약물감시(PV) 시장 분석 및 예측(-2035년) : 유형, 제품, 서비스, 기술, 구성 요소, 용도, 프로세스, 전개, 최종 사용자, 솔루션별

The global Pharmacovigilance (PV) market is projected to grow from $8.9 billion in 2025 to $15.1 billion by 2035, at a compound annual growth rate (CAGR) of 5.6%. The Pharmacovigilance (PV) Market is moderately consolidated, with spontaneous reporting remaining the leading surveillance method due to widespread regulatory adoption, while cohort event monitoring and targeted spontaneous reporting continue to expand for active safety surveillance. The market is witnessing growing adoption of AI-enabled pharmacovigilance platforms, cloud-based safety databases, and outsourced drug safety services to improve adverse event detection and regulatory compliance. Strategic collaborations are accelerating digital transformation across pharmacovigilance operations. For instance, in January 2025, IQVIA announced a strategic collaboration with NVIDIA to advance Healthcare-grade AI and automate complex pharmacovigilance, clinical, and medical safety workflows across the drug lifecycle, strengthening AI-driven drug safety capabilities.

Based on Product, the Services segment dominated the Pharmacovigilance Market in 2025 due to the increasing outsourcing of drug safety operations by pharmaceutical and biotechnology companies to specialized pharmacovigilance service providers. Services such as adverse event case processing, medical review, aggregate reporting, signal detection, risk management, and regulatory compliance are widely outsourced to improve operational efficiency, reduce costs, and ensure compliance with evolving global regulations. The growing number of clinical trials, increasing approvals of complex biologics and specialty drugs, and rising post-marketing surveillance requirements have further strengthened demand for pharmacovigilance services. Additionally, the expansion of global CROs and business process outsourcing providers continues to support the segment's market leadership.

Based on Technology, the AI-based segment is projected to register the fastest growth during the forecast period owing to the increasing adoption of artificial intelligence and machine learning technologies to automate pharmacovigilance workflows and improve drug safety monitoring. AI-based solutions enable faster adverse event case processing, intelligent signal detection, literature screening, duplicate identification, and regulatory reporting while reducing manual workload and operational costs. Pharmaceutical companies are increasingly deploying AI to manage growing volumes of real-world evidence and adverse event data with greater accuracy and speed. Rising investments in digital pharmacovigilance platforms, expanding use of predictive analytics, and increasing regulatory acceptance of AI-enabled safety monitoring are expected to accelerate segment growth throughout the forecast period.

Geographical Overview

North America dominated the Pharmacovigilance Market in 2025, supported by the presence of leading pharmaceutical and biotechnology companies, stringent drug safety regulations, and advanced healthcare infrastructure. The United States accounts for the largest regional share due to extensive clinical research activities, high volumes of drug approvals, and mandatory post-marketing surveillance requirements enforced by regulatory agencies. The widespread adoption of AI-enabled pharmacovigilance platforms, increasing outsourcing of drug safety operations, and strong presence of global contract research organizations (CROs) further strengthen the region's leadership. Canada also contributes through expanding pharmaceutical research, regulatory compliance initiatives, and investments in digital healthcare technologies.

Asia-Pacific is projected to register the fastest growth during the forecast period, driven by expanding pharmaceutical manufacturing, increasing clinical trial activity, and rising outsourcing of pharmacovigilance services to cost-efficient markets. Countries such as India, China, Japan, and South Korea are investing heavily in drug development, regulatory modernization, and digital healthcare infrastructure, creating strong demand for advanced pharmacovigilance solutions. Growing adoption of cloud-based drug safety platforms, increasing biologics and biosimilar development, rising regulatory reporting requirements, and the rapid expansion of contract research organizations (CROs) are expected to accelerate market growth across the region.

