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Diabetes, Metabolic Syndrome and Cardiovascular Disease

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Publication Date:
June 2015; Pages: 270
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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 10
1.1 Statement of Report 10
1.2 About this Report 10
1.3 Scope of the Report 11
1.4 Methodology 11
1.5 Executive Summary 13

2. Introduction 17
2.1 Demographics of Diabetes 18
2.1.1 Worldwide Diabetes 18
2.1.2 U.S. Diabetes 21
2.2 Economics of Diabetes 26
2.2.1 Worldwide Costs of Diabetes 26
2.2.2 Costs of Diabetes in the U.S. 27

3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 32
3.1 Pre-Diabetes Syndrome 33
3.2 Metabolic Syndrome 33
3.2.1 Prevalence of Metabolic Syndrome 36
3.2.2 Management of Metabolic Syndrome 37
3.2.3 The Outlook for Metabolic Syndrome 37
3.2.4 The Debate Regarding Metabolic Syndrome 37
3.3 Diabetes and Inflammation 39
3.4 Diagnosis of Diabetes Mellitus 40
3.5 Progression of Diabetes 40
3.6 Risk Factors and Diabetes 40
3.6.1 Obesity 41
3.6.2 Stress-Induced Hyperglycemia 44
3.7 Complications and Co-Morbidities in Type 2 Diabetes 45
3.7.1 Preventing Complications and Co-Morbidities in Diabetes 50
3.7.2 Hypoglycemia Resulting from Treatment 51
3.8 Cardiovascular Disease (CVD) 51
3.8.1 CVD Facts 51
3.8.2 Cardiac Care Therapeutics 58
3.8.2.1 Anti-Hypertensive Drugs 60
3.8.2.2 Cholesterol Management Drugs 61
3.8.2.3 Anticoagulants 65
3.8.3 CVD Diagnostics 65

4. Pharmaceutical Industry and the Anti-Diabetes Market 67
4.1 The Worldwide Pharmaceutical Industry 67
4.1.1 Pharmaceutical R&D Spending by Type, Growth Rate and Expenditure 67
4.1.2 Global Pharmaceutical Market 69
4.2 Total Diabetes Drug Market Size and Growth 75
4.2.1 Sales Forecast for the Global Anti-diabetes Drug Market 80
4.3 Diabetic Medications Overview 81
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 Fixed Dose Combination Therapies on the Market 106
5.1.10.1 Antidiabetic Drug Options for Youth with Recent-Onset Type 2 Diabetes Scarce 108
5.1.11 Comparisons of the Anti-Diabetes Drugs 108
5.2 Market Drivers and Trends 108
5.2.1 Market Share and Forecast of Non-Insulin Anti-Diabetic Drugs 108
5.2.2 Latest Additions to the U.S. Non-Insulin Diabetes Drug Market 111
5.3 Non-Insulin Anti-Diabetes Products in the Pipeline 111
5.3.1 Novel GLP-1 Agonists and Analogs 111
5.3.2 Novel DPP-IV Inhibitors 114
5.3.3 Sodium Glucose Cotransporter 2 (SGLT-2) Inhibitors 116
5.3.4 Emerging Anti-Diabetes Targets and Drugs in the Pipeline 117
5.3.4.1 Novel Approaches to Finding New Drug Targets 121

