Abstract
Metabolic Syndrome: Pipeline Analysis and U.S. Market Forecast is a thorough evaluation of marketed therapies and drugs in development for obesity, dyslipidemia, type 2 diabetes, and hypertension.
Metabolic Syndrome is a cluster of risk factors for atherosclerotic disease and type 2 diabetes mellitus comprising obesity, insulin resistance, hypertension, and dyslipidemia. The eligible treatment population in the U.S. for these four conditions is currently 40 million patients and will nearly double over the next 15 years, bringing unprecedented social and economic impacts.
Specifically, this report:
- Reveals the latest findings about the interactions among widely prevalent lifestyle factors such as poor nutrition, being overweight, and sedentary lifestyle, and how they contribute to insulin resistance, dyslipidemia, and high blood pressure.
- Assesses the strengths and weaknesses of 13 R&D pipelines focused on metabolic syndrome, comparing products and mechanisms in each disease category against one another and against the gold standard.
- Presents 15-year forecasts of sales in the U.S. of marketed and investigative therapies for each of the four disorders, taking into account unmet medical need, changes in epidemiology, patent expirations, and competitive drug launches.
- Spotlights the most promising drugs and early-stage mechanisms of action and the likely timeframe for their launch.
Decision makers in early-stage development are waking up to the need for solid market intelligence about competitor projects and the commercial potential of products in development. Forecasts are taking a central role in the commercial assessment of early-stage drug therapies, where they can serve as the repository of a companys latest thinking on both commercial and clinical questions. Through a reliable, early-stage forecast and an assessment of products in development, Metabolic Syndrome: Pipeline Analysis and U.S. Market Forecast provides R&D managers with the clinical data, the analytical tools, and the market intelligence they need to make informed decisions about individual projects and portfolios.
Table of Contents
Chapter 1: Introduction
- 1.1. Metabolic Syndrome: A Multifaceted Syndrome by Many Names
- 1.2. Etiology of Primary Components: The Vicious Cycle of "Diabesity"
- 1.3. Further Sequels: Endothelial Dysfunction, Inflammation, and Psychiatric Implications
- 1.4. The National Institutes of Health ATP III Guidelines and Definition
Chapter 2: Epidemiological Aspects
- 2.1. Overweight/Obesity and Lack of Physical Activity
- 2.2. Insulin Resistance and Diabetes
- 2.3. Elevated Blood Pressure and Hypertension
- 2.4. Dyslipidemia
- 2.5. Estimates for Prevalence and Incidence of the Metabolic Syndrome
Chapter 3: Current Options for Pharmacological Intervention
- 3.1. Limited Potential for Lifestyle Modifications
- 3.2. Current Pharmacological Treatment of Component Entities
- Drugs for Insulin Resistance and Emerging Type 2 Diabetes
- -Sulphonylureas--Stimulators of Basal Insulin Release
- -Post-Prandial Insulin Secretion Stimulators--the "Meglitinides"
- Insulin Sensitizers
- -Metformin (Bristol-Myers Squibbs glucophage/glucamet; generics)
- -Glitazones--The Original PPAR Agonists
- --Avandia (rosiglitazone maleate, GlaxoSmithKline)
- --Actos (pioglitazone HCl, Eli Lilly and Takeda)
- -Glitazone/Metformin Fixed Combination Products
- -Alpha-Glucosidase Inhibitors: Intestinally Acting Glucose Retardants
- Drugs for Dyslipidemia: Fibrates, Statins, and Niacin
- -Fibrates
- --Lopid (Pfizers gemfibrozil and generics)
- --TriCor/Lipanthyl/Lipidil (fenofibrate, Abbott Laboratories and Groupe Fournier; generics)
- --Bezalip (Roches bezafibrate)
- --Lipanor/Modalim (Sanofi-Aventis ciprofibrate)
- -Statins
- -Cholesterol Absorption Inhibitors
- --Ezetimibe (Schering-Plough/Merck & Co.s Zetia)
- -Niaspan and Advicor
- -Fibrates
- Hypertension: Drug Class Differences in the Metabolic Effects
- Weight Reduction Agents
- -Xenical (orlistat, Roche)
- -Meridia/Reductil (sibutramine, Abbott Laboratories)
- -"Short-Term Slimmers": No Relevance to the Metabolic Syndrome
Chapter 4: Unmet Treatment Need in the Metabolic Syndrome
- 4.1. Unmet Need in Current Drugs and Treatment Schedules
- Weight Reduction Drugs
- Glucose-Lowering Drugs
- Lipid-Lowering Drugs
- Anti-Hypertensive Drugs
- 4.2. Genetic Predisposition and Tailored Therapies: A Great Task Ahead
- 4.3. Unconventional Approaches: A Role for Neurotrophic Factors?
