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Diabetes, Metabolic Syndrome and Cardiovascular Disease

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Publication Date:
November 2014; Pages: 266
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Diabetes Metabolic Syndrome Sample

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

1. Overview 11
1.1 Statement of Report 11
1.2 About this Report 11
1.3 Scope of the Report 12
1.4 Methodology 12
1.5 Executive Summary 14

2. Introduction 18
2.1 Demographics of Diabetes 19
2.1.1 Worldwide Diabetes 19
2.1.2 U.S. Diabetes 22
2.2 Economics of Diabetes 27
2.2.1 Worldwide Costs of Diabetes 27
2.2.2 Costs of Diabetes in the U.S. 28

3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 33
3.1 Pre-Diabetes Syndrome 34
3.2 Metabolic Syndrome 34
3.2.1 Prevalence of Metabolic Syndrome 37
3.2.2 Management of Metabolic Syndrome 38
3.2.3 The Outlook for Metabolic Syndrome 38
3.2.4 The Debate Regarding Metabolic Syndrome 38
3.3 Diabetes and Inflammation 40
3.4 Diagnosis of Diabetes Mellitus 41
3.5 Progression of Diabetes 41
3.6 Risk Factors and Diabetes 41
3.6.1 Obesity 43
3.6.2 Stress-Induced Hyperglycemia 45
3.7 Complications and Co-Morbidities in Type 2 Diabetes 46
3.7.1 Preventing Complications and Co-Morbidities in Diabetes 50
3.7.2 Hypoglycemia Resulting from Treatment 52
3.8 Cardiovascular Disease (CVD) 52
3.8.1 CVD Facts 52
3.8.2 Cardiac Care Therapeutics 59
3.8.2.1 Anti-Hypertensive Drugs 61
3.8.2.2 Cholesterol Management Drugs 62
3.8.2.3 Anticoagulants 66
3.8.3 CVD Diagnostics 66

4. Pharmaceutical Industry and the Anti-Diabetes Market 68
4.1 The Worldwide Pharmaceutical Industry 68
4.1.1 Pharmaceutical R&D Spending by Type, Growth Rate and Expenditure 68
4.1.2 Global Pharmaceutical Market 70
4.2 Total Diabetes Drug Market Size and Growth 76
4.2.1 Sales Forecast for the Global Anti-Diabetes Drug Market 80
4.3 Diabetic Medications Overview 82
4.3.1 Recent Trends in Diabetic Drug Usage 84
4.3.2 Market Influence Factors 86

5. Non-Insulin Anti-Diabetes Products 88
5.1 Anti-Diabetic Drug Therapy Overview 88
5.1.1 Sulfonylureas 91
5.1.2 Meglitinides 92
5.1.3 Biguanides 93
5.1.4 Thiazolidinediones (TZDs) 94
5.1.5 α-Glucosidase Inhibitors 96
5.1.6 Amylin Analog 97
5.1.7 Glucagon-like Peptide (GLP-1) Analogs and Agonists/Incretin Mimetics 97
5.1.7.1 Byetta (Exenatide) 98
5.1.7.2 Bydureon (Exenatide LAR) 99
5.1.7.3 Victoza (Liraglutide) 99
5.1.7.4 Tanzeum (Albiglutide) 99
5.1.7.5 Trulicity (Dulaglutide) 100
5.1.8 DPP-IV Inhibitors 100
5.1.8.1 Januvia (Sitagliptin) 101
5.1.8.2 Onglyza (Saxagliptin) 102
5.1.8.3 Tradjenta (Linagliptin) 102
5.1.8.4 Galvus (Vildagliptin) 102
5.1.8.5 Nesina (Alogliptin) 102
5.1.9 SGLT-2 Inhibitors 103
5.1.9.1 Invokana (Canagliflozin) 104
5.1.9.2 Farxiga (Dapagliflozin) 104
5.1.9.3 Jardiance (Empagliflozin) 105
5.1.9.4 Suglat (Ipragliflozin) 105
5.1.9.5 Lusefi (Luseogliflozin) 105
5.1.10 Combination Therapy 106
5.1.10.1 Antidiabetic Drug Options for Youth with Recent-Onset Type 2 Diabetes Scarce 107
5.1.11 Comparisons of the Anti-Diabetes Drugs 107
5.2 Market Drivers and Trends 107
5.2.1 Market Share and Forecast of Non-Insulin Anti-Diabetic Drugs 108
5.3 Non-Insulin Anti-Diabetes Products in the Pipeline 110
5.3.1 Novel GLP-1 Agonists and Analogs 110
5.3.2 Novel DPP-IV Inhibitors 113
5.3.3 Sodium Glucose Cotransporter 2 (SGLT-2) Inhibitors 114
5.3.4 Emerging Anti-Diabetes Targets and Drugs in the Pipeline 115
5.3.4.1 Novel Approaches to Finding New Drug Targets 119

