Pharmacovigilance and Drug Safety Software Market - Growth, Trends, and Forecast (2019 - 2024)

The Pharmacovigilance and Drug Safety Software Market is segmented by Functionality, Mode of Delivery, End User, and Geography.

Market Snapshot

pharmacovigilance and drug safety software market
Study Period:


Base Year:


Fastest Growing Market:

Asia Pacific

Largest Market:

North America

Key Players:

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Pharmacovigilance and Drug Safety Software Market

The pharmacovigilance and drug safety software market is expected to register a healthy CAGR of nearly 6.4 % during the forecast period, 2019 - 2024.

  • Increasing incidence of adverse drug reactions (ADRs) is the major driving factor for the growth of the pharmacovigilance and drug safety software market.
  • According to research estimates, 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 regulation are driving the growth of the market.
  • However, lack of awareness and knowledge about pharmacovigilance and ADRs among healthcare professionals, lack of professionals in the field of pharmacovigilance, and dearth of standard regulations pertaining to ADR reporting are restraining the growth of the pharmacovigilance and drug safety software market.

Scope of the Report

Drug safety, or pharmacovigilance, is the science of detection, assessment, monitoring, and prevention of side effects associated with drugs. It helps understand more about the risks and benefits of a medicine. Pharmacovigilance is an important and integral part of clinical research. Currently, many pharmacovigilance centers are working for drug safety monitoring on a global level.

Adverse Event Reporting Software
Drug Safety Audits Software
Issue Tracking Software
Fully Integrated Software
Mode of Delivery
On-premise Delivery
On-demand/ Cloud-based (SaaS) Delivery
End Users
Pharmaceutical and Biotechnology Companies
Contract Research Organizations
Business Process Outsourcing Firms
Other Pharmacovigilance Service Providers
North America
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East & Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

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Key Market Trends

Drug Safety Audits Software Segment Leads the Market

The pharmacovigilance and drug safety software market is segmented on the basis of functionality, mode of delivery, and end users. 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, although the fully integrated software segment is the fastest growing, the leading segment in the market is that of drug safety audits software. 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.

pharmacovigilance and drug safety software market

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North America Dominates the Pharmacovigilance and Drug Safety Software Market

North America is 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.

pharmacovigilance and drug safety software market

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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. In February 2018, Ennov announced its plans to exhibit its solutions at the DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum. The exhibition showcased Ennov’s regulatory platform, which consists of Ennov Doc, Ennov Dossier, Ennov RIM, and Ennov IDMP. Additionally, in February 2018, ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced the launch of two new products, namely LifeSphere Publishing and LifeSphere Analytics, which may integrate with LifeSphere RIMS and LifeSphere IMDP.

Major Players

  1. Ab Cube
  2. ArisGloba
  3. Ennov Solutions Inc.
  4. Extedo GmbH
  5. United BioSource Corporation

* Complete list of players covered available in the table of contents below

pharmacovigilance and drug safety software market

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Large Population Addicted to Smoking

      2. 4.2.2 Awareness about the Hazards of Smoking

      3. 4.2.3 Banning Advertisements of Tobacco Products

    3. 4.3 Market Restraints

      1. 4.3.1 Adverse Effects of Drugs

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 Functionality

      1. 5.1.1 Adverse Event Reporting Software

      2. 5.1.2 Drug Safety Audits Software

      3. 5.1.3 Issue Tracking Software

      4. 5.1.4 Fully Integrated Software

    2. 5.2 Mode of Delivery

      1. 5.2.1 On-premise Delivery

      2. 5.2.2 On-demand/ Cloud-based (SaaS) Delivery

    3. 5.3 End Users

      1. 5.3.1 Pharmaceutical and Biotechnology Companies

      2. 5.3.2 Contract Research Organizations

      3. 5.3.3 Business Process Outsourcing Firms

      4. 5.3.4 Other Pharmacovigilance Service Providers

    4. 5.4 Geography

      1. 5.4.1 North America

        1. US

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. UK

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle East & Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Ab Cube

      2. 6.1.2 ArisGlobal

      3. 6.1.3 Ennov Solutions Inc.

      4. 6.1.4 Extedo GmbH

      5. 6.1.5 Online Business Applications Inc.

      6. 6.1.6 Oracle Corporation

      7. 6.1.7 Sarjen Systems Pvt Ltd

      8. 6.1.8 Sparta Systems Inc.

      9. 6.1.9 Umbra Global LLC

      10. 6.1.10 United BioSource Corporation

    2. *List Not Exhaustive

**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

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