医薬品品質管理ソフトウェアの世界市場：展開形態別、用途別、エンドユーザー別、地域別、機会、予測、2018年～2032年

世界の医薬品品質管理ソフトウェアの市場規模は、2025年～2032年の予測期間中に9.43%のCAGRで拡大し、2024年の23億4,000万米ドルから2032年には48億1,000万米ドルに成長すると予測されています。医薬品品質管理ソフトウェア市場は、製薬、バイオテクノロジー、医療機器の各企業が手動システムから自動化ソリューションに移行していることから、着実に成長しています。自動化された品質管理ソリューションは、監査、CAPA、トレーニング、文書管理などの品質タスクを管理することができます。これらのソリューションは、トレーサビリティを強化し、エラーを軽減し、企業が品質管理プロセスの監視を改善することを可能にします。これらのソフトウェア・ソリューションは、トレーサビリティと正確性を実現し、企業は監視の強化を管理することができます。クラウドベースのプラットフォームにより、企業は場所に関係なくチームとプロセスを管理できます。リアルタイムのアクセスにより、承認はより迅速に行われ、生産性も向上します。

この成長を後押ししている主な要因は2つあります。第一に、クラウドベースの人工知能（AI）ソリューションは、自動化とデータへの即時アクセスを提供します。これらは手作業を削減し、精度を高める。第二に、米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの組織による規制強化が、企業に高品質な基準の維持を促しています。コンプライアンスを維持し、監査に対応することは不可欠です。デジタル医薬品品質管理ソフトウェアは、これを容易にします。

例えば、Clarivate Plcは2024年4月、クラウドベースの規制コンプライアンス・ソフトウェアを提供するGlobal QMS, Inc.を買収し、ライフサイエンス企業が進化する世界規制をよりよく管理できるよう支援しています。

当レポートでは、世界の医薬品品質管理ソフトウェア市場について調査し、市場の概要とともに、展開形態別、用途別、エンドユーザー別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 米国の関税の影響

第4章 エグゼクティブサマリー

第5章 世界の医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• 市場規模分析と予測
• 市場シェア分析と予測
  • 展開形態別
    • オンプレミス
    • クラウドベース
  • 用途別
    • 品質保証・検査
    • 監査管理
    • ドキュメント管理
    • サプライヤー品質管理
    • トレーニング管理
    • その他
  • エンドユーザー別
    • バイオテクノロジー企業
    • 製薬会社
    • 医療機器企業
    • 契約製造会社（CMO）
    • その他
  • 地域別
    • 北米
    • 欧州
    • アジア太平洋
    • 南米
    • 中東・アフリカ
  • 企業別市場シェア分析（上位5社およびその他- 金額別、2024年）
• 2024年の市場マップ分析

第6章 北米の医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• 市場規模分析と予測
• 市場シェア分析と予測
• 国別市場評価
  • 米国
  • カナダ
  • メキシコ

第7章 欧州の医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• ドイツ
• フランス
• イタリア
• 英国
• ロシア
• オランダ
• スペイン
• トルコ
• ポーランド

第8章 アジア太平洋の医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• インド
• 中国
• 日本
• オーストラリア
• ベトナム
• 韓国
• インドネシア
• フィリピン

第9章 南米の医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• ブラジル
• アルゼンチン

第10章 中東・アフリカの医薬品品質管理ソフトウェア市場の見通し、2018年～2032年

• サウジアラビア
• アラブ首長国連邦
• 南アフリカ

第11章 ポーターのファイブフォース分析

第12章 PESTLE分析

第13章 価格分析

第14章 市場力学

• 市場の促進要因
• 市場の課題

第15章 市場動向と発展

第16章 ケーススタディ

第17章 競合情勢

• 市場リーダートップ5の競合マトリックス
• 参入企業トップ5のSWOT分析
• 市場の主要企業トップ10の情勢
  • IQVIA Holdings Inc.
  • MasterControl Solutions, Inc.
  • Qualio, Inc.
  • Veeva Systems Inc.
  • ETQ, LLC
  • Qualityze Inc.
  • AssurX, Inc.
  • Honeywell International Inc.
  • Ideagen
  • Oracle Corporation

