Pharmacovigilance Market Poised To Reach USD 20,902.9 Million By 2035 Amid Rising Demand For Drug Safety Monitoring | Future Market Insights, Inc.

(MENAFN- GlobeNewsWire - Nasdaq) The US pharmacovigilance market is expanding due to rising chronic diseases, stringent FDA regulations, and AI-driven advancements. Despite high costs, growing R&D and patient safety efforts drive demand.

NEWARK, Del, March 12, 2025 (GLOBE NEWSWIRE) -- The global pharmacovigilance market is projected to witness robust growth, reaching USD 9,000.0 million by 2025 and expanding at a CAGR of 8.8% to attain USD 20,902.9 million by 2035. In 2024, the market revenue stood at approximately USD 7,400.0 million, highlighting the increasing significance of drug safety monitoring worldwide.

The growing incidence of chronic and long-term diseases, often requiring complex medication regimens, has heightened the risk of adverse drug reactions (ADRs). In response, pharmacovigilance systems and databases have been enhanced to improve ADR reporting accuracy, enabling more effective monitoring and ensuring patient safety.

As a result of the development of chronic illnesses, which necessitates the use of pharmacovigilance more frequently, there is an increased demand for novel pharmaceuticals that are created through meticulous clinical research.

It is anticipated that demand for pharmacovigilance services is likely to increase, as adverse drug reactions (ADRs) happen more frequently. Additionally, a combination of rising expectations for drug safety and rising patient consumption of medications is the main driver of the pharmacovigilance market expansion during the forecast period.

Moreover, clinicians must perform comprehensive tests and data analysis to assure minimal adverse effects, which forces big pharmaceutical companies to work with renowned pharmacovigilance service providers.

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As the pharmaceutical industry continues to expand, a surge in new drug approvals-including biologics, generics, and personalized medicine -is expected. These advancements bring unprecedented opportunities for disease treatment, ranging from chronic conditions to rare genetic disorders. However, they also pose new challenges for pharmaceutical companies, emphasizing the need for comprehensive post-market surveillance.

With every new drug approval, the demand for robust pharmacovigilance systems escalates. The industry must focus on early detection, evaluation, and reporting of ADRs, ensuring that patient safety remains a top priority in the evolving healthcare landscape. As a result, investments in advanced pharmacovigilance technologies will be crucial in addressing emerging safety concerns and maintaining regulatory compliance across global markets.

As the pharmacovigilance sector continues to evolve, stakeholders-including pharmaceutical companies, regulatory bodies, and healthcare providers-must collaborate to strengthen drug safety protocols. The market's projected growth underscores the critical role of pharmacovigilance in ensuring that medical advancements translate into safer, more effective treatments for patients worldwide.

Key Differentiators in the Pharmacovigilance Market

• Regulatory-Driven Market Expansion – Global regulatory bodies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan) are enforcing stringent compliance measures, making pharmacovigilance a non-negotiable requirement for drug manufacturers. Proactive pharmacovigilance strategies will be critical in securing market approvals and avoiding costly product recalls.
• Rise of AI and Automation in Drug Safety – With the growing complexity of drug monitoring, AI-powered signal detection, predictive analytics, and automated case processing are revolutionizing pharmacovigilance. Companies that integrate AI-driven safety solutions can enhance efficiency by up to 40% while improving risk assessment accuracy.
• Outsourcing Trends Reshaping the Landscape – Cost optimization and regulatory complexities are prompting pharma companies to outsource pharmacovigilance services to contract research organizations (CROs) and specialized service providers. Strategic partnerships in pharmacovigilance outsourcing can streamline operations and accelerate global market access.
• The Expanding Scope of Pharmacovigilance – The market is not just limited to traditional pharmaceuticals. It now encompasses biologics, biosimilars, gene therapies, and personalized medicine, creating new challenges and opportunities for companies to innovate in drug safety monitoring.
• Digital Transformation in Drug Surveillance – The rise of real-world data (RWD) and real-world evidence (RWE) is transforming pharmacovigilance from a reactive approach to a predictive, preventive strategy. Companies that integrate cloud-based safety databases and mobile-based ADR reporting tools will gain a competitive edge.
  

