品質管理ソフトウェアの世界市場規模：展開タイプ別、組織規模別、業界別、地域別、予測

品質管理ソフトウェアの市場規模と予測

品質管理ソフトウェアの市場規模は、2024年に99億5,000万米ドルと評価され、2026～2032年にかけてCAGR 9.90%で成長し、2032年には197億9,000万米ドルに達すると予測されます。

品質管理ソフトウェア（QMS）は、企業内の製品品質の維持・監視に関わる手順を迅速化・改善するために設計されたデジタルプラットフォームです。このソフトウェアは、文書管理、コンプライアンス追跡、是正・予防措置（CAPA）、監査管理などのプロセスを自動化することで、企業が高水準を維持するのに役立ちます。品質関連データを一元化し、リアルタイムのモニタリングとレポーティングを可能にします。これにより、生産性が向上し、エラーが最小限に抑えられ、商品が規制および顧客基準を満たすことが保証されます。

技術の進歩に伴い、品質管理ソフトウェアの範囲は拡大しています。人工知能や機械学習との統合は、品質データの処理方法を変革し、予測される洞察やより積極的な品質管理アプローチをもたらす態勢を整えています。

さらに、モノのインターネット（IoT）デバイスを統合することで、製造ラインからリアルタイムのデータを提供し、品質パラメーターにこれまでにない可視性を提供することができます。企業がデジタルトランスフォーメーションを取り入れるにつれて、QMSはより直感的かつ統合的になり、製品の卓越性と業務効率を確保する役割を強化すると予想されます。

品質管理ソフトウェアの市場力学

世界の品質管理ソフトウェア市場を形成している主な市場力学は以下の通りである：

主な市場促進要因

規制コンプライアンス重視の高まり：法規制遵守の重要性はますます高まっており、企業全体で強固な品質管理システムが必要となっています。米国食品医薬品局（FDA）は、2020会計年度に品質および規制基準を満たさない企業に対して524件の警告書を発行したことを明らかにしました。このような規制当局の監視の強化により、企業はコンプライアンスを保証するために品質管理ソフトウェアに投資するようになっています。

顧客満足と製品品質への関心の高まり：企業は、顧客満足度を高めるための品質管理の価値をますます理解するようになっています。米国品質協会（ASQ）の世論調査によると、世界企業の49％が、顧客満足を品質の将来にとって重要な問題と捉えています。このような顧客満足度の重視が、製品やサービスの品質を高める品質管理ソフトウェアの利用を後押ししています。

シックスシグマとリーン生産方式の導入の増加：シックスシグマやリーン生産方式といった品質改善手法の採用が増加していることが、品質管理ソフトウェアの需要を押し上げています。Lean Enterprise Instituteの調査によると、リーンの概念を適用している企業の69.6%が、品質改善において中程度から大幅な進歩を遂げていると報告しています。企業がこれらの手法をサポートするツールを探しているため、この動向は品質管理ソフトウェア市場を強化すると予想されます。

主な課題

既存システムとの統合：品質管理ソフトウェア（QMS）市場でより困難なことのひとつは、新しいQMSソリューションと現行の企業システムとの統合です。多くの企業は、過去のシステムと最新のアプリケーションを組み合わせて利用しているため、互換性に懸念が生じる可能性があります。新しいQMSがERPやCRMシステムなどの既存のソフトウェアと効果的に接続できるようにするには、大幅な修正と技術的なスキルが必要であり、これがコスト増と導入期間の長期化につながることもあります。このような複雑さは、企業が新しいQMSソリューションを導入する意欲を失わせ、高度な機能や効率性の向上を活用する能力を制限することになりかねません。

データセキュリティとプライバシー：データセキュリティとプライバシーに関する懸念が高まる中、品質管理ソフトウェアは、機密情報を不正アクセスや侵害から確実に保護する必要があります。これは、ヘルスケアや銀行など、機密データを扱う業界にとって特に重要です。データを保護するために、QMSプロバイダーは、暗号化、安全なアクセス制御、頻繁な監査などの強固なセキュリティ対策を使用する必要があります。GDPRや HIPAAなどの規則に準拠することは、さらに困難を増します。これらの要件を満たせない場合、法的措置や評判の低下を招く可能性があるからです。

拡張性と柔軟性：ビジネスの拡大に伴い、品質管理要件も変化するため、それに応じて拡張・適応できるQMSが必要となります。現在の要件に適合するだけでなく、新たな規制基準や生産量の増加といった将来の変化にも適応できるQMSを見つけることは、重要な課題です。過度に硬直的なシステムや、拡張のために大幅な適応を必要とするシステムは、ボトルネックになる可能性があります。企業は、大きな追加費用を必要とせずに、新たな手順や市場の需要に適応し、ともに拡張できるシステムを必要としています。

