Pharmacovigilance Market to Reach US$ 17.82 Billion by 2032 at 11.5% CAGR; North America Leads with 40% Share - Key Players: IQVIA, ArisGlobal, Cognizant

The Global Pharmacovigilance Market reached US$ 7.45 billion in 2024 and is expected to reach US$ 17.82 billion by 2032, growing at a CAGR of 11.5% during the forecast period 2025-2032. The market is expanding steadily as regulatory authorities worldwide enforce stricter drug safety monitoring requirements and pharmaceutical companies increase focus on post-marketing surveillance.

Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems throughout a product's lifecycle. The growing volume of clinical trials, rising adoption of biologics and specialty drugs, and increasing incidence of adverse drug reactions are key factors driving demand for robust pharmacovigilance systems. Additionally, advancements in artificial intelligence, automation, and data analytics are transforming case processing, signal detection, and risk management activities. As outsourcing to contract research organizations (CROs) and adoption of cloud-based safety solutions continue to rise, pharmacovigilance is becoming an essential pillar of regulatory compliance and patient safety in the global pharmaceutical and biotechnology industry.

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The Pharmacovigilance Market is the sector that provides systems and services to monitor, assess, and manage the safety of pharmaceutical products throughout their lifecycle.

Key Developments
✅ December 2025: Regulatory authorities strengthened pharmacovigilance requirements, driving increased adoption of automated safety monitoring systems and real-time adverse event reporting platforms.

✅ October 2025: AI and machine learning were increasingly integrated into pharmacovigilance solutions to improve signal detection, case processing efficiency, and risk assessment accuracy.

✅ August 2025: Expansion of pharmacovigilance outsourcing and managed services supported pharmaceutical companies in meeting global compliance and post-marketing surveillance demands.

✅ June 2025: Growing use of real-world evidence and social media analytics enhanced early detection of drug safety issues and patient-reported outcomes.

✅ March 2025: Pharmaceutical and biotech companies increased investment in end-to-end pharmacovigilance platforms to streamline regulatory reporting and lifecycle safety management.

Mergers & Acquisitions
✅ December 2025: A global CRO or life sciences services company acquired a pharmacovigilance technology or services provider to expand its drug safety and regulatory compliance portfolio.

✅ October 2025: Strategic collaborations formed between pharmacovigilance software vendors and pharmaceutical companies to deploy AI-driven safety monitoring solutions.

✅ August 2025: Pharmacovigilance service providers partnered with healthcare IT firms to integrate safety databases with electronic health records and real-world data sources.

✅ June 2025: Technology companies entered alliances with CROs to enhance cloud-based pharmacovigilance platforms and global reporting capabilities.

✅ March 2025: Academic research organizations and pharmacovigilance startups established partnerships to advance signal detection methodologies and regulatory science.

Key Players
ArisGlobal | BioClinica | Capgemini | Cognizant | FMD K&L Inc. | Foresight Group International AG | IBM Corporation | Wipro Limited | IQVIA

Key Highlights

ArisGlobal - Holds a share of 12.8%: Provides life sciences software platforms for pharmacovigilance, regulatory compliance, and clinical data management, enabling efficient drug safety and regulatory operations.

BioClinica - Holds a share of 11.6%: Specializes in clinical trial imaging, data analytics, and technology solutions that enhance trial efficiency and data integrity.

Capgemini - Holds a share of 9.7%: Delivers digital transformation, cloud, and analytics services supporting clinical research, regulatory processes, and life sciences IT modernization.

Cognizant - Holds a share of 10.4%: Offers IT services, data management, and digital platforms tailored for pharmaceutical R&D, clinical trials, and healthcare operations.

FMD K&L Inc. - Holds a share of 6.2%: Focuses on regulatory intelligence, compliance consulting, and data solutions for life sciences and healthcare organizations.

Foresight Group International AG - Holds a share of 5.9%: Provides regulatory strategy, pharmacovigilance, and risk management services supporting global life sciences companies.

