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Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations

Summary

Type 1 Diabetes Mellitus (T1DM) is a chronic, progressive and serious disease characterized by a destruction or failure of insulin-secreting pancreatic beta cells, usually as a result of an autoimmune response. The resulting insulin deficiency prevents insulin-sensitive cells from carrying out essential glucose metabolism and leads to hyperglycemia (high blood glucose levels). As a result, immediate and lifelong treatment with exogenous insulin therapy is initiated upon diagnosis of T1DM. Exogenous insulin has remained the mainstay of T1DM therapy since it was used to treat the first human patient in 1922.

Consequently, insulin products comprise the vast majority of the T1DM market, which is largely monopolized by three big pharma players: Eli Lilly, Novo Nordisk and Sanofi. However, insulin treatment regimens are often inconvenient and are associated with undesirable side effects such as hypoglycemia (low blood glucose levels) and weight gain. In addition, there is a significant unmet need for more diversified treatment options including therapies capable of altering the clinical course of the pathological beta cell destruction and adjuvant therapies capable of improving glycemic control and reducing insulin requirements.

Scope

The report assesses the current T1DM market and forecasts market trends to 2021. Areas covered include -
- An introduction to T1DM, which includes classification, symptoms, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment
- An analysis of the leading insulin therapies in the current T1DM marketed products landscape.
- An analysis of the pipeline for T1DM. This includes a breakdown of pipeline molecules by stage of development, molecule type, route of administration, molecular target and novelty. Trends in T1DM clinical trial size, duration and failure rates, by molecule type and molecular target are discussed. A comparative analysis of the most promising pipeline molecules is also provided.
- Forecast projections for the T1DM market to 2021. An analysis is provided for the global market and each of the eight major markets. The forecast incorporates projected, low and high variance scenarios based on treatment usage patterns and annual therapy costs in each of the major markets.
- An analysis of strategic consolidations, including co-development and licensing deals, within the T1DM indication.

Reasons to buy

The report will provide clients with a strong understanding of the T1DM indication and an appreciation of the evolving landscape of the T1DM therapeutics market. The report will enable clients to -
- Appreciate the current T1DM marketed products landscape, including the dominant therapeutic strategies, products, and companies, and recognize gaps within the market and areas of unmet need
- Identify trends and developments within the T1DM pipeline and consider how the future competitive environment will be impacted.
- Consider market opportunities and potential risks by examining trends in T1DM clinical trial duration and size, as well as clinical trial failure rates, amongst clinical phases and molecule types
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the T1DM therapeutics market
- Understand how strategic consolidations have shaped the current T1DM pipeline and marketed products landscapes

