Diabetes, Metabolic Syndrome and Cardiovascular Disease

  • December 2012
  • -
  • TriMark Publications
  • -
  • 219 pages

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 TriMark Publications 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

TABLE OF CONTENTS

1. Overview 8
1.1 Statement of Report 8c
1.2 About this Report 8
1.3 Scope of the Report 9
1.4 Methodology 9
1.5 Executive Summary 10

2. Introduction 15
2.1 Demographics of Diabetes 16
2.1.1 Worldwide Diabetes 16
2.1.2 U.S. Diabetes 18
2.2 Economics of Diabetes 21

3. Understanding the Metabolic Conditions Underlying and Associated with
Diabetes 26
3.1 Pre-Diabetes Syndrome 27
3.2 Metabolic Syndrome 27
3.3 Diabetes and Inflammation 32
3.4 Diagnosis of Diabetes Mellitus 33
3.5 Progression of Diabetes 33
3.6 Risk Factors and Diabetes 33
3.6.1 Obesity 34
3.6.2 Stress-Induced Hyperglycemia 37
3.7 Complications and Co-Morbidities in Type 2 Diabetes 37
3.7.1 Preventing Complications and Co-Morbidities in Diabetes 40
3.8 Hypoglycemia Resulting from Treatment 41
3.9 Cardiovascular Disease (CVD) 41
3.9.1 CVD Facts 41
3.9.2 Cardiac Care Therapeutics 48
3.9.2.1 Anti-Hypertensive Drugs 49
3.9.2.2 Cholesterol Management Drugs 50
3.9.2.3 Anticoagulants 53
3.9.3 CVD Diagnostics 53

4. Pharmaceutical Industry and the Anti-Diabetes Market 56
4.1 The Worldwide Pharmaceutical Industry 56
4.1.1 Pharmaceutical Randamp;D Spending by Type, Growth Rate and Expenditure 56
4.1.2 Global Pharmaceutical Market 58
4.2 Total Diabetes Drug Market Size and Growth 62
4.2.1 Sales of Anti-Diabetic Drugs Continue to Rise 65
4.3 Diabetic Medications Overview 66
4.3.1 Recent Trends in Diabetic Drug Usage 67
4.3.2 Market Influence Factors 71

5. Non-Insulin Anti-Diabetes Products 73
5.1 Anti-Diabetic Drug Therapy Overview 73
5.1.1 Sulfonylureas 77
5.1.2 Meglitinides 78
5.1.3 Biguanides 79
5.1.4 Thiazolidinediones (TZDs) 80
5.1.5 a-Glucosidase Inhibitors 82
5.1.6 Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analogs and Agonists 83
5.1.6.1 Byetta (Exenatide) 84
5.1.6.2 Victoza (Liraglutide) 85
5.1.6.3 Bydureon (Exenatide LAR) 85
5.1.7 Amylin Analog 85
5.1.8 DPP-IV Inhibitors 86
5.1.8.1 Januvia (Sitagliptin) 86
5.1.8.2 Onglyza (Saxagliptin) 86
5.1.8.3 Tradjenta (Linagliptin) 86
5.1.8.4 Galvus (Vildagliptin) 87
5.1.9 Combination Therapy 87
5.1.9.1 Youth with Recent-Onset Type 2 Diabetes should be Started on Combination
Therapies 88
5.1.10 Comparisons of the Anti-Diabetes Drugs 88
5.2 Drivers and Trends 89
5.2.1 Market Share of Anti-Diabetic Drugs 89
5.2.2 Forecasts for Anti-Diabetic Drugs 90
5.2.3 Sales Forecast for the Global Diabetes Market 91
5.3 The Future 92
5.3.1 Practice Patterns 92
5.3.2 New Products in Pipeline 92
5.3.2.1 Novel GLP-1 Agonists and Analogs 93
5.3.2.2 Novel DPP-IV Inhibitors 94
5.3.2.3 Sodium Glucose Cotransporter 2 (SGLT-2) 95
5.3.2.4 Emerging Non-Insulin Anti-Diabetes Targets and Drugs in the Pipeline 96
5.3.2.5 Novel Approaches to Finding New Drug Targets 99
5.4 Anti-Diabetic Drug Patent Expiry 100
5.5 Regulatory Issues 100

