Global Life Sciences Quality Management Software Market Size Study, By Application, By Deployment Mode, By End Use, and Regional Forecasts 2022-2032

Description

The global life sciences quality management software market was valued at approximately USD 2.89 billion in 2023 and is projected to grow at a robust CAGR of 12.99% over the forecast period 2024-2032. The rising adoption of quality management software (QMS) in the life sciences industry is driven by the increasing need to comply with stringent regulatory guidelines established by agencies such as the FDA and ISO. The growing shift from traditional paper-based QMS to digital eQMS is revolutionizing the sector, enabling organizations to improve operational efficiency, ensure product safety, and enhance compliance.

Technological advancements, such as Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT), are transforming QMS by enabling predictive analytics and real-time data monitoring. These innovations streamline manufacturing processes, enhance decision-making, and help organizations maintain superior quality standards. For instance, the launch of AI-integrated solutions such as ComplianceQuest's Life Sciences Cloud and Dot Compliance's ChatGPT-enabled eQMS highlights the industry's move towards advanced technologies for quality assurance.

Key applications driving growth include data management, regulatory and compliance management, and risk management. The increasing complexity of regulatory requirements and the growing emphasis on patient safety have positioned QMS as a critical tool for life sciences companies. Additionally, deployment modes are shifting towards cloud-based solutions, which accounted for the largest market share in 2023, driven by their scalability, cost-effectiveness, and enhanced data accessibility.

Regionally, North America dominated the market in 2023 due to its stringent regulatory environment and well-established pharmaceutical and biotechnology sectors. However, Asia-Pacific is expected to exhibit the fastest growth, supported by the rise of contract research organizations (CROs) and contract manufacturing organizations (CMOs), alongside increasing investment in healthcare infrastructure in countries like China, Japan, and India.

Major market player included in this report are:

Dassault Systemes
IQVIA (Pilgrim)
MasterControl Solutions, Inc.
AmpleLogic
Qualio - QMS for Life Sciences
QT9 Software
Sparta Systems- TrackWise (Honeywell International Inc.)
AssurX, Inc
ETQ, LLC (Hexagon)
Veeva Systems
Qualityze
Ideagen
ComplianceQuest
Dot Compliance
AURA Quality Management

The detailed segments and sub-segment of the market are explained below:

By Application:

Data Management
Training Management
Supplier Management
Regulatory and Compliance Management
Corrective Action Preventive Action (CAPA) Management
Audit Management
Change Management
Non-Conformances Management
Inspection Management
Risk Management
Others

By Deployment Mode:

Cloud & Web-Based
On-Premises

By End Use:

Pharmaceutical Firms
Biotech Firms
CROs/CDMOs

By Region:

North America
U.S.
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
Denmark
Sweden
Norway
Asia-Pacific
China
Japan
India
South Korea
Australia
Thailand
Latin America
Brazil
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait

Years considered for the study are as follows:

Historical year - 2022
Base year - 2023
Forecast period - 2024 to 2032

Key Takeaways:

Market Estimates & Forecast for 10 years from 2022 to 2032.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country-level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand-side and supply-side analysis of the market.

Chapter 1. Global Life Sciences Quality Management Software Market Executive Summary

1.1. Global Life Sciences Quality Management Software Market Size & Forecast (2022-2032)
1.2. Regional Summary
1.3. Segmental Summary
- 1.3.1. By Application
- 1.3.2. By Deployment Mode
- 1.3.3. By End Use
1.4. Key Trends
1.5. Recession Impact
1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Life Sciences Quality Management Software Market Definition and Research Assumptions

2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
- 2.3.1. Inclusion & Exclusion
- 2.3.2. Limitations
- 2.3.3. Supply Side Analysis
  - 2.3.3.1. Availability
  - 2.3.3.2. Infrastructure
  - 2.3.3.3. Regulatory Environment
  - 2.3.3.4. Market Competition
  - 2.3.3.5. Economic Viability (Consumer's Perspective)
- 2.3.4. Demand Side Analysis
  - 2.3.4.1. Regulatory Frameworks
  - 2.3.4.2. Technological Advancements
  - 2.3.4.3. Environmental Considerations
  - 2.3.4.4. Consumer Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates

