Bye, bye blockbusters, hello niche busters.

time for a great white shark named Bruce. A mechanical beast weighing 1.5 tonnes, Bruce was the star of Jaws, a movie that grossed US$260 million in the United States, ushering Hollywood into the summer blockbuster era. Like the movie industry, the pharmaceutical sector has in recent decades come to rely on annual blockbusters to drive profits. But it appears the blockbuster model is broken. Unless drug companies find new products to replace the many bestsellers with expiring patents or adapt in other ways, such as focusing on niche markets, they may be entering dangerous waters. “Unless we reinvent ourselves through research, then we can face a bit of a dip, which is the situation we are in now,” says Paul Lévesque, president of Pfizer Canada. “That said, our industry is cyclical and this is not the first time we have faced a situation like this.” The so-called “blockbuster philosophy” that has dominated the pharmaceutical industry proposes that drugs should be developed for as many people as possible so as to achieve sales of at least US$1 billion. According to a recent analysis of growth rates of spending on prescription drugs in the United States, the number of products achieving that goal has been shrinking over the past few years (Health Affairs 2009;28:w151-60). From 1997 to 2006, the paper states, the number of US blockbuster drugs grew from 6 to 52. In 1996, blockbusters accounted for only 12% of drug sales. A decade later, that percentage had swelled to about 50%. Pfizer’s bestseller atorvastatin (Lipitor), dubbed by some “the ultimate blockbuster,” generated worldwide sales of US$13.6 billion at its peak in 2006. But many of those mega-sellers — including atorvastatin, fluticasone propionate (Flonase), clopidogrel bisulfate (Plavix) and sildenafil (Viagra) — have come off patent or will in the near future. In 2007, the number of blockbusters fell to 48 and accounted for 44% of all drug sales. Meanwhile, the percentage of US prescriptions filled with generic drugs is increasing rapidly, jumping from 51% in 2002 to 67% in 2007. Overall, the growth rate of spending on prescription drugs in the US fell to 1.6% in 2007, the lowest it’s been since 1974. “Slow sales growth is likely to put pressure on research budgets and marketing costs and to create incentives for mergers,” the study states. “The existence of fewer, larger entities with tighter research budgets may stifle or limit investment in innovation and the ongoing prospects for improved therapeutics reaching the market.” Lévesque isn’t so pessimistic about the state of his industry. He acknowledges that certain product categories are “satisfied” and are unlikely to produce more billion-dollar products. Still, he says, there is money to be made by targeting subpopulations within many categories. Furthermore, there are still diseases that aren’t fully understood, such as cancer and Alzheimer disease, so there is still potential for creating breakthrough pharmaceutical products. “I think we are going to have a new generation of blockbusters,” says Lévesque. In the meantime, he says, drug companies will continue to merge and consolidate research efforts to increase productivity. That will likely spell bad News CMAJ