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.
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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).
- 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?
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
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1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Overview 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology 10
2.5 Pathophysiology 11
2.6 Co-morbidities and Complications 13
2.7 Classification 15
2.8 Prognosis 15
2.9 Diagnosis 16
3 Marketed Products 43
3.1 Overview 43
3.2 Biguanides 44
3.2.1 Metformin – Various Companies 44
3.3 Sulfonylureas 45
3.4 Thiazolidinediones 46
3.4.1 Actos (pioglitazone) – Takeda 46
3.5 GLP-1 receptor agonists 47
3.5.1 Byetta (exenatide) – AstraZeneca 47
3.5.2 Bydureon (exenatide) – AstraZeneca 48
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