Key Trends and Drivers

Increasing Adoption of AI-Driven Pharmacovigilance Platforms:

The pharmacovigilance market is witnessing rapid adoption of artificial intelligence (AI), machine learning, and cloud-based technologies to automate adverse event case processing, signal detection, literature screening, and regulatory reporting. AI-powered pharmacovigilance platforms improve the speed, accuracy, and consistency of drug safety monitoring while reducing manual effort and operational costs. Pharmaceutical companies and contract research organizations (CROs) are increasingly integrating predictive analytics and real-world data into pharmacovigilance workflows to strengthen risk assessment and regulatory compliance. Growing digital transformation initiatives and rising investments in intelligent drug safety platforms are accelerating the adoption of AI-enabled pharmacovigilance solutions globally.

Growing Regulatory Focus on Drug Safety and Post-Marketing Surveillance:

The pharmacovigilance market is primarily driven by increasingly stringent global regulatory requirements for continuous drug safety monitoring throughout the product lifecycle. Regulatory authorities such as the FDA, EMA, MHRA, and PMDA are strengthening adverse event reporting, signal detection, and risk management requirements to improve patient safety. Rising approvals of complex biologics, specialty drugs, biosimilars, and advanced therapies are generating larger volumes of safety data, increasing the need for efficient pharmacovigilance systems. Furthermore, expanding clinical trials, growing outsourcing of pharmacovigilance services, and increasing adoption of risk-based regulatory frameworks continue to drive sustained demand for advanced drug safety solutions worldwide.

Research Scope

• Estimates and forecasts the overall market size across type, application, and region.
• Provides detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling.
• Identifies factors influencing market growth and challenges, opportunities, drivers, and restraints.
• Identifies factors that could limit company participation in international markets to help calibrate market share expectations and growth rates.
• Evaluates key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities.
• Analyzes smaller market segments strategically, focusing on their potential, growth patterns, and impact on the overall market.
• Outlines the competitive landscape, assessing business and corporate strategies to monitor and dissect competitive advancements.

Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.

TABLE OF CONTENTS

1 Executive Summary

• 1.1 Market Size and Forecast
• 1.2 Market Overview
• 1.3 Market Snapshot
• 1.4 Regional Snapshot
• 1.5 Strategic Recommendations
• 1.6 Analyst Notes

2 Market Highlights

• 2.1 Key Market Highlights by Type
• 2.2 Key Market Highlights by Product
• 2.3 Key Market Highlights by Services
• 2.4 Key Market Highlights by Technology
• 2.5 Key Market Highlights by Component
• 2.6 Key Market Highlights by Application
• 2.7 Key Market Highlights by Process
• 2.8 Key Market Highlights by End User
• 2.9 Key Market Highlights by Deployment
• 2.10 Key Market Highlights by Solutions

3 Market Dynamics

• 3.1 Macroeconomic Analysis
• 3.2 Market Trends
• 3.3 Market Drivers
• 3.4 Market Opportunities
• 3.5 Market Restraints
• 3.6 CAGR Growth Analysis
• 3.7 Impact Analysis
• 3.8 Emerging Markets
• 3.9 Technology Roadmap
• 3.10 Strategic Frameworks
  • 3.10.1 PORTER's 5 Forces Model
  • 3.10.2 ANSOFF Matrix
  • 3.10.3 4P's Model
  • 3.10.4 PESTEL Analysis