主要動向

AIと機械学習の統合：AIと機械学習が品質管理ソフトウェアに統合されつつあり、予測分析と自動意思決定が改善され、よりプロアクティブな品質管理と問題解決が実現されます。

クラウドベースのソリューション：クラウドベースのQMSソリューションは、その柔軟性、拡張性、費用対効果の高さから人気が高まっており、企業はどこからでも品質データやツールにアクセスできます。

IoTとリアルタイムモニタリング：モノのインターネット（IoT）技術を活用することで、工業プロセスのリアルタイムモニタリングが可能になり、継続的なフィードバックを通じてデータの精度と品質管理が向上します。

モバイルアクセシビリティ：モバイルフレンドリーなQMSプラットフォームは、品質管理ツールやデータへの外出先からのアクセスを可能にし、ユーザーがモバイルデバイスから品質に関する問題を管理・追跡できるようにすることで、効率性と応答性を向上させます。

目次

第1章 イントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 市場概要

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 品質管理ソフトウェア市場：展開タイプ別

• 概要
• オンプレミス
• クラウドベース

第6章 品質管理ソフトウェア市場：組織規模別

• 概要
• 中小企業（SME）
• 大企業

第7章 品質管理ソフトウェア市場：業界別

• 概要
• ヘルスケア
• 製造業
• IT・通信
• 航空宇宙・防衛
• 飲食品
• 政府機関
• 公益事業

第8章 品質管理ソフトウェア市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第9章 競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第10章 企業プロファイル

• Arena Solutions, Inc.
• Cority Software Inc.
• Dassault Systemes SE
• EtQ Management Consultants, Inc.
• Ideagen Plc.
• Intelex Technologies
• MasterControl, Inc.
• MetricStream, Inc.
• Microsoft Corporation
• Oracle Corporation

第11章 付録

• 関連レポート

Quality Management Software Market Size And Forecast

Quality Management Software Market size was valued at USD 9.95 Billion in 2024 and is projected to reach USD 19.79 Billion by 2032, growing at a CAGR of 9.90% from 2026 to 2032.

Quality Management Software (QMS) is a digital platform designed to expedite and improve the procedures involved in maintaining and monitoring product quality within a business. This software helps firms maintain high standards by automating processes including document control, compliance tracking, corrective and preventative actions (CAPA), and audit management. It centralizes quality-related data, allowing for real-time monitoring and reporting. This increases productivity, minimizes errors, and ensures that goods fulfill regulatory and customer standards.

The scope of Quality Management Software is expanding as technology advances. Integrations with artificial intelligence and machine learning are poised to transform how quality data is processed, resulting in predicted insights and more proactive quality management approaches.

Furthermore, the integration of Internet of Things (IoT) devices can provide real-time data from manufacturing lines, providing unprecedented visibility into quality parameters. As companies embrace digital transformation, QMS is anticipated to become more intuitive and integrated, enhancing its role in ensuring product excellence and operational efficiency.

Global Quality Management Software Market Dynamics

The key market dynamics that are shaping the global Quality Management Software Market include:

Key Market Drivers:

Growing Emphasis on Regulatory Compliance: Regulatory compliance is becoming increasingly important, necessitating strong quality management systems across businesses. The United States Food and Drug Administration (FDA) revealed that in fiscal year 2020, it issued 524 warning letters to corporations for failing to meet quality and regulatory criteria. This increased regulatory scrutiny is driving firms to invest in quality management software to assure compliance.

Rising Focus on Customer Satisfaction and Product Quality: Companies are increasingly understanding the value of quality management in boosting customer satisfaction. According to an American Society for Quality (ASQ) poll, 49% of worldwide firms view customer satisfaction as a significant problem for the future of quality. This emphasis on customer happiness is propelling the use of quality management software to enhance product and service quality.

Increasing Implementation of Six Sigma and Lean Manufacturing Principles: The increase in adoption of quality improvement approaches such as Six Sigma and lean manufacturing is driving up demand for quality management software. According to Lean Enterprise Institute research, 69.6% of firms applying lean concepts reported making moderate to significant progress in quality improvement. This trend is expected to enhance the Quality Management Software Market as businesses look for tools to support these techniques.

