Global Pharmacovigilance Market (2026-2031) - Growth Driven by Expanding Drug Development Pipelines and AI-Enabled Signal Detection

Global Pharmacovigilance Market (2026-2031) - Growth Driven by Expanding Drug Development Pipelines and AI-Enabled Signal Detection Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "Pharmacovigilance - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.

The global pharmacovigilance market was valued at USD 9.35 billion in 2025 and is expected to increase from USD 10.45 billion in 2026 to USD 18.26 billion by 2031. This represents a compound annual growth rate of 11.78% during the 2026-2031 forecast period. Market expansion is being driven by rising drug consumption, a growing pharmaceutical development pipeline, increasing adverse drug reaction reporting, and greater adoption of artificial intelligence in drug safety monitoring.

Drug Development Pipeline Strengthens Pharmacovigilance Demand

The approval of 50 new molecular entities by the U.S. Food and Drug Administration in 2024 highlighted the increasing post-marketing safety responsibilities facing pharmaceutical companies. Gene therapies, CAR-T treatments, combination products, and other advanced therapies have complex risk profiles that require continuous monitoring throughout their commercial life cycles.

Conditional drug approvals are also increasing demand for real-world evidence and post-authorization safety studies. As regulators require manufacturers to maintain comprehensive safety surveillance after launch, pharmaceutical and biotechnology companies are allocating more resources to scalable pharmacovigilance systems. These requirements are expected to support long-term market growth beyond the clinical development stage.

Adverse Drug Reactions Increase Safety Monitoring Requirements

The rising incidence of adverse drug reactions is generating higher case volumes across healthcare and pharmaceutical organizations. Polypharmacy among aging populations is contributing to more drug interactions, while advanced therapies require specialized, long-term monitoring. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has emphasized lifelong surveillance for CAR-T therapy recipients following concerns about potential secondary malignancies.

Large-scale vaccine programs have also demonstrated the importance of rapid signal-detection networks capable of processing millions of safety reports. Pharmaceutical companies, hospitals, regulators, and service providers are consequently investing in integrated safety databases, automated case intake, and advanced analytics.

Artificial Intelligence and Outsourcing Reshape Drug Safety Operations

Artificial intelligence, natural language processing, predictive analytics, and robotic process automation are transforming pharmacovigilance operations. These technologies support scientific literature reviews, adverse event intake, signal detection, and early risk assessment. AI models are also being used to evaluate potential off-target effects before patient dosing, enabling earlier risk-management planning.

Contract outsourcing accounted for 54.88% of pharmacovigilance market revenue in 2025 and is forecast to grow at a 13.48% CAGR through 2031. Although in-house teams retain responsibility for strategic safety decisions, many organizations are adopting hybrid operating models in which contract research organizations process routine cases and manage technology-intensive workflows.

External service hubs in India, Ireland, and Eastern Europe continue to attract outsourced pharmacovigilance workloads. Pharmaceutical companies are also consolidating vendor relationships through long-term service agreements that include automation, cloud infrastructure, and AI investment roadmaps.

Phase IV Studies Maintain Leading Market Position

Phase IV studies represented 32.05% of the pharmacovigilance market in 2025, reflecting regulatory demand for long-term monitoring after product approval. Post-authorization safety study budgets are rising as conditional approvals and advanced therapies increase the need for real-world safety data.

Preclinical safety assessments are projected to expand at a 12.88% CAGR, supported by risk-based analytics and predictive modeling. Updated ICH E6(R3) guidelines are encouraging sponsors to incorporate quality-by-design principles throughout development, improving the consistency and traceability of safety data. Decentralized clinical trials, wearable sensors, and direct-to-patient sampling are further expanding the volume and variety of information available for pharmacovigilance analysis.

Cybersecurity and Skilled-Labor Shortages Present Challenges

Cloud-based safety platforms improve scalability but also increase exposure to ransomware, unauthorized access, and other cybersecurity risks. Pharmaceutical sponsors must balance global analytics capabilities with data-minimization, localization, and privacy requirements under the General Data Protection Regulation and comparable legislation.

The shortage of specialized pharmacovigilance professionals and high employee turnover also remain significant operational constraints. Automation can reduce repetitive workloads, but experienced personnel continue to be essential for medical review, benefit-risk assessment, regulatory compliance, and signal validation.

Regional Pharmacovigilance Market Outlook

North America held 43.62% of the global pharmacovigilance market in 2025. Strong pharmaceutical research and development activity, widespread electronic health record adoption, and established regulatory requirements support the region's leadership. FDA guidance for validating AI-enabled systems is also encouraging investment in digital pharmacovigilance.

