Pharmacovigilance and Drug Safety Software Market

Market Overview

Global pharmacovigilance and drug safety software market is expected to reach USD 243.1 million in 2026 from USD 145.9 million in 2018 at a CAGR of 6.7% during the forecast period 2019–2026

Pharmacovigilance is the detection, assessment, understanding, and prevention of adverse drug reactions (ADR’s), severe adverse events (SAE’s), or severe events (SE’s) through a set of activities including data collection. Pharmacovigilance and drug safety software are generally used to identify the causes of withdrawal regarding drugs and prevent unnecessary future adverse events. It is beneficial to everyone concerned with the medical process, including consumers, prescribers, and makers for increasing efficacy of the pharmacovigilance process coupled with increasing drug safety.

Today, the number of casualties occurring due to medical errors is increasing at an alarming rate. Globally, around 142,000 people died in 2013 from adverse effects of medical errors, which increased from 94000 in 1990. In the U.S. alone, 251,454 people died due to faults in medical treatments in 2013, WHO. It is estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1 million excess injuries each year in the U.S hospitals.

Segmental Analysis

Role of Drug Safety Audits Software in Pharmacovigilance and Drug Safety Software Market

For better understand, we have segmented the global pharmacovigilance and drug safety software market by type and end-user.

By type, the  market is further segmented into drug safety audits software, fully integrated software, and issue tracking software. Drug safety audits software is expected to account for a significant share of the global pharmacovigilance and drug safety software market and is anticipated to exhibit profitable growth, which can be attributed to its ability to monitor and track serious adverse events, serious & non-serious adverse drug reactions, and medically related product information. Moreover, growing number of clinical trials and increasing pressure from the government authorities such as European Medicines Agency and the U.S. Food & Drug Administration (FDA) to follow and comply with safety guidelines are expected to contribute to the growing adoption of drug safety audits software.  The drug safety audit software segment was valued at USD 68.36 million in 2014.

The fully integrated software segment is expecting a steady growth in the global pharmacovigilance and drug safety software market. This can be attributed to its accuracy to avoid data redundancy by eliminating errors and tracking individual case safety reports. Moreover, a rise in the demand for fully integrated software across the globe for pharmacovigilance and data safety solutions is expected to support the market growth. The fully integrated software segment was valued at USD 13.82 million in 2014 and is likely to reach USD 14.99 million by the end of 2019.

By end-user, the global pharmacovigilance and drug safety software market is segmented into pharma and biotech companies, contract research organizations, and business process outsourcing.

Increasing research & development activities by the major pharmaceutical and biotechnology companies are driving the growth of the pharma & biotech company. Additionally, rising number of new and improved drugs in the pipeline and clinical trials need pharmacovigilance services, which is further contributing to the market growth.  Pharma and biotech companies were valued at USD 19.93 million in 2014, and it reaches USD 24.27 million by 2019.

Contract Research Organizations are actively participating in the research & development activities following the rising prevalence of chronic diseases across the globe. Moreover, active participation of the CRO’s in research & development is pushing the overall growth further. Contract Research Organizations was valued at USD 49.37 million in 2014, and it increased to USD 66.91 million by 2019.

Regional Analysis

North America Pharmacovigilance and Drug Safety Software Market to grow at a CAGR of 5%

Global Pharmacovigilance and drug safety software market is segmented into North America, Europe, Asia Pacific, and the Middle East and Africa.

North America is witnessing a strong growth in the market following the robust research & development activities on the drugs for treating severe and chronic diseases.  Moreover, rising prevalence of chronic diseases from the last two decades has developed the demand for research & development to find a cure. Growing number of cancer cases is a dire concern of this region. For instance, more than 1.7 million new cases of cancer were registered in the U.S. in 2018, National Care Institute. Whereas in Canada, it was estimated that over 206,200 new cases of cancer were registered in 2017, Canada Cancer Society.  North American pharmacovigilance and drug safety software was valued at USD 53.08 million in 2014 and is expected to grow at a CAGR of 5% during the forecast period 2016–2026.

Europe is the second leading region in the global pharmacovigilance and drug safety software market and is likely to continue the same during the forecast period 2016–2026. This can be attributed to increasing research & development activities to find a cure for several chronic diseases including neurological disorders such as epilepsy, schizophrenia, bipolar disorders, and seizures experienced in epilepsy by pharmaceutical and biotechnology industries. For instance, over 500,000 people are living with epilepsy with a daily incidence rate of approximately 87 people, Epilepsy Society. Moreover, rising incidences of other severe diseases, including cardiovascular diseases and arthritis across Europe is likely to boost the demand for pharmacovigilance and drug safety software market. In this region, the market was valued at USD 42.8 million in 2014 and is projected to grow at a CAGR of 6.2%.

Asia Pacific is witnessing significant growth in the global pharmacovigilance and drug safety software market on account of rising geriatric population and increasing prevalence of chronic diseases in the region. China is experiencing swift growth in the pharmacovigilance and drug safety software market as a result of ongoing development in the pharmacovigilance, geriatric population and prevalence of chronic diseases. For treating chronic and severe diseases such as gastrointestinal disorders, oncology, and neurology numerous Japanese companies are investing significantly in research and development. Currently, the country has several drugs in pipeline for treating these diseases.

Middle East is emerging in the pharmacovigilance and drug safety software market. This can be accredited to increasing research & development activities in the region. Moreover, African market is struggling to pace up the growth as a result poor healthcare infrastructure and sluggish economic growth in this region. 

Pharmacovigilance and Drug Safety Software Market Segmentation

By Type

• Drug safety audits software
• Fully integrated software
• Issue tracking software

By End Users

• Pharma and biotech companies
• Contract research organizations
• Business process outsourcing

By Region

North America

• U.S.
• Canada
• Mexico

Europe

• UK
• Germany
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia
• Rest of Asia-Pacific

LAMEA

• Brazil
• Saudi Arabia
• South Africa
• Rest of LAMEA