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Diabetes, Metabolic Syndrome and Cardiovascular Disease
Publication Date: 01-APR-09
Pages: 265
Study: TMRDIA
Format/Price: PDF document / $3,400.00
   


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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. 1. Overview 8
  2. 1.1 Statement of Report 8
  3. 1.2 About this Report 8
  4. 1.3 Scope of the Report 9
  5. 1.4 Methodology 9
  6. 1.5 Executive Summary 11
  7. 2. Introduction 17
  8. 2.1 Demographics of Diabetes 17
  9. 2.1.1 Worldwide Diabetes 17
  10. 2.1.2 U.S. Diabetes 18
  11. 2.2 Economics of Diabetes 22
  12. 3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 28
  13. 3.1 Pre-Diabetes Syndrome 29
  14. 3.2 Metabolic Syndrome 29
  15. 3.3 Diabetes and Inflammation 32
  16. 3.4 Progression of Diabetes 32
  17. 3.5 Complications and Co-Morbidities in Type 2 Diabetes 33
  18. 3.6 Hypoglycemia and Treatment 38
  19. 3.7 Risk Factors and Diabetes 39
  20. 3.8 Cardiovascular Disease (CVD) Facts 40
  21. 4. Pharmaceutical Industry and the Anti-Diabetes Market 51
  22. 4.1 The Worldwide Pharmaceutical Industry 51
  23. 4.2 Total Diabetes Drug Market Size and Growth 58
  24. 4.2.1 Sales of Anti-Diabetic Drugs Continue to Rise 61
  25. 4.3 Epidemiology/Cost of Treatment 62
  26. 4.4 Diabetic Medications Overview 63
  27. 4.4.1 Recent Trends in Diabetic Drug Usage 63
  28. 4.4.2 Market Influence Factors 67
  29. 5. Non-Insulin Anti-Diabetes Products 69
  30. 5.1 Anti-Diabetic Drug Therapy Overview 69
  31. 5.1.1 Sulfonylureas 72
  32. 5.1.2 Meglitinides 73
  33. 5.1.3 Biguanides 73
  34. 5.1.4 Thiazolidinediones (TZDs) 74
  35. 5.1.5 £\-Glucosidase Inhibitors 77
  36. 5.1.6 Incretin Mimetics/Glucagon-like Peptide (GLP-1) Analog 77
  37. 5.1.7 Amylin Analog 79
  38. 5.1.8 DPP-IV Inhibitors 79
  39. 5.1.9 Other Classes 81
  40. 5.1.10 Combination Therapy 81
  41. 5.2 Drivers and Trends 82
  42. 5.2.1 Market Share of Anti-Diabetic Drugs 82
  43. 5.2.2 Forecasts for Anti-Diabetic Drugs 82
  44. 5.2.3 Sales Forecast for the Global Diabetes Market 83
  45. 5.3 The Future 84
  46. 5.3.1 Practice Patterns 84
  47. 5.3.2 New Products in Pipeline 85
  48. 5.4 Anti-Diabetic Drug Patent Expiry 91
  49. 5.5 Regulatory Issues 91
  50. 6. Insulin 92
  51. 6.1 Insulin Markets 92
  52. 6.1.1 Major Players and Market Share 93
  53. 6.2 Insulin and Analogs 95
  54. 6.2.1 Rapid-Acting Insulin 95
  55. 6.2.2 Intermediate-Acting Insulin 97
  56. 6.2.3 Long-Acting Insulin/Ultra Long-Acting Insulin 97
  57. 6.2.4 Insulin Mixtures 99
  58. 6.3 Insulin Analogs 100
  59. 6.4 Non-Insulins in Development 100
  60. 6.5 Pipeline Insulin 101
  61. 6.6 Non-Invasive Insulin Delivery 101
  62. 6.6.1 Inhaled Insulin 101
  63. 6.6.1.1 Inhaled Insulin Overview 102
  64. 6.6.2 Oral Insulin 104
  65. 6.6.3 Transdermal Insulin 106
  66. 6.6.4 Oral Spray Insulin 108
  67. 6.7 Barriers for Non-Injected Insulin 109
  68. 6.8 Patient Potential for Non-Injected Insulin 109
  69. 6.9 Insulin Delivery Devices 109
  70. 6.9.1 Lancets and Lancing Devices 110
  71. 6.9.2 Insulin Pens 113
  72. 6.9.3 Injections Aids 117
  73. 6.9.3.1 Automatic Injectors 117
  74. 6.9.3.2 Syringe Magnifiers 118
  75. 6.9.3.3 Insulin Infusers 118
  76. 6.9.4 Insulin Jet Injectors 118
  77. 6.9.5 Insulin Pumps 119
  78. 6.9.5.1 External Insulin Pumps 119
  79. 6.9.5.2 Implantable Insulin Pumps 122
  80. 6.9.5.3 Insulin Pump Market Share 123
  81. 6.9.5.4 Drivers of Demand for Pumps 128
  82. 6.10 Market Forecasts for Insulin Administration Technologies 129
