Big pharma's future: Life after the patent cliff

It wasn’t that long ago that the branded drug industry was seen as an unstoppable titan of American industry, churning out a steady stream of breakthrough therapies and blockbuster products. But a tsunami of expiring patents on such top selling drugs as Lipitor, Plavix and Seroquel, combined with a slowdown in research and development, flattened the growth curve in recent years and opened the door for the ascendancy of generic drugs.

The loss of patent protection can be devastating for a branded drug. According to IMS Health, “over 80% of a brand’s prescription volume is replaced by generics within six months of patent loss.”

The expiration in late 2011 of Pfizer’s patent on Lipitor, the world’s biggest selling drug, greased the skids for the branded drug industry’s recent slide. In the first six months of 2012, total prescriptions dispensed for all branded drugs dropped more than 14%, according to IMS, while total generic prescriptions rose 4.4%. And in a remarkable reversal in fortune, generics now account for 86% of all dollar growth in the pharmaceutical industry. Just four years ago, in 2008, brand-name drugs generated 70% of the growth in U.S. pharmaceutical sales, according to IMS VP industry relations Doug Long.

“Generics are growing while brands are not,” Long said. Nevertheless, don’t count big pharma out. In a report on the global and U.S. outlook for pharmaceuticals through 2016, IMS said the impact of the patent cliff and lower-cost generic competition will peak for branded drug makers in 2012 and 2013. After that, look for a gradual return to growth for the industry, IMS and other experts predict, as patent expirations ease, health reform adds millions more Americans to the insurance rolls, and new drug therapies emerge, particularly in specialty medicines.

Steve Collis, president and CEO of drug wholesaling and health services giant AmerisourceBergen, agrees with that scenario. At an industry summit in mid-September, Collis predicted “a slower brand[ed]-to-generic [trend]” in 2013, and “a resumption in... top-line growth” for the pharmaceutical industry the following year.

Add the inescapable fact that America is aging, and you have the makings of a return to modest growth for the hard-pressed branded drug industry. “With 50,000 baby boomers entering Medicare every day, healthcare spending's going to be a tremendous focus," Collis said.

Also boosting the market for new drug therapies will be a trend already well under way: The expanding number of outlets for high-maintenance, high-cost specialty pharmaceuticals as retail pharmacists and the companies they work for upgrade their clinical services, add more specialty medicines to the mix, and target more patients with serious conditions who need a higher level of care. As Mike Johnsen of Drug Store News reported Friday, “the business of specialty pharmaceuticals will trend higher as the administration of those medicines expands beyond traditional care centers.”

Any number of factors — the presidential election, the pace of health reform, the success of big pharma’s R&D efforts, the emergence of bioequivalent specialty medicines, etc. — could scramble the outlook for branded and generic medicines, however. What’s your prediction for drug utilization over the next couple of years? As always, we invite you to comment.