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Pipeline Insight: Insulins
Inhalable insulins unlikely to become blockbusters

  • Publication Date:September 2006
  • Publisher:Datamonitor
  • Product Type: Report
  • Pages:133

Pipeline Insight: Insulins Inhalable insulins unlikely to become blockbusters

Introduction

Datamonitor expects the continuously growing prevalence of diabetes to drive growth in diabetes drug spending, potentially benefiting market uptake of novel insulin therapies. A set of novel, non-injectable insulins are poised to become available to patients in the next five years. By 2010, the market will thus have to absorb Pfizer's Exubera and at least three other inhalable insulins.

Scope

  • Assessment of the patient potential for developmental insulin therapy over the period 2006 to 2015
  • Overview of the insulin pipeline, with detailed information on the insulins in development and injectable comparators as well as market entry barriers
  • Commercial analysis of key insulin products in development regarding their ability to satisfy unmet needs, supported by the views of opinion leaders
  • Sales forecasts for four key inhalable insulin preparations in the seven major markets to 2015

Highlights

The diabetes market is worthy of investment because of the endemic size of its patient pool which is set to grow further. However, the efficacy of marketed injectable insulins is difficult to improve upon and this is reflected in the R&D pipeline for insulins, comprising a small set of only 17 novel insulin products in clinical development.

Datamonitor has identified three late-stage insulins likely to be launched into the diabetes market within the next five years. These are the inhalable formulations AERx-iDMS, AIR and Technosphere all of which may coexist with Exubera because their technical diversity is likely to cater for a wide spectrum of patient needs and preference.

The diabetes market will not be receptive to inhalable insulins until compelling data are generated that demonstrate compelling clinical benefits of inhalable insulins over injectables. This view is supported by the recent cost-benefit analyses of it by Germany's IQWiG and UK's NICE, and the distinct lack of opinion leader enthusiasm about Exubera.

Reasons to Purchase

  • Explore the key factors that will contribute to the success of the next generation of insulins
  • View independent sales forecasts for products in late stage development for insulin-based diabetes therapy
  • Understand physician opinions of non-injectable insulins and unmet needs in the diabetes market
  • 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
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