According to the latest publication by Meticulous Research®, the global pharmacovigilance market is projected to reach $18.05 billion by 2031, growing at a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031. The market's growth is primarily driven by the rising incidence of drug toxicity, stringent regulatory frameworks, increased pharmaceutical research spending, the need for new drug development, and a heightened focus on medical device safety. However, high costs associated with pharmacovigilance services can limit adoption among small and mid-sized companies, thereby restraining market growth.

Technological advancements in software, increased awareness regarding adverse drug reactions, therapeutic approaches involving combination drugs, and the growing outsourcing of pharmacovigilance services are expected to provide significant growth opportunities. However, data security risks and a shortage of skilled pharmacovigilance professionals pose major challenges.

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Key Players:

The leading companies in the pharmacovigilance market include: IQVIA (U.S.), Cognizant Technology Solutions Corporation (U.S.), Linical Co., Ltd (U.S.), International Business Machines Corporation (U.S.), Laboratory Corporation of America Holdings (U.S.), ICON plc (Ireland), Parexel International (U.S.), Wipro Limited (India), Sanofi S.A. (France), Pharmaceutical Product Development Inc. (a subsidiary of Thermo Fisher Scientific Inc.) (U.S.),

Market Segmentation:

The pharmacovigilance market is segmented by offering, drug development phase, therapeutic area, end user, and geography.

Offering:

• Software: Deployment Mode (On-premise and Cloud-based), Functionality (Issue Tracking Software, Adverse Event Reporting Software, Fully Integrated Software, Drug Safety Audit Software, and Other Functionalities)
• Services: Service Provider (In-house and Contract Outsourcing), Type (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining, and Other Services), Process (Core Services and Consulting Services), Process Outflow (Case Data Management, Signal Detection, Risk Management System)

In 2024, the services segment is expected to account for the major share of the pharmacovigilance market. This is due to the need for regulatory compliance, rising drug complexity, globalization of clinical trials, and increasing awareness about drug safety. Additionally, the outsourcing of pharmacovigilance services to third-party vendors contributes to this segment's large share.

Drug Development Phase:

• Phase I
• Phase II
• Phase III
• Phase IV
• Preclinical Studies

The Phase IV segment is anticipated to account for the largest share in 2024, driven by the larger and more complex study designs and sample sizes required post-approval, as well as increased spending on drug development, a rising number of drugs in the pipeline, and increasing regulatory requirements.

Therapeutic Area:

• Oncology
• Cardiology/Vascular Diseases
• Infectious Diseases
• Immunology
• Neurology
• Other Therapeutic Areas

Oncology is expected to hold the largest share of the market in 2024, driven by the high burden of cancer, increasing research in oncology, recent product approvals, a rising number of clinical trials, and growing public and private funding for cancer treatments.

End User:

• Pharmaceutical & Biotechnology Companies
• Medical Device Manufacturers
• Government Agencies
• Other End Users

The pharmaceutical & biotechnology companies segment is projected to hold the largest share in 2024, attributed to increased investments in R&D and rising funding for pharmaceutical research.

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Geography:

• North America (U.S. and Canada)
• Europe (Germany, France, U.K., Italy, Spain, Belgium, Netherlands, Denmark, Sweden, and Rest of Europe)
• Asia-Pacific (China, Japan, India, South Korea, Australia, and Rest of Asia-Pacific)
• Latin America (Brazil, Mexico, and Rest of Latin America)
• Middle East & Africa

Asia-Pacific is expected to register the highest growth rate during the forecast period due to increasing vaccine research, rising pharmaceutical R&D expenditure, a growing focus on personalized medicine, and advancements in the biotechnology sector.

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