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OpportunityAnalyzer: Acute Myeloid Leukemia - Opportunity Analysis and Forecasts to 2026

Published By :

GlobalData

Published Date : Jul 2017

Category :

Pharmaceutical

No. of Pages : 395 Pages

OpportunityAnalyzer: Acute Myeloid Leukemia - Opportunity Analysis and Forecasts to 2026

Summary

Acute myeloid leukemia (AML) is a rapidly progressing blood cancer with a poor overall prognosis. AML is relatively rare, and predominantly affects older adults. Although a number of acquired genetic and molecular abnormalities have been implicated in the manifestation of AML and disease progression, in most cases the stimuli causing these abnormalities to occur have not been identified.

Major drivers of the AML market in the 7MM will include an increasing number of elderly incident cases of AML, particularly in the US, the launch of premium-priced therapies, including AbbVie/Roches Venclexta, Celgenes enasidenib and CC-486, and Actiniums Iomab-B for elderly AML patients; Daiichi Sankyos quizartinib and Astellas gilteritinib for FLT3-mutated AML; and Jazzs Vyxeos for newly diagnosed elderly secondary AML patients, and an increasing branded drug treatment rate, particularly among elderly patients.

Barriers to the growth of the AML market in the 7MM will include a high enrollment rate of AML patients in clinical trials in the 5EU, the US, and Japan, pressure for cost-consciousness, particularly in the EU, limited adoption of the branded therapies due to positioning of most of them in combination with the relatively toxic current standard-of-care (SOC) regimens, loss of patent protection of Vidaza, Dacogen, Rydapt, and the prospective branded therapies Vyxeos and guadecitabine.

Key Questions Answered

- The AML market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the AML market?
- How will new pipeline agents such as Rydapt, enasidenib, Mylotarg, Vyxeos, and Venclexta impact the AML market?
- The current AML market is dominated by generic chemotherapies. How will the advent of targeted prescription drugs change the drug treatment landscape in AML? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Scope

