유럽의 약물감시 및 의약품 안전성 소프트웨어 시장 보고서 : 범위, 부문, 역학, 경쟁 분석(2021-2031년)

The pharmacovigilance and drug safety software market in Europe was valued at approximately US$ 52.38 million in 2023, with projections indicating it will grow to US$ 84.67 million by 2031, reflecting a compound annual growth rate (CAGR) of 6.2% during this period.

Globalization of Pharmacovigilance: A Catalyst for Market Growth

Pharmacovigilance, which involves the monitoring and assessment of adverse drug reactions (ADRs), is a critical aspect of drug regulation, clinical practice, and public health initiatives. The globalization of pharmacovigilance is fostering enhanced collaboration among various stakeholders, including regulatory authorities, healthcare providers, and pharmaceutical companies. For example, the European Medicines Agency (EMA) has increasingly emphasized the importance of international cooperation among pharmaceutical regulators, focusing on medicine safety, inspections, and the exchange of pertinent information. This collaborative framework not only facilitates data sharing but also improves the overall understanding of drug safety profiles.

As companies aim to capitalize on these global networks, the demand for integrated pharmacovigilance solutions that can function effectively across borders is becoming more pronounced. Governments worldwide are implementing pharmacovigilance programs in partnership with their national regulatory bodies, recognizing the vital role of pharmacovigilance in ensuring drug safety. The growing awareness and adoption of best practices in pharmacovigilance across various countries have significantly increased the demand for specialized software solutions. A notable example is Italy's Medical Agency, which launched the National Pharmacovigilance Network (RNF) in June 2022 to detect suspected ADRs. This system incorporates advanced functionalities for managing and analyzing ADR reports, ensuring accurate assessments of medicine safety. Additionally, the EudraVigilance System, utilized across European nations, generates reports on suspected ADRs, further enhancing pharmacovigilance efforts.

The globalization of pharmacovigilance also promotes cross-border collaboration. Several European initiatives, such as BeNeLuxA, the Nordic collaborations, and the Valletta Declaration, aim to improve patient access to innovative therapies. The BeNeLuxA initiative, for instance, enhances cooperation among Belgium, the Netherlands, Luxembourg, Austria, and Ireland, allowing middle-income countries to negotiate better drug pricing and share policy expertise. These collaborative efforts support comprehensive health technology assessments and improve transparency in pharmaceutical marketing. The establishment of robust pharmacovigilance systems capable of managing and reporting ADRs on a global scale is essential for advancing the globalization of pharmacovigilance, thereby driving the growth of the pharmacovigilance and drug safety software market.

Overview of the Europe Pharmacovigilance and Drug Safety Software Market

The increasing demand for pharmacovigilance and drug safety software in Europe can be attributed to several factors, including stringent regulatory requirements, a rise in drug approvals, a heightened focus on patient safety, and technological advancements. The EU's pharmacovigilance framework is among the most sophisticated globally, with regulatory bodies like the EMA enforcing rigorous pharmacovigilance standards that necessitate the adoption of advanced software solutions. The EU Pharmacovigilance Directive (2010/84/EU) and Regulation (EU) No 1235/2010 have introduced stricter monitoring rules for ADRs, compelling companies to report safety data in real-time and increasing the need for efficient software systems capable of handling large data volumes.

The European pharmaceutical sector has witnessed a surge in new drug approvals, further driving the demand for pharmacovigilance and drug safety software to monitor safety data effectively. For instance, in the second quarter of 2023, the EMA and the US FDA approved over 21 new oncology drugs. As more products enter the market, pharmaceutical companies require robust software solutions to ensure the safety and efficacy of these drugs. Major companies, such as Oracle Corp, are heavily investing in pharmacovigilance software to enhance their safety monitoring capabilities for newly approved products, utilizing platforms like Oracle Argus Safety and Veeva Vault Safety for effective adverse event management.

