약물감시 및 의약품 안전성 소프트웨어 시장 규모, 점유율, 동향 분석 보고서 : 기능성별, 전개별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Pharmacovigilance And Drug Safety Software Market Summary

The global pharmacovigilance and drug safety software market size was valued at USD 210.96 million in 2024 and is projected to reach USD 388.74 million by 2033, growing at a CAGR of 7.1% from 2025 to 2033. The growing availability of data, the need to process & derive insights from the generated data, stringent reporting norms & standards, and increasing software upgrades by key companies are some of the key drivers of this market.

INTIENT Pharmacovigilance by Accenture is a comprehensive product suite that helps in the collection and management of a full spectrum of pharmacovigilance data. The platform also enables users to understand potential compliance issues and emerging trends and report on adverse events. The rising incidence of adverse drug reactions (ADRs) and medication errors is a key factor driving the growth of the industry. As drug therapies become more complex and polypharmacy increases, healthcare systems face greater risks of adverse events that compromise patient safety and increase hospitalizations. According to an article published by Springer Nature, the proportion of urgent hospitalizations caused by ADRs was reported as 5.0% (95% CI 4.5-5.6%) among 5,707 consecutive patients hospitalized for acute medical illnesses between June 2018 and May 2021. Such findings highlight the critical need for advanced pharmacovigilance solutions that can efficiently detect, analyze, and prevent drug-related risks through real-time monitoring and automated reporting systems.

Moreover, increasing pressure to follow safety guidelines set by government authorities such as the European Medicines Agency and the U.S. FDA is contributing to the growing adoption of pharmacovigilance systems. Many pharmaceutical companies are moving toward outsourcing pharmacovigilance activities to curb operational costs. Manufacturers are gradually shifting from being fully integrated pharmaceutical companies to sharing costs by collaborating with service providers. Services outsourced range from medical writing and clinical trial data collection to medical reporting and other PV services. Outsourcing helps increase internal resource flexibility, improves timelines, and results in better outcomes.

Gobal Pharmacovigilance And Drug Safety Software Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global pharmacovigilance and drug safety software market report based on deployment, functionality, end use, and regions.

• Deployment Outlook (Revenue, USD Million, 2021 - 2033)
• On Premise
• On Demand
• Functionality Outlook (Revenue, USD Million, 2021 - 2033)
• Case data collection and management
• Adverse event reporting and analysis
• Signal detection and other safety risk assessment
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Healthcare Companies (Pharmaceuticals & Biotechnology Companies)
• CROs/BPOs or PV service providers when outsourced.
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Deployment
  • 1.2.2. Functionality
  • 1.2.3. End use
• 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
  • 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
• 1.10. Objectives

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
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Growing drug consumption and drug development rates
    • 3.2.1.2. Increasing incidence of ADR and drug toxicity
    • 3.2.1.3. Increasing trend of outsourcing pharmacovigilance services
    • 3.2.1.4. Increasing externalization of clinical trial studies by large pharmaceutical and biopharmaceutical companies
    • 3.2.1.5. Increasing regulatory burden on manufacturers
    • 3.2.1.6. Introduction of technologically advanced software services
    • 3.2.1.7. Rising investment on R&D by healthcare companies
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Shortage of skilled professionals
    • 3.2.2.2. Expensive technology for small and mid-sized Players
    • 3.2.2.3. Lack of Recognition
    • 3.2.2.4. Scarcity of integration standards
  • 3.2.3. Industry Opportunity Analysis
  • 3.2.4. Industry Challenge Analysis
  • 3.2.5. PV Services Pricing Models
    • 3.2.5.1. Drug Safety Budget Allocation By Activities
    • 3.2.5.2. By Development Phase
    • 3.2.5.3. By Therapeutic Area
    • 3.2.5.4. Pricing Level
      • 3.2.5.4.1.Project management
      • 3.2.5.4.2.Case processing
      • 3.2.5.4.3.ADR Reporting
      • 3.2.5.4.4.Medical writing
      • 3.2.5.4.5.Drug safety management
  • 3.2.6. Technology Overview
  • 3.2.7. Case Studies
  • 3.2.8. Inflation's Impact on the Overall PV and Drug Safety Software Market
  • 3.2.9. Market Competitive Factors and Strategies
  • 3.2.10. Healthcare Companies Using PV Services
• 3.3. Business Environment Analysis
  • 3.3.1. Porter's Five Forces Analysis
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTLE Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Economic and Social landscape
    • 3.3.2.3. Technological landscape
    • 3.3.2.4. Environmental landscape
    • 3.3.2.5. Legal Landscape

