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Are in-house diagnostic companies a must-have or a nice-to-have when trying to achieve personalized medicine leadership? And are pharmaceutical companies moving away from companion diagnostics? These questions are examined by Tessa Sandberg and Ewelina Golebiewska of Diaceutics.
It cannot escape those with a keen interest in personalized medicine (PM) that there is a rising number of partnering deals between pharmaceutical and diagnostic (Dx) companies. As part of the PM Readiness Benchmark 2016 Report, Diaceutics analyses the partnering deals of pharma companies identified as being important personalized medicine players between 2005 and 2014. This brief insight highlights some of the early observations.
Partnering activities include the acquisition or investment in strategic agreements between pharma and Dx companies. The first highlight from the report is that the number of such deals in the personalized medicine field has significantly increased from 2005 to 2014 (Figure 1). We can expect even more deals in the next few years as pharma increases its interdependency on Dx companies, both for development and commercialization purposes. Our data shows that pharma partnering with Dx companies is today clearly the preferred business model. However, leaders in the field are setting a trend by acquiring their own in-house Dx companies. This is of course the case for Roche, which acquired Ventana and many other Dx companies since, but also for Janssen and Novartis. These are all companies considered by Diaceutics to be potential personalized medicine disruptors1. To become a personalized medicine leader, will an in-house Dx company be a must-have or just a different personalized medicine strategy?
Figure 1. A significant increase is observed in the number of personalized medicine partnering deals made by twelve of the companies considered by Diaceutics as leading players in the field.
Let’s focus on Roche for a second, the pharma company that has made the most personalized medicine partnering deals lately. Despite strengthening its in-house Dx capabilities, Roche still partners with many external Dx companies such as Qiagen and Epic Sciences. These deals emphasise Roche’s intention to expand beyond its in-house Dx capabilities. Meanwhile, Roche’s Ventana also partners with other companies such as AstraZeneca and Pfizer/Merck Serono in the immune-oncology field for the development of a PD-L1 assay. Given Roche’s position as a personalized medicine leader, should pharma consider partnering with Roche to be a good deal or a threat?
Secondly, pharma invests in developing single companion diagnostic (CDx) tests which play a central role in the ‘one drug – one biomarker – one test’ model. However, the analysis of the personalized medicine partnering data suggests a shift from this model to a patient-centred model where multi-biomarker panels will lead towards the choice of the drug. Specifically, there is a trend of pharma increasingly investing in bioinformatics in order to develop multi-gene panels. For instance, most of the twelve featured personalized medicine pharma companies partnered in the last five years with genomic profiling research companies, companies expert in next-generation sequencing (NGS) platforms, NGS data management and interpretation. This insight is in line with an article by Bob Holland who challenges the ‘one drug – one test’ model. He doubts whether the model will survive much longer, as launching many different tests for the same indication will soon become too expensive and too complex2.
Thirdly, what we have discussed so far is mainly related to oncology and most partnering deals are performed in this area. However, other disease areas such as neurology, infectious diseases and cardiology have seen increased activity lately. Diaceutics’ data also shows an increase in the number of partnering deals beyond oncology from 2011 to 2014 – an indication that other disease areas are likely to become more prominent in the personalized medicine field.
To conclude, the data highlights that investing in strengthening in-house Dx capabilities is likely to be an important factor in achieving personalized medicine leadership. Time will tell whether acquiring in-house Dx development divisions is a must-have to achieve this goal. There are also clear trends in moving away from the ‘one drug – one biomarker – one test’ model towards multi-marker panels and in expanding pharma and Dx company partnering deals beyond oncology.
1 Definition of PM disruptor:
Companies that have embraced model migration and are most likely to competitively reshape therapy areas via personalized medicine. The mindset of companies categorized as PM disruptors is “Personalized medicine is the future model and we are aligning to deliver on it” (Source: Diaceutics).