Table Of Contents

Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Overview 9
2.2 Classification of Diabetes Mellitus 9
2.3 Symptoms 10
2.4 Etiology 11
2.4.1 Genetics 11
2.4.2 Age 11
2.4.3 Early Diet 11
2.4.4 Exposure to Infectious Agents 12
2.4.5 Vitamin D Deficiency 12
2.5 Pathophysiology 13
2.6 Epidemiology 15
2.7 Co-morbidities and Complications 16
2.7.1 Acute Metabolic Complications 16
2.7.2 Long-term Vascular Complications 17
2.7.3 Other Co-morbidities and Complications 19
2.8 Diagnosis 19
2.9 Treatment 20
2.9.1 Insulin Therapy 20
2.9.2 Non-insulin Adjunctive Therapy 22
2.9.3 Lifestyle Modifications 23
2.9.4 Beta Cell Replacement Therapy 23
2.10 Treatment Algorithm 24
2.10.1 Basal Insulin for MDI Therapy 26
2.10.2 Bolus Insulin for MDI Therapy 33
2.10.3 Bolus Insulin for CSII 37
3 Marketed Products 40
3.1 Overview 40
3.2 Human Insulin Products 42
3.2.1 Humulin Products - Eli Lilly 42
3.2.2 Novolin Products - Novo Nordisk 44
3.2.3 Afrezza (insulin human) - Sanofi and MannKind Corporation 45
3.3 Insulin Analog Products 46
3.3.1 Humalog (insulin lispro) - Eli Lilly and Company 46
3.3.2 Novolog (insulin aspart) Products - Novo Nordisk 48
3.3.3 Apidra (insulin glulisine) - Sanofi 49
3.3.4 Lantus (insulin glargine) - Sanofi 50
3.3.5 Levemir (insulin detemir) - Novo Nordisk 52
3.3.6 Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart) - Novo Nordisk 53
3.3.7 Toujeo (insulin glargine) - Sanofi 55
4 Pipeline 57
4.1 Overview 57
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 58
4.3 Pipeline Distribution by Molecular Target 61
4.3.1 Molecular Target Groups in the Pipeline 64
4.4 Clinical Trial Landscape 69
4.4.1 Clinical Trial Failure Rates 69
4.4.2 Clinical Trial Duration 74
4.4.3 Clinical Trial Size 78
4.4.4 Comparative Clinical Trial Metrics Analysis 82
4.5 Promising Pipeline Molecules 84
4.5.1 Insulin Therapies 84
4.5.2 Non-insulin Adjuvant Therapies 89
5 Market Forecast to 2021 99
5.1 Geographical Markets 99
5.2 Global Markets 99
5.3 North America 102
5.3.1 Treatment Usage Patterns 102
5.3.2 Annual Cost of Therapy 104
5.3.3 Market Size 106
5.4 Top Five European Markets 108
5.4.1 Treatment Usage Patterns 108
5.4.2 Annual Cost of Therapy 109
5.4.3 Market Size 111
5.5 Japan 113
5.5.1 Treatment Usage Patterns 113
5.5.2 Annual Cost of Therapy 114
5.5.3 Market Size 114
5.6 Drivers and Barriers for the T1DM Therapeutics Market 115
5.6.1 Drivers 115
5.6.2 Barriers 117
6 Strategic Consolidations 119
6.1 Licensing Deals 119
6.1.1 ViaCyte Enters into Option for Licensing Agreement with Janssen Research and Development 124
6.1.2 Eli Lilly Enters into Licensing Agreement with MacroGenics 124
6.1.3 Bayhill Therapeutics Enters into Licensing Agreement with Genentech 124
6.1.4 King's College Enters into Licensing Agreement with UCB 124
6.1.5 Nuvilex Enters into Licensing Agreement with University of Technology Sydney 125
6.1.6 Sanofi Enters into Licensing Agreement with MannKind for Afrezza 125
6.1.7 Eli Lilly Enters into Licensing Agreement with Adocia 125
6.2 Co-development Deals 126
6.2.1 GlaxoSmithKline Signs Partnership Agreement with Tolerx 131
6.2.2 Diamyd Medical Enters into Co-Development Agreement with Ortho-McNeil-Janssen 131
6.2.3 Osiris Therapeutics Enters into an Agreement with Juvenile Diabetes Research Foundation International 131
6.2.4 Transition Therapeutics Enters into Co-Development Agreement with Juvenile Diabetes Research Foundation 131
6.2.5 BioLineRx Enters into Co-Development Agreement with JHL Biotech 132
7 Appendix 133
7.1 All Pipeline Drugs by Phase of Development 133
7.1.1 Discovery 133
7.1.2 Preclinical 134
7.1.3 IND/CTA-filed 137
7.1.4 Phase I 138
7.1.5 Phase II 139
7.1.6 Phase III 140
7.1.7 Pre-registration 140
7.2 Market Forecasts to 2021 140
7.2.1 Global 140
7.2.2 US 141
7.2.3 Canada 141
7.2.4 UK 141
7.2.5 France 142
7.2.6 Germany 142
7.2.7 Italy 142
7.2.8 Spain 143
7.2.9 Japan 143
7.3 References 143
7.4 Heat Map References 153
7.5 Abbreviations 154
7.6 Research Methodology 156
7.7 Secondary Research 156
7.8 Marketed Product Profiles 157
7.9 Late-Stage Pipeline Candidates 157
7.10 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 157
7.11 Product Competitiveness Framework 157
7.12 Pipeline Analysis 157
7.12.1 Overall Pipeline 157
7.12.2 Clinical Trials 158
7.12.3 Failure Rate 158
7.12.4 Clinical Trial Size 158
7.12.5 Clinical Trial Duration 158
7.12.6 Clinical Trial Endpoint Analysis 158
7.13 Forecasting Model 158
7.14 Deals Data Analysis 159
7.15 Expert Panel Validation 160
7.16 Contact Us 160
7.17 Disclaimer 160

