Type 1 Diabetes - Canada 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 $6.6 billiion to $13.6 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 Canada were around $139m. This growth will be fueled by the significant increase in T1D prevalence in Canada 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.
*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.
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 Canada including product T1Dcription, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Canada from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting Canada 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 Canada.
Table Of Contents
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 Canada 27
5 Competitive Assessment 31
5.1 Overview 31
5.2 Current Treatments 34
5.2.1 Human Insulins (Injectable Formulations) 34
5.2.2 Humalog (insulin lispro) 37
5.2.3 NovoLog/NovoRapid (insulin aspart) 43
5.2.4 Apidra (insulin glulisine) 49
5.2.5 Lantus (insulin glargine) 55
5.2.6 Levemir (insulin detemir) 62
5.2.7 Tresiba (insulin degludec) 67
5.2.8 Pancreas and Islet Cell Transplantation 74
6 Unmet Need and Opportunity 77
6.1 Overview 77
6.2 Disease-Modifying Treatment - Preservation of Beta Cells 78
6.2.1 Unmet Need 78
6.2.2 Gap Analysis 79
6.2.3 Opportunity 80
6.3 Hypoglycemia Avoidance 80
6.3.1 Unmet Need 80
6.3.2 Gap Analysis 81
6.3.3 Opportunity 82
6.4 Weight Loss and Control of Associated Metabolic Syndrome 82
6.4.1 Unmet Need 82
6.4.2 Gap Analysis 83
6.4.3 Opportunity 83
6.5 Treatment for Brittle Diabetes 84
6.5.1 Unmet Need 84
6.5.2 Gap Analysis 84
6.5.3 Opportunity 85
6.6 Increased Patient Adherence to Therapy 85
6.6.1 Unmet Need 85
6.6.2 Gap Analysis 86
6.6.3 Opportunity 86
7 Pipeline Assessment 87
7.1 Overview 87
7.2 Clinical Trial Mapping 89
7.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 89
7.3 Promising Drugs in Clinical Development 90
7.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 92
7.3.2 Novel Formulation of Insulin Glargine: Toujeo 97
7.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 102
7.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 108
7.3.5 Adjunct Therapies 114
7.4 Biosimilar Insulins 125
7.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 125
7.4.2 Biosimilar Insulins Pipeline 128
7.4.3 Forecast 129
7.5 Artificial Pancreas 131
7.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 132
8 Market Outlook 138
8.1 Canada 138
8.1.1 Forecast 138
8.1.2 Key Events 143
8.1.3 Drivers and Barriers 143
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
List Of Tables
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 - Canada 30
Table 7: Insulins - Overview and Comparison 33
Table 8: Leading Treatments for Type 1 Diabetes, 2014 33
Table 9: Efficacy - Novolin R versus NovoLog 35
Table 10: Human Insulins SWOT Analysis, 2014 36
Table 11: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013-2023 37
Table 12: Product Profile - Humalog 39
Table 13: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 40
Table 14: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 41
Table 15: Humalog SWOT Analysis, 2014 42
Table 16: Global Sales Forecasts ($m) for Humalog, 2013-2023 43
Table 17: Product Profile - NovoLog/NovoRapid 45
Table 18: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 46
Table 19: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 47
Table 20: NovoLog SWOT Analysis, 2014 48
Table 21: Global Sales Forecasts ($m) for NovoLog, 2013-2023 49
Table 22: Product Profile - Apidra 51
Table 23: Efficacy - Apidra versus Humalog 52
Table 24: Adverse Events from Pooled Studies - Humalog versus Comparators 53
Table 25: Apidra SWOT Analysis, 2014 54
Table 26: Global Sales Forecasts ($m) for Apidra, 2013-2023 55
Table 27: Product Profile - Lantus 57
Table 28: Efficacy - Lantus versus NPH Insulin 58
Table 29: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 59
Table 30: Lantus SWOT Analysis, 2014 60
Table 31: Global Sales Forecasts ($m) for Lantus, 2013-2023 61
Table 32: Product Profile - Levemir 63
Table 33: Efficacy - Levemir versus Lantus in Adult T1D Patients 64
