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Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Strong Pipeline and Expanding Treatment Population to Encourage Robust Growth

Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Strong Pipeline and Expanding Treatment Population to Encourage Robust Growth

Summary


Type 2 Diabetes Mellitus (T2DM) is a metabolic disease characterized by chronic hyperglycemia (high blood glucose levels). Global prevalence has risen rapidly in the past several decades, particularly in line with obesity. This has been attributed to a range of factors, including economic development, increasing urbanization, aging populations, and changes in lifestyle patterns such as reduced levels of physical activity and consumption of higher-calorie diets.

This has led to strong commercial interest in the development of T2DM therapeutics. The current market is large and diverse, comprising several drug classes, including generic and branded drugs. Owing to the range of therapeutic options available, the treatment algorithm is complex. However, current treatment regimens are often associated with limited long-term efficacy, complex and inconvenient dosing regimens, and undesirable side effects such as weight gain and hypoglycemia (low blood glucose levels).

Scope

  • Metformin monotherapy will remain the first-line pharmacotherapy for T2DM.
  • The emergence of several new drug classes over the past decade, namely the Glucagon-Like Peptide-1 (GLP-1) receptor agonists, Dipeptidyl Peptidase 4 (DPP-4) inhibitors, and Sodium–Glucose Cotransporter 2 (SGLT-2) inhibitors, has led to considerable market growth.
  • Which products lead these drug classes and what threats do they face from the pipeline?
  • How will the continued uptake of newer drug classes impact established drug classes such as the sulfonylureas and thiazolidinediones?
  • Leading insulin therapy Lantus (insulin glargine) recently lost patent protection in most major markets.
  • Will recently approved insulin therapies such as Tresiba (insulin degludec) and Toujeo (insulin glargine) be able to capture a significant portion of Lantus’ market share?
  • The pipeline is large and highly innovative, comprising a range of molecule types and molecular targets.
  • How do different molecule types and molecular targets compare in terms of average failure rate, clinical trial duration, and clinical trial size?
  • Which late-stage pipeline molecules show the most promise and how will they impact the treatment algorithm over the forecast period?
  • Which late-stage pipeline molecules are expected to generate the highest revenues?
  • Over the 2014–2021 forecast period, the global T2DM market is expected to increase in value at a CAGR of 7.5% from $23.5 billion to $39.0 billion.
  • How do prevalence, diagnosis, and treatment patterns vary in the eight major markets?
  • Which factors will drive market growth most significantly?
  • Strategic consolidation activity in T2DM is considerable, with US-based companies being key players.
  • Do T2DM products tend to attract high levels of investment?
Reasons to buy
  • Understand the clinical context of the T2DM indication and the global burden of the disease by considering epidemiology, symptoms, etiology, pathophysiology, co-morbidities and complications, disease classification, disease prognosis, and treatment options
  • Appreciate the current T2DM marketed products landscape, including the dominant therapeutic strategies, products, and companies, and recognize gaps within the market and areas of unmet need
  • Identify key pipeline trends in molecule type and molecular target
  • Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in T2DM by examining clinical trial data and multi-scenario product forecast projections
  • Consider market opportunities and potential risks by examining trends in T2DM clinical trial size, duration, and failure rate by phase of development, molecule type, and molecular target
  • Discern variances in treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain, and Japan
  • Discover how strategic consolidations have shaped the current T2DM pipeline and marketed products landscapes


Type 2 Diabetes Mellitus Treatment Market Value Will Reach $39 Billion by 2021, says GBI Research

The global market for Type 2 Diabetes Mellitus (T2DM) therapeutics will rise in value from $23.5 billion in 2014 to an estimated $39.0 billion by 2021, driven primarily by rising disease prevalence and the continued uptake of recently approved and emerging branded treatments, according to business intelligence provider GBI Research.

The company’s latest report* states that this increase, which will occur across the eight major markets of the US, Canada, France, Germany, Italy, Spain, the UK, and Japan, represents a strong Compound Annual Growth Rate (CAGR) of 7.5%.

