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Diabetes, Metabolic Syndrome and Cardiovascular Disease

This TriMark Publications 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.

Table of Contents

• 1. Overview6
  • 1.1 Statement of Report6
  • 1.2 About this Report6
  • 1.3 Scope of the Report7
  • 1.4 Methodology8
  • 1.5 Executive Summary8
  
  
• 2. Introduction12
  • 2.1 Demographics of Diabetes12
    • 2.1.1 Worldwide Diabetes12
    • 2.1.2 U.S. Diabetes12
  • 2.2 Economics of Diabetes22
  
  
• 3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes28
  • 3.1 Pre-Diabetes Syndrome28
  • 3.2 Metabolic Syndrome29
  • 3.3 Diabetes and Inflammation30
  • 3.4 Progression of Diabetes30
  • 3.5 Complications and Co-Morbidities in Type 2 Diabetes30
  • 3.6 Hypoglycemia and Treatment33
  • 3.7 Risk Factors and Diabetes33
  • 3.8 Cardiovascular Disease Facts35
  
  
• 4. Current Treatment Paradigms41
  • 4.1 The Worldwide Pharmaceutical Industry41
    • 4.1.1 Total Diabetes Drug Market Size and Growth47
    • 4.1.2 Sales of Anti-diabetic Drugs Continue to Rise50
    • 4.1.3 Epidemiology/Cost of Treatment53
  • 4.2 Diabetic Medications Overview53
    • 4.2.1 Recent Trends in Diabetic Drug Usage55
    • 4.2.2 Factors that are Likely to Influence the Market56
    • 4.2.3 Anti-Diabetic Drug Therapy Overview57
      • 4.2.3.1 Sulfonylureas60
      • 4.2.3.2 Meglitinides61
      • 4.2.3.3 Biguanides62
      • 4.2.3.4 Thiazolidinediones (TZD's)63
      • 4.2.3.5 a-Glucosidase Inhibitors64
      • 4.2.3.6 Combination Therapy65
      • 4.2.3.7 Drivers and Trends65
      • 4.2.3.8 Market Share of Anti-Diabetic Drugs66
    • 4.2.4 Forecasts for Anti-Diabetic Drugs67
      • 4.2.4.1 Sales Forecast for the Global Diabetes Market67
      • 4.2.4.2 The Future68
        • 4.2.4.2.1 Practice Patterns69
        • 4.2.4.2.2 New Products in Pipeline69
    • 4.2.5 Anti-Diabetic Drug Patent Expiry70
    • 4.2.6 Regulatory Issues70
  • 4.3 Sulfonylureas and Meglitinides70
    • 4.3.1 First-generation Sulfonylurea Agents72
    • 4.3.2 Second-generation Sulfonylurea Agents73
    • 4.4.1 Thiazolidinediones73
    • 4.4.2 PPAR Agonists74
  • 4.5 a-Glucosidase Inhibitors74
  • 4.6 Insulin Markets74
    • 4.6.1 Major Players and Market Share75
    • 4.6.2 Rapid-Acting Insulin78
    • 4.6.3 Intermediate-Acting Insulin80
    • 4.6.4 Long-Acting Insulin80
    • 4.6.5 Ultra Long-Acting Insulin81
    • 4.6.6 Insulin Mixtures81
    • 4.6.7 Newly Approved Insulin82
    • 4.6.8 Pipeline Insulin83
    • 4.6.9 Insulin in Development83
      • 4.6.9.1 Inhaled Insulin Overview84
      • 4.6.9.2 Inhaled Insulin Pipeline84
      • 4.6.9.3 Oral insulin85
      • 4.6.9.4 Barriers for Non-Injected Insulin86
      • 4.6.9.5 Patient Potential for Non-Injected Insulin86
  • 4.7 Other Anti-diabetic Therapy Drug Candidates86
    • 4.7.1 Lipid Abnormalities86
    • 4.7.2 High Blood Pressure87
    • 4.7.3 Anticoagulants89
  • 4.8 Biguanides89
  • 4.9 Drugs Used "Off-Label"89
    • 4.9.1 Glucagon-Like Insulinotropic Peptide (GLP-1)89
    • 4.9.2 Pramlintide (Symlin)89
    • 4.9.3 Niacin Derivatives89
    • 4.9.4 Benfluorex90
    • 4.9.5 D-Chiro-Inositol90
    • 4.9.6 Exendin-490
  • 4.10 Investigational New Agents90
  • 4.11 New Medicines in Development90
  
