Pipeline Insight: Insulins - Inhalable insulins unlikely to become blockbusters
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Cardiovascular and Diabetes team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the insulin market - page 4
- The insulin pipeline comprises 17 developmental products in clinical development and exhibits diversity in the approaches to drug delivery - page 4
- The insulin segment of the diabetes market is shaped by unmet market needs as well as unmet clinical needs - page 5
- Datamonitor has identified two unmet market needs in the setting of diabetes - page 5
- Datamonitor has identified two unmet clinical needs in insulin therapy - page 7
- The commercial potential of inhalable insulins is limited - page 8
- There are three resistors to the market uptake of inhalable insulins - page 9
- The commercial potential of inhalable insulins is limited: Technosphere has greatest commercial potential - page 11
- CHAPTER 2 PIPELINE OVERVIEW - page 20
- Pipeline overview - page 20
- The majority of developmental insulin products target both types of diabetes - page 22
- The insulin pipeline is varied by formulation and modes of administration - page 23
- The insulin pipeline is poor in Phase III candidates - page 26
- The R&D landscape is dominated by Novo Nordisk - page 27
- Pipeline overview - page 20
- CHAPTER 3 PATIENT POTENTIAL - page 30
- Definition of diabetes - page 30
- Segmentation of diabetes - page 30
- Type 1 diabetes - page 30
- Type 1.5 diabetes - page 30
- Type 2 diabetes - page 31
- Epidemiology of diabetes - page 33
- Current prevalence of type 1 and type 2 diabetes - page 33
- Methodology - page 37
- Future prevalence of type 2 diabetes - page 38
- Use of insulin therapy in patients with type 2 diabetes - page 40
- Current prevalence of type 1 and type 2 diabetes - page 33
- Marketability considerations: unmet needs and barriers to market entry and uptake - page 42
- Unmet market needs - page 42
- Unmet market need 1: routine screening for the detection of type 2 diabetes mellitus - page 42
- Unmet market need 2: greater patient awareness - page 44
- Unmet market need 3: greater guideline awareness in physicians - page 45
- Unmet market need 4: non-invasive measurement of blood glucose - page 51
- Unmet clinical needs - page 51
- Unmet clinical need 1: improved ability to mimic endogenous insulin secretion patterns - page 52
- Unmet clinical need 2: reduced intra-individual insulin response variability - page 53
- Unmet market needs - page 42
- CHAPTER 4 R&D APPROACH - page 56
- Therapy overview in type 1 and type 2 diabetes - page 56
- Type 1 diabetes - page 56
- Type 2 diabetes - page 60
- Clinical trial issues in diabetes - page 63
- Patient compliance - page 63
- Efficacy - page 63
- Side effects - page 66
- Incidence of hypoglycemic events - page 66
- Delivery-related complications - page 66
- Weight gain - page 67
- The insulin market: comparator therapies - page 68
- Injectable insulins - page 69
- Marketed injectables - page 69
- Insulin analogs - page 71
- Inhalable insulins - page 74
- Marketed inhalable: Exubera - page 76
- Marketability considerations: the cost and the value of Exubera - page 76
- SWOT-Analysis: Exubera - page 78
- Forecast: Exubera - page 79
- Injectable insulins - page 69
- Therapy overview in type 1 and type 2 diabetes - page 56
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: INSULINS - page 81
- Overview of insulin therapies in late-stage development for diabetes - page 81
- Pipeline summary - page 81
- Competitive environment: three resistors to market uptake of inhalable insulins - page 82
- Resistors to market entry and uptake 1: insufficient unmet need for non-injectable insulin delivery - page 82
- Resistors to market entry and uptake 2: fear of potential side effects - page 85
- Resistors to market entry and uptake 3: competition from GLP-1 agonists - page 88
- Comparative overview: AIR, AERx, Technosphere and Exubera - page 89
- Market entry timing: Exubera's first-to-market advantage is limited - page 91
- Comparative forecasts: AIR, AERx, Technosphere and Exubera - page 94
- AERx-iDMS (Novo Nordisk) - page 97
- Drug overview - page 97
- Clinical data - page 97
- Phase IIa - page 97
- Phase II/III - page 98
- SWOT-Analysis: AERx-iDMS - page 99
- Forecast: AERx-iDMS - page 100
- Datamonitor comment: AERx-iDMS - page 101
- AIR insulin (Alkermes, Eli Lilly) - page 101
- Drug overview - page 102
- Clinical data - page 102
- Phase II - page 102
- SWOT-Analysis: AIR insulin - page 103
- Forecast: AIR insulin - page 104
- Datamonitor comment: AIR insulin - page 105
- Technosphere insulin (MannKind) - page 105
- Drug overview - page 105
- Clinical data - page 106
- Phase II - page 106
- SWOT-Analysis: Technosphere insulin - page 108
- Forecast: Technosphere insulin - page 109
- Datamonitor comment: Technosphere - page 110
