The global pharmacovigilance (PV) software market accounted for USD 117.3 million in 2015 and is expected to exhibit a growth rate of 6.6% over the forecast period. Rising incidence of adverse drug reactions (ADR) is the key contributing factor for the growth of the PV software market in the coming years.
Intensified guidelines enforced by government authorities, such as the U.S. FDA and European Medical Agency are expected to promote the adoption of PV systems over the forecast period. These systems play a crucial role in the clinical research as they are used to perform clinical studies and in conducting post marketing surveillance activities. ArisG and Argus are the most commonly used PV softwares for clinical studies worldwide. The benefits associated with its usage include ease of access and reduced data redundancy, which are anticipated to fuel the growth of this sector during the forecast period.
U.S. Pharmacovigilance software market, by functionality, 2014 - 2024 (USD Million)
Moreover, growing withdrawals of high profile drugs, and pressure on drug manufacturers to detect early signals of drug-related adverse interactions is anticipated to boost the usage rates of PV tools in the near future. Increasing concerns related to patient safety & stringent regulatory inspections to contain the incidence of serious drug-associated adverse events are some of the key contributing factors for the growth of the PV software market. The growing complexity of drug safety regulations is thus expected to boost the demand.
Rising ADR incidences spur the demand for cost-efficient ADR reporting systems, which was responsible for the dominance of this segment in 2015. ADRs are one of the major causes of morbidity in the developed countries. According to statistics reported by the NCBI, in 2013, around 4.2% to 30% of overall hospitalization in the U.S. and Canada, while 2.1% to 5.2% in the Europe was due to ADRs, which is responsible for further growth of this vertical.
Similarly, according to a study conducted by the European Commission, ADRs cause over 197,000 annual deaths. ADRs impose a substantial burden on the healthcare systems. All the aforementioned events are expected to result in the rising demand for PV softwares during the forecast period.
On-premise delivery mode involves the installation of services and solutions on computers present within the organization. Though these need to be installed within the organization premises, it can be accessed from remote locations thus providing the benefit of reduced costs due to power consumption and system maintenance. The introduction of cloud computing and its rapid adoption by the healthcare IT providers are expected to slow the growth of the on-premise segment over the forecast period.
PV softwares are widely accepted by pharma & biotech companies to facilitate clinical trial programs and to reduce the burden on medical expenditure. As a growing trend in PV outsourcing is observed in the pharmaceutical industry, manufacturers are now striving to identify various ways to contain costs and minimize operational expenses by gradually shifting from being fully-integrated pharmaceutical companies to sharing costs through collaborations with service providers. The aforementioned factor is expected to strengthen the growth of contract research firms that perform PV for pharmaceutical companies.
The services offered by PV software providers range from entry, management, scientific assessment, and validation of data. The major clinical research organization prefer to outsource these tasks as they help in increasing internal resource flexibility, improve timelines, and help gain better outcomes in the long term. It also facilitates better PV through increased regulatory compliance, higher quality and better productivity in terms of information management, and improved strategic outcomes.
North America dominated the PV software space in 2015. Increasing pressure to maintain electronic medical records due to the regulatory policies laid down by the U.S. FDA authorities is anticipated to boost the sector growth. Furthermore, the presence of big pharmaceutical companies and the availability of advanced technology for ADR reporting are the factors contributing toward regional growth. The Asia pacific regional vertical is anticipated to exhibit profitable growth due to growing healthcare expenditure and the presence of a large pool of business processing organizations in this region.
Some of the key players dominating the PV software market are Oracle Corporation, ArisGlobal, AB Cube, Max Application, Ennov Solutions Inc., Sparta Systems, Inc., EXTEDO GmbH, Online Business Applications, Inc., United BioSource Corporation, and Relsys. The companies are focused on the development of cost effective and fully integrated PV systems to gain profit and reduce healthcare expenditure. Companies are focusing on undertaking partnership agreements with contract research firms, which offer customized services, to gain a competitive advantage.
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