The global pharmacovigilance (PV) and drug safety software market is expected to reach US$ 292.97 million in 2027 from US$ 160.67 million in 2019. The market is estimated to grow with a CAGR of 7.6% from 2020-2027.

Rising incidences of adverse drug reaction (ADR) and globalization of pharmacovigilance have been boosting the market over the years. However, the expensive technology are likely to have a negative impact on the growth of the market in the coming years.

Adverse drug reactions (ADRs) is an important public health problem, signifying a significant cause of illness and death. Because all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. According to the Agency for Healthcare Research and Quality 2018, In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur from 10 to 20% of admissions; about 10 to 20% of these ADRs are severe. These statistics do not include the number of ADRs that occur in ambulatory and nursing home patients. Although the exact number of ADRs is not specified, ADRs represent a significant public health problem that is, for the most part, preventable.

In 2016, 1,238,178 reports related to suspected adverse reactions were collected and managed in EudraVigilance, 339,544 of which originate from the European Economic Area (EEA). European database for adverse drug reaction reports, which Member State and the Agency use for monitoring the safety of authorized medicines on the EU market. EudraVigilance now holds 10.8 million reports referring to 6.7 million cases and therefore is one of the most significant adverse drug reaction databases in the world. ADR reported by a patient or healthcare professional adds to safety monitoring and thus to the safe and effective use of medicines.

The increasing amount of data generated through adverse drug reaction report need to be handled and stored carefully. All these data come in different forms, language, location, etc. To arrange these uniformly the automation systems/software are helpful.

Based on software type the market is segmented into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. In 2019, the adverse event reporting software segment held the largest share of the market, by software. However, the fully integrated software segment is anticipated to grow at the highest rate during the forecast period owing to its accuracy to avoid data redundancy by eliminating errors and tracking individual case safety reports.

Based on delivery mode the market is segmented into on premise and cloud based. In 2019, the on premise segment held the largest share of the market, by delivery mode. However, Cloud based segment is expected to grow at the fastest rate during the coming years owing to the benefits associated such as remote access to data, real-time data tracking.

Based on end user the market is segmented into pharmaceutical and biotech companies, contract research organizations (CROs) and business process outsourcing (BPO) Firms. In 2019, the contract research organizations segment held the largest share of the market, by end user. Moreover, Contract Research Organizations segment is expected to grow at the fastest rate during the coming years owing to increasing drug discovery activities in the pharmaceutical companies

Central Drugs Standard Control Organization, Commission for Protection against Health Risks, Contract Research Organizations, Drug Safety and Effectiveness Network are among the major secondary sources referred to while preparing the report on the pharmacovigilance and drug safety software market.