Abstract
Overview
Introduction
Overview of innovative developmental agents exploring alternative methods of administering insulin.
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Cardiovascular and Diabetes team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the insulin market
- The insulin pipeline comprises 17 developmental products in clinical development and exhibits diversity in the approaches to drug delivery
- The insulin segment of the diabetes market is shaped by unmet market
needs as well as unmet clinical needs
- Datamonitor has identified two unmet market needs in the setting of diabetes
- Datamonitor has identified two unmet clinical needs in insulin therapy
- The commercial potential of inhalable insulins is limited
- There are three resistors to the market uptake of inhalable insulins
- The commercial potential of inhalable insulins is limited: Technosphere has greatest commercial potential
- CHAPTER 2 PIPELINE OVERVIEW
- Pipeline overview
- The majority of developmental insulin products target both types of diabetes
- The insulin pipeline is varied by formulation and modes of administration
- The insulin pipeline is poor in Phase III candidates
- The R&D landscape is dominated by Novo Nordisk
- Pipeline overview
- CHAPTER 3 PATIENT POTENTIAL
- Definition of diabetes
- Segmentation of diabetes
- Type 1 diabetes
- Type 1.5 diabetes
- Type 2 diabetes
- Epidemiology of diabetes
- Current prevalence of type 1 and type 2 diabetes
- Methodology
- Future prevalence of type 2 diabetes
- Use of insulin therapy in patients with type 2 diabetes
- Current prevalence of type 1 and type 2 diabetes
- Marketability considerations: unmet needs and barriers to market entry
and uptake
- Unmet market needs
- Unmet market need 1: routine screening for the detection of type 2 diabetes mellitus
- Unmet market need 2: greater patient awareness
- Unmet market need 3: greater guideline awareness in physicians
- Unmet market need 4: non-invasive measurement of blood glucose
- Unmet clinical needs
- Unmet clinical need 1: improved ability to mimic endogenous insulin secretion patterns
- Unmet clinical need 2: reduced intra-individual insulin response variability
- Unmet market needs
- CHAPTER 4 R&D APPROACH
- Therapy overview in type 1 and type 2 diabetes
- Type 1 diabetes
- Type 2 diabetes
- Clinical trial issues in diabetes
- Patient compliance
- Efficacy
- Side effects
- Incidence of hypoglycemic events
- Delivery-related complications
- Weight gain
- The insulin market: comparator therapies
- Injectable insulins
- Marketed injectables
- Insulin analogs
- Inhalable insulins
- Marketed inhalable: Exubera
- Marketability considerations: the cost and the value of Exubera
- SWOT-Analysis: Exubera
- Forecast: Exubera
- Injectable insulins
- Therapy overview in type 1 and type 2 diabetes
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: INSULINS
- Overview of insulin therapies in late-stage development for diabetes
- Pipeline summary
- Competitive environment: three resistors to market uptake of inhalable
insulins
- Resistors to market entry and uptake 1: insufficient unmet need for non-injectable insulin delivery
- Resistors to market entry and uptake 2: fear of potential side effects
- Resistors to market entry and uptake 3: competition from GLP-1 agonists
- Comparative overview: AIR, AERx, Technosphere and Exubera
- Market entry timing: Exubera's first-to-market advantage is limited
- Comparative forecasts: AIR, AERx, Technosphere and Exubera
- AERx-iDMS (Novo Nordisk)
- Drug overview
- Clinical data
- Phase IIa
- Phase II/III
- SWOT-Analysis: AERx-iDMS
- Forecast: AERx-iDMS
- Datamonitor comment: AERx-iDMS
- AIR insulin (Alkermes, Eli Lilly)
- Drug overview
- Clinical data
- Phase II
- SWOT-Analysis: AIR insulin
- Forecast: AIR insulin
- Datamonitor comment: AIR insulin
- Technosphere insulin (MannKind)
