Pharmacovigilance in 2021: exploding demand
From conversations with clients in pharmacovigilance (PV) and wider research, we’ve identified 4 key trends for 2021 and beyond that we wanted to share with you.
First, some statistics: according to a report by Grand View Research, the global pharmacovigilance market is predicted to grow by 11.5% annually (CAGR) from 2021 to 2028. This growth is the consequence of the prevalence of chronic diseases, such as diabetes, cardiovascular and respiratory disorders and oncological diseases, which in turn leads to more drug consumption and extensive clinical trials. The report highlights how a number of adverse drug reactions are expected to accelerate the demand for PV services.
In that vein, Deloitte has published a report. Already back in 2018, they found that a majority of surveyed biopharma companies are investing in PV-related automation (or considering to). They highlight how pharmacovigilance will go from “compiling data and preparing information for regulators to creating a learning system to improve a drug’s risk-benefit profile, help providers select the optimal treatment, and increase product quality and patient safety.”
In other words, to serve its industry’s needs the pharmacovigilance function must undergo fundamental changes to prepare for the expected explosion in demand.
With this backdrop, we want to highlight 4 near-term pharmacovigilance trends in 2021.
1. Integrating and combining secondary sources in pharmacovigilance
Increasingly, integrating and combining secondary data sources are becoming critical to identify early detection of safety concerns. Social media data is becoming a standard data source, but pharmacovigilance professionals are also expected to integrate with other secondary sources, such as political data and clinical and electronic health records.
2. New skills to manage big data
As secondary sources are being integrated, pharmacovigilance professionals need to manage big data, which requires new skills. To succeed, PV companies must invest in new solutions and training of their employees.
For example, pharmacovigilance professionals can apply technology solutions that take the researchers’ context into mind, finding more relevant literature and less noise.
3. Pharmacovigilance process automation
The expanding demand for pharmacovigilance coupled with the myriad of data sources will exert pressure on existing PV processes. This is leading many companies to look for ways to automate the most manual processes, such as detecting, collecting and monitoring information, to save costs and time.
Already back in 2018, Deloitte highlighted how a majority of surveyed companies are investing in PV-related automation, including signal detection.
For example, artificial intelligence finds the most relevant adverse events, extracts and cleans that data, and moves it to detailed review for analysis. These steps are crucial but currently highly manual. Freeing up this time will enable PV professionals to spend time on more valuable-added processes, such benefits-risk evaluation and management, signal investigation, and real-world evidence analysis.
Sanofi is one of many major pharmaceutical companies using artificial intelligence to “gather insights from the growing volume of real-world data.”
4. Pharmacovigilance unified in the cloud
Due to their siloed nature, current PV systems are struggling to manage the complex processes and amount of data, which makes it harder to collaborate and many duplicate entries.
As a result, more and more PV companies are moving to unified and cloud-based platforms. Having all the data on one platform makes it easier to comply with regulations, as there’s one source of truth for safety content. Needless to say, hosting these platforms in the cloud enables pharmacovigilance professionals to access the safety content wherever they have an Internet connection; critical in the era of home office.
Veeva is one such platform where companies can automate case intake, and process and analyse data.
Key takeaways
The pharmacovigilance market is growing rapidly, putting more strain on existing PV systems and processes. As a result, PV companies are:
Collecting secondary sources, such as social media data, and integrating it with other sources, such as political data and electronic health records.
Leveraging technology solutions to navigate and find relevant information in the swelling amount of big data.
Automating their most manual tasks, particularly relevant in signal management.
Integrating comprehensive cloud and data management systems.
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