Global Market Outlook on Pharmacovigilance Services

The major driver for case processing is stringent regulations and rising incidence rates of adverse drug reactions. Adverse drug reactions are causing over 100,000 death globally and awareness among public and demand for safe medication is on the rise

  • Demand for case processing is increasing, as the cost of the service in-house is way more when compared and also there has been a steady rise in the number of adverse events being reported
  • Companies are outsourcing most of the Phase IV and post marketing case processing segments to capture adverse events form various sources
  • Regulations varies from region to region and the current trend is harmonization of these across the globe. Hence local sourcing in areas where the company focuses is a must

Current Trends

Increased emphasis on drug safety and faster submissions for regulatory approval are among the key drivers for the need of innovation in the PV space. Greater dependency is seen on PV tools and software to improve process and drive value for better vigilance

Global Harmonization

Regulatory bodies like FDA, EMA and PMDA are adopting ICH E2B R3 standards for electronic reporting to allow easy and reliable transmission of safety data across borders. Various challenges involved are to meet patient privacy, who owns data and rules needed for enabling information-sharing

Innovation

Automated tools are being developed, which includes AI, machine learning etc., to examine closely online networks, social media, literatures and other data sources to signal potential adverse events

Integration- Services Providers and Clients

Increased outsourcing in terms of PV requires constant overview from the buyers. Currently with the increased adoption of automated platforms, it is best to integrate with the vendors to have transparency and efficiencies

End-to-End Tracking

Such tracking will help in data standardization(through analytics) to obtain an overall signal management with data integration and rationalization from multiple sources

Acquisitions to expand capability

Acquisition of Chiltren by Labcorp, Shin Nippon Biomedical Laboratories Ltd. by PPD are examples to prove that, major service vendors are expanding their services to cater to the developing need across geographies

Supportive Technologies Adopted by Suppliers

Buyers usually enjoy the privilege of the technology developed and adopted by the suppliers. So choosing the right vendor to engage is essential to obtain cost savings and timeliness in case reporting

Big players in PV case processing have already adapted to automation, meanwhile smaller players have either not adopted or are in process of making this shift

Outsourcing Models Followed by Peers

Pharma should prefer to engage with local suppliers with large research centers to develop and monitor trials to gain regulatory approval in those geographies. In the absence of a local office in certain countries, pharmaceutical companies typically engage with large Western CROs to manage regulatory services in these regions