Fiona Chisholm, Associate Analyst for GBI Research, says the more recently approved drug classes, namely Glucagon-Like Peptide-1 (GLP-1) receptor agonists, Dipeptidyl Peptidase-4 (DPP-4) inhibitors, and Sodium–Glucose Cotransporter 2 inhibitors, have already achieved considerable uptake and are expected to increase their market share over the forecast period.

Chisholm explains: “In comparison to many previously marketed therapies, several recently approved and pipeline treatments provide beneficial effects, such as improved weight control and lowered hypoglycemia risk, and offer improvements in dosing frequency and administration methods.

“Notable examples include two recently approved once-weekly GLP-1 receptor agonists, Tanzeum and Trulicity, and an orally administered GLP-1 receptor agonist, OG-217SC, which is in Phase II development, as well as ITCA 650, a subdermally administered osmotic pump in Phase III development that requires once or twice-yearly dosing.”

The analyst adds that there are also two once-weekly DPP-4 inhibitors, namely Zafatek, which has been recently approved, and omarigliptin, in the pre-registration Phase of development.

GBI Research’s report also states that the T2DM pipeline is large, with 520 products at an active and disclosed stage of development. In particular, the late-stage pipeline includes 16 products at the pre-registration Phase and 33 products in Phase III.

Chisholm continues: “Many products in the late-stage pipeline belong to drug classes that are already established in T2DM treatment and only provide more convenient dosing schedules or administration routes.

“However, higher levels of innovation are apparent in the early-stage pipeline, which may lead to considerable improvements in safety and efficacy over the longer term,” the analyst concludes.
0*Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Strong Pipeline and Expanding Treatment Population to Encourage Robust Growth

This report provides analysis of the Type 2 Diabetes Mellitus (T2DM) therapeutics space across the eight major countries of the US, Canada, France, Germany, Italy, Spain, the UK, and Japan, including annualized market data from 2014 and forecast to 2021.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts."

