약물감시 시장 : 시장 규모, 점유율 및 성장률, 산업 분석 - 유형별, 용도별, 지역별 인사이트 및 예측(2025-2034년)

Growth Factors of pharmacovigilance (PV) Market

The global pharmacovigilance (PV) market was valued at USD 9.35 billion in 2025 and is projected to reach USD 10.54 billion in 2026, eventually expanding to USD 31.56 billion by 2034, reflecting a CAGR of 14.69% during the forecast period. North America dominated the market in 2025 with a 40.84% share, driven by a strong pharmaceutical industry, high healthcare expenditure, advanced infrastructure, and a stringent regulatory environment. Key players in the market include IQVIA Inc., Laboratory Corporation of America Holdings, Accenture, Cognizant, Ergomed Group, Parexel International Corporation, ICON plc., and Quanticate, focusing on technological innovations, AI adoption, partnerships, and geographic expansion.

Pharmacovigilance involves monitoring, assessing, and preventing adverse drug reactions (ADRs) to ensure the safety and efficacy of medications. It spans preclinical, clinical, and post-marketing stages, collecting and analyzing data from healthcare providers, patients, and regulatory authorities. Increasing ADR reporting, rising drug launches, and investments in clinical trials are driving demand for PV services and software globally. For example, Australia reported 125,873 adverse event notifications in 2021-22, highlighting the need for robust drug safety monitoring.

Market Drivers

Rising ADR Awareness and Public Initiatives: Growing awareness among healthcare providers, patients, and governments has significantly fueled the market. Campaigns such as Uppsala Monitoring Centre's annual social media initiatives and MedSafety Week in 2023 educate the public about ADR reporting, leading to increased adoption of PV services.

Outsourcing Trend by Pharmaceutical Companies: Many pharmaceutical firms prefer outsourcing PV services to specialized providers to streamline operations, reduce costs, and access expert solutions. In 2024, ProPharma Group acquired Clinres Farmacija to expand post-marketing regulatory and PV services in Europe, reflecting this trend. Outsourcing enhances flexibility, regulatory compliance, and efficiency in monitoring marketed drugs.

Technological Innovations and AI Integration: Artificial intelligence is increasingly applied in PV for faster detection and assessment of adverse events. For instance, in April 2023, Parexel International collaborated with Partex to leverage AI-powered solutions in drug discovery and development, improving regulatory decision-making and workflow efficiency. AI adoption also helps PV professionals focus on value-added tasks, enhancing the overall efficacy of drug safety monitoring.

Market Restraints

Funding and Skilled Workforce Shortages: Despite high demand, limited funding and a shortage of trained PV professionals constrain market expansion, particularly in regions like Africa. Insufficient resources delay reporting, monitoring, and compliance with regulations, impacting market effectiveness.

Market Segmentation

By Type: The services segment dominated with a 91.43% share in 2026, driven by clinical trials, outsourcing trends, and the demand for post-marketing surveillance. The software segment is the fastest-growing, supported by automation, AI, cloud platforms, and collaborations, such as Accenture's 2022 cloud-based IT platform for Astellas Pharma.

By Deployment: The outsourced segment led in 2026 with 57.03% share, enabling pharmaceutical companies to adapt to evolving regulations efficiently and reduce operational costs. In-house operations remain significant but face challenges due to limited expertise and resources.

By End-User: Pharmaceutical & biotechnology companies accounted for 62.51% of the market in 2026, leveraging PV services for regulatory compliance and safety monitoring of new drugs. CROs represent the second-largest end-user segment, providing cost-effective clinical trial and safety solutions to pharmaceutical companies.

Regional Insights

• North America: Valued at USD 3.82 billion in 2025, projected USD 4.32 billion in 2026; dominance due to regulatory stringency, advanced PV services, and a strong pharmaceutical industry.
• Europe: Steady growth; UK projected at USD 0.62 billion, Germany at USD 0.58 billion in 2026, supported by ADR awareness and mergers/acquisitions, such as ProPharma's acquisition of a European PV company.
• Asia Pacific: Fastest-growing region; Japan USD 0.42 billion, China USD 0.57 billion, India USD 0.42 billion in 2026, fueled by awareness, regulatory support, and expansion of global players.
• Latin America & Middle East & Africa: Moderate growth expected due to improved healthcare infrastructure, rising R&D, and expansion of PV service providers.

Key Industry Players

Leading companies include IQVIA Inc., Laboratory Corporation of America Holdings, Parexel International Corporation, Accenture, Cognizant, Ergomed Group, Thermo Fisher Scientific, ICON plc., and Quanticate. Strategic initiatives such as Ergomed's acquisition of Panacea (2024) and Accenture's AI-driven collaboration with Salesforce (2023) enhance market presence and service capabilities.

