Type 1 Diabetes - 5EU Drug Forecast and Market Analysis to 2023

Type 1 Diabetes - 5EU Drug Forecast and Market Analysis to 2023


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Executive Summary

Type 1 Diabetes - 5EU 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 5.8% per year through 2023. This growth will be fueled by the increase in T1D prevalence in the 5EU 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 5EU including product T1Dcription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU 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 5EU.



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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 France 27

4.3 Germany 31

4.4 Italy 34

4.5 Spain 37

4.6 UK 40

5 Competitive Assessment 44

5.1 Overview 44

5.2 Current Treatments 47

5.2.1 Human Insulins (Injectable Formulations) 47

5.2.2 Humalog (insulin lispro) 50

5.2.3 NovoLog/NovoRapid (insulin aspart) 56

5.2.4 Apidra (insulin glulisine) 62

5.2.5 Lantus (insulin glargine) 68

5.2.6 Levemir (insulin detemir) 75

5.2.7 Tresiba (insulin degludec) 80

5.2.8 Pancreas and Islet Cell Transplantation 87

6 Unmet Need and Opportunity 90

6.1 Overview 90

6.2 Disease-Modifying Treatment - Preservation of Beta Cells 91

6.2.1 Unmet Need 91

6.2.2 Gap Analysis 92

6.2.3 Opportunity 93

6.3 Hypoglycemia Avoidance 93

6.3.1 Unmet Need 93

6.3.2 Gap Analysis 94

6.3.3 Opportunity 95

6.4 Weight Loss and Control of Associated Metabolic Syndrome 95

6.4.1 Unmet Need 95

6.4.2 Gap Analysis 96

6.4.3 Opportunity 96

6.5 Treatment for Brittle Diabetes 97

6.5.1 Unmet Need 97

6.5.2 Gap Analysis 97

6.5.3 Opportunity 98

6.6 Increased Patient Adherence to Therapy 98

6.6.1 Unmet Need 98

6.6.2 Gap Analysis 99

6.6.3 Opportunity 99

7 Pipeline Assessment 100

7.1 Overview 100

7.2 Clinical Trial Mapping 102

7.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 102

7.3 Promising Drugs in Clinical Development 103

7.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 105

7.3.2 Novel Formulation of Insulin Glargine: Toujeo 110

7.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 115

7.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 121

7.3.5 Adjunct Therapies 127

7.4 Biosimilar Insulins 138

7.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 138

7.4.2 Biosimilar Insulins Pipeline 141

7.4.3 Forecast 142

7.5 Artificial Pancreas 144

7.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 145

8 Market Outlook 151

8.1 5EU 151

8.1.1 Forecast 151

8.1.2 Key Events 156

8.1.3 Drivers and Barriers 157

9 Appendix 162

9.1 Bibliography 162

9.2 Abbreviations 178

9.3 Methodology 183

9.4 Forecasting Methodology 183

9.4.1 Diagnosed Type 1 Diabetes Patients 183

9.4.2 Percent Drug-Treated Patients 183

9.4.3 Drugs Included in Each Therapeutic Class 184

9.4.4 Launch and Patent Expiry Dates 184

9.4.5 General Pricing Assumptions 185

9.4.6 Individual Drug Assumptions 186

9.4.7 Pricing of Pipeline Agents 189

9.5 Physicians and Specialists Included in This Study 191

9.6 About the Authors 195

9.6.1 Author 195

9.6.2 Epidemiologist 195

9.6.3 Global Head of Healthcare 196

9.7 About GlobalData 197

9.8 Disclaimer 197

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 103

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 105

Figure 6: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 143

Figure 7: Sales for Type 1 Diabetes in the 5EU by Drug Class, 2013-2023 155

Figure 8: Sales for Type 1 Diabetes in the 5EU by Country, 2013-2023 156

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 - France 30

Table 7: Country Profile, T1D Management - Germany 33

Table 8: Country Profile, T1D Management - Italy 36

Table 9: Country Profile, T1D Management - Spain 39

Table 10: Country Profile, T1D Management - United Kingdom 42

Table 11: Insulins - Overview and Comparison 46

Table 12: Leading Treatments for Type 1 Diabetes, 2014 46

Table 13: Efficacy - Novolin R versus NovoLog 48

Table 14: Human Insulins SWOT Analysis, 2014 49

Table 15: Global Sales Forecasts (USDm) for Human Insulins (Regular, NPH, and Mix), 2013-2023 50