- Overview of insulin therapies in late-stage development for diabetes - page 81
- CHAPTER 6 OTHER INSULINS - page 111
- Alveair (inhalable insulin) - page 111
- Drug overview - page 111
- Clinical data - page 111
- Phase I - page 111
- AT-1391 - page 111
- Drug overview - page 111
- Clinical data - page 112
- Phase I - page 112
- DTY001 (Capsulin) - page 112
- Drug overview - page 112
- Clinical data - page 112
- Phase IIa - page 112
- Phase I/IIa - page 113
- Eligen oral insulin (Emisphere) - page 113
- Drug overview - page 113
- Intesulin (oral insulin, Coremed) - page 114
- Drug overview - page 114
- Intranasal Insulin (Bentley, Dong Sung, Biocon) - page 115
- Drug overview - page 115
- Clinical data - page 115
- Phase I - page 115
- KI-02212 (inhalable insulin, Kos) - page 116
- Drug overview - page 116
- Clinical data - page 116
- Phase IIa - page 116
- NBI-6024 - page 117
- Drug overview - page 117
- NN-344 - page 117
- Drug overview - page 117
- NN-5401 - page 117
- Drug overview - page 117
- Transdermal insulin patch (U-strip) - page 118
- Drug overview - page 118
- Oral-lyn (Generex) - page 118
- Drug overview - page 118
- Clinical data - page 119
- Phase III - page 119
- Phase II - page 119
- Phase IIa - page 120
- QDose (inhalable insulin, QDose) - page 120
- Drug overview - page 120
- Clinical data - page 120
- Viaject - page 121
- Drug overview - page 121
- Clinical data - page 121
- Alveair (inhalable insulin) - page 111
- APPENDIX A - page 122
- Bibliography - page 122
- Report methodology - page 129
- APPENDIX B - page 130
- About Datamonitor - page 130
- About Datamonitor Healthcare - page 130
- Datamonitor Healthcare's therapy area capabilities - page 131
- About the Cardiovascular and Diabetes team - page 132
- Disclaimer - page 133
- About Datamonitor - page 130
- List of Tables
- Table 1: Insulin pipeline, 2006 - page 21
- Table 2: Patient segments within the diabetes market targeted by developmental insulin products, 2006 - page 22
- Table 3: Modes of insulin delivery under development, 2006 - page 23
- Table 4: Acute pipeline of insulin products by company, 2006 - page 27
- Table 5: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025 - page 34
- Table 6: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015 - page 36
- Table 7: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2006-2015 - page 38
- Table 8: Insulin use in patients with type 2 diabetes (%), 2004 - page 40
- Table 9: Insulin use in patients with type 2 diabetes, 2006-2015 - page 40
- Table 10: Comparator Insulins, 2006 - page 69
- Table 11: Comparator Insulins by onset of action, 2006 - page 70
- Table 12: Comparator Pre-mixed insulins by onset of action, 2006 - page 72
- Table 13: Sales forecasts for Exubera in the seven major markets, 2006-2015 - page 79
- Table 14: Key pipeline non-injectable insulin therapies, 2006 - page 81
- Table 15: Comparison of developmental insulin products for intrapulmonary delivery, 2006 - page 90
- Table 16: Sales forecasts for inhalable insulins in the seven major markets, 2006-2015 - page 95
- Table 17: Sales forecasts for AERx-iDMS, 2010-2015 - page 100
- Table 18: Sales forecasts for AIR insulin the seven major markets, 2010-2015 - page 104
- Table 19: Sales forecasts for Technosphere in the seven major markets, 2010-2015 - page 109
- List of Figures
- Figure 1: Insulin pipeline, 2006 - page 20
- Figure 2: Patient segments within the diabetes market targeted by developmental insulin products, 2006 - page 22
- Figure 3: Modes of insulin delivery under development, 2006 - page 24
- Figure 4: Pipeline maturity: percentage of R&D products in each phase of development, 2006 - page 26
- Figure 5: Extent of collaboration in insulin R&D, 2006 - page 28
- Figure 6: Comparison of glucose testing - page 32
- Figure 7: Regulation of blood glucose levels by insulin, glucagon and amylin - page 58
- Figure 8: The history of antidiabetic drug classes - page 61
- Figure 9: The history of insulin - page 62
- Figure 10: SWOT-analysis: Exubera, 2006 - page 78
- Figure 11: Sales forecasts for Exubera in the seven major markets, 2006-2015 - page 79
- Figure 12: Exubera leads the market for inhalable insulins by 3.5 years - page 92
- Figure 13: Exubera's market lead will benefit inhalable insulins in general - page 93
- Figure 14: Comparative sales forecasts for AIR, AERx, Exubera and Technosphere , 2006-2015 - page 95
- Figure 15: SWOT-analysis: AERx-iDMS, 2006 - page 99
- Figure 16: Sales forecasts for AERx-iDMS, 2010-15 - page 100
- Figure 17: SWOT-analysis: AIR insulin, 2006 - page 103
- Figure 18: Sales forecasts for AIR insulin in the seven major markets, 2010-2015 - page 104
- Figure 19: SWOT-analysis: Technosphere insulin, 2006 - page 108
- Figure 20: Sales forecasts for Technosphere in the seven major markets, 2010-2015 - page 109
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