The global market for drugs to treat dyslipidemia will grow by an average of around 2% a year from 2012 to 2022, by which time it will be worth just over $31 billion, according to new research.
The launch of antidyslipidemic agents from two novel drug classes - proprotein convertase subtilisin/kexin type 9 (PCSK9) and cholesterylester transfer protein (CETP) inhibitors - will be the primary drivers of market growth during this period, and will offset the strong generalisation that has and will continue to impact this market to 2022, says the study, from Decision Resources.
Moreover, despite the continuing generic erosion of Pfizer's Lipitor (atorvastatin) and the launch of generic versions of AstraZeneca/Shionogi's Crestor (rosuvastatin) and Merck's ezetimibe franchise - Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin) and Liptruzet (ezetimibe/atorvastatin) - statins will remain the sales-leading drug class to 2022, it says.
"The failure of non-statin drugs to demonstrate a cardiovascular outcomes benefit above that of statin therapy in clinical trials has further cemented the first-line status of the statin class, and eroded physician willingness to address residual risk by normalising non-LDL [low-density lipoprotein] lipids," comments Decision Resources analyst Pam Narang.
The report expects the recent outcome of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, investigating the effect of high-density lipoprotein cholesterol (HDL-C)-raising with Merck & Co's Tredaptive (extended-release niacin and laripropant), 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," says Dr Narang.
The result of the outcomes trial IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) for ezetimibe is the most highly-anticipated near-term event in the dyslipidemia market, the report adds.
Positive data from IMPROVE-IT 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, agents which will initially target the most high-risk patients, it forecasts.
Launching in a specific patient subpopulation with the intention of gaining a broader label is an established development strategy, and one employed for prescription omega-3 fatty acid products Amarin's Vascepa and AstraZeneca's Epanova, it adds.