Sections
Title | Starting Page | Number of Pages |
---|
1 Table of Contents | 4 | 6 |
1.1 List of Tables | 7 | 1 |
1.2 List of Figures | 7 | 3 |
2 Introduction | 10 | 33 |
2.1 Disease Introduction | 10 | 1 |
2.2 Epidemiology | 10 | 1 |
2.3 Symptoms | 11 | 1 |
2.4 Etiology and Pathophysiology | 11 | 3 |
2.5 Diagnosis | 14 | 1 |
2.6 Classification | 15 | 1 |
2.7 Prognosis | 15 | 1 |
2.8 Treatment Options | 16 | 1 |
2.8.1 Treatment Algorithm | 16 | 2 |
2.8.2 Non-insulin T2DM Therapies | 18 | 1 |
2.8.2.1 Biguanides | 18 | 1 |
2.8.2.2 Sulfonylureas and Meglitinides | 18 | 1 |
2.8.2.3 Thiazolidinediones | 19 | 1 |
2.8.2.4 Glucagon-Like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase 4 Inhibitors | 19 | 1 |
2.8.2.5 Sodium Glucose Linked Transporter-2 (SGLT-2) Inhibitors | 20 | 1 |
2.8.2.6 Other Non-insulin Therapies | 21 | 1 |
| 21 | 1 |
2.8.2.6.2 Bile Acid Sequestrants | 21 | 1 |
2.8.3 Insulin T2DM Therapies | 21 | 1 |
2.9 Treatment Segments | 22 | 1 |
2.9.1 Non-insulin therapies | 23 | 1 |
2.9.1.1 Metformin monotherapy versus placebo | 23 | 1 |
2.9.1.2 Immediate-Release Metformin versus Extended-Release Metformin either as Monotherapies or in Combination with Other Oral Antidiabetic Agents | 24 | 1 |
2.9.1.3 Metformin Monotherapy versus Glyburide Monotherapy versus Metformin in Combination with Glyburide | 25 | 2 |
2.9.1.4 Actos (pioglitazone) versus Placebo as Monotherapy | 27 | 1 |
2.9.1.5 Byetta (exenatide) versus Bydureon (exenatide) either as Monotherapies or in Combination with Oral Antidiabetic Drugs | 28 | 2 |
2.9.1.6 Victoza (liraglutide) versus Tanzeum (albiglutide) in Combination with Oral Antidiabetic Drugs | 30 | 1 |
2.9.1.7 Trulicity (dulaglutide) versus Victoza (liraglutide) in Combination with Metformin | 31 | 1 |
2.9.1.8 Januvia (sitagliptin) versus Glipizide as Add-On Therapy to Metformin | 32 | 1 |
2.9.1.9 Galvus (vildagliptin) versus Actos (pioglitazone) as Add-On Therapy to Metformin | 33 | 1 |
2.9.1.10 Onglyza (saxagliptin) versus Forxiga (dapagliflozin) versus Onglyza in Combination with Forxiga as Add-On Therapies to Metformin | 34 | 1 |
2.9.1.11 Jardiance (empagliflozin), Trajenta (linagliptin) and Glyxambi (empagliflozin and linagliptin) as Monotherapies or as Add-On Therapies to Metformin | 35 | 2 |
2.9.1.12 Invokana (canagliflozin) versus Glimepiride as Add-On Therapy to Metformin | 37 | 1 |
2.9.2 Insulin Therapies | 38 | 1 |
2.9.2.1 Lantus (insulin glargine) versus Levemir (insulin detemir) as Add-On Therapy to Glucose-Lowering Drugs | 38 | 1 |
2.9.2.2 Lantus (insulin glargine) versus Toujeo (insulin glargine) as Add-On Therapies to Oral Antidiabetic Drugs or Meal-Time Insulin | 38 | 2 |
2.9.2.3 Tresiba (insulin degludec) versus Lantus (insulin glargine) as Add-On Therapy to Oral Antidiabetic Drugs | 40 | 1 |
2.10 Co-morbidities and Complications | 41 | 2 |
3 Marketed Products | 43 | 29 |
3.1 Overview | 43 | 1 |
3.2 Biguanides | 44 | 1 |
3.2.1 Metformin | 44 | 1 |
3.3 Sulfonylureas | 45 | 1 |
3.4 Thiazolidinediones | 46 | 1 |
3.4.1 Pioglitazone | 46 | 2 |
3.4.2 Duvie (lobeglitazone) Chong Kun Dang | 48 | 1 |
3.5 GLP-1 Receptor Agonists | 48 | 1 |
3.5.1 Byetta (exenatide) Eli Lilly | 48 | 1 |
3.5.2 Bydureon (exenatide) AstraZeneca | 49 | 1 |
3.5.3 Victoza (liraglutide) Novo Nordisk | 50 | 2 |
3.5.4 Lyxumia (lixisenatide) Sanofi | 52 | 1 |
3.5.5 Tanzeum (albiglutide) GlaxoSmithKline | 53 | 1 |
3.6 DPP-4 Inhibitors | 54 | 1 |