Moreover, European governments are implementing compliance measures to protect software data, particularly with the introduction of the EU General Data Protection Regulation (GDPR). This regulation mandates that pharmacovigilance and drug safety software not only meet regulatory standards but also ensure operational efficiency while safeguarding data privacy. Adhering to GDPR is crucial for maintaining trust with patients and regulatory bodies alike, thereby boosting the adoption of pharmacovigilance software across Europe.

The integration of artificial intelligence (AI), machine learning (ML), and other advanced technologies is revolutionizing pharmacovigilance processes. These innovations facilitate automated data processing, real-time signal detection, and advanced analytics, simplifying the management of safety data and compliance with regulatory requirements. For example, ArisGlobal's LifeSphere platform leverages AI to automate case processing and enhance signal detection capabilities, further driving the demand for pharmacovigilance and drug safety software in Europe.

Market Segmentation Analysis

The Europe pharmacovigilance and drug safety software market is segmented based on various criteria, including offering, deployment, enterprise size, form, functionality, end user, and country.

• Offering: The market is divided into software and services, with the software segment holding a larger share in 2023.
• Deployment: The market is categorized into cloud and on-premises solutions, with cloud solutions dominating in 2023.
• Enterprise Size: The market is segmented into large enterprises and SMEs, with large enterprises holding a significant share.
• Form: The market is classified into standard and customized solutions, with standard solutions leading in market share.
• Functionality: The market includes signal and risk management, issue tracking, case management, and more, with signal and risk management being the largest segment.
• End User: The market is divided into pharmaceutical and biotechnology companies, contract research organizations, and BPO firms, with pharmaceutical and biotechnology companies leading.
• Country: The market is segmented into Germany, France, the UK, Italy, Spain, and the Rest of Europe, with Germany dominating the market share in 2023.

Key Players in the Market

Leading companies in the Europe pharmacovigilance and drug safety software market include Veeva Systems Inc, IQVIA Holdings Inc, AB Cube S.A.S., ArisGlobal LLC, Oracle Corp, Max Application, ICON Plc, Cognizant Technology Solutions Corp, Accenture Plc, Syneos Health Inc, Genpact Ltd., Laboratory Corp of America Holdings, Parexel International Corp, Qinecsa Solutions, and Clinevo Technologies.

Table Of Contents

1. Introduction

• 1.1 Report Guidance
• 1.2 Market Segmentation

2. Executive Summary

• 2.1 Key Insights
• 2.2 Market Attractiveness

3. Research Methodology

• 3.1 Secondary Research
• 3.2 Primary Research
  • 3.2.1 Hypothesis formulation:
  • 3.2.2 Macro-economic factor analysis:
  • 3.2.3 Developing base number:
  • 3.2.4 Data Triangulation:
  • 3.2.5 Country level data:

4. Europe Pharmacovigilance and Drug Safety Software Market Landscape

• 4.1 Overview
• 4.2 Ecosystem Analysis
  • 4.2.1 Software/Service Providers:
  • 4.2.2 System Integrators:
  • 4.2.3 Regulatory Bodies:
  • 4.2.4 End-Users:
  • 4.2.5 List of Vendors in the Value Chain

5. Europe Pharmacovigilance and Drug Safety Software Market - Key Market Dynamics

• 5.1 Market Drivers
• 5.2 Market Restraints
• 5.3 Market Opportunities
• 5.4 Future Trends
• 5.5 Impact of Drivers and Restraints:

6. Europe Pharmacovigilance and Drug Safety Software Market - Analysis

• 6.1 Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Thousand), 2021-2031
• 6.2 Europe Pharmacovigilance and Drug Safety Software Market Forecast Analysis

7. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Offering

• 7.1 Software
  • 7.1.1 Overview
  • 7.1.2 Software: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 7.2 Services
  • 7.2.1 Overview
  • 7.2.2 Services: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

8. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Deployment

• 8.1 Cloud
  • 8.1.1 Overview
  • 8.1.2 Cloud: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 8.2 On Premises
  • 8.2.1 Overview
  • 8.2.1 On Premises: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

9. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Enterprise Size

• 9.1 Large Enterprises
  • 9.1.1 Overview
  • 9.1.2 Large Enterprises: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 9.2 SMEs
  • 9.2.1 Overview
  • 9.2.1 SMEs: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

10. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Form

• 10.1 Standard
  • 10.1.1 Overview
  • 10.1.2 Standard: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 10.2 Customized
  • 10.2.1 Overview
  • 10.2.1 Customized: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

11. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Functionality

• 11.1 Signal and Risk Management
  • 11.1.1 Overview
  • 11.1.2 Signal and Risk Management: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.2 Issue Tracking and Adverse Event Tracking
  • 11.2.1 Overview
  • 11.2.2 Issue Tracking and Adverse Event Tracking: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.3 Case Management
  • 11.3.1 Overview
  • 11.3.2 Case Management: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.4 Clinical Safety Management and Clinical Trial Safety
  • 11.4.1 Overview
  • 11.4.1 Clinical Safety Management and Clinical Trial Safety: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.5 Quality and Compliance
  • 11.5.1 Overview
  • 11.5.1 Quality and Compliance: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.6 Medical Writing
  • 11.6.1 Overview
  • 11.6.1 Medical Writing: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.7 Audit Support and Training Compliance
  • 11.7.1 Overview
  • 11.7.1 Audit Support and Training Compliance: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.8 Healthcare Analytics
  • 11.8.1 Overview
  • 11.8.1 Healthcare Analytics: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 11.9 Others
  • 11.9.1 Overview
  • 11.9.1 Others: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

12. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by End User

• 12.1 Pharmaceutical and Biotechnology Companies
  • 12.1.1 Overview
  • 12.1.2 Pharmaceutical and Biotechnology Companies: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 12.2 Contract Research Organizations
  • 12.2.1 Overview
  • 12.2.1 Contract Research Organizations: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 12.3 Business Process Outsourcing (BPO) Firms
  • 12.3.1 Overview
  • 12.3.1 Business Process Outsourcing (BPO) Firms: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
• 12.4 Others
  • 12.4.1 Overview
  • 12.4.1 Others: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)

13. Europe Pharmacovigilance and Drug Safety Software Market - Country Analysis

• 13.1 Europe
  • 13.1.1 Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast Analysis - by Country
    • 13.1.1.1 Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast Analysis - by Country
    • 13.1.1.2 Germany: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.2.1 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.2.2 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.2.3 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.2.4 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.2.5 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.2.6 Germany: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User
    • 13.1.1.3 France: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.3.1 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.3.2 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.3.3 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.3.4 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.3.5 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.3.6 France: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User
    • 13.1.1.4 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.4.1 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.4.2 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.4.3 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.4.4 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.4.5 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.4.6 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User
    • 13.1.1.5 Italy: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.5.1 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.5.2 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.5.3 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.5.4 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.5.5 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.5.6 Italy: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User
    • 13.1.1.6 Spain: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.6.1 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.6.2 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.6.3 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.6.4 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.6.5 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.6.6 Spain: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User
    • 13.1.1.7 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market - Revenue and Forecast, 2021-2031 (US$ Thousand)
      • 13.1.1.7.1 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by Offering
      • 13.1.1.7.2 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by Deployment
      • 13.1.1.7.3 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by Enterprise Size
      • 13.1.1.7.4 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by Form
      • 13.1.1.7.5 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by Functionality
      • 13.1.1.7.6 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Share - by End User

14. Competitive Landscape

• 14.1 Heat Map Analysis by Key Players
• 14.2 Company Positioning and Concentration

