[Report] Insulins Pipeline Insight Market Research, Trends, Analysis TOC

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
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
- 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
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
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
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
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

Pipeline Insight: Insulins - Inhalable insulins unlikely to become blockbusters

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