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With blockbuster drugs like Lipitor recently coming off patent and many others, including Plavix, heading toward the so-called "patent-cliff" as well, the pharmaceutical landscape is continuing its dramatic shift from branded drugs to generics.

According to data released by the IMS Institute for Healthcare Informatics in its report, The Use of Medicines in the United States: Review of 2010 (1), generic medicines accounted for more than three-quarters of the prescriptions dispensed by retail drugstores and long-term care facilities. And, all 10 of the most prescribed medicines in the U.S. last year were generics. This trend, of course hits big pharma directly in the pocketbook as the report noted that brands losing patent protection or exclusivity in 2010 resulted in a reduction in spending of $12.6B.

Furthermore, the report mentioned that the largest segments of the market, including branded drugs, oral formulations and small molecules, each declined or grew more slowly than the total market, while spending on generics, injectables and biologics increased at a higher rate.

With such an uncertain future for traditional small molecule drug development, pharmaceutical companies are developing a new pipeline of biologic-based drugs that potentially will fend off competition from generics. Pharmaceutical industry analyst firm Evaluate Pharma estimates that, "By 2014, five of the top five best-selling and 50% of the top 100 branded drugs will be proteins." (2)

This prediction is supported by the changing nature of the pharmaceutical pipeline. According to Jeff Mazzeo, Biopharmaceutical Business Director at Waters Corporation, a leading developer of life science analytical instrumentation, "approximately one-third of the drugs currently in clinical trials are protein based."

Chromatographic techniques and instrumentation for the analysis and characterization of protein-based drugs will be presented at Pittcon 2012, March 11 to 15, 2012, in Orlando, FL, USA.