The growth of personalised medicine will increase the number of alliances between diagnostic and pharmaceutical businesses, says a new PricewaterhouseCoopers (PwC) report.
The report, entitled Diagnostics 2009: Moving towards personalised medicine, says that significant further progress is needed in this area, as current patient response rates to medicines can be very low – varying from 20% to 75%.
PwC gives the example of GlaxoSmithKline’s recently announced deal with Enigma, a British diagnostics group, to develop a new test that can diagnose specific strains of influenza, including swine flu, in just an hour.
Loïc Kubitza, Director at PricewaterhouseCoopers, said: “We expect alliances with the pharmaceutical industry to increase in the next two to five years but this will be driven by factors including the pricing of diagnostics, the extent of reimbursement coverage, and the burden of any clinical validation work required for market access.”
However, the pricing of these diagnostic tests does not always reflect the cost of their development or contribution to overall health benefits, and this can adversely affect the business case for developing a new diagnostic.
“Addressing the pricing conundrum is a crucial factor to ensure that diagnostics play a full part in improving patient health, and will be a critical part of a pharmaceutical company’s toolkit in enhancing its product portfolio and pipeline,” Kubitza added.
PwC expects a number of factors to drive the continued development of personalised medicine – particularly the influence of regulatory agencies, including the FDA and EMEA, which are supporting the field of personalised medicine by introducing formal requirements to test for certain biomarkers before prescribing certain drugs.
Simon Friend, Global Pharmaceuticals and Life Sciences Industry Leader at PricewaterhouseCoopers, said: “Increasingly, pharmaceutical companies will not move a drug candidate to the clinical development stage without a clear biomarker development program.
“These companies understand the contribution of biomarkers and diagnostics in improving the design and probability of success of clinical trials. In addition, pressure from healthcare payers is putting more emphasis on the availability of a companion biomarker test when deciding on a drug’s reimbursement.”