Table 34: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 65
Table 35: Levemir SWOT Analysis, 2014 66
Table 36: Global Sales Forecasts ($m) for Levemir, 2013-2023 67
Table 37: Product Profile - Tresiba 70
Table 38: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 71
Table 39: Rate of Hypoglycemia - Levemir versus Lantus 72
Table 40: Tresiba SWOT Analysis, 2014 73
Table 41: Global Sales Forecasts ($m) for Tresiba, 2013-2023 74
Table 42: Unmet Need and Opportunity in T1D 78
Table 43: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 91
Table 44: Product Profile - Insulin Peglispro 94
Table 45: Insulin Peglispro SWOT Analysis, 2014 96
Table 46: Global Sales Forecasts ($m) for Insulin Peglispro, 2013-2023 97
Table 47: Product Profile - Toujeo 99
Table 48: Toujeo SWOT Analysis, 2014 101
Table 49: Global Sales Forecasts ($m) for Toujeo, 2013-2023 102
Table 50: Product Profile - Afrezza 104
Table 51: Efficacy - Afrezza versus NovoLog 105
Table 52: Adverse Events - Afrezza versus Subcutaneous Insulin 105
Table 53: Afrezza SWOT Analysis, 2014 106
Table 54: Global Sales Forecasts ($m) for Afrezza, 2013-2023 108
Table 55: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 112
Table 56: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 113
Table 57: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 114
Table 58: Product Profile - Victoza 116
Table 59: Victoza SWOT Analysis, 2014 119
Table 60: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013-2023 120
Table 61: Product Profile - Jardiance 122
Table 62: Jardiance SWOT Analysis, 2014 124
Table 63: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013-2023 125
Table 64: Drugs in Phase I and Phase II Development for T1D,* 2014 136
Table 65: Sales Forecasts ($m) for Type 1 Diabetes in Canada, 2013-2023 140
Table 66: Key Events Impacting Sales for T1D in Canada, 2013-2023 143
Table 67: Type 1 Diabetes Market - Drivers and Barriers in Canada, 2014 143
Table 68: Key Launch Dates 167
Table 69: Key Patent Expiries 168
Table 70: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 177
List Of Figures
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 90
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 92
Figure 6: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 130
Figure 7: Sales for Type 1 Diabetes in Canada by Drug Class, 2013-2023 142
Table Of Contents
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 Canada 27
5 Competitive Assessment 31
5.1 Overview 31
5.2 Current Treatments 34
5.2.1 Human Insulins (Injectable Formulations) 34
5.2.2 Humalog (insulin lispro) 37
5.2.3 NovoLog/NovoRapid (insulin aspart) 43
5.2.4 Apidra (insulin glulisine) 49
5.2.5 Lantus (insulin glargine) 55
5.2.6 Levemir (insulin detemir) 62
5.2.7 Tresiba (insulin degludec) 67
5.2.8 Pancreas and Islet Cell Transplantation 74
6 Unmet Need and Opportunity 77
6.1 Overview 77
6.2 Disease-Modifying Treatment - Preservation of Beta Cells 78
6.2.1 Unmet Need 78
6.2.2 Gap Analysis 79
6.2.3 Opportunity 80
6.3 Hypoglycemia Avoidance 80
6.3.1 Unmet Need 80
6.3.2 Gap Analysis 81
6.3.3 Opportunity 82
6.4 Weight Loss and Control of Associated Metabolic Syndrome 82
6.4.1 Unmet Need 82
6.4.2 Gap Analysis 83
6.4.3 Opportunity 83
6.5 Treatment for Brittle Diabetes 84
6.5.1 Unmet Need 84
6.5.2 Gap Analysis 84
6.5.3 Opportunity 85
6.6 Increased Patient Adherence to Therapy 85
6.6.1 Unmet Need 85
6.6.2 Gap Analysis 86
6.6.3 Opportunity 86
7 Pipeline Assessment 87
7.1 Overview 87
7.2 Clinical Trial Mapping 89
7.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 89
7.3 Promising Drugs in Clinical Development 90
7.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 92
7.3.2 Novel Formulation of Insulin Glargine: Toujeo 97
7.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 102
7.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 108
7.3.5 Adjunct Therapies 114
7.4 Biosimilar Insulins 125
7.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 125
7.4.2 Biosimilar Insulins Pipeline 128
7.4.3 Forecast 129
7.5 Artificial Pancreas 131