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Overview
2.2 Epidemiology
2.3 Symptoms
2.4 Etiology
2.5 Pathophysiology
2.6 Co-morbidities and Complications
2.7 Classification
2.8 Prognosis
2.9 Diagnosis
2.10 Assessing Treatment Effectiveness
2.11 Treatment Algorithm
2.12 Non-insulin T2DM Therapies
2.12.1 Biguanides
2.12.2 Sulfonylureas and Meglitinides
2.12.3 Thiazolidinediones
2.12.4 Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists and Dipeptidyl Peptidase 4 (DPP-4) Inhibitors
2.12.5 Sodium–Glucose Linked Transporter-2 (SGLT-2) Inhibitors
2.12.6 Other Non-insulin Therapies
2.13 Insulin T2DM Therapies
2.14 Treatment Segments
2.14.1 Non-insulin therapies
2.14.2 Insulin Therapies
3 Marketed Products
3.1 Overview
3.2 Biguanides
3.2.1 Metformin – Various Companies
3.3 Sulfonylureas
3.4 Thiazolidinediones
3.4.1 Actos (pioglitazone) – Takeda
3.5 GLP-1 receptor agonists
3.5.1 Byetta (exenatide) – AstraZeneca
3.5.2 Bydureon (exenatide) – AstraZeneca
3.5.3 Victoza (liraglutide) – Novo Nordisk
3.5.4 Tanzeum (albiglutide) – GlaxoSmithKline
3.5.5 Trulicity (dulaglutide) – Eli Lilly
3.6 DPP-4 Inhibitors
3.6.1 Januvia (sitagliptin) – Merck
3.6.2 Galvus (vildagliptin) – Novartis
3.6.3 Onglyza (saxagliptin) – AstraZeneca
3.6.4 Tradjenta (linagliptin) – Boehringer Ingelheim
3.6.5 Zafatek (trelagliptin succinate) – Takeda
3.7 SGLT-2 Inhibitors
3.7.1 Farxiga (dapagliflozin) – AstraZeneca
3.7.2 Invokana (canagliflozin) – Janssen
3.7.3 Jardiance (empagliflozin) – Boehringer Ingelheim
3.8 Insulin Therapies
3.8.1 Lantus (insulin glargine) – Sanofi
3.8.2 Levemir (insulin detemir) – Novo Nordisk
3.8.3 Tresiba (insulin degludec) – Novo Nordisk
3.8.4 Toujeo (insulin glargine) – Sanofi
3.9 Marketed Products Heat Maps
4 Pipeline
4.1 Overview
4.2 Pipeline Distribution by Stage of Development, Molecule Type and Program Type
4.3 Pipeline Distribution by Molecular Target
4.4 Clinical Trial Landscape
4.4.1 Clinical Trial Failure Rates
4.4.2 Clinical Trial Duration
4.4.3 Clinical Trial Size
4.5 Promising Pipeline Molecules
4.5.1 Omarigliptin – Merck
4.5.2 NN-9535 (semaglutide) and OG-217SC (semaglutide) – Novo Nordisk
4.5.3 ITCA 650 – Intarcia Therapeutics
4.5.4 LX-4211 (sotagliflozin) – Lexicon Pharmaceuticals
4.5.5 Insulin peglispro – Eli Lilly and Company
4.5.6 ISIS-GCGRRx – Isis Pharmaceuticals
4.5.7 BSN-175 (D-Tagatose) – Biospherics.net Incorporated
4.6 Pipeline Products Heat Map and Competitive Product Framework
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 T2DM Therapeutics Market
5.6.1 Drivers
5.6.2 Barriers
6 Strategic Consolidations
6.1 Licensing Deals
6.1.1 Sanofi Enters into Licensing Agreement with MannKind for Afrezza
6.1.2 Array BioPharma Enters into a Licensing Agreement with Amgen – Now Terminated
6.1.3 Emisphere Technologies Enters into a Licensing Agreement with Novo Nordisk
6.1.4 Eli Lilly Enters into Licensing Agreement with Adocia
6.1.5 Depomed Enters into a Licensing Agreement with Merck
6.2 Co-development Deals
6.2.1 Intarcia Therapeutics Enters into Co-Development Agreement with Les Laboratoires Servier for ITCA 650 (exenatide)
6.2.2 Merck Enters into Co-Development Agreement with Pfizer for PF-04971729 (ertugliflozin)
6.2.3 Eli Lilly Enters into a Co-development Agreement with Boehringer Ingelheim
6.2.4 Amylin Pharma Terminates Co-development Agreement with Eli Lilly for Exenatide
6.2.5 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb
6.2.6 Neurocrine Biosciences Enters into a Collaboration Agreement with Boehringer Ingelheim
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 References for Heat Maps
7.4.1 Marketed Products Heat Map
7.4.2 Pipeline Heat Map
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
List of Tables
Table 1: Dose Levels for Groups Initially Receiving Metformin in Combination with Glyburide, Metformin Monotherapy and Glyburide Monotherapy
Table 2: T2DM Therapeutics Market, Global, Breakdown of Multiple Molecular Targets, 2015
Table 3: T2DM Therapeutics Market, Global, Breakdown of ‘Other’ Molecular Targets, 2015
Table 4: T2DM Therapeutics, Global, All Pipeline Products, Discovery Phase, 2015
Table 5: T2DM Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2015
Table 6: T2DM Therapeutics, Global, All Pipeline Products, IND/CTA-filed Phase, 2015
Table 7: T2DM Therapeutics, Global, All Pipeline Products, Phase I, 2015
Table 8: T2DM Therapeutics, Global, All Pipeline Products, Phase II, 2015
Table 9: T2DM Therapeutics, Global, All Pipeline Products, Phase III, 2015
Table 10: T2DM Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015
Table 11: T2DM Therapeutics Market, Global, Market Forecast, 2014–2021
