Global Pharmacovigilance and Drug Safety Software Market Grows at a Staggering CAGR of 6.7%

Introduction

Pharmacovigilance is a set of activities, including data collection, that aims to identify, evaluate, comprehend, and prevent adverse drug reactions (ADRs), severe adverse events (SAEs), or severe events (S.E.s). To pinpoint drug withdrawal reasons and avoid needless future adverse events, pharmacovigilance and drug safety software are typically used. The improvement of pharmacovigilance effectiveness and drug safety benefits everyone involved in the medical process, including patients, doctors, and manufacturers.

Pharmacovigilance is used to determine which adverse events are more severe than a drug's efficacy threshold. Identifying the side effects that patients should risk experiencing based on how effectively they treat the disease. For instance, chemotherapy is known to have some very serious side effects, but in the case of cancer that poses a serious threat to the patient's life, these side effects are considered tolerable given the chance of the patient's recovery. The risk to the patient would be deemed too high, and the potential benefit would not be enough to outweigh the risk of a medication used to treat a headache caused by similar side effects.

Market Dynamics

Increasing Cases of Adverse Drug Reaction Drives the Market

Given the complexity of therapeutics, the aging of the population, and the rise in the prevalence of various diseases, adverse drug reactions (ADRs) continue to be a challenge in modern healthcare. An important aspect of drug therapy is managing a drug's side effects. These reactions can cause harm to people, overcrowding in hospitals, and an increase in medical expenses, which puts a heavy burden on the nation's healthcare systems. According to international studies, 10- 20% of inpatients experience adverse drug reactions (ADRs), which account for 3-7% of all hospitalizations. In the United States, serious adverse drug reactions (ADRs) were discovered to be the fourth to the sixth most common cause of death among hospitalized patients, leading to extended hospital stays and a doubling of treatment costs. Therefore, both healthcare teams and patients share the goal of early detection and prevention of ADRs. As a result, the market for pharmacovigilance and drug safety software will see increased demand as cases of adverse drug reactions rise.

Government Regulations for Pharmacovigilance gives Opportunity for Exponential Growth

Globally, governments are putting policies into place to encourage pharmacovigilance and the reporting of adverse drug reactions. Encouragement of the safe use of medications is a top priority for the Indian Pharmacopoeia Commission, which serves as the National Coordination Center (NCC) for India's Pharmacovigilance Program (PvPI). ADRs are currently reported to NCC by 179 monitoring facilities for adverse drug reactions (ADRs). India currently makes up 3% of the global safety database and has a 0.93 out of 1 completeness rating. Building monitoring and surveillance capabilities, working with other national health programs and organizations to increase ADR reporting, and ensuring that PvPI serves as a crucial knowledge repository for Indian regulators are just a few of the actions that NCC is taking to increase patient safety. For instance, the Open FDA initiative of the U.S. government provides application developers and scientists with open search-based programs that allow access to its database. In order to support an active surveillance system by providing pertinent statistical data more quickly, the U.S. launched another project called Mini-Sentinel.

Regional Analysis

North America is the s the highest contributor to the global Pharmacovigilance and Drug Safety Software market and is expected to grow at a CAGR of 5% during the forecast period as a result of active research and development efforts on medications for the treatment of severe and chronic diseases. Furthermore, the need for research and development to find a cure has grown as the prevalence of chronic diseases has increased over the past 20 years. The region is gravely concerned about the rising number of cancer cases. For instance, according to the National Care Institute, more than 1.7 million new cases of cancer were reported in the U.S. in 2018. In contrast, the Canadian Cancer Society estimates that over 206,200 new cases of cancer were reported in 2017.

Europe is the second leading region, and it is anticipated to grow at a CAGR of 6.2%. This can be attributed to the pharmaceutical and biotechnology industries' growing research and development efforts to find a cure for a number of chronic diseases, including neurological conditions like epilepsy, schizophrenia, bipolar disorder, and seizures experienced in epilepsy. According to the Epilepsy Society, over 500,000 people worldwide have epilepsy, with 87 new cases occurring every day. Additionally, the prevalence of other severe diseases like arthritis and cardiovascular diseases is predicted to increase in Europe, which will increase demand for pharmacovigilance and drug safety software.

Due to the rising geriatric population and rising prevalence of chronic diseases in the region, the Asia Pacific region is one of the regions that is experiencing significant growth in the global pharmacovigilance and drug safety software market. As a result of ongoing advancements in pharmacovigilance, a growing geriatric population, and the prevalence of chronic diseases, China is seeing rapid growth in the pharmacovigilance and drug safety software market. Numerous Japanese companies are making significant investments in R&D for the treatment of chronic and severe diseases like gastrointestinal disorders, oncology, and neurology. Several medications are currently being developed in the nation to treat these diseases.

The LAMEA region is growing in the market for software for pharmacovigilance and drug safety. This is attributable to the expansion of research and development activities in the area. Additionally, due to the region's subpar healthcare infrastructure and slow economic growth, the African market is finding it difficult to accelerate its growth. The Government of Abu Dhabi Department of Health released the Abu Dhabi Standard for Health Information Security and Cyber Security Standards on June 30, 2022. All medical and pharmaceutical establishments with licenses from the DoH (the "Licensed Entities") are required by the Circular to obtain a "secure" or "safe" certificate attesting to their compliance with the Standards. By December 31, 2022, Licensed Entities must complete an audit procedure to verify their self-certification with the Standards.

Key Highlights

• The global pharmacovigilance and drug safety software market was valued at USD 187.94 million in 2022. It is projected to reach USD 336.89 million by 2031, growing at a CAGR of 6.7% during the forecast period (2023-2031). 
• Based on functionality, the global pharmacovigilance and drug safety software market is bifurcated into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. The drug safety audits software segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period
• Based on the mode of delivery, the global pharmacovigilance and drug safety software market is bifurcated into on-premise delivery and on-demand/cloud-based (SAAS) delivery. The on-premise delivery segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period.
• Based on end-user, the global pharmacovigilance and drug safety software market is bifurcated into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers. The pharmaceutical and biotechnology companies segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period.
• North America is the highest contributor to the global pharmacovigilance and drug safety software market and is expected to grow at a CAGR of 5% during the forecast period.

Competitive Players

Competitive Analysis:

The global pharmacovigilance and drug safety Software market's major key players ArisGlobal, Ab Cube, Ennov Solutions Inc., Extedo GmbH, Online Business Applications Inc., Oracle Corporation, Sparta Systems Inc., Sarjen Systems Pvt Ltd, United BioSource Corporation, Max Application, Veeva Systems, APCER life sciences, and Phase Forward.

Recent Developments

Market News:

• In May 2022, APCER life sciences will extend Integrated Pharmacovigilance services with the Argus Cloud service of Oracle Corporation.

• In September 2022, Veeva Systems launched two new Veeva Crossix solutions to optimize omnichannel marketing.

Segmentation

Global Pharmacovigilance and Drug Safety Software Market: Segmentation

By Functionality

• Adverse Event Reporting Software
• Drug Safety Audits Software
• Issue Tracking Software
• Fully Integrated Software

By Mode of Delivery

• On-premise Delivery
• On-demand/Cloud-based (SaaS) Delivery

By End User

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations
• Business Process Outsourcing Firms

By Regions

• North America
• Europe
• Asia-Pacific
• LAMEA