제약 품질 관리 소프트웨어 시장 규모, 점유율, 동향 분석 보고서 : 용도별, 전개 모드별, 지역별, 부문 예측(2025-2030년)

Pharmaceutical Quality Management Software Market Growth & Trends:

The global pharmaceutical quality management software market size is expected to reach USD 3.85 billion by 2030, registering a CAGR of 12.99% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market growth is being propelled by the increasing expenses associated with drug manufacturing, the ever-evolving regulatory landscape, and the expanding integration of technology within the pharmaceutical sector. A quality management system ensures that a company's products meet market expectations and industry standards. Quality assurance methods are employed to ensure there are no defects, and all actions taken to address issues are well-documented.

A robust pharmaceutical quality management system (QMS) offers several advantages to businesses, including ensuring product integrity, expediting the introduction of new products to the market, reducing the time and cost associated with document management, aiding in the identification and resolution of issues, verifying the quality of supplier processes, and enabling employee skill enhancement through effective training. The COVID-19 pandemic positively affected the market. It led pharmaceutical manufacturers to recognize the significance of maintaining stringent quality standards amidst unprecedented challenges in the global healthcare industry.

This heightened awareness drove a surge in demand for efficient QMS solutions to guarantee the effectiveness, quality, and safety of pharmaceuticals and medical products. In addition, the adoption of quality management systems aided businesses in enhancing their quality management procedures, implementing risk mitigation strategies, and ensuring adherence to regulatory requirements. Furthermore, the various strategies employed by the key market competitors over the next few years are likely to drive market expansion.

For instance, in 2021, Arena Solutions, Inc., partnered with Rimsys Inc., a company that offers regulatory information management (RIM) software systems, to create a comprehensive quality and product-focused regulatory solution. This collaboration allowed the organization to expand its product offerings. In addition, in April 2021, Medidata, a company under Dassault Systemes, introduced Medidata Risk Management, a new addition to its Risk-Based Quality Management (RBQM) suite, which comprises a wide range of solutions aimed at speeding up the adoption of proactive oversight activities in clinical operations

Pharmaceutical Quality Management Software Market Report Highlights:

• Based on applications, the data management segment dominated the market in 2024 and accounted for the largest revenue share of 17.52%. Furthermore, the regulatory and compliance management segment is expected to grow at the fastest CAGR from 2025 to 2030.
• Based on deployment mode, the cloud & web-based segment held the largest market share of 77.02% in 2024 and is expected to register growth at the fastest CAGR during the forecast period. On-premises software accounted for a significant revenue share in 2024.
• North America pharmaceutical quality management software market dominated with the largest revenue share of 38.63% in 2024. Pharmaceutical quality management software market in the U.S. is experiencing significant growth, driven by an increasing emphasis on regulatory compliance and the need for enhanced operational efficiency within the pharmaceutical and biopharmaceutical industry.
• Pharmaceutical quality management software market in Asia Pacific is poised to grow at the fastest CAGR from 2025 to 2030 due to the increasing regulatory requirements imposed by health authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and local regulatory agencies.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Application Segment
  • 1.2.2. Deployment Mode
• 1.3. Information analysis
  • 1.3.1. Market formulation & data visualization
• 1.4. Data validation & publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
  • 1.8.1. Commodity Flow Analysis
• 1.9. Total Market: CAGR Calculation
• 1.10. Objectives
  • 1.10.1. Objective 1
  • 1.10.2. Objective 2

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Insights Landscape

Chapter 3. Pharmaceutical Quality Management Software Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Increasing cost of drugs manufacturing
    • 3.2.1.2. Increasing technological adoption in pharmaceutical companies
    • 3.2.1.3. Growing demand to comply with regulatory requirements
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Data security and privacy concerns
    • 3.2.2.2. A shortage of skilled professionals
• 3.3. Pharmaceutical Quality Management Software Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Technological landscape
    • 3.3.2.3. Economic landscape
    • 3.3.2.4. Environmental Landscape
    • 3.3.2.5. Legal Landscape
    • 3.3.2.6. Social Landscape
• 3.4. Technological Advancement
• 3.5. Case Studies

