How Automation Is Creating New Opportunities in the Pharmacovigilance Market

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How Automation Is Creating New Opportunities in the Pharmacovigilance Market

Polaris Market Research today announced findings from its latest report, projecting the global pharmacovigilance market to grow from USD 8.80 billion in 2025 to USD 14.51 billion by 2034, at a CAGR of 5.7% from 2026 to 2034. Increasing regulatory focus, growing drug consumption, adverse drug reaction monitoring needs, and rising pharmaceutical R&D activity are supporting demand for pharmacovigilance services and technologies.

Analyst Commentary on Pharmacovigilance Growth

The expansion of drug development and increasing volumes of safety data are making efficient safety monitoring increasingly important, while AI, analytics, automation, and cloud technologies are creating new ways to streamline case management and signal detection. — Polaris Market Research

Pharmacovigilance Statistics at a Glance

2025 Market Size: USD 8.80 Billion

2034 Projected Size: USD 14.51 Billion

CAGR (2026–2034): 5.7%

Largest Region (2025): North America, 40.6% share

Key Growth Drivers, Major Companies and Segments Covered

Growth Drivers: Increasing outsourcing of pharmacovigilance services, stricter regulatory requirements, higher drug consumption, rising adverse drug reactions, growing clinical-trial activity, and adoption of AI, machine learning, big data analytics, automation, EHR mining, and cloud technologies are driving market development.

Major Companies Covered: Laboratory Corporation of America Holdings; Cognizant; Thermo Fisher Scientific Inc.; ICON plc.; Accenture; IQVIA; Aris Global; IBM Corporation; United BioSource LLC; PAREXEL International Corporation; TAKE Solutions; and Pharmaceutical Development Group, Inc.

Segments Covered: By Service (In-house, Contract Sourcing), By Product Life Cycle (Pre-clinical, Phase I, Phase II, Phase III, Phase IV), By Type (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining), By Process Flow (Case Data Management, Signal Detection, Risk Management System), By Therapeutic Area (Oncology, Neurology, Cardiology, Respiratory Systems, Others), By End Use (Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, Others), By Region.

Read More @ https://www.polarismarketresearch.com/industry-analysis/pharmacovigilance-market

Recent Developments in the Pharmacovigilance

April 2026: The FDA made the ICH E2B(R3) format mandatory for Individual Case Safety Report submissions through its Electronic Submissions Gateway, according to the report.

January 2026: United BioSource LLC announced the acquisition of Evidinno Outcomes Research, with the stated objective of expanding health economics and real-world evidence capabilities.

September 2021: IQVIA announced a collaboration with NRx Pharmaceuticals to provide pharmacovigilance services and medical information supporting the emergency use authorization of ZYESAMI.

Regional Snapshot: North America Leads, Asia Pacific Fastest-Growing

North America led with 40.6% share in 2025, supported by the presence of major pharmacovigilance companies and substantial research and development activity. Asia Pacific is projected to register a significant CAGR of 10.1% through 2034, supported by company expansion and mergers and acquisitions. Japan is projected to grow at a 9.7% CAGR, with the report linking growth to the rising prevalence of chronic diseases.

Why It Matters for Buyers Evaluating Pharmacovigilance Services

For stakeholders evaluating pharmacovigilance services, technology, or outsourcing partners, the underlying report provides a view across service models, product life-cycle stages, safety-reporting approaches, process flows, therapeutic areas, end users, and regional markets. The report also tracks how AI can process high volumes of adverse-event data, support rapid identification of safety issues, and streamline case evaluation, reporting, and analysis.

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