Launch Excellence in a disrupted world: challenges and opportunity
It is now very clear that the global pharmaceutical industry is in a period of significant change, and with it the environment for innovative product launch. Molecular innovation is being supplemented, and in some instances could be replaced, by other forms of innovation, including highly individualized and procedure-like cell and gene therapies, prescription digital therapeutics, or innovation on existing, off-patent molecules.
The rise of specialty as the key value growth driver of the developed markets, has already created a situation where most launches, and almost 100% of the most successful launches, are for globally small, sometimes tiny, patient populations. 2018 was the first year in which both the FDA and the EMA approved more Orphan medicines, for rare diseases, than mainstream products. Mass market common, chronic diseases of the elderly don’t drive pharmaceutical value growth anymore; increasingly, the pipeline, the launches, and the pharmaceutical industry’s value growth is a product of high value therapies for small patient populations.
IQVIA is in the unique position of having the largest global database on past launch performance available, giving us an unmatched quantitative evidence base in research on Launch. In this white paper, we make extensive use of our core MIDAS database of global launch sales, as well as, when we search into the past of launch, the MIDAS based World Review. In all cases, note that the value figures provided are at list price, pre-rebates and discounts, and at ex-manufacturer level.
For our white paper, we focus on innovative, protected new products, defining these as New Active Substances (NAS). New Active Substances are novel and innovative active ingredients, small molecule, biologic or other, which have been launched on the global pharmaceutical market for the first time.