Pipeline Insight: Insulin Antidiabetics – Novel analogs show promise as alternative delivery methods prove less attractive.

Introduction

Datamonitor forecasts that the insulin antidiabetics market will grow from 10.6 billion in 2009 to $16.4 billion in 2019 for the seven major markets, with pipeline products contributing 18% of sales. Basal insulin analog Degludec (Novo Nordisk) will be the dominant pipeline entrant, while MannKind’s inhaled insulin Afrezza is forecast to gain only a small share of the prandial insulin market.
Features and benefits

* Comprehensive analysis of the current insulin antidiabetic pipeline including both reformulations of marketed insulins and novel analog products.* A detailed clinical and commercial assessment of all key emerging therapies.* Sales forecasts for key late-stage developmental insulin antidiabetic agents in the seven major markets to 2019.* Analysis of unmet needs in insulin therapies and key development R&D strategies including alternative delivery methods and new clinical profiles.
Highlights

A diabetes epidemic is sweeping the Western World as changes in diet and lifestyle lead to a sedentary obese population at risk of diabetes. All type 1 diabetes patients need insulin therapy and a majority of type 2 patients eventually fail on non-insulin treatment and use insulins, so the insulin market is increasing.Most of the insulin pipeline candidates are reformulations of marketed insulins to improve clinical characteristics or ease of use, being developed by small niche players. Insulin specialist Novo Nordisk is developing novel insulin analogs, while only two candidates come from Big Pharma companies.Datamonitor expects the basal insulin Degludec (insulin degludec, Novo Nordisk) to be a strong competitor for class leader Lantus. The pipeline basal insulin is forecast to reach blockbuster status with US sales above $1 billion by 2016. DegludecPlus, the fixed-ratio combination of Degludec with NovoRapid, will be less successful.
Your key questions answered

* Quantify the sales of pipeline drugs in the insulin antidiabetic market.* Identify licensing opportunities based on company portfolio and market needs.* Assess the remaining market opportunities and barriers to uptake for novel insulin therapies and formulations.

