GBI Research, the leading business intelligence provider, has released its latest research, “Type 2 Diabetes Therapeutics in Asia-Pacific Markets to 2020 Increasing Uptake of Novel Drug Classes to Drive Market Growth”, which provides insights into type 2 diabetes in the Asia-Pacific (APAC) markets of China, India, Japan and Australia. The report estimates the market size for 2013 and provides a forecast until 2020, and covers disease epidemiology, treatment algorithms, and treatment use patterns. It also provides in-depth analysis of the pipeline molecules, clinical trial failure rates, and recent deals. The report has been built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis carried out by GBI Research’s team of industry experts.

In 2013, the value of the type 2 diabetes therapeutics market in APAC countries was an estimated $6.5 billion, and it is forecast to grow at a Compound Annual Growth Rate (CAGR) of 7.1% between 2013 and 2020 to $10.5 billion. This strong growth is due to the anticipated approval of products in relatively novel treatment classes, such as Glucagon-Like Peptide-1 (GLP-1) agonists, Dipeptidyl Peptidase-4 (DPP-4) inhibitors, and Sodium Glucose Transporter-2 (SGLT-2) inhibitors, as well as the growth of the prevalence population in the APAC region, particularly in India and China.

Scope

The report analyzes the treatment use patterns, market characterization, pipeline analysis and key licensing and co-development deals of the type 2 diabetes in the APAC markets of China, India, Japan, and Australia.It includes –

• A brief introduction to type 2 diabetes, including its pathophysiology, etiology, diagnosis and treatment algorithms
• In-depth analysis of currently marketed drugs for type 2 diabetes, including analysis of their safety, efficacy, treatment patterns, and strengths and weaknesses, as well as a heat map comparing them in terms of safety and efficacy
• A comprehensive review of the pipeline for type 2 diabetes, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period; the pipeline is analyzed by Phase distribution, molecule type, program type, mechanism of action and molecular target
• Additional in-depth analysis of pipeline drug clinical trials by Phase, trial size, trial duration and program failure rate for each molecule type
• Multi-scenario market forecast data to 2020, taking into account how the market might be affected by the introduction of new drugs, the expiry of key patents on current drugs, and the changes in disease epidemiology across the key developed markets
• Discussion of the drivers of and barriers to market growth
• In-depth analysis of all licensing and co-development deals that have occurred in the type 2 diabetes market since 2006

Reasons to buy

The report will enhance your decision-making capability by allowing you to –

• Understand the type 2 diabetes pipeline and the factors that indicate that it is becoming more innovative
• Examine detailed profiles for promising pipeline products and gain an insight into how and with whom they are likely to compete in the market
• Follow the trends in type 2 diabetes clinical trial size and duration in relation to industry averages
• Assess the potential risk of future developmental programs for type 2 diabetes therapeutics, depending on the mechanism of action, by taking into account the recorded clinical trial failure rates
• Examine the growth patterns expected for the type 2 diabetes market over the forecast period and the countries that are expected to contribute the most to this growth, allowing you to devise a more effectively tailored country strategy through an understanding of key drivers and barriers
• Accelerate and strengthen your market position by identifying key companies for strategic partnerships

Table of Contents

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Symptoms 8
2.2 Etiology 8
2.3 Pathophysiology 9
2.4 Diagnosis 10
2.5 Epidemiology 12
2.6 Prognosis 13
2.7 Co-Morbidities and Complications 13
2.8 Treatment and Management 14
2.8.1 The Role of Insulin in Type 2 Diabetes 17
2.8.2 Non-Insulin Diabetic Drugs 18
2.8.3 Other Drugs 20

