Pharmaceutical Quality Management Software Market by Solution Type (Corrective Action Preventive Action (CAPA) Management, Audit Management, Document Management, Change Management, Training Management, Risk Management, Complaints Management, Regulatory an

Pharmaceutical Quality Management Software Market by Solution Type (Corrective Action Preventive Action (CAPA) Management, Audit Management, Document Management, Change Management, Training Management, Risk Management, Complaints Management, Regulatory and Compliance Management, Non-Conformances Handling, Supplier Quality Management, Inspection Management, Equipment Management, and Others), Deployment Model (On-Cloud, Web-Based, On-Premises), Enterprise Size (Small and Medium-sized Enterprises, Large Enterprises), End User (Pharmaceutical, Life Sciences, and Biotechnology Companies, Contract Research Organizations, and Others), and Region 2023-2028


The global pharmaceutical quality management software market size reached US$ 1.12 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 2.13 Billion by 2028, exhibiting a growth rate (CAGR) of 10.50% during 2023-2028. The rising digitization across the pharmaceutical industry, the surging need to comply with regulatory guidelines, and the increasing complexity of supply chains represent some of the key factors driving the market.

Pharmaceutical quality management software is a software system that is designed to manage and maintain the quality of pharmaceutical products throughout the entire product lifecycle. It is a comprehensive system that helps pharmaceutical companies to ensure that their products meet the highest standards of quality and safety, and comply with regulatory requirements. It assists in managing the creation, revision, and distribution of documents related to quality management processes, such as standard operating procedures (SOPs), work instructions, and policies. It also tracks employee training and certification, ensuring that all personnel are trained and qualified to perform their assigned tasks. In addition, it manages non-conformances, deviations, and incidents that may arise during the manufacturing processes and corrective and preventive actions (CAPAs) that are required to address non-conformances and prevent their recurrence. Owing to these properties, various companies are adopting pharmaceutical quality management software to streamline their quality management processes, reduce errors and inconsistencies, and improve compliance with regulatory requirements.

Pharmaceutical Quality Management Software Market Trends:
The market is primarily driven by the rising digitization in the pharmaceutical industry. Nowadays, companies are using advanced technologies, such as cloud computing, artificial intelligence (AI), and machine learning, to automate tasks, improve data analytics, and enhance collaboration and communication across the organization. In addition, the surging need to comply with regulatory requirements represents another major growth-inducing factor. The pharmaceutical industry is subject to strict regulatory requirements and standards, such as good manufacturing practice (GMP) and good laboratory practice (GLP), which require companies to maintain a high level of quality in their products and processes. Pharmaceutical quality management software helps companies to comply with these requirements and demonstrate their commitment to quality. Besides this, the pharmaceutical industry has a complex supply chain, involving multiple suppliers, manufacturers, and distributors. Pharmaceutical quality management software helps companies to manage this complexity and ensure that all parties involved in the supply chain meet the required quality standards. Moreover, the escalating demand for high-quality and safe pharmaceutical products is escalating the demand for pharmaceutical quality management software that enables companies to ensure that their products meet the highest standards of quality and safety, reducing the risk of product recalls, adverse events, and reputational damage. On account of these factors, the market is expected to witness positive growth in the coming years.

Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each segment of the global pharmaceutical quality management software market, along with forecasts at the global, regional, and country levels from 2023-2028. Our report has categorized the market based on solution type, deployment model, enterprise size, and end user.

Solution Type Insights:

Corrective Action Preventive Action (CAPA) Management
Audit Management
Document Management
Change Management
Training Management
Risk Management
Complaints Management
Regulatory and Compliance Management
Non-Conformances Handling
Supplier Quality Management
Inspection Management
Equipment Management
Others

The report has provided a detailed breakup and analysis of the pharmaceutical quality management software market based on the solution type. This includes corrective action preventive action (CAPA) management, audit management, document management, change management, training management, risk management, complaints management, regulatory and compliance management, non-conformances handling, supplier quality management, inspection management, equipment management, and others.

Deployment Model Insights:

On-Cloud
Web-Based
On-Premises

A detailed breakup and analysis of the pharmaceutical quality management software market based on the deployment model has also been provided in the report. This includes on-cloud, web-based, and on-premises.

