Pipeline Insight: Diabetes Drug Delivery and Diagnostics - Towards the Non-invasive Revolution
This report provides insightful analysis into insulin delivery and diagnostic devices currently in development for diabetes. It shall help you to predict future patitent potential in type 1 and type 2 diabetes through growth projections in seven major markets; Review the benefits and limitations of existing disease management including drugs to manage type 1 and type 2 diabetes and evaluate clinical trial design, provide interpretation of primary endpoints and identify key areas of unmet need in non-invasive diabetes therapy.
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope - page 3
- Datamonitor insight into the non-invasive diabetes market - page 4
- Key metrics - page 9
- CHAPTER 2 PATIENT POTENTIAL - page 13
- Etiology of diabetes - page 13
- Type 1 diabetes - page 13
- Type 2 diabetes - page 14
- Complications of diabetes - page 16
- Nephropathy - page 16
- Retinopathy - page 16
- Neuropathy - page 17
- Macrovascular complications - page 17
- Economic Impact of Diabetes - page 19
- Future trends in the incidence and prevalence of diabetes - page 19
- Low diagnosis rates remain an unresolved issue - page 20
- Segmentation by type - page 20
- Methodology - page 21
- Methodology - page 22
- Future trends in the incidence and prevalence of diabetes and insulin usage - page 22
- Type 1 and type 2 methodology - page 25
- Insulin usage methodology - page 25
- Etiology of diabetes - page 13
- CHAPTER 3 EXISTING THERAPY AND UNMET NEEDS IN DIABETES - page 26
- Existing drug therapies - page 27
- Sulfonylureas - page 27
- Biguanides - page 28
- Thiazolidinediones (TZD) - page 28
- Prandial glucose regulators (PGR) - page 29
- Alpha glucosidase inhibitors (AGI) - page 29
- Combination therapy - page 30
- Insulin - page 31
- Current pharmacological guidelines - page 33
- Diabetes Control and Complications Trial (DCCT) - page 34
- United Kingdom Prospective Diabetes Study (UKPDS) - page 35
- Comment on trials - page 36
- Unmet needs in insulin therapy - page 38
- Efficacy - page 38
- Mode of administration - page 39
- Side-effect profile - page 39
- Patient compliance - page 41
- Current self-monitoring blood glucose (SMBG) guidelines - page 42
- Clinical guidelines - page 43
- Patient potential - page 44
- Cost of monitoring - page 44
- Current Developments in Technologies and Devices - page 46
- Unmet needs in SMBG - page 48
- Non-invasive detection - page 48
- Continuous information - page 48
- Patient empowerment - page 48
- Accuracy - page 49
- Existing drug therapies - page 27
- CHAPTER 4 R&D APPROACH - page 50
- Classification of pipeline products - page 50
- Inhaled insulin - page 50
- Oral insulin - page 50
- Transdermal insulin - page 51
- Glucose monitors - page 51
- Issues in non-injected insulin clinical trial design - page 52
- Comparison alone or in combination with gold standard - page 52
- Patient sample size - page 52
- Length of trial - page 52
- Clinical trials endpoints in non-invasive insulins - page 53
- Efficacy - page 53
- Safety and side-effects - page 54
- Patient compliance - page 55
- Classification of pipeline products - page 50
- CHAPTER 5 DIABETES PIPELINE ANALYSIS - page 56
- Pipeline overview - page 56
- Key companies involved in the disease pipeline - page 57
- Eli Lilly - page 57
- Novo Nordisk - page 57
- Aventis - page 58
- R&D company strategy - page 58
- Licensing strategies are critical for technologically driven markets - page 58
- Targeting type 2 diabetes with non-invasive insulin - page 59
- Product roll-out not involved with the insulin market triumvirate of Lilly, Novo Nordisk and Aventis will face an uphill challenge - page 59
- CHAPTER 6 INHALED INSULIN LATE STAGE DRUG ANALYSIS & FORECASTS - page 60
- Overview for inhaled insulins - page 60
- AERx - page 60
- Drug overview - page 60
- Clinical trial data - page 61
- Patient potential - page 62
- Marketing factors - page 63
- Satisfaction of unmet needs - page 63
- Exubera - page 66
- Drug overview - page 66
- Clinical trial data - page 66
- Patient potential - page 69
- Marketing factors - page 70
- Satisfaction of unmet needs - page 70
- Other drugs in class - page 73
- Alkermes AIR - page 73
- Technosphere insulin - page 74
- Spiros - page 75
- Recently suspended projects - page 75
- AeroDose - page 75
- Drug overview - page 75
- Clinical trial data - page 76
- Patient potential - page 77
- Datamonitor comment - page 77
- CHAPTER 7 ORAL INSULIN LATE STAGE DRUG ANALYSIS & FORECASTS - page 78
- Oralin - page 78
- Drug overview - page 78
- Clinical Trials - page 78
- Patient Potential - page 80
- Marketing factors - page 81
- Satisfaction of unmet needs - page 81
- HIM2 - page 84
- Drug overview - page 84
- Clinical trial data - page 84
- Patient potential - page 86
- Marketing factors - page 86
- Satisfaction of unmet needs - page 86
- Oralin - page 78
- CHAPTER 8 LATE STAGE NON-INVASIVE INSULIN COMPARISONS - page 90
- Potential patient pool - page 91
- Efficacy compared to competitors - page 92
- Marketing strength - page 92
- Side-effect profile - page 92
- Compliance with treatment regimen - page 93