- Overview of AML, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized AML therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in nine patient segments , forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AML therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for AML. The most promising candidate in Phase III development are profiled.
- Analysis of the current and future market competition in the global AML market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global AML market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AML market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Acute Myeloid Leukemia: Executive Summary 12
2.1 New Entrants Will Drive Strong Growth in the US and EU AML Market from 2016 to 2026 13
2.2 R&D Strategies Target Underserved Patients and Aim to Circumvent Historical Difficulties 15
2.3 High Unmet Needs Exist in the AML Market, Especially for Elderly and Relapsed/Refractory Patients 16
2.4 Pipeline Agents Will Offer Incremental Improvements Over Current Therapies 16
2.5 Significant Opportunity Remains For Effective Therapies in AML 21
2.6 What Do Physicians Think? 22
3 Introduction 27
3.1 Catalyst 27
3.2 Related Reports 27
3.3 Upcoming Related Reports 27
4 Disease Overview 28
4.1 Etiology and Pathophysiology 28
4.1.1 Pathophysiology 29
4.1.2 Classification 30
4.1.3 Cytogenetic and Molecular Abnormalities 33
4.2 Prognosis 42
4.3 Quality of Life 42
4.4 Symptoms 43
5 Epidemiology 45
5.1 Disease Background 45
5.2 Risk Factors and Comorbidities 46
5.3 Global and Historical Trends 47
5.3.1 Incidence 47
5.3.2 Relative Survival 49
5.3.3 Subtypes 50
5.4 Forecast Methodology 51
5.4.1 Sources 52
5.4.2 Forecast Assumptions and Methods - Population 55
5.4.3 Forecast Assumptions and Methods - Incidence 55
5.4.4 Forecast Assumptions and Methods - Relative Survival 59
5.4.5 Forecast Assumptions and Methods - Subtypes of AML 61
5.4.6 Forecast Assumptions and Methods - Mutations and Biomarkers 62
5.4.7 Forecast Assumptions and Methods - Risk Groups 64
5.5 Epidemiological Forecast for Acute Myeloid Leukemia (2016-2026) 66
5.5.1 Adjusted Diagnosed Incident Cases of AML 66
5.5.2 Age-Specific Diagnosed Incident Cases of AML 67
5.5.3 Diagnosed Incident Cases of APL 68
5.5.4 Diagnosed Incident Cases of Secondary AML 68
5.5.5 Diagnosed Incident Cases of AML by Mutations and Biomarkers 69
5.5.6 Diagnosed Incident Cases of AML by Risk Groups 70
5.5.7 Five-Year Diagnosed Prevalent Cases of AML 71
5.6 Discussion 72
5.6.1 Epidemiological Forecast Insight 72
5.6.2 Limitations of Analysis 73
5.6.3 Strengths of Analysis 75
6 Current Treatment Options 76
6.1 Overview 76
6.2 Diagnosis and Treatment 82
6.2.1 Diagnosis 82
6.2.2 Treatment Guidelines and Leading Prescribed Drugs 85
6.3 Response Criteria and Outcome Measures 86
6.4 Clinical Practice 88
6.4.1 Younger AML Patients 91
6.4.2 Older AML Patients 94
6.5 Hematopoietic Stem Cell Transplant (HSCT) 98
6.6 Monitoring for Minimal Residual Disease 102
6.7 Acute Promyelocytic Leukemia 103
6.8 Product Profiles - Major Brands 105
6.8.1 Cytarabine 105
6.8.2 Dacogen (decitabine) 109
6.8.3 Vidaza (azacitidine) 115
6.8.4 Mylotarg (gemtuzumab ozogamicin) 124
6.8.5 Rydapt (midostaurin) 133
6.8.6 Other Therapeutic Classes for AML 141
7 Unmet Needs Assessment and Opportunity Analysis 143
7.1 Overview 143
7.2 Therapies That Prolong the Overall Survival of AML Patients 145
7.2.1 Unmet Need 145
7.2.2 Gap Analysis 148
7.2.3 Opportunity 149
