The global pharmacovigilance and drug safety software market size is calculated at USD 2.09 billion in 2025 and is forecasted to reach around USD 4.68 billion by 2034, accelerating at a CAGR of 9.37% from 2025 to 2034. The North America market size surpassed USD 980 million in 2024 and is expanding at a CAGR of 9.51% during the forecast period. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
3.1. Market Snapshot
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
5.1. COVID-19 Landscape: Pharmacovigilance and Drug Safety 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
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
8.1. Pharmacovigilance and Drug Safety Software Market, by Software Type
8.1.1. Adverse Event Reporting Software
8.1.1.1. Market Revenue and Forecast
8.1.2. Drug Safety Data Management Software
8.1.2.1. Market Revenue and Forecast
8.1.3. Signal Detection Software
8.1.3.1. Market Revenue and Forecast
8.1.4. Risk Management Software
8.1.4.1. Market Revenue and Forecast
8.1.5. Regulatory Compliance Software
8.1.5.1. Market Revenue and Forecast
8.1.6. Electronic Data Capture (EDC) & Analytics Integration Tools
8.1.6.1. Market Revenue and Forecast
9.1. Pharmacovigilance and Drug Safety Software Market, by Delivery Mode
9.1.1. On-Premise Software
9.1.1.1. Market Revenue and Forecast
9.1.2. Cloud-Based Software
9.1.2.1. Market Revenue and Forecast
9.1.3. Web-Based Software
9.1.3.1. Market Revenue and Forecast
10.1. Pharmacovigilance and Drug Safety Software Market, by Functionality
10.1.1. Case Data Entry & Processing
10.1.1.1. Market Revenue and Forecast
10.1.2. Signal Detection & Management
10.1.2.1. Market Revenue and Forecast
10.1.3. Benefit-Risk Evaluation
10.1.3.1. Market Revenue and Forecast
10.1.4. Submission to Regulatory Authorities
10.1.4.1. Market Revenue and Forecast
10.1.5. Data Integration (EHR, EDC, CRO)
10.1.5.1. Market Revenue and Forecast
10.1.6. Analytics & Dashboards
10.1.6.1. Market Revenue and Forecast
11.1. Pharmacovigilance and Drug Safety Software Market, by End User
11.1.1. Pharmaceutical & Biotechnology Companies
11.1.1.1. Market Revenue and Forecast
11.1.2. Contract Research Organizations (CROs)
11.1.2.1. Market Revenue and Forecast
11.1.3. Regulatory Agencies
11.1.3.1. Market Revenue and Forecast
11.1.4. Business Process Outsourcing (BPO) Firms
11.1.4.1. Market Revenue and Forecast
11.1.5. Hospitals & Healthcare Providers
11.1.5.1. Market Revenue and Forecast
12.1. North America
12.1.1. Market Revenue and Forecast, by Software Type
12.1.2. Market Revenue and Forecast, by Delivery Mode
12.1.3. Market Revenue and Forecast, by Functionality
12.1.4. Market Revenue and Forecast, by End User
12.1.5. U.S.
12.1.5.1. Market Revenue and Forecast, by Software Type
12.1.5.2. Market Revenue and Forecast, by Delivery Mode
12.1.5.3. Market Revenue and Forecast, by Functionality
12.1.5.4. Market Revenue and Forecast, by End User
12.1.6. Rest of North America
12.1.6.1. Market Revenue and Forecast, by Software Type
12.1.6.2. Market Revenue and Forecast, by Delivery Mode
12.1.6.3. Market Revenue and Forecast, by Functionality
12.1.6.4. Market Revenue and Forecast, by End User
12.2. Europe
12.2.1. Market Revenue and Forecast, by Software Type
12.2.2. Market Revenue and Forecast, by Delivery Mode
12.2.3. Market Revenue and Forecast, by Functionality
12.2.4. Market Revenue and Forecast, by End User
12.2.5. UK
12.2.5.1. Market Revenue and Forecast, by Software Type
12.2.5.2. Market Revenue and Forecast, by Delivery Mode
12.2.5.3. Market Revenue and Forecast, by Functionality
12.2.5.4. Market Revenue and Forecast, by End User
12.2.6. Germany
12.2.6.1. Market Revenue and Forecast, by Software Type
12.2.6.2. Market Revenue and Forecast, by Delivery Mode
12.2.6.3. Market Revenue and Forecast, by Functionality
12.2.6.4. Market Revenue and Forecast, by End User
12.2.7. France
12.2.7.1. Market Revenue and Forecast, by Software Type
12.2.7.2. Market Revenue and Forecast, by Delivery Mode
12.2.7.3. Market Revenue and Forecast, by Functionality
12.2.7.4. Market Revenue and Forecast, by End User
12.2.8. Rest of Europe
12.2.8.1. Market Revenue and Forecast, by Software Type
12.2.8.2. Market Revenue and Forecast, by Delivery Mode
12.2.8.3. Market Revenue and Forecast, by Functionality
12.2.8.4. Market Revenue and Forecast, by End User
12.3. APAC
12.3.1. Market Revenue and Forecast, by Software Type
