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Diabetes

Diabetes, Metabolic Syndrome and Cardiovascular Disease Markets

Reshaping Tomorrow's Diabetes Market

Publication Date   October 2005
Publisher   TriMark Publications
Product Type   Report
Pages   161
ISBN Number   TMRDIA05-1003
Product Code   TRI014
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Summary


This report describes the specific market segment of the pharmaceutical market for diabetes and two of its related diseases, metabolic syndrome and cardiovascular disease. It begins with a textbook explanation of the biology underlying diabetes, and then it reviews and evaluates widely accepted pharmaceutical approaches to diabetes that are currently in use. Finally, market forecasts and an analysis of products in the worldwide prescriptions market will help the reader understand the significance of past developments and speculate on future possibilities about the market of diabetes therapies as an area of research and investment. The principal objectives of this report are to: 1) identify viable technology drivers through a comprehensive look at various platform technologies for diabetes, metabolic syndrome and cardiovascular disease; 2) provide a complete understanding of the leading diabetes tests that are used for disease prediction, screening, prognosis and monitoring, encompassing their basic principles and applications; 3) discover feasible market opportunities via an identification of high-growth applications in different therapeutic areas, with a focus on the largest and most rapidly expanding markets for diabetes, metabolic syndrome and cardiovascular disease; 4) focus on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including forecasts for growth; and 5) summarize the blood glucose testing market, including definitions, processes and trends. Market figures regarding the current value of the diabetes drug market are taken from the most recently available data of the global pharmaceutical industry. The following categories of diabetes drugs will be covered herein: 1) rapid-acting insulin; 2) short-activity insulin; 3) intermediate-acting insulin; 4) long-acting insulin; 5) ultra-long-acting insulin; 6) insulin mixtures; 7) sulfonylureas; 8) meglitinides; 9) biguanides; 10) thiazolidinediones; and 11) alpha-glucosidase inhibitors.

Content


  • 1. Overview
    • 1.1 Statement of Report
    • 1.2 About this Report
    • 1.3 Scope of the Report
    • 1.4 Methodology
    • 1.5 Executive Summary
  • 2. Introduction
    • 2.1 Demographics of Diabetes
      • 2.1.1 Worldwide Diabetes
      • 2.1.2 U.S. Diabetes
    • 2.2 Economics of Diabetes
  • 3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes
    • 3.1 Pre-Diabetes Syndrome
    • 3.2 Metabolic Syndrome
    • 3.3 Diabetes and Inflammation
    • 3.4 Progression of Diabetes
    • 3.5 Complications and Co-Morbidities in Type 2 Diabetes
    • 3.6 Hypoglycemia and Treatment
    • 3.7 Risk Factors and Diabetes
    • 3.8 Cardiovascular Disease Facts
  • 4. Current Treatment Paradigms
    • 4.1 The Worldwide Pharmaceutical Industry
      • 4.1.1 Total Diabetes Drug Market Size and Growth
      • 4.1.2 Sales of Anti-diabetic Drugs Continue to Rise
      • 4.1.3 Epidemiology/Cost of Treatment
    • 4.2 Diabetic Medications Overview
      • 4.2.1 Recent Trends in Diabetic Drug Usage
      • 4.2.2 Factors that are Likely to Influence the Market
      • 4.2.3 Anti-Diabetic Drug Therapy Overview
        • 4.2.3.1 Sulfonylureas
        • 4.2.3.2 Meglitinides
        • 4.2.3.3 Biguanides
        • 4.2.3.4 Thiazolidinediones (TZD's)
        • 4.2.3.5 a-Glucosidase Inhibitors
        • 4.2.3.6 Combination Therapy