7.3 Elimination of Minimal Residual Disease 150
7.3.1 Unmet Need 150
7.3.2 Gap Analysis 151
7.3.3 Opportunity 152
7.4 Therapies That Achieve Durable Complete Remission in AML Patients 152
7.4.1 Unmet Need 152
7.4.2 Gap Analysis 153
7.4.3 Opportunity 154
7.5 Safer Treatment Options 155
7.5.1 Unmet Need 155
7.5.2 Gap Analysis 156
7.5.3 Opportunity 157
7.6 Maintenance Therapies 158
7.6.1 Unmet Need 158
7.6.2 Gap Analysis 159
7.6.3 Opportunity 159
7.7 Improvement in Guidelines Directing the Optimum Course of Therapy 160
7.7.1 Unmet Need 160
7.7.2 Gap Analysis 161
7.7.3 Opportunity 161
7.8 Therapies with More Convenient Administration and Dosing Regimens 162
7.8.1 Unmet Need 162
7.8.2 Gap Analysis 162
7.8.3 Opportunity 163
8 Research and Development Strategies 164
8.1 Overview 164
8.1.1 Targeting Multiple Patient Segments 165
8.1.2 Developing Novel Drugs in Combination with Established Therapies 166
8.1.3 Targeting Elderly AML Patients 167
8.1.4 Investigating New Targets Involved in the Pathogenesis of AML 168
8.1.5 Alliances Between Academic Groups and Pharmaceutical Companies 170
8.2 Clinical Trial Design 171
8.2.1 Current Clinical Trial Design 172
8.2.2 Selection of the Appropriate Efficacy Endpoints to Support Regulatory Approval 175
8.2.3 Selection of Active Comparator 178
8.2.4 Randomization of Stratification of Patients 179
8.2.5 Future Trends in Clinical Trial Design 180
9 Pipeline Assessment 182
9.1 Overview 182
9.2 Promising Drugs in Clinical Development 183
9.3 Hypomethylating Agents (HMAs) 186
9.3.1 CC-486 (oral azacitidine) 187
9.3.2 Guadecitabine (SGI-110) 195
9.4 FLT3 Tyrosine Kinase Inhibitors 204
9.4.1 Gilteritinib (ASP2215) 205
9.4.2 Quizartinib (AC220) 209
9.4.3 Crenolanib Besylate 216
9.5 Anti-CD33 Antibody Drug Conjugates (ADCs) 222
9.5.1 Vadastuximab Talirine (SGN-CD33A) 223
9.6 IDH2 Inhibitors 229
9.6.1 Enasidenib (AG-221) 229
9.7 Other Targeted Therapies 233
9.7.1 Venclexta/Venclyxto (venetoclax) 234
9.7.2 Idasanutlin 238
9.7.3 Pracinostat 242
9.7.4 Iomab-B 246
9.7.5 Volasertib (BI 6727) 249
9.7.6 Ganetespib (STA-9090) 255
9.8 Chemotherapy 259
9.8.1 Vyxeos (CPX-351) 259
9.8.2 Qinprezo (vosaroxin) 271
9.8.3 Sapacitabine (CYC682) 278
9.9 HSCT Alternatives 283
9.9.1 NiCord 283
9.10 Innovative Early-Stage Approaches 286
9.10.1 Epigenetic Modulators 288
9.10.2 Targeted Therapies 289
9.10.3 Immunotherapies 296
9.11 Other Drugs in Development 300
10 Pipeline Valuation Analysis 301
10.1 Clinical Benchmark of Key Pipeline Drugs 301
10.2 Commercial Benchmark of Key Pipeline Drugs 308
10.3 Competitive Assessment 314
10.4 Top-Line 10-Year Forecast 319
10.4.1 US 327
10.4.2 5EU 330
10.4.3 Japan 333
11 Appendix 337
11.1 Bibliography 337
11.2 Abbreviations 367
11.3 Methodology 373
11.4 Forecasting Methodology 373
11.4.1 Diagnosed Patients 373
11.4.2 Percent Drug-Treated Patients 374
11.4.3 Drugs Included in Each Therapeutic Class 374
11.4.4 Launch and Patent Expiry Dates 375
11.4.5 General Pricing Assumptions 376
11.4.6 Individual Drug Assumptions 377
11.4.7 Generic Erosion 383
11.4.8 Pricing of Pipeline Agents 383
11.5 Primary Research - KOLs Interviewed for this Report 390
11.5.1 KOLs 390
11.6 Primary Research - Prescriber Survey 392
11.7 About the Authors 392
11.7.1 Analyst 392
11.7.2 Therapy Area Director 392
11.7.3 Managing Epidemiologist 393
11.7.4 Global Director of Therapy Analysis and Epidemiology 393
11.7.5 Global Head and EVP of Healthcare Operations Strategy 394
11.8 About GlobalData 394
11.9 Contact Us 394
11.10 Disclaimer 395

