Pharmacovigilance Market Outlook 2025-2032: AI-Driven Safety Monitoring and Rising Regulatory Scrutiny Driving Growth

The pharmacovigilance market reached approximately US$ 8.85 billion in 2024 and is expected to reach around US$ 16.62 billion by 2032, growing at a CAGR of about 10.3% during the forecast period 2025-2032. Market growth is driven by increasing regulatory scrutiny on drug safety, rising adverse event reporting requirements, growing pharmaceutical and biotech pipelines, and the need for comprehensive post-marketing surveillance. Advances in real-world evidence analytics, artificial intelligence (AI), and automated case processing are improving signal detection, risk management, and compliance, supporting broader adoption of pharmacovigilance services and solutions.

North America held the largest market share due to stringent regulatory frameworks, high pharmaceutical activity, and widespread adoption of advanced safety monitoring technologies. Europe followed, supported by strong drug safety regulations and well-established reporting systems, while Asia-Pacific is expected to witness the fastest growth driven by expanding pharmaceutical manufacturing, increasing clinical trial activity, and growing emphasis on patient safety and regulatory compliance across emerging economies.

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The pharmacovigilance market refers to the global industry focused on systems, services, and software used to detect, assess, monitor, and prevent adverse drug reactions and ensure patient safety.

Key Developments
✅ January 2026: In North America, life sciences companies accelerated integration of AI-driven safety signal detection and predictive analytics into pharmacovigilance systems to enhance detection of adverse drug reactions and improve risk management.

✅ January 2026: In Europe, regulatory authorities updated guidance and compliance frameworks to support real-time safety reporting and electronic submission standards, enabling faster signal evaluation and global harmonization of pharmacovigilance processes.

✅ December 2025: In Asia-Pacific, pharmaceutical sponsors and contract safety service providers expanded adoption of cloud-based safety databases and integrated case processing platforms to improve scalability and cross-border data sharing.

✅ December 2025: Globally, advancements in natural language processing (NLP) and automation technologies strengthened literature monitoring and social media pharmacovigilance, enhancing proactive identification of safety trends.

✅ November 2025: In Latin America, regulatory agencies and industry stakeholders collaborated to enhance regional adverse event reporting networks, increasing reporting completeness and supporting post-marketing surveillance.

✅ October 2025: Worldwide, increased emphasis on signal validation and benefit-risk assessment frameworks supported more robust decision-making in drug safety and regulatory submissions.

Mergers & Acquisitions
✅ January 2026: In the United States, a leading pharmacovigilance solutions provider acquired an AI-based safety analytics startup to enhance its automated signal detection and case management capabilities.

✅ December 2025: In Europe, a global consulting and safety services firm completed the acquisition of a cloud-based adverse event reporting and pharmacovigilance platform to broaden its integrated compliance offerings.

✅ November 2025: In Asia-Pacific, a regional contract research and safety services company acquired a literature screening and NLP tools developer to strengthen its pharmacovigilance technology stack.

Key Players
Cognizant | IBM | IQVIA | ArisGlobal | BioClinica | Others

Key Highlights
Cognizant holds 24.8% share, driven by its end-to-end life sciences IT services, strong clinical data management capabilities, and large-scale global delivery model.

IBM holds 21.3% share, supported by its advanced analytics, AI-driven platforms, and secure enterprise infrastructure widely adopted in clinical research operations.

IQVIA holds 20.6% share, leveraging its vast healthcare data assets, clinical trial technology platforms, and deep regulatory and operational expertise.

ArisGlobal holds 18.1% share, driven by its life sciences software solutions, pharmacovigilance platforms, and strong adoption among pharmaceutical and biotech companies.

BioClinica holds 12.9% share, supported by its clinical imaging, endpoint management technologies, and specialized services across global clinical trials.

Others account for 2.3% share, comprising niche clinical trial technology providers and emerging digital health solution companies.

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Market Drivers
- Increasing volume of adverse drug reaction (ADR) reporting driven by expanding drug approvals and post-marketing surveillance requirements.

- Stringent global regulatory mandates for drug safety monitoring across clinical and post-approval stages.

- Rising complexity of drug portfolios, including biologics, biosimilars, and specialty medicines.

- Growing outsourcing of pharmacovigilance activities to CROs and specialized service providers.

- Adoption of digital health technologies and real-world evidence increasing the need for advanced safety data analysis.

Industry Developments
- Integration of AI, machine learning, and natural language processing for automated case processing and signal detection.

- Expansion of cloud-based pharmacovigilance platforms enabling scalable global safety operations.

- Increasing use of real-world data, social media monitoring, and electronic health records for proactive risk management.

- Strategic partnerships and acquisitions among PV service providers to expand global coverage and service capabilities.

- Growing focus on end-to-end pharmacovigilance solutions covering case intake, risk management, and regulatory reporting.

Regional Insights
North America - 40% share: "Driven by stringent FDA regulations, high drug approval volumes, advanced digital infrastructure, and strong presence of PV service providers."

Europe - 30% share: "Supported by EMA safety requirements, mature regulatory frameworks, and widespread adoption of outsourced pharmacovigilance services."

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

Latin America - 5% share: "Driven by improving regulatory oversight and rising demand for outsourced drug safety services."

Middle East & Africa - 3% share: "Supported by gradual strengthening of regulatory frameworks and growing focus on patient safety monitoring."

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Key Segments
By Service Provider
Contract outsourcing dominates the market, driven by increasing reliance on specialized pharmacovigilance service providers to manage large volumes of safety data, ensure regulatory compliance, and reduce operational costs. In-house services hold a significant share, particularly among large pharmaceutical companies that maintain internal pharmacovigilance teams to retain greater control over safety monitoring and reporting processes.

By Type of Reporting
Spontaneous reporting represents a major segment, supported by its widespread use as a primary method for adverse drug reaction (ADR) detection. Intensified ADR reporting holds a notable share, driven by increased regulatory focus on enhanced safety surveillance for high-risk drugs. Cohort event monitoring is gaining traction due to its structured approach to evaluating drug safety in defined patient populations. Targeted spontaneous reporting is expanding steadily, supported by its effectiveness in monitoring specific medicines or patient groups. EHR mining represents an emerging segment, driven by growing adoption of digital health records and advanced analytics for real-world safety signal detection.

By Clinical Trial Phase
Phase IV dominates the market, driven by stringent post-marketing surveillance requirements and ongoing safety monitoring of approved drugs. Phase III holds a substantial share due to large patient populations and extensive safety data generation prior to regulatory approval. Phase II represents a significant segment, supported by dose optimization and early efficacy evaluation studies. Phase I accounts for a smaller share, focused on initial safety and tolerability assessments. Preclinical pharmacovigilance contributes modestly, primarily supporting early toxicology and risk assessment activities.

By End-User
Pharmaceutical companies represent the largest end-user segment, driven by regulatory obligations for continuous drug safety monitoring across product lifecycles. Hospitals hold a significant share, supported by direct patient interaction, ADR identification, and reporting responsibilities within clinical and post-marketing settings.

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