Pharmaceutical Quality Management Software Market Size, Share, and Trends 2025 to 2034

Pharmaceutical Quality Management Software Market (By Solution / Module Type: Document Management, Audit Management, CAPA (Corrective & Preventive Action) Management, Change Management, Supplier Quality Management, Non-Conformance / Deviation Management, Training Management, Risk & Compliance Management, Inspection Management, Other Quality Modules; By Deployment Mode: On-Premises Deployment, Cloud / Web-Based Deployment, Hybrid Deployment; By Enterprise Size: Large Enterprises, Medium Enterprises, Small & Emerging Pharma / Biotech; By End-User / Application Sector: Pharmaceutical & Biotechnology Manufacturers, Contract Development & Manufacturing Organizations (CDMOs) / CMOs, Research & Development (R&D) Organizations, Generic Drug Manufacturers, Regulatory / Compliance Authorities) - Global Industry Analysis, Size, Trends, Leading Companies, Regional Outlook, and Forecast 2026 to 2035

Last Updated : 11 Dec 2025  |  Report Code : 7202  |  Category : Healthcare   |  Format : PDF / PPT / Excel

Chapter 1. Introduction

1.1. Research Objective

1.2. Scope of the Study

1.3. Definition

Chapter 2. Research Methodology

2.1. Research Approach

2.2. Data Sources

2.3. Assumptions & Limitations

Chapter 3. Executive Summary

3.1. Market Snapshot

Chapter 4. Market Variables and Scope 

4.1. Introduction

4.2. Market Classification and Scope

4.3. Industry Value Chain Analysis

4.3.1. Raw Material Procurement Analysis 

4.3.2. Sales and Distribution Channel Analysis

4.3.3. Downstream Buyer Analysis

Chapter 5. COVID 19 Impact on Pharmaceutical Quality Management Software Market 

5.1. COVID-19 Landscape: Pharmaceutical Quality Management Software Industry Impact

5.2. COVID 19 - Impact Assessment for the Industry

5.3. COVID 19 Impact: Global Major Government Policy

5.4. Market Trends and Opportunities in the COVID-19 Landscape

6.1. Market Dynamics

6.1.1. Market Drivers

6.1.2. Market Restraints

6.1.3. Market Opportunities

6.2. Porter’s Five Forces Analysis

6.2.1. Bargaining power of suppliers

6.2.2. Bargaining power of buyers

6.2.3. Threat of substitute

6.2.4. Threat of new entrants

6.2.5. Degree of competition

Chapter 7. Competitive Landscape

7.1.1. Company Market Share/Positioning Analysis

7.1.2. Key Strategies Adopted by Players

7.1.3. Vendor Landscape

7.1.3.1. List of Suppliers

7.1.3.2. List of Buyers

Chapter 8. Global Pharmaceutical Quality Management Software Market, By Solution / Module Type

8.1. Pharmaceutical Quality Management Software Market, by Solution / Module Type

8.1.1. Document Management

8.1.1.1. Market Revenue and Forecast

8.1.2. Audit Management

8.1.2.1. Market Revenue and Forecast

8.1.3. CAPA (Corrective & Preventive Action) Management

8.1.3.1. Market Revenue and Forecast

8.1.4. Change Management

8.1.4.1. Market Revenue and Forecast

8.1.5. Supplier Quality Management      

8.1.5.1. Market Revenue and Forecast 8.1.5. Lipid

8.1.6.1. Market Revenue and Forecast

8.1.6. Non-Conformance / Deviation Management

8.1.7.1. Market Revenue and Forecast

8.1.7. Training Management

8.1.8.1. Market Revenue and Forecast

8.1.8. Risk & Compliance Management

8.1.9.1. Market Revenue and Forecast

8.1.9. Inspection Management

8.1.1. Market Revenue and Forecast 

8.1.10.1.Other Quality Modules    

8.1.11. Market Revenue and Forecast 

8.1.12. Lipid

8.1.5.12.1. Market Revenue and Forecast 

 Chapter 9. Global Pharmaceutical Quality Management Software Market, By Deployment Mode

9.1. Pharmaceutical Quality Management Software Market, by Deployment Mode

9.1.1. On-Premises Deployment

9.1.1.1. Market Revenue and Forecast

9.1.2. Cloud / Web-Based Deployment

9.1.2.1. Market Revenue and Forecast

9.1.3. Hybrid Deployment

9.1.3.1. Market Revenue and Forecast

Chapter 10. Global Pharmaceutical Quality Management Software Market, By Enterprise Size 

10.1. Pharmaceutical Quality Management Software Market, by Enterprise Size

10.1.1. Large Enterprises

10.1.1.1. Market Revenue and Forecast

10.1.2. Medium Enterprises

10.1.2.1. Market Revenue and Forecast

10.1.3. Small & Emerging Pharma / Biotech

10.1.3.1. Market Revenue and Forecast

Chapter 11. Global Pharmaceutical Quality Management Software Market, By End-User / Application Sector 