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TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the Cardiovascular and diabetes pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Upcoming related reports 5
Table of Figures 14
Table of tables 16
1. Pipeline Overview and Dynamics 19
Key findings 19
Pipeline overview 20
Big Pharma playing a minor role in insulin development; uninterested in reformulating existing insulins 23
Traditional injectable delivery remains favored by developers, and oral formulations are also being pursued 25
Key R&D company strategies 27
Forecast pipeline 2010–19 28
Comparative forecast 29
2. Epidemiology of Diabetes 34
Key findings 34
Introduction 35
Disease definition, classification and diagnosis criteria 35
Strengths and weaknesses of Datamonitor’s epidemiologic projections 37
Risk factors of type 1 diabetes 38
Genetics 38
Environment 38
Ethnicity 38
Gender 38
Age 39
Global variation and temporal trends of incidence and prevalence of diabetes mellitus 39
Global variation of incidence and prevalence of type 1 diabetes 39
Global variation of type 2 diabetes prevalence 39
Temporal trends of type 1 diabetes mellitus 39
Temporal trends of type 2 diabetes mellitus 40
Epidemiologic forecasting of type 1 diabetes mellitus 40
Sources of epidemiologic data 41
Description of methods 42
US 42
Japan 42
France 43
Germany 43
Italy 43
Spain 44
UK 44
Results for type 1 diabetes 45
Incidence 45
Prevalence 46
Risk factors of type 2 diabetes 47
Age 47
Genetic history 47
Race 47
Gender 48
Diet and exercise 48
Co-morbidities of type 2 diabetes 48
Overweight and obesity 48
Smoking 48
Hypertension and high cholesterol 48
Epidemiologic forecasting of type 2 diabetes mellitus 49
Sources of epidemiologic data 49
Description of methods 50
US 50
Japan 51
France 51
Germany 51
Italy 52
Spain 52
UK 52
Diagnosis rates 53
Results for type 2 diabetes prevalence 53
Current diagnosed prevalent cases and future trends 53
Diagnosis rates of type 2 diabetes in 2010 56
Prevalence of impaired glucose tolerance 57
Discussion 59
Conclusions 60
3. Disease Overview – Market Potential 61
Key findings 61
Definition 62
Current treatment options 62
Type 1 diabetes 62
Insulin therapy in type 2 diabetes 64
Current insulin therapies 66
Marketed insulins 67
Insulin delivery 70
Current market overview 71
Unmet needs in insulin antidiabetic therapies 76
Unmet need 1: increased clinical effectiveness of insulins 76
Unmet need 2: reduced regimen complexity and blood glucose monitoring 77
Unmet need 3: reduced hypoglycemia and improved side effect profile 79
Unmet need 4: social issues and patient education 80
Unmet need 5: physician education and comfort with insulins 81
Unmet need 6: alternatives to injection-based therapy 83
Target product profile versus current level of attainment 84
Comparator insulins 84
4. R&D Approach 87
Key findings 87
Clinical trial design in insulin antidiabetics 88
Efficacy 88
Safety and side effects 88
Comparators and combinations 90
5. Pipeline Analysis & Forecasts: Basal insulins 92
Key findings 92
Overview for basal insulins 93
Marketed basal insulins 93
Pipeline summary and comparative forecasts 95
Pipeline summary 95
Comparative forecasts 96
Degludec (insulin degludec/Novo Nordisk) 100
Drug profile 101
Clinical trial data 101
SWOT analysis 105
Datamonitor drug assessment summary for Degludec 106
Clinical and commercial attractiveness 107
Satisfaction of unmet needs 108
Forecasts to 2019 111
DegludecPlus (insulin degludec+insulin aspart/Novo Nordisk) 113
Drug profile 114
Clinical trial data 114
SWOT analysis 118
Datamonitor drug assessment summary for DegludecPlus 120
Clinical and commercial attractiveness 121
Satisfaction of unmet needs 121
Forecasts to 2019 125
Basal insulins recently discontinued 127
SAR-161271 (Sanofi-Aventis) 127
Other long-acting insulins 128
Injected long-acting insulins 128
Transdermal long-acting insulins 128
Oral long-acting insulins 129
5. Pipeline Analysis & Forecasts: Prandial insulins 130
Key findings 130
Overview for prandial insulins 131
Marketed prandial insulins 131
Pipeline summary and comparative forecasts 133
Pipeline summary 133
Comparative forecasts 134
Afrezza (Technosphere insulin, MannKind) 138
Drug profile 140
Clinical trial data 140
SWOT analysis 144
Datamonitor drug assessment summary for Afrezza 146
Clinical and commercial attractiveness 147
Satisfaction of unmet needs 148
Forecasts to 2019 150
Other fast-acting insulins 153
Linjeta (VIAject insulin, Biodel) 153
Injected fast-acting insulins 154
Buccal fast-acting insulin 155
Oral fast-acting insulins 156
Nasal fast-acting insulin 157
Inhaled fast-acting insulins 157
Rectal fast-acting insulin 157
Bibliography 158
References for Chapter 1. Pipeline overview 158
Datamonitor reports 158
References for Chapter 2. Epidemiology of diabetes 158
Type 1 diabetes epidemiology references 158
Type 2 diabetes epidemiology references 159
References for Chapter 3. Disease overview 162
Articles 162
Other sources 163
Datamonitor reports 163
References for Chapter 4. R&D approach 163
Articles 163
Other sources 164
Datamonitor reports 164
References for Chapter 5. Pipeline analysis & forecasts: Basal Insulins 164
Articles 165
Other sources 165
Datamonitor reports 165
References for Chapter 6. Pipeline analysis & forecasts: Fast-acting insulins 166
Articles 166
Other sources 167
Datamonitor reports 167
Appendix A – Market Assumptions 168
New product launches 168
Patent expiries 170
Methodology and data definitions, limitations and assumptions 171
Standard units 171
Datamonitor forecast methodology 171
Japan methodology 171
Exchange rates 171
Datamonitor drug assessment scorecard 172
Appendix B 175
Contributing experts 175
Conferences attended 175
Report methodology 175
About Datamonitor 176
About Datamonitor Healthcare 176
About the Cardiovascular and Diabetes analysis team 177
Datamonitor consulting 177
Disclaimer 179

