Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia - high blood glucose levels - that results from defects in insulin secretion, insulin action, or a combination of these. This chronic hyperglycemia is associated with long-term damage, dysfunction and failure of multiple organs, including the eyes, kidneys, nerves, heart and blood vessels. The vast majority of diabetes mellitus patients can be classified as having either Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM). Approximately 90-95% of all diabetics have T2DM.
T2DM treatment has been revolutionized in the past decade, especially with the increased use of new therapies. The marketed products landscape comprises a wide range of treatment options, including biguanide (metformin), sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, and insulin therapies. Nevertheless, significant unmet need remains for products that can offer better glycemic control, as well as the prevention and cure of diabetic complications, such as diabetic nephropathy, retinopathy, and cardiovascular disease.
The current South-East Asia T2DM market contains novel products, including Jardiance, a SGLT-2 inhibitor; Victoza, a GLP-1 receptor agonist; and Januvia, a DPP-4 inhibitor.
- What are the competitive advantages of the existing novel drugs?
With over 500 active pipeline molecules, most of the late-stage investigational drug candidates are being evaluated, featuring improved dosing regimens and administration routes in comparison to currently marketed products and combination therapies.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the T2DM market?
Analysis of clinical trials since 2006 identified that the failure rates of T2DM molecules were highest in Phase III, at 49%, with the overall attrition rate for T2DM standing at 75%.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?
Over the 2015-2022 forecast period, the South-East Asia T2DM therapeutics market is expected to increase in value at a CAGR of 7.1%, from $1.7 billion to over $2.7 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the eight assessed South-East Asia markets?
Rising T2DM prevalence and the uptake of newer therapies will lead to significant market growth over the forecast period, despite generic sales erosion resulting from patent expirations.
- Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?
Reasons to buy
This report will enable you to -
- Understand the clinical context of T2DM by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty.
- Consider market opportunities and potential risks by examining trends in T2DM clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
- 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.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam, and Indonesia.
- Discover trends in licensing and co-development deals concerning T2DM products and identify the major strategic consolidations that have shaped the commercial landscape.
Table of Contents
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 11
2.5 Diagnosis 14
2.6 Classification 15
2.7 Prognosis 15
2.8 Treatment Options 16
2.8.1 Treatment Algorithm 16
2.8.2 Non-insulin T2DM Therapies 18
2.8.3 Insulin T2DM Therapies 21
2.9 Treatment Segments 22
2.9.1 Non-insulin therapies 23
2.9.2 Insulin Therapies 38
2.10 Co-morbidities and Complications 41
3 Marketed Products 43
3.1 Overview 43
3.2 Biguanides 44
3.2.1 Metformin 44
3.3 Sulfonylureas 45
3.4 Thiazolidinediones 46
3.4.1 Pioglitazone 46
3.4.2 Duvie (lobeglitazone) - Chong Kun Dang 48
3.5 GLP-1 Receptor Agonists 48
3.5.1 Byetta (exenatide) - Eli Lilly 48
3.5.2 Bydureon (exenatide) - AstraZeneca 49
3.5.3 Victoza (liraglutide) - Novo Nordisk 50
3.5.4 Lyxumia (lixisenatide) - Sanofi 52
3.5.5 Tanzeum (albiglutide) - GlaxoSmithKline 53
3.6 DPP-4 Inhibitors 54
3.6.1 Januvia (sitagliptin) - Merck 54
3.6.2 Galvus (vildagliptin) - Novartis 55
3.6.3 Onglyza (saxagliptin) - Bristol-Myers Squibb/AstraZeneca 57
3.6.4 Trajenta (linagliptin) - Bristol-Myers Squibb/AstraZeneca 58
4 Pipeline 72
4.1 Overview 72
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 73
4.3 Pipeline by Molecular Target 74
4.4 Promising Pipeline Candidates 78
4.4.1 NN-9535 (subcutaneous semaglutide) and OG-217SC (oral semaglutide) - Novo Nordisk 78
4.4.2 Trulicity (dulaglutide) 81
4.4.3 Ertugliflozin - Pfizer 83
4.4.4 Bexagliflozin - Theracos 84
4.4.5 Omarigliptin - Merck 86
4.5 Comparative Efficacy and Safety of Pipeline Products 88
4.6 Product Competitive Framework 88
5 Clinical Trial Analysis 92
5.1 Failure Rate 92
5.1.1 Overall Failure Rate 92
5.1.2 Failure Rate by Phase and Molecule Type 92
5.1.3 Failure Rate by Phase and Molecular Target 93
5.2 Clinical Trial Size 94
5.3 Clinical Trial Duration 98
5.3.1 Trial Duration by Stage of Development and Molecule Type 98
5.3.2 Trial Duration by Stage of Development and Molecular Target 100
5.4 Summary of Clinical Trial Metrics 100
MarketResearchReports.biz is the most comprehensive collection of market research reports. MarketResearchReports.Biz services are specially designed to save time and money for our clients. We are a one stop solution for all your research needs, our main offerings are syndicated research reports, custom research, subscription access and consulting services. We serve all sizes and types of companies spanning across various industries.