        • 4.2.3.7 Drivers and Trends
        • 4.2.3.8 Market Share of Anti-Diabetic Drugs
      • 4.2.4 Forecasts for Anti-Diabetic Drugs
        • 4.2.4.1 Sales Forecast for the Global Diabetes Market
        • 4.2.4.2 The Future
        • 4.2.4.2.1 Practice Patterns
        • 4.2.4.2.2 New Products in Pipeline
      • 4.2.5 Anti-Diabetic Drug Patent Expiry
      • 4.2.6 Regulatory Issues
    • 4.3 Sulfonylureas and Meglitinides
      • 4.3.1 First-generation Sulfonylurea Agents
      • 4.3.2 Second-generation Sulfonylurea Agents
      • 4.4.1 Thiazolidinediones
      • 4.4.2 PPAR Agonists
    • 4.5 a-Glucosidase Inhibitors
    • 4.6 Insulin Markets
      • 4.6.1 Major Players and Market Share
      • 4.6.2 Rapid-Acting Insulin
      • 4.6.3 Intermediate-Acting Insulin
      • 4.6.4 Long-Acting Insulin
      • 4.6.5 Ultra Long-Acting Insulin
      • 4.6.6 Insulin Mixtures
      • 4.6.7 Newly Approved Insulin
      • 4.6.8 Pipeline Insulin
      • 4.6.9 Insulin in Development
        • 4.6.9.1 Inhaled Insulin Overview
        • 4.6.9.2 Inhaled Insulin Pipeline
        • 4.6.9.3 Oral insulin
        • 4.6.9.4 Barriers for Non-Injected Insulin
        • 4.6.9.5 Patient Potential for Non-Injected Insulin
    • 4.7 Other Anti-diabetic Therapy Drug Candidates
      • 4.7.1 Lipid Abnormalities
      • 4.7.2 High Blood Pressure
      • 4.7.3 Anticoagulants
    • 4.8 Biguanides
    • 4.9 Drugs Used Off-Label
      • 4.9.1 Glucagon-Like Insulinotropic Peptide (GLP-1)
      • 4.9.2 Pramlintide (Symlin)
      • 4.9.3 Niacin Derivatives
      • 4.9.4 Benfluorex
      • 4.9.5 D-Chiro-Inositol
      • 4.9.6 Exendin-4
    • 4.10 Investigational New Agents
    • 4.11 New Medicines in Development
  • 5. Emerging Oral Anti-diabetes Products
    • 5.1 Novel Oral Medications
    • 5.2 PPAR agonists
    • 5.3 Insulin Mimetics
    • 5.4 GLP-1
    • 5.5 Immune Modulators
    • 5.6 Artificial Pancreas
      • 5.6.1 Pancreatic Transplantation
        • 5.6.1.1 Pancreatic Organ Transplantation
        • 5.6.1.2 Allo-Islet Transplantation
        • 5.6.1.3 Transplantation of Encapsulated Pancreatic Cells
        • 5.6.1.4 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells
      • 5.6.2 Current Status
    • 5.7 Other Type Drugs
    • 5.8 New Pipeline Diabetic Drug Candidates
    • 5.9 Drug Research Overview
  • 6. Projections for the Anti-diabetes Drug Market
    • 6.1 Implantable Insulin Pumps
      • 6.1.1 Market Share
      • 6.1.2 Drivers of Demand for Pumps
    • 6.2 Insulin Pills
    • 6.3 Transdermal Insulin
    • 6.4 Oral Spray Insulin
    • 6.5 Inhaled Insulin
      • 6.5.1 Important Players
    • 6.6 Insulin-Producing Cells
    • 6.7 Transplantation Procedures
    • 6.8 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes
  • 7. Diagnosing Diabetes Using In Vitro Laboratory Tests
    • 7.1 New Diagnostic Guidelines
    • 7.2 Diabetes Tests
      • 7.2.1 Fasting Plasma Glucose (FPG) Test
      • 7.2.2 Glucose Tolerance Test
      • 7.2.3 Test for Glycosylated Hemoglobin
      • 7.2.4 Fructosamine
    • 7.3 Glucose Monitoring
      • 7.3.1 Overview of Market Segment
      • 7.3.2 Competitive Strategies
      • 7.3.3 Analyses of the Current Market Conditions, Competition and Product Mix
        • 7.3.3.1 First-Generation Monitors
        • 7.3.3.2 Second-Generation Monitors
        • 7.3.3.3 Third-Generation SMBG Technologies
        • 7.3.3.4 Product Overview
        • 7.3.3.4.1 LifeScan
        • 7.3.3.4.2 Roche Diagnostics
        • 7.3.3.3 Bayer Diagnostics (Ames Division)
        • 7.3.3.3.1 Abbott Diagnostics
        • 7.3.3.3.2 Other Players
      • 7.3.4 Adjacent Markets
      • 7.3.5 What Are the Advantages of Using a Continuous Glucose-Monitoring Device?
