PharmaPoint: Type 1 Diabetes – Global Drug Forecast and Market Analysis to 2023

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.

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.

Key Highlights

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?

Companies mentioned

Novo Nordisk

Sanofi

Eli Lilly and Co.

Merck

Astra Zeneca

Mylan

Adocia

Halozyme Therapeutics

Biodel

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.1.3Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes

3.2Symptoms

3.3Prognosis

3.4Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.3.4Canada

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.38MM, Forecast Assumptions and Methods – Diagnosed Prevalent Cases of Type 2 Diabetes in Persons Ages =20 Years

4.4.48MM, Forecast Assumptions and Methods – Diagnosed Prevalent Cases of Type 1 Diabetes

4.5Epidemiological Forecast for Type 1 Diabetes (2013–2023)

4.5.1Diagnosed Prevalent Cases of Type 1 Diabetes

4.5.2Age-Specific Diagnosed Prevalent Cases of Type 1 Diabetes

4.5.3Sex-Specific Diagnosed Prevalent Cases of Type 1 Diabetes

4.5.4Age-Standardized Diagnosed Prevalence of Type 1 Diabetes

4.5.5Diagnosed Prevalent Cases of Type 1 Diabetes Segmented by Body Mass Index

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Therapies

5.1.3Clinical Practice

5.2US

5.3France

5.4Germany

5.5Italy

5.6Spain

5.7UK

5.8Japan

5.9Canada

6Competitive Assessment

6.1Overview

6.2Current Treatments

6.2.1Human Insulins (Injectable Formulations)

6.2.2Humalog (insulin lispro)

6.2.3NovoLog/NovoRapid (insulin aspart)

6.2.4Apidra (insulin glulisine)

6.2.5Lantus (insulin glargine)

6.2.6Levemir (insulin detemir)

6.2.7Tresiba (insulin degludec)

6.2.8Pancreas and Islet Cell Transplantation

7Unmet Need and Opportunity

7.1Overview

7.2Disease-Modifying Treatment – Preservation of Beta Cells

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Hypoglycemia Avoidance

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Weight Loss and Control of Associated Metabolic Syndrome

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Treatment for Brittle Diabetes

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Increased Patient Adherence to Therapy

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy

8.3Promising Drugs in Clinical Development

8.3.1Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro

8.3.2Novel Formulation of Insulin Glargine: Toujeo

8.3.3Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin)

8.3.4Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs

8.3.5Adjunct Therapies

8.4Biosimilar Insulins

8.4.1Overview of the Regulatory Processes for Biosimilar Insulins

8.4.2Biosimilar Insulins Pipeline

8.4.3Forecast

8.5Artificial Pancreas

8.6Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Novo Nordisk

9.3.2Sanofi

9.3.3Eli Lilly

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2United States

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Canada

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Type 1 Diabetes Patients

11.4.2Percent Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Pricing of Pipeline Agents

11.5Physicians and Specialists Included in This Study

11.6About the Authors

11.6.1Author

11.6.2Epidemiologist

11.6.3Global Head of Healthcare

11.7About GlobalData

11.8Contact Us

11.9Disclaimer

List of Tables

Table 1: Symptoms of T1D

Table 2: Risk Factors and Comorbidities for T1D

Table 3: 8MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of T1D

Table 4: 8MM, Sources of Epidemiological Data Used for the Prevalent Cases of T1D Segmented by BMI

Table 5: 8MM, Sources Not Used in the Epidemiological Analysis of T1D

Table 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013–2023

Table 7: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N (Row %), 2013

Table 8: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N (Row %), 2013

Table 9: Diagnostic Tests and Typical Criteria for Diagnosing T1D

Table 10: Treatment Guidelines for T1D

Table 11: Most Prescribed Drugs for T1D in the 8MM, 2014

Table 12: Percent of Patients on Different Insulin Regimens in the 8MM, 2013

Table 13: Country Profile, T1D Management – US

Table 14: Country Profile, T1D Management – France

Table 15: Country Profile, T1D Management – Germany

Table 16: Country Profile, T1D Management – Italy

Table 17: Country Profile, T1D Management – Spain

Table 18: Country Profile, T1D Management – United Kingdom

Table 19: Country Profile, T1D Management – Japan

Table 20: Country Profile, T1D Management – Canada

Table 21: Insulins – Overview and Comparison

Table 22: Leading Treatments for Type 1 Diabetes, 2014

Table 23: Efficacy – Novolin R versus NovoLog

Table 24: Human Insulins SWOT Analysis, 2014

Table 25: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013–2023

Table 26: Product Profile – Humalog

Table 27: Efficacy – Humalog versus Regular Human Insulin (Humulin R)

Table 28: Adverse Events – Humalog versus Regular Human Insulin (Humulin R)

Table 29: Humalog SWOT Analysis, 2014

Table 30: Global Sales Forecasts ($m) for Humalog, 2013–2023

Table 31: Product Profile – NovoLog/NovoRapid

Table 32: Efficacy – NovoLog versus Regular Human Insulin (Novolin R)

Table 33: Adverse Events – NovoLog versus Regular Human Insulin (Novolin R)