15. Industry Landscape

• 15.1 Overview
• 15.2 Market Initiative
• 15.3 Partnerships and Collaborations

16. Company Profiles

• 16.1 ArisGlobal LLC
  • 16.1.1 Key Facts
  • 16.1.2 Business Description
  • 16.1.3 Products and Services
  • 16.1.4 Financial Overview
  • 16.1.5 SWOT Analysis
  • 16.1.6 Key Developments
• 16.2 Max Application
  • 16.2.1 Key Facts
  • 16.2.2 Business Description
  • 16.2.3 Products and Services
  • 16.2.4 Financial Overview
  • 16.2.5 SWOT Analysis
  • 16.2.6 Key Developments
• 16.3 Oracle Corp
  • 16.3.1 Key Facts
  • 16.3.2 Business Description
  • 16.3.3 Products and Services
  • 16.3.4 Financial Overview
  • 16.3.5 SWOT Analysis
  • 16.3.6 Key Developments
• 16.4 Veeva Systems Inc
  • 16.4.1 Key Facts
  • 16.4.2 Business Description
  • 16.4.3 Products and Services
  • 16.4.4 Financial Overview
  • 16.4.5 SWOT Analysis
  • 16.4.6 Key Developments
• 16.5 IQVIA Holdings Inc
  • 16.5.1 Key Facts
  • 16.5.2 Business Description
  • 16.5.3 Products and Services
  • 16.5.4 Financial Overview
  • 16.5.5 SWOT Analysis
  • 16.5.6 Key Developments
• 16.6 ICON Plc
  • 16.6.1 Key Facts
  • 16.6.2 Business Description
  • 16.6.3 Products and Services
  • 16.6.4 Financial Overview
  • 16.6.5 SWOT Analysis
  • 16.6.6 Key Developments
• 16.7 Cognizant Technology Solutions Corp
  • 16.7.1 Key Facts
  • 16.7.2 Business Description
  • 16.7.3 Products and Services
  • 16.7.4 Financial Overview
  • 16.7.5 SWOT Analysis
  • 16.7.6 Key Developments
• 16.8 Accenture Plc
  • 16.8.1 Key Facts
  • 16.8.2 Business Description
  • 16.8.3 Products and Services
  • 16.8.4 Financial Overview
  • 16.8.5 SWOT Analysis
  • 16.8.6 Key Developments
• 16.9 Syneos Health Inc
  • 16.9.1 Key Facts
  • 16.9.2 Business Description
  • 16.9.3 Products and Services
  • 16.9.4 Financial Overview
  • 16.9.5 SWOT Analysis
  • 16.9.6 Key Developments
• 16.10 Genpact Ltd.
  • 16.10.1 Key Facts
  • 16.10.2 Business Description
  • 16.10.3 Products and Services
  • 16.10.4 Financial Overview
  • 16.10.5 SWOT Analysis
  • 16.10.6 Key Developments
• 16.11 AB Cube S.A.S.
  • 16.11.1 Key Facts
  • 16.11.2 Business Description
  • 16.11.3 Products and Services
  • 16.11.4 Financial Overview
  • 16.11.5 SWOT Analysis
  • 16.11.6 Key Developments
• 16.12 Laboratory Corp of America Holdings
  • 16.12.1 Key Facts
  • 16.12.2 Business Description
  • 16.12.3 Products and Services
  • 16.12.4 Financial Overview
  • 16.12.5 SWOT Analysis
  • 16.12.6 Key Developments
• 16.13 Parexel International Corp
  • 16.13.1 Key Facts
  • 16.13.2 Business Description
  • 16.13.3 Products and Services
  • 16.13.4 Financial Overview
  • 16.13.5 SWOT Analysis
  • 16.13.6 Key Developments
• 16.14 Qinecsa Solutions
  • 16.14.1 Key Facts
  • 16.14.2 Business Description
  • 16.14.3 Products and Services
  • 16.14.4 Financial Overview
  • 16.14.5 SWOT Analysis
  • 16.14.6 Key Developments
• 16.15 Clinevo Technologies
  • 16.15.1 Key Facts
  • 16.15.2 Business Description
  • 16.15.3 Products and Services
  • 16.15.4 Financial Overview
  • 16.15.5 SWOT Analysis
  • 16.15.6 Key Developments

17. Appendix

• 17.1 About Us
• 17.2 List of Abbreviations