Type 1 Diabetes - US Drug Forecast and Market Analysis to 2023

Type 1 Diabetes - US Drug Forecast and Market Analysis to 2023


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Executive Summary

Type 1 Diabetes - US Drug Forecast and Market Analysis to 2023

Summary

Type 1 diabetes (T1D) is an autoimmune disease that permanently destroys beta cells of the pancreatic islet, which means that the body can no longer produce insulin. Over the last 90 years, insulin therapy has been evolving continuously, as at present, no other treatment can be offered to a patient who is newly diagnosed with T1D. A variety of insulin analogs with different times of action - long-acting as well as short or rapid-acting analogs - have been on the market for the past decade. In addition, many other developments were happening in parallel, such as glucose monitoring and significant advances in insulin delivery systems. The T1D market will approximately double over the forecast period, growing from USD6.6 billiion to USD13.6 billion.This growth will be fueled by the significant increase in T1D prevalence as well as the uptake of the novel ultra-long-acting insulin analogs, novel ultra-rapid formulations of insulin analogs, and the adjunct therapies for T1D. The launches of these novel products will offset the dip in sales caused by the patent expiries of seven insulin products, and the consequent emergence of biosimilars.

GlobalData forecasts these numbers to grow by about 8.3% per year through 2023. This growth will be fueled by the significant increase in T1D prevalence in the US as well as by the uptake of the novel ultra-long-acting insulin analogs, novel ultra-rapid formulations of insulin analogs, and the adjunct therapies for T1D. The launches of these novel products will offset the dip in sales caused by the patent expiries of seven insulin products over the forecast period.

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Scope

Overview of T1D including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in the US including product T1Dcription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the US from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting the US T1D market.

Reasons to buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for T1D.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2013-2023 in the US.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 9

2 Introduction 10

2.1 Catalyst 10

2.2 Related Reports 11

2.3 Upcoming Related Reports 11

3 Disease Overview 12

3.1 Etiology and Pathophysiology 12

3.1.1 Etiology 12

3.1.2 Pathophysiology 14

3.1.3 Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes 15

3.2 Symptoms 16

3.3 Prognosis 17

3.4 Quality of Life 17

4 Disease Management 19

4.1 Diagnosis and Treatment Overview 19

4.1.1 Diagnosis 19

4.1.2 Treatment Guidelines and Leading Prescribed Therapies 21

4.1.3 Clinical Practice 23

4.2 US 27

5 Competitive Assessment 33

5.1 Overview 33

5.2 Current Treatments 36

5.2.1 Human Insulins (Injectable Formulations) 36

5.2.2 Humalog (insulin lispro) 39

5.2.3 NovoLog/NovoRapid (insulin aspart) 45

5.2.4 Apidra (insulin glulisine) 51

5.2.5 Lantus (insulin glargine) 57

5.2.6 Levemir (insulin detemir) 64

5.2.7 Tresiba (insulin degludec) 69

5.2.8 Pancreas and Islet Cell Transplantation 76

6 Unmet Need and Opportunity 79

6.1 Overview 79

6.2 Disease-Modifying Treatment - Preservation of Beta Cells 80

6.2.1 Unmet Need 80

6.2.2 Gap Analysis 81

6.2.3 Opportunity 82

6.3 Hypoglycemia Avoidance 82

6.3.1 Unmet Need 82

6.3.2 Gap Analysis 83

6.3.3 Opportunity 84

6.4 Weight Loss and Control of Associated Metabolic Syndrome 84

6.4.1 Unmet Need 84

6.4.2 Gap Analysis 85

6.4.3 Opportunity 85

6.5 Treatment for Brittle Diabetes 86

6.5.1 Unmet Need 86

6.5.2 Gap Analysis 86

6.5.3 Opportunity 87

6.6 Increased Patient Adherence to Therapy 87

6.6.1 Unmet Need 87

6.6.2 Gap Analysis 88

6.6.3 Opportunity 88

7 Pipeline Assessment 89

7.1 Overview 89

7.2 Clinical Trial Mapping 91

7.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 91

7.3 Promising Drugs in Clinical Development 92

7.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 94

7.3.2 Novel Formulation of Insulin Glargine: Toujeo 99

7.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 104

7.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 110

7.3.5 Adjunct Therapies 116

7.4 Biosimilar Insulins 127

7.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 127

7.4.2 Biosimilar Insulins Pipeline 130

7.4.3 Forecast 131

7.5 Artificial Pancreas 133

7.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 134

8 Market Outlook 140

8.1 United States 140

8.1.1 Forecast 140

8.1.2 Key Events 145

8.1.3 Drivers and Barriers 145

9 Appendix 149

9.1 Bibliography 149

9.2 Abbreviations 165

9.3 Methodology 170

9.4 Forecasting Methodology 170

9.4.1 Diagnosed Type 1 Diabetes Patients 170

9.4.2 Percent Drug-Treated Patients 170

9.4.3 Drugs Included in Each Therapeutic Class 171

9.4.4 Launch and Patent Expiry Dates 171

9.4.5 General Pricing Assumptions 172

9.4.6 Individual Drug Assumptions 173

9.4.7 Pricing of Pipeline Agents 176

9.5 Physicians and Specialists Included in This Study 178

9.6 About the Authors 182

9.6.1 Author 182

9.6.2 Epidemiologist 182

9.6.3 Global Head of Healthcare 183

9.7 About GlobalData 184

9.8 Disclaimer 184

1.2 List of Figures

Figure 1: Etiology of T1D 14

Figure 2: T1D - Disease Management Flowchart 26

Figure 3: Percent of Patients on Different Insulin Regimens in 2013 and 2018 (Average across the 8MM) 27

