Market Research Logo

Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations

Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations

Summary


Type 1 Diabetes Mellitus (T1DM) is a chronic, progressive and serious disease characterized by a destruction or failure of insulin-secreting pancreatic beta cells, usually as a result of an autoimmune response. The resulting insulin deficiency prevents insulin-sensitive cells from carrying out essential glucose metabolism and leads to hyperglycemia (high blood glucose levels). As a result, immediate and lifelong treatment with exogenous insulin therapy is initiated upon diagnosis of T1DM. Exogenous insulin has remained the mainstay of T1DM therapy since it was used to treat the first human patient in 1922.

Consequently, insulin products comprise the vast majority of the T1DM market, which is largely monopolized by three big pharma players: Eli Lilly, Novo Nordisk and Sanofi. However, insulin treatment regimens are often inconvenient and are associated with undesirable side effects such as hypoglycemia (low blood glucose levels) and weight gain. In addition, there is a significant unmet need for more diversified treatment options including therapies capable of altering the clinical course of the pathological beta cell destruction and adjuvant therapies capable of improving glycemic control and reducing insulin requirements.

Scope

The report assesses the current T1DM market and forecasts market trends to 2021. Areas covered include -

  • An introduction to T1DM, which includes classification, symptoms, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment
  • An analysis of the leading insulin therapies in the current T1DM marketed products landscape.
  • An analysis of the pipeline for T1DM. This includes a breakdown of pipeline molecules by stage of development, molecule type, route of administration, molecular target and novelty. Trends in T1DM clinical trial size, duration and failure rates, by molecule type and molecular target are discussed. A comparative analysis of the most promising pipeline molecules is also provided.
  • Forecast projections for the T1DM market to 2021. An analysis is provided for the global market and each of the eight major markets.
The forecast incorporates projected, low and high variance scenarios based on treatment usage patterns and annual therapy costs in each of the major markets.
  • An analysis of strategic consolidations, including co-development and licensing deals, within the T1DM indication.
Reasons to buy

The report will provide clients with a strong understanding of the T1DM indication and an appreciation of the evolving landscape of the T1DM therapeutics market. The report will enable clients to -
  • Appreciate the current T1DM marketed products landscape, including the dominant therapeutic strategies, products, and companies, and recognize gaps within the market and areas of unmet need
  • Identify trends and developments within the T1DM pipeline and consider how the future competitive environment will be impacted.
  • Consider market opportunities and potential risks by examining trends in T1DM clinical trial duration and size, as well as clinical trial failure rates, amongst clinical phases and molecule types
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the T1DM therapeutics market
  • Understand how strategic consolidations have shaped the current T1DM pipeline and marketed products landscapes


