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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

Press Release   •   Nov 29, 2016 05:56 EST

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.

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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

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Table of Contents

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 is the most comprehensive collection of market research reports. MarketResearchReports.Biz services are specially designed to save time and money for our clients. We are a one stop solution for all your research needs, our main offerings are syndicated research reports, custom research, subscription access and consulting services. We serve all sizes and types of companies spanning across various industries.