6. Insulin 101
6.1 Insulin Markets 101
6.1.1 Major Players and Market Share 102
6.1.2 Patent Expirations 104
6.1.3 Innovation Strategies 104
6.2 Insulin Therapeutics 105
6.2.1 Recommendations for Insulin Initiation and Administration 105
6.2.2 Short-Acting Insulin 108
6.2.3 Rapid-Acting Insulin 108
6.2.4 Intermediate-Acting Insulin 110
6.2.5 Long-Acting Insulin 110
6.2.6 Long-Acting Insulins in Development 111
6.2.7 Insulin Mixtures 112
6.3 Pipeline Insulin 112
6.4 Non-Invasive Insulin Delivery 113
6.4.1 Inhaled Insulin 114
6.4.1.1 A Chronicle of Inhaled Insulins 115
6.4.2 Oral Insulin 117
6.4.3 Transdermal Insulin 120
6.5 Barriers for Non-Injected Insulin 122
6.6 Patient Potential for Non-Injected Insulin 122
6.7 Insulin Delivery Devices 122
6.7.1 Insulin Pens 123
6.7.2 Injections Aids 128
6.7.2.1 Automatic Injectors 129
6.7.2.2 Syringe Magnifiers 129
6.7.2.3 Injection Ports 130
6.7.3 Insulin Jet Injectors 130
6.7.4 Insulin Pumps 131
6.7.4.1 External Insulin Pumps 132
6.7.4.2 Insulin Infusion Sets 136
6.7.4.3 Insulin Patch Pumps in Development or Only Available Outside the U.S.
137
6.7.4.4 Implantable Insulin Pumps 139
6.7.4.5 Insulin Pump Market Share 141
6.7.4.6 Drivers of Demand for Pumps 142
6.8 Market Forecasts for Insulin Administration Technologies 142

7. Emerging Anti-Diabetes Technologies and Products 143
7.1 Projections for the Anti-Diabetes Drug Market 143
7.2 Artificial Pancreas 146
7.3 Insulin-Producing Cells 147
7.3.1 Cell Therapy Companies for Diabetes 148
7.4 Pancreatic Transplantation 149
7.4.1 Candidates for Pancreatic Transplantation 150
7.4.1.1 Pancreatic Organ Transplantation 151
7.4.1.2 Allo-Islet Transplantation 151
7.4.1.3 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells
151
7.4.2 Current Status 152
7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes 152
7.6 Immune Modulators 153
7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 153
7.8 Other Anti-Diabetic Therapy Drug Candidates 154
7.8.1 Lipid Abnormalities 154
7.8.2 High Blood Pressure 155
7.8.3 Anti-Coagulants and Anti-Platelets 156
7.9 Drugs Used “Off-Label” 157
7.9.1 Warfarin Sodium 157

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 158
8.1 New Diagnostic Guidelines 158
8.2 Diabetes Tests 159
8.2.1 Fasting Plasma Glucose (FPG) Test 160
8.2.2 Glucose Tolerance Test 160
8.2.3 Test for Glycosylated Hemoglobin (HbA1c or A1c) 160
8.2.4 Fructosamine 161
8.2.5 Screening Tests for Diabetes-Related Complications 162
8.3 Glucose Monitoring 162
8.3.1 Overview of Market Segment 164
8.3.2 Competitive Strategies 164
8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 166
8.3.3.1 First-Generation Monitors 167
8.3.3.2 Second-Generation Monitors 167
8.3.3.3 Third-Generation SMBG Technologies 168
8.3.3.4 Product Overview 168
8.3.3.4.1 LifeScan 168
8.3.3.4.2 Roche Diagnostics 170
8.3.3.4.3 Bayer HealthCare 172
8.3.3.4.4 Abbott Diabetes Care 173
8.3.3.4.5 Other Players 174
8.3.4 What are the Advantages of Using a Continuous Glucose-Monitoring Device?
175
8.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 176
8.3.6 Future of Non-Invasive Glucose Technology 176
8.3.7 Lancets and Lancing Devices 176