  83. 7. Emerging Anti-Diabetes Products 130
  84. 7.1 Projections for the Anti-Diabetes Drug Market 130
  85. 7.2 Artificial Pancreas 134
  86. 7.3 Insulin-Producing Cells 135
  87. 7.3.1 Cell Therapy Companies for Diabetes 135
  88. 7.4 Transplantation Procedures 137
  89. 7.4.1 Pancreatic Transplantation 138
  90. 7.4.1.1 Pancreatic Organ Transplantation 138
  91. 7.4.1.2 Allo-Islet Transplantation 138
  92. 7.4.1.3 Transplantation of Encapsulated Pancreatic Cells 139
  93. 7.4.1.4 Implantation of Genetically Engineered-Cells or Embryonic Stem Cells 139
  94. 7.4.2 Current Status 140
  95. 7.5 Gastric Bypass Surgery to Treat Type 2 Diabetes 140
  96. 7.6 Immune Modulators 141
  97. 7.7 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes 141
  98. 7.8 Other Anti-Diabetic Therapy Drug Candidates 141
  99. 7.8.1 Lipid Abnormalities 142
  100. 7.8.2 High Blood Pressure 143
  101. 7.8.3 Anticoagulants 144
  102. 7.9 Drugs Used ¡§Off-Label¡¨ 145
  103. 7.9.1 Niacin Derivatives 145
  104. 7.9.2 Benfluorex 145
  105. 7.9.3 D-Chiro-Inositol 145
  106. 7.9.4 Warfarin Sodium 145
  107. 7.10 Pipeline Diabetic Drug Candidates 146
  108. 7.11 Drug Research Overview 149
  109. 7.12 Future Anti-Diabetic Drugs in Late-Stage Development 151
  110. 8. Diagnosing Diabetes Using In Vitro Laboratory Tests 154
  111. 8.1 New Diagnostic Guidelines 154
  112. 8.2 Diabetes Tests 155
  113. 8.2.1 Fasting Plasma Glucose (FPG) Test 155
  114. 8.2.2 Glucose Tolerance Test 155
  115. 8.2.3 Test for Glycosylated Hemoglobin 156
  116. 8.2.4 Fructosamine 157
  117. 8.3 Glucose Monitoring 157
  118. 8.3.1 Overview of Market Segment 160
  119. 8.3.2 Competitive Strategies 160
  120. 8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 162
  121. 8.3.3.1 First-Generation Monitors 162
  122. 8.3.3.2 Second-Generation Monitors 162
  123. 8.3.3.3 Third-Generation SMBG Technologies 164
  124. 8.3.3.4 Product Overview 165
  125. 8.3.3.4.1 LifeScan 165
  126. 8.3.3.4.2 Roche Diagnostics 168
  127. 8.3.3.4.3 Bayer Diagnostics 169
  128. 8.3.3.4.4 Abbott Diagnostics 172
  129. 8.3.3.4.5 Other Players 174
  130. 8.3.4 What Are the Advantages of Using a Continuous Glucose-Monitoring Device? 177
  131. 8.3.5 Other Monitoring Device Advancements 178
  132. 8.3.6 Future of Non-Invasive Glucose Technology 179
  133. 9. Market Trends, Challenges and Strategic Options 182
  134. 9.1 Overview 182
  135. 9.2 Diabetes Drug Market Trends 182
  136. 9.2.1 Overview 182
  137. 9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 182
  138. 9.2.3 Increasing Prevalence of Obesity 183
  139. 9.3 Diabetes Mellitus Market Challenges 185
  140. 9.3.1 Overview 185
  141. 9.3.2 Diabetic Pain Therapeutics 185
  142. 9.3.3 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels 186
  143. 9.3.4 Changing Consumer Preference Drives Product Development in Invasive Technology Segment 186
  144. 9.3.5 Non-Invasive Technology for Revenue Potential 186
  145. 9.3.6 Developing Countries Emerging as Key Markets for Diabetes Monitoring Devices 187
  146. 9.3.7 Consumer-Driven Marketing Campaigns¡XEssential, though Expensive 189
  147. 9.3.8 Escalating Expenditure for R&D and Marketing Triggers Consolidation 189
  148. 9.3.9 Market Size Predictions 191
  149. 9.3.10 Major Competitors 191
  150. 9.4 Strategic Options 192
  151. 9.4.1 Overview 192
  152. 9.4.2 Combined Self-Testing Glucose Monitor with Insulin Delivery 193
  153. 9.4.3 Diabetes Drugs in Pipeline 194
  154. 9.5 FDA Therapeutic Targets 196