3.6.1 Januvia (sitagliptin) Merck | 54 | 1 |
3.6.2 Galvus (vildagliptin) Novartis | 55 | 2 |
3.6.3 Onglyza (saxagliptin) Bristol-Myers Squibb/AstraZeneca | 57 | 1 |
3.6.4 Trajenta (linagliptin) Bristol-Myers Squibb/AstraZeneca | 58 | 1 |
3.6.5 Zemiglo (gemigliptin) LG Life Sciences | 59 | 1 |
3.6.6 Suganon (evogliptin) Dong-A ST | 59 | 1 |
3.6.7 Gadret (anagliptin) JW Pharmaceutical | 60 | 1 |
3.6.8 Nesina (alogliptin) Takeda | 61 | 1 |
3.6.9 Tenelia (teneligliptin) Mitsubishi Tanabe Pharma | 61 | 1 |
3.7 SGLT-2 Inhibitors | 62 | 1 |
3.7.1 Forxiga (dapagliflozin) AstraZeneca | 62 | 1 |
3.7.2 Invokana (canagliflozin) Janssen | 63 | 1 |
3.7.3 Jardiance (empagliflozin) Boehringer Ingelheim | 64 | 1 |
3.7.4 Suglat (ipragliflozin) Astellas | 65 | 1 |
3.8 Insulin Therapies | 66 | 1 |
3.8.1 Lantus (insulin glargine) Sanofi | 66 | 1 |
3.8.2 Levemir (insulin detemir) Novo Nordisk | 67 | 1 |
3.8.3 Tresiba (insulin degludec) Novo Nordisk | 67 | 1 |
3.8.4 Toujeo (insulin glargine) Sanofi | 68 | 1 |
3.9 Comparative Efficacy and Safety of Marketed Products | 69 | 3 |
4 Pipeline | 72 | 20 |
4.1 Overview | 72 | 1 |
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type | 73 | 1 |
4.3 Pipeline by Molecular Target | 74 | 4 |
4.4 Promising Pipeline Candidates | 78 | 1 |
4.4.1 NN-9535 (subcutaneous semaglutide) and OG-217SC (oral semaglutide) Novo Nordisk | 78 | 2 |
4.4.1.1 Forecast | 80 | 1 |
4.4.2 Trulicity (dulaglutide) | 81 | 2 |
4.4.2.1 Forecast | 83 | 1 |
4.4.3 Ertugliflozin Pfizer | 83 | 1 |
4.4.3.1 Forecast | 84 | 1 |
4.4.4 Bexagliflozin Theracos | 84 | 1 |
4.4.4.1 Forecast | 85 | 1 |
4.4.5 Omarigliptin Merck | 86 | 1 |
4.4.5.1 Forecast | 87 | 1 |
4.5 Comparative Efficacy and Safety of Pipeline Products | 88 | 1 |
4.6 Product Competitive Framework | 88 | 4 |
5 Clinical Trial Analysis | 92 | 10 |
5.1 Failure Rate | 92 | 1 |
5.1.1 Overall Failure Rate | 92 | 1 |
5.1.2 Failure Rate by Phase and Molecule Type | 92 | 1 |
5.1.3 Failure Rate by Phase and Molecular Target | 93 | 1 |
5.2 Clinical Trial Size | 94 | 4 |
5.3 Clinical Trial Duration | 98 | 1 |
5.3.1 Trial Duration by Stage of Development and Molecule Type | 98 | 2 |
5.3.2 Trial Duration by Stage of Development and Molecular Target | 100 | 1 |
5.4 Summary of Clinical Trial Metrics | 100 | 2 |
6 Multi-Scenario Forecast | 102 | 21 |
6.1 Geographical Markets | 102 | 1 |
6.2 South-East Asia Markets | 102 | 3 |
6.3 South Korea | 105 | 1 |
6.3.1 Treatment Usage Patterns | 105 | 1 |
6.3.2 Annual Cost of Therapy | 105 | 1 |
6.3.3 Market Size | 106 | 1 |
6.4 Singapore | 107 | 1 |
6.4.1 Treatment Usage Patterns | 107 | 1 |
6.4.2 Annual Cost of Therapy | 107 | 1 |
6.4.3 Market Size | 108 | 1 |
6.5 Taiwan | 109 | 1 |
6.5.1 Treatment Usage Patterns | 109 | 1 |
6.5.2 Annual Cost of Therapy | 109 | 1 |
6.5.3 Market Size | 110 | 1 |
6.6 Malaysia | 111 | 1 |
6.6.1 Treatment Usage Patterns | 111 | 1 |
6.6.2 Annual Cost of Therapy | 112 | 1 |
6.6.3 Market Size | 113 | 1 |
6.7 Philippines | 113 | 1 |
6.7.1 Treatment Usage Patterns | 113 | 1 |
6.7.2 Annual Cost of Therapy | 114 | 1 |
6.7.3 Market Size | 115 | 1 |
6.8 Thailand | 115 | 1 |
6.8.1 Treatment Usage Patterns | 115 | 1 |
6.8.2 Annual Cost of Therapy | 116 | 1 |
6.8.3 Market Size | 117 | 1 |
6.9 Vietnam | 118 | 1 |
6.9.1 Treatment Usage Patterns | 118 | 1 |
6.9.2 Annual Cost of Therapy | 118 | 1 |
6.9.3 Market Size | 119 | 1 |
6.10 Indonesia | 120 | 1 |
