Pipeline drugs 2010

Key Points

"We are very optimistic that the pipeline will be very rich for 2010," said Alan Goldhammer, vice president of Scientific & Regulatory Affairs for the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA), an organization of pharmaceutical industry research and biotechnology companies. In 2008, the most recent year for which data are available, PhRMA members invested an estimated $50.3 billion in developing new medications. That same year, industrywide research and investment reached a record $65.2 billion.

The sheer quantity of products in the pipeline today is immense. "If any number of them succeed, they have the potential to change the direction of treatment for several conditions, based on some of the phase 3 trials that we've seen," observed Brian Kolling, PharmD, director of Pipeline and Trend Forecasting for Part D at Prescription Solutions, a subsidiary of the pharmacy benefit management company UnitedHealth Group, in Minnetonka, Minnesota.

Goldhammer agreed, saying that he is pleased that the FDA seems to be moving ahead and making decisions on pending NDAs, and not allowing data to sit idle. Along those lines, he said, he expects the FDA to focus more on drugs that treat type 2 diabetes and address drug safety issues connected with therapies treating cardiovascular disorders.

Although the pipeline appears abundant, 2010 may not prove a banner year for drugmaker profits. Nonetheless, market analysts expect the next 12 months to yield important breakthroughs in certain categories.

Among them will be departures from some of the standard players of years past. Many therapeutic categories once brimming over with numerous drug-therapy advances are now on the back burner. The oncology market, for example, which produced noted developments in the early years of the new millennium, is currently quiet, as are treatments for neurologic disorders, although some innovative prospective treatments for Alzheimer's disease show promise. There also is little development on the horizon in the drug treatment of Parkinson's disease, schizophrenia, or depression.

On the other hand, of the developments expected in 2010, a few are already emerging to expectations that they will have profound impact on the treatment, management, and outcomes of several disease states. Among the key trends and therapeutic areas to watch: