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Diabetes, Metabolic Syndrome and Cardiovascular Disease

There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes among adults across the world.

To compound the global diabetes epidemic, health professionals are witnessing an alarming increase in inflammatory diseases resulting from adult onset (i.e., Type 2) diabetes. This phenomenon is referred to as "metabolic syndrome" where a confluence of inflammatory conditions occur along with the diabetes. As a result, growing evidence appears to show that metabolic syndrome makes the diabetic patient susceptible to degenerative health conditions such as cardiovascular disease, stroke and, now believed, Alzheimer\'s disease.

As the diabetes epidemic escalates, a new sense of urgency has taken hold. Proactive strategies for prevention of the disease are being put in place by international health organizations such as the World Health Organization (WHO), as well as by the health departments of industrialized and developing countries, and even at the local level where food ingredients regulations are being passed.

This report charts the changing landscape of the global diabetic population and explores the added health concerns resulting from the metabolic syndrome phenomenon and one of its major risk factors: cardiovascular disease (CVD). Furthermore, this study evaluates widely-accepted therapeutic approaches to diabetes that are currently in use, while providing an in-depth analysis of emerging technologies that will be used to treat diabetes and other inflammatory diseases in the future.

Table of Contents

• 1.Overview8
  • 1.1Statement of Report8
  • 1.2About this Report8
  • 1.3Scope of the Report9
  • 1.4Methodology9
  • 1.5Executive Summary11
  
  
• 2.Introduction17
  • 2.1Demographics of Diabetes17
    • 2.1.1Worldwide Diabetes17
    • 2.1.2U.S. Diabetes18
  • 2.2Economics of Diabetes22
  
  
• 3.Understanding the Metabolic Conditions Underlying and Associated with Diabetes28
  • 3.1Pre-Diabetes Syndrome29
  • 3.2Metabolic Syndrome29
  • 3.3Diabetes and Inflammation32
  • 3.4Progression of Diabetes32
  • 3.5Complications and Co-Morbidities in Type 2 Diabetes33
  • 3.6Hypoglycemia and Treatment38
  • 3.7Risk Factors and Diabetes39
  • 3.8Cardiovascular Disease (CVD) Facts40
  
  
• 4.Pharmaceutical Industry and the Anti-Diabetes Market51
  • 4.1The Worldwide Pharmaceutical Industry51
  • 4.2Total Diabetes Drug Market Size and Growth58
    • 4.2.1Sales of Anti-Diabetic Drugs Continue to Rise61
  • 4.3Epidemiology/Cost of Treatment62
  • 4.4Diabetic Medications Overview63
    • 4.4.1Recent Trends in Diabetic Drug Usage63
    • 4.4.2Market Influence Factors67
    
    
• 5.Non-Insulin Anti-Diabetes Products69
  • 5.1Anti-Diabetic Drug Therapy Overview69
    • 5.1.1Sulfonylureas72
    • 5.1.2Meglitinides73
    • 5.1.3Biguanides73
    • 5.1.4Thiazolidinediones (TZDs)74
    • 5.1.5£\\-Glucosidase Inhibitors77
    • 5.1.6Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analog77
    • 5.1.7Amylin Analog79
    • 5.1.8DPP-IV Inhibitors79
    • 5.1.9Other Classes81
    • 5.1.10Combination Therapy81
  • 5.2Drivers and Trends82
    • 5.2.1Market Share of Anti-Diabetic Drugs82
    • 5.2.2Forecasts for Anti-Diabetic Drugs82
    • 5.2.3Sales Forecast for the Global Diabetes Market83
  • 5.3The Future84
    • 5.3.1Practice Patterns84
    • 5.3.2New Products in Pipeline85
  • 5.4Anti-Diabetic Drug Patent Expiry91
  • 5.5Regulatory Issues91
  