  • 8. Insulin Delivery Technologies
    • 8.1 Lancets and Lancing Devices
    • 8.2 Insulin Pens
    • 8.3 Injections Aids
      • 8.3.1 Automatic Injectors
      • 8.3.2 Syringe Magnifiers
      • 8.3.3 Insulin Infusers
    • 8.4 Insulin Jet Injectors
    • 8.5 External Insulin Pumps
    • 8.6 Implantable Insulin Pumps
    • 8.7 Artificial Pancreas
    • 8.8 Insulin Patches
    • 8.9 Market Forecasts for Insulin Administration Technologies
      • 8.9.1 Insulin Inhalers
      • 8.9.2 Mouth Sprays
      • 8.9.3 Pills
      • 8.9.4 The Patch
  • 9. Market Trends, Challenges and Strategic Options
    • 9.1 Overview
    • 9.2 Diabetes Drug Market Trends
      • 9.2.1 Overview
      • 9.2.2 Emergence of Therapeutics with Improved Administration Characteristics
      • 9.2.3 Increasing Prevalence of Obesity
    • 9.3 Diabetes Mellitus Market Challenges
      • 9.3.1 Overview
      • 9.3.2 Diabetic Pain Therapeutics
      • 9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels
      • 9.3.4 Changing Consumer Preference Drives Product Development in Invasive Technology Segment
      • 9.3.5 Non-Invasive Technology for Revenue Potential
      • 9.3.6 Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices
      • 9.3.7 Consumer-Driven Marketing Campaigns-Essential, though Expensive
      • 9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation
      • 9.3.9 Market Size Predictions
      • 9.3.10 Major Competitors
    • 9.4 Strategic Options
      • 9.4.1 Overview
      • 9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery
      • 9.4.3 Diabetes Drugs in Pipeline
    • 9.5 FDA Therapeutic Targets
    • Appendix 1
    • Appendix 2
  • Index Of Figures
    • Figure 1: Demographic Changes in Diabetes Populations in 2010, 2025, 2050
    • Figure 2: Annual Number of New Cases of Diagnosed Diabetes Among Adults Aged 18 to 79 Years, U.S., 1997-2002
    • Figure 3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, U.S., 1997-2002
    • Figure 4: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Age, U.S., 1997-2002
    • Figure 5: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex, U.S., 1997-2002
    • Figure 6: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex and Age, U.S., 1997-2002
    • Figure 7: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Race, U.S., 1997-2002
    • Figure 8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, U.S., 2002
    • Figure 9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, U.S., 1980-2001
    • Figure 10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, U.S., 1980-2001
    • Figure 11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, U.S., 2002
    • Figure 12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002
    • Figure 13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-2002
    • Figure 14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002
    • Figure 15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-2002
    • Figure 16: How Diabetes Dollars Are Spent in the U.S.
    • Figure 17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the U.S. Adult Population
    • Figure 18: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA criteria) or the Two Hour Glucose Value (WHO Criteria)
    • Figure 19: Sales Forecast for the Global Diabetes Market
    • Figure 20: Utilization: Compliance by Class
    • Figure 21: Analysis of Diabetes Pipeline by Company, 2000
    • Figure 22: Relative Risk of Diabetes Complications by Mean HbA1c
    • Figure 23: Worldwide Diabetes Market, 2000, 2001, 2002 and 2007
  • Index Of Tables
    • Table 1: Total of People with Diabetes in the World and in Selected Nations, 2000 and 2030
    • Table 2: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 1997-2002
    • Table 3: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-2002
    • Table 4: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-2002
    • Table 5: Annual Estimated Cost of Diabetes Care, U.S.
    • Table 6: Impacts of Diabetes on Americans
    • Table 7: Leading Ten Diagnoses by Total U.S. Patient Visits, 2001
    • Table 8: U.S. Incidence of Diabetes by Age, 2005
    • Table 9: Prevalence, Cost and Medicines for Major Diseases in the U.S., 2005
    • Table 10: Top Ten Causes of Death in the U.S., 2003
    • Table 11: Per-Event Costs of Diabetes Complications (Estimated)
    • Table 12: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications
    • Table 13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease In Type 2 Diabetes Mellitus
    • Table 14: Average Years Gained Free of Diabetes-Related Disease with Intensive Management
    • Table 15: Worldwide Market for Cardiac Care Therapeutics
    • Table 16: Major Causes of End Stage Renal Disease
    • Table 17: Worldwide Clinical Development Costs for Drugs, 2003