11.1. Pharmaceutical Quality Management Software Market, by End-User / Application Sector

11.1.1. Pharmaceutical & Biotechnology Manufacturers

11.1.1.1. Market Revenue and Forecast

11.1.2. Contract Development & Manufacturing Organizations (CDMOs) / CMOs

11.1.2.1. Market Revenue and Forecast

11.1.3. Research & Development (R&D) Organizations

11.1.3.1. Market Revenue and Forecast

11.1.4. Generic Drug Manufacturers

11.1.4.1. Market Revenue and Forecast

11.1.5. Regulatory / Compliance Authorities

11.1.5.1. Market Revenue and Forecast

Chapter 12. Global Pharmaceutical Quality Management Software Market, Regional Estimates and Trend Forecast

12.1. North America

12.1.1. Market Revenue and Forecast, by Solution / Module Type

12.1.2. Market Revenue and Forecast, by Deployment Mode

12.1.3. Market Revenue and Forecast, by Enterprise Size

12.1.4. Market Revenue and Forecast, by End-User / Application Sector

12.1.5. U.S.

12.1.5.1. Market Revenue and Forecast, by Solution / Module Type

12.1.5.2. Market Revenue and Forecast, by Deployment Mode

12.1.5.3. Market Revenue and Forecast, by Enterprise Size

12.1.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.1.6. Rest of North America