6. Insulin 120
6.1 Insulin Markets 120
6.1.1 Major Players and Market Share 122
6.1.2 Patent Expirations 124
6.1.3 Pathway for Insulin Biosimilars 124
6.1.3.1 Regulatory Avenues for Biosimilar Approval 124
6.1.3.2 Lantus Biosimilars 125
6.1.3.3 Key Issues for Insulin Biosimilars 125
6.1.4 Innovation Strategies 126
6.2 Insulin Therapeutics 126
6.2.1 Recommendations for Insulin Initiation and Administration 127
6.2.2 Short-Acting Insulin 130
6.2.3 Rapid-Acting Insulin 131
6.2.3.1 Fast-Acting Insulins in Development 132
6.2.4 Intermediate-Acting Insulin 133
6.2.5 Long-Acting Insulin 133
6.2.6 Insulin Mixtures 134
6.3 Pipeline Insulins in Development 135
6.3.1 Tresiba (Novo Nordisk) 135
6.3.2 Ryzodeg (Novo Nordisk) 135
6.3.3 Toujeo (Sanofi) 135
6.3.4 BIOD-531 (Biodel) 135
6.3.5 Xultophy (Novo Nordisk) 136
6.3.6 LixiLan (Sanofi) 136
6.3.7 rHUPH20 and Insulin (Halozyme) 136
6.3.8 FIAsp (Novo Nordisk) 136
6.3.9 BIOD-238, BIOD-250, and BIOD-351 (Biodel) 136
6.3.10 InsuPatch and InsuPad (Insuline Medical) 137
6.4 Non-Invasive Insulin Delivery 138
6.4.1 Inhaled Insulin 139
6.4.1.1 Afrezza 139
6.4.1.2 Dance Pharmaceuticals and Aerogen (Dance-501) 140
6.4.1.3 A Chronicle of Inhaled Insulins 141
6.4.2 Oral Insulin 142
6.4.3 Transdermal Insulin 145
6.5 Barriers for Non-Injected Insulin 146
6.6 Patient Potential for Non-Injected Insulin 147
6.7 Insulin Delivery Devices 147
6.7.1 Insulin Pens 149
6.7.2 Injections Aids 153
6.7.2.1 Automatic Injectors 154
6.7.2.2 Syringe Magnifiers 154
6.7.2.3 Injection Ports 155
6.7.3 Insulin Jet Injectors 155
6.7.4 Insulin Pumps 156
6.7.4.1 External Insulin Pumps 157
6.7.4.2 OneTouch Ping 159
6.7.4.3 Accu-Chek Combo Insulin Pump System 160
6.7.4.4 MiniMed Paradigm Real-Time Revel 160
6.7.4.5 MiniMed 530G with Enlite 161
6.7.4.6 Insulet Omnipod 161
6.7.4.7 DANA IIS 162
6.7.4.8 t:slim (Tandem Diabetes Care) 162
6.7.4.9 Snap (Asante) 162
6.7.4.10 Animas Vibe Pump/CGM 163
6.7.5 Insulin Infusion Sets 163
6.7.6 Insulin Patch Pumps in Development or Only Available Outside the U.S. 163
6.7.7 Implantable Insulin Pumps 166
6.7.8 Insulin Pump Market Share 166
6.7.9 Drivers of Demand for Pumps 168
6.8 Market Forecasts for Insulin Administration Technologies 168