TABLE OF FIGURES
Figure 1: Distribution of developmental candidates in the insulins pipeline by phase, 2010 23
Figure 2: Distribution of developmental candidates in the insulins pipeline by developer, 2010 24
Figure 3: Distribution of developmental candidates in the insulins pipeline by developer and class of product, 2010 25
Figure 4: Insulin pipeline by delivery method, 2010 versus 2008 27
Figure 5: Insulin pipeline and marketed drug sales ($m) in the seven major markets 2009-2019 30
Figure 6: Insulin pipeline sales ($m) by brand in the seven major markets, 2010–19 31
Figure 7: Insulin pipeline sales ($m) by region in the seven major markets, 2010–19 32
Figure 8: Insulin pipeline and marketed drug sales ($m) in the seven major markets, 2009–2019 33
Figure 9: Number of prevalent cases of type 2 diabetes in those aged 20–79 years in the seven major markets, 2010–2020 55
Figure 10: Insulin antidiabetics sales ($m) by class in the seven major markets, 2006–09 72
Figure 11: Insulin sales (SUm) by class in the seven major markets, 2006–09 73
Figure 12: Insulin sales ($m) by country in the seven major markets, 2006–09 75
Figure 13: Insulin sales (SUm) by country in the seven major markets, 2006–09 76
Figure 14: Datamonitor drug assessment summary for basal insulins in development for diabetes, 2010 97
Figure 15: Basal insulin sales ($m) in the seven major markets by region, 2009–2019 99
Figure 16: Basal insulin sales ($m) for pipeline and marketed products by brand in the seven major markets, 2009–2019 100
Figure 17: Degludec (insulin degludec, Novo Nordisk) – SWOT analysis, 2010 105
Figure 18: Datamonitor’s competitive positioning analysis of Degludec (insulin degludec, Novo Nordisk), 2010 107
Figure 19: Degludec (insulin degludec, Novo Nordisk) sales ($m) by region in the seven major markets, 2010–19 112
Figure 20: DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk) – SWOT analysis, 2010 119
Figure 21: Datamonitor’s competitive positioning analysis of DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk), 2010 120
Figure 22: DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk) sales ($m) by region in the seven major markets, 2010–19 126
Figure 23: Prandial insulin analog sales ($m) by brand in the seven major markets, 2006–09 132
Figure 24: Datamonitor drug assessment summary for fast-acting insulin in development for diabetes, 2010 135
Figure 25: Prandial insulin sales ($m) by region in the seven major markets, 2009–2019 137
Figure 26: Prandial insulin sales ($m) in the seven major markets for pipeline and marketed products and biosimilars, 2009–2019 138
Figure 27: Afrezza (Technosphere insulin, MannKind) – SWOT analysis, 2010 145
Figure 28: Datamonitor’s competitive positioning analysis of Afrezza (Technosphere insulin, MannKind), 2010 146
Figure 29: Afrezza (Technosphere insulin, MannKind) sales ($m) by region in the seven major markets, 2010–19 152
Figure 30: Methodology for forecasting price to remove impact of currency fluctuations on future trends 172
Figure 31: Datamonitor drug assessment summary for basal insulins in development for diabetes, 2010 174