9. Market Trends, Challenges and Strategic Options 180
9.1 Overview 180
9.2 Diabetes Drug Market Trends 180
9.2.1 Overview 180
9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 180
9.2.3 Increasing Prevalence of Obesity 181
9.2.4 Consumer Preference Drives Product Development in Invasive Technology
Segment 182
9.2.5 Revenue Potential of Non-Invasive Technologies 182
9.3 Diabetes Mellitus Market Challenges 182
9.3.1 Overview 182
9.3.2 Diabetic Pain Therapeutics 183
9.3.3 Market Prospects of Inhalable Insulin 183
9.4 Strategic Options 183
9.4.1 Developing Countries are Key Markets for Growth 184
9.4.2 Consumer-Driven Marketing Campaigns 185
9.4.3 Diabetes Drugs in Pipeline 185
9.5 New FDA Guidelines for Developing Anti-Diabetic Drugs 186
9.6 Recent Industry Activity 187

10. Company Profiles 189
10.1 A. Menarini 189
10.2 Abbott Laboratories 189
10.3 Amgen 190
10.4 AstraZeneca 190
10.5 Bayer Pharma 192
10.6 BodyMedia 194
10.7 Cyber Medical Ltd. 194
10.8 Debiotech 194
10.9 DexCom 195
10.10 Echo Therapeutics 196
10.11 Eli Lilly 198
10.12 Elixir Pharmaceuticals 198
10.13 Eksigent Technologies 198
10.14 Flamel Technologies 199
10.15 GlaxoSmithKline 199
10.16 Insulet 199
10.17 iSense Corporation 200
10.18 Isis Pharmaceuticals, Inc. 200
10.19 Johnson andamp; Johnson 201
10.20 Kyorin 202
10.21 M-Biotech 203
10.22 Medtronic 203
10.23 Merck andamp; Company 203
10.24 Mitsubishi Tanabe Pharma Corporation 204
10.25 Nipro Diagnostics 204
10.26 Novartis 204
10.27 Novo Nordisk 205
10.28 Novocell 206
10.29 ONO Pharmaceutical 206
10.30 Orexigen Therapeutics 207
10.31 Pfizer 207
10.32 Roche Diagnostics 208
10.33 Sanofi-Aventis 209
10.34 Sensors for Medicine and Science 210
10.35 Siemens 211
10.36 Smiths Medical 211
10.37 SOOIL Development 212
10.38 Takeda 212
10.39 TheraFuse 212
10.40 U.S. Diagnostics 213
10.41 VeraLight 213
10.42 Vivus 213
10.43 Ypsomed Holding 214
Appendix 1: The History of Insulin 215


