While the ability of recombinant protein drugs to treat previously refractory conditions continues to generate excitement and investment, the complex structure of these therapeutic substances require special formulation and delivery strategies, creating special challenges for drug developers and their formulation technology and delivery device partners. The stakes are high. The current list of approved therapeutic proteins will grow at an exponential rate as the convergence of automated drug discovery and biotechnology production methods create new biological drugs for an expanding number of previously intractable ailments. Currently, more than two-thirds of all therapeutic proteins for chronic diseases are sold as combination pen or auto-injector products. We expect the impressive success of combination drug-device products to continue their dominance on a total market value basis. And while injection will remain the dominant route of administration for protein drugs for the rest of the decade, the recent clinical success of several inhaled protein products  will result in escalating interest in inhalation as a protein drug delivery method. Work on stabilized oral formulations is also making progress. In the near term, the cost per dose of recombinant proteins will continue to provide device technologists with enough running room to continue developing rather elegant protein-device combination products.

Publication Date: May 2008