1. Introduction
1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency & Limitations
1.4. Key Stakeholders
2. Research Methodology
2.1. Research Approach
2.2. Process of Data Collection & Validation
2.2.1. Secondary Research
2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
2.3. Market Sizing and Forecast
2.3.1. Market Size Estimation Approach
2.3.2. Growth Forecast Approach
2.4. Assumptions for this Study
3. Executive Summary
4. Market Insights
4.1. Overview
4.2. Factors Affecting Market Growth
4.2.1. Market Dynamics
4.2.1.1. Stringent Regulatory Standards for Pharmaceutical Production Driving the Adoption of Pharmaceutical Quality Management Systems
4.2.1.2. High Costs of Deploying Pharmaceutical Quality Management Systems Limiting their Adoption
4.2.1.3. Increasing Demand for Generic Drugs & Biopharmaceuticals Generating Growth Opportunities for Market Players
4.2.1.4. Security Concerns Associated with On-cloud Deployments Impacting the Implementation of Pharmaceutical QMS
4.2.2. Factor Analysis
4.3. Trends
4.3.1. Integration of Artificial Intelligence & Machine Learning into Pharmaceutical Quality Management Systems
4.3.2. Increasing Inclination Toward Personalized Medicine
4.4. Pharmaceutical Quality Management Systems Market: Regulatory Analysis
4.4.1. Overview
4.4.2. International Organization for Standardization (ISO)
4.4.3. Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
4.4.4. ICH Guideline Q10
4.4.5. Current Good Manufacturing Practice (cGMP)
4.5. Pricing Analysis
4.6. Case Studies
5. Pharmaceutical Quality Management Systems Market Assessment—by Solution Type
5.1. Overview
5.2. Non-Conformance/Deviation Management
5.3. Document Management
5.4. CAPA Management
5.5. Risk & Compliance Management
5.6. Inspection Management
5.7. Audit Management
5.8. Suppliers & Materials Management
5.9. Training Management
5.10. Change Management
5.11. Other Solution Types
6. Pharmaceutical Quality Management Systems Market Assessment—by Deployment Mode
6.1. Overview
6.2. Cloud/Web-based
6.3. On-premise
7. Pharmaceutical Quality Management Systems Market Assessment—by End User
7.1. Overview
7.2. Pharmaceutical And Biotechnology Companies
7.3. Contract Development and Manufacturing Organization/Contract Research Organization
7.4. Research Laboratories
8. Pharmaceutical Quality Management Systems Market Assessment—by Geography
8.1. Introduction
8.2. North America
8.2.1. U.S.
8.2.2. Canada
8.3. Europe
8.3.1. Germany
8.3.2. France
8.3.3. U.K.
8.3.4. Italy
8.3.5. Spain
8.3.6. Ireland
8.3.7. Belgium
8.3.8. Netherlands
8.3.9. Rest of Europe
8.4. Asia-Pacific
8.4.1. Japan
8.4.2. China
8.4.3. India
8.4.4. Singapore
8.4.5. Malaysia
8.4.6. Philippines
8.4.7. Vietnam
8.4.8. Rest of Asia-Pacific
8.5. Latin America
8.5.1. Brazil
8.5.2. Mexico
8.5.3. Rest of Latin America
8.6. Middle East & Africa
9. Competition Analysis
9.1. Overview
9.2. Key Growth Strategies
9.3. Competitive Benchmarking
9.4. Competitive Dashboard
9.4.1. Industry Leaders
9.4.2. Market Differentiators
9.4.3. Vanguards
9.4.4. Emerging Companies
9.5. Market Players Ranking (2023)
10. Company Profiles
10.1. Honeywell International Inc.
10.2. IQVIA Holdings Inc.
10.3. Dassault Systèmes SE
10.4. Körber AG
10.5. ANTARES VISION S.p.A.
10.6. EtQ Management Consultants Inc. (A Subsidiary of Hexagon AB)
10.7. Ideagen PLC (A Subsidiary of Rainforest Bidco Limited)
10.8. AssurX, Inc.
10.9. AXSource Consulting, Inc.
10.10. ComplianceQuest, Inc.
10.11. LogicGate, Inc.
10.12. MasterControl Solutions Inc.
(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)
11. Appendix
11.1. Available Customization
11.2. Related Reports
List of Tables
Table 1 Recent Biopharmaceutical Plant Capacity Expansions
Table 2 Overview of Product Lifecycle Stages
Table 3 Overview of Standards and Compliance Guidelines Related to Pharmaceutical Quality Management Systems
Table 4 GMP Regulations
Table 5 Pharmaceutical Quality Management Software: Pricing
Table 6 Global Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 7 Global Non-Conformance/Deviation Management Market, by Country/Region, 2022–2031 (USD Million)
Table 8 Global Document Management Market, by Country/Region, 2022–2031 (USD Million)
Table 9 Global CAPA Management Market, by Country/Region, 2022–2031 (USD Million)
Table 10 Global Risk & Compliance Management Market, by Country/Region, 2022–2031 (USD Million)
Table 11 Global Inspection Management Market, by Country/Region, 2022–2031 (USD Million)
Table 12 Global Audit Management Market, by Country/Region, 2022–2031 (USD Million)
Table 13 Global Suppliers & Materials Management Market, by Country/Region, 2022–2031 (USD Million)
Table 14 Global Training Management Market, by Country/Region, 2022–2031 (USD Million)
Table 15 Global Change Management Market, by Country/Region, 2022–2031 (USD Million)
Table 16 Global Other Solution Types Market, by Country/Region, 2022–2031 (USD Million)
Table 17 Global Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 18 Global Cloud/Web-Based Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 19 Global On-Premise Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 20 Global Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 21 Global Pharmaceutical Quality Management Systems Market for Pharmaceutical and Biotechnology Companies, by Country/Region, 2022–2031 (USD Million)
Table 22 Global Pharmaceutical Quality Management Systems Market For CDMO/CRO, by Country/Region, 2022–2031 (USD Million)
Table 23 Global Pharmaceutical Quality Management Systems Market for Research Laboratories, by Country/Region, 2022–2031 (USD Million)
Table 24 Global Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 25 North America: Pharmaceutical Quality Management Systems Market, by Country, 2022–2031 (USD Million)
Table 26 North America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 27 North America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 28 North America: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 29 U.S.: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 30 U.S.: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 31 U.S.: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 32 Canada: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 33 Canada: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 34 Canada: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 35 Europe: Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 36 Europe: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 37 Europe: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 38 Europe: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 39 Germany: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 40 Germany: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 41 Germany: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 42 France: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 43 France: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 44 France: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 45 U.K.: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 46 U.K.: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 