4 Segment Analysis

• 4.1 Market Size & Forecast by Type (2020-2035)
  • 4.1.1 Spontaneous Reporting
  • 4.1.2 Intensified ADR Reporting
  • 4.1.3 Targeted Spontaneous Reporting
  • 4.1.4 Cohort Event Monitoring
  • 4.1.5 EHR Mining
  • 4.1.6 Others
• 4.2 Market Size & Forecast by Product (2020-2035)
  • 4.2.1 Software
  • 4.2.2 Services
  • 4.2.3 Others
• 4.3 Market Size & Forecast by Services (2020-2035)
  • 4.3.1 Contract Outsourcing
  • 4.3.2 In-house
  • 4.3.3 Others
• 4.4 Market Size & Forecast by Technology (2020-2035)
  • 4.4.1 AI-based
  • 4.4.2 Cloud-based
  • 4.4.3 On-premise
  • 4.4.4 Big Data
  • 4.4.5 Others
• 4.5 Market Size & Forecast by Component (2020-2035)
  • 4.5.1 Software
  • 4.5.2 Hardware
  • 4.5.3 Others
• 4.6 Market Size & Forecast by Application (2020-2035)
  • 4.6.1 Pharmaceuticals
  • 4.6.2 Biotechnology
  • 4.6.3 Medical Devices
  • 4.6.4 Others
• 4.7 Market Size & Forecast by Process (2020-2035)
  • 4.7.1 Case Data Management
  • 4.7.2 Signal Detection
  • 4.7.3 Risk Management
  • 4.7.4 Others
• 4.8 Market Size & Forecast by End User (2020-2035)
  • 4.8.1 Pharmaceutical Companies
  • 4.8.2 Biotechnology Companies
  • 4.8.3 Contract Research Organizations
  • 4.8.4 Others
• 4.9 Market Size & Forecast by Deployment (2020-2035)
  • 4.9.1 On-premise
  • 4.9.2 Cloud
  • 4.9.3 Hybrid
  • 4.9.4 Others
• 4.10 Market Size & Forecast by Solutions (2020-2035)
  • 4.10.1 Adverse Event Reporting
  • 4.10.2 Drug Safety Audits
  • 4.10.3 Risk Management Systems
  • 4.10.4 Others