6. Insulin 122
6.1 Insulin Markets 122
6.1.1 Major Players and Market Share 124
6.1.2 Patent Expirations 126
6.1.3 Pathway for Insulin Biosimilars 126
6.1.3.1 Regulatory Avenues for Biosimilar Approval 126
6.1.3.2 Lantus Biosimilars 127
6.1.3.2.1 Abasaglar (formerly Abasria) and Basaglar 127
6.1.3.2.2 Other Biosimilars 127
6.1.3.3 Key Issues for Insulin Biosimilars 127
6.1.4 Innovation Strategies 128
6.2 Insulin Therapeutics 128
6.2.1 Recommendations for Insulin Initiation and Administration 130
6.2.2 Short-Acting Insulin 132
6.2.3 Rapid-Acting Insulin 133
6.2.3.1 Ultra Fast-Acting Insulins in Development 134
6.2.4 Intermediate-Acting Insulin 135
6.2.5 Long-Acting Insulin 136
6.2.6 Insulin Mixtures 137
6.3 Pipeline Insulins in Development 138
6.3.1 Tresiba (Novo Nordisk) 138
6.3.2 Ryzodeg (Novo Nordisk) 138
6.3.3 BIOD-531 (Biodel) 138
6.3.4 Xultophy (Novo Nordisk) 138
6.3.5 LixiLan (Sanofi) 139
6.3.6 rHUPH20 and Insulin (Halozyme) 139
6.3.7 FIAsp (Novo Nordisk) 139
6.3.8 BIOD-238, BIOD-250, and BIOD-351 (Biodel) 139
6.3.9 InsuPatch and InsuPad (Insuline Medical) 139
6.3.10 Smart Insulins 140
6.4 Non-Invasive Insulin Delivery 141
6.4.1 Inhaled Insulin 142
6.4.1.1 Afrezza 142
6.4.1.2 Dance Pharmaceuticals and Aerogen (Dance-501) 143
6.4.1.3 A Chronicle of Inhaled Insulins 144
6.4.2 Oral Insulin 145
6.4.3 Transdermal Insulin 148
6.5 Barriers for Non-Injected Insulin 150
6.6 Patient Potential for Non-Injected Insulin 150
6.7 Insulin Delivery Devices 150
6.7.1 Insulin Pens 152
6.7.2 Injections Aids 155
6.7.2.1 Automatic Injectors 156
6.7.2.2 Syringe Magnifiers 157
6.7.2.3 Injection Ports 157
6.7.3 Insulin Jet Injectors 158
6.7.4 Insulin Pumps 158
6.7.4.1 External Insulin Pumps 159
6.7.4.2 Animas OneTouch Ping 162
6.7.4.3 Animas Vibe 162
6.7.4.4 Accu-Chek® Combo Insulin Pump System (Roche) 163
6.7.4.5 MiniMed Paradigm Real-Time Revel (Medtronic) 163
6.7.4.6 MiniMed 530G with Enlite (Medtronic) 164
6.7.4.7 Insulet Omnipod 164
6.7.4.8 DANA IIS (Sooil) 165
6.7.4.9 t:flex (Tandem Diabetes Care) 165
6.7.4.10 t:slim (Tandem Diabetes Care) 165
6.7.4.11 Snap (Asante) 165
6.7.5 Insulin Infusion Sets 166
6.7.6 Insulin Patch Pumps in Development or Only Available Outside the U.S. 167
6.7.7 Implantable Insulin Pumps 169
6.7.8 Insulin Pump Market Share 170
6.7.9 Drivers of Demand for Pumps 171
6.8 Market Forecasts for Insulin Administration Technologies 171

