Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe

J Pers Med. 2015 Jun 12;5(2):213-28. doi: 10.3390/jpm5020213.


The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

Keywords: Stratified medicine; companion diagnostics; cost-effectiveness; market access; value addition.

Publication types

  • Review