Summary

Pharmaceutical Quality Management Software Market Growth & Trends

The global pharmaceutical quality management software market size is expected to reach USD 3.9 billion by 2030, according to a new report by Grand View Research, Inc., expanding at a CAGR of 12.58% over the forecast period. 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 Systèmes, 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 Highlight

• The cloud & web-based deployment mode segment dominated the market in 2022 due to the high demand for cloud and web-based solutions as they enable organizations to readily adapt their software usage to evolving regulatory requirements and operational requirements

• The data management application segment held the largest share of over 17% in 2022. The rising volume of inconsistent healthcare data and high demand from regulatory organizations for reports that adhere to exacting quality standards are the main factors influencing this growth

• The regulatory and compliance management segment is anticipated to register the fastest CAGR during the forecast period due to factors, such as the increasing number of counterfeit drugs and the recall of drugs from the market

• North America dominated the market in 2022. The growth of the region is driven by the factors, such as the growing need for better production & quality control standards and the increasing use of advanced technologies

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Market Definitions
1.2. Regional Scope
1.3. Estimates and Forecast Timeline
1.4. Research Methodology
1.5. Information Procurement
1.5.1. Purchased Database
1.5.2. GVR’s Internal Database
1.5.3. Secondary Sources & Third-Party Perspectives
1.5.4. Primary Research
1.6. Information Analysis
1.6.1. Data Analysis Models
1.7. Market Formulation & Data Visualization
1.8. Model Details
1.8.1. Commodity Flow Analysis
1.9. List of Secondary Sources
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. 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 Trends and Outlook
3.3. Market Dynamics
3.3.1. Increasing cost of drugs manufacturing
3.3.2. Increasing technological adoption in pharmaceutical companies
3.3.3. Growing demand to comply with regulatory requirements
3.4. Market Restraint Analysis
3.4.1. Data Security and Privacy Concerns
3.4.2. High Cost
3.5. Business Environment Analysis
3.5.1. PESTLE Analysis
3.5.2. Porter’s Five Forces Analysis
3.6. COVID-19 Impact Analysis
Chapter 4. Application Business Analysis
4.1. Pharmaceutical quality management software Market: Application Movement Analysis
4.2. Pharmaceutical quality management software Market: Application Segment Dashboard
4.3. Data Management
4.3.1. Global Data Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4. Training management
4.4.1. Global Training management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5. Supplier management
4.5.1. Global Supplier management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6. Regulatory and Compliance Management
4.6.1. Global Regulatory and Compliance Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7. Corrective Action Preventive Action (CAPA) Management
4.7.1. Global Corrective Action Preventive Action (CAPA) Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.8. Audit Management
4.8.1. Global Audit Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.9. Change Management
4.9.1. Global Change Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.10. Non-Conformances Management
4.10.1. Global Non-Conformances Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.11. Inspection Management
4.11.1. Global Inspection Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.12. Risk Management
4.12.1. Global Risk Management Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.13. Others
4.13.1. Global Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 5. Deployment Mode Business Analysis
5.1. Pharmaceutical quality management software Market: Deployment Mode Movement Analysis, 2022 & 2030
5.2. Cloud-based & Web-Based
5.2.1. Global Cloud-based & Web-Based Market Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3. On-premises
5.3.1. Global On-premises Market Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4. Web Based
5.4.1. Global Web Based Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6. Regional Business Analysis
6.1. Regional Market Snapshot
6.2. Market Share Analysis by Country, 2022
6.2.1. North America
6.2.2. Europe
6.2.3. Asia Pacific
6.2.4. Latin America
6.2.5. MEA
6.3. North America
6.3.1. North America Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.3.2. U.S.
6.3.2.1. U.S. Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.3.2.2. Key Country Dynamics
6.3.2.3. Regulatory Framework
6.3.2.4. Competitive Scenario
6.3.3. Canada
6.3.3.1. Canada Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.3.3.2. Key Country Dynamics
6.3.3.3. Regulatory Framework
6.3.3.4. Competitive Scenario
6.4. Europe
6.4.1. Europe Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.2. Germany
6.4.2.1. Germany Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.2.2. Key Country Dynamics
6.4.2.3. Regulatory Framework
6.4.2.4. Competitive Scenario
6.4.3. UK
6.4.3.1. UK Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.3.2. Key Country Dynamics
6.4.3.3. Regulatory Framework
6.4.3.4. Competitive Scenario
