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Pharmacovigilance and Drug Safety Software Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

  • ID: 5295029
  • Report
  • February 2022
  • Region: Global
  • 120 Pages
  • Mordor Intelligence


  • Ab Cube
  • ArisGlobal
  • Ennov Solutions Inc.
  • Extedo GmbH
  • Max Application
  • Oracle Corporation

The pharmacovigilance and drug safety software market is estimated to be valued at USD 165.08 million in 2021. It is expected to reach approximately USD 238.68 million in 2027, registering a CAGR of nearly 6.49% during the forecast period.

The evolving threat of the COVID-19 infection is adversely affecting communities, industries, businesses, and lives worldwide. Medical monitoring and safety reporting are essential as several potential therapies are used to treat the coronavirus infection. Medications like Lopinavir/Ritonavir, hydroxychloroquine (HCQ), and Remdesivir are repurposed to treat the infection. The chances of the suspected adverse drug reaction for some of these medicines have already been submitted to the individual case safety reports database named VigiBase, managed by Uppsala Monitoring Centre (UMC). Thus, the rising incidence of adverse drug reactions is anticipated to accelerate the demand for adverse event reporting systems amid the pandemic.

In March 2021, in response to COVID-19, Federal Drug Administration launched the FAERS Public Dashboard for COVID-19 emergency use authorization (EUA) products. The COVID-19 EUA FAERS Public Dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA in COVID-19. Such government initiatives will open up growth horizons to the market studied.

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

For instance, as per the article titled ‘Urgent Hospital Admissions Caused by Adverse Drug Reactions and Medication Errors - A Population-Based Study in Spain’ published in 2020, a total of 847 patients were urgently hospitalized. Of those, 71 were admitted due to an ADR (8.4%). The mean age was 73 ± 15.9 years, and the mean number of prescribed medications was 7.3 ± 3.6 drugs/patient on admission. Thus, more hospital admissions are due to adverse drug reactions. This is likely to boost the need for AER software in the coming years.

Factors like the increasing adoption of pharmacovigilance and drug safety software by the outsourcing companies involved in contract research and contract manufacturing due to the rising number of drugs, an upward trend in polypharmacy, and government policies about drug safety regulations are driving the market growth. However, a lack of awareness and knowledge about pharmacovigilance and ADRs among healthcare professionals and the adverse effects of drugs are restraining the growth of the pharmacovigilance and drug safety software market.

Key Market Trends

Fully Integrated Software Expected to Witness a High CAGR Over the Forecast Period

Monitoring and tracking an organization's drug safety reporting process can help ensure that issues are reported and addressed as soon as they happen, preventing delays and/or false reporting, which can lead to regulatory non-compliance, monetary fines, and unwanted attention.

The issue tracking software allows for electronic reporting of suspected adverse drug reactions and effective data analysis. This allows for the early discovery of safety issues. Vertical growth is projected to be aided by a strong foothold of key market players operating in the field of issue tracking software. For instance, in October 2020, Extedo GmbH launched its new product EXTEDOpulse, which offers five major hubs covering planning and tracking, document management, registration management, submission management, and safety management. It effectively prepares and tracks regulatory actions, processes, filings, and commitments for a client's complete product line.

Moreover, with the COVID-19 pandemic, many companies have launched new issue tracking software to better serve the patients. For instance, in May 2021, Dialog Solutions introduced the next-generation of pharmacovigilance literature monitoring: Drug Safety Triager. In May 2020, the Medicines and Healthcare Products Regulatory Agency launched “Yellow Card COVID-19  reporting site”, a new pharmacovigilance reporting platform for COVID-19 treatments. A new online reporting site may track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the disease. Thus, the launch of such product may work in the favor of the segment gowth.

The increasing incidence of adverse drug reactions (ADR) is expected to propel the demand for AER software in the coming years.

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. 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. For instance, between 2020 and 2021, monitoring by the Vaccine Adverse Event Reporting System detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses ). Thus, the regulatory authorities' growing need for medical information is also anticipated to fuel this segment's growth.

Initiatives undertaken by the governments are also propelling the market's growth 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. The United States initiated another project called Mini-Sentinel to promote an active surveillance system by providing relevant statistical data in less time.

Moreover, in response to the pandemic, the Food and Drug Administration of the United States introduced FDA Adverse Event Reporting System (FAERS), a dashboard for COVID-19 emergency use authorization (EUA) products. The tool provides updates of adverse event reports submitted for drugs under emergency use authorization for COVID-19.

Competitive Landscape

The companies operating in the pharmacovigilance and drug safety software market are capitalizing on innovative research, focusing on the development of editing techniques. In September 2019, Bayer launched SafeTrack, a digital adverse event reporting tool. This adverse event report tool will help patients and healthcare professionals report adverse events more easily, quickly, and conveniently. 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.

The key market players include Ab Cube, ArisGlobal, Ennov Solutions Inc., Extedo GmbH, Online Business Applications Inc., Oracle Corporation, Sarjen Systems Pvt Ltd, Sparta Systems Inc., United BioSource Corporation, Max Application, Veeva Systems, and Phase Forward.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support
Note: Product cover images may vary from those shown


  • Ab Cube
  • ArisGlobal
  • Ennov Solutions Inc.
  • Extedo GmbH
  • Max Application
  • Oracle Corporation

1.1 Study Assumptions and Market Definition
1.2 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
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - USD million)
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
5.4.1 North America United States Canada Mexico
5.4.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.4.4 Middle-East and Africa GCC South Africa Rest of Middle-East and Africa
5.4.5 South America Brazil Argentina Rest of South America
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
Note: Product cover images may vary from those shown

A selection of companies mentioned in this report includes:

  • Ab Cube
  • ArisGlobal
  • Ennov Solutions Inc.
  • Extedo GmbH
  • Online Business Applications Inc.
  • Oracle Corporation
  • Sarjen Systems Pvt Ltd
  • Sparta Systems Inc.
  • United BioSource Corporation
  • Max Application
  • Veeva Systems
  • Phase Forward
Note: Product cover images may vary from those shown