5 Regional Analysis

• 5.1 Global Market Overview
• 5.2 North America Market Size (2020-2035)
  • 5.2.1 United States
    • 5.2.1.1 Type
    • 5.2.1.2 Product
    • 5.2.1.3 Services
    • 5.2.1.4 Technology
    • 5.2.1.5 Component
    • 5.2.1.6 Application
    • 5.2.1.7 Process
    • 5.2.1.8 End User
    • 5.2.1.9 Deployment
    • 5.2.1.10 Solutions
  • 5.2.2 Canada
    • 5.2.2.1 Type
    • 5.2.2.2 Product
    • 5.2.2.3 Services
    • 5.2.2.4 Technology
    • 5.2.2.5 Component
    • 5.2.2.6 Application
    • 5.2.2.7 Process
    • 5.2.2.8 End User
    • 5.2.2.9 Deployment
    • 5.2.2.10 Solutions
  • 5.2.3 Mexico
    • 5.2.3.1 Type
    • 5.2.3.2 Product
    • 5.2.3.3 Services
    • 5.2.3.4 Technology
    • 5.2.3.5 Component
    • 5.2.3.6 Application
    • 5.2.3.7 Process
    • 5.2.3.8 End User
    • 5.2.3.9 Deployment
    • 5.2.3.10 Solutions
• 5.3 Latin America Market Size (2020-2035)
  • 5.3.1 Brazil
    • 5.3.1.1 Type
    • 5.3.1.2 Product
    • 5.3.1.3 Services
    • 5.3.1.4 Technology
    • 5.3.1.5 Component
    • 5.3.1.6 Application
    • 5.3.1.7 Process
    • 5.3.1.8 End User
    • 5.3.1.9 Deployment
    • 5.3.1.10 Solutions
  • 5.3.2 Argentina
    • 5.3.2.1 Type
    • 5.3.2.2 Product
    • 5.3.2.3 Services
    • 5.3.2.4 Technology
    • 5.3.2.5 Component
    • 5.3.2.6 Application
    • 5.3.2.7 Process
    • 5.3.2.8 End User
    • 5.3.2.9 Deployment
    • 5.3.2.10 Solutions
  • 5.3.3 Rest of Latin America
    • 5.3.3.1 Type
    • 5.3.3.2 Product
    • 5.3.3.3 Services
    • 5.3.3.4 Technology
    • 5.3.3.5 Component
    • 5.3.3.6 Application
    • 5.3.3.7 Process
    • 5.3.3.8 End User
    • 5.3.3.9 Deployment
    • 5.3.3.10 Solutions
• 5.4 Asia-Pacific Market Size (2020-2035)
  • 5.4.1 China
    • 5.4.1.1 Type
    • 5.4.1.2 Product
    • 5.4.1.3 Services
    • 5.4.1.4 Technology
    • 5.4.1.5 Component
    • 5.4.1.6 Application
    • 5.4.1.7 Process
    • 5.4.1.8 End User
    • 5.4.1.9 Deployment
    • 5.4.1.10 Solutions
  • 5.4.2 India
    • 5.4.2.1 Type
    • 5.4.2.2 Product
    • 5.4.2.3 Services
    • 5.4.2.4 Technology
    • 5.4.2.5 Component
    • 5.4.2.6 Application
    • 5.4.2.7 Process
    • 5.4.2.8 End User
    • 5.4.2.9 Deployment
    • 5.4.2.10 Solutions
  • 5.4.3 South Korea
    • 5.4.3.1 Type
    • 5.4.3.2 Product
    • 5.4.3.3 Services
    • 5.4.3.4 Technology
    • 5.4.3.5 Component
    • 5.4.3.6 Application
    • 5.4.3.7 Process
    • 5.4.3.8 End User
    • 5.4.3.9 Deployment
    • 5.4.3.10 Solutions
  • 5.4.4 Japan
    • 5.4.4.1 Type
    • 5.4.4.2 Product
    • 5.4.4.3 Services
    • 5.4.4.4 Technology
    • 5.4.4.5 Component
    • 5.4.4.6 Application
    • 5.4.4.7 Process
    • 5.4.4.8 End User
    • 5.4.4.9 Deployment
    • 5.4.4.10 Solutions
  • 5.4.5 Australia
    • 5.4.5.1 Type
    • 5.4.5.2 Product
    • 5.4.5.3 Services
    • 5.4.5.4 Technology
    • 5.4.5.5 Component
    • 5.4.5.6 Application
    • 5.4.5.7 Process
    • 5.4.5.8 End User
    • 5.4.5.9 Deployment
    • 5.4.5.10 Solutions
  • 5.4.6 Taiwan
    • 5.4.6.1 Type
    • 5.4.6.2 Product
    • 5.4.6.3 Services
    • 5.4.6.4 Technology
    • 5.4.6.5 Component
    • 5.4.6.6 Application
    • 5.4.6.7 Process
    • 5.4.6.8 End User
    • 5.4.6.9 Deployment