- Drug overview
- Clinical data
- Phase II
- SWOT-Analysis: Technosphere insulin
- Forecast: Technosphere insulin
- Datamonitor comment: Technosphere
- Overview of insulin therapies in late-stage development for diabetes
- CHAPTER 6 OTHER INSULINS
- Alveair (inhalable insulin)
- Drug overview
- Clinical data
- Phase I
- AT-1391
- Drug overview
- Clinical data
- Phase I
- DTY001 (Capsulin)
- Drug overview
- Clinical data
- Phase IIa
- Phase I/IIa
- Eligen oral insulin (Emisphere)
- Drug overview
- Intesulin (oral insulin, Coremed)
- Drug overview
- Intranasal Insulin (Bentley, Dong Sung, Biocon)
- Drug overview
- Clinical data
- Phase I
- KI-02212 (inhalable insulin, Kos)
- Drug overview
- Clinical data
- Phase IIa
- NBI-6024
- Drug overview
- NN-344
- Drug overview
- NN-5401
- Drug overview
- Transdermal insulin patch (U-strip)
- Drug overview
- Oral-lyn (Generex)
- Drug overview
- Clinical data
- Phase III
- Phase II
- Phase IIa
- QDose (inhalable insulin, QDose)
- Drug overview
- Clinical data
- Viaject
- Drug overview
- Clinical data
- Alveair (inhalable insulin)
- APPENDIX A
- Bibliography
- Report methodology
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Cardiovascular and Diabetes team
- Disclaimer
- List of Tables
- Table 1: Insulin pipeline, 2006
- Table 2: Patient segments within the diabetes market targeted by developmental insulin products, 2006
- Table 3: Modes of insulin delivery under development, 2006
- Table 4: Acute pipeline of insulin products by company, 2006
- Table 5: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025
- Table 6: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015
- Table 7: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2006-2015
- Table 8: Insulin use in patients with type 2 diabetes (%), 2004
- Table 9: Insulin use in patients with type 2 diabetes, 2006-2015
- Table 10: Comparator Insulins, 2006
- Table 11: Comparator Insulins by onset of action, 2006
- Table 12: Comparator Pre-mixed insulins by onset of action, 2006
- Table 13: Sales forecasts for Exubera in the seven major markets, 2006-2015
- Table 14: Key pipeline non-injectable insulin therapies, 2006
- Table 15: Comparison of developmental insulin products for intrapulmonary delivery, 2006
- Table 16: Sales forecasts for inhalable insulins in the seven major markets, 2006-2015
- Table 17: Sales forecasts for AERx-iDMS, 2010-2015
- Table 18: Sales forecasts for AIR insulin the seven major markets, 2010-2015
- Table 19: Sales forecasts for Technosphere in the seven major markets, 2010-2015
- List of Figures
- Figure 1: Insulin pipeline, 2006
- Figure 2: Patient segments within the diabetes market targeted by developmental insulin products, 2006
- Figure 3: Modes of insulin delivery under development, 2006
- Figure 4: Pipeline maturity: percentage of R&D products in each phase of development, 2006
- Figure 5: Extent of collaboration in insulin R&D, 2006
- Figure 6: Comparison of glucose testing
- Figure 7: Regulation of blood glucose levels by insulin, glucagon and amylin
- Figure 8: The history of antidiabetic drug classes
- Figure 9: The history of insulin
- Figure 10: SWOT-analysis: Exubera, 2006
- Figure 11: Sales forecasts for Exubera in the seven major markets, 2006-2015
- Figure 12: Exubera leads the market for inhalable insulins by 3.5 years
- Figure 13: Exubera's market lead will benefit inhalable insulins in general
- Figure 14: Comparative sales forecasts for AIR, AERx, Exubera and Technosphere , 2006-2015
- Figure 15: SWOT-analysis: AERx-iDMS, 2006
- Figure 16: Sales forecasts for AERx-iDMS, 2010-15
- Figure 17: SWOT-analysis: AIR insulin, 2006
- Figure 18: Sales forecasts for AIR insulin in the seven major markets, 2010-2015
- Figure 19: SWOT-analysis: Technosphere insulin, 2006
- Figure 20: Sales forecasts for Technosphere in the seven major markets, 2010-2015
- About Datamonitor