  
• 6.Insulin92
  • 6.1Insulin Markets92
    • 6.1.1Major Players and Market Share93
  • 6.2Insulin and Analogs95
    • 6.2.1Rapid-Acting Insulin95
    • 6.2.2Intermediate-Acting Insulin97
    • 6.2.3Long-Acting Insulin/Ultra Long-Acting Insulin97
    • 6.2.4Insulin Mixtures99
  • 6.3Insulin Analogs100
  • 6.4Non-Insulins in Development100
  • 6.5Pipeline Insulin101
  • 6.6Non-Invasive Insulin Delivery101
    • 6.6.1Inhaled Insulin101
      • 6.6.1.1Inhaled Insulin Overview102
    • 6.6.2Oral Insulin104
    • 6.6.3Transdermal Insulin106
    • 6.6.4Oral Spray Insulin108
  • 6.7Barriers for Non-Injected Insulin109
  • 6.8Patient Potential for Non-Injected Insulin109
  • 6.9Insulin Delivery Devices109
    • 6.9.1Lancets and Lancing Devices110
    • 6.9.2Insulin Pens113
    • 6.9.3Injections Aids117
      • 6.9.3.1Automatic Injectors117
      • 6.9.3.2Syringe Magnifiers118
      • 6.9.3.3Insulin Infusers118
    • 6.9.4Insulin Jet Injectors118
    • 6.9.5Insulin Pumps119
      • 6.9.5.1External Insulin Pumps119
      • 6.9.5.2Implantable Insulin Pumps122
      • 6.9.5.3Insulin Pump Market Share123
      • 6.9.5.4Drivers of Demand for Pumps128
  • 6.10Market Forecasts for Insulin Administration Technologies129
  
  
• 7.Emerging Anti-Diabetes Products130
  • 7.1Projections for the Anti-Diabetes Drug Market130
  • 7.2Artificial Pancreas134
  • 7.3Insulin-Producing Cells135
    • 7.3.1Cell Therapy Companies for Diabetes135
  • 7.4Transplantation Procedures137
    • 7.4.1Pancreatic Transplantation138
      • 7.4.1.1Pancreatic Organ Transplantation138
      • 7.4.1.2Allo-Islet Transplantation138
      • 7.4.1.3Transplantation of Encapsulated Pancreatic Cells139
      • 7.4.1.4Implantation of Genetically Engineered-Cells or Embryonic Stem Cells139
    • 7.4.2Current Status140
  • 7.5Gastric Bypass Surgery to Treat Type 2 Diabetes140
  • 7.6Immune Modulators141
  • 7.7Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes141
  • 7.8Other Anti-Diabetic Therapy Drug Candidates141
    • 7.8.1Lipid Abnormalities142
    • 7.8.2High Blood Pressure143
    • 7.8.3Anticoagulants144
  • 7.9Drugs Used ¡§Off-Label¡¨145
    • 7.9.1Niacin Derivatives145
    • 7.9.2Benfluorex145
    • 7.9.3D-Chiro-Inositol145
    • 7.9.4Warfarin Sodium145
  • 7.10 Pipeline Diabetic Drug Candidates146
  • 7.11Drug Research Overview149
  • 7.12Future Anti-Diabetic Drugs in Late-Stage Development151
  
  
• 8.Diagnosing Diabetes Using In Vitro Laboratory Tests154
  • 8.1New Diagnostic Guidelines154
  • 8.2Diabetes Tests155
    • 8.2.1Fasting Plasma Glucose (FPG) Test155
    • 8.2.2Glucose Tolerance Test155
    • 8.2.3Test for Glycosylated Hemoglobin156
    • 8.2.4Fructosamine157
  • 8.3Glucose Monitoring157
    • 8.3.1Overview of Market Segment160
    • 8.3.2Competitive Strategies160
    • 8.3.3Analyses of the Current Market Conditions, Competition and Product Mix162
      • 8.3.3.1First-Generation Monitors162
      • 8.3.3.2Second-Generation Monitors162
      • 8.3.3.3Third-Generation SMBG Technologies164
      • 8.3.3.4Product Overview165
        • 8.3.3.4.1 LifeScan165
        • 8.3.3.4.2 Roche Diagnostics168
        • 8.3.3.4.3 Bayer Diagnostics169
        • 8.3.3.4.4 Abbott Diagnostics172
        • 8.3.3.4.5 Other Players174
    • 8.3.4What Are the Advantages of Using a Continuous Glucose-Monitoring Device?177
    • 8.3.5Other Monitoring Device Advancements178
    • 8.3.6Future of Non-Invasive Glucose Technology179
    
