems. Cloud platforms provide real-time data access and easy updates. This helps global teams work better together. Quality assurance and inspection lead among applications. They are vital for product safety and meeting regulations. Audit management, document management, and supplier quality management also play key roles. Pharmaceutical companies are the biggest users. They face strict regulations and need strong quality controls. Biotechnology and medical device companies are growing users too. They also face increasing quality demands.

For instance, in June 2024, AmpleLogic launched a cloud-based electronic quality management system (eQMS) designed for pharmaceuticals and biotech. It includes modules like CAPA, audit management, and change control, ensuring compliance with FDA and GAMP standards.

North America Dominates the Market

North America remains the largest segment in the pharmaceutical quality management software (PQMS) market, largely driven by a combination of a stringent regulatory climate, high amount of investment into pharmaceutical R&D, and early adoption of digital technologies. Regulators, such as the Food and Drug Administration (FDA), impose stringent quality and compliance regulatory standards, creating strong incentives for pharmaceutical companies to utilize quality management systems. The North America region also contains many of the leading software providers that actively pursue innovation - with key areas of investment into cloud-based systems, automation, and AI. There is rapidly increasing reliance within pharmaceutical companies in the U.S. and Canada, upon digital tools that enhance operations and compliance with audits and drive regulations from various regions across the world into their global supply chains. The focus is on improving product quality and reducing errors and direct operational cost and preserving operational capacity. The pace of change for digital transformation has increased and remains consistent with that trend, which will drive demand for PQMS alternatives that ensure users benefit from scalable, secure and integrated solutions.

For instance, in April 2025, Veeva Systems announced Veeva AI, a new initiative that adds AI Agents and AI Shortcuts powered by large language models (LLMs) across its Vault Platform and applications, helping life sciences companies automate tasks and improve productivity across clinical, regulatory, safety, quality, medical, and commercial functions. In another instance, in May 2025, MasterControl Solutions Inc. achieved FedRAMP authorization for its quality management system, highlighting its dedication to cloud security and regulatory compliance in the pharmaceutical industry.

Impact of U.S. Tariffs on Global Pharmaceutical Quality Management Software Market

US tariffs on pharmaceutical imports are having an indirect effect on the pharmaceutical quality management software (PQMS) market. While tariffs increase the price for important pharma inputs, for example Active Pharmaceutical Ingredients (APIs) and raw materials, they increase total production costs and thereby may tighten caps on operational budgets, while companies are less likely to spend money on a new or upgraded quality management system.

However, while operational budgets may be tighter, pressure for companies to remain compliant with enforceable rules and regulations, for example, from the Food and Drug Administration (FDA), has not changed. As a result, companies are forced to pursue more efficient, automated methods to manage the related oversight cost and to eliminate avoidable operational risks. In that regard, PQMS is a growingly useful tool for companies to manage compliance, to reduce or eliminate mistakes, and to manage relationships, especially with respect to global supply chains.

In the long-run, tariffs may decrease initial spending but they sustain pressures to invest in quality management tools so companies can remain competitive, compliant, and ultimately strategic, in a changing trade environment.

Key Players Landscape and Outlook

Major players in the pharmaceutical quality management software (PQMS) market concentrated on innovation and compliance. They implemented cloud-based platforms that are highly flexible and easily scalable. Many companies are deploying artificial intelligence (AI) and automation to improve data accuracy and speed of delivery. Companies such as Veeva Systems Inc, MasterControl Solutions Inc., and Honeywell International Inc. are developing solutions to meet global regulatory requirements using standards set by the FDA and EMA. Many key players are also making strategic alliances to expand their companies, developing the software for use by both large and small pharmaceutical companies and biotech companies. The goal of these key players will be to improve efficiencies, ensure compliance with the various regulations, and support global companies operating on a global basis.

For instance, on August 2024, Honeywell International Inc. launched its Honeywell quality management review (HQMR) system for the life sciences industry to help manufacturers boost efficiency and ensure quality compliance.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Global Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Deployment Mode
    • 5.2.1.1. On-premises
    • 5.2.1.2. Cloud-based
  • 5.2.2. By Application
    • 5.2.2.1. Quality Assurance and Inspection
    • 5.2.2.2. Audit Management
    • 5.2.2.3. Document Management
    • 5.2.2.4. Supplier Quality Management
    • 5.2.2.5. Training Management
    • 5.2.2.6. Others
  • 5.2.3. By End-user
    • 5.2.3.1. Biotechnology Companies
    • 5.2.3.2. Pharmaceutical Companies
    • 5.2.3.3. Medical Device Companies
    • 5.2.3.4. Contract Manufacturing Companies (CMOs)
    • 5.2.3.5. Others
  • 5.2.4. By Region
    • 5.2.4.1. North America
    • 5.2.4.2. Europe
    • 5.2.4.3. Asia-Pacific
    • 5.2.4.4. South America
    • 5.2.4.5. Middle East and Africa
  • 5.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 5.3. Market Map Analysis, 2024
  • 5.3.1. By Deployment Mode
  • 5.3.2. By Application
  • 5.3.3. By End-user
  • 5.3.4. By Region

