The World Health Organization Estimate that 135 Million People Suffer from Type 2 Diabetes and 300 Million People Suffer from Obesity

Research and Markets (http://www.researchandmarkets.com/reports/c32172) has announced the addition of Metabolic Diseases Pipeline Analysis: Focus on Dyslipidemia, Diabetes, and Obesity to their offering.

Metabolic diseases affect millions of people worldwide. Thousands of metabolic diseases have been identified in humans, yet just a handful of these diseases account for the vast majority of the morbidity and mortality. The World Health Organization (WHO) estimates that type 2 diabetes affects 135 million people worldwide and that 300 million people meet the criteria for obesity. Dyslipidemia is another major metabolic disorder, affecting approximately 300 million people in the United States, Japan, and Western Europe.

Because these three disorders - type 2 diabetes, obesity, and dyslipidemia -are highly prevalent and lead to significant morbidity and mortality, they are the main focus of this report. We also discuss several metabolic disorders that are less severe but account for significant morbidity. These disorders include "metabolic syndrome" (which comprises several conditions), polycystic ovarian syndrome (PCOS), and non-alcoholic steatohepatitis (NASH). (We do not discuss hypertension, a common feature of metabolic syndrome, in this report because it is multifactorial in origin and not generally considered a metabolic disorder.)

In this report, Decision Resources review the etiology and biological features of the aforementioned disorders and discuss the major marketed and emerging classes of drugs used in treatment. (At present, no drugs are commercially available for the treatment of NASH or PCOS.) Following this discussion, we profile companies that either have launched drugs for major metabolic diseases or have drugs in late-stage clinical development. (We do not profile manufacturers of generic drugs targeting these diseases, although we discuss their drugs when relevant.) We conclude with a discussion of the commercial outlook for pharmacological therapies targeting metabolic disorders.

Summary
Which companies are the major players in the metabolic disease market
The metabolic disease market is large and heterogeneous, encompassing such widespread diseases as high cholesterol (dyslipidemia), diabetes, and obesity. Not surprisingly, these markets have been a major focus of multinational pharmaceutical companies seeking to develop potential blockbusters. Major players in the metabolic disease markets include Pfizer, Eli Lilly, Novo Nordisk, Abbott Laboratories, and Sanofi-Aventis. Although these and other companies have strong internal research organizations, many have also entered into alliances with emerging players in this field to acquire fresh technologies, potential targets, and/or novel therapies.

Which companies are the emerging players developing promising treatments for metabolic diseases
Many young biopharmaceutical companies are developing novel therapies for the treatment of metabolic diseases. Though many of these therapies are in early-stage development, a few have reached late-stage development or gained marketing approval. One emerging company that has recently scored multiple successes is Amylin Pharmaceuticals, which had two novel therapies for treating diabetes approved by the FDA in 2005. Other emerging players with drugs that have successfully advanced to mid- and late-stage development include Alizyme, Isis Pharmaceuticals, Ligand Pharmaceuticals, and Metabolex.

What is the commercial outlook for the metabolic disease market
Although the metabolic disease market is already a multibillion-dollar market, there remains significant room for growth. A number of factors will continue to fuel this growth, including the increasing prevalence of obesity, type 2 diabetes, and abnormal blood lipid levels (dyslipidemias). Furthermore, we believe that the growing recognition of the benefits of treating these conditions early and aggressively will drive demand for more effective therapies. In turn, advances in the treatment of metabolic diseases are making it possible to better control conditions such as diabetes and dyslipidemia.

Within the metabolic disease market, the focus has traditionally been on treating individual conditions, and this approach is likely to remain the primary driver of many drug development programs. Many of these metabolic disorders (together with hypertension) occur comorbidly; however, attempting to conduct clinical trials with a single agent aimed at several metabolic disorders is a daunting and uncertain task. Nonetheless, some companies are developing drugs with the goal of treating more than a single metabolic disorder. One novel class of agents that, may be able to effectively treat both type 2 diabetes and dyslipidemia are the dual peroxisome proliferator-activated receptor (PPAR) agonists. (Drug candidates from this class are in various stages of development by several companies profiled in this report.) However, the outlook for these drugs recently deteriorated; preclinical data suggested potential carcinogenic risks and clinical data suggested an increased risk of congestive heart failure (CHF).

Some companies are pursuing an alternative route: they are developing combination therapies in which fixed doses of two therapeutic molecules are combined into a single pill. Several combination therapies have reached the market. Though they represent clinically useful advances in the treatment of metabolic diseases, much of the development focus continues to be on new agents that treat single metabolic disorders.

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Laura Wood
Senior Manager
Research and Markets
Fax: +353 1 4100 980




The World Health Organization Estimate that 135 Million People Suffer from Type 2 Diabetes and 300 Million People Suffer from Obesity



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