IBM Corporation - Holds a share of 8.1%: Enables life sciences digital ecosystems through AI, cloud computing, and advanced analytics for clinical research and regulatory workflows.

Wipro Limited - Holds a share of 7.6%: Delivers IT services, automation, and data analytics solutions supporting clinical development, regulatory compliance, and healthcare IT transformation.

IQVIA - Holds a share of 17.7%: Leads the market with integrated clinical research services, real-world evidence analytics, and advanced data platforms supporting end-to-end drug development.

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Market Drivers
- Rising incidence of adverse drug reactions and increasing focus on patient safety across healthcare systems.

- Stringent regulatory requirements for drug safety monitoring and post-marketing surveillance.

- Growing number of clinical trials and increasing approval of new drugs and biologics.

- Expanding adoption of pharmacovigilance systems by pharmaceutical, biotechnology, and CRO organizations.

- Increasing use of real-world data and electronic health records for drug safety assessment.

- Advancements in AI, machine learning, and automation to improve signal detection and case processing.

- Rising outsourcing of pharmacovigilance activities to specialized service providers.

Industry Developments
- Implementation of AI-driven tools for adverse event detection, case intake, and signal management.

- Expansion of cloud-based pharmacovigilance platforms for global safety data management.

- Growing partnerships between pharmaceutical companies and pharmacovigilance service providers.

- Integration of real-world evidence and social media data into safety surveillance programs.

- Increasing adoption of end-to-end pharmacovigilance solutions covering pre- and post-marketing phases.

- Rising mergers, acquisitions, and investments in pharmacovigilance technology and service providers.

- Enhanced focus on compliance with global regulations such as FDA, EMA, and ICH guidelines.

Regional Insights
North America - 40% share: Driven by stringent regulatory frameworks, strong pharmaceutical presence, and advanced safety monitoring infrastructure.

Europe - 32% share: Supported by robust pharmacovigilance regulations, centralized reporting systems, and strong public healthcare oversight.

Asia Pacific - 22% share: Fueled by growing pharmaceutical manufacturing, increasing clinical trial activity, and strengthening regulatory compliance.

Latin America - 4% share: Boosted by improving regulatory frameworks and expanding drug safety monitoring initiatives.

Middle East & Africa - 2% share: Driven by increasing awareness of drug safety, regulatory modernization, and healthcare system development.

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Key Segments

➥ By Service Provider
Contract Outsourcing: Pharmacovigilance activities outsourced to contract research organizations and specialized service providers to reduce operational costs, ensure regulatory compliance, and access expert safety monitoring capabilities.

In-house: Pharmacovigilance functions managed internally by pharmaceutical and healthcare organizations, allowing greater control over safety data, processes, and regulatory reporting.

➥ By Type of Reporting
Intensified ADR Reporting: Enhanced monitoring and systematic reporting of adverse drug reactions, particularly for newly launched or high-risk medicines.

Spontaneous Reporting: Voluntary reporting of adverse drug reactions by healthcare professionals, patients, and manufacturers to identify potential safety signals.

Cohort Event Monitoring: Active surveillance method that tracks adverse events in defined patient cohorts to assess real-world drug safety.

Targeted Spontaneous Reporting: Focused reporting approach targeting specific drugs, populations, or adverse events to improve signal detection efficiency.

EHR Mining: Use of electronic health records and advanced analytics to identify, monitor, and assess drug safety signals from real-world clinical data.

➥ By Clinical Trial Phase
Preclinical: Safety assessment conducted during laboratory and animal studies to identify potential toxicities before human trials.

Phase I: Early-stage clinical trials focused on evaluating safety, tolerability, and dosage in healthy volunteers or small patient groups.

Phase II: Mid-stage trials assessing drug efficacy, optimal dosing, and continued safety evaluation in targeted patient populations.

Phase III: Large-scale trials designed to confirm efficacy, monitor adverse reactions, and support regulatory approval.

Phase IV: Post-marketing surveillance studies focused on long-term safety, rare adverse events, and real-world effectiveness.

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