  155. 9.5.1 FDA Targets Cardiotoxicity 197
  156. 9.5.2 Avandia FDA Warning 197
  157. 9.6 Outlook to Anti-Diabetes Drugs 197
  158. 9.7 Outlook for Cardiovascular Drugs 201
  159. 10. Company Profiles 203
  160. 10.1 A. Menarini 203
  161. 10.2 Abbott Laboratories 203
  162. 10.3 Amgen 204
  163. 10.4 AstraZeneca 205
  164. 10.5 Bayer 206
  165. 10.6 BodyMedia 208
  166. 10.7 Cybermedical 208
  167. 10.8 Debiotech 208
  168. 10.9 DexCom 209
  169. 10.10 Echo Therapeutics 210
  170. 10.11 Elixir Pharmaceuticals 211
  171. 10.12 Eksigent 211
  172. 10.13 Flamel Technologies 211
  173. 10.14 GlaxoSmithKline 212
  174. 10.15 GlucoLight 212
  175. 10.16 Insulet 212
  176. 10.17 iSense Corporation 213
  177. 10.18 Isis Pharmaceuticals, Inc. 213
  178. 10.19 Johnson & Johnson 214
  179. 10.20 KYORIN 215
  180. 10.21 M-Biotech 215
  181. 10.22 Medtronic 215
  182. 10.23 Merck & Co. 217
  183. 10.24 Merck KGaA 218
  184. 10.25 MicroIslet 218
  185. 10.26 Mitsubishi Tanabe Pharma Corporation 219
  186. 10.27 Nipro Diabetes Systems 219
  187. 10.28 Novartis 219
  188. 10.29 Novo Nordisk 220
  189. 10.30 Novocell 221
  190. 10.31 ONO Pharmaceutical 221
  191. 10.32 Orexigen Therapeutics 222
  192. 10.33 Pfizer 223
  193. 10.34 ReNeuron 223
  194. 10.35 Roche Diagnostics 224
  195. 10.36 Sanofi-Aventis 225
  196. 10.37 Sensors for Medicine and Science 226
  197. 10.38 Siemens 227
  198. 10.39 Smiths Medical 227
  199. 10.40 Servier 228
  200. 10.41 SOOIL Development 228
  201. 10.42 Takeda 228
  202. 10.43 TheraFuse 229
  203. 10.44 Teco Diagnostics 229
  204. 10.45 Transition Therapeutics 229
  205. 10.46 U.S. Diagnostics 229
  206. 10.47 VeraLight 230
  207. 10.48 Vivus 230
  208. 10.49 Ypsomed Holding 231
  209. Appendix 1: Contact Information for Companies Profiled 232
  210. Appendix 2: Prescribing Patterns for Anti-Hyperglycemic Drugs 238
  211. Appendix 3: Detailed List of Insulins Available 239
  212. Appendix 4: The History of Insulin 240
  213. Appendix 5: Diabetes and Obesity Drugs in Development 245
  214. Appendix 6: Pharmaceutical Sampling Practices 253
  215. INDEX OF FIGURES
  216. Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2025 17
  217. Figure 2.2: Prevalence of Diabetes by Age in the U.S, 2007 18
  218. Figure 2.3: New Adult Cases of Diabetes Diagnosed in the U.S., 2007 19
  219. Figure 2.4: Distribution of Duration of Diabetes among Adults Aged 18 to 79 Years in the U.S., 2005 20
  220. Figure 2.5: Number of Persons with Diagnosed Diabetes in the U.S., 1980-2007 20
  221. Figure 2.6: Treatment with Insulin or Oral Medication among Adults Diagnosed with Diabetes, 2007 21
  222. Figure 2.7: Rate of New Diabetes Cases among Children in the U.S., 2007 22
  223. Figure 2.8: Expenditure Associated with Diabetes Complications in the U.S., 2007 25
  224. Figure 2.9: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 27
  225. Figure 3.1: Prevalence of Complications in Diabetics vs. People with Normal Blood Sugar Levels, 2007 34
  226. Figure 3.2: Per Capita Costs for Diabetes-related Complications per Year, 2007 35
  227. Figure 3.3: Total Spending on Healthcare in the U.S., 1960-2008 36
  228. Figure 3.4: Percentage Breakdown of U.S. Healthcare Spending, 2008 36
  229. Figure 3.5: Percentage of U.S. Population that Smokes, 1965-2005 42
  230. Figure 3.6: Heart Disease Death Rate by Race and Sex in the U.S., 1979-2006 42
  231. Figure 3.7: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007 43
  232. Figure 3.8: Annual Death Rate of U.S. Population from Strokes, 1950-2008 43