7. Emerging Anti-Diabetes Technologies and Products 169
7.1 Projections for the Anti-Diabetes Drug Market 169
7.2 Artificial Pancreas 172
7.2.1 MiniMed 530G System 173
7.2.2 Animas Vibe System 174
7.2.3 Next Generation Medtronic Artificial Pancreas Systems 174
7.2.4 FDA’s Artificial Pancreas Guidance Document 174
7.3 Insulin-Producing Cells 174
7.3.1 Gene Therapy 175
7.3.2 Cell Therapy Companies for Diabetes 176
7.3.2.1 ViaCyte (formerly Novocell, Inc.) 176
7.3.2.2 Sernova 177
7.4 Pancreatic Transplantation 177
7.4.1 Candidates for Pancreatic Transplantation 178
7.4.1.1 Pancreatic Organ Transplantation 178
7.4.1.2 Allo-Islet Transplantation 179
7.4.1.3 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells 179
7.4.2 ADA Position on Pancreatic Transplantation 179
7.5 Immune Modulators 180
7.6 Gastric Bypass Surgery to Treat Type 2 Diabetes 181
7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 181
7.7.1 Xenical (Roche) 181
7.7.2 Qsymia (Vivus) 181
7.7.3 Belviq (Arena Pharmaceuticals) 182
7.7.4 Contrave (Orexigen Therapeutics) 182
7.7.5 Anti-Obesity Drugs in Development 182
7.8 Other Anti-Diabetic Therapy Drug Candidates 182
7.8.1 Lipid Abnormalities 182
7.8.1.1 New Cholesterol Guidelines 183
7.8.2 High Blood Pressure 185
7.8.3 Aspirin Therapy 187
7.9 Drugs Used “Off-Label” 187
7.9.1 Warfarin Sodium 187
7.10 Insulin and Anti-Diabetes Drug Combinations 187
7.10.1 Xultophy (Novo Nordisk) 187
7.10.2 LixiLan (Sanofi) 188

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 189
8.1 Diagnostic Guidelines 189
8.2 Diagnosis of Diabetes 189
8.2.1 Fasting Plasma Glucose (FPG) Test 192
8.2.2 Glucose Tolerance Test 193
8.2.3 Test for Glycosylated Hemoglobin (HbA1c or A1c) 193
8.2.4 Fructosamine 194
8.2.5 Screening Tests for Diabetes-Related Complications 195
8.3 Glucose Monitoring 196
8.3.1 Overview of Market Segment 198
8.3.2 Competitive Strategies 198
8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 200
8.3.3.1 First-Generation Monitors 201
8.3.3.2 Second-Generation Monitors 201
8.3.3.3 Third-Generation SMBG Technologies 202
8.3.3.4 Product Overview 202
8.3.3.4.1 LifeScan, Inc. 202
8.3.3.4.2 Roche Diagnostics 205
8.3.3.4.3 Bayer HealthCare 206
8.3.3.4.4 Abbott Diabetes Care 208
8.3.3.4.5 Other Players 210
8.3.4 What are the Advantages of Using a Continuous Glucose-Monitoring Device? 211
8.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 212
8.3.6 Future of Non-Invasive Glucose Technology 212
8.3.7 Lancets and Lancing Devices 212

9. Market Trends, Challenges and Strategic Options 216
9.1 Overview 216
9.2 Diabetes Drug Market Trends 216
9.2.1 Overview 216
9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 216
9.2.2.1 Barriers to the Initiation of Insulin Therapy in Type 2 Diabetics 218
9.2.3 Increasing Prevalence of Obesity 218
9.2.4 Consumer Preference Drives Product Development in Invasive Technology Segment 219
9.3 Diabetes Mellitus Market Challenges 219
9.3.1 Overview 219
9.3.2 Patent Expirations 220
9.3.3 Market Prospects of Inhalable Insulin 220
9.4 Strategic Options 221
9.4.1 Developing Countries are Key Markets for Growth 222
9.4.2 Consumer-Driven Marketing Campaigns 223
9.4.3 Strategies for Successful New Product Launches 223
9.4.4 Collaborations and Strategic Alliances 224
9.5 FDA Guidelines for Developing Anti-Diabetic Drugs 224
9.6 Recent Industry Activity 225

