Pharmacovigilance Market to Reach USD 19.4 Billion by 2035, Driven by Surge in Clinical Trials and Increased Global Drug Consumption | TMR

The global Pharmacovigilance Market is set for robust expansion over the next decade, with market value projected to rise from US$ 8.3 Bn in 2024 to US$ 19.4 Bn by 2035, expanding at a CAGR of 7.9% from 2025 to 2035, according to the latest market analysis.

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Growing drug consumption, increasing chronic disease prevalence, rapid expansion of clinical trials, and the widespread adoption of outsourcing models are some of the major forces shaping the industry's future. Regulatory bodies worldwide are emphasizing stringent drug safety monitoring, further amplifying the demand for advanced pharmacovigilance (PV) systems.

Drug Safety Becomes Central to Global Healthcare Strategy
Pharmacovigilance plays a pivotal role in detecting, assessing, and preventing adverse drug reactions (ADRs), safeguarding patient wellbeing across the drug lifecycle. With rising R&D investments and a surge in new drug launches, the volume of safety data that must be monitored has increased significantly.

A growing emphasis on patient safety-as demonstrated by studies reporting ADR prevalence as high as 6.2% in hospital settings-continues to underscore the need for robust PV systems.

Outsourcing Leads the Market as Pharma Companies Prioritize Efficiency
The Contract Outsourcing delivery mode remains the dominant segment due to its cost efficiency, scalability, and access to specialized expertise. Outsourcing enables pharma and biotech companies to leverage:

Advanced AI/ML-driven PV platforms

Global regulatory expertise of CROs

Skilled workforce and optimized case processing capacity

A recent industry shift highlights that more than 60% of case-processing operations are now outsourced, with automation usage expected to triple in the next year-underscoring a major transformation in pharmacovigilance operations.

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Clinical Trial Growth Accelerates Demand for Safety Monitoring
Emerging economies such as India, China, and Brazil are hosting an increasing number of clinical trials due to diverse patient pools and cost advantages. India's clinical trial market alone is expected to exceed US$ 2 Bn by 2030, generating significant safety data requiring continuous evaluation.

This rapid expansion increases the need for pre-marketing and post-marketing surveillance, further pushing demand for pharmacovigilance technologies and services.

North America Remains the Global Leader
North America held the largest market share in 2024, driven by:

Stringent FDA and Health Canada regulatory frameworks

Rapid adoption of AI and data analytics

Increasing patient-driven ADR reporting

Highly advanced healthcare infrastructure

The region continues to invest heavily in real-time safety assessment systems and automated reporting technologies, setting a benchmark for global pharmacovigilance standards.

Competitive Landscape: Key Players Strengthen Their Global Presence
Leading companies in the market include:
IQVIA Inc., Cognizant, ICON plc., ArisGlobal, Linical, ITClinical, TAKE Solutions, Parexel, Wipro, United BioSource LLC, Ergomed Group, Quanticate, among others.

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