  233. Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 2008 45
  234. Figure 3.10: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008 48
  235. Figure 3.11: Percentage of U.S. Population that is Overweight, 1976-2004 50
  236. Figure 4.1: Medical Research in the U.S. Outpaces the Rest of the World 52
  237. Figure 4.2: Cost of Diabetes in the U.S., 2007 62
  238. Figure 4.3: Top Therapeutic Classes Contributing to Drug Trend, 2007 65
  239. Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2006 65
  240. Figure 5.1: Comparison of the Effects of the Pioglitazone and Rosiglitazone on Lipids 76
  241. Figure 5.2: U.S. Non-Insulin Anti-Diabetes Sales, 2006 83
  242. Figure 5.3: Sales Forecast for the Global Diabetes Market, 1992-2012 84
  243. Figure 6.1: Insulin Pump Market Share, 2007 123
  244. Figure 6.2: Relative Risk of Diabetes Complications by Mean HbA1c 123
  245. Figure 9.1: Relationship between Diabetes Therapy and the Proposed Timeline 195
  246. Figure A3.1: Novo Nordisk¡¦s Rising Market Share in the U.S. Insulin Market, 1982-2008 244
  247. INDEX OF TABLES
  248. Table 1.1: Criteria for the Diagnosis of Diabetes 11
  249. Table 2.1: Top Ten Countries in Number of Diabetics (20 to 79 Age Group) in the World, 2007 and 2025 17
  250. Table 2.2: Annual Estimated Cost of Diabetes Care in the U.S., 2007 23
  251. Table 2.3: Impact of Diabetes on Americans 24
  252. Table 2.4: How Diabetes Dollars are Spent in the U.S., 2007 24
  253. Table 3.1: Percentage of GDP Healthcare Spending by Country, 2008 37
  254. Table 3.2: Life Expectancy Rate by Country, 2008 37
  255. Table 3.3: Normal Glucose Values¡XFasting State 39
  256. Table 3.4: Percentage of Adults Smokers by Country, 2008 44
  257. Table 3.5: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 45
  258. Table 3.6: Death Rate from Cardiovascular Diseases by Country, 2008 49
  259. Table 4.1: Leading Therapy Classes for R&D, 2008 51
  260. Table 4.2: Pharmaceutical R&D Expenditures by World Region, 1990-2007 52
  261. Table 4.3: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2007 53
  262. Table 4.4: Global Pharmaceutical Sales, 2007 53
  263. Table 4.5: World Pharmaceutical Sales Share by Region, 2007 54
  264. Table 4.6: The World¡¦s Top-Selling Drugs (Audited Market), 2007 55
  265. Table 4.7: Pharmaceutical Product Sales by Country Market, 2007 55
  266. Table 4.8: Top Ten Global Pharmaceutical Companies by Global Sales, 2007 56
  267. Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales (Audited Market), 2007 56
  268. Table 4.10: Leading Ten Therapeutic Classes by U.S. Sales, 2003-2007 56
  269. Table 4.11: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006 and 2007 57
  270. Table 4.12: Top Ten Brand Drugs by U.S. Retail, 2007 57
  271. Table 4.13: Worldwide Anti-Diabetes Drug Market, 2006-2012 58
  272. Table 4.14: Oral Anti-Diabetic Therapy Major World Markets, 2006 59
  273. Table 4.15: The Leading Ten Anti-Diabetics by Sales, 2007 61
  274. Table 4.16: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes, 2008 61
  275. Table 4.17: Summary of Glucose-Lowering Interventions as Monotherapy 67
  276. Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 70
  277. Table 5.2: Average Dose and Cost Comparison of Hypoglycemic Agents 71
  278. Table 5.3: Relative Efficacy of Diabetes Drugs 72
  279. Table 5.4: Thiazolidinediones Available for Type 2 Diabetes Mellitus 75
  280. Table 5.5: Fixed Drug Combinations 81
  281. Table 5.6: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-1 88
