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PharmaPoint: Type 1 Diabetes - Global 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.

Highlights

Key Questions Answered

- Insulin therapy has been the cornerstone of the T1D treatment. The advances in insulin therapies have contributed to better treatment of T1D patients; nevertheless, the overall life expectancy in T1D patients is still 10-15 years less than in the healthy population. Therefore, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the T1D market?
- The current late-stage T1D pipeline encompasses one novel ultra-long-acting insulin analog, several novel ultra-rapid formulations of already marketed human insulins and rapid-insulin analogs, biosimilar versions of marketed insulins, and last but not least, adjunctive therapies that are focused on complementing intensive insulin therapy. Will the late-stage drugs make a significant impact on the T1D market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?
- We have seen a significant increase in T1D diagnosed prevalence over the past 10 years. How will epidemiological changes impact the growth of the future market?

Key Findings

- The main driver of the enormous expansion of the T1D market will be the significant increase in T1D diagnosed prevalence as well as the uptake of novel ultra-long-acting insulin analogs , novel ultra-rapid-acting formulations of currently marketed rapid-acting insulin analogs and adjunct therapies such as GLP-1 RAs and SGLT-2, inhibitors.
- The major global barrier for the T1Dmarket will be the biosimilar erosion of the leading insulin brands for T1D treatment, such as Lantus (insulin glargine), Levemir (insulin detemir), Humalog (insulin lispro), and NovoLog (insulin aspart).
- The dynamics of the insulin market will not change drastically over the next 10 years in terms of the current and future players in the T1D market and GlobalData expects that Novo Nordisk, Sanofi, and Eli Lilly will continue ruling this space, as they are undertaking various strategies to defend their franchises from upcoming biosimilar erosion.
- One of the largest unmet needs is a need for therapies that would interfere with the pathogenic processes involved in the eradication of the beta cells in T1D patients. Other unmet needs include hypoglycemia avoidance, weight loss and control of the associated metabolic syndrome, treatment for brittle diabetes, and increased patient compliance.