12.3.2. Market Revenue and Forecast, by Delivery Mode
12.3.3. Market Revenue and Forecast, by Functionality
12.3.4. Market Revenue and Forecast, by End User
12.3.5. India
12.3.5.1. Market Revenue and Forecast, by Software Type
12.3.5.2. Market Revenue and Forecast, by Delivery Mode
12.3.5.3. Market Revenue and Forecast, by Functionality
12.3.5.4. Market Revenue and Forecast, by End User
12.3.6. China
12.3.6.1. Market Revenue and Forecast, by Software Type
12.3.6.2. Market Revenue and Forecast, by Delivery Mode
12.3.6.3. Market Revenue and Forecast, by Functionality
12.3.6.4. Market Revenue and Forecast, by End User
12.3.7. Japan
12.3.7.1. Market Revenue and Forecast, by Software Type
12.3.7.2. Market Revenue and Forecast, by Delivery Mode
12.3.7.3. Market Revenue and Forecast, by Functionality
12.3.7.4. Market Revenue and Forecast, by End User
12.3.8. Rest of APAC
12.3.8.1. Market Revenue and Forecast, by Software Type
12.3.8.2. Market Revenue and Forecast, by Delivery Mode
12.3.8.3. Market Revenue and Forecast, by Functionality
12.3.8.4. Market Revenue and Forecast, by End User
12.4. MEA
12.4.1. Market Revenue and Forecast, by Software Type
12.4.2. Market Revenue and Forecast, by Delivery Mode
12.4.3. Market Revenue and Forecast, by Functionality
12.4.4. Market Revenue and Forecast, by End User
12.4.5. GCC
12.4.5.1. Market Revenue and Forecast, by Software Type
12.4.5.2. Market Revenue and Forecast, by Delivery Mode
12.4.5.3. Market Revenue and Forecast, by Functionality
12.4.5.4. Market Revenue and Forecast, by End User
12.4.6. North Africa
12.4.6.1. Market Revenue and Forecast, by Software Type
12.4.6.2. Market Revenue and Forecast, by Delivery Mode
12.4.6.3. Market Revenue and Forecast, by Functionality
12.4.6.4. Market Revenue and Forecast, by End User
12.4.7. South Africa
12.4.7.1. Market Revenue and Forecast, by Software Type
12.4.7.2. Market Revenue and Forecast, by Delivery Mode
12.4.7.3. Market Revenue and Forecast, by Functionality
12.4.7.4. Market Revenue and Forecast, by End User
12.4.8. Rest of MEA
12.4.8.1. Market Revenue and Forecast, by Software Type
12.4.8.2. Market Revenue and Forecast, by Delivery Mode
12.4.8.3. Market Revenue and Forecast, by Functionality
12.4.8.4. Market Revenue and Forecast, by End User
12.5. Latin America
12.5.1. Market Revenue and Forecast, by Software Type
12.5.2. Market Revenue and Forecast, by Delivery Mode
12.5.3. Market Revenue and Forecast, by Functionality
12.5.4. Market Revenue and Forecast, by End User
12.5.5. Brazil
12.5.5.1. Market Revenue and Forecast, by Software Type
12.5.5.2. Market Revenue and Forecast, by Delivery Mode
12.5.5.3. Market Revenue and Forecast, by Functionality
12.5.5.4. Market Revenue and Forecast, by End User
12.5.6. Rest of LATAM
12.5.6.1. Market Revenue and Forecast, by Software Type
12.5.6.2. Market Revenue and Forecast, by Delivery Mode
12.5.6.3. Market Revenue and Forecast, by Functionality
12.5.6.4. Market Revenue and Forecast, by End User
13.1. Oracle Health Sciences
13.1.1. Company Overview
13.1.2. Product Offerings
13.1.3. Financial Performance
13.1.4. Recent Initiatives
13.2. ArisGlobal
13.2.1. Company Overview
13.2.2. Product Offerings
13.2.3. Financial Performance
13.2.4. Recent Initiatives
13.3. Veeva Systems
13.3.1. Company Overview
13.3.2. Product Offerings
13.3.3. Financial Performance
13.3.4. Recent Initiatives
13.4. IQVIA
13.4.1. Company Overview
13.4.2. Product Offerings
13.4.3. Financial Performance
13.4.4. Recent Initiatives
13.5. AB Cube
13.5.1. Company Overview
13.5.2. Product Offerings
13.5.3. Financial Performance
13.5.4. Recent Initiatives
13.6. Ennov
13.6.1. Company Overview
13.6.2. Product Offerings
13.6.3. Financial Performance
13.6.4. Recent Initiatives
13.7. Extedo
13.7.1. Company Overview
13.7.2. Product Offerings
13.7.3. Financial Performance
13.7.4. Recent Initiatives
13.8. Sparta Systems (a Honeywell company)
13.8.1. Company Overview
13.8.2. Product Offerings
13.8.3. Financial Performance
13.8.4. Recent Initiatives
13.9. Sarjen Systems
13.9.1. Company Overview
13.9.2. Product Offerings
13.9.3. Financial Performance
13.9.4. Recent Initiatives
13.10. Max Application
13.10.1. Company Overview
13.10.2. Product Offerings
13.10.3. Financial Performance
13.10.4. Recent Initiatives
14.1. Primary Research
14.2. Secondary Research
14.3. Assumptions
15.1. About Us
15.2. Glossary of Terms
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