약물감시 및 안전성 시험 아웃소싱 서비스 시장 : 예측(-2030년)

A Growing Focus on Precision Medicine and a Converging Ecosystem of Service Providers is Driving Market Growth

The global pharmaceutical industry strives to build an inclusive partner ecosystem that integrates technology, data, and regulatory standardization-enabled innovation into clinical trial delivery. This transformation aims to reduce the burden on investigators and sites while improving the efficiency and accuracy of adverse event (AE) tracking. Driven by the growing volume of adverse event reports, diverse datasets from disparate sources, the advent of digital technologies and tools, and the need for patient inclusivity in safety monitoring and reporting is resulting in a 10.4% CAGR across the global PV and safety testing services market. The global pharmacovigilance and safety testing services market was valued at $6.92 billion in 2024 and is expected to reach $12.49 billion by 2030.

While the industry is seeing technology convergence through the advent of cloud-based technologies (apart from pure play tech vendors that act as key enablers for technology-enabled PV services), eClinical solution vendors have also developed unique PV platforms to support adverse event data capture. For CROs, pharmaceutical companies, and drug regulatory agencies, technology licensing is the go-to option for adopting these solutions, making these companies potential partners.

Across the various services, regulatory compliance is one of the most crucial activities across PV and safety testing. It ensures that pharmaceutical companies adhere to global safety standards for monitoring, reporting, and managing adverse drug reactions (ADRs), as well as the timely submission of Individual Case Safety Reports (ICSRs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs). Adverse event monitoring (characterized by detecting, assessing, understanding, and preventing adverse effects) is among the most outsourced activities across the PV and safety testing services landscape, considering a general rise in AE reports.

While the industry is dominated by CROs, pure-play PV vendors focused on specific services, including regulatory affairs, data management, and stakeholder interaction, are also playing a significant role in driving market growth. In this regard, almost two-thirds of pharma and life sciences companies are known to outsource PV services to either a single or multiple vendors. In addition to the pure-play vendors and CROs that primarily contribute to the market, technology companies such as TCS, Capgemini, Accenture, and Oracle have been playing a key role as tech enablers in not only supporting CROs and other companies in providing PV services to pharma clients, but they have also developed unique capabilities/platforms that allow them to directly partner with the pharma companies as PV service providers.

The report answers the following questions:

• What are the general industry trends pertaining to the pharmacovigilance and safety testing services industry?
• What are the key drivers triggering the large-scale outsourcing of these activities?
• Who are the leading players driving market growth?
• What are the most prevalent business models across this market?
• What is the opportunity for small to mid-segment CRO and pharma companies with respect to partnering with PV vendors to support post-market surveillance and other PV activities?

Report Summary: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

The global Pharmacovigilance and Safety Testing Outsourcing Services Market is undergoing rapid digital transformation, driven by increasing drug development complexity, stringent compliance mandates, and the integration of AI-based automation. Valued at USD 6.92 billion in 2024, the market is projected to reach USD 12.49 billion by 2030, growing at a CAGR of 10.4%.

The pharmacovigilance outsourcing market is increasingly shaped by the convergence of contract research organizations (CROs), pure-play pharmacovigilance vendors, and technology enablers offering AI-driven data analytics, real-time adverse event tracking, and predictive safety monitoring. Global pharmaceutical and biotechnology companies are outsourcing PV operations to enhance regulatory compliance, improve efficiency, and reduce costs.

Key Market Insights:

• Cloud-based PV platforms and automation tools are streamlining safety data collection and regulatory submissions.
• AI and NLP technologies are revolutionizing case processing, signal detection, and aggregate reporting.
• Over 65% of pharma companies have outsourced partial or complete PV functions.
• APAC leads as a high-growth hub (CAGR 16.7%) for cost-effective pharmacovigilance outsourcing services.
• Growing regulatory harmonization (FDA Sentinel, EMA PRAC reforms) supports market scalability.

As the global pharmacovigilance market transitions toward data-driven, technology-enabled operations, outsourcing partners capable of offering integrated, AI-powered, and compliance-ready solutions will gain a decisive competitive advantage.

Market Overview: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

The pharmacovigilance outsourcing market is experiencing unprecedented growth as the pharmaceutical industry builds an inclusive partner ecosystem that integrates technology, data management, and regulatory standardization to improve clinical safety operations. The global Pharmacovigilance and Safety Testing Outsourcing Services Market was valued at USD 6.92 billion in 2024 and is expected to reach USD 12.49 billion by 2030, supported by a 10.4% CAGR.

This transformation aims to reduce the burden on investigators and clinical sites while improving the accuracy of adverse event (AE) tracking and regulatory reporting. The surge in AE report volumes, the diversification of data sources, and the adoption of digital health platforms are fueling new investments in AI-powered pharmacovigilance tools and automated signal detection systems.

