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

Product Code : MDHC00122302
Survey : Mordor Intelligence
Publish On : 12, August, 2022
Category : Healthcare and Pharmaceuticals
Study Area : North America (U.S. and Others), Europe (Germany, France, U.K. and Others), Asia-Pacific (Japan, China, India and Others), Rest of World (Brazil, Rest of Latin America, Middle East & Others)
Report format : PDF
Sales price option (consumption tax not included)
Single User USD4950 / Question Form
5 User USD6750 / Question Form
Enterprise User USD9000 / Question Form
 - 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

[Report Description]

The pharmacovigilance and drug safety software market estimated to be valued at USD USD 163.08 million in 2020 and is expected to reach approximately USD 238.68 million in 2026, registering a CAGR of nearly 6.49% during the forecast period.

The evolving threat of COVID-19 infection is adversely affecting communities, industries, businesses, and lives around the world. Medical monitoring and safety reporting are essential as several potential therapies are being used to treat the coronavirus-induced infection. The medications like Lopinavir/Ritonavir, hydroxychloroquine (HCQ), and Remdesivir are being repurposed to treat coronavirus 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 pandemics.

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 a high growth due to the increasing incidence of adverse drug reactions (ADRs) that is the major driving factor for the growth of the pharmacovigilance and drug safety software market. For instance, as per the data published by the Center for Disease Control and Prevention, in 2019, adverse drug events (ADE) account for nearly 700,000 emergency department visits and 100,000 hospitalizations each year. Nearly 5% of hospitalized patients experience an ADE, making them one of the most common types of inpatient errors. This is likely to boost the need for AER software in the coming years.

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 regulations are driving the growth of the market. However, lack of awareness and knowledge about pharmacovigilance and ADRs among healthcare professionals, and adverse effects of drugs are found restraining the growth of the pharmacovigilance and drug safety software market.

Key Market Trends

Fully Integrated Software Expected to Grow With High CAGR Over the Forecast Period

Monitoring and tracking the efficiency and accuracy of organizations drug safety reporting process can help to ensure that issues are logged and investigated when they arise, thus, avoiding delays and/or inaccurate reporting, which may result in the lack of regulatory compliance, monetary fines, and unwanted scrutiny.

The issue tracking software facilitates electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues. Strong foothold of key market players operating in the arena of issue tracking software is likely to bode well for vertical growth. 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 efficiently plans and tracks the regulatory activities, processes, submissions, and commitments related to clients entire portfolio of products.

Moreover, with the COVID 19 pandemic, many of the companies have launched new issue tracking software to better serve the patients. For instance, I n 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 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. For instance, in 2020, Dexmedetomidine HCL in 0.9% Sodium Chloride Injection by Fresenius Kabi USA were recalled due to cross-contamination of lidocaine which could result in a potentially life-threatening allergic reaction. Thus, the growing need for medical information by the regulatory authorities is also anticipated to fuel this segment s growth.

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.

Moreover, in response to the pandemic, Food and Drug Administration of United States has 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 the innovative researches focusing on the development of editing techniques. In September 2019 the other company Bayer launched SafeTrack, which is a digital adverse event reporting tool. This adverse event report tool will help patients and healthcare professionals reporting 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 among others.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format

  • 3 months of analyst support

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

5.1 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


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