Personalised medicine development is occupying a growing role in the clinical pipelines of drug developers and leading companies to change their R&D paradigms, including how they make “go/no-go” decisions, according to a new study.

“Early indications show that development of personalised medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry,” according to Christopher-Paul Milne, associate director at the US Tufts Center for the Study of Drug Development (CSDD) and author of the study, which appears in the newly-published November/December issue of the Tufts CSDD Impact Report.

The study notes that the scientific, regulatory, commercial and practical challenges confronting developers in creating personalised medicines are significant and, as a result, approaches taken by individual companies in the pursuit of these new medicines vary greatly. In particular, developers are working with academic medical centres to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities, says Dr Milne.

His findings also reveal that:

- the magnitude of resources required to create personalised medicines means developers must team with multiple external partners, presenting challenges for project stewardship and intellectual property rights;

- biomarkers are increasingly being used to better understand patient response, but companies still cannot use biomarker data to support approval until the regulators’ capacity to evaluate it catches up to the science;

- oncology leads other therapeutic areas in the number of personalised medicines on the market as well as in the pipeline, with the expectation that within the decade all oncology drugs will have a related diagnostic; and

- other key therapeutic areas in which personalised medicine is making headway include cardiovascular, central nervous system and immunologic therapies. Elsewhere, personalised medicine development is just getting started for metabolic and respiratory therapies, as well as virology, the study notes.

• PricewaterhouseCoopers has forecast that the US market for personalised medicine will grow around 11% a year from a value of $232 billion in 2009 and could reach $425 billion by 2015, while earlier this month a report from UBM Canon Data Products Group projected that sales of biomarkers for use in clinical trials will grow 37.6% by 2015.