3 Marketed Products 21
3.1 Metformin 21
3.2 DPP-4 Inhibitors 22
3.2.1 Januvia (sitagliptin)/Janumet (sitagliptin and metformin), Merck 22
3.2.2 Tradjenta (linagliptin) – Boehringer Ingelheim 23
3.2.3 Onglyza (saxagliptin) – Bristol-Myers Squibb and AstraZeneca 24
3.2.4 Nesina (alogliptin) – Takeda 24
3.2.5 Galvus (vildagliptin) – Novartis 25
3.2.6 Tenelia (teneligliptin) – Daiichi Sankyo and Mitsubishi Tanabe 26
3.3 GLP-1 Agonists 27
3.3.1 Byetta and Bydureon (exenatide) – Bristol-Myers Squibb 27
3.3.2 Victoza (liraglutide) – Novo Nordisk 27
3.3.3 Lyxumia (lixisenatide) – Sanofi 28
3.4 Sulfonylureas 29
3.4.1 Glimepiride 29
3.4.2 Gliclazide 30
3.5 Thiazolidinediones 30
3.5.1 Actos (pioglitazone) – Takeda Pharmaceuticals 30
3.6 Long-Acting Insulins 31
3.6.1 Lantus (insulin glargine) – Sanofi 31
3.6.2 Levemir (insulin detemir) – Novo Nordisk 32
3.7 SGLT Inhibitors 33
3.7.1 Forxiga (dapagliflozin) – Bristol-Myers Squibb 33
3.7.2 Invokana (canagliflozin) – Janssen 33
3.8 Comparative Efficacy and Safety 34

4 Type 2 Diabetes Market to 2020 – Pipeline Products 36
4.1 Overall Pipeline 36
4.2 Pipeline Analysis by Molecule Type 37
4.3 Pipeline Analysis by Mechanism of Action 38
4.4 Clinical Trials 42
4.4.1 Failure Rate 42
4.4.2 Patient Enrollment and Clinical Trial Size 46
4.4.3 Duration 47
4.5 Promising Drug Candidates in the Pipeline 48
4.5.1 LY-2189265 (dulaglutide) – Eli Lilly 48
4.5.2 Albiglutide – GlaxoSmithKline 49
4.5.3 Ipragliflozin – Astellas Pharma 50
4.5.4 Semaglutide – Novo Nordisk 50

5 Market Forecast to 2020 51
5.1 Geographical Markets 51
5.1.1 Asia-Pacific Market 51
5.1.2 China 53
5.1.3 India 55
5.1.4 Japan 57
5.1.5 Australia 59
5.2 Drivers and Barriers 61
5.2.1 Drivers 61
5.2.2 Barriers 61

6 Deals and Strategic Consolidations 62
6.1 Major Licensing Deals 63
6.1.1 Viking Therapeutics Enters into Licensing Agreement with Ligand Pharma 64
6.1.2 Zosano Pharma Enters into Licensing Agreement with Novo Nordisk 64
6.1.3 Sirona Biochem Enters into Licensing Agreement with Wanbang Biopharma for SGLT2 Inhibitor 65
6.1.4 Depomed Expands Licensing Agreement with Merck for Metformin Patents 65
6.1.5 Chugai Pharma Enters into Licensing Agreement with Kowa and Sanofi for SGLT2 Inhibitor CSG452 65
6.2 Major Co-development Deals 65
6.2.1 Yabao Pharma Enters into Co-Development Agreement with Eli Lilly for LY2608204 66
6.2.2 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb 66
6.2.3 Isis Pharmaceuticals Enters into a Collaboration Agreement with Janssen Pharmaceuticals 67
6.2.4 Merck Enters into Co-Development Agreement with Pfizer for Ertugliflozin 67

7 Appendix 68
7.1 All Pipeline Drugs by Phase 68
7.1.1 Discovery 68
7.1.2 IND/CTA-Filed 71
7.1.3 Preclinical 72
7.1.4 Phase I 82
7.1.5 Phase II 85
7.1.6 Phase III 88
7.1.7 Pre-registration 90
7.1.8 Undisclosed 91
7.2 Market Forecasts to 2019 92
7.2.1 Global 92
7.2.2 China 93
7.2.3 India 93
7.2.4 Japan 94
7.2.5 Australia 94
7.3 Market Definitions 95
7.4 Abbreviations 95
7.5 References 97
7.6 Research Methodology 103
7.6.1 Coverage 103
7.6.2 Secondary Research 103
7.6.3 Primary Research 103
7.6.4 Therapeutic Landscape 104
7.6.5 Geographical Landscape 106
7.6.6 Pipeline Analysis 107
7.7 Expert Panel Validation 107
7.8 Contact Us 107
7.9 Disclaimer 107