Europe remains a major market due to its mature regulatory framework, the EudraVigilance network, and growing demand for monitoring advanced therapy medicinal products. Regulatory interest in transparent AI systems is expected to promote innovation while maintaining stringent drug safety standards.

Asia-Pacific is forecast to record the fastest regional growth, with a 13.12% CAGR through 2031. Regulatory reforms in China, expanding clinical trial activity in India, and greater alignment of electronic submission standards across ASEAN countries are supporting market development. South America, the Middle East, and Africa are also expected to generate incremental growth as local pharmaceutical manufacturing, imports, and safety-monitoring infrastructure expand.

Key Topics Covered:

1 Introduction

1.1 Study Assumptions and Market Definition

1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

4.1 Market Overview

4.2 Market Drivers

4.2.1 Increasing Drug Consumption & Development Pipeline

4.2.2 Growing Incidence Of Adverse Drug Reactions (ADRS)

4.2.3 Outsourcing Of Pv Services To CRO/BPO Vendors

4.2.4 AI-Enabled Signal Detection & Predictive Analytics

4.2.5 Expansion Of Real-World Evidence (RWE) Platforms

4.2.6 Stringent Regulatory Mandates For Proactive Post-Marketing Safety Surveillance

4.3 Market Restraints

4.3.1 Cyber-Security & Data-Privacy Risks

4.3.2 Lack Of Global Regulatory Harmonisation & Data Standards

4.3.3 Shortage Of Specialised PV Talent & High Staff Turnover

4.3.4 Complexity Of Combination & ATMP Therapies

4.4 Value / Supply-Chain Analysis

4.5 Regulatory Landscape

4.6 Technology Outlook

4.7 Porter's Five Forces Analysis

4.7.1 Bargaining Power of Suppliers

4.7.2 Bargaining Power of Buyers

4.7.3 Threat of New Entrants

4.7.4 Threat of Substitutes

4.7.5 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value-USD)

5.1 By Clinical Trial Phase

5.1.1 Pre-clinical

5.1.2 Phase I

5.1.3 Phase II

5.1.4 Phase III

5.1.5 Phase IV

5.2 By Service Provider

5.2.1 In-house

5.2.2 Contract Outsourcing

5.3 By Type of Reporting

5.3.1 Spontaneous Reporting

5.3.2 Intensified ADR Reporting

5.3.3 Targeted Spontaneous Reporting

5.3.4 Cohort Event Monitoring

5.3.5 EHR Mining

5.4 By End-User

5.4.1 Hospitals

5.4.2 Pharmaceutical Companies

5.4.3 CROs & Other End-Users

5.5 By Geography

5.5.1 North America

5.5.1.1 United States

5.5.1.2 Canada

5.5.1.3 Mexico

5.5.2 Europe

5.5.2.1 Germany

5.5.2.2 United Kingdom

5.5.2.3 France

5.5.2.4 Italy

5.5.2.5 Spain

5.5.2.6 Rest of Europe

5.5.3 Asia-Pacific

5.5.3.1 China

5.5.3.2 Japan

5.5.3.3 India

5.5.3.4 Australia

5.5.3.5 South Korea

5.5.3.6 Rest of Asia-Pacific

5.5.4 Middle East and Africa

5.5.4.1 GCC

5.5.4.2 South Africa

5.5.4.3 Rest of Middle East and Africa

5.5.5 South America

5.5.5.1 Brazil

5.5.5.2 Argentina

5.5.5.3 Rest of South America

6 Competitive Landscape

6.1 Market Concentration

6.2 Market Share Analysis

6.3 Company profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)

6.3.1 Accenture

6.3.2 ArisGlobal

6.3.3 BioClinica (NOW Clario)

6.3.4 Capgemini

6.3.5 Cognizant

6.3.6 IBM

6.3.7 ICON plc

6.3.8 IQVIA

6.3.9 ITClinical

6.3.10 Labcorp

6.3.11 Linical Accelovance

6.3.12 Parexel

6.3.13 UBC (United BioSource)

6.3.14 TAKE Solutions (Navitas Life Sciences)

6.3.15 Wipro

6.3.16 Oracle Health Sciences

6.3.17 Ennov

6.3.18 Extedo

6.3.19 Clarivate (Drug Safety Triager)

6.3.20 SGS Life Sciences

7 Market Opportunities and Future Outlook

7.1 White-Space and Unmet-Need Assessment

For more information about this report visit https://www.researchandmarkets.com/r/r6hsng

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