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

Pages: 198 Published: March 01, 2015 Report Code: GDHC346CFR

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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. 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. *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 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.

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

4Disease Management

4.1Diagnosis and Treatment Overview

4.1.1Diagnosis

4.1.2Treatment Guidelines and Leading Prescribed Therapies

4.1.3Clinical Practice

4.2France

4.3Germany

4.4Italy

4.5Spain

4.6UK

5Competitive Assessment

5.1Overview

5.2Current Treatments

5.2.1Human Insulins (Injectable Formulations)

5.2.2Humalog (insulin lispro)

5.2.3NovoLog/NovoRapid (insulin aspart)

5.2.4Apidra (insulin glulisine)

5.2.5Lantus (insulin glargine)

5.2.6Levemir (insulin detemir)

5.2.7Tresiba (insulin degludec)

5.2.8Pancreas and Islet Cell Transplantation

6Unmet Need and Opportunity

6.1Overview

6.2Disease-Modifying Treatment – Preservation of Beta Cells

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Hypoglycemia Avoidance

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Weight Loss and Control of Associated Metabolic Syndrome

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Treatment for Brittle Diabetes

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Increased Patient Adherence to Therapy

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Clinical Trial Mapping

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

7.3Promising Drugs in Clinical Development

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

7.3.2Novel Formulation of Insulin Glargine: Toujeo

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

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

7.3.5Adjunct Therapies

7.4Biosimilar Insulins

7.4.1Overview of the Regulatory Processes for Biosimilar Insulins

7.4.2Biosimilar Insulins Pipeline

7.4.3Forecast

7.5Artificial Pancreas

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

8Market Outlook

8.15EU

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Diagnosed Type 1 Diabetes Patients

9.4.2Percent Drug-Treated Patients

9.4.3Drugs Included in Each Therapeutic Class

9.4.4Launch and Patent Expiry Dates

9.4.5General Pricing Assumptions

9.4.6Individual Drug Assumptions

9.4.7Pricing of Pipeline Agents

9.5Physicians and Specialists Included in This Study

9.6About the Authors

9.6.1Author

9.6.2Epidemiologist

9.6.3Global Head of Healthcare

9.7About GlobalData

9.8Disclaimer

List of Tables

Table 1: Symptoms of T1D

Table 2: Diagnostic Tests and Typical Criteria for Diagnosing T1D

Table 3: Treatment Guidelines for T1D

Table 4: Most Prescribed Drugs for T1D in the 8MM, 2014

Table 5: Percent of Patients on Different Insulin Regimens in the 8MM, 2013

Table 6: Country Profile, T1D Management – France

Table 7: Country Profile, T1D Management – Germany

Table 8: Country Profile, T1D Management – Italy

Table 9: Country Profile, T1D Management – Spain

Table 10: Country Profile, T1D Management – United Kingdom

Table 11: Insulins – Overview and Comparison

Table 12: Leading Treatments for Type 1 Diabetes, 2014

Table 13: Efficacy – Novolin R versus NovoLog

Table 14: Human Insulins SWOT Analysis, 2014

Table 15: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013–2023

Table 16: Product Profile – Humalog

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

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

Table 19: Humalog SWOT Analysis, 2014

Table 20: Global Sales Forecasts ($m) for Humalog, 2013–2023

Table 21: Product Profile – NovoLog/NovoRapid

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

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

Table 24: NovoLog SWOT Analysis, 2014

Table 25: Global Sales Forecasts ($m) for NovoLog, 2013–2023

Table 26: Product Profile – Apidra

Table 27: Efficacy – Apidra versus Humalog

Table 28: Adverse Events from Pooled Studies – Humalog versus Comparators

Table 29: Apidra SWOT Analysis, 2014

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

Table 31: Product Profile – Lantus

Table 32: Efficacy – Lantus versus NPH Insulin

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

Table 34: Lantus SWOT Analysis, 2014

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

Table 36: Product Profile – Levemir

Table 37: Efficacy – Levemir versus Lantus in Adult T1D Patients

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

Table 39: Levemir SWOT Analysis, 2014

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

Table 41: Product Profile – Tresiba

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

Table 43: Rate of Hypoglycemia – Levemir versus Lantus

Table 44: Tresiba SWOT Analysis, 2014

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

Table 46: Unmet Need and Opportunity in T1D

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

Table 48: Product Profile – Insulin Peglispro

Table 49: Insulin Peglispro SWOT Analysis, 2014

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

Table 51: Product Profile – Toujeo

Table 52: Toujeo SWOT Analysis, 2014

Table 53: Global Sales Forecasts ($m) for Toujeo, 2013–2023

Table 54: Product Profile – Afrezza

Table 55: Efficacy – Afrezza versus NovoLog

Table 56: Adverse Events – Afrezza versus Subcutaneous Insulin

Table 57: Afrezza SWOT Analysis, 2014

Table 58: Global Sales Forecasts ($m) for Afrezza, 2013–2023

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

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

Table 61: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013–2023

Table 62: Product Profile – Victoza

Table 63: Victoza SWOT Analysis, 2014

Table 64: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013–2023

Table 65: Product Profile – Jardiance

Table 66: Jardiance SWOT Analysis, 2014

Table 67: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013–2023

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

Table 69: Sales Forecasts ($m) for Type 1 Diabetes in the 5EU, 2013–2023

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

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

Table 72: Key Launch Dates

Table 73: Key Patent Expiries

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

List of Figures

Figure 1: Etiology of T1D

Figure 2: T1D – Disease Management Flowchart

Figure 3: Percent of Patients on Different Insulin Regimens in 2013 and 2018 (Average across the 8MM)

Figure 4: T1D Therapeutics – Clinical Trials by Country and by General Class, 2014

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

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

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

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

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