Key Challenges:

Integration with Existing Systems: One of the more difficulties in the Quality Management Software (QMS) market is integrating new QMS solutions with current enterprise systems. Many firms utilize a combination of historical systems and contemporary applications, which can lead to compatibility concerns. Ensuring that a new QMS connects effectively with existing software, such as ERP or CRM systems, necessitates substantial modification and technical skill, which sometimes leads to increased costs and longer implementation times. This complexity can dissuade firms from implementing new QMS solutions, limiting their ability to take advantage of advanced capabilities and increased efficiencies.

Data Security and Privacy: With growing worries about data security and privacy, quality management software must ensure that sensitive information is safeguarded against unauthorized access and breaches. This is especially important for industries that handle sensitive data, such as healthcare or banking. To preserve data, QMS providers must use robust security measures such as encryption, secure access controls, and frequent audits. Compliance with rules such as GDPR and HIPAA adds another layer of difficulty, as failure to achieve these requirements can result in legal ramifications and harm to reputation.

Scalability and Flexibility: As businesses expand, their quality management requirements change, needing a QMS that can scale and adapt accordingly. Finding a QMS that not only fits current requirements but is also adaptable to future changes, such as new regulatory standards or greater production quantities, is a significant task. Systems that are excessively rigid or require significant adaptation to scale might become bottlenecks. Companies require a system that can scale with them and adapt to new procedures or market demands without requiring significant additional expenses.

Key Trends:

AI and Machine Learning Integration: AI and machine learning are increasingly being integrated into Quality Management Software, which improves predictive analytics and automated decision-making, resulting in more proactive quality management and problem resolution.

Cloud-Based Solutions: Cloud-based QMS solutions are becoming increasingly popular due to their flexibility, scalability, and cost-effectiveness, allowing businesses to access quality data and tools from anywhere.

IoT and Real-Time Monitoring: The use of Internet of Things (IoT) technology enables real-time monitoring of industrial processes, boosting data accuracy and quality control through continuous feedback.

Mobile Accessibility: Mobile-friendly QMS platforms provide on-the-go access to quality management tools and data, improving efficiency and responsiveness by allowing users to manage and track quality concerns from their mobile devices.

Global Quality Management Software Market Regional Analysis

Here is a more detailed regional analysis of the global Quality Management Software Market:

North America:

North America currently reigns supreme in the quality management software (QMS) market, holding the largest market share. The Quality Management Software Market in North America is being driven by an increased focus on regulatory compliance. In fiscal year 2021, the United States Food and Drug Administration (FDA) recorded 3,706 medical device recalls, a 26.5% increase over the previous year, underlining the importance of strong quality control systems.

Furthermore, the FDA's Center for Devices and Radiological Health (CDRH) reported that 89% of inspections in 2020 either yielded no action or resulted in voluntary actions, indicating increased compliance efforts. These regulatory requirements are leading firms, particularly those in healthcare and manufacturing, to implement quality management software to ensure standard adherence and reduce compliance risk.

North America's technological supremacy is a major driver of the Quality Management Software Market. The US manufacturing sector's productivity improved by 3.8% in 2021, above the broader nonfarm business sector's growth of 2.2%, owing largely to modern technologies such as quality control systems. According to the Software & Information Industry Association (SIIA), 94% of firms in the United States employ cloud-based software, demonstrating the region's preparedness to accept new technologies such as QMS. This early adoption tendency is driving the growth of the Quality Management Software Market, as companies attempt to improve quality systems and preserve a competitive advantage.

Asia Pacific:

Rapid industrial growth in the Asia-Pacific region, notably in manufacturing powerhouses such as China and India, is driving the Quality Management Software Market. China's National Bureau of Statistics reported a 3.6% growth in industrial output year on year in 2022, whereas India's Ministry of Statistics reported a 5.2% increase in the Index of Industrial Production in January 2023.

The Asian Development Bank projects a 4.8% growth in developing Asia's economy in 2023, with industrial expansion playing a vital role. This spike in industrial activity is driving increasing demand for quality management systems, as businesses struggle to maintain high standards and remain competitive globally. According to a poll conducted by the Asian Productivity Organization, 68% of enterprises in the region regard quality management as critical to competitiveness, demonstrating the growing demand for QMS software.

The Quality Management Software Market in Asia-Pacific is being driven by an increasing realization of the long-term benefits of quality management. According to a survey conducted by the Asian productivity organization, 78% of regional enterprises have implemented quality management systems, with 62% identifying increased product quality as a key advantage. Between 2018 and 2022, the China association for quality reported a 15% improvement in customer satisfaction for enterprises that implemented complete quality management systems. In Japan, the Ministry of Economy, Trade, and Industry discovered that enterprises with advanced quality processes experienced 23% higher export growth.