12.1.6.1. Market Revenue and Forecast, by Solution / Module Type

12.1.6.2. Market Revenue and Forecast, by Deployment Mode

12.1.6.3. Market Revenue and Forecast, by Enterprise Size

12.1.6.4. Market Revenue and Forecast, by End-User / Application Sector

12.2. Europe

12.2.1. Market Revenue and Forecast, by Solution / Module Type

12.2.2. Market Revenue and Forecast, by Deployment Mode

12.2.3. Market Revenue and Forecast, by Enterprise Size

12.2.4. Market Revenue and Forecast, by End-User / Application Sector

12.2.5. UK

12.2.5.1. Market Revenue and Forecast, by Solution / Module Type

12.2.5.2. Market Revenue and Forecast, by Deployment Mode

12.2.5.3. Market Revenue and Forecast, by Enterprise Size

12.2.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.2.6. Germany

12.2.6.1. Market Revenue and Forecast, by Solution / Module Type

12.2.6.2. Market Revenue and Forecast, by Deployment Mode

12.2.6.3. Market Revenue and Forecast, by Enterprise Size

12.2.6.4. Market Revenue and Forecast, by End-User / Application Sector

12.2.7. France

12.2.7.1. Market Revenue and Forecast, by Solution / Module Type

12.2.7.2. Market Revenue and Forecast, by Deployment Mode

12.2.7.3. Market Revenue and Forecast, by Enterprise Size

12.2.7.4. Market Revenue and Forecast, by End-User / Application Sector

12.2.8. Rest of Europe

12.2.8.1. Market Revenue and Forecast, by Solution / Module Type

12.2.8.2. Market Revenue and Forecast, by Deployment Mode

12.2.8.3. Market Revenue and Forecast, by Enterprise Size

12.2.8.4. Market Revenue and Forecast, by End-User / Application Sector

12.3. APAC

12.3.1. Market Revenue and Forecast, by Solution / Module Type

12.3.2. Market Revenue and Forecast, by Deployment Mode

12.3.3. Market Revenue and Forecast, by Enterprise Size

12.3.4. Market Revenue and Forecast, by End-User / Application Sector

12.3.5. India

12.3.5.1. Market Revenue and Forecast, by Solution / Module Type

12.3.5.2. Market Revenue and Forecast, by Deployment Mode

12.3.5.3. Market Revenue and Forecast, by Enterprise Size

12.3.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.3.6. China

12.3.6.1. Market Revenue and Forecast, by Solution / Module Type

12.3.6.2. Market Revenue and Forecast, by Deployment Mode

12.3.6.3. Market Revenue and Forecast, by Enterprise Size

12.3.6.4. Market Revenue and Forecast, by End-User / Application Sector

12.3.7. Japan

12.3.7.1. Market Revenue and Forecast, by Solution / Module Type

12.3.7.2. Market Revenue and Forecast, by Deployment Mode

12.3.7.3. Market Revenue and Forecast, by Enterprise Size

12.3.7.4. Market Revenue and Forecast, by End-User / Application Sector

12.3.8. Rest of APAC

12.3.8.1. Market Revenue and Forecast, by Solution / Module Type

12.3.8.2. Market Revenue and Forecast, by Deployment Mode

12.3.8.3. Market Revenue and Forecast, by Enterprise Size

12.3.8.4. Market Revenue and Forecast, by End-User / Application Sector

12.4. MEA

12.4.1. Market Revenue and Forecast, by Solution / Module Type

12.4.2. Market Revenue and Forecast, by Deployment Mode

12.4.3. Market Revenue and Forecast, by Enterprise Size

12.4.4. Market Revenue and Forecast, by End-User / Application Sector

12.4.5. GCC

12.4.5.1. Market Revenue and Forecast, by Solution / Module Type

12.4.5.2. Market Revenue and Forecast, by Deployment Mode

12.4.5.3. Market Revenue and Forecast, by Enterprise Size

12.4.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.4.6. North Africa

12.4.6.1. Market Revenue and Forecast, by Solution / Module Type

12.4.6.2. Market Revenue and Forecast, by Deployment Mode

12.4.6.3. Market Revenue and Forecast, by Enterprise Size

12.4.6.4. Market Revenue and Forecast, by End-User / Application Sector

12.4.7. South Africa

12.4.7.1. Market Revenue and Forecast, by Solution / Module Type

12.4.7.2. Market Revenue and Forecast, by Deployment Mode

12.4.7.3. Market Revenue and Forecast, by Enterprise Size

12.4.7.4. Market Revenue and Forecast, by End-User / Application Sector

12.4.8. Rest of MEA

12.4.8.1. Market Revenue and Forecast, by Solution / Module Type

12.4.8.2. Market Revenue and Forecast, by Deployment Mode

12.4.8.3. Market Revenue and Forecast, by Enterprise Size

12.4.8.4. Market Revenue and Forecast, by End-User / Application Sector

12.5. Latin America

12.5.1. Market Revenue and Forecast, by Solution / Module Type

12.5.2. Market Revenue and Forecast, by Deployment Mode

12.5.3. Market Revenue and Forecast, by Enterprise Size

12.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.5.5. Brazil

12.5.5.1. Market Revenue and Forecast, by Solution / Module Type

12.5.5.2. Market Revenue and Forecast, by Deployment Mode

12.5.5.3. Market Revenue and Forecast, by Enterprise Size

12.5.5.4. Market Revenue and Forecast, by End-User / Application Sector

12.5.6. Rest of LATAM

12.5.6.1. Market Revenue and Forecast, by Solution / Module Type

12.5.6.2. Market Revenue and Forecast, by Deployment Mode

12.5.6.3. Market Revenue and Forecast, by Enterprise Size

12.5.6.4. Market Revenue and Forecast, by End-User / Application Sector

Chapter 13. Company Profiles

13.1. Veeva Systems

13.1.1. Company Overview

13.1.2. Product Offerings

13.1.3. Financial Performance

13.1.4. Recent Initiatives

13.2. IQVIA

13.2.1. Company Overview

13.2.2. Product Offerings

13.2.3. Financial Performance

13.2.4. Recent Initiatives

13.3. Honeywell International Inc

13.3.1. Company Overview

13.3.2. Product Offerings

13.3.3. Financial Performance

13.3.4. Recent Initiatives

13.4. MasterControl Solutions, Inc

13.4.1. Company Overview

13.4.2. Product Offerings

13.4.3. Financial Performance

13.4.4. Recent Initiatives

13.5. ETQ

13.5.1. Company Overview

13.5.2. Product Offerings

13.5.3. Financial Performance

13.5.4. Recent Initiatives

13.6. Qualio

13.6.1. Company Overview

13.6.2. Product Offerings

13.6.3. Financial Performance

13.6.4. Recent Initiatives

13.7. MasterControl

13.7.1. Company Overview

13.7.2. Product Offerings

13.7.3. Financial Performance

13.7.4. Recent Initiatives

Chapter 14. Research Methodology

14.1. Primary Research

14.2. Secondary Research

14.3. Assumptions

Chapter 15. Appendix

15.1. About Us

15.2. Glossary of Terms

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Frequently Asked Questions

The pharmaceutical quality management software market size is expected to increase from USD 2.35 billion in 2025 to USD 8.03 billion by 2035

The pharmaceutical quality management software market is expected to grow at a compound annual growth rate (CAGR) of around 13.07% from 2026 to 2035

The major players in the pharmaceutical quality management software market include IQVIA, Honeywell International Inc, MasterControl Solutions. Inc, ETQ, Veeva Systems, Qualio, and MasterControl

The driving factors of the pharmaceutical quality management software market are rising research & development investments, increasing healthcare demands from an aging population, pressure to meet stringent regulatory standards, and the incorporation of advanced technologies like AI, ML, and robotics.

North America region will lead the global pharmaceutical quality management software market during the forecast period 2025 to 2034.

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