Technology Integration and Ecosystem Convergence:

The industry is witnessing technology convergence through the rise of cloud-based pharmacovigilance solutions and intelligent automation. Leading eClinical solution vendors have introduced specialized PV platforms to streamline adverse event data capture and regulatory submissions. Meanwhile, global technology firms-such as TCS, Accenture, Capgemini, and Oracle-have emerged as critical enablers in the Pharmacovigilance Outsourcing Market, offering data-driven compliance solutions and AI-enhanced risk management systems.

Service Landscape:

Among outsourced pharmacovigilance services, regulatory compliance remains the cornerstone, ensuring adherence to global safety standards for adverse drug reaction (ADR) monitoring, Individual Case Safety Reports (ICSRs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs). Adverse event monitoring-focusing on the detection, assessment, and prevention of AEs-is among the most outsourced functions in the pharmacovigilance market, given the rise in global drug development programs.

Outsourcing Dynamics:

The Pharmacovigilance and Safety Testing Outsourcing Services Market is primarily dominated by CROs, complemented by pure-play PV vendors specializing in regulatory submissions, case management, and stakeholder engagement. Nearly two-thirds of life sciences companies outsource PV functions to single or multi-vendor networks. This model is reinforced by tech-driven alliances, allowing CROs and PV vendors to leverage cloud-based tools for efficiency and global scalability.

Collectively, these shifts highlight a strategic transition from manual safety monitoring to digitally integrated pharmacovigilance ecosystems that prioritize speed, accuracy, and real-time compliance.

Scope of Analysis: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

This study examines the global Pharmacovigilance and Safety Testing Outsourcing Services Market over the period 2024-2030, with emphasis on outsourced PV activities, service delivery models, and digital enablement.

Service Categories Covered:

• Regulatory Compliance & Risk Management
• Adverse Event (AE) Monitoring & Reporting
• Case Processing & Aggregate Reporting
• Signal Detection & Data Management
• Pharmacovigilance-as-a-Service (PVaaS)

Geographic Coverage: North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

The analysis benchmarks CROs, pure-play PV vendors, and technology providers by revenue, service depth, and compliance innovation. Exclusions include in-house pharmacovigilance departments and non-clinical safety evaluations.

Forecasts are based on Frost & Sullivan's bottom-up growth model, integrating primary research (executive interviews, trial pipeline data) and secondary sources (regulatory submissions, company reports, and WHO-FDA databases).

This report provides strategic insights into how digital adoption, global harmonization, and outsourcing maturity will shape the next phase of growth in the pharmacovigilance outsourcing market.

Revenue Forecast: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

The global Pharmacovigilance and Safety Testing Outsourcing Services Market is projected to grow from USD 6.92 billion in 2024 to USD 12.49 billion by 2030, reflecting a CAGR of 10.4%.

By Service Segment:

• Regulatory Compliance: 21.5% share
• Adverse Event Monitoring: 17.9%
• Case Processing: 17.5%
• Signal & Risk Management: 13.9%
• Aggregate Reporting: 13.1%
• Other Support Services: 16.1%

The pharmacovigilance outsourcing market will continue to expand as AI-based automation, data interoperability, and end-to-end PV workflow digitization become standard across pharmaceutical safety programs worldwide.

Segmentation Analysis: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

By Vendor Type:

• Contract Research Organizations (CROs): Offer full-service PV outsourcing, including post-market safety, case management, and analytics.
• Pure-Play PV Vendors: Focus on specific functions like reporting, compliance, and risk evaluation.
• Technology Partners: Enable platform-based PV automation and analytics.

By Service Line:

• Case Processing & Adverse Event Monitoring dominate, accounting for over 35% of total market revenue.
• Regulatory & Compliance Services are critical for global audit-readiness.
• Signal Detection & Risk Evaluation show high AI-integration potential.

By End-User:

• Pharmaceutical and Biotechnology Companies represent 65% of total demand.
• Regulatory Agencies & CRO Partnerships support surveillance and data transparency initiatives.

By Geography:

• APAC: Key outsourcing destination; growing hub for pharmacovigilance market expansion.
• North America: Leading in innovation and automation adoption.
• Europe: Regulatory-driven maturity, GDPR-aligned services.

The segmentation reveals an industry in transition-shifting from cost-based outsourcing toward strategic, long-term technology-enabled partnerships.

Growth Drivers: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

• AI-Powered Automation: Reduces manual workloads in signal detection and case review.
• Precision Medicine Growth: Expanding pharmacogenomic data accelerates personalized safety testing.
• Regulatory Harmonization: ICH, EMA, and FDA frameworks enhance global data consistency.
• Rising Outsourcing Penetration: Growing dependency on CROs and PV vendors for global safety monitoring.
• Cloud and Analytics Adoption: Digitized safety systems improve real-time surveillance.
• Emerging Market Growth: APAC and LATAM offer cost-efficient pharmacovigilance outsourcing services.

Together, these trends define the pharmacovigilance market's shift toward digital scalability and predictive intelligence.