6.4.4. France
6.4.4.1. France Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.4.2. Key Country Dynamics
6.4.4.3. Regulatory Framework
6.4.4.4. Competitive Scenario
6.4.5. Italy
6.4.5.1. Italy Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.5.2. Key Country Dynamics
6.4.5.3. Regulatory Framework
6.4.5.4. Competitive Scenario
6.4.6. Spain
6.4.6.1. Spain Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.6.2. Key Country Dynamics
6.4.6.3. Regulatory Framework
6.4.6.4. Competitive Scenario
6.4.7. Denmark
6.4.7.1. Denmark Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.7.2. Key Country Dynamics
6.4.7.3. Regulatory Framework
6.4.7.4. Competitive Scenario
6.4.8. Sweden
6.4.8.1. Sweden Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.8.2. Key Country Dynamics
6.4.8.3. Regulatory Framework
6.4.8.4. Competitive Scenario
6.4.9. Norway
6.4.9.1. Norway Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.4.9.2. Key Country Dynamics
6.4.9.3. Regulatory Framework
6.4.9.4. Competitive Scenario
6.5. Asia Pacific
6.5.1. Asia Pacific Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.2. Japan
6.5.2.1. Japan Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.2.2. Key Country Dynamics
6.5.2.3. Regulatory Framework
6.5.2.4. Competitive Scenario
6.5.3. China
6.5.3.1. China Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.3.2. Key Country Dynamics
6.5.3.3. Regulatory Framework
6.5.3.4. Competitive Scenario
6.5.4. India
6.5.4.1. India Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.4.2. Key Country Dynamics
6.5.4.3. Regulatory Framework
6.5.4.4. Competitive Scenario
6.5.5. South Korea
6.5.5.1. South Korea Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.5.2. Key Country Dynamics
6.5.5.3. Regulatory Framework
6.5.5.4. Competitive Scenario
6.5.6. Australia
6.5.6.1. Australia Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.6.2. Key Country Dynamics
6.5.6.3. Regulatory Framework
6.5.6.4. Competitive Scenario
6.5.7. Thailand
6.5.7.1. Thailand Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.5.7.2. Key Country Dynamics
6.5.7.3. Regulatory Framework
6.5.7.4. Competitive Scenario
6.6. Latin America
6.6.1. Latin America Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.6.2. Brazil
6.6.2.1. Brazil Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.6.2.2. Key Country Dynamics
6.6.2.3. Regulatory Framework
6.6.2.4. Competitive Scenario
6.6.3. Mexico
6.6.3.1. Mexico Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.6.3.2. Key Country Dynamics
6.6.3.3. Regulatory Framework
6.6.3.4. Competitive Scenario
6.6.4. Argentina
6.6.4.1. Argentina Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.6.4.2. Key Country Dynamics
6.6.4.3. Regulatory Framework
6.6.4.4. Competitive Scenario
6.7. MEA
6.7.1. MEA Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.7.2. South Africa
6.7.2.1. South Africa Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.7.2.2. Key Country Dynamics
6.7.2.3. Regulatory Framework
6.7.2.4. Competitive Scenario
6.7.3. Saudi Arabia
6.7.3.1. Saudi Arabia Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.7.3.2. Key Country Dynamics
6.7.3.3. Regulatory Framework
6.7.3.4. Competitive Scenario
6.7.4. UAE
6.7.4.1. UAE Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.7.4.2. Key Country Dynamics
6.7.4.3. Regulatory Framework
6.7.4.4. Competitive Scenario
6.7.5. Kuwait
6.7.5.1. Kuwait Pharmaceutical quality management software Market, 2018 - 2030 (USD Million)
6.7.5.2. Key Country Dynamics
6.7.5.3. Regulatory Framework
6.7.5.4. Competitive Scenario
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.2. Strategy Mapping
7.2.1. Expansion
7.2.2. Acquisition
7.2.3. Collaborations
7.2.4. New Product Launches
7.2.5. Others
7.3. Company Profiles/Listing
7.3.1. MasterControl Solutions, Inc.
7.3.1.1. Overview
7.3.1.2. Financial Performance
7.3.1.3. Product Benchmarking
7.3.1.4. Strategic Initiatives
7.3.2. AmpleLogic
7.3.2.1. Overview
7.3.2.2. Financial Performance
7.3.2.3. Product Benchmarking
7.3.2.4. Strategic Initiatives
7.3.3. Qualio
7.3.3.1. Overview
7.3.3.2. Financial Performance
7.3.3.3. Product Benchmarking
7.3.3.4. Strategic Initiatives
7.3.4. Pilgrim (IQVIA)
7.3.4.1. Overview
7.3.4.2. Financial Performance
7.3.4.3. Product Benchmarking
7.3.4.4. Strategic Initiatives
7.3.5. QT9
7.3.5.1. Overview
7.3.5.2. Financial Performance
7.3.5.3. Product Benchmarking
7.3.5.4. Strategic Initiatives
7.3.6. Sparta Systems (TrackWise)
7.3.6.1. Overview
7.3.6.2. Financial Performance
7.3.6.3. Product Benchmarking
7.3.6.4. Strategic Initiatives
7.3.7. AssurX, Inc.
7.3.7.1. Overview
7.3.7.2. Financial Performance
7.3.7.3. Product Benchmarking
7.3.7.4. Strategic Initiatives
7.3.8. Dassault Systèmes
7.3.8.1. Overview
7.3.8.2. Financial Performance
7.3.8.3. Product Benchmarking
7.3.8.4. Strategic Initiatives
7.3.9. ETQ, LLC (Hexagon)
7.3.9.1. Overview
7.3.9.2. Financial Performance
7.3.9.3. Product Benchmarking
7.3.9.4. Strategic Initiatives
7.3.10. Veeva Systems
7.3.10.1. Overview
7.3.10.2. Financial Performance
7.3.10.3. Product Benchmarking
7.3.10.4. Strategic Initiatives
7.3.11. Qualityze Inc.
7.3.11.1. Overview
7.3.11.2. Financial Performance
7.3.11.3. Product Benchmarking
7.3.11.4. Strategic Initiatives
7.3.12. Ideagen
7.3.12.1. Overview
7.3.12.2. Financial Performance
7.3.12.3. Product Benchmarking
7.3.12.4. Strategic Initiatives