Stem cell technologies may have their biggest impact on healthcare by cutting waste and costs in the early stages of drug development, a new US report suggests.

According to the report’s publisher, Kalorama Information, millions of dollars could be saved in pharmaceutical development costs if preclinical testing using stem cell technologies were to root out the adverse effects or lack of efficacy that too often do not show up in animal studies.

The discovery and commercialisation of a new drug takes over 14 years and costs more than $1 billion, Kalorama Information points out. Yet over 90% of compounds entering clinical development fail to make it to market.

A particular weak spot in this expensive and high-risk process is early toxicity testing, as “there are currently no good models for determining whether a drug will be toxic in humans”, Kalorama Information says. Even compounds that survive the long haul to market may end up being taken off it “at huge expense” if missed adverse effects emerge with long-term use.

Yet stem cell technology “could provide a virtually endless supply of liver or heart cells for testing, saving developers tens, if not hundreds of millions of dollars in direct testing fees, as well as indirect costs related to drug recalls”, comments Kalorama Information publisher Bruce Carlson.

Stem Cells for Safer Medicines
As the report, Stem Cells: Worldwide Markets for Transplantation, Cord Blood Banking and Drug Development, notes, GlaxoSmithKline, AstraZeneca and Roche recognised this potential last year when they set up a new venture, Stem Cells for Safer Medicines Ltd, to develop effective ways of using human embryonic stem cells to screen for potentially dangerous side-effects before pipeline drugs enter clinical trials.

While it is unlikely stem cell-based drug development technologies will become available before 2012 at the earliest, they may prove to be a more significant advance than the more widely discussed application of stem cells as disease therapies, Kalorama Information predicts.