Conclusion

The global pharmacovigilance market is expected to grow from USD 9.35 billion in 2025 to USD 31.56 billion by 2034, driven by increasing ADR reporting, pharmaceutical outsourcing trends, AI adoption, and growing clinical trials. North America leads the market, while Asia Pacific exhibits the fastest growth. Services dominate due to outsourcing and clinical demand, and software adoption is rising rapidly with technological innovation. Strategic collaborations, AI-powered platforms, and public awareness campaigns will continue to fuel market expansion, ensuring improved drug safety, regulatory compliance, and public health outcomes globally.

Segmentation By Type

• Service
• Software

By Deployment

• In-house
• Outsource

By End User

• Contract Research Organizations (CROs)
• Pharmaceutical & Biotechnology Companies
• Others

By Region

• North America (By Type, Deployment, End-User, and Country)
  • U.S. (By Type)
  • Canada (By Type)
• Europe (By Type, Deployment, End-User, and Country/Sub-Region)
  • Germany (By Type)
  • U.K. (By Type)
  • France (By Type)
  • Italy (By Type)
  • Spain (By Type)
  • Rest of Europe (By Type)
• Asia Pacific (By Type, Deployment, End-User, and Country/Sub-Region)
  • China (By Type)
  • Japan (By Type)
  • India (By Type)
  • Australia (By Type)
  • Southeast Asia (By Type)
  • Rest of Asia Pacific (By Type)
• Latin America (By Type, Deployment, End-User, and Country/Sub-Region)
  • Brazil (By Type)
  • Mexico (By Type)
  • Rest of Latin America (By Type)
• Middle East & Africa (By Type, Deployment, End-User, and Country/Sub-Region)
  • GCC (By Type)
  • South Africa (By Type)
• Rest of the Middle East & Africa (By Type)

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Snapshot of Rate of Adverse Drug Reactions - By Key Region/Countries
• 4.2. Regulatory Scenario in the Pharmacovigilance Industry
• 4.3. Overview of Government Initiatives in Safe Medicine Use
• 4.4. Key Industry Developments (Mergers, Acquisitions, Collaborations, etc.)
• 4.5. Impact of COVID-19 on the Market

5. Global Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Type
  • 5.1.1. Service
  • 5.1.2. Software
• 5.2. Market Analysis, Insights and Forecast - By Deployment
  • 5.2.1. In-house
  • 5.2.2. Outsource
• 5.3. Market Analysis, Insights and Forecast - By End User
  • 5.3.1. Contract Research Organizations (CROs)
  • 5.3.2. Pharmaceutical & Biotechnology Companies
  • 5.3.3. Others
• 5.4. Market Analysis, Insights and Forecast - By Region
  • 5.4.1. North America
  • 5.4.2. Europe
  • 5.4.3. Asia Pacific
  • 5.4.4. Latin America
  • 5.4.5. Middle East & Africa

6. North America Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Type
  • 6.1.1. Service
  • 6.1.2. Software
• 6.2. Market Analysis, Insights and Forecast - By Deployment
  • 6.2.1. In-house
  • 6.2.2. Outsource
• 6.3. Market Analysis, Insights and Forecast - By End User
  • 6.3.1. Contract Research Organizations (CROs)
  • 6.3.2. Pharmaceutical & Biotechnology Companies
  • 6.3.3. Others
• 6.4. Market Analysis, Insights and Forecast - By Country
  • 6.4.1. U.S.
    • 6.4.1.1. By Type
  • 6.4.2. Canada
    • 6.4.2.1. By Type

7. Europe Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Type
  • 7.1.1. Service
  • 7.1.2. Software
• 7.2. Market Analysis, Insights and Forecast - By Deployment
  • 7.2.1. In-house
  • 7.2.2. Outsource
• 7.3. Market Analysis, Insights and Forecast - By End User
  • 7.3.1. Contract Research Organizations (CROs)
  • 7.3.2. Pharmaceutical & Biotechnology Companies
  • 7.3.3. Others
• 7.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.4.1. Germany
    • 7.4.1.1. By Type
  • 7.4.2. U.K.
    • 7.4.2.1. By Type
  • 7.4.3. France
    • 7.4.3.1. By Type
  • 7.4.4. Italy
    • 7.4.4.1. By Type
  • 7.4.5. Spain
    • 7.4.5.1. By Type
  • 7.4.6. Rest of Europe
    • 7.4.6.1. By Type

