Current trends in drug development point toward a growing number of therapies that are targeting smaller patient populations. As the batch sizes required to manufacture clinical and commercial supply of these therapies are smaller than in the days of blockbuster medicines, the equipment and processes for manufacturing have had to change as well, creating challenges for smaller pharmaceutical companies.
A major factor of decreasing batch size is the steady increase of therapies for rare diseases. This trend has continued in 2019, where the number of drugs in development increased over 2018 by seven percent to almost 5,000 drugs (PharmaProjects, January 2019). Another reason for smaller batch size is the targeting of existing drugs to more specific patient populations. Examples of this are Roche’s Herceptin® and Kadcyla® products. Herceptin was originally developed for a specific subset of breast cancer patients. Kadcyla incorporates the Herceptin antibody but is an even more targeted therapeutic, servicing an even smaller subset of patients with breast cancer.