Global Life Sciences Quality Management Software Market Size Study, By Application (Data Management, Regulatory and Compliance Management, Others), By Deployment Mode (Cloud & Web-Based, On-Premise), By End Use (Pharmaceutical Firms, Biotech Firms, CROs/CDMOs), and Regional Forecasts 2022-2032

January 2025 | 285 pages | ID: G2FB7F1D59D9EN
Bizwit Research & Consulting LLP

Abstracts

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 Syst?mes
• 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.

Contents

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 Syst?mes
  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

12. LIST OF TABLES

1. TABLE 1. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, REPORT SCOPE

2. TABLE 2. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES & FORECASTS BY REGION 2022-2032 (USD MILLION)

3. TABLE 3. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES & FORECASTS BY APPLICATION 2022-2032 (USD MILLION)

4. TABLE 4. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES & FORECASTS BY DEPLOYMENT MODE 2022-2032 (USD MILLION)

5. TABLE 5. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES & FORECASTS BY END USE 2022-2032 (USD MILLION)

6. TABLE 6. REGIONAL BREAKDOWN OF APPLICATION REVENUE TRENDS, 2022-2032 (USD MILLION)

7. TABLE 7. REGIONAL BREAKDOWN OF DEPLOYMENT MODE REVENUE TRENDS, 2022-2032 (USD MILLION)

8. TABLE 8. REGIONAL BREAKDOWN OF END USE REVENUE TRENDS, 2022-2032 (USD MILLION)

9. TABLE 9. NORTH AMERICA LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES BY COUNTRY 2022-2032 (USD MILLION)

10. TABLE 10. EUROPE LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES BY COUNTRY 2022-2032 (USD MILLION)

11. TABLE 11. ASIA PACIFIC LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES BY COUNTRY 2022-2032 (USD MILLION)

12. TABLE 12. LATIN AMERICA LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES BY COUNTRY 2022-2032 (USD MILLION)

13. TABLE 13. MIDDLE EAST & AFRICA LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET ESTIMATES BY COUNTRY 2022-2032 (USD MILLION)

14. TABLE 14. COMPARISON OF CLOUD & WEB-BASED AND ON-PREMISES MARKET SHARES, 2022 & 2032

15. TABLE 15. KEY DRIVERS INFLUENCING ADOPTION OF AI IN LIFE SCIENCES QMS

16. TABLE 16. IMPACT OF REGULATORY STANDARDS ON QMS ADOPTION TRENDS BY REGION, 2022-2032

17. TABLE 17. SWOT ANALYSIS OF KEY MARKET PLAYERS (DASSAULT SYST?MES, IQVIA, MASTERCONTROL SOLUTIONS, INC.)

18. TABLE 18. MARKET SHARE BY PHARMACEUTICAL VS. BIOTECH FIRMS, 2022 & 2032

19. TABLE 19. KEY INVESTMENT PATTERNS IN CLOUD-BASED QMS SOLUTIONS (2022-2032)

20. TABLE 20. INTEGRATION OF AI IN EQMS: COST-BENEFIT ANALYSIS

This list is not complete; the final report does contain more than 100 tables. The list may be updated in the final deliverable.

12. LIST OF FIGURES

1. FIG 1. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, RESEARCH METHODOLOGY

2. FIG 2. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, MARKET ESTIMATION TECHNIQUES

3. FIG 3. GLOBAL MARKET SIZE ESTIMATES & FORECAST METHODS

4. FIG 4. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, KEY TRENDS 2023

5. FIG 5. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, GROWTH PROSPECTS 2022-2032

6. FIG 6. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, PORTER’S FIVE FORCE ANALYSIS

7. FIG 7. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, PESTEL ANALYSIS

8. FIG 8. GLOBAL LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET, VALUE CHAIN ANALYSIS

9. FIG 9. REGIONAL BREAKDOWN OF MARKET REVENUE SHARES, 2022-2032

10. FIG 10. ADOPTION TRENDS FOR CLOUD-BASED SOLUTIONS VS. ON-PREMISES SYSTEMS, 2022-2032

11. FIG 11. SEGMENTAL SHARE ANALYSIS: APPLICATIONS IN LIFE SCIENCES QMS, 2023

12. FIG 12. NORTH AMERICA LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET SNAPSHOT, 2023

13. FIG 13. EUROPE LIFE SCIENCES QUALITY MANAGEMENT SOFTWARE MARKET TRENDS, 2022-2032

14. FIG 14. AI-DRIVEN INSIGHTS: IMPACT ON REGULATORY COMPLIANCE AND EFFICIENCY METRICS

15. FIG 15. COMPARATIVE ANALYSIS: CLOUD-BASED VS. TRADITIONAL QMS SOLUTIONS IN THE PHARMACEUTICAL SECTOR

16. FIG 16. TOP INVESTMENT TRENDS IN SAAS-BASED QMS SOLUTIONS BY REGION, 2022-2032

17. FIG 17. REVENUE SHARE BY PHARMACEUTICAL AND BIOTECH FIRMS, 2022 & 2032

18. FIG 18. COMPETITIVE LANDSCAPE: REVENUE SHARE ANALYSIS OF TOP PLAYERS, 2023

19. FIG 19. REGULATORY UPDATES INFLUENCING QMS ADOPTION TRENDS (FDA, EMA, ISO)

20. FIG 20. REGIONAL TRENDS IN CLOUD-BASED QMS IMPLEMENTATION, 2022-2032

This list is not complete; the final report does contain more than 50 figures. The list may be updated in the final deliverable.