7. Emerging Anti-Diabetes Technologies and Products 172
7.1 Projections for the Anti-Diabetes Drug Market 172
7.2 Artificial Pancreas 176
7.2.1 MiniMed 530G System 177
7.2.2 Animas® Vibe™ System 177
7.2.3 Next generation Medtronic Artificial Pancreas Systems (MiniMed 640G) 177
7.2.4 FDA’s Artificial Pancreas Guidance Document 178
7.3 Insulin-Producing Cells 178
7.3.1 Gene Therapy 179
7.3.2 Cell Therapy Companies for Diabetes 180
7.3.2.1 ViaCyte (formerly Novocell, Inc.) 180
7.3.2.2 Sernova 180
7.4 Pancreatic Transplantation 181
7.4.1 Candidates for Pancreatic Transplantation 181
7.4.1.1 Pancreatic Organ Transplantation 182
7.4.1.2 Allo-Islet Transplantation 182
7.4.1.3 Implantation of Genetically Engineered -Cells or Embryonic Stem Cells 183
7.4.2 ADA Position on Pancreatic Transplantation 183
7.5 Immune Modulators 184
7.6 Gastric Bypass Surgery to Treat Type 2 Diabetes 184
7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 185
7.7.1 Xenical (Roche) 185
7.7.2 Qsymia (Vivus) 185
7.7.3 Belviq (Arena Pharmaceuticals) 185
7.7.4 Contrave (Orexigen Therapeutics) 185
7.7.5 Anti-Obesity Drugs in Development 186
7.8 Other Anti-Diabetic Therapy Drug Candidates 186
7.8.1 Lipid Abnormalities 186
7.8.1.1 New Cholesterol Guidelines 186
7.8.2 High Blood Pressure 189
7.8.3 Aspirin Therapy 191
7.8.4 Pre-Mixed Glucagon for Self-Treating Hypoglycemia 191
7.9 Drugs Used “Off-Label” 191
7.9.1 Warfarin Sodium 191
7.10 Insulin and Anti-diabetes Drug Combinations 191
7.10.1 Xultophy (Novo Nordisk) 191
7.10.2 LixiLan (Sanofi) 192

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 193
8.1 Diagnostic Guidelines 193
8.2 Diagnosis of Diabetes 193
8.2.1 Fasting Plasma Glucose (FPG) Test 196
8.2.2 Glucose Tolerance Test 197
8.2.3 Test for Glycosylated Hemoglobin (HbA1c or A1c) 197
8.2.4 Fructosamine 198
8.2.5 Screening Tests for Diabetes-Related Complications 199
8.3 Glucose Monitoring 200
8.3.1 Overview of Market Segment 202
8.3.2 Competitive Strategies 202
8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 204
8.3.3.1 First-Generation Monitors 205
8.3.3.2 Second-Generation Monitors 205
8.3.3.3 Third-Generation SMBG Technologies 206
8.3.3.4 Product Overview 206
8.3.3.4.1 LifeScan 206
8.3.3.4.2 Roche Diagnostics 209
8.3.3.4.3 Bayer HealthCare 210
8.3.3.4.4 Abbott Diabetes Care 212
8.3.3.4.5 Other Players 214
8.3.4 What are the Advantages of Using a Continuous Glucose-Monitoring Device? 215
8.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 216
8.3.6 Future of Non-Invasive Glucose Technology 216
8.3.7 Lancets and Lancing Devices 216

9. Market Trends, Challenges and Strategic Options 220
9.1 Overview 220
9.2 Diabetes Drug Market Trends 220
9.2.1 Overview 220
9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 220
9.2.2.1 Barriers to the Initiation of Insulin Therapy in Type 2 Diabetics 222
9.2.3 Increasing Prevalence of Obesity 222
9.2.4 Consumer Preference Drives Product Development in Invasive Technology Segment 223
9.3 Diabetes Mellitus Market Challenges 223
9.3.1 Overview 223
9.3.2 Patent Expirations 224
9.3.3 Market Prospects of Inhalable Insulin 224
9.4 Strategic Options 225
9.4.1 Developing Countries are Key Markets for Growth 226
9.4.2 Consumer-Driven Marketing Campaigns 227
9.4.3 Strategies for Successful New Product Launches 227
9.4.4 Collaborations and Strategic Alliances 228
9.5 FDA Guidelines for Developing Anti-Diabetic Drugs 229
9.6 Recent Industry Activity 229