Scope

- Overview of type 1 diabetes, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized T1D therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the T1D therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global T1Dtherapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global T1D therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T1D therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global T1D therapeutics market from 2013-2023.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Type 1 Diabetes - Global Drug Forecast and Market Analysis to 2023
1 Table of Contents
1 Table of Contents 11
1.1 List of Tables 16
1.2 List of Figures 21
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 26
3.1.3 Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes 27
3.2 Symptoms 28
3.3 Prognosis 29
3.4 Quality of Life 29
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 32
4.3 Global Trends 34
4.3.1 US 34
4.3.2 5EU 35
4.3.3 Japan 35
4.3.4 Canada 36
4.4 Forecast Methodology 36
4.4.1 Sources Used 38
4.4.2 Sources Not Used 41
4.4.3 8MM, Forecast Assumptions and Methods - Diagnosed Prevalent Cases of Type 2 Diabetes in Persons Ages ?20 Years 42
4.4.4 8MM, Forecast Assumptions and Methods - Diagnosed Prevalent Cases of Type 1 Diabetes 45
4.5 Epidemiological Forecast for Type 1 Diabetes (2013-2023) 51
4.5.1 Diagnosed Prevalent Cases of Type 1 Diabetes 51
4.5.2 Age-Specific Diagnosed Prevalent Cases of Type 1 Diabetes 52
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Type 1 Diabetes 54
4.5.4 Age-Standardized Diagnosed Prevalence of Type 1 Diabetes 56
4.5.5 Diagnosed Prevalent Cases of Type 1 Diabetes Segmented by Body Mass Index 58
4.6 Discussion 59
4.6.1 Epidemiological Forecast Insight 59
4.6.2 Limitations of the Analysis 59
4.6.3 Strengths of the Analysis 60
5 Disease Management 61
5.1 Diagnosis and Treatment Overview 61
5.1.1 Diagnosis 61
5.1.2 Treatment Guidelines and Leading Prescribed Therapies 63
5.1.3 Clinical Practice 65
5.2 US 70
5.3 France 74
5.4 Germany 77
5.5 Italy 80
5.6 Spain 83
5.7 UK 86
5.8 Japan 89
5.9 Canada 91
6 Competitive Assessment 94
6.1 Overview 94
6.2 Current Treatments 97
6.2.1 Human Insulins (Injectable Formulations) 97
6.2.2 Humalog (insulin lispro) 100
6.2.3 NovoLog/NovoRapid (insulin aspart) 106
6.2.4 Apidra (insulin glulisine) 112
6.2.5 Lantus (insulin glargine) 118
6.2.6 Levemir (insulin detemir) 125
6.2.7 Tresiba (insulin degludec) 130
6.2.8 Pancreas and Islet Cell Transplantation 137
7 Unmet Need and Opportunity 140
7.1 Overview 140
7.2 Disease-Modifying Treatment - Preservation of Beta Cells 141
7.2.1 Unmet Need 141
7.2.2 Gap Analysis 142
7.2.3 Opportunity 143
7.3 Hypoglycemia Avoidance 143
7.3.1 Unmet Need 143
7.3.2 Gap Analysis 144
7.3.3 Opportunity 145
7.4 Weight Loss and Control of Associated Metabolic Syndrome 145
7.4.1 Unmet Need 145
7.4.2 Gap Analysis 146
7.4.3 Opportunity 146
7.5 Treatment for Brittle Diabetes 147
7.5.1 Unmet Need 147
7.5.2 Gap Analysis 147
7.5.3 Opportunity 148
7.6 Increased Patient Adherence to Therapy 148
7.6.1 Unmet Need 148
7.6.2 Gap Analysis 149
7.6.3 Opportunity 149
8 Pipeline Assessment 150
8.1 Overview 150
8.2 Clinical Trial Mapping 152
8.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 152
8.3 Promising Drugs in Clinical Development 153
8.3.1 Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro 155
8.3.2 Novel Formulation of Insulin Glargine: Toujeo 160
8.3.3 Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin) 165
8.3.4 Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs 171
8.3.5 Adjunct Therapies 177
8.4 Biosimilar Insulins 188
8.4.1 Overview of the Regulatory Processes for Biosimilar Insulins 188
8.4.2 Biosimilar Insulins Pipeline 191
8.4.3 Forecast 192
8.5 Artificial Pancreas 194
8.6 Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins 195
9 Current and Future Players 201
9.1 Overview 201
9.2 Trends in Corporate Strategy 203
9.3 Company Profiles 204
9.3.1 Novo Nordisk 204
9.3.2 Sanofi 207
9.3.3 Eli Lilly 210
10 Market Outlook 214
10.1 Global Markets 214
10.1.1 Forecast 214
10.1.2 Drivers and Barriers - Global Issues 220
10.2 United States 222
10.2.1 Forecast 222
10.2.2 Key Events 227
10.2.3 Drivers and Barriers 227
10.3 5EU 230
10.3.1 Forecast 230
10.3.2 Key Events 235
10.3.3 Drivers and Barriers 236
10.4 Japan 240
10.4.1 Forecast 240
10.4.2 Key Events 245
10.4.3 Drivers and Barriers 245
10.5 Canada 247
10.5.1 Forecast 247
10.5.2 Key Events 252
10.5.3 Drivers and Barriers 252
11 Appendix 254
11.1 Bibliography 254
11.2 Abbreviations 270
11.3 Methodology 275
11.4 Forecasting Methodology 275
11.4.1 Diagnosed Type 1 Diabetes Patients 275
11.4.2 Percent Drug-Treated Patients 275
11.4.3 Drugs Included in Each Therapeutic Class 276
11.4.4 Launch and Patent Expiry Dates 276
11.4.5 General Pricing Assumptions 277
11.4.6 Individual Drug Assumptions 278
11.4.7 Pricing of Pipeline Agents 281
11.5 Physicians and Specialists Included in This Study 283
11.6 About the Authors 286
11.6.1 Author 286
11.6.2 Epidemiologist 286
11.6.3 Global Head of Healthcare 287
11.7 About GlobalData 288
11.8 Disclaimer 288