1.1 List of Tables
Table 1: Acute Myeloid Leukemia: Key Metrics in the Seven Major Pharmaceutical Markets, 2016-2026 12
Table 2: Classification of AML Subtypes - WHO System 32
Table 3: Classification of AML Subtypes - FAB System 33
Table 4: Common Cytogenetic Abnormalities in AML 35
Table 5: Symptoms of AML 44
Table 6: Risk Factors for AML in Adults 47
Table 7: AML Coding System by Country 48
Table 8: Five-Year Relative Survival of AML by Age, 2016 50
Table 9: Risk Group Classification Guidelines 65
Table 10: 7MM, Adjusted Diagnosed Incident Cases of AML, Ages 18 Years, Both Sexes, Select Years 2016-2026 67
Table 11: 7MM, Age-Specific Adjusted Diagnosed Incident Cases of AML, Both Sexes, 2016 67
Table 12: 7MM, Mutations and Biomarkers in Diagnosed Incident Cases of AML, Ages 18 Years, Both Sexes, 2016 70
Table 13: 7MM, Five-Year Diagnosed Prevalent Cases of AML, Ages 18 Years, Both Sexes, Select Years 2016-2026 71
Table 14: Leading Treatments for AML 82
Table 15: Treatment Guidelines for Acute Myeloid Leukemia 85
Table 16: Most Commonly Used Regimens in Acute Myeloid Leukemia 86
Table 17: Types of Responses - AML 87
Table 18: Outcome Measures in AML 87
Table 19: Induction and Consolidation Regimens for APL by Patient Risk Group 104
Table 20: Product Profile - Cytarabine (generic) 107
Table 21: Cytarabine SWOT Analysis 109
Table 22: Product Profile - Dacogen 110
Table 23: Efficacy of Dacogen versus Physicians Choice of Treatment (DACO-016 Trial; NCT00260832) 113
Table 24: Safety of Dacogen (decitabine) in AML Patients (DACO-016 Trial; NCT00260832) 114
Table 25: Dacogen SWOT Analysis 115
Table 26: Product Profile - Vidaza 117
Table 27: Efficacy of Vidaza versus Conventional Care Regimens in Newly Diagnosed or Secondary Elderly AML Patients with >30% Blasts (NCT01074047; AML-001) 121
Table 28: Efficacy of Vidaza plus Revlimid (lenalidomide) in Newly Diagnosed Elderly AML Patients (NCT00890929) 121
Table 29: Safety of Vidaza (azacitidine) in Newly Diagnosed or Secondary Elderly AML Patients with >30% Blasts (NCT01074047; AML-001) 122
Table 30: Safety of Vidaza + Revlimid in Newly Diagnosed Elderly AML Patients (NCT00890929) 123
Table 31: Vidaza SWOT Analysis 123
Table 32: Product Profile - Mylotarg (Gemtuzumab Ozogamicin [GO]) 125
Table 33: Efficacy of Mylotarg versus Best Supportive Care in Previously Untreated Elderly AML Patients (NCT00091234; AML-19) 129
Table 34: Efficacy Analysis of Mylotarg in the ALFA 0701 Phase III Trial (EudraCT 2007-002933-36) 130
Table 35: Safety of Mylotarg in Previously Untreated Elderly AML Patients (NCT00091234; AML-19) 131
Table 36: Safety of Mylotarg in Previously Untreated Elderly AML Patients (EudraCT 2007-002933-36; ALFA-001) 132
Table 37: Mylotarg SWOT Analysis 132
Table 38: Product Profile - Midostaurin 134
Table 39: Efficacy of Rydapt in Combination with Azacitidine in Patients with AML/MDS (Trial NCT01202877) 138
Table 40: Safety of Rydapt in Combination with Vidaza in Patients with AML/MDS (>65 years of age) (NCT01202877) 140
Table 41: Rydapt SWOT Analysis 141
Table 42: Other Therapeutic Agents Prescribed for AML 142
Table 43: Overall Unmet Needs in AML - Current Level of Attainment 144
Table 44: Clinical Trial Design of Key Registrational Trials in AML Patients Who Are Eligible for Intensive Chemotherapy 172
Table 45: Clinical Trial Design of Key Registrational Trials in AML Patients Who Are Not Eligible for Intensive Chemotherapy 173
Table 46: Clinical Trial Design of Key Registrational Trials of Late Stage Pipeline Products Evaluated in the Maintenance Setting Following First-Line Consolidation Treatment 174
Table 47: Clinical Trial Design of Key Registrational Trials of Late Stage Pipeline Products Evaluated in Patients with Relapsed/Refractory AML 174
Table 48: AML - Late-Stage Pipeline, 2017 186
Table 49: Product Profile - CC-486 188
Table 50: Efficacy of CC-486 in AML Patients 191