    • 5.4.6.10 Solutions
  • 5.4.7 Rest of APAC
    • 5.4.7.1 Type
    • 5.4.7.2 Product
    • 5.4.7.3 Services
    • 5.4.7.4 Technology
    • 5.4.7.5 Component
    • 5.4.7.6 Application
    • 5.4.7.7 Process
    • 5.4.7.8 End User
    • 5.4.7.9 Deployment
    • 5.4.7.10 Solutions
• 5.5 Europe Market Size (2020-2035)
  • 5.5.1 Germany
    • 5.5.1.1 Type
    • 5.5.1.2 Product
    • 5.5.1.3 Services
    • 5.5.1.4 Technology
    • 5.5.1.5 Component
    • 5.5.1.6 Application
    • 5.5.1.7 Process
    • 5.5.1.8 End User
    • 5.5.1.9 Deployment
    • 5.5.1.10 Solutions
  • 5.5.2 France
    • 5.5.2.1 Type
    • 5.5.2.2 Product
    • 5.5.2.3 Services
    • 5.5.2.4 Technology
    • 5.5.2.5 Component
    • 5.5.2.6 Application
    • 5.5.2.7 Process
    • 5.5.2.8 End User
    • 5.5.2.9 Deployment
    • 5.5.2.10 Solutions
  • 5.5.3 United Kingdom
    • 5.5.3.1 Type
    • 5.5.3.2 Product
    • 5.5.3.3 Services
    • 5.5.3.4 Technology
    • 5.5.3.5 Component
    • 5.5.3.6 Application
    • 5.5.3.7 Process
    • 5.5.3.8 End User
    • 5.5.3.9 Deployment
    • 5.5.3.10 Solutions
  • 5.5.4 Spain
    • 5.5.4.1 Type
    • 5.5.4.2 Product
    • 5.5.4.3 Services
    • 5.5.4.4 Technology
    • 5.5.4.5 Component
    • 5.5.4.6 Application
    • 5.5.4.7 Process
    • 5.5.4.8 End User
    • 5.5.4.9 Deployment
    • 5.5.4.10 Solutions
  • 5.5.5 Italy
    • 5.5.5.1 Type
    • 5.5.5.2 Product
    • 5.5.5.3 Services
    • 5.5.5.4 Technology
    • 5.5.5.5 Component
    • 5.5.5.6 Application
    • 5.5.5.7 Process
    • 5.5.5.8 End User
    • 5.5.5.9 Deployment
    • 5.5.5.10 Solutions
  • 5.5.6 Rest of Europe
    • 5.5.6.1 Type
    • 5.5.6.2 Product
    • 5.5.6.3 Services
    • 5.5.6.4 Technology
    • 5.5.6.5 Component
    • 5.5.6.6 Application
    • 5.5.6.7 Process
    • 5.5.6.8 End User
    • 5.5.6.9 Deployment
    • 5.5.6.10 Solutions
• 5.6 Middle East & Africa Market Size (2020-2035)
  • 5.6.1 Saudi Arabia
    • 5.6.1.1 Type
    • 5.6.1.2 Product
    • 5.6.1.3 Services
    • 5.6.1.4 Technology
    • 5.6.1.5 Component
    • 5.6.1.6 Application
    • 5.6.1.7 Process
    • 5.6.1.8 End User
    • 5.6.1.9 Deployment
    • 5.6.1.10 Solutions
  • 5.6.2 United Arab Emirates
    • 5.6.2.1 Type
    • 5.6.2.2 Product
    • 5.6.2.3 Services
    • 5.6.2.4 Technology
    • 5.6.2.5 Component
    • 5.6.2.6 Application
    • 5.6.2.7 Process
    • 5.6.2.8 End User
    • 5.6.2.9 Deployment
    • 5.6.2.10 Solutions
  • 5.6.3 South Africa
    • 5.6.3.1 Type
    • 5.6.3.2 Product
    • 5.6.3.3 Services
    • 5.6.3.4 Technology
    • 5.6.3.5 Component
    • 5.6.3.6 Application
    • 5.6.3.7 Process
    • 5.6.3.8 End User
    • 5.6.3.9 Deployment
    • 5.6.3.10 Solutions
  • 5.6.4 Sub-Saharan Africa
    • 5.6.4.1 Type
    • 5.6.4.2 Product
    • 5.6.4.3 Services
    • 5.6.4.4 Technology
    • 5.6.4.5 Component
    • 5.6.4.6 Application
    • 5.6.4.7 Process
    • 5.6.4.8 End User
    • 5.6.4.9 Deployment
    • 5.6.4.10 Solutions
  • 5.6.5 Rest of MEA
    • 5.6.5.1 Type
    • 5.6.5.2 Product
    • 5.6.5.3 Services
    • 5.6.5.4 Technology
    • 5.6.5.5 Component
    • 5.6.5.6 Application
    • 5.6.5.7 Process
    • 5.6.5.8 End User
    • 5.6.5.9 Deployment
    • 5.6.5.10 Solutions

