Pharmacovigilance (PV) Operations State of the Market 2025

The surge in case volumes, more stringent regulatory demands, and therapeutic areas’ rising complexities are significantly transforming pharmacovigilance (PV). As the industry adapts to more tailored reporting requirements and longer patient monitoring periods, enterprises are under pressure to optimize operations without compromising quality. This evolution has led to a reassessment of sourcing strategies, with many exploring flexible engagement models and realigning investments to balance cost and efficiency.

Providers are responding by deepening their therapeutic expertise, expanding their service offerings, and integrating automation and analytics throughout the value chain. Adopting AI-enabled tools, predictive signal detection, and real-world data is accelerating operational agility and regulatory compliance. Meanwhile, commercial models are shifting away from transactional engagements toward hybrid and value-linked constructs. These shifts are intensifying competition among CROs, BPOs, and niche players, each aiming to demonstrate adaptability, innovation, and compliance strength. The report helps business and procurement leaders understand how to evolve sourcing approaches to meet future demands while ensuring long-term PV resilience.