North America Pharmacovigilance and Drug Safety Software Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Software Type (Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, and Fully Integrated Software); Delivery Mode (On-premise, and Cloud-based); End User (Pharmaceutical and Biotech Companies, Contract Research Organizations (CROs), and Business Process Outsourcing (BPO) Firms)
The pharmacovigilance and drug safety software market in North America is expected to grow from US$ 73.4 million in 2019 to US$ 136.0 million by 2027; it is estimated to grow at a CAGR of 8% 2019-2027. Pharmacovigilance is a key component of effective drug regulation systems, clinical practices, and public health programs. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled. In the current network of pharmacovigilance centers coordinated by the Uppsala Monitoring Centre, pharmacovigilance is a critical and integral part of clinical research, and it is growing in many countries. Today, many pharmacovigilance centers are working for drug safety monitoring. However, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs.
The centralized reporting and storage of adverse drug reaction reports would help in monitoring and preventing future adverse reaction from the drug consumption. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) are strengthening the pharmacovigilance area by interacting on different topics related to post-marketing safety and scientific exchange. Discussions on priority such as biosimilars; medicines for cancer, orphan disease, and children; and blood-based products. Thus, increasing globalization in the pharmacovigilance sector helps in drug safety software. It improves the quality and efficacy of pharmacovigilance and drug safety software, which favors the growth of the pharmacovigilance and drug safety software market in North America.
The North America pharmacovigilance and drug safety software market is segmented on the bases of software type, delivery mode, and end user. In 2019, the adverse event reporting software accounted for the largest market share in the market. In pharmacovigilance, the high volume of adverse reaction report event data is generated. These reports may not be in a uniform format. Therefore, it becomes difficult to classify the event manually. Manual processing and classification of adverse event reports is costly and time-consuming operation. To overcome these challenges, companies are incorporating automated solutions. Therefore, the market growth is expected to bolster during the forecast period.
Since the COVID-19 outbreak, North America has been recording the growing number of COVID-19 confirmed cases. Several measures are being taken to restrain the disease and prevent the transmission of virus. Nevertheless, the excessive number of confirmed cases has cancelled doctor's appointment, decreased the demand for elective pharmacovigilance and drug safety software due to long period of lockdown. In the US, due to a growing number of contaminated patients, healthcare practitioners and leading organizations are distracting the flow of health services from research and development to primary care, which slows down the process of innovation. In addition, many health organizations, such as FDA, are evaluating the effects of the pandemic, and how clinical trials and pharmacovigilance programmes can be handled in the coming years. The rapidly changing situation indicates that sponsors need to be more cautious and diligent in assessing the consequences of the pandemic and shifts in authority expectations to minimize the impact on safety reporting and to ensure patient safety. The value of demanding updated guidelines and implementing regulatory changes quickly is greater than ever as it can mitigate disruption to clinical trials. To deal successfully with a highly complex situation, a proven and comprehensive safety reporting solution may be required.
The overall North America pharmacovigilance and drug safety software market size has been derived using both primary and secondary sources. To begin the research process, exhaustive secondary research has been conducted using internal and external sources to obtain qualitative and quantitative information related to the market. The process also serves the purpose of obtaining an overview and forecast for the North America pharmacovigilance and drug safety software market with respect to all the segments pertaining to the region. Also, multiple primary interviews have been conducted with industry participants and commentators to validate the data, as well as to gain more analytical insights into the topic. The participants of this process include industry experts such as VPs, business development managers, market intelligence managers, and national sales managers, along with external consultants such as valuation experts, research analysts, and key opinion leaders, specializing in the North America pharmacovigilance and drug safety software market. Veeva Systems, IQVIA Inc., Ennov, AB Cube, United Biosource LLC, ArisGlobal LLC, Sparta Systems, Oracle Corporation, Sarjen Systems Pvt. Ltd, EXTEDO, and Online Business Applications, Inc. are among the players operating in the market.
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