Pharmacovigilance Market Size Worth USD 16.3 Billion, Globally, by 2033 at a CAGR of 7.5%

Market Overview:

According to IMARC Group's latest research publication, "Pharmacovigilance Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2025-2033", The global pharmacovigilance market size reached USD 8.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 16.3 Billion by 2033, exhibiting a growth rate (CAGR) of 7.5% during 2025-2033.

This detailed analysis primarily encompasses industry size, business trends, market share, key growth factors, and regional forecasts. The report offers a comprehensive overview and integrates research findings, market assessments, and data from different sources. It also includes pivotal market dynamics like drivers and challenges, while also highlighting growth opportunities, financial insights, technological improvements, emerging trends, and innovations. Besides this, the report provides regional market evaluation, along with a competitive landscape analysis.

How AI is Reshaping the Future of Pharmacovigilance Market

• AI enhances pharmacovigilance operations with automated adverse event detection and predictive analytics, reducing signal detection time by 40% through advanced algorithms.
• European Medicines Agency released AI tools and guidelines in 2024, demonstrating regulatory support for technology adoption in drug safety monitoring across global markets.
• Companies like Sanofi and Deloitte's ConvergeHEALTH Safety platform use AI to streamline case intake, while ArisGlobal's FAERS II integration enhances electronic safety submissions.
• Natural language processing algorithms process massive datasets from electronic health records and patient registries, improving signal detection accuracy and reducing manual workload significantly.
• AI-powered predictive analytics enable proactive risk management by anticipating adverse drug reactions, facilitating early interventions that minimize health complications across global pharmaceutical markets.

Download a sample PDF of this report: https://www.imarcgroup.com/pharmacovigilance-market/requestsample

Key Trends in the Pharmacovigilance Market

• Surge in Contract Outsourcing Services: Pharmaceutical companies increasingly outsource pharmacovigilance activities to specialized firms for cost efficiency and regulatory compliance. Contract outsourcing holds 61.2% market share, with companies like IQVIA partnering with pharmaceutical firms. This trend allows organizations to focus on core innovation while maintaining comprehensive drug safety monitoring.
• Technology-Driven Safety Monitoring: Advanced technologies like machine learning and natural language processing transform traditional pharmacovigilance into data-rich ecosystems. The global ML industry reached USD 31 billion in 2024, with pharmacovigilance as one of its fastest-growing applications, processing massive datasets at unprecedented speed and scale.
• Regulatory Intensification and Compliance: Global regulatory bodies like USFDA, EMA, CDSCO, and TGA increase vigilance with strict safety reporting mandates. FDA's Sentinel Initiative expanded to monitor over 100 million patients, while drug recalls due to contamination underscore non-negotiable testing standards driving market growth.
• Phase IV Post-Marketing Dominance: Post-marketing surveillance phase holds 76.5% market share due to regulatory requirements for continuous safety assessments after drug approval. The integration of real-world evidence and big data analytics enables efficient long-term safety monitoring and risk management.
• Rising Complexity in Drug Development: Novel biologics, gene therapies, and personalized medicine increase safety monitoring complexity. Over 22,000 new clinical trials launched in 2023, featuring adaptive protocols and decentralized elements, requiring agile real-time safety systems across multiple geographies.

Growth Factors in the Pharmacovigilance Market

• Rising Adverse Drug Reactions: Growing prevalence of ADRs from polypharmacy and substance abuse drives demand for comprehensive safety monitoring. Chronic disease patients often use multiple therapeutic agents simultaneously, increasing safety risks and making ADR monitoring more vital than ever.
• Expansion of Pharmaceutical Industry: Growth of pharmaceutical and biotechnology industries drives demand for thorough safety monitoring during drug development. The surge in chronic diseases and new drug launches boosts demand for robust pharmacovigilance systems across global markets.
• Government Regulatory Mandates: Stricter regulatory requirements worldwide enhance pharmacovigilance adoption. FDA's guidance on AI deployment in regulatory decision-making and India's ADRMS software launch under 'Digital India' initiative strengthen compliance frameworks and market expansion.
• Technological Advancements: Rising adoption of AI, big data analytics, and electronic health records enhances signal detection efficiency. Technologies improve drug safety evaluation accuracy, with partnerships like Cognizant and Medable introducing streamlined safety monitoring at every trial touchpoint.
• Outsourcing Cost Efficiency: Pharmaceutical companies outsource to expert service providers offering scalable infrastructure and regional regulatory intelligence. Strategic partnerships like IQVIA with NRx Pharmaceuticals illustrate how outsourcing evolved from cost-cutting to performance enhancement.

Ask analyst of customized report: https://www.imarcgroup.com/request?type=report&id=3609&flag=E

Leading Companies Operating in the Global Pharmacovigilance Industry:

• Accenture plc
• ArisGlobal LLC
• BioClinica Inc. (Cinven Partners LLP)
• Capgemini
• Cognizant
• International Business Machines Corporation
• ICON plc.
• IQVIA Inc.
• ITClinical
• Parexel International Corporation
• Wipro Limited

Pharmacovigilance Market Report Segmentation:

Breakup By Service Provider:

• In-house
• Contract Outsourcing

Contract outsourcing accounts for the majority of shares (61.2%) on account of cost efficiency, specialized expertise, and regulatory compliance benefits.

Breakup By Product Life Cycle:

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Phase IV dominates the market with 76.5% share due to focus on post-marketing surveillance and long-term drug safety evaluation.

Breakup By Type:

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining

Spontaneous reporting holds the largest share (31.9%) owing to its widespread use in identifying adverse drug reactions cost-effectively.

Breakup By Process Flow:

• Signal Detection
• Risk Assessment
• Risk Management
• Medical Writing and Reporting
• Others

Signal detection dominates with 38.2% market share due to its central role in detecting and managing safety concerns through real-time data collection.

Breakup By Therapeutic Area:

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

Oncology leads the market with 27.8% share due to the highest number of clinical trials, complex immunotherapies, and increasing global cancer prevalence.

Breakup By End Use:

• Pharmaceuticals Companies
• Biotechnology Companies
• Medical Device Companies
• Others

Pharmaceutical companies dominate with 44.2% share due to significant responsibilities in drug development, safety monitoring, and regulatory compliance.

Breakup By Region:

• North America (United States, Canada)
• Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
• Latin America (Brazil, Mexico, Others)
• Middle East and Africa

North America enjoys the leading position with 33.7% market share owing to advanced healthcare infrastructure, stringent FDA regulations, and significant investments in drug safety programs.

Recent News and Developments in Pharmacovigilance Market

• January 2025: Clinigen formed a strategic partnership with Tepsivo, acquiring a minority stake in the global digital pharmacovigilance services provider to modernize PV services and accelerate drug development worldwide.
• January 2025: IQVIA partnered with NVIDIA aimed at advancing "agentic AI" applications across the therapeutic lifecycle, enhancing pharmacovigilance capabilities through cutting-edge artificial intelligence integration.
• August 2024: The Pharmacovigilance Programme of India (PvPI) launched ADRMS software as part of 'Digital India' initiative, creating India's first safety database for comprehensive adverse event reporting.

Note: If you require specific details, data, or insights that are not currently included in the scope of this report, we are happy to accommodate your request. As part of our customization service, we will gather and provide the additional information you need, tailored to your specific requirements. Please let us know your exact needs, and we will ensure the report is updated accordingly to meet your expectations.

About Us:

IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

Contact Us:

IMARC Group

134 N 4th St. Brooklyn, NY 11249, USA

Email: sales@imarcgroup.com

Tel No:(D) +91 120 433 0800

United States: +1-201971-6302