Pipeline Insight: Insulins - Inhalable Insulins Unlikely To Become Blockbusters

Published by: Datamonitor

Published: Sep. 14, 2006 - 133 Pages

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

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

Abstract

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.

• 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

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.

• 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

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