  
• 5. Emerging Oral Anti-diabetes Products95
  • 5.1 Novel Oral Medications95
  • 5.2 PPAR agonists95
  • 5.3 Insulin Mimetics95
  • 5.4 GLP-195
  • 5.5 Immune Modulators96
  • 5.6 Artificial Pancreas96
    • 5.6.1 Pancreatic Transplantation97
      • 5.6.1.1 Pancreatic Organ Transplantation97
      • 5.6.1.2 Allo-Islet Transplantation97
      • 5.6.1.3 Transplantation of Encapsulated Pancreatic Cells97
      • 5.6.1.4 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells98
    • 5.6.2 Current Status98
  • 5.7 Other Type Drugs99
  • 5.8 New Pipeline Diabetic Drug Candidates99
  • 5.9 Drug Research Overview103
  
  
• 6. Projections for the Anti-diabetes Drug Market106
  • 6.1 Implantable Insulin Pumps109
    • 6.1.1 Market Share110
    • 6.1.2 Drivers of Demand for Pumps114
  • 6.2 Insulin Pills114
  • 6.3 Transdermal Insulin115
  • 6.4 Oral Spray Insulin115
  • 6.5 Inhaled Insulin116
    • 6.5.1 Important Players117
  • 6.6 Insulin-Producing Cells118
  • 6.7 Transplantation Procedures119
  • 6.8 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes120
  
  
• 7. Diagnosing Diabetes Using In Vitro Laboratory Tests121
  • 7.1 New Diagnostic Guidelines121
  • 7.2 Diabetes Tests121
    • 7.2.1 Fasting Plasma Glucose (FPG) Test121
    • 7.2.2 Glucose Tolerance Test122
    • 7.2.3 Test for Glycosylated Hemoglobin122
    • 7.2.4 Fructosamine122
  • 7.3 Glucose Monitoring123
    • 7.3.1 Overview of Market Segment126
    • 7.3.2 Competitive Strategies126
    • 7.3.3 Analyses of the Current Market Conditions, Competition and Product Mix127
      • 7.3.3.1 First-Generation Monitors127
      • 7.3.3.2 Second-Generation Monitors128
      • 7.3.3.3 Third-Generation SMBG Technologies129
      • 7.3.3.4 Product Overview129
        • 7.3.3.4.1 LifeScan130
        • 7.3.3.4.2 Roche Diagnostics133
      • 7.3.3.3 Bayer Diagnostics (Ames Division)133
        • 7.3.3.3.1 Abbott Diagnostics135
        • 7.3.3.3.2 Other Players135
    • 7.3.4 Adjacent Markets138
    • 7.3.5 What Are the Advantages of Using a Continuous Glucose-Monitoring Device?138
    
    
• 8. Insulin Delivery Technologies139
  • 8.1 Lancets and Lancing Devices139
  • 8.2 Insulin Pens141
  • 8.3 Injections Aids145
    • 8.3.1 Automatic Injectors145
    • 8.3.2 Syringe Magnifiers145
    • 8.3.3 Insulin Infusers145
  • 8.4 Insulin Jet Injectors146
  • 8.5 External Insulin Pumps146
  • 8.6 Implantable Insulin Pumps146
  • 8.7 Artificial Pancreas146
  • 8.8 Insulin Patches146
  • 8.9 Market Forecasts for Insulin Administration Technologies147
    • 8.9.1 Insulin Inhalers147
    • 8.9.2 Mouth Sprays147
    • 8.9.3 Pills147
    • 8.9.4 The Patch148
    
