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

Type 1 Diabetes Mellitus Therapeutics in Major
Developed Markets to 2021 - Innovative and
Diversified Pipeline to Drive Market Growth
Despite Patent Expirations
No of Pages – 160
Publishing Date - November 1, 2015
Browse detailed TOC, Tables, Figures, Charts in Type 1 Diabetes Mellitus Therapeutics in
Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market
Growth Despite Patent Expirations at- http://www.absolutereports.com/10070573
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, comorbidities 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
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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 & 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
Report Details –
Date of Publishing - November 1, 2015
No of Pages – 160
Single User PDF License – $4995
Corporate License – $14985
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PDF document links to a research report which includes a complete market forecast up to 2021 for Type 1 Diabetes Mellitus Therapeutics in major developed markets, Disease pathophysiology and epidemiology, treatment algorithm, key currently marketed drug products and therapies, promising pipeline molecules, main drivers, , barriers, clinical trial results and important co-development and licensing deals between major pharmaceutical companies are also discussed in detail.

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