10. Company Profiles 228
10.1 A. Menarini 228
10.2 Abbott Laboratories 228
10.3 Abbvie 232
10.4 Amgen 232
10.5 Amylin Pharmaceuticals (bought by Bristol-Myers Squibb) 233
10.6 Animas (part of Johnson & Johnson) 233
10.7 Asante 233
10.8 Astellas Pharma, Inc. 233
10.9 AstraZeneca Plc 234
10.10 Bayer 235
10.11 Becton, Dickinson and Company 237
10.12 Biocon 238
10.13 Biodel 239
10.14 BodyMedia 239
10.15 Boehringer Ingelheim 239
10.16 Bristol Myers Squibb 240
10.17 Cellnovo 240
10.18 CeQur 240
10.19 ConjuChem 240
10.20 Daiichi Sankyo 241
10.21 Dance Biopharm 241
10.22 Debiotech 241
10.23 DexCom 241
10.24 Echo Therapeutics, Inc. 243
10.25 Eli Lilly 244
10.26 FIFTY50 Medical, Inc. 245
10.27 Flamel Technologies 245
10.28 Generex Biotechnology Corporation 245
10.29 GlaxoSmithKline Plc 245
10.30 Halozyme Therapeutics 246
10.31 Insulet 246
10.32 Insuline Medical Ltd. 247
10.33 Intarcia Therapeutics, Inc. 247
10.34 Janssen Research & Development 247
10.35 Johnson & Johnson 248
10.36 Kowa Pharmaceuticals 249
10.37 Lexicon Pharmaceuticals 249
10.38 MannKind Corporation 250
10.39 Medipacs 250
10.40 Medtronic 250
10.41 Merck & Company, Inc. 251
10.42 Mitsubishi Tanabe Pharma Corporation 252
10.43 Novartis 252
10.44 Novo Nordisk 252
10.45 Oramed Pharmaceuticals 253
10.46 Orexigen Therapeutics, Inc. 253
10.47 Owen Mumford 254
10.48 PhaseBio Pharmaceuticals 254
10.49 Pfizer 254
10.50 Prometheon Pharma 255
10.51 Roche Diagnostics 255
10.52 Sanofi-Aventis 257
10.53 Sernova 258
10.54 Smiths Medical 258
10.55 SOOIL Development 259
10.56 Taisho Pharmaceuticals 259
10.57 Takeda 259
10.58 Tandem Diabetes Care, Inc. 259
10.59 Theracos, Inc. 260
10.60 Transdermal Specialties, Inc. 260
10.61 TransTech Pharma 260
10.62 Valeritas 260
10.63 Viacyte, Inc. (formerly Novocell) 261
10.64 Vivus, Inc. 261
10.65 Ypsomed Holding 261
10.66 Zealand Pharma A/S 261

Appendix 1: The History of Insulin 263


INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 19
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 20
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years,
1980-2012 23
Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2012 24
Figure 2.5: Diagnosed and Undiagnosed Diabetes by Age in the U.S., 2013 24
Figure 2.6: Number of Deaths from Diabetes by Age in the U.S., 2010 26
Figure 2.7: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 27
Figure 2.8: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (USD),
2013 28
Figure 2.9: How Diabetes Dollars are Spent in the U.S., 2012 30
Figure 2.10: Percent of Medical Condition-Specific Expenditures Associated with Diabetes, 2012 31
Figure 3.1: Maintenance of Normal Blood Sugar Levels 33
Figure 3.2: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults, 2012 43
Figure 3.3: Prevalence of Obesity Among Adults in the U.S., 2009-2010 44
Figure 3.4: Percentage of Obese Children and Adolescents in the U.S., 2009-2010 44
Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 45
Figure 3.6: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S., 1997-2011 46
Figure 3.7: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011 50
Figure 3.8: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, in the U.S., 1997-2011 50
Figure 3.9: Annual Death Rate of U.S. Population from Heart Disease, 1950-2009 54
Figure 3.10: Annual Death Rate of U.S. Population from Strokes, 1950-2009 55
Figure 3.11: Percentage Breakdown of Deaths Attributable to Cardiovascular Disease in the U.S., 2010 55
Figure 3.12: Death Rates from Cardiovascular Disease by State, 2010 56
Figure 3.13: Percentage of Obese Adults in the U.S., 1960-2010 57
Figure 3.14: Percentage of Obese Children and Adolescents in the U.S., 1971-2010 58
Figure 3.15: Number of Annual Prescriptions for Popular Cholesterol Drugs, 2007-2012 63
Figure 4.1: Sales Forecast for the Global Diabetes Drug Market, 2010-2018 81
Figure 4.2: Sales Forecast for the U.S. Diabetes Drug Market, 2010-2018 82
Figure 4.3: Percentage of U.S. Diabetics Taking Medications, 2010-2012 83
Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2013 85
Figure 5.1: Overview of GLP-1 and Blood Glucose 97
Figure 5.2: Overview of DPP-4 Inhibitors and Blood Glucose 101
Figure 5.3: SGLT-2 Inhibitor Mechanism of Action 103
Figure 5.4: Global Non-Insulin Anti-Diabetes Sales by Drug Class, 2013 108
Figure 5.5: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class, 2013 108
Figure 6.1: Global Sales of Lantus, 2005-2013 123
Figure 6.2: Insulin Pump Market Share, 2013 167


INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 20
Table 2.2: Top Ten Countries with the Largest Estimated Number of Diabetics (20-79 Years Age Group), \
2013 and 2035 21
Table 2.3: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 21
Table 2.4: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013 22
Table 2.5: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 24
Table 2.6: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 25
Table 2.7: Cost of Diagnosed Diabetes in the U.S., 2012 29
Table 2.8: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 30
Table 2.9: Healthcare Utilization by Diabetic Patients, 2012 31
Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for Metabolic Syndrome 35
Table 3.2: Ethnic Specific Values for Waist Circumference in IDF’s Metabolic Syndrome Criteria 35
Table 3.3: American Heart Association and National Heart, Lung, and Blood Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome 35
Table 3.4: Additional Metabolic Criteria for Research 37
Table 3.5: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 46
Table 3.6: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 48
Table 3.7: Prevalence of Complications Among Patients with Diabetes 49
Table 3.8: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 49
Table 3.9: Major Causes of End-Stage Renal Disease 49
Table 3.10: Clinical Recommendations for Adults with Diabetes 51
Table 3.11: Laboratory Assessment of Diabetic Vascular Disease 51
Table 3.12: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 52
Table 3.13: Summary of Cardiovascular Diseases (CVDs) 52
Table 3.14: Death Rate from Cardiovascular Diseases by Country, 2008 54
Table 3.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.,
2010 58
Table 3.16: Selected Patent Expirations of Cardiac Care Drugs, 2012-2016 60
Table 3.17: Worldwide Market for Cardiac Care Therapeutics, 2010-2017 61
Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2010-2014 68
Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2013 68
Table 4.3: Leading Therapy Classes for R&D, 2014 69
Table 4.4: Leading Disease Indications for R&D, 2014 70
Table 4.5: Cost of Clinical Trial Protocol Procedure by Endpoint Type, 2012 70
Table 4.6: Global Pharmaceutical Sales by Region and Country, 2012 and 2017, and CAGR 2008-2012 and
2013-2017 71
Table 4.7: World Pharmaceutical Sales Share by Region, 2012 72
Table 4.8: Leading Ten Therapeutic Classes by U.S. Sales, 2009-2013 73
Table 4.9: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2009-2013 73
Table 4.10: Estimated Leading Therapy Classes by Global Sales in the Developed Market, 2017 73
Table 4.11: Estimated Leading Therapy Classes by Global Sales in the Pharmerging Market, 2017 74
Table 4.12: Top Selling Drugs in the U.S., 2013 74
Table 4.13: Top Selling Drugs Worldwide, 2013 75
Table 4.14: Top Ten Global Pharmaceutical Companies by Global Sales, 2013 75
Table 4.15: Worldwide Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2010-2018 76
Table 4.16: U.S. Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2010-2018 76
Table 4.17: Anti-diabetic Therapy Markets, 2013 77
Table 4.18: The Leading Five Anti-Diabetics by Global Sales, 2013 80
Table 4.19: The Leading Five Anti-Diabetics by U.S. Sales, 2013 80
Table 4.20: Top Five Branded Anti-Diabetics by Prescription in the U.S., 2013 80
Table 4.21: American College of Physicians 2012 Practical Guideline for the Use of Anti-Diabetes Drugs for Type 2 Diabetes 82
Table 4.22: Summary of Glucose-Lowering Interventions as Monotherapy 83
Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 89