    
• 9.Market Trends, Challenges and Strategic Options182
  • 9.1Overview182
  • 9.2Diabetes Drug Market Trends182
    • 9.2.1Overview182
    • 9.2.2Emergence of Therapeutics with Improved Administration Characteristics182
    • 9.2.3Increasing Prevalence of Obesity183
  • 9.3Diabetes Mellitus Market Challenges185
    • 9.3.1Overview185
    • 9.3.2Diabetic Pain Therapeutics185
    • 9.3.3Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels186
    • 9.3.4Changing Consumer Preference Drives Product Development in Invasive Technology Segment186
    • 9.3.5Non-Invasive Technology for Revenue Potential186
    • 9.3.6Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices187
    • 9.3.7Consumer-Driven Marketing Campaigns¡XEssential, though Expensive189
    • 9.3.8Escalating Expenditure for R&D and Marketing Triggers Consolidation189
    • 9.3.9Market Size Predictions191
    • 9.3.10Major Competitors191
  • 9.4Strategic Options192
    • 9.4.1Overview192
    • 9.4.2Combined Self-Testing Glucose Monitor with Insulin Delivery193
    • 9.4.3Diabetes Drugs in Pipeline194
  • 9.5FDA Therapeutic Targets196
    • 9.5.1FDA Targets Cardiotoxicity197
    • 9.5.2Avandia FDA Warning197
  • 9.6Outlook to Anti-Diabetes Drugs197
  • 9.7Outlook for Cardiovascular Drugs201
  
  
• 10.Company Profiles203
  • 10.1A. Menarini203
  • 10.2Abbott Laboratories203
  • 10.3Amgen204
  • 10.4AstraZeneca205
  • 10.5Bayer206
  • 10.6BodyMedia208
  • 10.7Cybermedical208
  • 10.8Debiotech208
  • 10.9DexCom209
  • 10.10Echo Therapeutics210
  • 10.11Elixir Pharmaceuticals211
  • 10.12Eksigent211
  • 10.13Flamel Technologies211
  • 10.14GlaxoSmithKline212
  • 10.15GlucoLight212
  • 10.16Insulet212
  • 10.17iSense Corporation213
  • 10.18Isis Pharmaceuticals, Inc.213
  • 10.19Johnson & Johnson214
  • 10.20KYORIN215
  • 10.21M-Biotech215
  • 10.22Medtronic215
  • 10.23Merck & Co.217
  • 10.24Merck KGaA218
  • 10.25MicroIslet218
  • 10.26Mitsubishi Tanabe Pharma Corporation219
  • 10.27Nipro Diabetes Systems219
  • 10.28Novartis219
  • 10.29Novo Nordisk220
  • 10.30Novocell221
  • 10.31ONO Pharmaceutical221
  • 10.32Orexigen Therapeutics222
  • 10.33Pfizer223
  • 10.34ReNeuron223
  • 10.35Roche Diagnostics224
  • 10.36Sanofi-Aventis225
  • 10.37Sensors for Medicine and Science226
  • 10.38Siemens227
  • 10.39Smiths Medical227
  • 10.40Servier228
  • 10.41SOOIL Development228
  • 10.42Takeda228
  • 10.43TheraFuse229
  • 10.44Teco Diagnostics229
  • 10.45Transition Therapeutics229
  • 10.46U.S. Diagnostics229
  • 10.47VeraLight230
  • 10.48Vivus230
  • 10.49Ypsomed Holding231
  
  

 

Appendix 1: Contact Information for Companies Profiled232

Appendix 2: Prescribing Patterns for Anti-Hyperglycemic Drugs238

Appendix 3: Detailed List of Insulins Available239

Appendix 4: The History of Insulin240

Appendix 5: Diabetes and Obesity Drugs in Development245

Appendix 6: Pharmaceutical Sampling Practices253

INDEX OF FIGURES

Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-202517

Figure 2.2: Prevalence of Diabetes by Age in the U.S, 200718

Figure 2.3: New Adult Cases of Diabetes Diagnosed in the U.S., 200719

Figure 2.4: Distribution of Duration of Diabetes among Adults Aged 18 to 79 Years in the U.S., 200520