10. Company Profiles 232
10.1 A. Menarini 232
10.2 Abbott Laboratories 232
10.3 Abbvie 236
10.4 Amgen 236
10.5 Amylin Pharmaceuticals (bought by Bristol-Myers Squibb) 237
10.6 Animas (part of Johnson & Johnson) 237
10.7 Asante 237
10.8 Astellas Pharma, Inc. 237
10.9 AstraZeneca PLC 238
10.10 Bayer 239
10.11 Becton, Dickinson and Company 241
10.12 Biocon 242
10.13 Biodel 243
10.14 BodyMedia 243
10.15 Boehringer Ingelheim 243
10.16 Bristol Myers Squibb 244
10.17 Cellnovo 244
10.18 CeQur 244
10.19 ConjuChem 244
10.20 Daiichi Sankyo 245
10.21 Dance Biopharm 245
10.22 Debiotech 245
10.23 DexCom 245
10.24 Echo Therapeutics, Inc. 247
10.25 Eli Lilly 248
10.26 FIFTY50 Medical, Inc. 249
10.27 Flamel Technologies 249
10.28 Generex Biotechnology Corporation 249
10.29 GlaxoSmithKline PLC 250
10.30 Halozyme Therapeutics 250
10.31 Insulet 250
10.32 Insuline Medical Ltd. 251
10.33 Intarcia Therapeutics, Inc. 251
10.34 Janssen Research & Development 251
10.35 Johnson & Johnson 252
10.36 Kowa Pharmaceuticals 253
10.37 Lexicon Pharmaceuticals 253
10.38 MannKind Corporation 254
10.39 Medipacs 254
10.40 Medtronic 254
10.41 Merck & Company, Inc. 255
10.42 Mitsubishi Tanabe Pharma Corporation 256
10.43 Novartis 256
10.44 Novo Nordisk 256
10.45 Oramed Pharmaceuticals 257
10.46 Orexigen Therapeutics, Inc. 257
10.47 Owen Mumford 258
10.48 PhaseBio Pharmaceuticals 258
10.49 Pfizer 258
10.50 Prometheon Pharma 259
10.51 Roche Diagnostics 259
10.52 Sanofi 261
10.53 Sernova 262
10.54 Smiths Medical 262
10.55 SOOIL Development 263
10.56 Taisho Pharmaceuticals 263
10.57 Takeda 263
10.58 Tandem Diabetes Care, Inc. 263
10.59 Theracos, Inc. 264
10.60 Transdermal Specialties, Inc. 264
10.61 Valeritas 264
10.62 ViaCyte, Inc. (formerly Novocell) 264
10.63 Vivus, Inc. 265
10.64 vTv Therapeutics (formerly TransTech Pharma) 265
10.65 Ypsomed Holding 265
10.66 Zealand Pharma 265

Appendix 1: The History of Insulin 267


INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 18
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 19
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years,
1980-2012 22
Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2012 23
Figure 2.5: Diagnosed and Undiagnosed Diabetes by Age in the U.S., 2013 23
Figure 2.6: Number of Deaths from Diabetes by Age in the U.S., 2010 25
Figure 2.7: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 26
Figure 2.8: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (USD),
2013 27
Figure 2.9: How Diabetes Dollars are Spent in the U.S., 2012 29
Figure 3.1: Maintenance of Normal Blood Sugar Levels 32
Figure 3.2: Prevalence of Self-Reported Obesity (BMI 30) Among U.S. Adults, 2012 42
Figure 3.3: Prevalence of Obesity Among Adults in the U.S., 2009-2010 43
Figure 3.4: Percentage of Obese Children and Adolescents in the U.S., 2009-2010 43
Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 44
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 45
Figure 3.7: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age in the U.S., 1997-2011 49
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 49
Figure 3.9: Annual Death Rate of U.S. Population from Heart Disease, 1950-2009 53
Figure 3.10: Annual Death Rate of U.S. Population from Strokes, 1950-2009 54
Figure 3.11: Percentage Breakdown of Deaths Attributable to Cardiovascular Disease in the U.S., 2010 54
Figure 3.12: Death Rates from Cardiovascular Disease by State, 2010 55
Figure 3.13: Percentage of Obese Adults in the U.S., 1960-2010 56
Figure 3.14: Percentage of Obese Children and Adolescents in the U.S., 1971-2010 57
Figure 3.15: Number of Annual Prescriptions for Popular Cholesterol Drugs, 2007-2012 62
Figure 4.1: Sales Forecast for the Global Diabetes Drug Market, 2012-2019 81
Figure 4.2: Sales Forecast for the U.S. Diabetes Drug Market, 2012-2019 81
Figure 4.3: Percentage of U.S. Diabetics Taking Medications, 2010-2012 82
Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2014 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, 2014 109
Figure 5.5: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class, 2014 109
Figure 6.1: Global Sales of Lantus, 2005-2014 125
Figure 6.2: Insulin Pump Market Share, 2014 170


INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 19
Table 2.2: Top Ten Countries with the Largest Estimated Number of Diabetics (20 to 79 Years Age Group),
2013 and 2035 20
Table 2.3: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 20
Table 2.4: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013 21
Table 2.5: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 23
Table 2.6: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 24
Table 2.7: Cost of Diagnosed Diabetes in the U.S., 2012 28
Table 2.8: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 29
Table 2.9: Healthcare Utilization by Diabetic Patients, 2012 30
Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for Metabolic Syndrome 34
Table 3.2: Ethnic Specific Values for Waist Circumference in IDF’s Metabolic Syndrome Criteria 34
Table 3.3: American Heart Association and National Heart, Lung, and Blood Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome 34
Table 3.4: Additional Metabolic Criteria for Research 36
Table 3.5: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 45
Table 3.6: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 47
Table 3.7: Prevalence of Complications Among Patients with Diabetes 48
Table 3.8: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 48
Table 3.9: Major Causes of End-Stage Renal Disease 48
Table 3.10: Clinical Recommendations for Adults with Diabetes 50
Table 3.11: Laboratory Assessment of Diabetic Vascular Disease 50
Table 3.12: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 51
Table 3.13: Summary of Cardiovascular Diseases (CVDs) 51
Table 3.14: Death Rate from Cardiovascular Diseases by Country, 2008 53
Table 3.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.,
2010 57
Table 3.16: Selected Patent Expirations of Cardiac Care Drugs, 2012-2016 59
Table 3.17: Worldwide Market for Cardiac Care Therapeutics, 2010-2017 60
Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2010-2014 67
Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2014 67
Table 4.3: Leading Therapy Classes for R&D, 2014 68
Table 4.4: Leading Disease Indications for R&D, 2014 69
Table 4.5: Cost of Clinical Trial Protocol Procedure by Endpoint Type, 2012 69
Table 4.6: Global Pharmaceutical Sales by Region and Country, 2012 and 2017, and CAGR 2008-2012 and
2013-2017 70
Table 4.7: World Pharmaceutical Sales Share by Region, 2013 71
Table 4.8: Leading Ten Therapeutic Classes by Global Sales, 2010-2014 72
Table 4.9: Estimated Leading Therapy Classes by Global Sales in the Developed Market, 2018 72
Table 4.10: Estimated Leading Therapy Classes by Global Sales in the Pharmerging Market, 2018 73
Table 4.11: Leading Ten Therapeutic Classes by U.S. Sales, 2009-2013 73
Table 4.12: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2009-2013 73
Table 4.13: Top Selling Drugs Worldwide by Sales, 2014 74
Table 4.14: Top Selling Drugs in the U.S. by Sales, 2014 74
Table 4.15: Top Ten Global Pharmaceutical Companies by Global Sales, 2014 75
Table 4.16: Worldwide Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2012-2019 76
Table 4.17: U.S. Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2012-2019 76
Table 4.18: Anti-Diabetic Therapy Markets, 2014 76
Table 4.19: Top Ten Branded Anti-Diabetics by Sales Worldwide, 2014 79
Table 4.20: Top Ten Branded Anti-Diabetics by Monthly Prescriptions Worldwide, 2014 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 Non-Insulin Anti-Diabetes Drug Market, 2012-2019 110
