Shire faced multiple issues in creating a development and commercialization strategy for a pre-Phase II asset in the US and three non-US regions. One pivotal challenge involved forecasting the relative market potential for two distinct indications. RG+A conducted a Dynamic Practice Simulation® (DPS) study with 400 physicians in seven markets. The split sample design allowed Shire to analyze how each indication would perform as the launch indication and as the second indication. The study showed that indication A would gather more use than indication B. For clinical development, it also pinpointed pivotal clinical endpoints, patient targets, and possible combination therapies. For commercial development, it pinpointed physician segments, key market messages, and how both of these varied from region to region. After reviewing these results, Shire continued development of indication A, but not B.
As part of a larger acquisition, Shire acquired a pre-Phase II asset in the gastroentereology (GE) market. The product could be supported for two different indications. To guide development and commercialization strategies, Shire sought a research design that would provide peak market forecasts for each indication and at the same time estimate the investment and describe clinical and marketing activities that would be key to success. Specifically, Shire wanted to identify physicians and patients to target, a clinical profile to pursue, likely brand positioning for each indication, and how the market opportunity varied in different regions of the world.
RG+A executed a DPS® study with 400 physicians in four markets (100 in US, 50 each in six non-US). In each market, half the respondents were GEs, while the other half were primary care physicians (PCPs). The study included three rounds of simulation: one in the current market, the second after the launch of the first-to-market indication, and the last after the launch of the second-to-market indication.
To help Shire determine which indication to develop first, half the physicians saw indication A come to market before indication B, while the other half saw indication B first. To test for spillover, each physician treated 3 patients per indication in each round.
The study revealed that indication A was likely to gather more market use than indication B. In part, this was due with lower market satisfaction to the disease that indication A treats. More important, indication A had the ability to grow the market and take share from competitors at the same time.
The study also determined that the majority of use in indication A would come in combination with the current standard of care, and identified the specific target symptom and safety labeling that would drive Indication A use.
Finally, the study identified clear patient targets within the group of patients being treated for indication A.
We determined that aggressive development in indication A would likely yield significant market benefits over time. We highlighted key elements of the clinical plan, identified specific targets for market preparation and pre-launch education, and pinpointed specific differences between how to promote and educate in one of the non-US regions as compared to the US and the other non-US region we evaluated.
The client continued to develop indication A aggressively and did not proceed with trials in indication B.