Chapter 4. Pharmacovigilance and Drug Safety Software Market: Deployment Estimates & Trend Analysis

• 4.1. Deployment Dashboard
• 4.2. Deployment Market Share Movement Analysis, 2024 & 2033
• 4.3. Market Size & Forecasts and Trend Analysis, by Deployment, 2021 to 2033 (USD Million)
• 4.4. On-Premise
  • 4.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. On-Demand
  • 4.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Pharmacovigilance and Drug Safety Software Market: Functionality Estimates & Trend Analysis

• 5.1. Functionality Dashboard
• 5.2. Functionality Market Share Movement Analysis, 2024 & 2033
• 5.3. Market Size & Forecasts and Trend Analysis, by Functionality, 2021 to 2033 (USD Million)
• 5.4. Case data collection and management
  • 5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Adverse event reporting and analysis
  • 5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Signal detection and other safety risk assessment
  • 5.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Pharmacovigilance and Drug Safety Software Market: End Use Estimates & Trend Analysis

• 6.1. End use Segment Dashboard
• 6.2. End use Market Share Movement Analysis, 2024 & 2033
• 6.3. Market Size & Forecasts and Trend Analysis, by End Use, 2021 to 2033 (USD Million)
• 6.4. Healthcare Companies (Pharmaceuticals & Biotechnology Companies)
  • 6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. CROs/BPOs or PV service providers when outsourced.
  • 6.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Others
  • 6.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Pharmacovigilance and Drug Safety Software Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Dashboard
• 7.2. Regional Market: Key Takeaways
• 7.3. North America
  • 7.3.1. North America Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.3.2. U.S.
    • 7.3.2.1. Key country dynamic
    • 7.3.2.2. Regulatory framework
    • 7.3.2.3. Competitive insights
    • 7.3.2.4. U.S. Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.3.3. Canada
    • 7.3.3.1. Key country dynamic
    • 7.3.3.2. Regulatory framework
    • 7.3.3.3. Competitive insights
    • 7.3.3.4. Canada Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.3.4. Mexico
    • 7.3.4.1. Key country dynamic
    • 7.3.4.2. Regulatory framework
    • 7.3.4.3. Competitive insights
    • 7.3.4.4. Mexico Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.4. Europe
  • 7.4.1. Europe Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.2. Germany
    • 7.4.2.1. Key country dynamic
    • 7.4.2.2. Regulatory framework
    • 7.4.2.3. Competitive insights
    • 7.4.2.4. Germany Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. UK
    • 7.4.3.1. Key country dynamic
    • 7.4.3.2. Regulatory framework
    • 7.4.3.3. Competitive insights
    • 7.4.3.4. UK Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. France
    • 7.4.4.1. Key country dynamic
    • 7.4.4.2. Regulatory framework
    • 7.4.4.3. Competitive insights
    • 7.4.4.4. France Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.5. Italy
    • 7.4.5.1. Key country dynamic
    • 7.4.5.2. Regulatory framework
    • 7.4.5.3. Competitive insights
    • 7.4.5.4. Italy Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.6. Spain
    • 7.4.6.1. Key country dynamic
    • 7.4.6.2. Regulatory framework
    • 7.4.6.3. Competitive insights
    • 7.4.6.4. Spain Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.7. Denmark
    • 7.4.7.1. Key country dynamic
    • 7.4.7.2. Regulatory framework
    • 7.4.7.3. Competitive insights
    • 7.4.7.4. Denmark Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.8. Sweden
    • 7.4.8.1. Key country dynamic
    • 7.4.8.2. Regulatory framework
    • 7.4.8.3. Competitive insights
    • 7.4.8.4. Sweden Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.4.9. Norway
    • 7.4.9.1. Key country dynamic
    • 7.4.9.2. Regulatory framework
    • 7.4.9.3. Competitive insights
    • 7.4.9.4. Norway Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.5. Asia Pacific
  • 7.5.1. Asia Pacific Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. Japan
    • 7.5.2.1. Key country dynamic
    • 7.5.2.2. Regulatory framework
    • 7.5.2.3. Competitive insights
    • 7.5.2.4. Japan Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. China
    • 7.5.3.1. Key country dynamic
    • 7.5.3.2. Regulatory framework
    • 7.5.3.3. Competitive insights
    • 7.5.3.4. China Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. India
    • 7.5.4.1. Key country dynamic
    • 7.5.4.2. Regulatory framework
    • 7.5.4.3. Competitive insights