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Overview
2.2 Classification of Diabetes Mellitus
2.3 Symptoms
2.4 Etiology
2.4.1 Genetics
2.4.2 Age
2.4.3 Early Diet
2.4.4 Exposure to Infectious Agents
2.4.5 Vitamin D Deficiency
2.5 Pathophysiology
2.6 Epidemiology
2.7 Co-morbidities and Complications
2.7.1 Acute Metabolic Complications
2.7.2 Long-term Vascular Complications
2.7.3 Other Co-morbidities and Complications
2.8 Diagnosis
2.9 Treatment
2.9.1 Insulin Therapy
2.9.2 Non-insulin Adjunctive Therapy
2.9.3 Lifestyle Modifications
2.9.4 Beta Cell Replacement Therapy
2.10 Treatment Algorithm
2.10.1 Basal Insulin for MDI Therapy
2.10.2 Bolus Insulin for MDI Therapy
2.10.3 Bolus Insulin for CSII
3 Marketed Products
3.1 Overview
3.2 Human Insulin Products
3.2.1 Humulin Products – Eli Lilly
3.2.2 Novolin Products – Novo Nordisk
3.2.3 Afrezza (insulin human) – Sanofi and MannKind Corporation
3.3 Insulin Analog Products
3.3.1 Humalog (insulin lispro) – Eli Lilly and Company
3.3.2 Novolog (insulin aspart) Products – Novo Nordisk
3.3.3 Apidra (insulin glulisine) - Sanofi
3.3.4 Lantus (insulin glargine) - Sanofi
3.3.5 Levemir (insulin detemir) – Novo Nordisk
3.3.6 Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart) – Novo Nordisk
3.3.7 Toujeo (insulin glargine) – Sanofi
4 Pipeline
4.1 Overview
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type
4.3 Pipeline Distribution by Molecular Target
4.3.1 Molecular Target Groups in the Pipeline
4.4 Clinical Trial Landscape
4.4.1 Clinical Trial Failure Rates
4.4.2 Clinical Trial Duration
4.4.3 Clinical Trial Size
4.4.4 Comparative Clinical Trial Metrics Analysis
4.5 Promising Pipeline Molecules
4.5.1 Insulin Therapies
4.5.2 Non-insulin Adjuvant Therapies
5 Market Forecast to 2021
5.1 Geographical Markets
5.2 Global Markets
5.3 North America
5.3.1 Treatment Usage Patterns
5.3.2 Annual Cost of Therapy
5.3.3 Market Size
5.4 Top Five European Markets
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Japan
5.5.1 Treatment Usage Patterns
5.5.2 Annual Cost of Therapy
5.5.3 Market Size
5.6 Drivers and Barriers for the T1DM Therapeutics Market
5.6.1 Drivers
5.6.2 Barriers
6 Strategic Consolidations
6.1 Licensing Deals
6.1.1 ViaCyte Enters into Option for Licensing Agreement with Janssen Research & Development
6.1.2 Eli Lilly Enters into Licensing Agreement with MacroGenics
6.1.3 Bayhill Therapeutics Enters into Licensing Agreement with Genentech
6.1.4 King's College Enters into Licensing Agreement with UCB
6.1.5 Nuvilex Enters into Licensing Agreement with University of Technology Sydney
6.1.6 Sanofi Enters into Licensing Agreement with MannKind for Afrezza
6.1.7 Eli Lilly Enters into Licensing Agreement with Adocia
6.2 Co-development Deals
6.2.1 GlaxoSmithKline Signs Partnership Agreement with Tolerx
6.2.2 Diamyd Medical Enters into Co-Development Agreement with Ortho-McNeil-Janssen
6.2.3 Osiris Therapeutics Enters into an Agreement with Juvenile Diabetes Research Foundation International
6.2.4 Transition Therapeutics Enters into Co-Development Agreement with Juvenile Diabetes Research Foundation
6.2.5 BioLineRx Enters into Co-Development Agreement with JHL Biotech
7 Appendix
7.1 All Pipeline Drugs by Phase of Development
7.1.1 Discovery
7.1.2 Preclinical
7.1.3 IND/CTA-filed
7.1.4 Phase I
7.1.5 Phase II
7.1.6 Phase III
7.1.7 Pre-registration
7.2 Market Forecasts to 2021
7.2.1 Global
7.2.2 US
7.2.3 Canada
7.2.4 UK
7.2.5 France
7.2.6 Germany
7.2.7 Italy
7.2.8 Spain
7.2.9 Japan
7.3 References
7.4 Heat Map References
7.5 Abbreviations
7.6 Research Methodology
7.7 Secondary Research
7.8 Marketed Product Profiles
7.9 Late-Stage Pipeline Candidates
7.10 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
7.11 Product Competitiveness Framework
7.12 Pipeline Analysis
7.12.1 Overall Pipeline
7.12.2 Clinical Trials
7.12.3 Failure Rate
7.12.4 Clinical Trial Size
7.12.5 Clinical Trial Duration
7.12.6 Clinical Trial Endpoint Analysis
7.13 Forecasting Model
7.14 Deals Data Analysis
7.15 Expert Panel Validation
7.16 Contact Us
7.17 Disclaimer
1.1 List of Tables
Table 1: T1DM Therapeutics Market, Common Endpoints in T1DM Trials
Table 2: T1DM Therapeutics Market, Global, Breakdown of Multiple Molecular Targets, 2015
Table 3: T1DM Therapeutics Market, Global, Breakdown of ‘Other’ Molecular Targets, 2015
Table 4: T1DM Therapeutics Market, Global, All Pipeline Products, Discovery Phase, 2015
Table 5: T1DM Therapeutics Market, Global, All Pipeline Products, Preclinical Phase, 2015
Table 6: T1DM Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed Phase, 2015
