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

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


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  • Pages: 181
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Executive Summary

Type 1 Diabetes - Japan 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.

The 2013 base-year market sales of T1D products in Japan were around USD592m. This growth will be fueled by the increase in T1D prevalence in Japan, 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 Japan including product T1Dcription, safety and efficacy profiles as well as a SWOT analysis.

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

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



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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 Japan 27

5 Competitive Assessment 30

5.1 Overview 30

5.2 Current Treatments 33

5.2.1 Human Insulins (Injectable Formulations) 33

5.2.2 Humalog (insulin lispro) 36

5.2.3 NovoLog/NovoRapid (insulin aspart) 42

5.2.4 Apidra (insulin glulisine) 48

5.2.5 Lantus (insulin glargine) 54

5.2.6 Levemir (insulin detemir) 61

5.2.7 Tresiba (insulin degludec) 66

5.2.8 Pancreas and Islet Cell Transplantation 73

6 Unmet Need and Opportunity 76

6.1 Overview 76

6.2 Disease-Modifying Treatment - Preservation of Beta Cells 77

6.2.1 Unmet Need 77

6.2.2 Gap Analysis 78

6.2.3 Opportunity 79

6.3 Hypoglycemia Avoidance 79

6.3.1 Unmet Need 79

6.3.2 Gap Analysis 80

6.3.3 Opportunity 81

6.4 Weight Loss and Control of Associated Metabolic Syndrome 81

6.4.1 Unmet Need 81

6.4.2 Gap Analysis 82

6.4.3 Opportunity 82

6.5 Treatment for Brittle Diabetes 83

6.5.1 Unmet Need 83

6.5.2 Gap Analysis 83

6.5.3 Opportunity 84

6.6 Increased Patient Adherence to Therapy 84

6.6.1 Unmet Need 84

6.6.2 Gap Analysis 85

6.6.3 Opportunity 85

7 Pipeline Assessment 86

7.1 Overview 86

7.2 Clinical Trial Mapping 88

7.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 88

7.3 Promising Drugs in Clinical Development 89

7.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 91

7.3.2 Novel Formulation of Insulin Glargine: Toujeo 96

7.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 101

7.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 107

7.3.5 Adjunct Therapies 113

7.4 Biosimilar Insulins 124

7.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 124

7.4.2 Biosimilar Insulins Pipeline 127

7.4.3 Forecast 128

7.5 Artificial Pancreas 130

7.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 131

8 Market Outlook 137

8.1 Japan 137

8.1.1 Forecast 137

8.1.2 Key Events 142

8.1.3 Drivers and Barriers 142

9 Appendix 145

9.1 Bibliography 145

9.2 Abbreviations 161

9.3 Methodology 166

9.4 Forecasting Methodology 166

9.4.1 Diagnosed Type 1 Diabetes Patients 166

9.4.2 Percent Drug-Treated Patients 166

9.4.3 Drugs Included in Each Therapeutic Class 167

9.4.4 Launch and Patent Expiry Dates 167

9.4.5 General Pricing Assumptions 168

9.4.6 Individual Drug Assumptions 169

9.4.7 Pricing of Pipeline Agents 172

9.5 Physicians and Specialists Included in This Study 174

9.6 About the Authors 178

9.6.1 Author 178

9.6.2 Epidemiologist 178

9.6.3 Global Head of Healthcare 179

9.7 About GlobalData 180

9.8 Disclaimer 180

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 89

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 91

Figure 6: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 129

Figure 7: Sales for Type 1 Diabetes in Japan by Drug Class, 2013-2023 141

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 - Japan 28

Table 7: Insulins - Overview and Comparison 32

Table 8: Leading Treatments for Type 1 Diabetes, 2014 32

Table 9: Efficacy - Novolin R versus NovoLog 34

Table 10: Human Insulins SWOT Analysis, 2014 35

Table 11: Global Sales Forecasts (USDm) for Human Insulins (Regular, NPH, and Mix), 2013-2023 36

Table 12: Product Profile - Humalog 38

Table 13: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 39

Table 14: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 40

Table 15: Humalog SWOT Analysis, 2014 41

Table 16: Global Sales Forecasts (USDm) for Humalog, 2013-2023 42

Table 17: Product Profile - NovoLog/NovoRapid 44

Table 18: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 45

Table 19: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 46

Table 20: NovoLog SWOT Analysis, 2014 47

Table 21: Global Sales Forecasts (USDm) for NovoLog, 2013-2023 48

Table 22: Product Profile - Apidra 50

Table 23: Efficacy - Apidra versus Humalog 51

Table 24: Adverse Events from Pooled Studies - Humalog versus Comparators 52

Table 25: Apidra SWOT Analysis, 2014 53

Table 26: Global Sales Forecasts (USDm) for Apidra, 2013-2023 54

Table 27: Product Profile - Lantus 56

Table 28: Efficacy - Lantus versus NPH Insulin 57

Table 29: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 58

Table 30: Lantus SWOT Analysis, 2014 59

Table 31: Global Sales Forecasts (USDm) for Lantus, 2013-2023 60

Table 32: Product Profile - Levemir 62

Table 33: Efficacy - Levemir versus Lantus in Adult T1D Patients 63

Table 34: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 64

Table 35: Levemir SWOT Analysis, 2014 65

Table 36: Global Sales Forecasts (USDm) for Levemir, 2013-2023 66

Table 37: Product Profile - Tresiba 69

Table 38: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 70

Table 39: Rate of Hypoglycemia - Levemir versus Lantus 71

Table 40: Tresiba SWOT Analysis, 2014 72

Table 41: Global Sales Forecasts (USDm) for Tresiba, 2013-2023 73

Table 42: Unmet Need and Opportunity in T1D 77

Table 43: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 90

Table 44: Product Profile - Insulin Peglispro 93

Table 45: Insulin Peglispro SWOT Analysis, 2014 95

Table 46: Global Sales Forecasts (USDm) for Insulin Peglispro, 2013-2023 96

Table 47: Product Profile - Toujeo 98

Table 48: Toujeo SWOT Analysis, 2014 100

Table 49: Global Sales Forecasts (USDm) for Toujeo, 2013-2023 101

Table 50: Product Profile - Afrezza 103

Table 51: Efficacy - Afrezza versus NovoLog 104

Table 52: Adverse Events - Afrezza versus Subcutaneous Insulin 104

Table 53: Afrezza SWOT Analysis, 2014 105

Table 54: Global Sales Forecasts (USDm) for Afrezza, 2013-2023 107

Table 55: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 111

Table 56: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 112

Table 57: Global Sales Forecasts (USDm) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 113

Table 58: Product Profile - Victoza 115

Table 59: Victoza SWOT Analysis, 2014 118

Table 60: Global Sales Forecasts (USDm) GLP-1 Receptor Agonists, 2013-2023 119

Table 61: Product Profile - Jardiance 121

Table 62: Jardiance SWOT Analysis, 2014 123

Table 63: Global Sales Forecasts (USDm) for SGLT-2 inhibitors, 2013-2023 124

Table 64: Drugs in Phase I and Phase II Development for T1D,* 2014 135

Table 65: Sales Forecasts (USDm) for Type 1 Diabetes in Japan, 2013-2023 139

Table 66: Key Events Impacting Sales for T1D in Japan, 2013-2023 142

Table 67: Type 1 Diabetes Market - Drivers and Barriers in Japan, 2014 142

Table 68: Key Launch Dates 167

Table 69: Key Patent Expiries 168

Table 70: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 177

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