약물감시(Pharmacovigilance) 시장 규모, 점유율, 예측 및 동향 분석 : 제품별, 단계별, 치료 영역별, 최종 사용자별 - 세계 전망(-2031년)

Pharmacovigilance Market Size, Share, Forecast, & Trends Analysis by Offering (Software [Adverse Event Reporting, Issue Tracking, Drug Safety Audit], Services [Spontaneous Reporting, Case Logging]), Phase, Therapeutic Area, End User-Global Forecast to 2031

The pharmacovigilance market is projected to reach $18.05 billion by 2031 at a CAGR of 10.7% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the pharmacovigilance market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. The growth of the pharmacovigilance market is mainly driven by the rising incidence of drug toxicity, stringent regulatory frameworks, increasing pharmaceutical research spending, rising need for new drug development, and the increasing focus on medical device safety. However, the high costs of pharmacovigilance services limit their adoption among small & mid-sized companies, restraining the growth of this market.

Furthermore, the introduction of technologically advanced software, growing awareness regarding adverse drug reactions, therapeutic approaches requiring a combination of drugs, and the increasing outsourcing of pharmacovigilance services are expected to generate growth opportunities for the stakeholders in this market. However, data security risks and the shortage of skilled pharmacovigilance professionals pose major challenges for market growth.

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over four years (2020-2024). The key players operating in the pharmacovigilance market are IQVIA (U.S.), Cognizant Technology Solutions Corporation (U.S.), Linical Co., Ltd (U.S.), International Business Machines Corporation (U.S.), Laboratory Corporation of America Holdings (U.S.), ICON plc (Ireland), Parexel International (U.S.), Wipro Limited (India), Sanofi S.A. (France), Pharmaceutical Product Development Inc. (a subsidiary of Thermo Fisher Scientific Inc.) (U.S.), Capgemini SE (France), Syneos Health (U.S.), ArisGlobal (U.S.), Ennov (France), EXTEDO GmbH (Germany), Oracle Corporation (U.S.), Sparta Systems Inc. (U.S.), United BioSource, LLC (UBC) (U.S.), and AB Cube S.A.S. (France).

Based on offering, in 2024, the services segment is expected to account for the largest share of over 97.6% of the pharmacovigilance market. The services segment is further segmented into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, EHR mining, and other services based on type. The increasing number of molecules in clinical development and the growing importance of drug safety are driving the outsourcing of pharmacovigilance services. Additionally, the need for regulatory compliance, rising drug complexity, globalization of clinical trials, and increasing awareness about drug safety are further contributing to the segment's growth.

Based on drug development phase, the Phase IV segment is projected to witness the highest growth rate during the forecast period 2024-2031. The study design and sample sizes are larger and more complex in Phase IV as the drug is tested post-approval; hence, the demand for pharmacovigilance services is higher in Phase IV due to the need for efficient management and data analysis. Additionally, the high complexity of Phase IV is increasing the adoption of pharmacovigilance services for the efficient management of clinical trials.

Based on therapeutic area, in 2024, the oncology segment is expected to account for the largest share of the pharmacovigilance market. According to GLOBOCAN, the prevalence of cancer is expected to reach 32.64 million in 2045 from 19.98 million in 2022. The rising prevalence of cancer is increasing the demand for newer therapies and drugs, driving the adoption of pharmacovigilance software and services. Additionally, the availability of funding for oncology, life sciences & healthcare research, the increasing demand for personalized therapies, and the high cancer incidence necessitating newer therapies to be launched in the market are contributing to segment growth.

Based on end user, in 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the pharmacovigilance market. The large market share of this segment is attributed to the increasing R&D investments by pharmaceutical & biotechnology companies and rising funding for pharmaceutical research. Additionally, changing regulations across the pharmaceutical industry are increasing the adoption of pharmacovigilance tools to support regulatory submissions for drug approval, timely & accurate reporting of ADRs, and ensuring compliance with changing regulatory requirements.

An in-depth analysis of the geographical scenario of the global pharmacovigilance market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region.