Table 5.2: Branded Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes in the U.S., 2014 90
Table 5.3: Relative Efficacy of Diabetes Drugs 91
Table 5.4: Fixed-Dose Oral Anti-Diabetes Drug Combinations 106
Table 5.5: Worldwide Anti-Diabetes Non-Insulin Drug Market, 2010-2018 109
Table 5.6: U.S. Anti-Diabetes Non-Insulin Drug Market, 2010-2018 109
Table 5.7: GLP-1 Agonist Pipeline: Selected Drugs in Development 110
Table 5.8: DPP-IV Inhibitor Pipeline: Selected Drugs in Development 113
Table 5.9: SGLT-2 Inhibitor Pipeline: Selected Drugs in Development 115
Table 5.10: Fixed-Dose Combination Drugs with SGLT-2 Inhibitor: Selected Drugs in Development 115
Table 5.11: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 116
Table 6.1: Value Market Shares of Animal, Human and Modern Insulin, 1995-2013 120
Table 6.2: Worldwide Insulin Market, 2010-2018 121
Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2013 121
Table 6.4: U.S. Insulin Market, 2010-2018 121
Table 6.5: Key Drivers of the Type 2 Diabetes Insulin Market, 2013 122
Table 6.6: Worldwide Insulin Sales and Value Market Share by Company, 2013 122
Table 6.7: U.S. Insulin Sales and Value Market Share by Company, 2013 123
Table 6.8: Insulins on the U.S. Market 126
Table 6.9: Pharmacokinetics of Therapeutic Insulins on the U.S. Market 128
Table 6.10: Comparison of Recommendations from Existing Guidelines 130
Table 6.11: Pharmacokinetics of Short-Acting Insulins 130
Table 6.12: Pharmacokinetics of Rapid-Acting Insulins 131
Table 6.13: Pharmacokinetics of Intermediate-Acting Insulins 133
Table 6.14: Pharmacokinetics of Long-Acting Insulins 133
Table 6.15: Pharmacokinetics of Insulin Mixtures 134
Table 6.16: A Comparison of Existing Insulin Delivery Devices 148
Table 6.17: Insulin Pens 150
Table 6.18: Estimated Worldwide Demand for Insulin Pens by Volume, 2013-2018 152
Table 6.19: Injection Aids 153
Table 6.20: Jet Injectors 155
Table 6.21: Control Averages by Treatment 156
Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 157
Table 6.23: Leading Insulin Pump Manufacturers 157
Table 6.24: Comparison of Current External Insulin Pumps on the Market 158
Table 6.25: Insulin Infusion Sets 163
Table 6.26: Worldwide Insulin Pump Market, 2013-2018 167
Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 172
Table 7.2: Cells of the Pancreas 175
Table 7.3: Statin Recommendations for Designated Treatment Groups 183
Table 7.4: Statins Currently Available in the U.S. 184
Table 7.5: Statin Intensity Chart 184
Table 7.6: Summary of Non-Statin Cholesterol Lowering Drugs 185
Table 7.7: Suggested Pharmacological Treatment Agents for Hypertension 186
Table 8.1: Criteria for the Diagnosis of Diabetes 190
Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 190
Table 8.3: Normal Glucose Values—Fasting State 190
Table 8.4: Criteria for Testing for Diabetes in Asymptomatic Adults 191
Table 8.5: Criteria for Type 2 Diabetes in Asymptomatic Children 191
Table 8.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 192
Table 8.7: Laboratory Assessment of Diabetic Vascular Disease 196
Table 8.8: Worldwide Glucose Self-Testing Market Sales (includes Meters, Strips and Lancets),
2012-2018 197
Table 8.9: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips and Lancets), 2012-2018 197
Table 8.10: Market Share of U.S. Blood Glucose Self-Testing, 2013 198
Table 8.11: Lancet Characteristics 215
Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2013 222
Table A1.1: Select Archived Press Release Excerpts 266

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