Furthermore, the Indian Ministry of Micro, Small, and Medium Enterprises reported a 31% decrease in defect rates and a 27% increase in productivity among SMEs who use quality management systems. These findings demonstrate a growing understanding of the benefits of quality management, which is driving higher adoption of QMS software throughout the area.

Global Quality Management Software Market: Segmentation Analysis

The Global Quality Management Software Market is Segmented on the basis of Deployment Type, Organization Size, Verticals, And Geography.

Quality Management Software Market, By Deployment Type

• On-Premises
• Cloud-Based

Based on Deployment Type, the market is bifurcated into On-Premises, and Cloud-Based. The on-premise category dominates the QMS market, accounting for the vast bulk of revenue. However, the cloud-based market is growing the fastest due to benefits such as cost, scalability, and ease. While on-premise solutions provide more control, cloud solutions are becoming more appealing with advantages such as remote access and automatic updates. This pattern shows that cloud computing may become dominant in the future.

Quality Management Software Market, By Organization Size

• Small and Medium Enterprises (SMEs)
• Large Enterprises

Based on Organization Size, the market is segmented into Small and Medium Enterprises (SMEs), and Large Enterprises. Large organizations presently retain the majority of the QMS market due to their complicated workflows and stringent regulatory requirements, while SMEs are the fastest-growing group. Cloud-based QMS solutions, noted for their low cost and ease of use, are especially appealing to SMEs. As these businesses become more aware of the benefits of quality management, and cloud technology becomes more accessible, the SME category is expected to expand significantly in the coming years.

Quality Management Software Market, By Verticals

• Healthcare
• Manufacturing
• IT & Telecom
• Aerospace & Defense
• Food & Beverage
• Government
• Utilities

Based on Verticals, the market is segmented into Healthcare, Manufacturing, IT & Telecom, Aerospace & Defense, Food & Beverage, Government, and Utilities. The manufacturing industry now dominates the quality management system market. This is owing to the established emphasis on quality control in manufacturing and the requirement to follow tight rules. However, the healthcare industry is growing the fastest. This is being pushed by an increased emphasis on patient safety and quality of care, as well as new rules such as the PPACA (US), which require quality management methods in healthcare. As healthcare organizations strive for better patient outcomes, they are turning to QMS solutions to increase efficiency and compliance.

Key Players

The "Global Quality Management Software Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Arena Solutions, Inc., Cority Software Inc., Dassault Systemes SE, EtQ Management Consultants, Inc., Ideagen Plc., Intelex Technologies, MasterControl, Inc., MetricStream, Inc., Microsoft Corporation, Oracle Corporation, Pilgrim Quality Solution, Plex Systems, Inc., SAP SE, Siemens AG, Sparta Systems Inc., uniPoint Software, Inc., and Veeva Systems. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Quality Management Software Market Recent Developments
• In January 2024, Master Control, a provider of quality management and sophisticated manufacturing execution software, officially introduced its cutting-edge Quality Event Management (QEM) product. This revolutionary tool provides customers with unrivaled flexibility in configuring procedures, creating forms, and capturing data linked to quality events.
• In April 2023, Greenlight Guru, a creator of cloud-based software solutions for MedTech enterprises, will debut its Export API. The new functionality allowed clients to export data from the QMS platform to third-party software such as CRM, ERP, and business intelligence solutions. Furthermore, the new API feature allowed users to increase productivity.
• In April 2023, Qualityze, a developer of quality management software, will launch Qualityze EQMS, a cloud-based quality management solution for the telecoms industry. The program was developed on Salesforce, Inc.'s cloud platform to assist telecommunications organizations in meeting multiple quality objectives with increased security, dependability, and flexibility.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY DEPLOYMENT TYPE

• 5.1 Overview
• 5.2 On-Premises
• 5.3 Cloud-Based

6 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ORGANIZATION SIZE

• 6.1 Overview
• 6.2 Small and Medium Enterprises (SMEs)
• 6.3 Large Enterprises

7 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY VERTICALS

• 7.1 Overview
• 7.2 Healthcare
• 7.3 Manufacturing
• 7.4 IT & Telecom
• 7.5 Aerospace & Defense
• 7.6 Food & Beverage
• 7.7 Government
• 7.8 Utilities

8 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East and Africa

9 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Arena Solutions, Inc.
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Cority Software Inc.
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Dassault Systemes SE
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 EtQ Management Consultants, Inc.
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Ideagen Plc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Intelex Technologies
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 MasterControl, Inc.
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 MetricStream, Inc.
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Microsoft Corporation
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Oracle Corporation
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 Appendix

• 11.1 Related Reports