Pharmacovigilance (PV) software comprises drug safety management software solution that enables to create, classify, review, submit, and maintain pharmacovigilance data and adverse event reports. This PV software is used by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms (BPOs), and other pharmacovigilance service providers.

The global pharmacovigilance software market is poised to grow at a CAGR of 6.5% during 2014-2019, and is expected to reach a value of $154.1 Million in 2019. Factors such as rising incidence rates of adverse drug reactions (ADRs) and increasing adoption of pharmacovigilance software by outsourcing companies are driving the growth of the global drug safety software market. In addition; government regulatory bodies (such as the U.S. FDA and EMEA) have intensified safety regulations for prior and post commercialization of drugs, which has increased pressure on the pharmaceutical and biotechnology companies to manufacture safe drugs and evaluate their results post sales. Thus, growing complexity related to drug safety regulations is expected to drive the growth of the market during the forecast period.

North America is expected to account for the largest share of the drug safety software market, followed by Europe, in 2014. However, Asian and Latin American countries represent high growth markets, owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations. Some of the key players in the global market include ArisGlobal (U.S.), Ennov Solutions Inc. (U.S.), EXTEDO GmbH (U.S.), Online Business Applications, Inc. (U.S.), Oracle Corporation (U.S.), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (U.S.), and United BioSource Corporation (U.S.), among others.

Pharmacovigilance Software Market : Scope of the Report

This research report categorizes the pharmacovigilance software market into the following segments:

Pharmacovigilance and Drug Safety Software Market, By Functionality

Adverse Event Reporting Software

Drug Safety Audits Software

Issue Tracking Software

Fully Integrated Software

Pharmacovigilance and Drug Safety Software Market, By Delivery Mode

On-premise Delivery Mode

On-demand/Cloud based (SaaS) Delivery Mode

Pharmacovigilance and Drug Safety Software Market, By End User

Pharma and Biotech Companies

Contract Research Organizations (CROs)

Business Process Outsourcing (BPO) Firms

Other Pharmacovigilance Service Providers

Pharmacovigilance and Drug Safety Software Market, By Region

North America U.S. Canada

Europe Germany U.K. France Rest of Europe

Asia-Pacific Japan India China Rest of Asia-Pacific

Rest of the World (RoW) Latin America Middle East Africa



On the basis of functionality, the global pharmacovigilance software market is classified into four major segments, namely, adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software.

The global drug safety software market is divided into two segments on the basis of delivery mode, namely, on-premise delivery mode and on-demand/cloud based (SaaS) delivery mode. This market is also divided into pharma and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, and other pharmacovigilance service providers on the basis of type of end user.

The global pharmacovigilance software market is expected to grow at a CAGR of 6.5% from 2014 to 2019. Factors such as increasing incidence rates of adverse drug reactions (ADRs) and growing adoption of pharmacovigilance software by organizations such as CROs and BPOs are driving the growth of the global market. In addition; government regulatory bodies (such as the U.S. FDA and EMEA) have intensified safety regulations for prior and post commercialization of drugs, which has increased pressure on the pharmaceutical and biotechnology companies to manufacture safe drugs and evaluate their results post sales. Thus, growing complexity related to drug safety regulations is expected to drive the growth of the market during the forecast period.

On the basis of regions, this market is classified into four regions and their respective countries, namely, North America (U.S. and Canada), Europe (Germany, U.K., France, and Rest of Europe), Asia-Pacific (Japan, India, China, and Rest of Asia-pacific), and the Rest of the World (Latin America, Middle East, and Africa). North America is expected to account for the largest share of the drug safety software market, followed by Europe, in 2014. However, Asian and Latin American countries represent high growth markets, owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations.

New service launches; agreements, and partnerships; software developments; and geographical expansions are some of the key strategies adopted by most of the market players to achieve growth in the market.