Table 34: NovoLog SWOT Analysis, 2014

Table 35: Global Sales Forecasts ($m) for NovoLog, 2013–2023

Table 36: Product Profile – Apidra

Table 37: Efficacy – Apidra versus Humalog

Table 38: Adverse Events from Pooled Studies – Humalog versus Comparators

Table 39: Apidra SWOT Analysis, 2014

Table 40: Global Sales Forecasts ($m) for Apidra, 2013–2023

Table 41: Product Profile – Lantus

Table 42: Efficacy – Lantus versus NPH Insulin

Table 43: Adverse Events from Pooled Studies in Adults – Lantus versus NPH insulin

Table 44: Lantus SWOT Analysis, 2014

Table 45: Global Sales Forecasts ($m) for Lantus, 2013–2023

Table 46: Product Profile – Levemir

Table 47: Efficacy – Levemir versus Lantus in Adult T1D Patients

Table 48: Adverse Events from Two Pooled Studies in Adults – Levemir versus Lantus

Table 49: Levemir SWOT Analysis, 2014

Table 50: Global Sales Forecasts ($m) for Levemir, 2013–2023

Table 51: Product Profile – Tresiba

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

Table 53: Rate of Hypoglycemia – Levemir versus Lantus

Table 54: Tresiba SWOT Analysis, 2014

Table 55: Global Sales Forecasts ($m) for Tresiba, 2013–2023

Table 56: Unmet Need and Opportunity in T1D

Table 57: T1D – Late-Stage Pipeline Excluding Biosimilars, 2014

Table 58: Product Profile – Insulin Peglispro

Table 59: Insulin Peglispro SWOT Analysis, 2014

Table 60: Global Sales Forecasts ($m) for Insulin Peglispro, 2013–2023

Table 61: Product Profile – Toujeo

Table 62: Toujeo SWOT Analysis, 2014

Table 63: Global Sales Forecasts ($m) for Toujeo, 2013–2023

Table 64: Product Profile – Afrezza

Table 65: Efficacy – Afrezza versus NovoLog

Table 66: Adverse Events – Afrezza versus Subcutaneous Insulin

Table 67: Afrezza SWOT Analysis, 2014

Table 68: Global Sales Forecasts ($m) for Afrezza, 2013–2023

Table 69: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014

Table 70: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014

Table 71: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013–2023

Table 72: Product Profile – Victoza

Table 73: Victoza SWOT Analysis, 2014

Table 74: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013–2023

Table 75: Product Profile – Jardiance

Table 76: Jardiance SWOT Analysis, 2014

Table 77: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013–2023

Table 78: Drugs in Phase I and Phase II Development for T1D,* 2014

Table 79: Key Companies in the T1D Market in the 8MM, 2014

Table 80: Novo Nordisk’s T1D Portfolio Assessment, 2014

Table 81: Novo Nordisk SWOT Analysis, 2014

Table 82: Sanofi’s T1D Portfolio Assessment, 2014

Table 83: Sanofi SWOT Analysis, 2014

Table 84: Eli Lilly’s T1D Portfolio Assessment, 2014

Table 85: Eli Lilly SWOT Analysis, 2014

Table 86: Global Sales Forecasts ($m) for Type 1 Diabetes, 2013–2023

Table 87: Type 1 Diabetes Market – Drivers and Barriers, 2014

Table 88: Sales Forecasts ($m) for Type 1 Diabetes in the United States, 2013–2023

Table 89: Key Events Impacting Sales for T1D in the US, 2013–2023

Table 90: Type 1 Diabetes Market – Drivers and Barriers in the US, 2014

Table 91: Sales Forecasts ($m) for Type 1 Diabetes in the 5EU, 2013–2023

Table 92: Key Events Impacting Sales for T1D in the 5EU, 2013–2023

Table 93: Type 1 Diabetes Market – Drivers and Barriers in the 5EU, 2014

Table 94: Sales Forecasts ($m) for Type 1 Diabetes in Japan, 2013–2023

Table 95: Key Events Impacting Sales for T1D in Japan, 2013–2023

Table 96: Type 1 Diabetes Market – Drivers and Barriers in Japan, 2014

Table 97: Sales Forecasts ($m) for Type 1 Diabetes in Canada, 2013–2023

Table 98: Key Events Impacting Sales for T1D in Canada, 2013–2023

Table 99: Type 1 Diabetes Market – Drivers and Barriers in Canada, 2014

Table 100: Key Launch Dates

Table 101: Key Patent Expiries

Table 102: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

Figure 1: Etiology of T1D

Figure 2: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013–2023

Figure 3: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N, 2013–2023

Figure 4: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N, 2013

Figure 5: 8MM, Age-Standardized Diagnosed Prevalence (%) of T1D, All Ages, by Sex, 2013

Figure 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, by BMI (kg/m2), 2013

Figure 7: T1D – Disease Management Flowchart

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

Figure 9: T1D Therapeutics – Clinical Trials by Country and by General Class, 2014

Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013–2023

Figure 11: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013–2023

Figure 12: Company Portfolio Gap Analysis in Type 1 Diabetes, 2013–2023

Figure 13: Global Sales for Type 1 Diabetes by Region, 2013–2023

Figure 14: Sales for Type 1 Diabetes in the United States by Drug Class, 2013–2023

Figure 15: Sales for Type 1 Diabetes in the 5EU by Drug Class, 2013–2023

Figure 16: Sales for Type 1 Diabetes in the 5EU by Country, 2013–2023

Figure 17: Sales for Type 1 Diabetes in Japan by Drug Class, 2013–2023

Figure 18: Sales for Type 1 Diabetes in Canada by Drug Class, 2013–2023

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