TABLE OF TABLES
Table 1: Insulin pipeline products in clinical development for diabetes, 2010 21
Table 2: Insulin antidiabetic pipeline by mechanism of action, 2010 26
Table 3: Insulin antidiabetic pipeline by delivery method, 2010 26
Table 4: Forecast insulin antidiabetics pipeline drugs in the seven major markets, 2010–19 28
Table 5: Sales forecast for pipeline insulin antidiabetics in the seven major markets ($m), 2010–19 29
Table 6: 1999 World Health Organization definitions of diabetes mellitus and prediabetes 36
Table 7: Summary of sources used to forecast incidence of type 1 diabetes mellitus in those aged 0–14 years, published between 1993 and 2008 41
Table 8: Incident cases of type 1 diabetes mellitus in those aged 0–14 in the seven major markets, 2010–2020 45
Table 9: Incidence rates per 100,000 of type 1 diabetes mellitus in those aged 0–14 in the seven major markets, 2010–2020 46
Table 10: Number of prevalent cases and percent of population that has type 1 diabetes in those aged 0–79 in the seven major markets, 2010 47
Table 11: Summary of sources used in analyses of type 2 diabetes mellitus, published between 1999 and 2009 49
Table 12: Diagnosed prevalent cases (000s) of type 2 diabetes mellitus in those aged 20–79 years, in the seven major markets, 2010–2020 53
Table 13: Percent of population aged 20–79 years with type 2 diabetes mellitus in the seven major markets (%), 2010–2020 54
Table 14: Prevalent cases of type 2 diabetes in the seven major markets by age group, 2010 56
Table 15: Percentage of type 2 diabetes cases in each age group by country in the seven major markets (%), 2010 56
Table 16: Percentage of undiagnosed diabetes in those aged 20–79 in the seven major markets , 2010 (%) 57
Table 17: Prevalence of impaired glucose tolerance in those aged 20–79 years in the seven major markets, 2010–2020 57
Table 18: Prevalence rates of impaired glucose tolerance in those aged 20–79 years in the seven major markets (%), 2010–2020 59
Table 19: Key marketed insulins by onset of action, 2010 68
Table 20: Leading insulin antidiabetic brands in the seven major markets, 2009 74
Table 21: Comparator insulin treatments for diabetes, 2010 85
Table 22: Ability of current class comparators to meet unmet needs in diabetes, 2010 86
Table 23: Lantus (Sanofi-Aventis) – drug profile, 2010 93
Table 24: Levemir (Novo Nordisk) – drug profile, 2010 94
Table 25: Key products in late-stage R&D pipeline for long-acting insulins, 2010 96
Table 26: Forecast assumptions for basal insulin class pipeline antidiabetics across the seven major markets, 2010 98
Table 27: Sales forecasts for pipeline basal insulins in the seven major markets ($m), 2009–2019 98
Table 28: Degludec (Novo Nordisk) – drug profile, 2010 101
Table 29: Degludec (insulin degludec, Novo Nordisk): ongoing Phase III trials, 2010 103
Table 30: Ability of Degludec (insulin degludec, Novo Nordisk) vs basal insulin class comparator Lantus (insulin glargine, Sanofi-Aventis) to address unmet needs in diabetes 110
Table 31: Sales forecasts ($m) for Degludec (insulin degludec, Novo Nordisk) in the seven major markets, 2010–19 111
Table 32: Factors affecting revenues of Degludec (insulin degludec, Novo Nordisk), 2010–19 113
Table 33: DegludecPlus (Novo Nordisk) – drug profile, 2010 114
Table 34: DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk) – recently completed Phase III trials, 2010 116
Table 35: DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk) – ongoing Phase III trials, 2010 117
Table 36: Ability of DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk) vs basal insulin class comparator Lantus (insulin glargine, Sanofi-Aventis) to address unmet needs in diabetes 124
Table 37: Sales forecasts ($m) for Degludec (insulin degludec, Novo Nordisk) in the seven major markets, 2010–19 125
Table 38: Factors affecting revenues of DegludecPlus (insulin degludec/insulin aspart, Novo Nordisk), 2010–19 127
Table 39: NovoRapid (Novo Nordisk) – drug profile, 2010 133
Table 40: Key product in late-stage R&D pipeline for long-acting insulins, 2010 134
Table 41: Forecast assumptions for prandial insulin class pipeline antidiabetic Afrezza across the seven major markets, 2010 136
Table 42: Sales forecasts for pipeline basal insulins in the seven major markets ($m), 2010–19 136
Table 43: Afrezza (MannKind) – drug profile, 2010 140
Table 44: Afrezza (Technosphere insulin, MannKind): Phase III trial results, 2010 142
Table 45: Afrezza (Technosphere insulin, Mannkind) ongoing Phase III trials in diabetes, 2010 143
Table 46: Ability of Afrezza (Technosphere insulin, MannKind) vs prandial insulin class comparator NovoRapid (insulin aspart, Novo Nordisk) to address unmet needs in diabetes 150
Table 47: Sales forecasts ($m) for Afrezza (Technosphere insulin, MannKind) in the seven major markets, 2010–19 151
Table 48: Factors affecting revenues of Afrezza (Technosphere insulin, MannKind), 2010–19 153
Table 49: Datamonitor’s estimated launch dates for diabetes products in the seven major markets, 2010–19 168
Table 50: Patent expiry or loss of market exclusivity dates for approved diabetes drugs in the seven major markets, 2010–19 170
Table 51: Datamonitor drug assessment parameters 173


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