Pharmacovigilance Market to be Worth $18.05 Billion by 2031

Pharmacovigilance Market Size, Share, Forecast, & Trends Analysis by Offering (Software [Adverse Event Reporting, Issue Tracking, Drug Safety Audit], Services [Spontaneous Reporting, Case Logging]), Phase, Therapeutic Area, End User – Global Forecast to 2031

Meticulous Research^®—a leading global market research company, published a research report titled, ‘Pharmacovigilance Market Size, Share, Forecast, & Trends Analysis by Offering (Software [Adverse Event Reporting, Issue Tracking, Drug Safety Audit], Services [Spontaneous Reporting, Case Logging]), Phase, Therapeutic Area, End User – Global Forecast to 2031.’

According to this latest publication from Meticulous Research^®, the pharmacovigilance market is projected to reach $18.05 billion by 2031 at a CAGR of 10.7% from 2024 to 2031. The growth of this market is mainly driven by the rising incidence of drug toxicity, stringent regulatory frameworks, increasing pharmaceutical research spending, rising need for new drug development, and the increasing focus on medical device safety. However, the high costs of pharmacovigilance services limit their adoption among small & mid-sized companies, restraining the growth of this market.

Furthermore, the introduction of technologically advanced software, growing awareness regarding adverse drug reactions, therapeutic approaches requiring a combination of drugs, and the increasing outsourcing of pharmacovigilance services are expected to generate growth opportunities for the stakeholders in this market. However, data security risks and the shortage of skilled pharmacovigilance professionals are major challenges for market growth.

Key Players

The key players operating in the pharmacovigilance market are 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.), Capgemini SE (France), Syneos Health (U.S.), ArisGlobal (U.S.), Ennov (France), EXTEDO GmbH (Germany), Oracle Corporation (U.S.), Sparta Systems Inc. (U.S.), United BioSource, LLC (UBC) (U.S.), and AB Cube S.A.S. (France).

Pharmacovigilance Market: Future Outlook

The pharmacovigilance market is segmented by 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 (Case Logging, Case Data Analysis, and Medical Review & Reporting), Signal Detection (Adverse Event Logging, Adverse Event Analysis, and Adverse Event Review & Reporting), Risk Management System (Risk Evaluation System and Risk Mitigation System)}]), Drug Development Phase (Phase IV, Phase III, Phase II, Phase I, and Preclinical Studies), Therapeutic Area (Oncology, Cardiology/Vascular Diseases, Infectious Diseases, Immunology, Neurology, and Other Therapeutic Areas), End User (Pharmaceutical & Biotechnology Companies, Medical Device Manufacturers, Government Agencies, and Other End User), and Geography. The study also evaluates industry competitors and analyzes the market at the regional and country levels.

Based on offering, in 2024, the services segment is expected to account for the major share of the pharmacovigilance market. The segment’s large share is attributed to the need for regulatory compliance, rising drug complexity, globalization of clinical trials, and increasing awareness about drug safety. The increasing outsourcing of pharmacovigilance services to third-party vendors also contributes to the segment’s large share.

Based on drug development phase, in 2024, the Phase IV segment is expected to account for the largest share of the pharmacovigilance market. The study design and sample sizes are larger and more complex in Phase IV as the drug is tested post-approval; hence, the demand for pharmacovigilance services is higher in Phase IV due to the need for efficient management and data analysis. Pharmaceutical companies’ increasing spending on drug development, the rising number of drugs in the pipeline, increasing regulatory requirements from Phase IV clinical trials, and the pharmacoeconomic evaluation of drugs in Phase IV are increasing the demand for pharmacovigilance services in Phase IV, contributing to the segment’s large share.

Based on therapeutic area, in 2024, the oncology segment is expected to account for the largest share of the pharmacovigilance market. The high burden of cancer, increasing research on cancer medicine, recent product approvals, rising number of clinical trials, and increasing public & private funding for the development of oncology treatments contribute to the segment’s large share. According to ClinicalTrials.gov, a database of publicly and privately funded global clinical trials, from 2017 to 2022, oncology had the highest number of clinical trials among all therapeutic areas.

Based on end user, in 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the pharmacovigilance market. The large share of this segment is attributed to pharmaceutical & biotechnology companies’ increased investments in R&D and rising funding for pharmaceutical research. The rising demand for new drugs and therapies is driving an increase in funding for research laboratories, boosting the demand for pharmacovigilance solutions. For instance, NIH funding for research increased from USD 42 billion in 2021 to USD 45 billion in 2022 (Source: Congressional Research Service).

This research report provides a comprehensive analysis of the pharmacovigilance market in 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), and the Middle East & Africa.

Based on geography, Asia-Pacific is slated to register the highest growth rate during the forecast period. Increasing research on vaccines, rising pharmaceutical R&D expenditure, the growing focus on personalized medicine, and advancements in the biotechnology sector are driving market growth in the region.

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Key Questions Answered in the Report:

Which are the high-growth market segments in terms of offering, drug development phase, therapeutic area, end user, and geography?
What was the historical market size for pharmacovigilance globally?
What are the market forecasts and estimates for the period 2024–2031?
What are the major drivers, restraints, opportunities, challenges, and trends in the pharmacovigilance market?
Who are the major players in the pharmacovigilance market?
What is the competitive landscape like, and who are the market leaders in the pharmacovigilance market?
What are the recent developments in the pharmacovigilance market?
What are the growth strategies adopted by major players in the pharmacovigilance market?
What are the geographical trends, and which are the high-growth regions/countries?

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