Table 51: Efficacy of CC-486 Extended Dosing Schedules in WHO-Defined RAEB-1 or RAEB-2 MDS (Ad hoc Analysis of Two Ongoing Phase I/II Studies) 193
Table 52: Safety of CC-486 in AML Patients 194
Table 53: CC-486 SWOT Analysis 195
Table 54: Product Profile - Guadecitabine 197
Table 55: Efficacy of Five- and 10-day Regimens of Guadecitabine in Previously Untreated Elderly AML Patients 199
Table 56: Efficacy of Guadecitabine in Elderly Patients Ineligible for Intensive Chemotherapy (Trial NCT01261312) 200
Table 57: Efficacy of Guadecitabine + Chemotherapy in Elderly Newly Diagnosed AML 200
Table 58: Efficacy of Guadecitabine in Relapsed/Refractory AML 201
Table 59: Safety of Guadecitabine in Elderly Patients Ineligible for Intensive Chemotherapy 202
Table 60: Safety of Guadecitabine in Previously Untreated Elderly AML Patients 203
Table 61: Guadecitabine SWOT Analysis 204
Table 62: Product Profile - Gilteritinib 206
Table 63: Efficacy of Gilteritinib in Refractory/Relapsed AML Patients (Trial NCT02014558) 208
Table 64: Gilteritinib SWOT Analysis 209
Table 65: Product Profile - Quizartinib 210
Table 66: Efficacy of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients (Trial NCT01565668) 213
Table 67: Efficacy of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients as a Bridge to HSCT 213
Table 68: Safety of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients (Trial NCT01565668) 215
Table 69: Quizartinib SWOT Analysis 215
Table 70: Product Profile - Crenolanib Besylate 217
Table 71: Patient Characteristics in the Two Phase II Trials of Crenolanib 219
Table 72: Efficacy of Crenolanib in Relapsed/Refractory FLT3-ITD and/or TKD AML 219
Table 73: Efficacy of Crenolanib + Standard Induction Chemotherapy in Newly Diagnosed FLT3-Mutated AML 220
Table 74: Safety of Crenolanib in Relapsed/Refractory FLT3-Mutated AML 221
Table 75: Crenolanib SWOT Analysis 222
Table 76: Product Profile - Vadastuximab Talirine 224
Table 77: Patient Characteristics in the Phase I Trial of Vadastuximab Talirine (NCT01902329) 226
Table 78: Efficacy Analysis of Vadastuximab Talirine Monotherapy or in Combination with an HMA 226
Table 79: Efficacy Analysis of Vadastuximab Talirine in Combination with 7+3 227
Table 80: Efficacy Analysis of Vadastuximab Talirine Consolidation and Maintenance Setting 228
Table 81: Vadastuximab Talirine SWOT Analysis 229
Table 82: Product Profile - Enasidenib (AG-221) 230
Table 83: Efficacy Analysis of Enasidenib in Relapsed/Refractory AML (NCT01915498) 232
Table 84: Enasidenib SWOT Analysis 233
Table 85: Product Profile - Venclexta (Venetoclax) 235
Table 86: Efficacy Analysis of Venclexta in Elderly Patients with Newly Diagnosed AML (NCT02203773) 236
Table 87: Efficacy of Venclexta + LDAC Regimen in Elderly Patients (NCT02287233) 237
Table 88: Safety Profile of Venclexta in Combination with Azacitidine or Decitabine (NCT02203773) 238
Table 89: Venclexta SWOT Analysis 238
Table 90: Product Profile - Idasanutlin 239
Table 91: Efficacy Analysis of Idasanutlin + Cytarabine in Relapsed/Refractory AML 241
Table 92: Idasanutlin SWOT Analysis 241
Table 93: Product Profile - Pracinostat 243
Table 94: Efficacy Analysis of Pracinostat + Azacitidine in Elderly Patients with Newly Diagnosed AML 245
Table 95: Safety Profile of Pracinostat + Azacitidine in Newly Diagnosed Elderly AML Patients 245
Table 96: Pracinostat SWOT Analysis 246
Table 97: Product Profile - Iomab-B 247
Table 98: Safety Profile of Iomab-B 248
Table 99: Iomab-B SWOT Analysis 249
Table 100: Product Profile - Volasertib 250
Table 101: Initial Efficacy Analysis of Volasertib + LDAC in the Phase III POLO-AML-2 Trial 252
Table 102: Efficacy of Volasertib with LDAC in Elderly AML Patients Ineligible for Intensive Therapy (Trial NCT00804856) 253
Table 103: Safety of Volasertib with LDAC in Elderly AML Patients Ineligible for Intensive Therapy (Trial NCT00804856) 254