INDEX OF FIGURES

Figure 2.1: Worldwide Rates of Diabetes Cases, 2012, 2020 and 2030 16
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011
18
Figure 2.3: Prevalence of Diabetes by Age in the U.S, 2010 19
Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2010 20
Figure 2.5: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79
Years) with Diabetes, 2011 21
Figure 2.6: How Diabetes Dollars are Spent in the U.S., 2007 23
Figure 3.1: Maintenance of Normal Blood Sugar Levels 26
Figure 3.2: Obesity (BMI ³ 30) Prevalence in U.S. Adults, 2010 35
Figure 3.3: Percentage of Obese Adults in the U.S., 2009-2010 35
Figure 3.4: Percentage of Obese Children and Adolescents in the U.S., 2009-2010
36
Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S.,
1963-2008 36
Figure 3.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008
43
Figure 3.7: Heart Disease Death Rate by Race and Sex in the U.S., 1979-2008 44
Figure 3.8: Annual Death Rate of U.S. Population from Strokes, 1950-2008 44
Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 2008 45
Figure 3.10: Percentage of U.S. Population That Smokes, 1965-2010 46
Figure 3.11: Percentage of Obese Adults in the U.S., 1960-2008 47
Figure 3.12: Percentage of Obese Children and Adolescents in the U.S., 1971-2008
48
Figure 3.13: Number of Annual Prescriptions for Popular Cholesterol Drugs,
2006-2010 51
Figure 4.1: Top Therapeutic Classes Contributing to Growth in U.S. Drug
Spending, 2010-2011 68
Figure 4.2: Top Ten Diabetes Medications in the U.S., by Number of Prescriptions
69
Figure 4.3: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2010 69
Figure 5.1: Comparison of the Effects of the Pioglitazone and Rosiglitazone on
Lipids 81
Figure 5.2: Overview of GLP-1 and Blood Glucose 84
Figure 5.3: Global Non-Insulin Anti-Diabetes Sales by Drug Class, 2010 89
Figure 5.4: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class, 2010
90
Figure 5.5: Sales Forecast for the Global Diabetes Drug Market, 2008-2016 91
Figure 5.6: Sales Forecast for the U.S. Diabetes Drug Market, 2008-2016 92
Figure 6.1: Global Sales of Lantus, 2005-2011 104
Figure 6.2: Insulin Pump Market Share, 2011 141