Table 12: T2DM Therapeutics Market, US, Market Forecast, 2014–2021
Table 13: T2DM Therapeutics Market, Canada, Market Forecast, 2014–2021
Table 14: T2DM Therapeutics Market, UK, Market Forecast, 2014–2021
Table 15: T2DM Therapeutics Market, France, Market Forecast, 2014–2021
Table 16: T2DM Therapeutics Market, Germany, Market Forecast, 2014–2021
Table 17: T2DM Therapeutics Market, Italy, Market Forecast, 2014–2021
Table 18: T2DM Therapeutics Market, Spain, Market Forecast, 2014–2021
Table 19: T2DM Therapeutics Market, Japan, Market Forecast, 2014–2021
1.2 List of Figures
Figure 1: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015
Figure 2: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015 (continued)
Figure 3: T2DM Therapeutics Market, Global, Pipeline, 2015
Figure 4: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015
Figure 5: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of GPCR Molecular Targets, 2015
Figure 6: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Protein Kinase Molecular Targets, 2015
Figure 7: T2DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006–2015
Figure 8: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2015
Figure 9: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006–2015
Figure 10: T2DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, (months), 2006–2015
Figure 11: T2DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target, (months), 2006–2015
Figure 12: T2DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type, (participants), 2006–2015
Figure 13: T2DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecular Target, (participants), 2006–2015
Figure 14: T2DM Mellitus Therapeutics Market, Global, Cumulative Clinical Trial Recruitment Size by Stage of Development and Molecule Type, (participants), 2006–2015
Figure 15: T2DM Therapeutics Market, Global, Cumulative Clinical Trial Recruitment Size by Stage of Development and Molecular Target, (participants), 2006–2015
Figure 16: T2DM Therapeutics Market, Global, Omarigliptin Forecast ($m), 2015–2021
Figure 17: T2DM Therapeutics Market, Global, Semaglutide Products Forecast ($bn), 2017–2021
Figure 18: T2DM Therapeutics Market, Global, ITCA-650 Forecast ($m), 2017–2021
Figure 19: T2DM Therapeutics Market, Global, LX-4211 Forecast ($m), 2018–2021
Figure 20: T2DM Therapeutics Market, Global, insulin peglispro Forecast ($m), 2018–2021
Figure 21: T2DM Therapeutics Market, Global, ISIS-GCGRRx Forecast ($m), 2020–2021
Figure 22: T2DM Therapeutics Market, Global, BSN-175 Forecast ($m), 2018–2021
Figure 23: T2DM Market, Global, Heat Map for Pipeline Products, 2015
Figure 24: T2DM Therapeutics Market, Global, Competitiveness Framework for Marketed and Pipeline Products, 2015
Figure 25: T2DM Therapeutics Market, Global, Treatment Usage Patterns, 2014–2021
Figure 26: T2DM Therapeutics Market, Global, Market Size ($bn), 2014–2021
Figure 27: T2DM Therapeutics Market, North America, Treatment Patterns, 2014–2021
Figure 28: T2DM Therapeutics Market, North America, Annual Cost of Therapy ($), 2014–2021
Figure 29: T2DM Therapeutics Market, North America, Market Size ($bn), 2014–2021
Figure 30: T2DM Therapeutics Market, Top Five EU Countries, Treatment Usage Patterns, 2014–2021
Figure 31: T2DM Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2014–2021
Figure 32: T2DM Therapeutics Market, Top Five Countries of Europe, Market Size ($bn), 2014–2021
Figure 33: T2DM Therapeutics Market, Japan, Treatment Usage Patterns, 2014–2021
Figure 34: T2DM Therapeutics Market, Japan, Annual Cost of Therapy (ACoT) ($), 2014–2021
Figure 35: T2DM Therapeutics Market, Japan, Market Size ($bn), 2014–2021
Figure 36: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), 2006–2015
Figure 37: T2DM Mellitus Therapeutics Market, Global, Licensing Deals by Region, 2006–2015
Figure 38: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006–2014
Figure 39: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006–2015
Figure 40: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006–2015
Figure 41: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006–2015
Figure 42: T2DM Therapeutics Market, Global, Co-development Deals by Value ($m), 2006–2015
Figure 43: T2DM Therapeutics Market, Global, Co-Development Deals by Region, 2006–2015
Figure 44: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006–2014
Figure 45: T2DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006–2015
Figure 46: T2DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006–2015
Figure 47: T2DM Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006–2015

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