Enterprise Size Insights:

Small and Medium-sized Enterprises
Large Enterprises

The report has provided a detailed breakup and analysis of the pharmaceutical quality management software market based on the enterprise size. This includes small and medium-sized enterprises, and large enterprises.

End User Insights:

Pharmaceutical, Life Sciences, and Biotechnology Companies
Contract Research Organizations
Others

A detailed breakup and analysis of the pharmaceutical quality management software market based on the end user has also been provided in the report. This includes pharmaceutical, life sciences, and biotechnology companies, contract research organizations, and others. According to the report, pharmaceutical, life sciences, and biotechnology companies accounted for the largest market share.

Regional Insights:

North America
United States
Canada
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America was the largest market for pharmaceutical quality management software. Some of the factors driving the North America pharmaceutical quality management software market include increasing regulatory compliance requirements, growing complexity of pharmaceutical supply chains, and escalating demand for automation and digitization.

Competitive Landscape:
The report has also provided a comprehensive analysis of the competitive landscape in the global pharmaceutical quality management software market. Competitive analysis such as market structure, market share by key players, player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided. Some of the companies covered include AssurX Inc., ComplianceQuest, Dassault Systèmes SE (Dassault Group), ETQ LLC (Hexagon AB), Ideagen, IQVIA Inc., Mastercontrol Inc., Qualio, Veeva Systems Inc, etc. Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Questions Answered in This Report:
How has the global pharmaceutical quality management software market performed so far, and how will it perform in the coming years?
What are the drivers, restraints, and opportunities in the global pharmaceutical quality management software market?
What is the impact of each driver, restraint, and opportunity on the global pharmaceutical quality management software market?
What are the key regional markets?
Which countries represent the most attractive pharmaceutical quality management software market?
What is the breakup of the market based on the solution type?
Which is the most attractive solution type in the pharmaceutical quality management software market?
What is the breakup of the market based on the deployment model?
Which is the most attractive deployment model in the pharmaceutical quality management software market?
What is the breakup of the market based on enterprise size?
Which is the most attractive enterprise size in the pharmaceutical quality management software market?
What is the breakup of the market based on the end user?
Which is the most attractive end user in the pharmaceutical quality management software market?
What is the competitive structure of the global pharmaceutical quality management software market?
Who are the key players/companies in the global pharmaceutical quality management software market?