    • Table 18: Pharmaceutical R&D Expenditures by World Region, 1990-2003
    • Table 19: U.S. Listed Pharmaceutical Companies Ranked by 2001 R&D Expenditures
    • Table 20: Global Pharmaceutical Sales
    • Table 21: World Pharmaceutical Sales Share by Region 2003
    • Table 22: The World's Top-Selling Drugs 2003
    • Table 23: Pharmaceutical Product Sales by Country Market
    • Table 24: Top Pharmaceutical Companies by Market Capitalization
    • Table 25: Leading Therapy Classes Global Pharmaceutical Sales 2000 and 2003
    • Table 26: Leading Ten Therapeutic Classes by U.S. Sales, 2002
    • Table 27: Top Ten Drug Classes by Retail Dollars
    • Table 28: Top Ten Drugs by Retail Dollars
    • Table 29: Top Ten Pharmaceutical Firms by Retail Dollars
    • Table 30: Worldwide Anti-Diabetes Drug Market
    • Table 31: Oral Anti-Diabetic Therapy Major World Markets, 2003
    • Table 32: Worldwide Market Share of Anti-Diabetic Drugs by Type, 2003 and 2007
    • Table 33: The Leading Five Oral Anti-diabetics For 2004
    • Table 34: Oral Hypoglycemic Drugs Used to Treat Type 2 Diabetes
    • Table 35: Worldwide Sales of Avandia
    • Table 36: Worldwide Sales of Actos
    • Table 37: Worldwide Sales of Glucophage
    • Table 38: Worldwide Sales of Starlix
    • Table 39: World Diabetes Pharmaceutical Market
    • Table 40: Trends In Prescription Drug Use Among Patients with Type 2 Diabetes, 1997-2002
    • Table 41: Classes of Oral Hypoglycemic Agents
    • Table 42: Clinical Efficacy of Oral Hypoglycemic Agents
    • Table 43: Average Dose and Cost Comparison of Hypoglycemic Agents
    • Table 44: Average Dose and Cost Comparison of Hypoglycemic Agents
    • Table 45: Relative Efficacy of Oral Agents for Diabetes
    • Table 46: Thiazolidinediones Available for Type 2 Diabetes Mellitus
    • Table 47: Therapeutic Comparison of the Available Thiazolidinediones
    • Table 48: Oralin Sales Forecast Through 2008
    • Table 49: AERx Sales Forecast Through 2008
    • Table 50: HIM 2 Sales Forecast Through 2008
    • Table 51: Oral Anti-diabetic Agents and Their Approved Indications and Uses
    • Table 52: Brand and Generic Names for the Sulfonylureas Sold in the U.S.
    • Table 53: Preparations of Sulfonylurea Tablets
    • Table 54: Worldwide Insulin Sales
    • Table 55: Worldwide Insulin Sales and Market Share by World Region 2003
    • Table 56: Worldwide Insulin Sales and Market Share by Company, 2003
    • Table 57: U.S. Insulin Sales and Market Share by Company, 2003
    • Table 58: U.S. Insulin Sales, 2000-2009
    • Table 59: Worldwide Recombinant Human Insulin Sales and Market Share by Company, 2005
    • Table 60: Pharmacokinetics of Available Insulins
    • Table 61: Action Times for Each Insulin
    • Table 62: Key Drivers of the Type 2 Diabetes Insulin Market to 2012
    • Table 63: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes
    • Table 64: Agents for Lowering Lipid Levels in Patients with Dyslipidemia
    • Table 65: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes
    • Table 66: New Drugs in Human Clinical Trials by Disease Type
    • Table 67: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-1
    • Table 68: Cells of the Pancreas
    • Table 69: Selected Mid-2004 Press Releases on Emerging Anti-diabetes Agents
    • Table 70: Diabetes Agents in the Pipeline
    • Table 71: Control Averages by Treatment
    • Table 72: Reduced Risk for Various Diseases When Blood Glucose is Near Normal
    • Table 73: Worldwide Diabetes Market, through 2007 ($ Millions)
    • Table 74: Types of Insulin Pumps on the Market
    • Table 75: Laboratory Assessment of Diabetic Vascular Disease
    • Table 76: The Global Population of Persons with Diabetes
    • Table 77: The Glucose Market for OTC Testing in the U.S., 1996-2007
    • Table 78: The Glucose Market for OTC Testing Worldwide, 2000-2007
    • Table 79: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements
    • Table 80: Lancet Characteristics
    • Table 81: Lancing Device Characteristics
    • Table 82: Worldwide Insulin Injector Pen Dollar Volume, 1998-2006
    • Table 83: Insulin Delivery Systems Percent Retail Market Share
    • Table 84: Insulin Delivery Systems Percent Retail Market Share by Company, 2003
    • Table 85: Summary of Inhaled Insulin Products
    • Table 86: Worldwide Diabetes Drugs in Pipeline, 2004
    • Table 87: Top Therapeutic Drug Categories Worldwide, 2004
    • Table 88: Top Therapeutic Categories in U.S. Development, 2003
    • Table 89: Pharmaceutical Companies Number of Products in Development
    • Table 90: Pharmaceutical Companies Number of Diabetes Products in Development
    • Table 91: Drugs in Preclinical Testing, 2004
    • Table 92: New Diabetes Drugs in Pipeline without Major Pharma Alliances 158a