Pharmacovigilance Market to Surpass US$ 19.4 Bn by 2035 at 7.9% CAGR | Transparency Market Research

Pharmacovigilance ensures drug safety by detecting, assessing, and preventing adverse reactions across the product lifecycle.

WILMINGTON, DE, UNITED STATES, August 26, 2025 /EINPresswire.com/ -- The global pharmacovigilance (PV) market is on a strong growth trajectory, fueled by rising drug consumption, expansion of clinical trials, and the increasing role of outsourcing in pharmaceutical operations. Valued at US$ 8.3 billion in 2024, the market is projected to expand at a CAGR of 7.9% from 2025 to 2035, reaching US$ 19.4 billion by 2035.
Pharmacovigilance, which involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related issues, plays a critical role in ensuring patient safety across all stages of a drug’s lifecycle. With the rising complexity of drug development and the surge in global regulatory scrutiny, the pharmacovigilance market has emerged as a vital pillar of the pharmaceutical and biotechnology industries.

Market Overview: Pharmacovigilance has transitioned from being a compliance-driven activity to a core strategic function within pharma. The demand for efficient, technology-driven drug surveillance systems is higher than ever before, particularly as chronic diseases and specialty drugs grow in prevalence.
The increasing adoption of artificial intelligence (AI), machine learning (ML), and big data analytics is revolutionizing pharmacovigilance operations by enabling faster case processing, more accurate adverse event reporting, and advanced signal detection. Pharmaceutical companies are increasingly outsourcing pharmacovigilance tasks to specialized service providers and Contract Research Organizations (CROs), ensuring regulatory compliance while maintaining operational efficiency.

Key Drivers of Market Growth

1. Increased Drug Consumption
o Rising incidence of chronic diseases such as cancer, diabetes, and cardiovascular disorders has resulted in higher drug usage, increasing the likelihood of ADRs.
o For instance, a 2024 cross-sectional study in Sri Lanka reported a 6.2% prevalence of ADRs among hospitalized patients, with diabetes mellitus being a significant contributor.
2. Expansion of Clinical Trials
o The rapid increase in global clinical trials, particularly in cost-effective markets such as India, has fueled demand for advanced pharmacovigilance systems.
o India’s clinical trial market alone is projected to surpass US$ 2 billion by 2030, producing massive volumes of safety data requiring robust monitoring.
3. Outsourcing Trends in Pharma
o Pharma companies are increasingly outsourcing pharmacovigilance to CROs to access specialized expertise, advanced technology, and global compliance frameworks.
o In 2024, more than 40% of pharma companies outsourced over 60% of their case processing tasks, demonstrating the market’s reliance on CROs.
4. Regulatory Pressure and Compliance
o Agencies like the FDA (U.S.), EMA (Europe), and PMDA (Japan) enforce stringent reporting requirements, compelling pharma companies to invest heavily in pharmacovigilance infrastructure.

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Key Players and Industry Leaders

The competitive landscape of the pharmacovigilance market is characterized by a mix of global consulting firms, CROs, and dedicated pharmacovigilance service providers. Major players include:
• Accenture
• IQVIA Inc.
• Cognizant
• ICON plc.
• Parexel International Corporation
• Wipro
• ArisGlobal
• United BioSource LLC
• Ergomed Group
• Quanticate
These players are focusing on expanding global operations, strengthening AI/automation capabilities, and forming collaborations with regulatory agencies to enhance drug safety initiatives.

Recent Developments

• Ergomed plc (2024): PrimeVigilance, Ergomed’s PV unit, acquired Panacea to expand its global presence in pharmacovigilance, regulatory affairs, and quality assurance.
• ICON plc (2023): Partnered with the U.S. BARDA to conduct clinical trials for next-generation COVID-19 vaccines, underscoring the critical role of PV in pandemic preparedness.
• TFS Survey (2024): Reported a surge in automation adoption in PV, with automation usage in case processing expected to rise from 20% to over 60% within a year.

Market New Opportunities and Challenges

Opportunities:
• Adoption of AI & Automation: Leveraging automation in case reporting, data analysis, and ADR detection offers faster turnaround times and improved accuracy.
• Expansion in Emerging Economies: Asia Pacific and Latin America present lucrative growth opportunities due to increasing clinical trial activities and regulatory harmonization.
• Integration of Real-World Evidence (RWE): Growing reliance on patient-reported outcomes and real-world data is reshaping pharmacovigilance
processes.

Challenges:
• High Implementation Costs: Setting up advanced PV systems and maintaining compliance is resource-intensive.
• Complex Global Regulatory Landscape: Companies face challenges in navigating diverse compliance requirements across geographies.
• Data Privacy Concerns: Growing emphasis on GDPR and patient confidentiality adds complexity to pharmacovigilance operations.

Latest Market Trends

1. Shift Toward Centralized PV Hubs: Consolidating operations for efficiency and cost reduction.
2. Patient-Centric Pharmacovigilance: Increased use of mobile apps and online platforms to report ADRs directly by patients.
3. End-to-End PV Services: Vendors offering integrated solutions covering clinical trials to post-market surveillance.
4. Cloud-Based PV Solutions: Growing demand for scalable, secure cloud-based platforms for real-time monitoring.

Future Outlook

The pharmacovigilance market is set for significant transformation over the next decade. Analysts predict that integration of AI-driven predictive analytics will enable proactive identification of risks before drugs reach the market. Moreover, collaborations between pharma companies, CROs, and technology providers will create more efficient and transparent pharmacovigilance ecosystems.
By 2035, pharmacovigilance is expected to shift from a reactive model (reporting ADRs) to a predictive and preventive model, ensuring safer therapies and higher patient trust.

Market Segmentation

By Phase:
• Pre-Clinical
• Phase I
• Phase II
• Phase III
• Phase IV

By Type:
• Spontaneous Reporting
• Targeted Reporting
• Cohort Event Monitoring
• Epidemiological Studies
• Post-Marketing Surveillance

By Delivery Mode:
• In-house
• Contract Outsourcing (leading segment)

By Therapeutic Area:
• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Autoimmune Diseases
• Infectious Diseases

By End-User:
• Pharmaceutical & Biotechnology Companies
• CROs
• Regulatory Authorities

Regional Insights

• North America: Dominates the market due to stringent FDA requirements, advanced healthcare infrastructure, and rapid adoption of AI in PV processes.
• Europe: Strong regulatory framework (EMA) and active ADR reporting systems contribute to substantial market share.
• Asia Pacific: Fastest-growing region, driven by clinical trial expansion in India, China, and Japan. Increasing outsourcing to CROs adds momentum.
• Latin America & Middle East & Africa: Gradual adoption of pharmacovigilance systems, with opportunities for growth through regulatory alignment and infrastructure development.

Why Buy This Report?

• Comprehensive Market Coverage: Detailed analysis of the global pharmacovigilance market size, growth forecasts, and key segments.
• In-Depth Competitive Analysis: Profiles of leading players, their strategies, and recent developments.
• Regulatory Insights: Coverage of global compliance frameworks shaping pharmacovigilance operations.
• Opportunities and Risks: Identification of growth opportunities and potential challenges across regions.
• Technology Trends: Insights into how AI, automation, and big data are transforming the market.
• Strategic Decision Support: Equips stakeholders with actionable intelligence for investment, expansion, and operational strategies.

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