Global Pharmacovigilance and Drug Safety Software Market - Segmented by Functionality, Mode of Delivery, End Users, and Geography - Growth, Trends, and Forecast (2018 - 2023)

  • ID: 4591731
  • Report
  • Region: Global
  • 114 pages
  • Mordor Intelligence
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  • Ab Cube
  • Arisglobal
  • Ennov Solutions Inc.
  • Extedo Gmbh
  • Oracle Corporation
  • Sarjen Systems Pvt Ltd
  • MORE
The global pharmacovigilance and drug safety software market is projected to witness a CAGR of 6% during the forecast period of 2018-2023.

Increasing Incidences of Adverse Drug Reactions (ADRs)

Adverse drug reaction (ADR) refers to injuries arising from the consumption of medication. ADR may arise due to a single dose of the medication or may manifest after prolonged exposure. ADR can also arise due to the interaction between two or more drug substances consumed simultaneously or in quick succession. ADRs cause considerable mortality and morbidity worldwide. According to research estimates, approximately 5% of all hospital admissions in Europe are caused by ADRs. Additionally, there is a high incidence rate of ADR among hospitalized patients. Pharmacovigilance assumes great importance in such settings. The World Health Organization (WHO), in 1971, devised an international system for monitoring adverse reactions to drugs by using information derived from member states. The global database for ADRs is maintained by Uppsala Monitoring Centre (UMC), based in Sweden. The database contains reports of suspected ADRs, so-called Individual Case Safety Reports (ICSRs), and collected by national drug authorities in over 110 countries spanning over more than 100,000 different medicinal products. The extensive nature of this database is indicative of the myriad of ADR cases that arise globally and need to be monitored for mitigating future incidences. Thus, the increasing incidence of ADRs is driving the growth of global pharmacovigilance and drug safety software market. Apart from these, factors, like increasing adoption of pharmacovigilance software by outsourcing companies involved in contract research and contract manufacturing, and government policies pertaining to drug safety regulation are driving the growth of this market.

Lack of Pharmacovigilance Professionals

Healthcare professionals play a crucial role in the pharmacovigilance system. Professionals in this field are required to possess considerable knowledge and expertise in the field of medication safety to successfully contribute to this area through early recognition, management, and reporting of the medicine safety issues. Furthermore, the healthcare professionals should be well educated about the necessity and procedure of adverse event reporting. They should possess a combination of training and research skills in this area. Despite global concerns against medication safety, there is a lack of awareness and knowledge of pharmacovigilance and ADR reporting among healthcare professionals. Moreover, recent studies have indicated that ADRs are poorly reported by healthcare providers, especially in developing countries. Consequently, the lack of pharmacovigilance professionals inhibits the growth of this market. Further, the lack of standard regulations in adverse drug reaction reporting is restraining the growth of this market.

Drug Safety Audits Software Leads the Market 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 recent trends the fully integrated software category is the fastest growing category, but the market leader in the segment is drug safety audits software. Its high market share is attributed to the increasing number of contract research and manufacturing organizations, which are making extensive use of safety audits for ensuring compliance with standards set by apex drug regulatory bodies.

Key Developments in the Market
  • February 2018: Ennov announced that it will be exhibiting at the DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum. The exhibition will showcase Ennov’s regulatory platform, which consists of Ennov Doc, Ennov Dossier, Ennov RIM, and Ennov IDMP.
  • February 2018: ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced two new products - LifeSphere Publishing and LifeSphere Analytics, which will integrate with LifeSphere RIMS and LifeSphere IMDP.

Reasons to Purchase the Report
  • Follow the current and future pharmacovigilance and drug safety software market in the developed and emerging markets.
  • Analyzing various perspectives of the market with the help of Porter’s Five Forces Analysis.
  • Identify the segment that is expected to dominate the market.
  • Identify the regions that are expected to witness the fastest growth during the forecast period.
  • Identify the latest developments, market shares, and strategies employed by the major market players.
  • 3 month analyst support along with the Market Estimate sheet (in Excel).
Customization of the Report

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Note: Product cover images may vary from those shown
2 of 5


  • Ab Cube
  • Arisglobal
  • Ennov Solutions Inc.
  • Extedo Gmbh
  • Oracle Corporation
  • Sarjen Systems Pvt Ltd
  • MORE
1. Introduction
1.1 Market Definition

2. Research Methodology

3. Executive Summary

4. Key Inferences

5. Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Products and Services
5.2.5 Competitive Rivalry within the Industry

6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1 Drivers
6.1.1 Development of Novel and Safe Drugs
6.1.2 Increasing Adoption of Pharmacovigilance Software by Outsourcing Companies
6.1.3 Increasing Incidence Rates of Adverse Drug Reactions (ADRs)
6.1.4 Government Policies Pertaining to Drug Safety Regulations
6.2 Market Restraints
6.2.1 Shortage of Standard Regulations
6.2.2 Lack of Pharmacovigilance Professionals
6.3 Opportunities
6.4 Key Challenges

7. Market Segmentation
7.1 By Functionality
7.1.1 Adverse Event Reporting Software
7.1.2 Drug Safety Audits Software
7.1.3 Issue Tracking Software
7.1.4 Fully Integrated Software
7.2 By Mode of Delivery
7.2.1 On-premise Delivery
7.2.2 On-demand/ Cloud-based (SaaS) Delivery
7.3 By End Users
7.3.1 Pharma and Biotech Companies
7.3.2 Contract Research Organisations
7.3.3 Business Process Outsourcing Firms
7.3.4 Other Pharmacovigilance Service Providers
7.4 By Geography
7.4.1 North America US Canada Mexico Rest of North America
7.4.2 Europe UK Germany France Italy Spain Rest of Europe
7.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
7.4.4 Middle East & Africa GCC South Africa Rest of Middle East & Africa
7.4.5 South America Brazil Argentina Rest of South America

8. Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches

9. Key Players
9.1 Ab Cube
9.2 ArisGlobal
9.3 Ennov Solutions, Inc.
9.4 Extedo GmbH
9.5 Online Business Applications, Inc.
9.6 Oracle Corporation
9.7 Sarjen Systems Pvt Ltd
9.8 Sparta Systems, Inc.
9.9 Umbra Global LLC
9.10 United BioSource Corporation
9.11 List not Exhaustive

10. Future of the Market
Note: Product cover images may vary from those shown
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4 of 5
  • Arisglobal
  • Ennov Solutions Inc.
  • Extedo Gmbh
  • Online Business Applications Inc.
  • Oracle Corporation
  • Sarjen Systems Pvt Ltd
  • Sparta Systems Inc.
  • United Biosource Corporation
  • Ab Cube
  • Umbra Global Llc.
Note: Product cover images may vary from those shown
5 of 5
Note: Product cover images may vary from those shown