    
• 9. Market Trends, Challenges and Strategic Options149
  • 9.1 Overview149
  • 9.2 Diabetes Drug Market Trends149
    • 9.2.1 Overview149
    • 9.2.2 Emergence of Therapeutics with Improved Administration Characteristics149
    • 9.2.3 Increasing Prevalence of Obesity149
  • 9.3 Diabetes Mellitus Market Challenges151
    • 9.3.1 Overview151
    • 9.3.2 Diabetic Pain Therapeutics151
    • 9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels151
    • 9.3.4 Changing Consumer Preference Drives Product Development in Invasive Technology Segment152
    • 9.3.5 Non-Invasive Technology for Revenue Potential152
    • 9.3.6 Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices152
    • 9.3.7 Consumer-Driven Marketing Campaigns-Essential, though Expensive153
    • 9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation153
    • 9.3.9 Market Size Predictions153
    • 9.3.10 Major Competitors153
  • 9.4 Strategic Options154
    • 9.4.1 Overview154
    • 9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery154
    • 9.4.3 Diabetes Drugs in Pipeline155
  • 9.5 FDA Therapeutic Targets158
  
  

Appendix 1159

Appendix 2160

INDEX OF FIGURES

Figure 1: Demographic Changes in Diabetes Populations in 2010, 2025, 205013

Figure 2: Annual Number of New Cases of Diagnosed Diabetes Among Adults Aged 18 to 79 Years, U.S., 1997-200214

Figure 3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, U.S., 1997-200214

Figure 4: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Age, U.S., 1997-200215

Figure 5: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex, U.S., 1997-200215

Figure 6: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex and Age, U.S., 1997-200216

Figure 7: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Race, U.S., 1997-200216

Figure 8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, U.S., 200217

Figure 9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, U.S., 1980-200117

Figure 10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, U.S., 1980-200118

Figure 11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, U.S., 200218

Figure 12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-200219

Figure 13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, U.S., 1997-200219

Figure 14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-200220

Figure 15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-200221

Figure 16: How Diabetes Dollars Are Spent in the U.S.25

Figure 17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the U.S. Adult Population29

Figure 18: Overlap Between Individuals Diagnosed as Diabetic According to Fasting Plasma Glucose Concentration (ADA criteria) or the Two Hour Glucose Value (WHO Criteria)34

Figure 19: Sales Forecast for the Global Diabetes Market68

Figure 20: Utilization: Compliance by Class77

Figure 21: Analysis of Diabetes Pipeline by Company, 200093

Figure 22: Relative Risk of Diabetes Complications by Mean HbA1c110

Figure 23: Worldwide Diabetes Market, 2000, 2001, 2002 and 2007111

INDEX OF TABLES

Table 1: Total of People with Diabetes in the World and in Selected Nations, 2000 and 203012

Table 2: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication U.S., 1997-200220

Table 3: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, U.S., 1997-200221

Table 4: Percentages of Adults with Diabetes Using Diabetes Medication by Age, U.S., 1997-200222

Table 5: Annual Estimated Cost of Diabetes Care, U.S.22

Table 6: Impacts of Diabetes on Americans23

Table 7: Leading Ten Diagnoses by Total U.S. Patient Visits, 200123

Table 8: U.S. Incidence of Diabetes by Age, 200523

Table 9: Prevalence, Cost and Medicines for Major Diseases in the U.S., 200524

Table 10: Top Ten Causes of Death in the U.S., 200324

Table 11: Per-Event Costs of Diabetes Complications (Estimated)26

Table 12: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications31

Table 13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease In Type 2 Diabetes Mellitus32

Table 14: Average Years Gained Free of Diabetes-Related Disease with Intensive Management33

