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Feb 01st
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Dyslipidemia - Pipeline Assessment and Market Forecasts to 2016

GlobalData, the industry analysis specialist's new report, "Dyslipidemia - Pipeline Analysis and Market Forecasts to 2016" is an essential source of information and analysis on the global dyslipidemia market. The report identifies the key trends shaping and driving the global dyslipidemia market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global dyslipidemia sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData's team of industry experts.

The Dyslipidemia Market is Forecast to Decline until 2016

GlobalData estimated the global dyslipidemia market to be valued at $34.4 billion in 2009. It is expected to decline at a compound annual growth rate (CAGR) of approximately 3.7% from $34.4 billion in 2009 to $26.3 billion by 2016. Although the cardiovascular market expanded considerably from 2004 to 2008, growth in the seven major markets is expected to slow down from 2013 onwards. The decline in sales during this period will be due to the expiry of many leading brands' patents. Pfizer's Lipitor, a major blockbuster in the dyslipidemia market, is set to expire in 2011. Following the expiry of Lipitor's patent, Simcor and Trilipix's patents will also expire in 2011. The patents of Zetia, Vyotrin, Lescol, Livalo and Lovaza are set to expire between 2012 and 2014. The market growth will be sustained by the launch of major new products with safety and convenience advantages such as once-daily administration and combinational therapies. The New Drug Application for Cetriad, being co-developed by AstraZeneca and Abbott Laboratories, has been filed with the US FDA and is currently the most anticipated drug in the pipeline.

Competition in the Dyslipidemia Market is Strong

GlobalData found that the current competition in the dyslipidemia market is becoming intense due to the increased entry of combinational therapies and the use of statins, fibrates, niacin and omega-3 fatty acid derivatives as antidyslipidemic agents. It projects that Lipitor, Trilipix and Simcor will be the leading competitiors in the global dyslipidemia market. Pfizer, Abbott Laboratories, AstraZeneca and Merck will continue to be the market leaders until the patents on their drugs expire inbetween 2011 and 2014. The market is set to shrink following the expiry of Pfizer's Lipitor. Also Simcor, Trilipix, Vyotrin, Zetia, Lescol, Lovaza and Livalo are all set to expire between 2011 and 2014. The dyslipidemia market is expected to show decline due to patent expiries in the near future.

Strong Pipeline Dominated by First-in-class and Me-Too Products

GlobalData found that there are over 98 molecules in various stages of the pipeline. Cetriad, Trilipix in combination with atorvastatin, Trilipix in combination with simvastatin, RG1658, MK-0524A, Caduet, GFT-505, AEGR-733, AMR-101and MK-859 are some of the promising molecules in the late stage pipeline of dyslipidemia. Some of these molecules differ in their target and mechanism of action from the existing therapies. Most of these molecules are combination products of already marketed drugs. Novelty exists in terms of using two different drugs in combination in order to increase efficacy. Some of the drugs in the late stage pipeline, such as GFT-505 and MK-0524A, are completely novel to the dyslipidemia market and these drugs, if approved, would introduce drug classes with better efficacy. Although the dyslipidemia pipeline is strong in terms of first-in-class and me-too products, only a small number of products are expected to enter the market before 2016. Inspite of the strong pipeline, the market is declining due to the patent expiries of major blockbuster drugs.

Unmet needs Exists in Terms of the Safety and Efficacy of the Currently Marketed Products

GlobalData has found that several conventional therapies for the treatment of dyslipidemia such as statins, fibrates, combinational therapies, niacin and prescription omega-3 esters are mainstay therapies for dyslipidemia. These molecules offer substantial efficacy combined with durable responses and convenient dose frequencies. Combination therapies lead the market and are the preferred first-line therapies for dyslipidemia. Dyslipidemic drugs do not completely cure the disease; rather they offer symptomatic treatments and are associated with safety concerns. Thus, there are unmet needs in the market in terms of efficacy and safety. Any new treatment in the pipeline targeting safety and efficacy - with pricing as another prime factor - is likely to attain blockbuster drug status.

Current Treatment Options are Moderately Successful in Meeting the Market Demand by offering Symptomatic Treatments

GlobalData has found that the available treatment options have been moderately successful in meeting the market demand. The current therapeutics provides rapid decrease in LDL-C (low density lipoprotein-cholesterol), TG (tryglycerides), TC (total cholesterol) levels and increase in HDL-C (high density lipoprotein-cholesterol) levels and improves patients' overall quality of life. The drugs approved for the treatment of dyslipidemia can prevent cardiovascular abnormalities like cardiovascular disease. Overall, there is strong competition among the currently marketed products based on providing symptomatic treatment of the disease. Though dyslipidemia treatments are only symptomatic, they treat patients effectively. Hence the market for dyslipidemia treatment is strong. However, safety remains a concern as antidyslipidemic drugs are associated with serious adverse effects such as myopathy or rhabdomylosis, liver disease and increased liver enzymes. There is a lot of market potential for any new entrant that can cater to these unmet needs. A product with disease modifying mechanisms and a better safety profile and good efficacy is sure to achieve blockbuster drug status by targeting these existing unmet needs. Thus, a strong opportunity exists for any drug that offers better efficacy and safety than is provided by the current players.

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