Table 16: Product Profile - Humalog 52

Table 17: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 53

Table 18: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 54

Table 19: Humalog SWOT Analysis, 2014 55

Table 20: Global Sales Forecasts (USDm) for Humalog, 2013-2023 56

Table 21: Product Profile - NovoLog/NovoRapid 58

Table 22: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 59

Table 23: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 60

Table 24: NovoLog SWOT Analysis, 2014 61

Table 25: Global Sales Forecasts (USDm) for NovoLog, 2013-2023 62

Table 26: Product Profile - Apidra 64

Table 27: Efficacy - Apidra versus Humalog 65

Table 28: Adverse Events from Pooled Studies - Humalog versus Comparators 66

Table 29: Apidra SWOT Analysis, 2014 67

Table 30: Global Sales Forecasts (USDm) for Apidra, 2013-2023 68

Table 31: Product Profile - Lantus 70

Table 32: Efficacy - Lantus versus NPH Insulin 71

Table 33: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 72

Table 34: Lantus SWOT Analysis, 2014 73

Table 35: Global Sales Forecasts (USDm) for Lantus, 2013-2023 74

Table 36: Product Profile - Levemir 76

Table 37: Efficacy - Levemir versus Lantus in Adult T1D Patients 77

Table 38: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 78

Table 39: Levemir SWOT Analysis, 2014 79

Table 40: Global Sales Forecasts (USDm) for Levemir, 2013-2023 80

Table 41: Product Profile - Tresiba 83

Table 42: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 84

Table 43: Rate of Hypoglycemia - Levemir versus Lantus 85

Table 44: Tresiba SWOT Analysis, 2014 86

Table 45: Global Sales Forecasts (USDm) for Tresiba, 2013-2023 87

Table 46: Unmet Need and Opportunity in T1D 91

Table 47: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 104

Table 48: Product Profile - Insulin Peglispro 107

Table 49: Insulin Peglispro SWOT Analysis, 2014 109

Table 50: Global Sales Forecasts (USDm) for Insulin Peglispro, 2013-2023 110

Table 51: Product Profile - Toujeo 112

Table 52: Toujeo SWOT Analysis, 2014 114

Table 53: Global Sales Forecasts (USDm) for Toujeo, 2013-2023 115

Table 54: Product Profile - Afrezza 117

Table 55: Efficacy - Afrezza versus NovoLog 118

Table 56: Adverse Events - Afrezza versus Subcutaneous Insulin 118

Table 57: Afrezza SWOT Analysis, 2014 119

Table 58: Global Sales Forecasts (USDm) for Afrezza, 2013-2023 121

Table 59: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 125

Table 60: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 126

Table 61: Global Sales Forecasts (USDm) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 127

Table 62: Product Profile - Victoza 129

Table 63: Victoza SWOT Analysis, 2014 132

Table 64: Global Sales Forecasts (USDm) GLP-1 Receptor Agonists, 2013-2023 133

Table 65: Product Profile - Jardiance 135

Table 66: Jardiance SWOT Analysis, 2014 137

Table 67: Global Sales Forecasts (USDm) for SGLT-2 inhibitors, 2013-2023 138

Table 68: Drugs in Phase I and Phase II Development for T1D,* 2014 149

Table 69: Sales Forecasts (USDm) for Type 1 Diabetes in the 5EU, 2013-2023 153

Table 70: Key Events Impacting Sales for T1D in the 5EU, 2013-2023 156

Table 71: Type 1 Diabetes Market - Drivers and Barriers in the 5EU, 2014 157

Table 72: Key Launch Dates 184

Table 73: Key Patent Expiries 185

Table 74: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 194

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