Table 104: Volasertib SWOT Analysis 255
Table 105: Product Profile - Ganetespib 256
Table 106: Efficacy Analysis of Ganetespib + LDAC in the Phase III AML-LI-1 Trial 258
Table 107: Safety Analysis of Ganetespib + LDAC in the Phase III AML-LI-1 Trial 258
Table 108: Ganetespib SWOT Analysis 259
Table 109: Product Profile - Vyxeos 261
Table 110: Patients Characteristics in the Phase III Trial (Celator, NCT01696084) of Vyxeos 264
Table 111: Efficacy of Vyxeos versus 7+3 in the Phase III Trial (Celator, NCT01696084) 265
Table 112: Subgroup Efficacy Analysis of the Phase III Trial (Celator, NCT01696084) of Vyxeos in sAML 265
Table 113: Post-HSCT Efficacy Analysis of the Phase III Trial (Celator, NCT01696084) of Vyxeos in sAML 266
Table 114: Efficacy of Vyxeos versus 7+3 Regimen in Patients Between 60 and 75 Years of Age with Newly Diagnosed AML (Trial NCT00788892) 267
Table 115: Efficacy of Vyxeos in AML Patients (18-65 years of age) in First Relapse (Trial NCT00822094) 268
Table 116: Safety Profile of Vyxeos in Elderly sAML 269
Table 117: Safety of Vyxeos in AML Patients (18-65 years of age) in First Relapse (Trial NCT00822094) 270
Table 118: Vyxeos SWOT Analysis 271
Table 119: Product Profile - Qinprezo 273
Table 120: Efficacy of Qinprezo in Refractory/Relapsed AML Patients of All Ages (Trial NCT01191801; VALOR) 275
Table 121: Efficacy of Qinprezo in Elderly (60 years and older) Refractory/Relapsed AML Patients After a Longer Follow-up Time(Trial NCT01191801; VALOR) 276
Table 122: Safety of Qinprezo in Refractory/Relapsed AML Patients of All Ages (Trial NCT01191801; VALOR) 277
Table 123: Qinprezo SWOT Analysis 278
Table 124: Product Profile - Sapacitabine 279
Table 125: Efficacy of Sapacitabine in Elderly Patients with Newly Diagnosed AML (>70 years) (Trial NCT01303796; SEAMLESS) 281
Table 126: Safety of Sapacitabine in Elderly Patients with Newly Diagnosed AML (Trial NCT01303796) 282
Table 127: Sapacitabine SWOT Analysis 282
Table 128: Product Profile - NiCord 284
Table 129: NiCord SWOT Analysis 286
Table 130: Early-Stage Pipeline Products in AML 287
Table 131: Drugs in Development for AML, 2017 300
Table 132: Clinical Benchmark of Key Pipeline Drugs - Therapies For Elderly AML Patients Who Are Not Eligible For Intensive Therapy ( 60 Years and Older) 302
Table 133: Clinical Benchmark of Key Pipeline Drugs - Therapies for Young and Elderly AML Patients Who Are Eligible For Intensive Therapy (Ages 18 and Older) 304
Table 134: Clinical Benchmark of Key Pipeline Drugs - Therapies for Young and Elderly AML Patients Who Are Eligible For Intensive Therapy (Ages 18 and Older)continued from Table 124 304
Table 135: Clinical Benchmark of Key Pipeline Drugs - FLT3 TKIs (Ages 18 and Older) 307
Table 136: Commercial Benchmark of Key Pipeline Drugs - Therapies for Elderly AML Patients Who Are Not Eligible For Intensive Therapy (60 Years and Older) 309
Table 137: Commercial Benchmark of Key Pipeline Drugs - Therapies for Young and Elderly AML Patients Who Are Eligible For Intensive Therapy (Ages 18 and Older ) 311
Table 138: Commercial Benchmark of Key Pipeline Drugs - Therapies for Young and Elderly AML Patients Who Are Eligible For Intensive Therapy (Ages 18 and Older )continued from Table 128 312
Table 139: Commercial Benchmark of Key Pipeline Drugs - FLT3 TKIs 313
Table 140: Top-Line Sales Forecasts ($m) for AML, 2016-2026 320
Table 141: Key Events Impacting Sales of AML Products, 2016-2026 324
Table 142: AML Market - Global Drivers and Barriers, 20162026 326
Table 143: Sales Forecast ($M) for AML in the US, 2016-2026 328
Table 144: Sales Forecast ($M) for AML in the 5EU, 2016-2026 331
Table 145: Sales Forecast ($M) for AML in Japan, 2016-2026 335
Table 146: Key Historical and Projected Launch Dates for AML 375
Table 147: Key Historical and Projected Patent Expiry Dates for AML 376
Table 148: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 392