1.1 List of Tables

Table 1: T1DM Therapeutics Market, Common Endpoints in T1DM Trials 25
Table 2: T1DM Therapeutics Market, Global, Breakdown of Multiple Molecular Targets, 2015 66
Table 3: T1DM Therapeutics Market, Global, Breakdown of ‘Other' Molecular Targets, 2015 69
Table 4: T1DM Therapeutics Market, Global, All Pipeline Products, Discovery Phase, 2015 133
Table 5: T1DM Therapeutics Market, Global, All Pipeline Products, Preclinical Phase, 2015 134
Table 6: T1DM Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed Phase, 2015 137
Table 7: T1DM Therapeutics Market, Global, All Pipeline Products, Phase I, 2015 138
Table 8: T1DM Therapeutics Market, Global, All Pipeline Products, Phase II, 2015 139
Table 9: T1DM Therapeutics Market, Global, All Pipeline Products, Phase III, 2015 140
Table 10: T1DM Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2015 140
Table 11: T1DM Therapeutics Market, Global, Market Forecast, 2014-2021 140
Table 12: T1DM Therapeutics Market, US, Market Forecast, 2014-2021 141
Table 13: T1DM Therapeutics Market, Canada, Market Forecast, 2014-2021 141
Table 14: T1DM Therapeutics Market, UK, Market Forecast, 2014-2021 141
Table 15: T1DM Therapeutics Market, France, Market Forecast, 2014-2021 142
Table 16: T1DM Therapeutics Market, Germany, Market Forecast, 2014-2021 142
Table 17: T1DM Therapeutics Market, Italy, Market Forecast, 2014-2021 142
Table 18: T1DM Therapeutics Market, Spain, Market Forecast, 2014-2021 143
Table 19: T1DM Therapeutics Market, Japan, Market Forecast, 2014-2021 143

1.2 List of Figures

Figure 1: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens, 2015 27
Figure 2: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015 28
Figure 3: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015 29
Figure 4: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015 30
Figure 5: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for MDI Regimens, 2015 34
Figure 6: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for CSII, 2015 37
Figure 7: T1DM Therapeutics Market, Global, Pipeline, 2015 59
Figure 8: T1DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015 62
Figure 9: T1DM Therapeutics Market, Global, Breakdown of Molecular Target Groups, 2015 63
Figure 10: T1DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006-2015 70
Figure 11: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015 71
Figure 12: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2015 73
Figure 13: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2015 75
Figure 14: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2015 77
Figure 15: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type (participants), 2006-2015 79
Figure 16: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecular Target (participants), 2006-2015 81
Figure 17: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecule Type, 2006-2015 83
Figure 18: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecular Target, 2006-2015 84
Figure 19: T1DM Therapeutics Market, Global, NN-1218 Forecast ($m), 2017-2021 86
Figure 20: T1DM Therapeutics Market, Global, Insulin Peglispro Forecast ($m), 2018-2021 88
Figure 21: T1DM Therapeutics Market, Global, Jardiance Forecast ($m), 2018-2021 91
Figure 22: T1DM Therapeutics Market, Global, Farxiga Forecast ($m), 2018-2021 92
Figure 23: T1DM Therapeutics Market, Global, Sotagliflozin Forecast ($m), 2018-2021 95
Figure 24: T1DM Therapeutics Market, Global, Glassia Forecast ($m), 2018-2021 97
Figure 25: T1DM Therapeutics Market, Global, Adjuvant Therapy Pipeline Products, 2015 98
Figure 26: T1DM Therapeutics Market, Global, Treatment Usage Patterns (million), 2014-2021 100
Figure 27: T1DM Therapeutics Market, Global, Market Size ($bn), 2014-2021 101
Figure 28: T1DM Therapeutics Market, North America, Treatment Patterns, 2014-2021 103
Figure 29: T1DM Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021 105
Figure 30: T1DM Therapeutics Market, North America, Market Size, 2014-2021 107
Figure 31: T1DM Therapeutics Market, Top Five European Countries, Treatment Usage Patterns (‘000), 2014-2021 108
Figure 32: T1DM Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2014-2021 110
Figure 33: T1DM Therapeutics Market, Top Five Countries of Europe, Market Size ($m), 2014-2021 112
Figure 34: T1DM Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014-2021 113
Figure 35: T1DM Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 114
Figure 36: T1DM Therapeutics Market, Japan, Market Size ($m), 2014-2021 115
Figure 37: T1DM Therapeutics Market, Global, Licensing Deals by Region and Deal Value ($m), 2006-2015 119
Figure 38: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, 2006-2014 120
Figure 39: T1DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2015 121
Figure 40: T1DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006-2015 123
Figure 41: T1DM Therapeutics Market, Global, Co-development Deals by Region and Deal Value ($m), 2006-2015 126
Figure 42: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, 2006-2014 127
Figure 43: T1DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2015 128
Figure 44: T1DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006-2015 130

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