Market Report Source

Overview

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 of this report:

• 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.

Research and analysis 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

Key reasons to read this report:

• 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.

Table of Contents

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

APPENDIX
Bibliography
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