8. Asia Pacific Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Type
  • 8.1.1. Service
  • 8.1.2. Software
• 8.2. Market Analysis, Insights and Forecast - By Deployment
  • 8.2.1. In-house
  • 8.2.2. Outsource
• 8.3. Market Analysis, Insights and Forecast - By End User
  • 8.3.1. Contract Research Organizations (CROs)
  • 8.3.2. Pharmaceutical & Biotechnology Companies
  • 8.3.3. Others
• 8.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.4.1. China
    • 8.4.1.1. By Type
  • 8.4.2. Japan
    • 8.4.2.1. By Type
  • 8.4.3. India
    • 8.4.3.1. By Type
  • 8.4.4. Australia
    • 8.4.4.1. By Type
  • 8.4.5. Southeast Asia
    • 8.4.5.1. By Type
  • 8.4.6. Rest of Asia Pacific
    • 8.4.6.1. By Type

9. Latin America Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Type
  • 9.1.1. Service
  • 9.1.2. Software
• 9.2. Market Analysis, Insights and Forecast - By Deployment
  • 9.2.1. In-house
  • 9.2.2. Outsource
• 9.3. Market Analysis, Insights and Forecast - By End User
  • 9.3.1. Contract Research Organizations (CROs)
  • 9.3.2. Pharmaceutical & Biotechnology Companies
  • 9.3.3. Others
• 9.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 9.4.1. Brazil
    • 9.4.1.1. By Type
  • 9.4.2. Mexico
    • 9.4.2.1. By Type
  • 9.4.3. Rest of Latin America
    • 9.4.3.1. By Type

10. Middle East & Africa Pharmacovigilance Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Type
  • 10.1.1. Service
  • 10.1.2. Software
• 10.2. Market Analysis, Insights and Forecast - By Deployment
  • 10.2.1. In-house
  • 10.2.2. Outsource
• 10.3. Market Analysis, Insights and Forecast - By End User
  • 10.3.1. Contract Research Organizations (CROs)
  • 10.3.2. Pharmaceutical & Biotechnology Companies
  • 10.3.3. Others
• 10.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 10.4.1. GCC
    • 10.4.1.1. By Type
  • 10.4.2. South Africa
    • 10.4.2.1. By Type
  • 10.4.3. Rest of Middle East & Africa
    • 10.4.3.1. By Type

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles
  • 11.2.1. IQVIA Inc.
    • 11.2.1.1. Overview
    • 11.2.1.2. Products & Services
    • 11.2.1.3. SWOT Analysis
    • 11.2.1.4. Recent Developments
    • 11.2.1.5. Strategies
    • 11.2.1.6. Financials (Based on Availability)
  • 11.2.2. Labcorp Drug Development
    • 11.2.2.1. Overview
    • 11.2.2.2. Products & Services
    • 11.2.2.3. SWOT Analysis
    • 11.2.2.4. Recent Developments
    • 11.2.2.5. Strategies
    • 11.2.2.6. Financials (Based on Availability)
  • 11.2.3. Parexel International Corporation
    • 11.2.3.1. Overview
    • 11.2.3.2. Products & Services
    • 11.2.3.3. SWOT Analysis
    • 11.2.3.4. Recent Developments
    • 11.2.3.5. Strategies
    • 11.2.3.6. Financials (Based on Availability)
  • 11.2.4. Accenture
    • 11.2.4.1. Overview
    • 11.2.4.2. Products & Services
    • 11.2.4.3. SWOT Analysis
    • 11.2.4.4. Recent Developments
    • 11.2.4.5. Strategies
    • 11.2.4.6. Financials (Based on Availability)
  • 11.2.5. Cognizant
    • 11.2.5.1. Overview
    • 11.2.5.2. Products & Services
    • 11.2.5.3. SWOT Analysis
    • 11.2.5.4. Recent Developments
    • 11.2.5.5. Strategies
    • 11.2.5.6. Financials (Based on Availability)
  • 11.2.6. Ergomed Group
    • 11.2.6.1. Overview
    • 11.2.6.2. Products & Services
    • 11.2.6.3. SWOT Analysis
    • 11.2.6.4. Recent Developments
    • 11.2.6.5. Strategies
    • 11.2.6.6. Financials (Based on Availability)
  • 11.2.7. Thermo Fisher Scientific Inc. (Pharmaceutical Product Development, LLC)
    • 11.2.7.1. Overview
    • 11.2.7.2. Products & Services
    • 11.2.7.3. SWOT Analysis
    • 11.2.7.4. Recent Developments
    • 11.2.7.5. Strategies
    • 11.2.7.6. Financials (Based on Availability)
  • 11.2.8. ICON plc.
    • 11.2.8.1. Overview
    • 11.2.8.2. Products & Services
    • 11.2.8.3. SWOT Analysis
    • 11.2.8.4. Recent Developments
    • 11.2.8.5. Strategies
    • 11.2.8.6. Financials (Based on Availability)
  • 11.2.9. Quanticate
    • 11.2.9.1. Overview
    • 11.2.9.2. Products & Services
    • 11.2.9.3. SWOT Analysis
    • 11.2.9.4. Recent Developments
    • 11.2.9.5. Strategies
    • 11.2.9.6. Financials (Based on Availability)