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Published by: Datamonitor
Published: Jul. 10, 2008 - 105 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the insulin antidiabetic market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Related reports
- Upcoming report
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview: Insulin antidiabetics
- Key companies involved in the insulin antidiabetic pipeline
- Key R&D company strategies
- CHAPTER 3 DISEASE OVERVIEW - 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
- Epidemic rise in incidence of type 2 diabetes
- Etiology
- Mechanisms of development of diabetes
- Genetic or acquired causes
- Risk factors
- Obesity
- Type 2 diabetes epidemic hand-in-hand with obesity epidemic
- Race
- Type 2 diabetes more prevalent in Hispanics and African Americans than in Caucasians
- Family history
- Type 2 diabetes in first-degree relatives is a strong prognostic indicator
- Advanced age
- Gender and other factors
- Gestational diabetes mellitus
- Unmet need in insulin therapy
- Unmet need 1: injection based therapy
- Unmet need 2: discreet administration
- Unmet need 3: social issues
- Unmet need 4: reduced intra-individual insulin response variability
- Unmet need 5: regime complexity
- Unmet need 6: infrastructure burden
- Unmet need 7: under diagnosis
- CHAPTER 4 R&D APPROACH
- Therapy overview in type 1 diabetes
- Initiation of insulin therapy
- Intensive glucose therapy - implications of the ACCORD and ADVANCE trials
- Treatment focus - the end of a purely glucose-centric approach?
- Diabetologist versus general practitioner
- Comparator therapies
- Injectable insulins
- Marketed injectables
- Insulin analogs
- Initiation of insulin therapy in type 2 diabetes
- Classification of pipeline products
- Injectable insulin
- FT-105
- Hepatic directed vesicles - short-acting
- Hepatic directed vesicles - long-acting
- NN-1250
- NN-5401
- VIAject
- Oral insulin
- AI-401
- DTY-001 (Capsulin)
- IN-105
- Insulin (oral nanotechnology)
- Oral gel capsule
- Inhaled insulin
- ProMaxx
- KI-02212
- MAP-0001
- Q-Dose
- Technosphere insulin
- Dermal insulin
- AT-1391
- TPM insulin
- U-Strip
- Nasal insulin
- Intranasal insulin
- Nasulin
- Buccal insulin
- Oralin
- VIAtab
- Rectal insulin
- Clinical trial design in diabetes mellitus
- Efficacy
- Control of average blood glucose levels
- Safety and side effects
- Weight gain
- Future trends
- FDA guidance February 2008
- Cardiovascular endpoints
- Clinical endpoint selection
- CHAPTER 5 INSULIN LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for insulin antidiabetics
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Technosphere insulin
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- VIAject
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Other drug
- AI-401
- Late-stage development compounds recently discontinued
- BIBLIOGRAPHY
- APPENDIX
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Key parameters of the diabetes market for the seven major markets, 2007 and 2017
- Table 2: Forecast key pipeline insulin products in diabetes, 2009- 2017 ($m)
- Table 3: R&D pipeline in insulin antidiabetics, 2008
- Table 4: Number of key insulin antidiabetic drugs by delivery method and phase of development, 2008
- Table 5: Prevalence of diabetes mellitus in the seven major markets (millions)
- 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), 2007-2017
- Table 8: Selected marketed insulins, 2008
- Table 9: Marketed insulins by onset of action, 2006
- Table 10: Marketed pre-mixed insulins by onset of action, 2008
- Table 11: Key products in late-stage R&D pipeline for non-insulin antidiabetics, 2008
- Table 12: Datamonitor forecast for key pipeline insulin antidiabetics across the seven major markets, 2009-2017
- Table 13: Impacting factors on the revenues of Technosphere insulin, 2008-2017
- Table 14: Ongoing clinical trials of Technosphere insulin
- Table 15: Impacting factors on the revenues of VIAject, 2008-2017
- Table 16: Ongoing clinical trials of VIAject, 2008
- Table 17: Discontinued R&D projects in insulin antidiabetics, 2005-08
- List of Figures
- Figure 1: Datamonitor's competitive positioning analysis of insulin antidiabetics, 2008
- Figure 2: Overview of insulin antidiabetic pipeline, 2008
- Figure 3: Distribution of key insulin antidiabetic drugs by delivery method, 2008
- Figure 4: Percentage of insulin antidiabetic R&D products in development by phase, 2008
- Figure 5: Distribution of insulin antidiabetic candidates between company types, 2008
- Figure 6: Comparison of glucose testing
- Figure 7: Datamonitor's competitive positioning analysis of insulin antidiabetics, 2008
- Figure 8: Datamonitor forecast for key pipeline insulin antidiabetics across the seven major markets, 2008-2017
- Figure 9: SWOT analysis of Technosphere insulin
- Figure 10: Sales forecast for Technosphere insulin in diabetes to 2017, seven major markets
- Figure 11: Datamonitor forecast for Technosphere in the US, Japan and 5EU, 2011-2017
- Figure 12: Datamonitor's competitive positioning analysis of Technosphere insulin, 2008
- Figure 13: SWOT analysis of VIAject insulin
- Figure 14: Sales forecast for VIAject in diabetes to 2017, seven major markets
- Figure 15: Datamonitor forecast for VIAject in the US, Japan and 5EU, 2011-2017
- Figure 16: Datamonitor's competitive positioning analysis of VIAject, 2008
AbstractIntroduction
Alternative delivery methods under development have so far failed to live up to expectations. In many cases the technical difficulties associated with the delivery technique have not been overcome, leading to a return to injection based therapies. Big Pharma have all but exited the development of new insulin therapies leaving the field to small niche players.
Scope- Comprehensive analysis of the current insulin antidiabetic pipeline detailing the broad range of developmental classes.
- A detailed clinical and commercial assessment of all key emerging therapies.
- Sales based sales forecasts for key late-stage developmental non-insulin antidiabetics agents in the seven major markets to 2017.
Highlights
Interest in inhaled insulin candidates has dropped significantly since 2007. Questions over reimbursement, social acceptability, pulmonary function and a potential lung cancer signal have led to the leading insulin companies cancelling their inhaled insulin programs
The insulin antidiabetic pipeline is mainly focused on new drug delivery methodologies rather than developing new injection based therapies. 76% of the pipeline is non-injection based therapies
Small companies dominate the pipeline with Big Pharma almost absent. Of the top twenty pharmaceutical companies only Abbott has an insulin candidate
Reasons to Purchase- Quantify the future drugs in the insulin antidiabetic market.
- Identify licensing opportunities based on company portfolio and market needs.
- Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs.
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