Growth Restraints: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

• Data Privacy and Localization Laws: Challenges from GDPR, HIPAA, and PIPL regulations.
• Fragmented Regulatory Ecosystem: Inconsistent reporting standards delay harmonization.
• Skill Shortages: Lack of experienced PV specialists and QPPVs in emerging economies.
• Cost-Intensive AI Integration: Upfront automation investments slow small vendor adoption.
• Operational Complexity: Cross-border pharmacovigilance outsourcing models increase oversight costs.

Addressing these constraints through standardized frameworks and AI-driven efficiency will determine the Pharmacovigilance Outsourcing Market's long-term resilience.

Competitive Landscape: Global Pharmacovigilance and Safety Testing Outsourcing Services Market

The pharmacovigilance outsourcing market is moderately fragmented, featuring global CROs, specialized PV firms, and tech-enabled service providers.

Leading Participants:

• CROs: IQVIA, ICON plc, Parexel, Fortrea, Syneos Health, Medpace.
• PV Specialists: PrimeVigilance, Freyr Solutions, Quanticate, Insuvia, Qinecsa, iVigee.
• Tech Providers: Oracle, ArisGlobal, Veeva Systems, Accenture, and TCS.

Strategic Trends:

• Digital Transformation: AI, NLP, and automation embedded in safety operations.
• Collaborative Partnerships: CRO-tech alliances for platform-based delivery models.
• Regulatory Adaptation: Strong compliance with EMA PRAC and FDA's Sentinel standards.
• Geographic Diversification: APAC emerging as a pharmacovigilance outsourcing powerhouse.
• M&A Activity: Vendors expanding service portfolios via acquisitions and technology partnerships.

Competitive differentiation increases depends on data analytics maturity, automation scalability, and regulatory expertise. Vendors that combine AI-driven PV platforms with global delivery capabilities will lead the next evolution of the Pharmacovigilance and Safety Testing Outsourcing Services Market.

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Table of Contents

Research Scope

• Scope of Analysis
• Market Segmentation

Growth Environment: Transformation in PV and Safety Testing Outsourcing Services Industry

• Why Is It Increasingly Difficult to Grow?
• The Strategic Imperative 8
• The Impact of the Top 3 Strategic Imperatives on the Pharmacovigilance and Safety Testing Services Industry

Ecosystem in PV and Safety Testing Outsourcing Services

• Pharmacovigilance and Safety Testing Outsourcing Services
• Key Definitions
• Market Trend Analysis
• Pharmacovigilance and Safety Testing Outsourcing Services: Across Drug Development Value Chain
• Vendor Ecosystem
• Multi-Vendor System in Pharmacovigilance Services
• Competitive Environment
• Key Competitors

Growth Generator in PV and Safety Testing Services Industry

• Growth Metrics
• Growth Drivers
• Growth Restraints
• Forecast Assumptions
• Revenue Forecast Methodology
• Revenue Forecast
• Revenue Forecast: Type of Services
• Revenue Forecast Analysis
• Revenue Share by Type of PV and Safety Testing Services
• Revenue Forecast by Region: Overall
• Revenue Forecast Analysis: North America
• Revenue Forecast Analysis: Europe
• Revenue Forecast Analysis: APAC
• Revenue Forecast Analysis: LATAM and Caribbean
• Revenue Forecast Analysis: Middle East and Africa MEA
• Revenue Share Analysis: Top Players
• Revenue Forecast Analysis: CROs
• Revenue Forecast Analysis: Pure Play Vendors
• Revenue Forecast/Share Analysis: Tech Vendors/eClinical Solution Players: Key Enablers of PV Services

Growth Generator: Signal and Risk Management Services

• Growth Metrics
• Revenue Forecast: Signal and Risk Management
• Revenue Forecast: Signal and Risk Management by Region
• Revenue Forecast Analysis

Growth Generator: Adverse Event Monitoring

• Growth Metrics
• Revenue Forecast: Adverse Event Monitoring
• Revenue Forecast: Adverse Event Monitoring by Region

Growth Generator: Case Processing

• Growth Metrics
• Revenue Forecast: Case Processing
• Revenue Forecast: Case Processing by Region
• Revenue Forecast Analysis

Growth Generator: Aggregate Reporting

• Growth Metrics
• Revenue Forecast: Aggregate Reporting
• Revenue Forecast: Aggregate Reporting by Region
• Revenue Forecast Analysis

Growth Generator: Regulatory Compliance

• Growth Metrics
• Revenue Forecast: Regulatory Compliance
• Revenue Forecast: Regulatory Compliance by Region
• Revenue Forecast Analysis

Growth Opportunity Universe in Pharmacovigilance and Safety Testing Outsourcing Services Industry

• Growth Opportunity 1: Pharmacovigilance-as-a-Service
• Growth Opportunity 2: Precision Pharmacovigilance for Precision Medicine
• Growth Opportunity 3: Tailor-Made PV Solutions for Small to Mid-Segment Pharma Companies
• Growth Opportunity 4: Safety Monitoring Services for Digital Therapeutics

Appendix & Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• List of Exhibits
• Legal Disclaimer

Author: Aarti Siddhesh Chitale