Global Pharmacovigilance and Drug Safety Software Market to Reach USD 350.8 Million by 2033, Bolstered by Stringent Regulations

December 25, 2024 | Healthcare

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The latest report by IMARC Group, titled “Pharmacovigilance and Drug Safety Software Market Report by Functionality (Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, Fully Integrated Software), Delivery Mode (On-premises, Cloud-based), End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms, and Others), and Region 2025-2033,” finds that the global pharmacovigilance and drug safety software market reached a value of USD 214.2 Million in 2024. Pharmacovigilance (PV) and drug safety software is a management solution that enables the creation, classification, review, submission, and maintenance of PV data and adverse event reports. The process involves monitoring medical drug effects to identify and examine the unfavorable reactions of the drugs. It creates more knowledge and awareness among healthcare professionals. PV and drug safety software offers swift science-based safety decisions, ensures global regulatory compliance, integrates safety and risk management, and lowers the cost of PV procedures. As a result, the software is extensively employed by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms (BPOs), and other PV service providers.

Global Pharmacovigilance and Drug Safety Software Market Trends:

The market is primarily driven by the growing adoption of PV and drug safety software by various clinical research and outsourcing companies. The rising prevalence of chronic diseases, coupled with the increasing incidence rates of adverse drug reactions (ADRs), are also fueling the growth of the market. In addition to this, the easy adoption of the software due to the availability of cutting-edge technology is also propelling the market growth. Governments across various countries are imposing strict regulations for the commercialization of drugs. Consequently, the growing complexity related to drug safety regulations is also propelling the market growth. Furthermore, rapid digitization of clinical trials, along with the adoption of advanced technologies that improve compliance and product safety in PV and drug safety software, is creating a positive outlook for the market. Looking forward, the market is expected to reach a value of USD 350.8 Million by 2033, exhibiting a CAGR of 5.63% during the forecast period (2025-2033).

Market Summary:

Based on the functionality, the market has been segmented into adverse event reporting, drug safety audits, issue tracking, and fully integrated software.
On the basis of the delivery mode, the market has been classified into on-premises and cloud-based delivery modes.
The market has been categorized based on the end user into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and others.
Region-wise, the market has been divided into North America (the United States and Canada), Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others), Latin America (Brazil, Mexico, and others), and Middle East and Africa.
The competitive landscape of the market has been examined, with some of the key players being Ab Cube SARL, Anju Software Inc., ArisGlobal LLC, Cognizant Technology Solutions, Ennov Solutions Inc., Extedo GmbH, Max Application, Oracle Corporation, Sarjen Systems Private Limited, Sparta Systems Inc. (Honeywell International Inc.), Tata Consultancy Services Limited, United BioSource LLC, and Wipro Limited.

Report Coverage:

Report Features	Details
Base Year of the Analysis	2024
Historical Period	2019-2024
Forecast Period	2025-2033
Units	Million USD
Segment Coverage	Functionality, Delivery Mode, End User, Region
Region Covered	Asia Pacific, Europe, North America, Latin America, Middle East and Africa
Countries Covered	United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico
Companies Covered	Ab Cube, Anju Software Inc., ArisGlobal LLC, Cognizant, Ennov Solutions Inc., Extedo GmbH, Max Application, Oracle Corporation, Sarjen Systems Pvt Ltd, Sparta Systems Inc. (Honeywell International Inc.), Tata Consultancy Services Limited, United BioSource LLC and Wipro Limited.
Customization Scope	10% Free Customization
Post-Sale Analyst Support	10-12 Weeks
Delivery Format	PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)

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Global Pharmacovigilance and Drug Safety Software Market to Reach USD 350.8 Million by 2033, Bolstered by Stringent Regulations

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