7.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 132
8 Market Outlook 138
8.1 Canada 138
8.1.1 Forecast 138
8.1.2 Key Events 143
8.1.3 Drivers and Barriers 143
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
List Of Tables
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 - Canada 30
Table 7: Insulins - Overview and Comparison 33
Table 8: Leading Treatments for Type 1 Diabetes, 2014 33
Table 9: Efficacy - Novolin R versus NovoLog 35
Table 10: Human Insulins SWOT Analysis, 2014 36
Table 11: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013-2023 37
Table 12: Product Profile - Humalog 39
Table 13: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 40
Table 14: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 41
Table 15: Humalog SWOT Analysis, 2014 42
Table 16: Global Sales Forecasts ($m) for Humalog, 2013-2023 43
Table 17: Product Profile - NovoLog/NovoRapid 45
Table 18: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 46
Table 19: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 47
Table 20: NovoLog SWOT Analysis, 2014 48
Table 21: Global Sales Forecasts ($m) for NovoLog, 2013-2023 49
Table 22: Product Profile - Apidra 51
Table 23: Efficacy - Apidra versus Humalog 52
Table 24: Adverse Events from Pooled Studies - Humalog versus Comparators 53
Table 25: Apidra SWOT Analysis, 2014 54
Table 26: Global Sales Forecasts ($m) for Apidra, 2013-2023 55
Table 27: Product Profile - Lantus 57
Table 28: Efficacy - Lantus versus NPH Insulin 58
Table 29: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 59
Table 30: Lantus SWOT Analysis, 2014 60
Table 31: Global Sales Forecasts ($m) for Lantus, 2013-2023 61
Table 32: Product Profile - Levemir 63
Table 33: Efficacy - Levemir versus Lantus in Adult T1D Patients 64
Table 34: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 65
Table 35: Levemir SWOT Analysis, 2014 66
Table 36: Global Sales Forecasts ($m) for Levemir, 2013-2023 67
Table 37: Product Profile - Tresiba 70
Table 38: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 71
Table 39: Rate of Hypoglycemia - Levemir versus Lantus 72
Table 40: Tresiba SWOT Analysis, 2014 73
Table 41: Global Sales Forecasts ($m) for Tresiba, 2013-2023 74
Table 42: Unmet Need and Opportunity in T1D 78
Table 43: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 91
Table 44: Product Profile - Insulin Peglispro 94
Table 45: Insulin Peglispro SWOT Analysis, 2014 96
Table 46: Global Sales Forecasts ($m) for Insulin Peglispro, 2013-2023 97
Table 47: Product Profile - Toujeo 99
Table 48: Toujeo SWOT Analysis, 2014 101
Table 49: Global Sales Forecasts ($m) for Toujeo, 2013-2023 102
Table 50: Product Profile - Afrezza 104
Table 51: Efficacy - Afrezza versus NovoLog 105
Table 52: Adverse Events - Afrezza versus Subcutaneous Insulin 105
Table 53: Afrezza SWOT Analysis, 2014 106
Table 54: Global Sales Forecasts ($m) for Afrezza, 2013-2023 108
Table 55: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 112
Table 56: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 113
Table 57: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 114
Table 58: Product Profile - Victoza 116
Table 59: Victoza SWOT Analysis, 2014 119
Table 60: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013-2023 120
Table 61: Product Profile - Jardiance 122
Table 62: Jardiance SWOT Analysis, 2014 124
Table 63: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013-2023 125
Table 64: Drugs in Phase I and Phase II Development for T1D,* 2014 136
Table 65: Sales Forecasts ($m) for Type 1 Diabetes in Canada, 2013-2023 140
Table 66: Key Events Impacting Sales for T1D in Canada, 2013-2023 143
Table 67: Type 1 Diabetes Market - Drivers and Barriers in Canada, 2014 143
Table 68: Key Launch Dates 167
Table 69: Key Patent Expiries 168
Table 70: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 177
List Of Figures
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 90
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 92
Figure 6: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 130
Figure 7: Sales for Type 1 Diabetes in Canada by Drug Class, 2013-2023 142