Chapter 4. Pharmaceutical Quality Management Software Market: Application Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Pharmaceutical Quality Management Software Market Application Movement Analysis
• 4.3. Global Pharmaceutical Quality Management Software Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 4.4. Data Management
  • 4.4.1. Data Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.5. Training Management
  • 4.5.1. Training Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.6. Supplier Management
  • 4.6.1. Supplier Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.7. Regulatory and Compliance Management
  • 4.7.1. Regulatory and Compliance Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.8. Corrective Action Preventive Action (CAPA) Management
  • 4.8.1. Corrective Action Preventive Action (CAPA) Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.9. Audit Management
  • 4.9.1. Audit Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.10. Change Management
  • 4.10.1. Change Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.11. Non-conformances Management
  • 4.11.1. Non-conformances Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.12. Inspection Management
  • 4.12.1. Inspection Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.13. Risk Management
  • 4.13.1. Risk Management Market estimates and forecasts 2018 to 2030 (USD Million)
• 4.14. Others
  • 4.14.1. Others Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. Pharmaceutical Quality Management Software Market: Deployment Mode Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Pharmaceutical Quality Management Software Market Deployment Mode Movement Analysis
• 5.3. Global Pharmaceutical Quality Management Software Market Size & Trend Analysis, by Deployment Mode, 2018 to 2030 (USD Million)
• 5.4. Cloud & Web Based
  • 5.4.1. Cloud & Web Based Market estimates and forecasts 2018 to 2030 (USD Million)
• 5.5. On-premise
  • 5.5.1. On-premise Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Pharmaceutical Quality Management Software Market: Regional Estimates & Trend Analysis