Table 15: Worldwide Market for Cardiac Care Therapeutics37

Table 16: Major Causes of End Stage Renal Disease40

Table 17: Worldwide Clinical Development Costs for Drugs, 200341

Table 18: Pharmaceutical R&D Expenditures by World Region, 1990-200342

Table 19: U.S. Listed Pharmaceutical Companies Ranked by 2001 R&D Expenditures42

Table 20: Global Pharmaceutical Sales43

Table 21: World Pharmaceutical Sales Share by Region 200343

Table 22: The World's Top-Selling Drugs 200344

Table 23: Pharmaceutical Product Sales by Country Market44

Table 24: Top Pharmaceutical Companies by Market Capitalization 45

Table 25: Leading Therapy Classes Global Pharmaceutical Sales 2000 and 200345

Table 26: Leading Ten Therapeutic Classes by U.S. Sales, 200246

Table 27: Top Ten Drug Classes by Retail Dollars46

Table 28: Top Ten Drugs by Retail Dollars46

Table 29: Top Ten Pharmaceutical Firms by Retail Dollars47

Table 30: Worldwide Anti-Diabetes Drug Market48

Table 31: Oral Anti-Diabetic Therapy Major World Markets, 200348

Table 32: Worldwide Market Share of Anti-Diabetic Drugs by Type, 2003 and 200749

Table 33: The Leading Five Oral Anti-diabetics For 200450

Table 34: Oral Hypoglycemic Drugs Used to Treat Type 2 Diabetes51

Table 35: Worldwide Sales of Avandia51

Table 36: Worldwide Sales of Actos52

Table 37: Worldwide Sales of Glucophage52

Table 38: Worldwide Sales of Starlix53

Table 39: World Diabetes Pharmaceutical Market54

Table 40: Trends In Prescription Drug Use Among Patients with Type 2 Diabetes, 1997-200256

Table 41: Classes of Oral Hypoglycemic Agents58

Table 42: Clinical Efficacy of Oral Hypoglycemic Agents58

Table 43: Average Dose and Cost Comparison of Hypoglycemic Agents59

Table 44: Average Dose and Cost Comparison of Hypoglycemic Agents60

Table 45: Relative Efficacy of Oral Agents for Diabetes60

Table 46: Thiazolidinediones Available for Type 2 Diabetes Mellitus63

Table 47: Therapeutic Comparison of the Available Thiazolidinediones63

Table 48: Oralin Sales Forecast Through 200866

Table 49: AERx Sales Forecast Through 200866

Table 50: HIM 2 Sales Forecast Through 200866

Table 51: Oral Anti-diabetic Agents and Their Approved Indications and Uses72

Table 52: Brand and Generic Names for the Sulfonylureas Sold in the U.S.72

Table 53: Preparations of Sulfonylurea Tablets73

Table 54: Worldwide Insulin Sales75

Table 55: Worldwide Insulin Sales and Market Share by World Region 200375

Table 56: Worldwide Insulin Sales and Market Share by Company, 200376

Table 57: U.S. Insulin Sales and Market Share by Company, 200376

Table 58: U.S. Insulin Sales, 2000-200976

Table 59: Worldwide Recombinant Human Insulin Sales and Market Share by Company, 200578

Table 60: Pharmacokinetics of Available Insulins78

Table 61: Action Times for Each Insulin81

Table 62: Key Drivers of the Type 2 Diabetes Insulin Market to 201286

Table 63: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes87

Table 64: Agents for Lowering Lipid Levels in Patients with Dyslipidemia87

Table 65: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes88

Table 66: New Drugs in Human Clinical Trials by Disease Type94

Table 67: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-196

Table 68: Cells of the Pancreas98

Table 69: Selected Mid-2004 Press Releases on Emerging Anti-diabetes Agents99

Table 70: Diabetes Agents in the Pipeline100

Table 71: Control Averages by Treatment110

Table 72: Reduced Risk for Various Diseases When Blood Glucose is Near Normal110

Table 73: Worldwide Diabetes Market, through 2007 ($ Millions)111

Table 74: Types of Insulin Pumps on the Market111

Table 75: Laboratory Assessment of Diabetic Vascular Disease123

Table 76: The Global Population of Persons with Diabetes124

Table 77: The Glucose Market for OTC Testing in the U.S., 1996-2007125

Table 78: The Glucose Market for OTC Testing Worldwide, 2000-2007125

Table 79: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements126

Table 80: Lancet Characteristics141

Table 81: Lancing Device Characteristics141

Table 82: Worldwide Insulin Injector Pen Dollar Volume, 1998-2006143

Table 83: Insulin Delivery Systems Percent Retail Market Share144

Table 84: Insulin Delivery Systems Percent Retail Market Share by Company, 2003145

Table 85: Summary of Inhaled Insulin Products148

Table 86: Worldwide Diabetes Drugs in Pipeline, 2004155

Table 87: Top Therapeutic Drug Categories Worldwide, 2004156

Table 88: Top Therapeutic Categories in U.S. Development, 2003156

Table 89: Pharmaceutical Companies Number of Products in Development156

Table 90: Pharmaceutical Companies Number of Diabetes Products in Development157

Table 91: Drugs in Preclinical Testing, 2004157

Table 92: New Diabetes Drugs in Pipeline without Major Pharma Alliances158

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