1.1 List of Tables
Table 1: Symptoms of T1D 28
Table 2: Risk Factors and Comorbidities for T1D 33
Table 3: 8MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of T1D 37
Table 4: 8MM, Sources of Epidemiological Data Used for the Prevalent Cases of T1D Segmented by BMI 37
Table 5: 8MM, Sources Not Used in the Epidemiological Analysis of T1D 42
Table 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013-2023 51
Table 7: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N (Row %), 2013 53
Table 8: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N (Row %), 2013 55
Table 9: Diagnostic Tests and Typical Criteria for Diagnosing T1D 62
Table 10: Treatment Guidelines for T1D 64
Table 11: Most Prescribed Drugs for T1D in the 8MM, 2014 67
Table 12: Percent of Patients on Different Insulin Regimens in the 8MM, 2013 68
Table 13: Country Profile, T1D Management - US 73
Table 14: Country Profile, T1D Management - France 76
Table 15: Country Profile, T1D Management - Germany 79
Table 16: Country Profile, T1D Management - Italy 82
Table 17: Country Profile, T1D Management - Spain 85
Table 18: Country Profile, T1D Management - United Kingdom 88
Table 19: Country Profile, T1D Management - Japan 90
Table 20: Country Profile, T1D Management - Canada 93
Table 21: Insulins - Overview and Comparison 96
Table 22: Leading Treatments for Type 1 Diabetes, 2014 96
Table 23: Efficacy - Novolin R versus NovoLog 98
Table 24: Human Insulins SWOT Analysis, 2014 99
Table 25: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013-2023 100
Table 26: Product Profile - Humalog 102
Table 27: Efficacy - Humalog versus Regular Human Insulin (Humulin R) 103
Table 28: Adverse Events - Humalog versus Regular Human Insulin (Humulin R) 104
Table 29: Humalog SWOT Analysis, 2014 105
Table 30: Global Sales Forecasts ($m) for Humalog, 2013-2023 106
Table 31: Product Profile - NovoLog/NovoRapid 108
Table 32: Efficacy - NovoLog versus Regular Human Insulin (Novolin R) 109
Table 33: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R) 110
Table 34: NovoLog SWOT Analysis, 2014 111
Table 35: Global Sales Forecasts ($m) for NovoLog, 2013-2023 112
Table 36: Product Profile - Apidra 114
Table 37: Efficacy - Apidra versus Humalog 115
Table 38: Adverse Events from Pooled Studies - Humalog versus Comparators 116
Table 39: Apidra SWOT Analysis, 2014 117
Table 40: Global Sales Forecasts ($m) for Apidra, 2013-2023 118
Table 41: Product Profile - Lantus 120
Table 42: Efficacy - Lantus versus NPH Insulin 121
Table 43: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin 122
Table 44: Lantus SWOT Analysis, 2014 123
Table 45: Global Sales Forecasts ($m) for Lantus, 2013-2023 124
Table 46: Product Profile - Levemir 126
Table 47: Efficacy - Levemir versus Lantus in Adult T1D Patients 127
Table 48: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus 128
Table 49: Levemir SWOT Analysis, 2014 129
Table 50: Global Sales Forecasts ($m) for Levemir, 2013-2023 130
Table 51: Product Profile - Tresiba 133
Table 52: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial) 134
Table 53: Rate of Hypoglycemia - Levemir versus Lantus 135
Table 54: Tresiba SWOT Analysis, 2014 136
Table 55: Global Sales Forecasts ($m) for Tresiba, 2013-2023 137
Table 56: Unmet Need and Opportunity in T1D 141
Table 57: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014 154
Table 58: Product Profile - Insulin Peglispro 157
Table 59: Insulin Peglispro SWOT Analysis, 2014 159
Table 60: Global Sales Forecasts ($m) for Insulin Peglispro, 2013-2023 160
Table 61: Product Profile - Toujeo 162
Table 62: Toujeo SWOT Analysis, 2014 164
Table 63: Global Sales Forecasts ($m) for Toujeo, 2013-2023 165
Table 64: Product Profile - Afrezza 167
Table 65: Efficacy - Afrezza versus NovoLog 168
Table 66: Adverse Events - Afrezza versus Subcutaneous Insulin 168
Table 67: Afrezza SWOT Analysis, 2014 169
Table 68: Global Sales Forecasts ($m) for Afrezza, 2013-2023 171
Table 69: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014 175
Table 70: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014 176
Table 71: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023 177
Table 72: Product Profile - Victoza 179
Table 73: Victoza SWOT Analysis, 2014 182
Table 74: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013-2023 183
Table 75: Product Profile - Jardiance 185
Table 76: Jardiance SWOT Analysis, 2014 187
Table 77: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013-2023 188
Table 78: Drugs in Phase I and Phase II Development for T1D,* 2014 199
Table 79: Key Companies in the T1D Market in the 8MM, 2014 202
Table 80: Novo Nordisk's T1D Portfolio Assessment, 2014 206
Table 81: Novo Nordisk SWOT Analysis, 2014 207
Table 82: Sanofi's T1D Portfolio Assessment, 2014 209
Table 83: Sanofi SWOT Analysis, 2014 210
Table 84: Eli Lilly's T1D Portfolio Assessment, 2014 212
Table 85: Eli Lilly SWOT Analysis, 2014 213
Table 86: Global Sales Forecasts ($m) for Type 1 Diabetes, 2013-2023 217
Table 87: Type 1 Diabetes Market - Drivers and Barriers, 2014 220
Table 88: Sales Forecasts ($m) for Type 1 Diabetes in the United States, 2013-2023 224
Table 89: Key Events Impacting Sales for T1D in the US, 2013-2023 227
Table 90: Type 1 Diabetes Market - Drivers and Barriers in the US, 2014 227
Table 91: Sales Forecasts ($m) for Type 1 Diabetes in the 5EU, 2013-2023 232
Table 92: Key Events Impacting Sales for T1D in the 5EU, 2013-2023 235
Table 93: Type 1 Diabetes Market - Drivers and Barriers in the 5EU, 2014 236
Table 94: Sales Forecasts ($m) for Type 1 Diabetes in Japan, 2013-2023 242
Table 95: Key Events Impacting Sales for T1D in Japan, 2013-2023 245
Table 96: Type 1 Diabetes Market - Drivers and Barriers in Japan, 2014 245
Table 97: Sales Forecasts ($m) for Type 1 Diabetes in Canada, 2013-2023 249
Table 98: Key Events Impacting Sales for T1D in Canada, 2013-2023 252
Table 99: Type 1 Diabetes Market - Drivers and Barriers in Canada, 2014 252
Table 100: Key Launch Dates 276
Table 101: Key Patent Expiries 277
Table 102: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 285

