Direct molecular evolution: lifecycle management for biologics

In 2005, 83% of pharmaceutical drug sales were from small-molecule products. Their share of total turnover is forecast to fall to 76% by 2010, in part due to the number of challenges the product class faces, not least of which is a very high level of competition from generics players. Biologics accounted for just 15% of sales in 2005, but this is expected to grow to 22% by 2010, with a new report by independent market analyst Datamonitor forecasting the value of the biologics market will reach $106.0 billion by 2010 - a 70% increase on 2005 sale value.

But, while biologics have an extremely attractive growth rate profile compared to small molecules, the market expansion will not continue at the same rate, due in part to the emergence of bio-similars. Thus, biologics manufacturers need to look at optimizing the lifecycle of their products through directed molecular evolution (DME), according to Datamonitor pharmaceutical markets analyst John Bird.

Biologics (composed of therapeutic proteins and monoclonal antibodies: MAbs) do not face the intense generic pressures of the small molecule class, although bio-similars (or bio-generics) are an emerging threat, particularly for therapeutic proteins.