With the market for lipid lowerers expected to grow apace and a patient population of 266 million in the seven largest pharmaceutical markets, there is no shortage of drug manufacturers willing to invest in the market, says a new report from Datamonitor.

Pfizer’s Lipitor (atorvastatin) is the most widely used treatment for lowering cholesterol and the best-selling pharmaceutical product of any kind in the world, becoming the first ever $10 billion product. It currently commands approximately 40% of the worldwide sales in the lipid-lowering market, more than 42% of the US market in total prescriptions and continues to post strong growth (18% growth in 2003/04) around the world.

However, Lipitor is at risk of US generic erosion come 2010 and, to that end, Pfizer is developing a product combining the active ingredient atorvastatin with torcetrapib, which will both cut the bad LDL-cholesterol and raise the good HDL-cholesterol. In clinical trials, torcetrapib plus atorvastatin increased HDL-c levels by 55% - significantly more than any other compound currently on the market. It also decreased LDL-c by 17%, beyond the reductions seen during the placebo phase of the study when patients received atorvastatin only. And, combined with Pfizer’s marketing prowess, Datamonitor forecasts that this new drug combo will reach sales in excess of $4.3 billion dollars in 2015.

But coming up behind is Japan Tobacco/Roche’s JTT-705, which looks set to become the second most successful drug in the pipeline, with sales of $674m by 2015. JTT-705 has a great potential as an adjunctive (combination) therapy as physicians will be able to prescribe it to patients receiving any statin, adds Datamonitor. But it is not alone, and approximately 69% of the drugs in the lipid-lowering pipeline are being trialed as adjuncts, although 90% of these are in either Phase I or II.

Of this pipeline of 44, nine compounds are from the peroxisome proliferators-activated receptor class. However, warns Datamonitor, with the dyslipidaemia market already saturated with third-generation statins, finding a superior therapy is likely to be difficult. However, it concludes, the possible improvement with drug classes such as PPAR alpha agonists could expand the adjunctive market. This potential is set to increase because the number of patients with mixed dyslipidaemia and diabetes is increasing, which is expanding the patient population.