Figure 2.5: Number of Persons with Diagnosed Diabetes in the U.S., 1980-200720

Figure 2.6: Treatment with Insulin or Oral Medication among Adults Diagnosed with Diabetes, 200721

Figure 2.7: Rate of New Diabetes Cases among Children in the U.S., 200722

Figure 2.8: Expenditure Associated with Diabetes Complications in the U.S., 200725

Figure 2.9: Diabetes Death Rate by Race and Sex in the U.S., 1979-200627

Figure 3.1: Prevalence of Complications in Diabetics vs. People with Normal Blood Sugar Levels, 200734

Figure 3.2: Per Capita Costs for Diabetes-related Complications per Year, 200735

Figure 3.3: Total Spending on Healthcare in the U.S., 1960-200836

Figure 3.4: Percentage Breakdown of U.S. Healthcare Spending, 200836

Figure 3.5: Percentage of U.S. Population that Smokes, 1965-200542

Figure 3.6: Heart Disease Death Rate by Race and Sex in the U.S., 1979-200642

Figure 3.7: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-200743

Figure 3.8: Annual Death Rate of U.S. Population from Strokes, 1950-200843

Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 200845

Figure 3.10: Annual Death Rate of U.S. Population from Heart Disease, 1950-200848

Figure 3.11: Percentage of U.S. Population that is Overweight, 1976-200450

Figure 4.1: Medical Research in the U.S. Outpaces the Rest of the World52

Figure 4.2: Cost of Diabetes in the U.S., 200762

Figure 4.3: Top Therapeutic Classes Contributing to Drug Trend, 200765

Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 200665

Figure 5.1: Comparison of the Effects of the Pioglitazone and Rosiglitazone on Lipids76

Figure 5.2: U.S. Non-Insulin Anti-Diabetes Sales, 200683

Figure 5.3: Sales Forecast for the Global Diabetes Market, 1992-201284

Figure 6.1: Insulin Pump Market Share, 2007123

Figure 6.2: Relative Risk of Diabetes Complications by Mean HbA1c123

Figure 9.1: Relationship between Diabetes Therapy and the Proposed Timeline195

Figure A3.1: Novo Nordisk¡¦s Rising Market Share in the U.S. Insulin Market, 1982-2008244

INDEX OF TABLES

Table 1.1: Criteria for the Diagnosis of Diabetes11

Table 2.1: Top Ten Countries in Number of Diabetics (20 to 79 Age Group) in the World, 2007 and 202517

Table 2.2: Annual Estimated Cost of Diabetes Care in the U.S., 200723

Table 2.3: Impact of Diabetes on Americans24

Table 2.4: How Diabetes Dollars are Spent in the U.S., 200724

Table 3.1: Percentage of GDP Healthcare Spending by Country, 200837

Table 3.2: Life Expectancy Rate by Country, 200837

Table 3.3: Normal Glucose Values¡XFasting State39

Table 3.4: Percentage of Adults Smokers by Country, 200844

Table 3.5: Worldwide Market for Cardiac Care Therapeutics, 2003-201045

Table 3.6: Death Rate from Cardiovascular Diseases by Country, 200849

Table 4.1: Leading Therapy Classes for R&D, 200851

Table 4.2: Pharmaceutical R&D Expenditures by World Region, 1990-200752

Table 4.3: Pharmaceutical Companies Ranked by Total R&D Expenditures, 200753

Table 4.4: Global Pharmaceutical Sales, 200753

Table 4.5: World Pharmaceutical Sales Share by Region, 200754

Table 4.6: The World¡¦s Top-Selling Drugs (Audited Market), 200755

Table 4.7: Pharmaceutical Product Sales by Country Market, 200755

Table 4.8: Top Ten Global Pharmaceutical Companies by Global Sales, 200756

Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales (Audited Market), 200756