- Improvement in quality of life - page 93
- Methodology and assumptions - page 94
- CHAPTER 9 INNOVATIVE PROJECTS IN NON-INVASIVE INSULINS - page 95
- Macrulin - page 95
- Clinical trial data - page 95
- Emisphere - page 96
- Preclinical trial results - page 96
- RAPID - page 97
- Preclinical trial results - page 97
- CAPIC - page 97
- Preclinical trial results - page 98
- ProMaxx - page 99
- Preclinical trial results - page 99
- Medusa - page 100
- Unigene - page 100
- Preclinical trial results - page 101
- Genteric - page 101
- Islet cell transplantation - page 101
- Clinical trial results - page 102
- Transdermal insulin - page 103
- Micropor - page 103
- Preclinical trial results - page 103
- Transfersomes - page 104
- Preclinical trial results - page 104
- Macrulin - page 95
- CHAPTER 10 INNOVATIVE EARLY STAGE GLUCOSE MONITORING PROJECTS - page 105
- Existing and future technologies in glucose monitoring - page 106
- Existing technologies - page 106
- Drawbacks of current SMBG devices - page 106
- SpectRx - page 109
- Preclinical trial results - page 110
- Sensys - page 111
- Preclinical trial results - page 111
- GlucoNIR - page 112
- Preclinical trial results - page 113
- OrSense - page 113
- Preclinical trial results - page 114
- Pendragon - page 114
- Preclinical trial data - page 115
- Symphony - page 115
- Preclinical trial data - page 116
- Animas - page 116
- Infratec - page 117
- Preclinical trial data - page 117
- Existing and future technologies in glucose monitoring - page 106
- CHAPTER 11 OPINION LEADER TRANSCRIPTS - page 119
- Contributing experts - page 119
- Gerald Bernstein - page 120
- Combination Therapy - page 120
- Non-Invasive Insulin - page 121
- Current Market for Non-Invasive Glucose Monitoring - page 125
- Bernard Charbonnel - page 128
- Combination Therapy - page 128
- Non-Invasive Insulin - page 129
- Current Market for Non-Invasive Glucose Monitoring - page 133
- Vivian Fonseca - page 135
- Combination Therapy - page 135
- Non-Invasive Insulin - page 136
- Late Stage Non-Invasive Insulin - page 137
- Current Market for Non-Invasive Glucose Monitoring - page 138
- CHAPTER 12 APPENDIX A - page 141
- List of tables - page 141
- List of figures - page 141
- Bibliography - page 142
- R&D research methodology - page 146
- Introduction - page 146
- Hypothesis formulation - page 146
- Hypothesis testing - page 147
- Data verification and quality control - page 148
- CHAPTER 13 APPENDIX B: ABOUT DATAMONITOR - page 149
- About Datamonitor - page 149
- About Datamonitor Healthcare - page 149
- Datamonitor Healthcare’s research and analysis methodologies - page 150
- Datamonitor Healthcare’s therapy area capabilities - page 150
- Datamonitor Healthcare’s Consulting expertise - page 151
- Key therapy team members - page 151
- Disclaimer - page 153
- About Datamonitor - page 149
- List of Tables
- Table 1: Combined type 1 and type 2 diabetes population and insulin use in seven major markets, 2003-2010 - page 9
- Table 2: Population of patients using glucose monitoring in seven major markets, 2003 - page 10
- Table 3: Forecast of non-invasive insulins, 2005-2010 - page 10
- Table 2: Diagnostic criteria for diabetes - page 15
- Table 3: Type 1 and 2 diabetes prevalence across seven major markets, 2003 - page 20
- Table 4: Type 1 and 2 diabetes populations across seven major markets, 2003 - page 21
- Table 5: Population of patients using glucose monitoring in seven major markets, 2003 - page 22
- Table 6: Future prevalence of type 2 diabetes, 2003-2011 - page 23
- Table 7: Future prevalence of type 1 diabetes, 2003-2011 - page 23
- Table 8: Combined type 1 and type 2 diabetes population and insulin use in seven major markets, 2003-2010 - page 24
- Table 9: Review of diabetic class profiles - page 33
- Figure 4: Unmet needs in diabetes therapy, 2003 - page 38
- Table 10: Major glucose monitors (US brand names) - page 46
- Table 11: Non-invasive insulin pipeline - page 56
- Table 12: Revenue forecast for AERx, 2006-2010 - page 65
- Table 13: Revenue forecast for Exubera, 2005-2010 - page 72
- Table 14: Revenue forecast for Oralin, 2007-2010 - page 83
- Table 15: Revenue forecast for HIM2, 2008-2010 - page 88
- Table 3: Forecast of non-invasive insulins, 2005-2010 - page 94
- Table 16: Non-invasive glucose monitors in development - page 106
- List of Figures
Figure 1: Comparison of non-invasive insulins in late-stage pipeline - page 11
- List of Figures
- Figure 2: Clinical course and management of type 2 diabetes - page 26
- Figure 3: Common insulin regimens - page 31
- Figure 5: SWOT analysis of AERx - page 64
- Figure 6: Comparison of AERx to injected insulin - page 65
- Figure 7: SWOT analysis for Exubera - page 71
- Figure 8: Comparison of Exubera to injected insulin - page 72
- Figure 9: SWOT analysis for Oralin - page 82
- Figure 10: Comparison of Oralin to injected insulin - page 83
- Figure 11: SWOT analysis of HIM2 - page 87
- Figure 12: Comparison of HIM2 to injected insulin - page 88
- Figure 13: Comparison of non-invasive insulins in late-stage pipeline - page 91
- Figure 14: Datamonitor’s Healthcare Consultancy - page 151
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