Forecasting and Testing Response to the Target Product Profile

With the market landscape and target product profile in hand—plus a quantitative assessment of prescribing intention, willingness to pay, and access environment—it’s time to develop a forecast.

A forecast can be developed based on projected patient volume and anticipated market share. A market growth factor should be included based on market landscape dynamics, and reflective of anticipated market shaping efforts and available diagnostic tools. There’s ongoing debate as to the validity of risk-adjusting to net present value; early in the process, the landscape risks are often challenging to define and quantify. It can be enough to aim for a market share or volume factor alone.

While not necessarily embedded in the forecast, regulatory risk should be part of the new product planning evaluation. Teams should evaluate the regulatory risk profile of an asset with respect to stage gate and portfolio resource decisions.