In 2024, North America is expected to account for the largest share of over 44.3% of the pharmacovigilance market. The large share of the regional market is attributed to the presence of key players, advanced infrastructure and resources supporting research & development, the large number of clinical trials and drug approvals, and increased reporting of adverse drug events in the region.

Scope of the Report:

Pharmacovigilance Market Assessment-by Offering

• Software
  • Software, by Deployment Mode
• On-premise
• Cloud-based
  • Software, by Functionality
• Issue Tracking Software
• Adverse Event Reporting Software
• Fully Integrated Software
• Drug Safety Audit Software
• Other Functionalities
• Services
  • Services, by Service Provider
• In-house
• Contract Outsourcing
  • Services, by Type
• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining
• Other Services
  • Services, by Process
• Core Services
• Consulting Services
  • Services, by Process Outflow
• Case Data Management
• Case Logging
• Case Data Analysis
• Medical Review & Reporting
• Signal Detection
• Adverse Event Logging
• Adverse Event Analysis
• Adverse Event Review & Reporting
• Risk Management System
• Risk Evaluation System
• Risk Mitigation System

Note: Other Functionalities comprise reporting and analytics, case management, and signal management.

Note: Other Services comprise case processing, signal management, regulatory intelligence, and consulting services.

Pharmacovigilance Market Assessment-by Drug Development Phase

• Phase IV
• Phase III
• Phase II
• Phase I
• Preclinical Studies

Pharmacovigilance Market Assessment-by Therapeutic Area

• Oncology
• Cardiology/Vascular Diseases
• Infectious Diseases
• Immunology
• Neurology
• Other Therapeutic Areas

Pharmacovigilance Market Assessment-by End User

• Pharmaceutical & Biotechnology Companies
• Medical Device Manufacturers
• Government Agencies
• Other End Users

Note: Other End Users comprise CROs and BPOs.

Pharmacovigilance Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K
  • Italy
  • Spain
  • Belgium
  • Netherlands
  • Sweden
  • Denmark
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Data Collection & Validation Process
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders from the Industry
• 2.3. Market Sizing & Forecasting
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Drivers
  • 4.2.1. Rising Incidence of Drug Toxicity
  • 4.2.2. Stringent Regulatory Frameworks
  • 4.2.3. Increasing Pharmaceutical Research Spending
  • 4.2.4. Rising Need for the Development of New Drugs
  • 4.2.5. Growing Focus on Medical Device Safety
• 4.3. Restraints
  • 4.3.1. High Costs of Pharmacovigilance Services
• 4.4. Opportunities
  • 4.4.1. Introduction of Technologically Advanced Software
  • 4.4.2 Growing Awareness Regarding the Reporting of Adverse Drug Reactions
  • 4.4.3. Therapeutic Approaches Requiring Drug Combinations
  • 4.4.4. Increasing Outsourcing of Pharmacovigilance Services
• 4.5. Challenges
  • 4.5.1. Data Security Risks
  • 4.5.2. Shortage of Skilled Pharmacovigilance Professionals
• 4.6. Factor Analysis
• 4.7. Trends
• 4.8. Regulatory Analysis
• 4.9. Porter's Five Force Analysis

5. Pharmacovigilance Market Assessment-by Offering

• 5.1. Overview
• 5.2. Software
  • 5.2.1. Software, by Deployment Mode
    • 5.2.1.1. On-premise
    • 5.2.1.2. Cloud-based
  • 5.2.2. Software, by Functionality
    • 5.2.2.1. Issue Tracking Software
    • 5.2.2.2. Adverse Event Reporting Software
    • 5.2.2.3. Fully Integrated Software
    • 5.2.2.4. Drug Safety Audit Software
    • 5.2.2.5. Other Functionalities
• 5.3. Services
  • 5.3.1. Services, by Service Provider
    • 5.3.1.1. In-house
    • 5.3.1.2. Contract Outsourcing
  • 5.3.2. Services, by Type
    • 5.3.2.1. Spontaneous Reporting
    • 5.3.2.2. Intensified ADR Reporting
    • 5.3.2.3. Targeted Spontaneous Reporting
    • 5.3.2.4. Cohort Event Monitoring
    • 5.3.2.5. EHR Mining
    • 5.3.2.6. Other Services
  • 5.3.3. Services, by process
    • 5.3.3.1. Core Services
    • 5.3.3.2. Consulting Services
  • 5.3.4. Services, by Process Outflow
    • 5.3.4.1. Case Data Management
      • 5.3.4.1.1. Case Logging
      • 5.3.4.1.2. Case Data Analysis
      • 5.3.4.1.3. Medical Review & Reporting
    • 5.3.4.2. Signal Detection
      • 5.3.4.2.1. Adverse Event Logging
      • 5.3.4.2.2. Adverse Event Analysis
      • 5.3.4.2.3. Adverse Event Review & Reporting
    • 5.3.4.3. Risk Management Systems
      • 5.3.4.3.1. Risk Evaluation Systems
      • 5.3.4.3.2. Risk Mitigation Systems

