Current cholesterol drug market valued at $34B

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The global market for drugs used in the management of cholesterol is currently valued at around $34 billion; and sales of the major branded drugs amounted to approximately $27.3 billion in 2007, according to a recent Research & Markets report.

The most widely prescribed drugs for cholesterol management are HMG-CoA reductase inhibitors, or statins, according to the report.

In terms of revenue, Research & Markets said that Pfizer’s Lipitor (atorvastatin) remains the largest selling drug of any kind worldwide – accounting for around 40 percent of the market for cholesterol management drugs by value. Without a viable replacement in the pipeline, Pfizer is keen to hold onto its Lipitor revenue for as long as possible, the authors noted.

For some time, Pfizer has been embroiled in a worldwide patent litigation battle with Ranbaxy, which is equally keen to launch generic atorvastatin in key markets, the report said. While Pfizer should be able to fend off generic competition in the U.S. at least until its basic patent expires in March 2010, Lipitor has also been facing competition from multiple entries of generic simvastatin. During 2007, sales of Lipitor have been squeezed, particularly in the U. S. For the full year, Pfizer reported a decline of 8.3 percent in U.S. sales and 1.6 percent worldwide.

Research & Markets also said that new fixed-dose combinations aimed at improved cholesterol management, or more than one heart disease risk factor, are also likely to gain in popularity. The approval of Abbott’s Simcor (niacin+simvastatin) is just one of several combination products expected over the next few years.

Among the current and upcoming products evaluated with Research & Markets five-year sales report forecasts: Pfizer’s Lipitor and Caduet (amlodipine+atorvastatin); Merck’s Zocor (simvastatin) and Tredaptive (niacin+laropiprant); Merck and Schering-Plough’s Zetia (ezetimibe) and Vytorin (ezetimibe+simvastatin); AstraZeneca’s Crestor (rosuvastatin); Abbott’s TriCor (fenofibrate) and ABT-335 (SLV348); Novartis’ Lescol (fluvastatin);  Kos Pharmaceutical’s Niaspan (niacin); and Bayer’s Simcor (niacin+simvastatin).

Espicom has identified 15 drugs in development for atherosclerosis and coronary artery disease. Among these are three launched products in Phase III trials for atherosclerosis indications, including AstraZeneca’s Crestor (rosuvastatin), which has shown promise in atherosclerosis progression. Of the novel candidates in development, the authors have selected just one for analysis: Generx (alferminogene tadenovec, Ad5FGF-4) from Cardium Therapeutics, which is in Phase III for myocardial ischaemia and associated angina.