Clinical research depends heavily on software. Pharmacovigilance and drug safety software reduce administrative burden and workload by consolidating information in a single location, and it supports the trial by facilitating collaboration among all healthcare professionals. Meeting deadlines is the most difficult challenge for many pharmacovigilance and drug safety research teams, especially when they are supported by manual and time-consuming processes. Several organizations’ 2019 goal was to find a new and different approach that addresses the need for increased transparency, improved compliance, increased efficiency, and cost effectiveness while minimizing human involvement through automation and insights. The incorporation of pharmacovigilance and drug safety software greatly improves the speed and efficiency with which the study data is maintained, managed, planned, performed, and reported. As a result, these software are excellent tools in the clinical research domain for collecting trial-specific data in order to track study performance, schedule, monitor, and so on.

Market Dynamics

Rising incidences of adverse drug reactions (ADRs) bolster the demand for pharmacovigilance and drug safety software market

According to the British Medical Association, adverse reactions are becoming more common, and no medicine can ever be guaranteed to be completely safe. Furthermore, according to a study of hospital admissions in the United Kingdom published in 2004, 6.5% of people admitted to hospital had an ADR, and in 80% of those cases, the ADR was the direct cause of the admission. Furthermore, the study discovered that more than 2% of those admitted to the hospital with ADR died. To address this, pharmacovigilance and drug safety software play an important role in detecting, investigating, communicating, and implementing appropriate actions. Effective pharmacovigilance and drug safety software has gained widespread attention due to the detection of ADRs, allowing for more effective advice to be given to those prescribing and using medication and ensuring higher standards of safety and efficacy. But apart from that, the Uppsala Monitoring Centre in Sweden runs the World Health Organization (WHO) Program for International Drug Monitoring. The program allows participating countries to work together to monitor drug safety. At the moment, the program has 79 member countries and 18 associate members. Each member country's designated National Centre submits individual case reports of suspected ADRs to be stored in a common database. The MHRA is the designated National Centre for the United Kingdom. The WHO database currently contains approximately 3.4 million ADR case records, making it a valuable data source for pharmacovigilance. However, access to these data is primarily restricted to National Centers.

COVID-19 impact on pharmacovigilance and drug safety software market

The global pandemic, long predicted by experts in the field of infectious diseases and global public health, has arrived and brought the life to which had grown accustomed to an abrupt halt. Monitoring the safety of medicines was on top priority during the pandemic. A collection of therapies for consideration in the treatment of corona virus infections has been identified and is currently being deployed in several countries. According to the World Health Organization (WHO), the use of newer drugs such as "remdesivir" and of repurposed drugs such as "hydroxychloroquine and lopinavir/ritonavir" are being explored for effective against COVID-19. Reports of suspected adverse drug reactions (ADRs) for these different therapies was recorded in "Vigibase", the global database of individual case study safety reports, managed by the Uppsala Monitoring Center (personal knowledge). Furthermore, pharmacovigilance has grown in popularity, with a wide range of opportunities that bring pharmacovigilance and drug safety software closer to healthcare systems by providing clinicians with supportive data for making appropriate treatment decisions in the absence of data from randomized clinical trials. Additionally, provide supporting data that includes both treatment benefits and risks. 

Market Segmentation

The global pharmacovigilance and drug safety software market is segmented based on functionality, delivery mode, and end-user. By functionality, the market is segmented as adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. By delivery mode, the market is bifurcated into on-premise delivery mode and on-demand/cloud based (SaaS) delivery mode. By end-user, the market is segregated as pharmacy and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, and other pharmacovigilance service providers.

Based on functionality, the drug safety audit software segment will record highest market share in the forthcoming years. Further, by delivery mode, on-demand/cloud based SaaS delivery mode is projected to hold significant CAGR in the forecast period. Furthermore, by end-user, the contract research organizations (CROS) and business process outsourcing (BPOs) firms is expected to hold the largest market share for the global pharmacovigilance and drug safety software market.

Regional Landscape

In the coming years, North America is expected to have the largest market share. As a result of government-aided initiatives that encourage the use of pharmacovigilance software systems, the regional market is expected to grow significantly in the coming years. For example, the favorable Food and Drug Initiatives (FDA) provide scientists and application developers with access to its massive database via open search-based program, which is highly supported to increase usage rates during the forecast period. For records, Mini-Sentinel is a novel project launched by the US FDA that promotes active surveillance systems capable of providing statistically relevant data in less time. This type of initiative contributes to the expansion of the global pharmacovigilance and drug safety software market.

Asia Pacific, on the other hand, is expected to have the fastest growing CAGR in the coming years. China, Singapore, Taiwan, and South Korea are the prominent countries in the Asia Pacific region that have gained significant importance and are a strong contributor to the growth of the global pharmacovigilance and drug safety software market. Aside from that, Latin American countries are expected to be high growth markets, owing to an increase in research outsourcing by pharmaceutical behemoths and growing public and private investments in pharmaceutical R&D in these emerging regions.

Competitive Landscape

The market is competitive in nature owing to presence of prominent healthcare functionality companies. These prominent players involved in pharmacovigilance and drug safety software market are ArisGlobal, Ennov, EXTEDO, Online Business Applications, Inc., Oracle Corporation, Sarjen Systems Pvt. Ltd, Sparta Systems, Inc., United BioSource LLC, and among others

Market Segmentation

Market By Functionality
Adverse Event Reporting Software
Drug Safety Audits Software
Issue Tracking Software
Fully Integrated Software

Market By Delivery Mode
On-premise Delivery Mode
On-demand/Cloud based (SaaS) Delivery Mode

Market By End User
Pharma and Biotech Companies
Contract Research Organizations (CROs)
Business Process Outsourcing (BPO) Firms
Other Pharmacovigilance Service Providers

Market By Geography

North America
•    U.S.
•    Canada

Europe
•    U.K.
•    Germany
•    France
•    Spain
•    Rest of Europe

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

Latin America
•    Brazil 
•    Mexico
•    Rest of Latin America

Middle East & Africa
•    GCC
•    South Africa
•    Rest of Middle East & Africa