Table 7: T1DM Therapeutics Market, Global, All Pipeline Products, Phase I, 2015
Table 8: T1DM Therapeutics Market, Global, All Pipeline Products, Phase II, 2015
Table 9: T1DM Therapeutics Market, Global, All Pipeline Products, Phase III, 2015
Table 10: T1DM Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2015
Table 11: T1DM Therapeutics Market, Global, Market Forecast, 2014–2021
Table 12: T1DM Therapeutics Market, US, Market Forecast, 2014–2021
Table 13: T1DM Therapeutics Market, Canada, Market Forecast, 2014–2021
Table 14: T1DM Therapeutics Market, UK, Market Forecast, 2014–2021
Table 15: T1DM Therapeutics Market, France, Market Forecast, 2014–2021
Table 16: T1DM Therapeutics Market, Germany, Market Forecast, 2014–2021
Table 17: T1DM Therapeutics Market, Italy, Market Forecast, 2014–2021
Table 18: T1DM Therapeutics Market, Spain, Market Forecast, 2014–2021
Table 19: T1DM Therapeutics Market, Japan, Market Forecast, 2014–2021
1.2 List of Figures
Figure 1: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens, 2015
Figure 2: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
Figure 3: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
Figure 4: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
Figure 5: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for MDI Regimens, 2015
Figure 6: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for CSII, 2015
Figure 7: T1DM Therapeutics Market, Global, Pipeline, 2015
Figure 8: T1DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015
Figure 9: T1DM Therapeutics Market, Global, Breakdown of Molecular Target Groups, 2015
Figure 10: T1DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006–2015
Figure 11: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2015
Figure 12: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006–2015
Figure 13: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006–2015
Figure 14: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006–2015
Figure 15: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type (participants), 2006–2015
Figure 16: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecular Target (participants), 2006–2015
Figure 17: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecule Type, 2006–2015
Figure 18: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecular Target, 2006–2015
Figure 19: T1DM Therapeutics Market, Global, NN-1218 Forecast ($m), 2017–2021
Figure 20: T1DM Therapeutics Market, Global, Insulin Peglispro Forecast ($m), 2018–2021
Figure 21: T1DM Therapeutics Market, Global, Jardiance Forecast ($m), 2018–2021
Figure 22: T1DM Therapeutics Market, Global, Farxiga Forecast ($m), 2018–2021
Figure 23: T1DM Therapeutics Market, Global, Sotagliflozin Forecast ($m), 2018–2021
Figure 24: T1DM Therapeutics Market, Global, Glassia Forecast ($m), 2018–2021
Figure 25: T1DM Therapeutics Market, Global, Adjuvant Therapy Pipeline Products, 2015
Figure 26: T1DM Therapeutics Market, Global, Treatment Usage Patterns (million), 2014–2021
Figure 27: T1DM Therapeutics Market, Global, Market Size ($bn), 2014–2021
Figure 28: T1DM Therapeutics Market, North America, Treatment Patterns, 2014–2021
Figure 29: T1DM Therapeutics Market, North America, Annual Cost of Therapy ($), 2014–2021
Figure 30: T1DM Therapeutics Market, North America, Market Size, 2014–2021
Figure 31: T1DM Therapeutics Market, Top Five European Countries, Treatment Usage Patterns (‘000), 2014–2021
Figure 32: T1DM Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2014–2021
Figure 33: T1DM Therapeutics Market, Top Five Countries of Europe, Market Size ($m), 2014–2021
Figure 34: T1DM Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2014–2021
Figure 35: T1DM Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014–2021
Figure 36: T1DM Therapeutics Market, Japan, Market Size ($m), 2014–2021
Figure 37: T1DM Therapeutics Market, Global, Licensing Deals by Region and Deal Value ($m), 2006–2015
Figure 38: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, 2006–2014
Figure 39: T1DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006–2015
Figure 40: T1DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006–2015
Figure 41: T1DM Therapeutics Market, Global, Co-development Deals by Region and Deal Value ($m), 2006–2015
Figure 42: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, 2006–2014
Figure 43: T1DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006–2015
Figure 44: T1DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006–2015

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report