  282. Table 5.7: DPP-IV Inhibitor Pipeline 89
  283. Table 6.1: Available Therapeutic Insulin Alternatives 92
  284. Table 6.2: Worldwide Insulin Sales, 2005-2012 93
  285. Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2007 93
  286. Table 6.4: Worldwide Insulin Sales and Market Share by Company, 2007 94
  287. Table 6.5: U.S. Insulin Sales and Market Share by Company, 2007 94
  288. Table 6.6: U.S. Retail Insulin Sales, 2006-2009 95
  289. Table 6.7: Comparison of Rapid-Acting Insulins 96
  290. Table 6.8: Comparison of Long-Acting Insulins 98
  291. Table 6.9: Pharmacokinetics of Available Insulins 98
  292. Table 6.10: Status of Inhaled Insulin Products, 2009 103
  293. Table 6.11: Key Drivers of the Type 2 Diabetes Insulin Market, 2012 109
  294. Table 6.12: A Comparison of Existing Insulin Delivery Devices 110
  295. Table 6.13: Lancet Characteristics 112
  296. Table 6.14: Lancing Device Characteristics 113
  297. Table 6.15: Insulin Pens 114
  298. Table 6.16: Worldwide Demand for Insulin Injector Pens by Volume, 2006-2010 115
  299. Table 6.17: Injection Aids 118
  300. Table 6.18: Jet Injectors 118
  301. Table 6.19: Leading Insulin Pump Manufacturers 119
  302. Table 6.20: External Insulin Pumps 120
  303. Table 6.21: Comparison of Current Insulin Pumps on the Market 120
  304. Table 6.22: Control Averages by Treatment 122
  305. Table 6.23: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 122
  306. Table 6.24: Worldwide Diabetes Market, 2008 124
  307. Table 6.25: Types of Insulin Pumps on the Market 124
  308. Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 134
  309. Table 7.2: Cells of the Pancreas 140
  310. Table 7.3: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes 142
  311. Table 7.4: Agents for Lowering Lipid Levels in Patients with Dyslipidemia 143
  312. Table 7.5: Suggested Pharmacological Treatment Agents for Hypertension in Patients with Diabetes 144
  313. Table 7.6: Selected Mid-2008 Press Releases on Emerging Anti-Diabetes Agents 146
  314. Table 7.7: Diabetes Agents in the Pipeline 147
  315. Table 7.8: Future Anti-Diabetic Drugs in Late-Stage Development 151
  316. Table 8.1: Laboratory Assessment of Diabetic Vascular Disease 158
  317. Table 8.2: Worldwide Market for Diabetes Self-Testing (Meters, Strips and Lancets), 2004-2012 158
  318. Table 8.3: Market for Glucose Self-Testing in the U.S., 2004-2012 159
  319. Table 8.4: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007 160
  320. Table 9.1: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 188
  321. Table 9.2: Selected Licensing Deals in the Diabetes Arena, 2003-2008 190
  322. Table 9.3: Top Therapeutic Categories in U.S. Development, 2008 194
  323. Table 9.4: Pharmaceutical Companies by Number of Products in R&D Pipeline, 2007 194
  324. Table 9.5: Pharmaceutical Companies by Number of Diabetes Products in Development 195
  325. Table 9.6: Selected New Diabetes Drugs in Pipeline, 2007 196
  326. Table 9.7: Comparison of New Molecular Entity Outcomes for FDA and EMEA (Jan 2006 to October 2008) 197
  327. Table 9.8: Upcoming Milestones for Selected Diabetes Drugs 200
  328. Table 9.9: Overview of Blockbuster Drugs Coming Off-Patent, 2008 to 2012 201
  329. Table A1.1: Company Headquarters Contact Information 232
  330. Table A3.1: Current Insulins 239
  331. Table A4.1: Select Archived Press Release Excerpts 243
  332. Table A5.1: The Diabetes/Obesity Pipeline by Developmental Stage, 2009 245

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