47 U.K.: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 48 Italy: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 49 Italy: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 50 Italy: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 51 Spain: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 52 Spain: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 53 Spain: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 54 Ireland: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 55 Ireland: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 56 Ireland: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 57 Belgium: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 58 Belgium: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 59 Belgium: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 60 Netherlands: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 61 Netherlands: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 62 Netherlands: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 63 Rest of Europe: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 64 Rest of Europe: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 65 Rest of Europe: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 66 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 67 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 68 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 69 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 70 China: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 71 China: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 72 China: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 73 Japan: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 74 Japan: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 75 Japan: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 76 India: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 77 India: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 78 India: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 79 Singapore: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 80 Singapore: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 81 Singapore: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 82 Malaysia: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 83 Malaysia: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 84 Malaysia: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 85 Philippines: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 86 Philippines: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 87 Philippines: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 88 Vietnam: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 89 Vietnam: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 90 Vietnam: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 91 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 92 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 93 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 94 Latin America: Pharmaceutical Quality Management Systems Market, by Country/Region, 2022–2031 (USD Million)
Table 95 Latin America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 96 Latin America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 97 Latin America: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 98 Brazil: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 99 Brazil: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 100 Brazil: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 101 Mexico: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 102 Mexico: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 103 Mexico: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 104 Rest of Latin America: Regulatory Agencies for Pharmaceutical Quality Management Systems
Table 105 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 106 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 107 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 108 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by Solution Type, 2022–2031 (USD Million)
Table 109 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2022–2031 (USD Million)
Table 110 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by End User, 2022–2031 (USD Million)
Table 111 Recent Developments, by Company, 2021–2024
Table 112 Pharmaceutical Quality Management Systems Market: Competitive Benchmarking by Solution
List of Figures
Figure 1 Research Process
Figure 2 Secondary Sources Referred for This Study
Figure 3 Primary Research Techniques
Figure 4 Key Executives Interviewed
Figure 5 Breakdown of Primary Interviews (Supply Side & Demand Side)
Figure 6 Market Sizing and Growth Forecast Approach
Figure 7 Applications of QMS In the Pharmaceutical Industry
Figure 8 Global Pharmaceutical Quality Management Systems Market, by Solution Type, 2024 Vs. 2031 (USD Million)
Figure 9 Global Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2024 Vs. 2031 (USD Million)
Figure 10 Global Pharmaceutical Quality Management Systems Market, by End User, 2024 Vs. 2031 (USD Million)
Figure 11 Global Pharmaceutical Quality Management Systems Market, by Geography
Figure 12 Impact Analysis of Market Dynamics
Figure 13 Global Pharmaceutical R&D Expenditure, 2012–2026 (USD Billion)
Figure 14 Global Increase in The Number of Personalized Medicines, 2008–2020
Figure 15 Advantages of Integrating AI into Pharmaceutical QMS
Figure 16 Global Pharmaceutical Quality Management Systems Market, by Solution Type, 2024 Vs. 2031 (USD Million)
Figure 17 Global Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2024 Vs. 2031 (USD Million)
Figure 18 Global Pharmaceutical Quality Management Systems Market, by End User, 2024 Vs. 2031 (USD Million)
Figure 19 Global Pharmaceutical R&D Expenditure (2016–2024)
Figure 20 Global Pharmaceutical Quality Management Systems Market Assessment, by Country/Region, 2024 Vs. 2031 (USD Million)
Figure 21 North America: Pharmaceutical Quality Management Systems Market Snapshot
Figure 22 Europe: Pharmaceutical Quality Management Systems Market Snapshot
Figure 23 Asia-Pacific: Pharmaceutical Quality Management Systems Market Snapshot
Figure 24 India's Drug & Pharmaceutical Export Trend, 2017–2022
Figure 25 Clinical Trial Activities in Malaysia, 2015-2025
Figure 26 Latin America: Pharmaceutical Quality Management Systems Market Snapshot
Figure 27 Key Growth Strategies Adopted by Leading Players (2021-2024)
Figure 28 Pharmaceutical Quality Management Systems Market: Competitive Benchmarking, by Region
Figure 29 Competitive Dashboard: Pharmaceutical Quality Management Systems Market
Figure 30 Global Pharmaceutical Quality Management Systems Market Ranking Analysis, by Key Players (2023)
Figure 31 Honeywell International Inc.: Financial Overview (2023)
Figure 32 IQVIA Holding Inc.: Financial Overview (2023)
Figure 33 Dassault Systèmes SE: Financial Overview (2023)
Figure 34 Körber AG: Financial Overview (2023)
Figure 35 ANTARES VISION S.P.A.: Financial Overview (2023)
Figure 36 Hexagon AB: Financial Overview (2023)
Figure 37 Ideagen PLC: Financial Overview (2023)