第18章 戦略的提言

第19章 調査会社について・免責事項

List of Tables

• Table 1. Competition Matrix of Top 5 Market Leaders
• Table 2. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 3. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Global Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 2. Global Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 3. Global Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 4. Global Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 5. Global Pharmaceutical Quality Management Software Market Share (%), By Region, 2018-2032F
• Figure 6. North America Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 7. North America Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 8. North America Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 9. North America Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 10. North America Pharmaceutical Quality Management Software Market Share (%), By Country, 2018-2032F
• Figure 11. United States Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 12. United States Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 13. United States Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 14. United States Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 15. Canada Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 16. Canada Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 17. Canada Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 18. Canada Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 19. Mexico Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 20. Mexico Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 21. Mexico Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 22. Mexico Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 23. Europe Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 24. Europe Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 25. Europe Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 26. Europe Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 27. Europe Pharmaceutical Quality Management Software Market Share (%), By Country, 2018-2032F
• Figure 28. Germany Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 29. Germany Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 30. Germany Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 31. Germany Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 32. France Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 33. France Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 34. France Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 35. France Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 36. Italy Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 37. Italy Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 38. Italy Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 39. Italy Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 40. United Kingdom Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 41. United Kingdom Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 42. United Kingdom Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 43. United Kingdom Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 44. Russia Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 45. Russia Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 46. Russia Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 47. Russia Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 48. Netherlands Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 49. Netherlands Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 50. Netherlands Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 51. Netherlands Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 52. Spain Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 53. Spain Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 54. Spain Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 55. Spain Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 56. Turkey Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 57. Turkey Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 58. Turkey Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 59. Turkey Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 60. Poland Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 61. Poland Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 62. Poland Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 63. Poland Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 64. South America Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 65. South America Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 66. South America Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 67. South America Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 68. South America Pharmaceutical Quality Management Software Market Share (%), By Country, 2018-2032F
• Figure 69. Brazil Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 70. Brazil Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 71. Brazil Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 72. Brazil Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 73. Argentina Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 74. Argentina Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 75. Argentina Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 76. Argentina Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 77. Asia-Pacific Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 78. Asia-Pacific Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 79. Asia-Pacific Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 80. Asia-Pacific Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 81. Asia-Pacific Pharmaceutical Quality Management Software Market Share (%), By Country, 2018-2032F
• Figure 82. India Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 83. India Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 84. India Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 85. India Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 86. China Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 87. China Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 88. China Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 89. China Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 90. Japan Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 91. Japan Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 92. Japan Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 93. Japan Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 94. Australia Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 95. Australia Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 96. Australia Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 97. Australia Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 98. Vietnam Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 99. Vietnam Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 100. Vietnam Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 101. Vietnam Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 102. South Korea Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 103. South Korea Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 104. South Korea Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 105. South Korea Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 106. Indonesia Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 107. Indonesia Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 108. Indonesia Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 109. Indonesia Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 110. Philippines Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 111. Philippines Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 112. Philippines Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 113. Philippines Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 114. Middle East & Africa Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 115. Middle East & Africa Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 116. Middle East & Africa Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 117. Middle East & Africa Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 118. Middle East & Africa Pharmaceutical Quality Management Software Market Share (%), By Country, 2018-2032F
• Figure 119. Saudi Arabia Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 120. Saudi Arabia Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 121. Saudi Arabia Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 122. Saudi Arabia Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 123. UAE Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 124. UAE Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 125. UAE Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 126. UAE Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 127. South Africa Pharmaceutical Quality Management Software Market, By Value, In USD Billion, 2018-2032F
• Figure 128. South Africa Pharmaceutical Quality Management Software Market Share (%), By Deployment Mode, 2018-2032F
• Figure 129. South Africa Pharmaceutical Quality Management Software Market Share (%), By Application, 2018-2032F
• Figure 130. South Africa Pharmaceutical Quality Management Software Market Share (%), By End-user, 2018-2032F
• Figure 131. By Deployment Mode Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 132. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 133. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2024
• Figure 134. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2024

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