Chapter 3. Global Life Sciences Quality Management Software Market Dynamics

3.1. Market Drivers
- 3.1.1. Increasing demand for regulatory compliance in life sciences
- 3.1.2. Transition from paper-based QMS to digital QMS
- 3.1.3. Advancements in AI and IoT integration for QMS
3.2. Market Challenges
- 3.2.1. High implementation costs of advanced QMS systems
- 3.2.2. Challenges in data security and integration in cloud-based QMS
3.3. Market Opportunities
- 3.3.1. Growing adoption of cloud-based solutions in emerging economies
- 3.3.2. Rising importance of risk and compliance management

Chapter 4. Global Life Sciences Quality Management Software Market Industry Analysis

4.1. Porter's 5 Force Model
- 4.1.1. Bargaining Power of Suppliers
- 4.1.2. Bargaining Power of Buyers
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
4.2. PESTEL Analysis
4.3. Top Investment Opportunities
4.4. Top Winning Strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspective
4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Life Sciences Quality Management Software Market Size & Forecasts by Application 2022-2032

5.1. Segment Dashboard
5.2. Revenue Trend Analysis (USD Million)
- 5.2.1. Data Management
- 5.2.2. Training Management
- 5.2.3. Supplier Management
- 5.2.4. Regulatory and Compliance Management
- 5.2.5. Corrective Action Preventive Action (CAPA) Management
- 5.2.6. Audit Management
- 5.2.7. Change Management
- 5.2.8. Non-Conformances Management
- 5.2.9. Inspection Management
- 5.2.10. Risk Management
- 5.2.11. Others

Chapter 6. Global Life Sciences Quality Management Software Market Size & Forecasts by Deployment Mode 2022-2032

6.1. Segment Dashboard
6.2. Revenue Trend Analysis (USD Million)
- 6.2.1. Cloud & Web-Based
- 6.2.2. On-Premises

Chapter 7. Global Life Sciences Quality Management Software Market Size & Forecasts by End Use 2022-2032

7.1. Segment Dashboard
7.2. Revenue Trend Analysis (USD Million)
- 7.2.1. Pharmaceutical Firms
- 7.2.2. Biotech Firms
- 7.2.3. CROs/CDMOs

Chapter 8. Global Life Sciences Quality Management Software Market Size & Forecasts by Region 2024-2032

8.1. North America
- 8.1.1. U.S.
- 8.1.2. Canada
- 8.1.3. Mexico
8.2. Europe
- 8.2.1. Germany
- 8.2.2. UK
- 8.2.3. France
- 8.2.4. Italy
- 8.2.5. Spain
- 8.2.6. Denmark
- 8.2.7. Sweden
- 8.2.8. Norway
8.3. Asia-Pacific
- 8.3.1. China
- 8.3.2. Japan
- 8.3.3. India
- 8.3.4. South Korea
- 8.3.5. Australia
- 8.3.6. Thailand
8.4. Latin America
- 8.4.1. Brazil
- 8.4.2. Argentina
8.5. Middle East & Africa
- 8.5.1. South Africa
- 8.5.2. Saudi Arabia
- 8.5.3. UAE
- 8.5.4. Kuwait

Chapter 9. Competitive Intelligence

9.1. Key Company SWOT Analysis
- 9.1.1. Dassault Systemes
- 9.1.2. IQVIA (Pilgrim)
- 9.1.3. MasterControl Solutions, Inc.
9.2. Top Market Strategies
9.3. Company Profiles

Chapter 10. Research Process

10.1. Research Process
- 10.1.1. Data Mining
- 10.1.2. Analysis
- 10.1.3. Market Estimation
- 10.1.4. Validation
- 10.1.5. Publishing
10.2. Research Attributes