INDEX OF TABLES

Table 2.1: Top Ten Countries with the Largest Estimated Number of Diabetics (20
to 79 Years Age Group),
2012 and 2030 17
Table 2.2: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20
Years or Older, 2010 19
Table 2.3: Cost of Diagnosed Diabetes in the U.S., 2007 21
Table 2.4: Medical Care Costs Attributable to Diabetes in the U.S., 2010 22
Table 2.5: Healthcare Utilization by Diabetic Patients 22
Table 2.6: Annual Cost of Care of UnitedHealthcare Adult Members with Diabetes,
2009 23
Table 2.7: Per-Event Costs of Diabetes Complications 24
Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for
Metabolic Syndrome 28
Table 3.2: American Heart Association and National Heart, Lung, and Blood
Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome 28
Table 3.3: Additional Metabolic Criteria for Research 30
Table 3.4: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 37
Table 3.5: Odds Ratio of Progression to Complications Associated with Type 2
Diabetes 39
Table 3.6: Prevalence of Complications Among Patients with Diabetes 39
Table 3.7: Novel Risk Factors and Possible Mechanisms of the Excess Risk of
Coronary Heart Disease in Type 2 Diabetes Mellitus 39
Table 3.8: Major Causes of End-Stage Renal Disease 39
Table 3.9: Clinical Recommendations for Adults with Diabetes 40
Table 3.10: Laboratory Assessment of Diabetic Vascular Disease 40
Table 3.11: Average Years Gained Free of Diabetes-related Disease with Intensive
Management 41
Table 3.12: Summary of Cardiovascular Diseases (CVDs) 41
Table 3.13: Death Rate from Cardiovascular Diseases by Country, 2008 43
Table 3.14: Percentage of Adults Smokers by Country, 2008 47
Table 3.15: Selected Potential Patent Expirations of Cardiac Care Drugs,
2012-2013 48
Table 3.16: Worldwide Market for Cardiac Care Therapeutics, 2007-2014 49
Table 4.1: Global Randamp;D Spending in the Pharmaceutical Industry, 2008-2012 56
Table 4.2: Pharmaceutical Companies Ranked by Total Randamp;D Expenditures, 2011 56
Table 4.3: Leading Therapy Classes for Randamp;D, 2012 57
Table 4.4: Global Pharmaceutical Sales by Region and Country, 2010 and 2015, and
CAGR 2006-2010 and
2011-2015 58
Table 4.5: World Pharmaceutical Sales Share by Region, 2010 59
Table 4.6: Top Ten Global Pharmaceutical Companies by Global Sales, 2011 59
Table 4.7: Leading Ten Therapeutic Classes by U.S. Sales, 2006-2011 60
Table 4.8: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions,
2006-2011 60
Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales, 2015, and
CAGR 2011-2015 61
Table 4.10: Top Selling Drugs in the U.S., 2010 61
Table 4.11: Worldwide Anti-Diabetes Drug Market, 2008-2016 63
Table 4.12: Oral Anti-Diabetic Therapy Major World Markets, 2010 63
Table 4.13: The Leading Five Anti-Diabetics by Sales, 2011 65
Table 4.14: American College of Physicians 2012 Practical Guideline for the Use
of Anti-Diabetes Drugs for Type 2 Diabetes 66
Table 4.15: Summary of Glucose-Lowering Interventions as Monotherapy 70
Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 73
Table 5.2: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes, 2012 75
Table 5.3: Relative Efficacy of Diabetes Drugs 75
Table 5.4: Average Dose and Cost Comparison of Oral Hypoglycemic Agents 76
Table 5.5: Fixed-Dose Oral Anti-Diabetes Drug Combinations 88
Table 5.6: Delivery Method of Non-Insulin Anti-Diabetes Drugs in the Pipeline,
2011 93
Table 5.7: GLP-1 Agonist Pipeline: Selected Drugs in Development that Target
GLP-1 94
Table 5.8: DPP-IV Inhibitor Pipeline 95
Table 5.9: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 97
Table 6.1: Value Market Shares of Animal, Human and Modern Insulin, 1995-2010
101
Table 6.2: Worldwide Insulin Sales, 2008-2016 102
Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2011 102
Table 6.4: Estimated U.S. Retail Insulin Sales, 2011-2016 102
Table 6.5: Worldwide Insulin Sales and Market Share by Company, 2011 103
Table 6.6: U.S. Insulin Sales and Market Share by Company, 2011 103
Table 6.7: Insulins on the U.S. Market 105
Table 6.8: Pharmacokinetics of Therapeutic Insulins on the U.S. Market 106
Table 6.9: Pharmacokinetics of Short-Acting Insulins 108
Table 6.10: Pharmacokinetics of Rapid-Acting Insulins 108
Table 6.11: Pharmacokinetics of Intermediate-Acting Insulins 110
Table 6.12: Pharmacokinetics of Long-Acting Insulins 110
Table 6.13: Pharmacokinetics of Insulin Mixtures 112
Table 6.14: Status of Inhaled Insulin Products, 2011 117
Table 6.15: Key Drivers of the Type 2 Diabetes Insulin Market, 2012 122
Table 6.16: A Comparison of Existing Insulin Delivery Devices 123
Table 6.17: Insulin Pens 125
Table 6.18: Estimated Worldwide Demand for Insulin Injector Pens by Volume,
2012-2016 127
Table 6.19: Injection Aids 128
Table 6.20: Jet Injectors 130
Table 6.21: Control Averages by Treatment 131
Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal
131
Table 6.23: Leading Insulin Pump Manufacturers 132
Table 6.24: Comparison of Current External Insulin Pumps on the Market 132
Table 6.25: Insulin Infusion Sets 137
Table 6.26: Worldwide Insulin Pump Market, 2009-2016 141
Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 146
Table 7.2: Cells of the Pancreas 148
Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with
Diabetes 154
Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia 155
Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in
Patients with Diabetes 156
Table 8.1: Criteria for the Diagnosis of Diabetes 159
Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 159
Table 8.3: Laboratory Assessment of Diabetic Vascular Disease 163
Table 8.4: Worldwide Glucose Self-Testing Market Sales (Meters and Strips),
2010-2016 163
Table 8.5: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips,
and Lancets), 2010-2016 164
Table 8.6: Market Share of U.S. Blood Glucose Self-Testing, 2011 164
Table 8.7: Lancet Characteristics 179
Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 185
Table 9.2: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 186
Table 9.3: Selected Diabetes Drugs in Clinical Trials, 2011 186
Table A1.1: Select Archived Press Release Excerpts 218

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