BURLINGTON, Mass., Aug. 20, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the dyslipidemia market will grow to just over $31 billion in 2022, at an annual rate of 2 percent from 2012. The launch of antidyslipidemic agents from two novel drug classes–PCSK9 and CETP inhibitors–will be the primary drivers of market growth, off-setting the voracious genericization that has and will continue to impact the market through 2022.
The Pharmacor advisory service entitled Dyslipidemia finds that, despite continued generic erosion of Pfizer's Lipitor (atorvastatin) and the launch of generic versions of AstraZeneca's/Shionogi's Crestor and Merck's ezetimibe franchise—Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Liptruzet (ezetimibe/atorvastatin)—statins will remain the sales-leading drug class through 2022.
"The failure of non-statin drugs to demonstrate a cardiovascular outcomes benefit above that of statin therapy in clinical trial has further cemented the first-line status of the statin class, and eroded physician willingness to address residual risk by normalizing non-LDL lipids," said Decision Resources Analyst Pam Narang, M.Sc., Ph.D. "Decision Resources expects the recent outcome of the HPS2-THRIVE study that investigated the effect of HDL-C raising with Merck's Tredaptive to spell the end for niacin-based drugs. Yet we see continued physician optimism for CETP inhibitors, which also primarily target HDL-C. While this enthusiasm is driven by their additional LDL-C lowering ability, the pendulum appears to be swinging back to LDL-C as the most robust modifiable dyslipidemia target, according to experts we interviewed."
The report findings also reveal the result of the outcomes trial IMPROVE-IT for ezetimibe is the most highly anticipated near-term event in the dyslipidemia market. Positive data from this trial will have a significant effect on physician prescribing and provide further validation of the LDL-C hypothesis, which will impact emerging LDL-C lowering agents such as the PCSK9 inhibitors. These agents will initially target the most high-risk patients. Launching in a specific patient subpopulation with the intention of gaining a broader label is an established development strategy, and one previously employed for prescription omega-3 fatty acids, Amarin's Vascepa and AstraZeneca's Epanova.
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