1.2 List of Figures
Figure 1: Etiology of T1D 26
Figure 2: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013-2023 52
Figure 3: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N, 2013-2023 54
Figure 4: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N, 2013 56
Figure 5: 8MM, Age-Standardized Diagnosed Prevalence (%) of T1D, All Ages, by Sex, 2013 57
Figure 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, by BMI (kg/m2), 2013 58
Figure 7: T1D - Disease Management Flowchart 68
Figure 8: Percent of Patients on Different Insulin Regimens in 2013 and 2018 (Average across the 8MM) 69
Figure 9: T1D Therapeutics - Clinical Trials by Country and by General Class, 2014 153
Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023 155
Figure 11: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023 193
Figure 12: Company Portfolio Gap Analysis in Type 1 Diabetes, 2013-2023 203
Figure 13: Global Sales for Type 1 Diabetes by Region, 2013-2023 219
Figure 14: Sales for Type 1 Diabetes in the United States by Drug Class, 2013-2023 226
Figure 15: Sales for Type 1 Diabetes in the 5EU by Drug Class, 2013-2023 234
Figure 16: Sales for Type 1 Diabetes in the 5EU by Country, 2013-2023 235
Figure 17: Sales for Type 1 Diabetes in Japan by Drug Class, 2013-2023 244
Figure 18: Sales for Type 1 Diabetes in Canada by Drug Class, 2013-2023 251

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