Metabolic Syndrome

Pharmacor -- April 2007

  Introduction:

Despite a metabolic syndrome population of 175 million patients, recognition and treatment rates for early stages of this condition are relatively low. With the medical community approaching a consensus definition of the disorder, treatment guidelines based on increased understanding of pathophysiology and outcomes-based clinical trial data will crystallize. These guidelines will present unique opportunities for novel drug classes.

  Questions Answered in This Report:

Regulatory and reimbursement authorities lag behind the medical and scientific communities in understanding metabolic syndrome as a genuine disorder. What impact will this lag have on the uptake of current and emerging agents for metabolic syndrome? What strategies are pharmaceutical companies implementing to circumnavigate this problem?

Expert physicians interviewed cite diet and exercise as preferred treatment options in the management of metabolic syndrome. The treatment of emerging risk factors with single drugs is commonplace, and there is enormous opportunity for agents that target all comorbidities of metabolic syndrome. How will treatment patterns change as these emerging therapies are introduced to the market?

Current blockbuster agents—including atorvastatin (Pfizer’s Lipitor), pioglitazone (Takeda’s Actos), and rosiglitazone (GlaxoSmithKline’s Avandia)--will go off patent during the second half of our 2005-2015 study period, and companies are repositioning such drugs by including them in fixed-dose combinations. What will be the impact of generics erosion on the projected sales of these single agents? Which fixed-dose combinations present the optimum market opportunity in the metabolic syndrome population?

The failure of torcetrapib (Pfizer) has cast serious doubt on the entire CETP inhibitor class, leaving niacin derivatives as the only HDL-raising drugs in the late-stage pipeline. Do physicians perceive raising HDL levels as an important treatment modality in cardiovascular risk reduction? What opportunity do the improved formulations of niacin have in the metabolic syndrome market?

  Scope:

Markets: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 41country-specific interviews with thought-leading endocrinologists and cardiologists.

Epidemiology: Prevalence of AHA/NHLBI- and IDF-defined metabolic syndrome, glucose status in the United States in AHA/NHLBI- and IDF-defined metabolic syndrome.

Population segments in market forecast: AHA/NHLBI-defined metabolic syndrome.

Emerging therapies: Phase II: 12 drugs; Phase III: 15 drugs; preregistration: 4 drugs; registered: 31 drugs. Coverage of 12 select preclinical and Phase I products.

Market forecast features: We include drugs that have a mechanism of action relevant to the underlying pathophysiology of metabolic syndrome. We expand coverage of agents used to treat metabolic syndrome to include individual forecasts for top-selling statins, antidiabetic agents, antihypertensive agents, and fixed-dose combination agents through 2015.