6. Pharmacovigilance Market Assessment-by Drug Development Phase

• 6.1. Overview
• 6.2. Phase IV
• 6.3. Phase III
• 6.4. Phase II
• 6.5. Phase I
• 6.6. Preclinical Studies

7. Pharmacovigilance Market Assessment-by Therapeutic Area

• 7.1. Oncology
• 7.2. Cardiology/Vascular Diseases
• 7.3. Infectious Diseases
• 7.4. Immunology
• 7.5. Neurology
• 7.6. Other Therapeutic Areas

8. Pharmacovigilance Market Assessment-by End User

• 8.1. Overview
• 8.2. Pharmaceutical & Biotechnology Companies
• 8.3. Medical Device Manufacturers
• 8.4. Government Agencies
• 8.5. Other End Users

9. Pharmacovigilance Market Assessment-by Geography

• 9.1. Overview
• 9.2. North America
  • 9.2.1. U.S.
  • 9.2.2. Canada
• 9.3. Europe
  • 9.3.1. Germany
  • 9.3.2. France
  • 9.3.3. U.K.
  • 9.3.4. Italy
  • 9.3.5. Spain
  • 9.3.6. Belgium
  • 9.3.7. Netherlands
  • 9.3.8. Denmark
  • 9.3.9. Sweden
  • 9.3.10. Rest of Europe (RoE)
• 9.4. Asia-Pacific
  • 9.4.1. Japan
  • 9.4.2. China
  • 9.4.3. India
  • 9.4.4. South Korea
  • 9.4.5. Australia
  • 9.4.6. Rest of Asia-Pacific (RoAPAC)
• 9.5. Latin America
  • 9.5.1. Brazil
  • 9.5.2. Mexico
  • 9.5.3. Rest of Latin America (RoLATAM)
• 9.6. Middle East & Africa

10. Competition Analysis

• 10.1. Overview
• 10.2. Key Growth Strategies
• 10.3. Competitive Benchmarking
• 10.4. Competitive Dashboard
  • 10.4.1. Industry Leaders
  • 10.4.2. Market Differentiators
  • 10.4.3. Vanguards
  • 10.4.4. Emerging Companies
• 10.5. Market Share Analysis/Market Rankings of Key Players (2023)

11. Company Profiles (Company Overview, Financial Overview, Product Portfolio, Strategic Developments, and *SWOT Analysis)

• 11.1. IQVIA
• 11.2. Cognizant Technology Solutions Corporation
• 11.3. Linical Co., Ltd
• 11.4. International Business Machines Corporation
• 11.5. Laboratory Corporation of America Holdings
• 11.6. ICON plc
• 11.7. Parexel International
• 11.8. Wipro Limited
• 11.9. Sanofi S.A.
• 11.10 Pharmaceutical Product Development, Inc. (A Subsidiary of Thermo Fisher Scientific Inc.)
• 11.11. Capgemini SE
• 11.12. Syneos Health
• 11.13. ArisGlobal
• 11.14. Ennov
• 11.15. EXTEDO GmbH
• 11.16. Oracle Corporation
• 11.17. Sparta Systems Inc
• 11.18. United BioSource, LLC (UBC)
• 11.19. AB Cube S.A.S.

(Note: SWOT analysis will be provided for the top 5 companies.)

12. Appendix

• 12.1. Available Customization
• 12.2. Related Reports