Table 5.6: U.S. Non-Insulin Anti-Diabetes Drug Market, 2012-2019 110
Table 5.7: Diabetes Drugs Approved for U.S. Market, 2014 and 2015 111
Table 5.8: GLP-1 Agonist Pipeline: Selected Drugs in Development 112
Table 5.9: DPP-IV Inhibitor Pipeline: Selected Drugs in Development 115
Table 5.10: SGLT-2 Inhibitor Pipeline: Selected Drugs in Development 116
Table 5.11: Fixed-Dose Combination Drugs with SGLT-2 Inhibitor: Selected Drugs in Development 116
Table 5.12: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 118
Table 6.1: Value Market Shares of Animal, Human and Modern Insulin, 1995-2014 122
Table 6.2: Worldwide Insulin Market, 2012-2019 123
Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2014 123
Table 6.4: U.S. Insulin Market, 2012-2019 123
Table 6.5: Key Drivers of the Type 2 Diabetes Insulin Market, 2014 124
Table 6.6: Worldwide Insulin Sales and Value Market Share by Company, 2014 124
Table 6.7: U.S. Insulin Sales and Value Market Share by Company, 2014 125
Table 6.8: Insulins on the U.S. Market 128
Table 6.9: Pharmacokinetics of Therapeutic Insulins on the U.S. Market 129
Table 6.10: Comparison of Recommendations from Existing Guidelines 132
Table 6.11: Pharmacokinetics of Short-Acting Insulins 132
Table 6.12: Pharmacokinetics of Rapid-Acting Insulins 133
Table 6.13: Pharmacokinetics of Intermediate-Acting Insulins 135
Table 6.14: Pharmacokinetics of Long-Acting Insulins 136
Table 6.15: Pharmacokinetics of Insulin Mixtures 137
Table 6.16: A Comparison of Existing Insulin Delivery Devices 151
Table 6.17: Insulin Pens 152
Table 6.18: Estimated Worldwide Demand for Insulin Pens by Volume, 2013-2018 155
Table 6.19: Injection Aids 156
Table 6.20: Jet Injectors 158
Table 6.21: Control Averages by Treatment 159
Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 159
Table 6.23: Leading Insulin Pump Manufacturers 160
Table 6.24: Comparison of Current External Insulin Pumps on the Market 160
Table 6.25: Insulin Infusion Sets 166
Table 6.26: Worldwide Insulin Pump Market, 2013-2019 170
Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 173
Table 7.2: Cells of the Pancreas 179
Table 7.3: Statin Recommendations for Designated Treatment Groups 187
Table 7.4: Statins Currently Available in the U.S. 187
Table 7.5: Statin Intensity Chart 188
Table 7.6: Summary of Non-Statin Cholesterol Lowering Drugs 188
Table 7.7: Suggested Pharmacological Treatment Agents for Hypertension 190
Table 8.1: Criteria for the Diagnosis of Diabetes 194
Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 194
Table 8.3: Normal Glucose Values—Fasting State 194
Table 8.4: Criteria for Testing for Diabetes in Asymptomatic Adults 195
Table 8.5: Criteria for Type 2 Diabetes in Asymptomatic Children 195
Table 8.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 196
Table 8.7: Laboratory Assessment of Diabetic Vascular Disease 200
Table 8.8: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and Lancets), 2012-2018 201
Table 8.9: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips and Lancets), 2012-2018 201
Table 8.10: Market Share of U.S. Blood Glucose Self-Testing, 2013 202
Table 8.11: Lancet Characteristics 219
Table 9.1: BRIC Countries, Percentage of GDP Spent on Healthcare, 2013 226
Table A1.1: Select Archived Press Release Excerpts 270

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