"As the pharmaceutical landscape evolves with new drug innovations, the importance of comprehensive pharmacovigilance strategies cannot be overstated. The industry's focus is shifting towards real-time safety monitoring, AI-driven signal detection, and regulatory compliance to safeguard patient health. Companies that invest in advanced pharmacovigilance technologies will be better positioned to navigate the increasingly stringent regulatory landscape and ensure drug safety." says Sabyasachi Ghosh Associate Vice President at Future Market Insights (FMI) analyst.

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Strategic Implications for Industry Leaders

• For Pharmaceutical Executives: Investing in cutting-edge safety monitoring systems and AI-driven pharmacovigilance can enhance regulatory compliance, reduce liabilities, and improve patient safety.
• For Biotech Innovators: Early integration of pharmacovigilance in clinical trials ensures seamless regulatory approvals and accelerates market entry for high-value biologics and gene therapies.
• For CROs & Outsourcing Partners: Offering cost-effective, high-compliance pharmacovigilance services will be key to capturing pharma companies seeking regulatory-ready solutions.
• For Regulatory & Compliance Leaders: Leveraging automated reporting systems and real-world data analytics can help navigate evolving global safety standards efficiently.

The Future of Pharmacovigilance:

With a dynamic regulatory landscape, rising drug complexities, and digital transformation accelerating the pharmacovigilance sector, decision-makers must act now to stay ahead. Strategic investments in AI, outsourcing, and advanced safety monitoring will differentiate market leaders from the competition.

Critical Highlights of the Pharmacovigilance Industry

• China is projected to experience the highest growth, with a CAGR of 8.9% from 2025 to 2035.
• India follows closely with a CAGR of 7.9%, indicating strong market expansion.
• Germany is expected to grow at a CAGR of 7.3%, reflecting steady progress.
• Brazil shows a CAGR of 6.0%, demonstrating moderate but significant growth.

Competition Dynamics in the Pharmacovigilance Market

The pharmacovigilance market is expanding rapidly, driven by increasing regulatory requirements, a rising incidence of adverse drug reactions (ADRs), and advancements in drug safety monitoring technologies. Leading players are focusing on automation, AI-powered data analysis, and global pharmacovigilance services to strengthen their market position. The industry remains highly competitive, with contract research organizations (CROs) and pharmaceutical companies actively investing in innovative drug safety solutions.

Leading Companies in the Pharmacovigilance Market

• IQVIA
• PARAXEL International Corporation
• Bioclinica
• Pharmaceutical Product Development (PPD)
• IBM Corporation
• ICON, plc
• PRA Health Sciences
• Covance Inc
• ArisGlobal
• Linical Accelovance
• Laboratory Corporation of America Holdings
• Accenture
• Clinquest Group B.V. (Linical Americas)
• Cognizant
• Capgemini
• ProPharma Group
• Freyr
• Syneos Health
• Midas Pharma
• CambReg

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Essential Segments of the Global Pharmacovigilance Market

By Type of Pharmacovigilance:

Clinical Trial Pharmacovigilance, Post-Marketing Pharmacovigilance, Comparative Pharmacovigilance, Herbal and Traditional Medicine Pharmacovigilance, Vaccine Pharmacovigilance, Targeted Pharmacovigilance and Active and Passive Pharmacovigilance

By Phases:

Pre-clinical, Phase I, Phase II, Phase III, and Phase IV

By Drug Class:

Large Molecule Drugs, Small Molecule Drugs and Herbal & Natural Products

By Therapeutic:

Oncology, Cardiology, Neurology, Immunology & Autoimmune Diseases, Gene & Cell Therapy-Related Adverse Events and Others

By Delivery Mode:

In-House Pharmacovigilance and Outsourced Pharmacovigilance

By End User:

Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations (CROs), Business Process Outsourcing (BPOs) Firms, Regulatory Authorities (e.g., FDA, EMA, MHRA), and Hospitals & Healthcare Providers

By Region:

North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, Middle East & Africa

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