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Background

Personalized medicine involves the use of molecular diagnostics to tailor treatment to the individual characteristics of each patient. The area has generated significant interest across the healthcare sector given its potential to improve patient outcomes and guide the optimal deployment of resources.

Pharmaceutical companies in particular are increasingly exploring the use of companion diagnostics to optimise the development and commercialisation of new products. This is most evident in oncology, where the use of biomarkers is becoming a critical element in the strategic plans for many new therapies. Precedent has already been established in this disease area with HER2 testing in breast cancer, and K-RAS testing in colorectal cancer.

Despite the obvious promise that personalized medicine and theranostics hold, there are still numerous technological, regulatory and commercial challenges facing companies in this field. From a commercial perspective, there are clearly a new set of issues associated with coordinating the simultaneous launch of a pharmaceutical and diagnostic. It is also more complex to evaluate the financial impact of using such companion diagnostics, which could limit the overall target patient population but may dramatically alter the value proposition to physicians, patients and payors.

Globe provides commercial evaluation and information to support strategic decision making for companies operating in the field of personalized medicine (see Our Services).