OpportunityAnalyzer: Acute Myeloid Leukemia (AML) – Opportunity Analysis and Forecasts to 2024

Table 1: Classification of AML Subtypes – WHO System

Table 2: Classification of AML Subtypes – FAB System

Table 3: Common Cytogenetic Abnormalities in AML

Table 4: Symptoms of AML

Table 5: Risk Factors for AML in Adults

Table 6: Incidence of AML per 100,000 Population in Japan, 1993–2002, All Ages

Table 7: Estimated Frequencies of Cytogenetic Abnormalities in AML

Table 8: Risk Group Classification Guidelines

Table 9: 7MM, Sources of AML Diagnosed Incidence

Table 10: 7MM, Adjusted Diagnosed Incident Cases of AML, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 11: 7MM, Adjusted Diagnosed Incident Cases of AML by Age, Both Sexes, N (Row %), 2014

Table 12: 7MM, Adjusted Diagnosed Incident Cases of AML by Sex, N (Row %), 2014

Table 13: 7MM, Diagnosed Incident Cases of APL, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 14: 7MM, Diagnosed Incident Cases of MDS/tAML, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 15: 7MM, Diagnosed Incident Cases of AML Subtypes by Age, Both Sexes, N (Row % in Each Subtype), 2014

Table 16: 7MM, Diagnosed Incident Cases of AML with FLT3 Mutations, Both Sexes, Ages =20 Years, N, Selected Years 2014–2024

Table 17: 7MM, Diagnosed Incident Cases of AML by Risk Group Classification, Both Sexes, Ages =20 Years, N (Row %), 2014

Table 18: US, Risk Group Classification of AML Incident Cases by Age, Both Sexes, N (Row %), 2014

Table 19: 7MM, Five-Year Diagnosed Prevalent Cases of AML, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 20: 7MM, Five-Year Diagnosed Prevalent Cases of AML by Age, Both Sexes, N (Row %), 2014

Table 21: 7MM, Five-Year Diagnosed Prevalent Cases of APL, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 22: 7MM, Five-Year Diagnosed Prevalent Cases of MDS/tAML, Both Sexes, Ages =20 Years, N, Selected Years, 2014–2024

Table 23: 7MM, Five-Year Diagnosed Prevalent Cases of AML Subtypes by Age, Both Sexes, N (Row %), 2014

Table 24: Types of Responses – AML

Table 25: Outcome Measures in AML

Table 26: Induction and Consolidation Regimens for APL by Patient Risk Group

Table 27: Leading Treatments for AML

Table 28: Product Profile – Cytarabine (generic)

Table 29: Cytarabine SWOT Analysis

Table 30: Product Profile – Dacogen

Table 31: Efficacy of Dacogen vs Physicians’ Choice of Treatment (DACO-016 Trial; NCT00260832)

Table 32: Safety of Dacogen (decitabine) in AML Patients (DACO-016 Trial; NCT00260832)

Table 33: Dacogen SWOT Analysis

Table 34: Product Profile – Vidaza

Table 35: Efficacy of Vidaza vs Conventional Care Regimens in Newly Diagnosed or Secondary Elderly AML Patients with >30% Blasts (NCT01074047; AML-001)

Table 36: Safety of Vidaza (azacitidine) in Newly Diagnosed or Secondary Elderly AML Patients with >30% Blasts (NCT01074047; AML-001)

Table 37: Vidaza SWOT Analysis

Table 38: Product Profile – Mylotarg (Gemtuzumab Ozogamicin [GO])

Table 39: Efficacy of Mylotarg vs Best Supportive Care in Previously Untreated Elderly AML Patients (NCT00091234; AML-19)

Table 40: Safety of Mylotarg in Previously Untreated Elderly AML Patients (NCT00091234; AML-19)

Table 41: Mylotarg SWOT Analysis

Table 42: Other Therapeutic Agents Prescribed for AML

Table 43: Overall Unmet Needs in AML – Current Level of Attainment

Table 44: Design of Current Phase III Trials in AML

Table 45: AML – Late-Stage Pipeline, 2015

Table 46: Product Profile – CC-486

Table 47: Efficacy of CC-486 in AML Patients

Table 48: 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)

Table 49: Safety of CC-486 in AML Patients

Table 50: CC-486 SWOT Analysis

Table 51: Global Sales Forecast ($m) for CC-486, 2014–2024

Table 52: Product Profile – Guadecitabine

Table 53: Efficacy of Guadecitabine in Previously Untreated Elderly AML Patients (Trial NCT02348489)

Table 54: Efficacy of Guadecitabine in Elderly Patients Ineligible for Intensive Chemotherapy (Trial NCT01261312)

Table 55: Safety of Guadecitabine in Elderly Patients Ineligible for Intensive Chemotherapy

Table 56: Safety of Guadecitabine in Previously Untreated Elderly AML Patients (Trial NCT02348489)

Table 57: Safety of Guadecitabine in Refractory/Relapsed AML Patients

Table 58: Guadecitabine SWOT Analysis

Table 59: Global Sales Forecast ($m) for Guadecitabine (SGI-110), 2014–2024

Table 60: Product Profile – Vyxeos

Table 61: Efficacy of Vyxeos versus 7+3 Regimen in Patients Between 60 and 75 Years of Age with Newly Diagnosed AML (Trial NCT00788892)

