Companion Diagnostics Development and Commercialization : A Case Study from the Diagnostics’ Perspective

Abstract: The value proposition of Personalized Medicine is to deliver the “right drug, to the right patient, at the right time”. Companion diagnostics is the required tool for Personalized Medicine used to aid clinical decision making with the aim to identify patients who are most suitable for a given treatment approach and to avoid adverse effects. However, even 16 years after the first co-approval of a therapeutic drug and an associated diagnostic test (trastuzumab (Herceptin1) from Genentech and the HercepTest1 from Dako), the co-development and co-approval of drug-diagnostic pairs is a challenging task.This study has the aim to identify major challenges for diagnostics companies when developing and commercializing companion diagnostics. This is achieved by (1) a literature research and (2) an empirical case study in form of interviews with diagnostics companies. The collected data is analyzed and discussed with focus on current regulatory and reimbursement frameworks in the USA and European Union. The co-development strategies and business models of companion diagnostics developers are identified.The conclusion of this study is that the major hurdles for companion diagnostics development and commercialization are gaps in scientific evidence and lacking regulatory guidelines for co-development and clinical biomarker studies. Companion diagnostics commercialization is further challenged by poor reimbursement levels. The main strategy of diagnostics companies to address these challenges is the demonstration of a beneficial outcome for patients in form of clinical studies. Small companies with limited resources for clinical research receive funding from academic research grants, patient support groups, pharmaceutical industry, and governmental Innovation agencies.Finally the formation of a new “pharma-diagnostics” sectoral innovation system as a result of the emerging paradigm of stratified medicine has been proposed.