6. North America Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 6.1. Market Size Analysis & Forecast
  • 6.1.1. By Value
• 6.2. Market Share Analysis & Forecast
  • 6.2.1. By Deployment Mode
    • 6.2.1.1. On-premises
    • 6.2.1.2. Cloud-based
  • 6.2.2. By Application
    • 6.2.2.1. Quality Assurance and Inspection
    • 6.2.2.2. Audit Management
    • 6.2.2.3. Document Management
    • 6.2.2.4. Supplier Quality Management
    • 6.2.2.5. Training Management
    • 6.2.2.6. Others
  • 6.2.3. By End-user
    • 6.2.3.1. Biotechnology Companies
    • 6.2.3.2. Pharmaceutical Companies
    • 6.2.3.3. Medical Device Companies
    • 6.2.3.4. Contract Manufacturing Companies (CMOs)
    • 6.2.3.5. Others
  • 6.2.4. By Country Share
    • 6.2.4.1. United States
    • 6.2.4.2. Canada
    • 6.2.4.3. Mexico
• 6.3. Country Market Assessment
  • 6.3.1. United States Pharmaceutical Quality Management Software Market Outlook, 2018-2032F*
    • 6.3.1.1. Market Size Analysis & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share Analysis & Forecast
      • 6.3.1.2.1. By Deployment Mode
        • 6.3.1.2.1.1. On-premises
        • 6.3.1.2.1.2. Cloud-based
      • 6.3.1.2.2. By Application
        • 6.3.1.2.2.1. Quality Assurance and Inspection
        • 6.3.1.2.2.2. Audit Management
        • 6.3.1.2.2.3. Document Management
        • 6.3.1.2.2.4. Supplier Quality Management
        • 6.3.1.2.2.5. Training Management
        • 6.3.1.2.2.6. Others
      • 6.3.1.2.3. By End-user
        • 6.3.1.2.3.1. Biotechnology Companies
        • 6.3.1.2.3.2. Pharmaceutical Companies
        • 6.3.1.2.3.3. Medical Device Companies
        • 6.3.1.2.3.4. Contract Manufacturing Companies (CMOs)
        • 6.3.1.2.3.5. Others
  • 6.3.2. Canada
  • 6.3.3. Mexico

All segments will be provided for all regions and countries covered

7. Europe Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 7.1. Germany
• 7.2. France
• 7.3. Italy
• 7.4. United Kingdom
• 7.5. Russia
• 7.6. Netherlands
• 7.7. Spain
• 7.8. Turkey
• 7.9. Poland

8. Asia-Pacific Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 8.1. India
• 8.2. China
• 8.3. Japan
• 8.4. Australia
• 8.5. Vietnam
• 8.6. South Korea
• 8.7. Indonesia
• 8.8. Philippines

9. South America Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 9.1. Brazil
• 9.2. Argentina

10. Middle East and Africa Pharmaceutical Quality Management Software Market Outlook, 2018-2032F

• 10.1. Saudi Arabia
• 10.2. UAE
• 10.3. South Africa

11. Porter's Five Forces Analysis

12. PESTLE Analysis

13. Pricing Analysis

14. Market Dynamics

• 14.1. Market Drivers
• 14.2. Market Challenges

15. Market Trends and Developments

16. Case Studies

17. Competitive Landscape

• 17.1. Competition Matrix of Top 5 Market Leaders
• 17.2. SWOT Analysis for Top 5 Players
• 17.3. Key Players Landscape for Top 10 Market Players
  • 17.3.1. IQVIA Holdings Inc.
    • 17.3.1.1. Company Details
    • 17.3.1.2. Key Management Personnel
    • 17.3.1.3. Products and Services
    • 17.3.1.4. Financials (As Reported)
    • 17.3.1.5. Key Market Focus and Geographical Presence
    • 17.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 17.3.2. MasterControl Solutions, Inc.
  • 17.3.3. Qualio, Inc.
  • 17.3.4. Veeva Systems Inc.
  • 17.3.5. ETQ, LLC
  • 17.3.6. Qualityze Inc.
  • 17.3.7. AssurX, Inc.
  • 17.3.8. Honeywell International Inc.
  • 17.3.9. Ideagen
  • 17.3.10. Oracle Corporation

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

18. Strategic Recommendations

19. About Us and Disclaimer