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

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OpportunityAnalyzer: Acute Myeloid Leukemia - Opportunity Analysis and Forecasts to 2026
Published: July 1, 2017 Content info: 395 Pages
Description

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/Roche's Venclexta, Celgene's enasidenib and CC-486, and Actinium's Iomab-B for elderly AML patients; Daiichi Sankyo's quizartinib and Astellas' gilteritinib for FLT3-mutated AML; and Jazz's 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.
Table of Contents
Product Code: GDHC074POA

Table of Contents

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

List of Tables

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 ($m) for AML, 2016-2026 320
  • Table 141: Key Events Impacting Sales of AML Products, 2016-2026 324
  • Table 142: AML Market - Global Drivers and Barriers, 2016?2026 326
  • Table 143: Sales Forecast ($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

List of Figures

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: Dacogen's Development in AML 112
  • Figure 18: Vidaza's Development in AML 119
  • Figure 19: Mylotarg's Development in AML 128
  • Figure 20: Rydapt's (Midostaurin's) Development in AML 136
  • Figure 21: Overview of The Clinical Development Pipeline in AML 183
  • Figure 22: CC-486's Development in AML 190
  • Figure 23: Guadecitabine's (SGI-110) Development in AML 198
  • Figure 24: Gilteritinib (ASP2215)'s Development in AML 207
  • Figure 25: Quizartinib's Development in AML 212
  • Figure 26: Crenolanib's Development in AML 218
  • Figure 27: Vadastuximab Talirine's Development in AML 225
  • Figure 28: Enasidenib's Development in AML 231
  • Figure 29: Venclexta (Venetoclax)'s Development in AML 236
  • Figure 30: Idasanutlin's Development in AML 240
  • Figure 31: Pracinostat's Development in AML 244
  • Figure 32: Iomab-B's Development in AML 248
  • Figure 33: Volasertib's Development in AML 252
  • Figure 34: Ganetespib's Development in AML 257
  • Figure 35: Vyxeos' Development in AML 263
  • Figure 36: Qinprezo's (vosaroxin) Development in AML 274
  • Figure 37: Sapacitabine's Development in AML 280
  • Figure 38: NiCord's 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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