Table 4.10: Leading Ten Therapeutic Classes by U.S. Sales, 2003-200756

Table 4.11: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006 and 200757

Table 4.12: Top Ten Brand Drugs by U.S. Retail, 200757

Table 4.13: Worldwide Anti-Diabetes Drug Market, 2006-201258

Table 4.14: Oral Anti-Diabetic Therapy Major World Markets, 200659

Table 4.15: The Leading Ten Anti-Diabetics by Sales, 200761

Table 4.16: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes, 200861

Table 4.17: Summary of Glucose-Lowering Interventions as Monotherapy67

Table 5.1: Classes of Non-Insulin Hypoglycemic Agents70

Table 5.2: Average Dose and Cost Comparison of Hypoglycemic Agents71

Table 5.3: Relative Efficacy of Diabetes Drugs72

Table 5.4: Thiazolidinediones Available for Type 2 Diabetes Mellitus75

Table 5.5: Fixed Drug Combinations81

Table 5.6: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-188

Table 5.7: DPP-IV Inhibitor Pipeline89

Table 6.1: Available Therapeutic Insulin Alternatives92

Table 6.2: Worldwide Insulin Sales, 2005-201293

Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 200793

Table 6.4: Worldwide Insulin Sales and Market Share by Company, 200794

Table 6.5: U.S. Insulin Sales and Market Share by Company, 200794

Table 6.6: U.S. Retail Insulin Sales, 2006-200995

Table 6.7: Comparison of Rapid-Acting Insulins96

Table 6.8: Comparison of Long-Acting Insulins98

Table 6.9: Pharmacokinetics of Available Insulins98

Table 6.10: Status of Inhaled Insulin Products, 2009103

Table 6.11: Key Drivers of the Type 2 Diabetes Insulin Market, 2012109

Table 6.12: A Comparison of Existing Insulin Delivery Devices110

Table 6.13: Lancet Characteristics112

Table 6.14: Lancing Device Characteristics113

Table 6.15: Insulin Pens114

Table 6.16: Worldwide Demand for Insulin Injector Pens by Volume, 2006-2010115

Table 6.17: Injection Aids118

Table 6.18: Jet Injectors118

Table 6.19: Leading Insulin Pump Manufacturers119

Table 6.20: External Insulin Pumps120

Table 6.21: Comparison of Current Insulin Pumps on the Market120

Table 6.22: Control Averages by Treatment122

Table 6.23: Reduced Risk for Various Diseases When Blood Glucose is Near Normal122

Table 6.24: Worldwide Diabetes Market, 2008124

Table 6.25: Types of Insulin Pumps on the Market124

Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies134

Table 7.2: Cells of the Pancreas140

Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes142

Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia143

Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes144

Table 7.6: Selected Mid-2008 Press Releases on Emerging Anti-Diabetes Agents146

Table 7.7: Diabetes Agents in the Pipeline147

Table 7.8: Future Anti-Diabetic Drugs in Late-Stage Development151

Table 8.1: Laboratory Assessment of Diabetic Vascular Disease158

Table 8.2: Worldwide Market for Diabetes Self-Testing (Meters, Strips and Lancets), 2004-2012158

Table 8.3: Market for Glucose Self-Testing in the U.S., 2004-2012159

Table 8.4: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007160

Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008188

Table 9.2: Selected Licensing Deals in the Diabetes Arena, 2003-2008190

Table 9.3: Top Therapeutic Categories in U.S. Development, 2008194

Table 9.4: Pharmaceutical Companies by Number of Products in R&D Pipeline, 2007194

Table 9.5: Pharmaceutical Companies by Number of Diabetes Products in Development195

Table 9.6: Selected New Diabetes Drugs in Pipeline, 2007196

Table 9.7: Comparison of New Molecular Entity Outcomes for FDA and EMEA (Jan 2006 to October 2008)197

Table 9.8: Upcoming Milestones for Selected Diabetes Drugs200

Table 9.9: Overview of Blockbuster Drugs Coming Off-Patent, 2008 to 2012201

Table A1.1: Company Headquarters Contact Information232

Table A3.1: Current Insulins239

Table A4.1: Select Archived Press Release Excerpts243

Table A5.1: The Diabetes/Obesity Pipeline by Developmental Stage, 2009245

 

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