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Pharmacovigilance and Drug Safety Software Markets: Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, Fully Integrated Software - Global Forecast to 2026 -

DUBLIN--(BUSINESS WIRE)--The "Pharmacovigilance and Drug Safety Software Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)" report has been added to's offering.

The pharmacovigilance and drug safety software market is expected to register a high growth due to the increasing incidence of adverse drug reactions (ADRs) that is the major driving factor for the growth of the pharmacovigilance and drug safety software market.

According to the National Institute of Health, approximately 5% of all hospital admissions in Europe are caused by ADRs. Furthermore, factors, like the increasing adoption of pharmacovigilance and drug safety software by the outsourcing companies involved in contract research and contract manufacturing, owing to the rising number of drugs on the market, and an upward trend in polypharmacy, and government policies pertaining to drug safety regulations are driving the growth of the market.

However, lack of awareness and knowledge about pharmacovigilance and ADRs among healthcare professionals, and adverse effects of drugs are found restraining the growth of the pharmacovigilance and drug safety software market.

Key Market Trends

Drug Safety Audits Software is Expected to Hold a High Market Share in the Functionality Segment

By functionality, the pharmacovigilance and drug safety software market has been segmented into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software.

Based on the recent trends, the high market share of the drug safety audits software segment is attributed to the increasing number of contract research and manufacturing organizations that are making extensive use of drug safety audits software for ensuring compliance with standards set by apex drug regulatory bodies. In addition, the fully integrated software segment is also one of the fastest-growing segments in the market.

North America Dominates the Market and Expected to do the Same in the Forecast Period

North America is found dominating the pharmacovigilance and drug safety software market, due to the increasing research expenditure and government initiatives in the region. Adverse drug reactions are one of the major causes of hospitalizations and deaths in the United States, thus, fueling the pharmacovigilance and drug safety software market.

Furthermore, initiatives undertaken by the governments are also propelling the growth of the market in North America. For instance, the Open FDA initiative undertaken by the US government provides access to its database, by open search-based programs, for application developers and scientists. Additionally, the United States initiated another project, called Mini-Sentinel, to promote active surveillance system by providing relevant statistical data in less time.

Competitive Landscape

The companies operating in the pharmacovigilance and drug safety software market are capitalizing on the innovative researches focusing on the development of editing techniques. Key strategies implemented by the market players, including mergers, acquisitions, and strategic collaborations for R&D outsourcing or manufacturing activities, are driving the market growth.


Key Topics Covered:



1.1 Study Deliverables

1.2 Study Assumptions

1.3 Scope of the Study







4.1 Market Overview

4.2 Market Drivers

4.2.1 Increasing Incidence of Adverse Drug Reactions (ADRs)

4.2.2 Increasing Adoption Of Pharmacovigilance Software By Outsourcing Companies

4.3 Market Restraints

4.3.1 Lack of Awareness About Pharmacovigilance

4.4 Porter's Five Forces Analysis



5.1 By Functionality

5.1.1 Adverse Event Reporting Software

5.1.2 Drug Safety Audits Software

5.1.3 Issue Tracking Software

5.1.4 Fully Integrated Software

5.2 By Mode of Delivery

5.2.1 On-premise Delivery

5.2.2 On-demand/ Cloud-based (SaaS) Delivery

5.3 By End-Users

5.3.1 Pharmaceutical and Biotechnology Companies

5.3.2 Contract Research Organizations

5.3.3 Business Process Outsourcing Firms

5.3.4 Other Pharmacovigilance Service Providers

5.4 Geography



6.1 Company Profiles

6.1.1 Ab Cube

6.1.2 ArisGlobal

6.1.3 Ennov Solutions Inc.

6.1.4 Extedo GmbH

6.1.5 Online Business Applications Inc.

6.1.6 Oracle Corporation

6.1.7 Sarjen Systems Pvt Ltd

6.1.8 Sparta Systems Inc.

6.1.9 United BioSource Corporation

6.1.10 Max Application

6.1.11 Veeva Systems

6.1.12 Phase Forward




For more information about this report visit

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Last Updated: 03-Mar-2021