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The Dyslipidemia Market: Can Growth Be Sustained as Statin Patents Expire?


Description: Dyslipidemia is a key independent risk factor for cardiovascular disease (CVD); CVD is the largest therapeutic segment of the world pharmaceutical market, and treatment of dyslipidemia represents a major sector of the CVD market. This report provides an overview of the condition, its role in CVD, and its prevalence. We discuss Dyslipidemia treatments, with a focus on the statins as the dominant treatment choice worldwide. We review key patent expiries, including the imminent U.S. expiries of pravastatin (Bristol-Myers Squibb’s Pravachol) and simvastatin (Merck & Co.’s Zocor) and the expected 2011 patent expiry of the best-selling statin, atorvastatin (Pfizer’s Lipitor). In addition, we discuss emerging agents in this market, highlighting the effect generic agents may have on their adoption, or the effect these new agents may have on generics erosion of the market. Finally, we present our expectations for the market throughout our 2004-2014 forecast period.

The cardiovascular market is the largest therapeutic segment in the world pharmaceutical market. In 2004, sales of cardiovascular drugs exceeded $63.1 billion in the seven major markets that we cover (United States, France, Germany, Italy, Spain, the United Kingdom, and Japan). Nearly 40% ($24 billion) of those sales were for agents prescribed to treat dyslipidemia, an abnormality in blood lipid levels recognized as an independent risk factor for cardiovascular disease (CVD). IMS reports that, by 2003, agents for the reduction of cholesterol and triglyceride (TG) levels had become the largest selling class of drugs in the world, owing essentially to the sales of six statins. Sales of these agents have seen dramatic growth, increasing at a rate of 14.2% per year from 1998 to 2004. In 2004, global sales of statins reached $22.6 billion, with most of those sales in the United States. Statin sales have been a major growth driver for the companies that market them; however, 2006 will bring a signifi cant change to the market as generic forms of two of the top selling statins, pravastatin (Bristol-Myers Squibb’s Pravachol) and simvastatin (Merck & Co.’s Zocor), are introduced to the U.S. market. This report provides an overview of dyslipidemia, its role in CVD, and its prevalence in the seven markets we cover. We discuss current treatments for dyslipidemia, with a focus on the statins as the dominant treatment choice worldwide. We review key patent expiries, including the imminent U.S. expiries of pravastatin and simvastatin and the expected 2011 patent expiry of the best-selling statin, atorvastatin (Pfi zer’s Lipitor). We also discuss emerging agents in this market, highlighting the effect generic agents may


Contents: Contents
Statins and the Cardiovascular Market
Overview of Dyslipidemia
Lipoproteins in the Blood
Dyslipidemia and Cardiovascular Disease
Prevalence of Dyslipidemia
Current Treatments
Statins
Fibrates
Cholesterol Modulators
Bile Acid Sequestrants
Nicotinic Acid (Niacin)
Cholesterol Absorption Inhibitors
Combination Products
Current Market Status
United States
Europe
Japan
Key Patent Expiries
Agents in Development
PPAR Agonists
Cholesterol Modulators
CETP Inhibitors
ACAT Inhibitors
Nicotinic Acid Antagonists
Squalene Synthetase Inhibitors
Combination Products
Lp-PLA2 Inhibitor
Statins
Market Outlook
United States
Europe
Japan

Figure 1 Prevalence of Dyslipidemia in the Seven Major Markets, 2005
Table 1 Sales of Leading Agents for the Treatment of Dyslipidemia, 2005 (millions of U.S. dollars)
Figure 2 U.S. Sales of Statins and Ezetimibe-Containing Combinations, 1999-2004 Figure 3 Distribution of the European Dyslipidemia Market, 2004
Table 1 Sales of Leading Agents for the Treatment of Dyslipidemia, 2005
Table 2 Drugs in Clinical Development for the Treatment of Dyslipidemia, 2006
Table 3 Dyslipidemia Sales in the Seven Major Markets, 2004-2014




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