The Blockbuster Drug Model

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The concept of a blockbuster drug is perhaps the biggest consequence of the currently practiced drug development strategy. A blockbuster drug according to Drews & Duyk (2004) is one that is typically marketed for upwards of 20 million people, generating upwards of $1billion a year in sales (Drews & Duyk, 2004). The success of most blockbuster drugs is hinged on their being taken by a large number of people for long periods of time (Tait and Mittra, 2004). All drugs are required to go through the same approval process, whether or not the projected market is two million or twenty thousand people (Klein & Tabarrok, 2003). This means that with the current test and approval process, most drugs will take approximately the same time to get to market (Klein & Tabarrok, 2003), making the “blockbuster drug model” an attractive adaptation. The blockbuster drug model according to Keefer (2003) is that in which drug manufacturers “derive a majority of their revenue from the sales of a few individual patented products”. The need by the pharmaceutical companies to recoup the vast sums and still be profitable becomes paramount (Rioux, 2000; Michalowski, 2001). From this perspective, it may be inferred that the blockbuster syndrome is a consequence rather than a cause of the high discovery, development and approval costs (Klein & Tabarrok, 2003). While this may be debatable, the clear result of the high drug discovery and development costs is that pharmaceutical companies rely on blockbusters for their financial sustenance and growth (Rioux, 2000; Michalowski, 2001). 

The following table illustrates the results of the blockbuster model for the top 11 pharmaceutical companies in the world in 2002.

This approach is investor driven and has been applied successfully in both the automobile and movie industries (Keefer, 2003). It is however causing a significant amount of economic pressure on the drug discovery and development process. In fact, Joe Chimera, PhD, the head of the Pharmaceutical Technology Group for BioSignia observes that “the pressure to maintain the existing types of margins to keep shareholders happy is forcing pharmaceutical companies to focus their efforts on developing at a minimum one or two big blockbusters a year” (Keefer, 2003). The blockbuster model has also resulted in a sharp decline in pharmaceutical innovations (Whittaker, 2003). According to Tait and Mittra (2004), the drugs that are “cheapest to develop – and have the largest potential markets have already been produced and are either off-patent or nearing that point”. This position is collaborated by Frank (2003) and Whittaker (2003). Frank (2003) observed that of the 98 NDA applications approved by the FDA in 2000, only 27 (about 28%) were for New Molecular Entities (NME) i.e., new chemical entities that have not hitherto been tested in humans in a quest to seek drug approval. The rest of it was for “products that represent new formulations and new methods of delivering existing drugs” (Frank, 2003). These ‘new’ drugs have variously been described as “less new” (Frank, 2003), “follower” (Rasmussen, 2003) and “me-too” (Koppal, 2004). The bottom line is they have resulted in an “innovation gap” in the pharmaceutical industry resulting in unmet medical needs remaining unmet (Whittaker, 2003).

Besides the innovation gap, there are other problems that have resulted from the blockbuster drug model. These include the emergence of “orphaned” drugs (drugs for rare diseases that are overlooked or lost in the quest for the blockbusters), and the consequences of patent protection. These are discussed in the following sections.