Diabetes, Metabolic Syndrome and Cardiovascular Disease

  • November 2014
  • -
  • TriMark Publications
  • -
  • 266 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 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 RandD 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 ?-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 and 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 and Development 247
10.35 Johnson and 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 and 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

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