Table 62: Efficacy of Vyxeos in AML Patients (18–65 years of age) in First Relapse (Trial NCT00822094)

Table 63: Safety of Vyxeos in AML Patients (18–65 years of age) in First Relapse (Trial NCT00822094)

Table 64: Vyxeos SWOT Analysis

Table 65: Global Sales Forecast ($m) for Vyxeos, 2014–2024

Table 66: Product Profile – Qinprezo

Table 67: Efficacy of Qinprezo in Refractory/Relapsed AML Patients of All Ages (Trial NCT01191801; VALOR)

Table 68: Safety of Qinprezo in Refractory/Relapsed AML Patients of All Ages (Trial NCT01191801; VALOR)

Table 69: Qinprezo SWOT Analysis

Table 70: Global Sales Forecast ($m) for Qinprezo, 2014–2024

Table 71: Product Profile – Sapacitabine

Table 72: Efficacy of Sapacitabine in Elderly Patients with Newly Diagnosed AML (>70 years) (Trial NCT01303796; SEAMLESS)

Table 73: Safety of Sapacitabine in Elderly Patients with Newly Diagnosed AML (Trial NCT01303796)

Table 74: Sapacitabine SWOT Analysis

Table 75: Global Sales Forecast ($m) for Sapacitabine, 2014–2024

Table 76: Product Profile – Gilteritinib

Table 77: Efficacy of Gilteritinib in Refractory/Relapsed AML Patients (Trial NCT02014558)

Table 78: Safety of Gilteritinib in Refractory/Relapsed AML Patients (Trial NCT02014558)

Table 79: Gilteritinib SWOT Analysis

Table 80: Global Sales Forecast ($m) for Gilteritinib, 2014–2024

Table 81: Product Profile – Midostaurin

Table 82: Efficacy of Midostaurin in Combination with Vidaza in Patients with AML/MDS (>65 years of age) (Trial NCT01202877)

Table 83: Safety of Midostaurin in Combination with Vidaza in Patients with AML/MDS (>65 years of age) (NCT01202877)

Table 84: Midostaurin SWOT Analysis

Table 85: Global Sales Forecast ($m) for Midostaurin, 2014–2024

Table 86: Product Profile – Quizartinib

Table 87: Efficacy of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients (Trial NCT01565668)

Table 88: Efficacy of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients as a Bridge to HSCT

Table 89: Safety of Quizartinib in FLT3-ITD(+) Refractory/Relapsed AML Patients (Trial NCT01565668)

Table 90: Quizartinib SWOT Analysis

Table 91: Global Sales Forecast ($m) for Quizartinib, 2014–2024

Table 92: Product Profile – Volasertib

Table 93: Efficacy of Volasertib with LDAC in Elderly AML Patients Ineligible for Intensive therapy (Trial NCT00804856)

Table 94: Safety of Volasertib with LDAC in Elderly AML Patients Ineligible for Intensive Therapy (Trial NCT00804856)

Table 95: Volasertib SWOT Analysis

Table 96: Global Sales Forecast ($m) for Volasertib, 2014–2024

Table 97: Product Profile – Ganetespib

Table 98: Ganetespib SWOT Analysis

Table 99: Global Sales Forecast ($m) for Ganetespib, 2014–2024

Table 100: Early-Stage Pipeline Products in AML

Table 101: Clinical Benchmark of Key Pipeline Drugs – First-Line Therapies for Newly Diagnosed AML Patients (all ages >20 years)

Table 102: Clinical Benchmark of Key Pipeline Drugs – First-Line Therapies for Newly Diagnosed AML Patients (all ages >20 years)

Table 103: Clinical Benchmark of Key Pipeline Drugs – Refractory/Relapsed AML Patients (all ages >20 years)

Table 104: Commercial Benchmark of Key Marketed and Pipeline Drugs – First-Line Therapies for Newly Diagnosed AML patients (all ages >20 years)

Table 105: Commercial Benchmark of Key Pipeline Drugs – First-Line Therapies for Newly Diagnosed AML Patients (all ages >20 years)

Table 106: Commercial Benchmark of Key Pipeline Drugs – Relapsed/Refractory AML Patients (all ages >20 years)

Table 107: Global Top-Line Sales Forecasts ($m) for AML, 2014–2024

Table 108: Key Events Impacting Sales for AML in the US, 2014–2024

Table 109: Key Events Impacting Sales for AML in Japan, 2014–2024

Table 110: Key Events Impacting Sales for AML in the 5EU, 2014–2024

Table 111: AML Market in the US – Drivers and Barriers, 2014

Table 112: 5EU AML Market – Drivers and Barriers, 2014

Table 113: Japan AML Market – Drivers and Barriers, 2014

Table 114: Key Launch Dates

Table 115: Key Patent Expiries

Table 116: Average Body Weight, Height and Surface Area, Across the 7MM

Table 117: High-Prescribing Physicians Surveyed by Country