1.2 List of Figures
Figure 1: Global Sales for AML by Country/Region, 2016 and 2026 14
Figure 2: Competitive Assessment of Marketed And Pipeline Agents in Elderly AML Patients Who Are Not Eligible For Intensive Therapy (60 Years And Older), 2016-2026 18
Figure 3: Competitive Assessment of Marketed And Pipeline Agents in Young and Elderly AML Patients Who Are Eligible For Intensive Therapy (18 Years And Older), 2016-2026 19
Figure 4: Competitive Assessment of Marketed And Pipeline Agents in Patients With FLT3+ AML (18 Years And Older), 2016-2026 20
Figure 5: Comparison of Normal and Leukemia Blood Cell Differentiation 30
Figure 6: 7MM, Age-Standardized Adjusted Diagnosed Incidence of AML, Ages 18 Years, 2016 49
Figure 7: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of AML 52
Figure 8: 7MM Sources Used, Relative Survival of AML 53
Figure 9: 7MM, Sources Used, Diagnosed Incident Cases of APL 53
Figure 10: 7MM, Sources Used, Diagnosed Incident Cases of Secondary AML 54
Figure 11: 7MM, Diagnosed Incident Cases of APL, Both Sexes, Ages 18 Years, 2016 68
Figure 12: 7MM, Diagnosed Incident Cases of Secondary AML, Both Sexes, Ages 18 Years, 2016 69
Figure 13: 7MM, Diagnosed Incident Cases of AML by Risk Group, Both Sexes, Ages 18 Years, 2016 70
Figure 14: 7MM, Five-Year Diagnosed Prevalent Cases of AML by Age, Both Sexes, 2016 72
Figure 15: Disease Management Flowchart for AML in Patients Younger Than 60 Years 92
Figure 16: Disease Management Flowchart for AML in Elderly Patients 98
Figure 17: Dacogens Development in AML 112
Figure 18: Vidazas Development in AML 119
Figure 19: Mylotargs Development in AML 128
Figure 20: Rydapts (Midostaurins) Development in AML 136
Figure 21: Overview of The Clinical Development Pipeline in AML 183
Figure 22: CC-486s Development in AML 190
Figure 23: Guadecitabines (SGI-110) Development in AML 198
Figure 24: Gilteritinib (ASP2215)s Development in AML 207
Figure 25: Quizartinibs Development in AML 212
Figure 26: Crenolanibs Development in AML 218
Figure 27: Vadastuximab Talirines Development in AML 225
Figure 28: Enasidenibs Development in AML 231
Figure 29: Venclexta (Venetoclax)s Development in AML 236
Figure 30: Idasanutlins Development in AML 240
Figure 31: Pracinostats Development in AML 244
Figure 32: Iomab-Bs Development in AML 248
Figure 33: Volasertibs Development in AML 252
Figure 34: Ganetespibs Development in AML 257
Figure 35: Vyxeos Development in AML 263
Figure 36: Qinprezos (vosaroxin) Development in AML 274
Figure 37: Sapacitabines Development in AML 280
Figure 38: NiCords Development in AML 285
Figure 39: Competitive Assessment of Marketed and Pipeline Agents For Elderly AML Patients Who Are Not Eligible For Intensive Therapy (60 Years And Older), 2016-2026 315
Figure 40: Competitive Assessment of Marketed and Pipeline Agents For Young And Elderly AML Patients Who Are Eligible For Intensive Therapy (18 Years And Older), 2016-2026 316
Figure 41: Competitive Assessment of Marketed and Pipeline Agents For FLT3+ AML Patients (18 Years And Older), 2016-2026 318
Figure 42: Top-Line Sales for AML by Country/Region, 2016 and 2026 321
Figure 43: Global Sales for AML by Drug Class, 2016 and 2026 323
Figure 44: Global Sales for AML by Drug Class in the US, 2016 and 2026 329
Figure 45: Global Sales for AML by Drug Class in the 5EU, 2016 and 2026 333
Figure 46: Global Sales for AML by Drug Class in Japan, 2016 and 2026 336

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