    • 7.5.4.4. India Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. South Korea
    • 7.5.5.1. Key country dynamic
    • 7.5.5.2. Regulatory framework
    • 7.5.5.3. Competitive insights
    • 7.5.5.4. South Korea Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Australia
    • 7.5.6.1. Key country dynamic
    • 7.5.6.2. Regulatory framework
    • 7.5.6.3. Competitive insights
    • 7.5.6.4. Australia Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Thailand
    • 7.5.7.1. Key country dynamic
    • 7.5.7.2. Regulatory framework
    • 7.5.7.3. Competitive insights
    • 7.5.7.4. Thailand Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.6. Latin America
  • 7.6.1. Latin America Pharmacovigilance and Drug Safety Software Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Brazil
    • 7.6.2.1. Key country dynamic
    • 7.6.2.2. Regulatory framework
    • 7.6.2.3. Competitive insights
    • 7.6.2.4. Brazil Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. Argentina
    • 7.6.3.1. Key country dynamic
    • 7.6.3.2. Regulatory framework
    • 7.6.3.3. Competitive insights
    • 7.6.3.4. Argentina Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.7. MEA
  • 7.7.1. MEA Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. South Africa
    • 7.7.2.1. Key country dynamic
    • 7.7.2.2. Regulatory framework
    • 7.7.2.3. Competitive insights
    • 7.7.2.4. South Africa Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Saudi Arabia
    • 7.7.3.1. Key country dynamic
    • 7.7.3.2. Regulatory framework
    • 7.7.3.3. Competitive insights
    • 7.7.3.4. Saudi Arabia Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.7.4. UAE
    • 7.7.4.1. Key country dynamic
    • 7.7.4.2. Regulatory framework
    • 7.7.4.3. Competitive insights
    • 7.7.4.4. UAE Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)
  • 7.7.5. Kuwait
    • 7.7.5.1. Key country dynamic
    • 7.7.5.2. Regulatory framework
    • 7.7.5.3. Competitive insights
    • 7.7.5.4. Kuwait Pharmacovigilance and Drug Safety Software market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis/Company Market Share Analysis, (2024)
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. Oracle (Cerner)
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial performance
    • 8.5.1.3. Product benchmarking
    • 8.5.1.4. Strategic initiatives
  • 8.5.2. Accenture
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial performance
    • 8.5.2.3. Product benchmarking
    • 8.5.2.4. Strategic initiatives
  • 8.5.3. IBM Corporation
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial performance
    • 8.5.3.3. Product benchmarking
    • 8.5.3.4. Strategic initiatives
  • 8.5.4. ITClinical
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial performance
    • 8.5.4.3. Product benchmarking
    • 8.5.4.4. Strategic initiatives
  • 8.5.5. UBC (United BioSource Corporation)
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial performance
    • 8.5.5.3. Product benchmarking
    • 8.5.5.4. Strategic initiatives
  • 8.5.6. Ab Cube
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial performance
    • 8.5.6.3. Product benchmarking
    • 8.5.6.4. Strategic initiatives
  • 8.5.7. Ennov
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial performance
    • 8.5.7.3. Product benchmarking
    • 8.5.7.4. Strategic initiatives
  • 8.5.8. EXTEDO
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial performance
    • 8.5.8.3. Product benchmarking
    • 8.5.8.4. Strategic initiatives
  • 8.5.9. Veeva Systems
    • 8.5.9.1. Overview
    • 8.5.9.2. Financial performance
    • 8.5.9.3. Product benchmarking
    • 8.5.9.4. Strategic initiatives
  • 8.5.10. IQVIA
    • 8.5.10.1. Overview
    • 8.5.10.2. Financial performance
    • 8.5.10.3. Product benchmarking
    • 8.5.10.4. Strategic initiatives
  • 8.5.11. Sarjen Systems Pvt. Ltd.
    • 8.5.11.1. Overview
    • 8.5.11.2. Financial performance
    • 8.5.11.3. Product benchmarking
    • 8.5.11.4. Strategic initiatives
  • 8.5.12. Flex Databases
    • 8.5.12.1. Overview
    • 8.5.12.2. Financial performance
    • 8.5.12.3. Product benchmarking
    • 8.5.12.4. Strategic initiatives
  • 8.5.13. Tepsivo Oy
    • 8.5.13.1. Overview
    • 8.5.13.2. Financial performance
    • 8.5.13.3. Product benchmarking
    • 8.5.13.4. Strategic initiatives
  • 8.5.14. ArisGlobal
    • 8.5.14.1. Overview
    • 8.5.14.2. Financial performance
    • 8.5.14.3. Product benchmarking
    • 8.5.14.4. Strategic initiatives
  • 8.5.15. EVERSANA
    • 8.5.15.1. Overview
    • 8.5.15.2. Financial performance
    • 8.5.15.3. Product benchmarking
    • 8.5.15.4. Strategic initiatives