6.10.1 Treatment Usage Patterns | 120 | 1 |
6.10.2 Annual Cost of Therapy | 121 | 1 |
6.10.3 Market Size | 122 | 1 |
7 Market Dynamics, (Drivers and Barriers) | 123 | 2 |
7.1 Drivers | 123 | 1 |
7.1.1 Aging Population, Increasing Obesity and Growing Economy | 123 | 1 |
7.1.2 Increasing Awareness of T2DM | 123 | 1 |
7.1.3 Continued Uptake of Recently Approved Drug Classes | 123 | 1 |
7.1.4 Promising Late-Stage Pipeline Products can Change the Treatment Paradigm | 123 | 1 |
7.1.5 Enhanced Usage of Combination Therapies | 123 | 1 |
7.2 Barriers | 124 | 1 |
7.2.1 Non-pharmacological First-line Treatment | 124 | 1 |
7.2.2 Widespread Usage of Generic Drugs | 124 | 1 |
7.2.3 Poor Adherence to Treatment Regimens | 124 | 1 |
7.2.4 Generic Erosion Resulting from Patent Expirations | 124 | 1 |
8 Deals and Strategic Consolidations | 125 | 13 |
8.1 Licensing Deals | 125 | 1 |
8.1.1 Deals by Region and Value | 125 | 1 |
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value | 126 | 1 |
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target | 127 | 2 |
8.1.4 Key Licensing Deals | 129 | 1 |
8.1.4.1 Emisphere Signs New Licensing Agreement with Novo Nordisk to Develop Oral Formulations Targeting Metabolic Indications | 129 | 1 |
8.1.4.2 Amunix Announces Exclusive Agreements with Naia to Develop GLP-1 and GLP-2 XTEN Products | 130 | 1 |
8.1.4.3 Eli Lilly Enters into Licensing Agreement with Adocia | 130 | 1 |
8.2 Co-development Deals | 130 | 1 |
8.2.1 Deals by Region and Value | 130 | 2 |
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value | 132 | 2 |
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target | 134 | 2 |
8.2.4 Key Co-Development Deals | 136 | 1 |
8.2.4.1 Intarcia Therapeutics Enters into Co-Development Agreement with Servier for ITCA 650 | 136 | 1 |
8.2.4.2 Merck Enters into Co-Development Agreement with Pfizer for ertugliflozin | 137 | 1 |
8.2.4.3 AstraZeneca Enters into Research Agreement with Inserm | 137 | 1 |
8.2.4.4 Intarcia Therapeutics Enters into Co-Development Agreement with Numab | 137 | 1 |
8.2.4.5 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb | 137 | 1 |
9 Appendix | 138 | 39 |
9.1 All Pipeline Drugs by Phase of Development | 138 | 17 |
9.1.1 Discovery | 138 | 3 |
9.1.2 Preclinical | 141 | 8 |
9.1.3 IND/CTA-filed | 149 | 1 |
9.1.4 Phase I | 149 | 2 |
9.1.5 Phase II | 151 | 2 |
9.1.6 Phase III | 153 | 1 |
9.1.7 Pre-registration | 154 | 1 |
9.2 Market Forecasts to 2022 | 155 | 5 |
9.2.1 South-East Asia | 155 | 1 |
9.2.2 South Korea | 155 | 1 |
9.2.3 Singapore | 156 | 1 |
9.2.4 Taiwan | 156 | 1 |
9.2.5 Malaysia | 157 | 1 |
9.2.6 Philippines | 157 | 1 |
9.2.7 Thailand | 158 | 1 |
9.2.8 Vietnam | 158 | 1 |
9.2.9 Indonesia | 159 | 1 |
9.3 References | 159 | 11 |
9.4 Abbreviations | 170 | 2 |
9.5 Research Methodology | 172 | 4 |
9.5.1 Secondary Research | 172 | 1 |
9.5.2 Marketed Product Profiles | 173 | 1 |
9.5.3 Late-Stage Pipeline Candidates | 173 | 1 |
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products | 173 | 1 |
9.5.5 Pipeline Analysis | 173 | 1 |
9.5.5.1 Overall Pipeline | 173 | 1 |
9.5.5.2 Clinical Trials | 174 | 1 |
9.5.5.2.1 Failure Rate | 174 | 1 |
9.5.5.2.2 Clinical Trial Size | 174 | 1 |
9.5.5.2.3 Clinical Trial Duration | 174 | 1 |
9.5.5.2.4 Clinical Trial Endpoint Analysis | 174 | 1 |
9.5.6 Forecasting Model | 174 | 1 |
9.5.7 Deals Data Analysis | 175 | 1 |
9.6 Contact Us | 176 | 1 |
9.7 Disclaimer | 176 | 1 |