List of Tables

Table 1: Type 2 Diabetes Market, Global, HbA1c and Mean Blood Glucose, 2013 11
Table 2: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Discovery), 2014 68
Table 3: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (IND/CTA-Filed), 2014 71
Table 4: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Preclinical), 2014 72
Table 5: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Phase I), 2014 82
Table 6: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Phase II), 2014 85
Table 7: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Phase III), 2014 88
Table 8: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Pre-registration), 2014 90
Table 9: Type 2 Diabetes Market, Global, Pharmaceutical Pipeline (Undisclosed), 2014 91
Table 10: Type 2 Diabetes Market, Asia-Pacific, Forecast Data, 2013–2020 92
Table 11: Type 2 Diabetes Market, China, Forecast Data, 2013–2020 93
Table 12: Type 2 Diabetes Market, India, Forecast Data, 2013–2020 93
Table 13: Type 2 Diabetes Market, Japan, Forecast Data, 2013–2020 94
Table 14: Type 2 Diabetes Market, Australia, Forecast Data, 2013–2020 94

List of Figures

Figure 1: Type 2 Diabetes Market, Global, Composite Treatment Algorithm, 2013 16
Figure 2: Type 2 Diabetes Market, Global, Composite Treatment Algorithm, 2013 17
Figure 3: Type 2 Diabetes Market, Global, Januvia (sitagliptin)/Janumet (sitagliptin and metformin) Annual Sales ($bn), 2007–2013 23
Figure 4: Type 2 Diabetes Market, Global, Galvus (vildagliptin) Annual Sales ($m), 2007–2013 26
Figure 5: Type 2 Diabetes Market, Global, Victoza (liraglutide) Annual Sales ($bn), 2010–2013 28
Figure 6: Type 2 Diabetes Market, Global, Lantus (insulin glargine) Annual Sales ($bn), 2007–2013 32
Figure 7: Type 2 Diabetes Market, Global, Comparative Safety and Efficacy of Marketed Products Heatmap, 2013 35
Figure 8: Type 2 Diabetes Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2014 37
Figure 9: Type 2 Diabetes Market, Global, Pipeline by Molecule Type and Stage of Development, 2014 38
Figure 10: Type 2 Diabetes Market, Global, Pipeline by Mechanism of Action, 2014 40
Figure 11: Type 2 Diabetes Market, Global, Pipeline by Mechanism of Action, 2014 41
Figure 12: Type 2 Diabetes Market, Global, Pipeline by Mechanism of Action, Molecule Type and Stage of Development, 2014 42
Figure 13: Type 2 Diabetes Market, Global, Clinical Trial Failure Rate (%), 2014 43
Figure 14: Type 2 Diabetes Market, Global, Clinical Trial Failure Rate by Mechanism of Action (%), 2014 45
Figure 15: Type 2 Diabetes Market, Global, Clinical Trial Size, 2014 47
Figure 16: Type 2 Diabetes Market, Global, Clinical Trial Duration (months), 2014 48
Figure 17: Type 2 Diabetes Market, Asia-Pacific, Treatment Use Patterns and Market Size, 2013–2020 52
Figure 18: Type 2 Diabetes Market, China, Treatment Use Patterns, Annual Cost of Therapy ($) and Market Size, 2013–2020 54
Figure 19: Type 2 Diabetes Market, India, Treatment Use Patterns, Annual Cost of Therapy ($), and Market Size, 2013–2020 56
Figure 20: Type 2 Diabetes Market, Japan, Treatment Use Patterns, Annual Cost of Therapy ($), Market Size, 2013–2020 58
Figure 21: Type 2 Diabetes Market, Australia, Treatment Use Patterns, Annual Cost of Therapy ($), Market Size, 2013–2020 60
Figure 22: Type 2 Diabetes Market, Global, Deals by Value, Year and Stage of Development, 2006–2014 62
Figure 23: Type 2 Diabetes Market, Global, Deals by Phase, Molecule Type and Mechanism of Action, 2006–2014 63
Figure 24: Type 2 Diabetes Market, Global, Licensing Deals by Geography, 2006–2014 64
Figure 25: Type 2 Diabetes Market, Global, Co–development Deals by Geography, 2006–2014 66
Figure 26: GBI Research Market Forecasting Model (Example) 106