1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
4.1 Overview
4.2 Key Industry Trends
5 Global Pharmaceutical Quality Management Software Market
5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast
6 Market Breakup by Solution Type
6.1 Corrective Action Preventive Action (CAPA) Management
6.1.1 Market Trends
6.1.2 Market Forecast
6.2 Audit Management
6.2.1 Market Trends
6.2.2 Market Forecast
6.3 Document Management
6.3.1 Market Trends
6.3.2 Market Forecast
6.4 Change Management
6.4.1 Market Trends
6.4.2 Market Forecast
6.5 Training Management
6.5.1 Market Trends
6.5.2 Market Forecast
6.6 Risk Management
6.6.1 Market Trends
6.6.2 Market Forecast
6.7 Complaints Management
6.7.1 Market Trends
6.7.2 Market Forecast
6.8 Regulatory and Compliance Management
6.8.1 Market Trends
6.8.2 Market Forecast
 6.9 Non-Conformances Handling
6.9.1 Market Trends
6.9.2 Market Forecast
6.10 Supplier Quality Management
6.10.1 Market Trends
6.10.2 Market Forecast
6.11 Inspection Management
6.11.1 Market Trends
6.11.2 Market Forecast
6.12 Equipment Management
6.12.1 Market Trends
6.12.2 Market Forecast
6.13 Others
6.13.1 Market Trends
6.13.2 Market Forecast
7 Market Breakup by Deployment Model
7.1 On-Cloud
7.1.1 Market Trends
7.1.2 Market Forecast
7.2 Web-Based
7.2.1 Market Trends
7.2.2 Market Forecast
7.3 On-Premises
7.3.1 Market Trends
7.3.2 Market Forecast
8 Market Breakup by Enterprise Size
8.1 Small and Medium-sized Enterprises
8.1.1 Market Trends
8.1.2 Market Forecast
8.2 Large Enterprise
8.2.1 Market Trends
8.2.2 Market Forecast
9 Market Breakup by End User
9.1 Pharmaceutical, Life Sciences, and Biotechnology Companies
9.1.1 Market Trends
9.1.2 Market Forecast
9.2 Contract Research Organizations
9.2.1 Market Trends
9.2.2 Market Forecast
9.3 Others
9.3.1 Market Trends
9.3.2 Market Forecast
10 Market Breakup by Region
10.1 North America
10.1.1 United States
 10.1.1.1 Market Trends
 10.1.1.2 Market Forecast
10.1.2 Canada
 10.1.2.1 Market Trends
 10.1.2.2 Market Forecast
10.2 Asia-Pacific
10.2.1 China
 10.2.1.1 Market Trends
 10.2.1.2 Market Forecast
10.2.2 Japan
 10.2.2.1 Market Trends
 10.2.2.2 Market Forecast
10.2.3 India
 10.2.3.1 Market Trends
 10.2.3.2 Market Forecast
10.2.4 South Korea
 10.2.4.1 Market Trends
 10.2.4.2 Market Forecast
10.2.5 Australia
 10.2.5.1 Market Trends
 10.2.5.2 Market Forecast
10.2.6 Indonesia
 10.2.6.1 Market Trends
 10.2.6.2 Market Forecast
10.2.7 Others
 10.2.7.1 Market Trends
 10.2.7.2 Market Forecast
10.3 Europe
10.3.1 Germany
 10.3.1.1 Market Trends
 10.3.1.2 Market Forecast
10.3.2 France
 10.3.2.1 Market Trends
 10.3.2.2 Market Forecast
10.3.3 United Kingdom
 10.3.3.1 Market Trends
 10.3.3.2 Market Forecast
10.3.4 Italy
 10.3.4.1 Market Trends
 10.3.4.2 Market Forecast
10.3.5 Spain
 10.3.5.1 Market Trends
 10.3.5.2 Market Forecast
10.3.6 Russia
 10.3.6.1 Market Trends
 10.3.6.2 Market Forecast
10.3.7 Others
 10.3.7.1 Market Trends
 10.3.7.2 Market Forecast
10.4 Latin America
10.4.1 Brazil
 10.4.1.1 Market Trends
 10.4.1.2 Market Forecast
10.4.2 Mexico
 10.4.2.1 Market Trends
 10.4.2.2 Market Forecast
10.4.3 Others
 10.4.3.1 Market Trends
 10.4.3.2 Market Forecast
10.5 Middle East and Africa
10.5.1 Market Trends
10.5.2 Market Breakup by Country
10.5.3 Market Forecast
11 Drivers, Restraints, and Opportunities
11.1 Overview
11.2 Drivers
11.3 Restraints
11.4 Opportunities
12 Value Chain Analysis
13 Porters Five Forces Analysis
13.1 Overview
13.2 Bargaining Power of Buyers
13.3 Bargaining Power of Suppliers
13.4 Degree of Competition
13.5 Threat of New Entrants
13.6 Threat of Substitutes
14 Price Analysis
15 Competitive Landscape
15.1 Market Structure
15.2 Key Players
15.3 Profiles of Key Players
15.3.1 AssurX Inc.
 15.3.1.1 Company Overview
 15.3.1.2 Product Portfolio
15.3.2 ComplianceQuest
 15.3.2.1 Company Overview
 15.3.2.2 Product Portfolio
15.3.3 Dassault Systèmes SE (Dassault Group)
 15.3.3.1 Company Overview
 15.3.3.2 Product Portfolio
 15.3.3.3 Financials
 15.3.3.4 SWOT Analysis
15.3.4 ETQ LLC (Hexagon AB)
 15.3.4.1 Company Overview
 15.3.4.2 Product Portfolio
15.3.5 Ideagen
 15.3.5.1 Company Overview
 15.3.5.2 Product Portfolio
15.3.6 IQVIA Inc.
 15.3.6.1 Company Overview
 15.3.6.2 Product Portfolio
15.3.7 Mastercontrol Inc.
 15.3.7.1 Company Overview
 15.3.7.2 Product Portfolio
15.3.8 Qualio
 15.3.8.1 Company Overview
 15.3.8.2 Product Portfolio
15.3.9 Veeva Systems Inc.
 15.3.9.1 Company Overview
 15.3.9.2 Product Portfolio
 15.3.9.3 Financials
 15.3.9.4 SWOT AnalysisKindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

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