6 Market Strategy

• 6.1 Demand-Supply Gap Analysis
• 6.2 Trade & Logistics Constraints
• 6.3 Price-Cost-Margin Trends
• 6.4 Market Penetration
• 6.5 Consumer Analysis
• 6.6 Regulatory Snapshot

7 Competitive Intelligence

• 7.1 Market Positioning
• 7.2 Market Share
• 7.3 Competition Benchmarking
• 7.4 Top Company Strategies

8 Company Profiles

• 8.1 IQVIA
  • 8.1.1 Overview
  • 8.1.2 Product Summary
  • 8.1.3 Financial Performance
  • 8.1.4 SWOT Analysis
• 8.2 Parexel
  • 8.2.1 Overview
  • 8.2.2 Product Summary
  • 8.2.3 Financial Performance
  • 8.2.4 SWOT Analysis
• 8.3 Covance
  • 8.3.1 Overview
  • 8.3.2 Product Summary
  • 8.3.3 Financial Performance
  • 8.3.4 SWOT Analysis
• 8.4 PPD
  • 8.4.1 Overview
  • 8.4.2 Product Summary
  • 8.4.3 Financial Performance
  • 8.4.4 SWOT Analysis
• 8.5 ICON plc
  • 8.5.1 Overview
  • 8.5.2 Product Summary
  • 8.5.3 Financial Performance
  • 8.5.4 SWOT Analysis
• 8.6 Syneos Health
  • 8.6.1 Overview
  • 8.6.2 Product Summary
  • 8.6.3 Financial Performance
  • 8.6.4 SWOT Analysis
• 8.7 Pharm-Olam
  • 8.7.1 Overview
  • 8.7.2 Product Summary
  • 8.7.3 Financial Performance
  • 8.7.4 SWOT Analysis
• 8.8 PRA Health Sciences
  • 8.8.1 Overview
  • 8.8.2 Product Summary
  • 8.8.3 Financial Performance
  • 8.8.4 SWOT Analysis
• 8.9 Medpace
  • 8.9.1 Overview
  • 8.9.2 Product Summary
  • 8.9.3 Financial Performance
  • 8.9.4 SWOT Analysis
• 8.10 Charles River Laboratories
  • 8.10.1 Overview
  • 8.10.2 Product Summary
  • 8.10.3 Financial Performance
  • 8.10.4 SWOT Analysis
• 8.11 Wuxi AppTec
  • 8.11.1 Overview
  • 8.11.2 Product Summary
  • 8.11.3 Financial Performance
  • 8.11.4 SWOT Analysis
• 8.12 Labcorp Drug Development
  • 8.12.1 Overview
  • 8.12.2 Product Summary
  • 8.12.3 Financial Performance
  • 8.12.4 SWOT Analysis
• 8.13 Genpact
  • 8.13.1 Overview
  • 8.13.2 Product Summary
  • 8.13.3 Financial Performance
  • 8.13.4 SWOT Analysis
• 8.14 Accenture
  • 8.14.1 Overview
  • 8.14.2 Product Summary
  • 8.14.3 Financial Performance
  • 8.14.4 SWOT Analysis
• 8.15 Cognizant
  • 8.15.1 Overview
  • 8.15.2 Product Summary
  • 8.15.3 Financial Performance
  • 8.15.4 SWOT Analysis
• 8.16 Tata Consultancy Services
  • 8.16.1 Overview
  • 8.16.2 Product Summary
  • 8.16.3 Financial Performance
  • 8.16.4 SWOT Analysis
• 8.17 Infosys
  • 8.17.1 Overview
  • 8.17.2 Product Summary
  • 8.17.3 Financial Performance
  • 8.17.4 SWOT Analysis
• 8.18 Oracle
  • 8.18.1 Overview
  • 8.18.2 Product Summary
  • 8.18.3 Financial Performance
  • 8.18.4 SWOT Analysis
• 8.19 ArisGlobal
  • 8.19.1 Overview
  • 8.19.2 Product Summary
  • 8.19.3 Financial Performance
  • 8.19.4 SWOT Analysis
• 8.20 BioClinica
  • 8.20.1 Overview
  • 8.20.2 Product Summary
  • 8.20.3 Financial Performance
  • 8.20.4 SWOT Analysis

9 About Us

• 9.1 About Us
• 9.2 Research Methodology
• 9.3 Research Workflow
• 9.4 Consulting Services
• 9.5 Our Clients
• 9.6 Client Testimonials
• 9.7 Contact Us