- 4.4. Summary
Chapter 5: Improvements Ahead--Breakthroughs on the Horizon?
- 5.1. Pharmacological Strategies to Support Weight Loss: A Bumpy Road
- Regenerons Axokine: A Nerve Growth Factor Agonist Completing Clinical Development
- Acomplia (rimonabant) and Other CB1 Receptor Antagonists for Slimming
- New Pancreatic Lipase Inhibitors in the Pipeline
- Symlin (Pramlintide acetate, an Analog of Amylin)
- An Appetite Suppressant from a South African Cactus
- Targeting the Adrenergic System--Adjusting the Metabolic Rate
- 5-HT2c Receptor Agonists
- Neuropeptide Y Receptor Agonists
- Melanocortin Receptor Agonists
- 5.2. Potential Treatments for Insulin Resistance and Diabetes
- Dual PPAR Stimulators--A New Class of Drugs Tailored to Metabolic Syndrome Therapy
- Dipeptidyl Peptidase Inhibitors--Blocking Degradation of Glucagon- Like Peptide 1
- Glucagon-Like Peptide Analogs
- Sodium-Dependent Glucose Co-Transporter (SGLT) Inhibitors
- An Antisense PTP-1B Gene Silencer
- 5.3. New Developments in Lipid Disorders
- Cholesteryl Ester Transfer Protein (CETP) Inhibitors
- Ibrolipim: A Lipoprotein Lipase Activator
- An Antibody Mix for Dyslipidemia
- Inhibition of Acetyl-CoA Carboxylase
- Antisense Drugs
- Omacor, an FDA-Approved Nutritional Supplement
- 5.4. Targeting Hypertension in the Metabolic Syndrome
- Renin Inhibitors
- Selective Aldosterone Blockade
- Endothelin A Receptor Antagonists
- 5.5. Potential Improvements in the Therapy of Gout
Chapter 6: U.S. Market Forecast for Metabolic Syndrome Component Disorders: 2003-2018
- 6.1 United States Market Forecast for Dyslipidemia
- Market Overview
- Patent Expirations
- Drug Launches
- Epidemiology
- 6.2. United States Market Forecast for Type 2 Diabetes
- Market Overview
- Patent Expirations
- Drug Launches
- Epidemiology
- 6.3. United States Market Forecast for Obesity
- Market Overview
- Patent Expirations
- Drug Launches
- Epidemiology
- 6.4. United States Market Forecast for Hypertension
- Market Overview
- Patent Expirations
- Drug Launches
- Epidemiology
Chapter 7: Pipeline and Research Program Profiles
- 7.1. Sanofi-Aventis
- 7.2. Eli Lilly
- 7.3. Novo Nordisk
- 7.4. Bristol-Myers Squibb
- 7.5. GlaxoSmithKline
- 7.6. Roche
- 7.7. Merck & Co./Banyu
- 7.8. DeveloGen
- 7.9. Wellstat
- 7.10. Amylin Pharmaceuticals
- 7.11. Ligand Pharmaceuticals
- 7.12. Regeneron Pharmaceuticals
- 7.13. Biovitrum
