Launching a first-in-class drug is high on the wish list of most pharma companies, but achieving that goal is not without its challenges. While patient demand for innovative therapies will always be high, modelling their impact on the treatment landscape is an uncertain business and the stakes are too high to rely on little more than guesswork.

This is where analogues come in, and the choice of analogue can be make-or-break for building a robust forecast that is anchored in commercial reality.

When you are forecasting for an entirely new therapy, market information becomes your best friend. The more unique the therapy, the more precious this information becomes. Without it, there is a danger of internal enthusiasm and optimism skewing your data which can have huge implications for things like resource allocation.

But how do you identify the right analogues for your groundbreaking new therapy? The most relevant case studies may not be immediately obvious – perhaps they are in a totally different disease area, or launched many years ago. You need two things; a substantial back catalogue and some creative thinking to develop a basket of analogues that can reasonably reflect your new drug. Together, these give you the scope and flexibility to create a strong forecasting model.

Further considerations

Patient-based forecasting: Patient-based forecasting is a critical tool to help you understand the opportunity for new therapies and model potential use. This is particularly important in the light of the trend towards precision medicine which results in narrower patient populations, especially in oncology where factors like tumour location, biomarker presence and prior treatments all come into play.

This level of detail requires the ability to segment analogues to a similar depth in order to confidently predict revenue potential – and this can have a significant impact on forecast market share. In addition to analogues with a comparable label, your “basket” needs to include features like the level of clinical benefit, tolerability, competitive landscape, and marketing presence.

Keep an eye on the recent past: Traditionally, forecasters would pick analogues from well-established case studies that have been through most, if not all, of the commercial lifecycle. However, the rate of innovation today means that more recent examples may provide valuable insights. Breakthroughs in mRNA, cell and gene therapy and in indications such as obesity may point to more current commercial trends. While you wouldn’t exclusively use these as analogues, they may provide a useful addition to help you triangulate a modern launch.

Ready to learn more?
We have much more detail in our article “Calibrating for complex new drugs with analogue forecasting”. Take a look, and get in touch if you would like to find out more about J+D’s new Forecast Analogue Library.