Pharmacovigilance software is a drug safety management software solution that supports case management, report preparation, electronic submissions and benefit & risk management as per the guidelines set by ICH, FDA, EMA and other national authorities. In simple words, pharmacovigilance software enables to create, classify, review, submit, and maintain pharmacovigilance data and adverse drug event reports. With this support, pharmacovigilance is pushing new boundaries in market enabling companies to implement proactive safety surveillance programs. This software is used by pharma and biotech companies, contract research organizations (CROs), business process outsourcing firms and other similar service providers to develop novel and safe drugs which is one of the key driving factors for its market growth.
Pharmacovigilance software which is able to uncover, evaluate and avert the temporary and enduring side effects of medications, can also be used to identify the cause of withdrawal and helps to inhibit unnecessary future events. This software is beneficial to everyone concerned with the medical process including, the makers, prescribers and consumers of drugs.
North America holds the largest share of the global pharmacovigilance software market, followed by Europe. However, Asian and Latin American countries also contribute to its market at a high growth rate because of rise in research outsourcing by pharmaceutical companies and increased public and private investments in pharmaceutical R&D
Aging population and prevalence of chronic disorders increased the need for new drug development. Relating to these factors, increasing incidence rates of adverse drug reaction, government policies pertaining to drug safety regulations are some key factors driving the pharmacovigilance market. The limitations of financial resources and personnel faced by small organizations are minimized by using pharmacovigilance software. The shortage of standard regulations and lack of pharmacovigilance professionals are some of the key factors restraining the growth of this market.
The Key players in global pharmacovigilance and drug safety software market include ArisGlobal, Ennov Solutions Inc, EXTEDO GmbH, Online Business Applications, Inc, Oracle Corporation, Sarjen Systems Pvt. Ltd, Sparta Systems Inc, United BioSource Corporation, AB Cube and UMBRA Global LLC among others
Key Deliverables in the Study?
1) Market Definition for the specified topic along with identification of key drivers and restraints for the market.
2) Market analysis for the Global Pharmacovigilance Software Market in Healthcare Industry, with region specific assessments and competition analysis on a global and regional scale.
3) Identification of factors instrumental in changing the market scenarios, rising prospective opportunities and identification of key companies which can influence the market on a global and regional scale.
4) Extensively researched competitive landscape section with profiles of major companies along with their strategic initiatives and market shares.
5)Identification and analysis of the Macro and Micro factors that affect the Global Pharmacovigilance Software Market in Healthcare Industry on both global and regional scale.
6) A comprehensive list of key market players along with the analysis of their current strategic interests and key financial information.
1.1 Report Description
1.2 Research Methodology
2. Executive Summary
3. Market Overview
3.1 Market Definition
3.2 Market Drivers
3.2.1 Development of novel and safe drugs
3.2.2 Prevalence of chronic disorders
3.3.3 Aging population
3.3.4 High incidence rates of adverse drug reaction
3.4.5 Government policies pertaining to drug safety regulations
3.3 Market Restraints
3.3.1 Shortage of standard regulations
3.3.2 Lack of pharmacovigilance professionals
3.4 Market Opportunitites
3.5 Market Threats
4. Porters Five Force Analysis
4.1 Bargaining Power of suppliers
4.2 Bargaining power of buyers
4.3 Degree of competition
4.4 Threat of substitution
4.5 Threat of new entrants
5. Market Segmentation
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 Pharma and Biotech Companies
5.3.2 Contract Research Organizations
5.3.3 Business Process Outsourcing Firms
5.3.4 Other pharmacovigilance service providers
5.4 By Geography
5.4.1 North America
220.127.116.11 Scandinavian Regions
18.104.22.168 Rest of Europe
5.4.4 Rest of Asia Pacific
6. Competitive Landscape
7. Company Profiles
7.2 Ennov Solutions Inc
7.3 EXTEDO GmbH
7.4 Online Business Applications, Inc
7.5 Oracle Corporation
7.6 Sarjen Systems Pvt. Ltd
7.7 Sparta Systems Inc
7.8 United BioSource Corporation
7.9 AB Cube
7.10 UMBRA Global LLC