• 6.1. Regional Market Share Analysis, 2024 & 2030
• 6.2. Regional Market Dashboard
• 6.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 6.4. North America
  • 6.4.1. U.S.
    • 6.4.1.1. Key country dynamics
    • 6.4.1.2. Regulatory framework
    • 6.4.1.3. Competitive scenario
    • 6.4.1.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.2. Canada
    • 6.4.2.1. Key country dynamics
    • 6.4.2.2. Regulatory framework
    • 6.4.2.3. Competitive scenario
    • 6.4.2.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.3. Mexico
    • 6.4.3.1. Key country dynamics
    • 6.4.3.2. Regulatory framework
    • 6.4.3.3. Competitive scenario
    • 6.4.3.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
• 6.5. Europe
  • 6.5.1. UK
    • 6.5.1.1. Key country dynamics
    • 6.5.1.2. Regulatory framework
    • 6.5.1.3. Competitive scenario
    • 6.5.1.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.2. Germany
    • 6.5.2.1. Key country dynamics
    • 6.5.2.2. Regulatory framework
    • 6.5.2.3. Competitive scenario
    • 6.5.2.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.3. France
    • 6.5.3.1. Key country dynamics
    • 6.5.3.2. Regulatory framework
    • 6.5.3.3. Competitive scenario
    • 6.5.3.4. France market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.4. Italy
    • 6.5.4.1. Key country dynamics
    • 6.5.4.2. Regulatory framework
    • 6.5.4.3. Competitive scenario
    • 6.5.4.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.5. Spain
    • 6.5.5.1. Key country dynamics
    • 6.5.5.2. Regulatory framework
    • 6.5.5.3. Competitive scenario
    • 6.5.5.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.6. Norway
    • 6.5.6.1. Key country dynamics
    • 6.5.6.2. Regulatory framework
    • 6.5.6.3. Competitive scenario
    • 6.5.6.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.7. Sweden
    • 6.5.7.1. Key country dynamics
    • 6.5.7.2. Regulatory framework
    • 6.5.7.3. Competitive scenario
    • 6.5.7.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5.8. Denmark
    • 6.5.8.1. Key country dynamics
    • 6.5.8.2. Regulatory framework
    • 6.5.8.3. Competitive scenario
    • 6.5.8.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
• 6.6. Asia Pacific
  • 6.6.1. Japan
    • 6.6.1.1. Key country dynamics
    • 6.6.1.2. Regulatory framework
    • 6.6.1.3. Competitive scenario
    • 6.6.1.4. Japan market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6.2. China
    • 6.6.2.1. Key country dynamics
    • 6.6.2.2. Regulatory framework
    • 6.6.2.3. Competitive scenario
    • 6.6.2.4. China market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6.3. India
    • 6.6.3.1. Key country dynamics
    • 6.6.3.2. Regulatory framework
    • 6.6.3.3. Competitive scenario
    • 6.6.3.4. India market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6.4. Australia
    • 6.6.4.1. Key country dynamics
    • 6.6.4.2. Regulatory framework
    • 6.6.4.3. Competitive scenario
    • 6.6.4.4. Australia market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6.5. South Korea
    • 6.6.5.1. Key country dynamics
    • 6.6.5.2. Regulatory framework
    • 6.6.5.3. Competitive scenario
    • 6.6.5.4. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6.6. Thailand
    • 6.6.6.1. Key country dynamics
    • 6.6.6.2. Regulatory framework
    • 6.6.6.3. Competitive scenario
    • 6.6.6.4. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
• 6.7. Latin America
  • 6.7.1. Brazil
    • 6.7.1.1. Key country dynamics
    • 6.7.1.2. Regulatory framework
    • 6.7.1.3. Competitive scenario
    • 6.7.1.4. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.7.2. Argentina
    • 6.7.2.1. Key country dynamics
    • 6.7.2.2. Regulatory framework
    • 6.7.2.3. Competitive scenario
    • 6.7.2.4. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
• 6.8. MEA
  • 6.8.1. South Africa
    • 6.8.1.1. Key country dynamics
    • 6.8.1.2. Regulatory framework
    • 6.8.1.3. Competitive scenario
    • 6.8.1.4. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.8.2. Saudi Arabia
    • 6.8.2.1. Key country dynamics
    • 6.8.2.2. Regulatory framework
    • 6.8.2.3. Competitive scenario
    • 6.8.2.4. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.8.3. UAE
    • 6.8.3.1. Key country dynamics
    • 6.8.3.2. Regulatory framework
    • 6.8.3.3. Competitive scenario
    • 6.8.3.4. UAE market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.8.4. Kuwait
    • 6.8.4.1. Key country dynamics
    • 6.8.4.2. Regulatory framework
    • 6.8.4.3. Competitive scenario
    • 6.8.4.4. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Company/Competition Categorization
• 7.2. Strategy Mapping
• 7.3. Company Market Position Analysis, 2024
• 7.4. Company Profiles/Listing
  • 7.4.1. MasterControl Solutions, Inc.
    • 7.4.1.1. Company overview
    • 7.4.1.2. Financial performance
    • 7.4.1.3. Product benchmarking
    • 7.4.1.4. Strategic initiatives
  • 7.4.2. AmpleLogic
    • 7.4.2.1. Company overview
    • 7.4.2.2. Financial performance
    • 7.4.2.3. Product benchmarking
    • 7.4.2.4. Strategic initiatives
  • 7.4.3. Qualio
    • 7.4.3.1. Company overview
    • 7.4.3.2. Financial performance
    • 7.4.3.3. Product benchmarking
    • 7.4.3.4. Strategic initiatives
  • 7.4.4. Pilgrim (IQVIA)
    • 7.4.4.1. Company overview
    • 7.4.4.2. Financial performance
    • 7.4.4.3. Product benchmarking
    • 7.4.4.4. Strategic initiatives
  • 7.4.5. QT9
    • 7.4.5.1. Company overview
    • 7.4.5.2. Financial performance
    • 7.4.5.3. Product benchmarking
    • 7.4.5.4. Strategic initiatives
  • 7.4.6. Sparta Systems (TrackWise)
    • 7.4.6.1. Company overview
    • 7.4.6.2. Financial performance
    • 7.4.6.3. Product benchmarking
    • 7.4.6.4. Strategic initiatives
  • 7.4.7. AssurX, Inc
    • 7.4.7.1. Company overview
    • 7.4.7.2. Financial performance
    • 7.4.7.3. Product benchmarking
    • 7.4.7.4. Strategic initiatives
  • 7.4.8. Dassault Systemes
    • 7.4.8.1. Company overview
    • 7.4.8.2. Financial performance
    • 7.4.8.3. Product benchmarking
    • 7.4.8.4. Strategic initiatives
  • 7.4.9. ETQ, LLC (Hexagon)
    • 7.4.9.1. Company overview
    • 7.4.9.2. Financial performance
    • 7.4.9.3. Product benchmarking
    • 7.4.9.4. Strategic initiatives
  • 7.4.10. Veeva Systems
    • 7.4.10.1. Company overview
    • 7.4.10.2. Financial performance
    • 7.4.10.3. Product benchmarking
    • 7.4.10.4. Strategic initiatives
  • 7.4.11. Qualityze Inc.
    • 7.4.11.1. Company overview
    • 7.4.11.2. Financial performance
    • 7.4.11.3. Product benchmarking
    • 7.4.11.4. Strategic initiatives
  • 7.4.12. Ideagen
    • 7.4.12.1. Company overview
    • 7.4.12.2. Financial performance
    • 7.4.12.3. Product benchmarking
    • 7.4.12.4. Strategic initiatives