Figure 4: T1D Therapeutics - Clinical Trials by Country and by General Class, 2014 92

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 94

Figure 6: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 132

Figure 7: Sales for Type 1 Diabetes in the United States by Drug Class, 2013-2023 144

1.1 List of Tables

Table 1: Symptoms of T1D 16

Table 2: Diagnostic Tests and Typical Criteria for Diagnosing T1D 20

Table 3: Treatment Guidelines for T1D 22

Table 4: Most Prescribed Drugs for T1D in the 8MM, 2014 25

Table 5: Percent of Patients on Different Insulin Regimens in the 8MM, 2013 26

Table 6: Country Profile, T1D Management - US 31

Table 7: Insulins - Overview and Comparison 35

Table 8: Leading Treatments for Type 1 Diabetes, 2014 35

Table 9: Efficacy - Novolin R versus NovoLog 37

Table 10: Human Insulins SWOT Analysis, 2014 38

Table 11: Global Sales Forecasts (USDm) for Human Insulins (Regular, NPH, and Mix), 2013-2023 39

Table 12: Product Profile - Humalog 41

Table 13: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 42

Table 14: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 43

Table 15: Humalog SWOT Analysis, 2014 44

Table 16: Global Sales Forecasts (USDm) for Humalog, 2013-2023 45

Table 17: Product Profile - NovoLog/NovoRapid 47

Table 18: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 48

Table 19: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 49

Table 20: NovoLog SWOT Analysis, 2014 50

Table 21: Global Sales Forecasts (USDm) for NovoLog, 2013-2023 51

Table 22: Product Profile - Apidra 53

Table 23: Efficacy - Apidra versus Humalog 54

Table 24: Adverse Events from Pooled Studies - Humalog versus Comparators 55

Table 25: Apidra SWOT Analysis, 2014 56

Table 26: Global Sales Forecasts (USDm) for Apidra, 2013-2023 57

Table 27: Product Profile - Lantus 59

Table 28: Efficacy - Lantus versus NPH Insulin 60

Table 29: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 61

Table 30: Lantus SWOT Analysis, 2014 62

Table 31: Global Sales Forecasts (USDm) for Lantus, 2013-2023 63

Table 32: Product Profile - Levemir 65

Table 33: Efficacy - Levemir versus Lantus in Adult T1D Patients 66

Table 34: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 67

Table 35: Levemir SWOT Analysis, 2014 68

Table 36: Global Sales Forecasts (USDm) for Levemir, 2013-2023 69

Table 37: Product Profile - Tresiba 72

Table 38: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 73

Table 39: Rate of Hypoglycemia - Levemir versus Lantus 74

Table 40: Tresiba SWOT Analysis, 2014 75

Table 41: Global Sales Forecasts (USDm) for Tresiba, 2013-2023 76

Table 42: Unmet Need and Opportunity in T1D 80

Table 43: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 93

Table 44: Product Profile - Insulin Peglispro 96

Table 45: Insulin Peglispro SWOT Analysis, 2014 98

Table 46: Global Sales Forecasts (USDm) for Insulin Peglispro, 2013-2023 99

Table 47: Product Profile - Toujeo 101

Table 48: Toujeo SWOT Analysis, 2014 103

Table 49: Global Sales Forecasts (USDm) for Toujeo, 2013-2023 104

Table 50: Product Profile - Afrezza 106

Table 51: Efficacy - Afrezza versus NovoLog 107

Table 52: Adverse Events - Afrezza versus Subcutaneous Insulin 107

Table 53: Afrezza SWOT Analysis, 2014 108

Table 54: Global Sales Forecasts (USDm) for Afrezza, 2013-2023 110

Table 55: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 114

Table 56: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 115

Table 57: Global Sales Forecasts (USDm) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 116

Table 58: Product Profile - Victoza 118

Table 59: Victoza SWOT Analysis, 2014 121

Table 60: Global Sales Forecasts (USDm) GLP-1 Receptor Agonists, 2013-2023 122

Table 61: Product Profile - Jardiance 124

Table 62: Jardiance SWOT Analysis, 2014 126

Table 63: Global Sales Forecasts (USDm) for SGLT-2 inhibitors, 2013-2023 127

Table 64: Drugs in Phase I and Phase II Development for T1D,* 2014 138

Table 65: Sales Forecasts (USDm) for Type 1 Diabetes in the United States, 2013-2023 142

Table 66: Key Events Impacting Sales for T1D in the US, 2013-2023 145

Table 67: Type 1 Diabetes Market - Drivers and Barriers in the US, 2014 145

Table 68: Key Launch Dates 171

Table 69: Key Patent Expiries 172

Table 70: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 181

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