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

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


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Executive Summary

Acute myeloid (myelogenous, myelocytic) leukemia (AML) is a rapidly progressing blood cancer with an extremely poor overall prognosis. AML predominantly affects the elderly population and this subgroup of patients has an exceptionally high level of unmet needs. GlobalData estimates the 2014 sales for AML at approximately $342 million across the 7MM covered in this report. The market will increase by almost three-fold over the forecast period, reaching $932 million in 2024 at a CAGR of 10.5%. This growth will be driven by an increase in incident cases of AML as well as the approval and uptake of premium-priced products, such as FLT3 kinase inhibitors (quizartinib and midostaurin), a PI3 kinase inhibitor (volasertib) and new formulations of existing chemotherapies such as Vyxeos (CPX-351), guadecitabine and CC-486. GlobalData expects, by the end of the forecast period, new branded therapies Vyxeos, volasertib and CC-486 will dominate the market along with generic azacitidine. The AML pipeline is weak in terms of efficacy; however, GlobalData expects none of these drugs to have a major impact on the overall AML market. The challenge for new entrants into the AML market is to meet the critically high unmet needs of AML patients and improve overall survival. One of the opportunities for the companies is to work cooperatively to develop therapies that work in combination with chemotherapy backbone.

 

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 four patient segments (including, young patients, elderly patients, refractory/relapsed patients and FLT3 mutated patients), forecast from 2014 to 2024.

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 different lines of therapy. The most promising candidate in Phase III development is profiled.

Analysis of the current and future market competition in the global AML therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.



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2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Pathophysiology

3.1.2Classification

3.1.3Cytogenetic and Molecular Abnormalities

3.2Prognosis

3.3Quality of Life

3.4Symptoms

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.2.1Increased age is associated with increased risk and worsened prognosis

4.2.2Smoking increases the risk of M2 AML

4.2.3APL is relatively common among Spanish and Italian origins

4.2.4Chemotherapy and radiation therapy increases the risk of AML

4.2.5Benzene increases risk of AML

4.3Global Trends

4.3.1Incidence

4.3.2Survival and Prevalence

4.3.3Subtypes and Mutations

4.3.4Risk Groups

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources not Used

4.5Epidemiological Forecast for Acute Myeloid Leukemia (2014–2024)

4.5.1Adjusted Diagnosed Incident Cases of AML

4.5.2Adjusted Diagnosed Incident Cases of AML by Age

4.5.3Adjusted Diagnosed Incident Cases of AML by Sex

4.5.4Age-Standardized Incidence of AML

4.5.5APL and MDS/tAML

4.5.6APL and MDS/tAML by Age

4.5.7Diagnosed Incident Cases of AML with FLT3 Mutations

4.5.8Diagnosed Incident Cases of AML by Risk Group Classifications

4.5.9Five-Year Diagnosed Prevalent Cases of AML

4.5.10Five-Year Diagnosed Prevalent Cases of AML by Age

4.5.11Five-Year Diagnosed Prevalent Cases of APL and MDS/tAML

4.5.12Five-Year Diagnosed Prevalent Cases of APL and MDS/tAML by Age

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Treatment Overview

5.2Response Criteria and Outcome Measures

5.3General Treatment Overview

5.3.1Younger AML Patients

5.3.2Older AML Patients

5.4Hematopoietic Stem Cell Transplant

5.5Monitoring for Residual Disease

5.6Acute Promyelocytic Leukemia

6Current Treatment Options

6.1Overview

6.2Product Profiles – Major Brands

6.2.1Cytarabine

6.2.2Dacogen (decitabine)

6.2.3Vidaza (azacitidine)

6.2.4Mylotarg (gemtuzumab ozogamicin)

6.2.5Other Therapeutic Agents for AML

7Unmet Needs Assessment and Opportunity Analysis

7.1Overview

7.2Unmet Needs Analysis

7.2.1Unmet Need: Therapies that Prolong the OS of AML Patients

7.2.2Unmet Need: Elimination of Residual Disease

7.2.3Unmet Need: Therapies that Achieve Durable CR in AML Patients

7.2.4Unmet Need: Safety

7.2.5Unmet Need: Maintenance Therapies

7.2.6Unmet Need: Improvement in Guidelines Directing the Optimum Course of Therapy

7.2.7Unmet Need: Therapies with More Convenient Administration and Dosing Regimens

7.3Opportunity Analysis

7.3.1Opportunity: Targeting Minimal Residual Disease (Leukemic Stem Cells)

7.3.2Opportunity: Targeting Driver Molecular Mutations with Combination Therapy

7.3.3Opportunity: Development of Immunotherapies for AML

7.3.4Opportunity: Use of Differentiation Agents in AML

7.3.5Opportunity: Development of Oral Maintenance Therapies

7.3.6Opportunity: Development of Safer Conditioning Regimens pre-HSCT

8R&D Strategies

8.1Overview

8.1.1Targeting Multiple Patient Segments

8.1.2Developing Novel Drugs in Combination with Established Therapies

8.1.3Targeting Elderly AML Patients

8.1.4Investigating New Targets Involved in the Pathogenesis of AML

8.1.5Alliances Between Academic Groups and Pharmaceutical Companies

8.2Clinical Trial Design

8.2.1Selection of the Appropriate Efficacy Endpoints to Support Regulatory Approval

8.2.2Selection of Active Comparator

8.2.3Randomization and Stratification of Patients

8.2.4Current Clinical Trial Design

8.2.5Future Trends in Clinical Trial Design

9Pipeline Assessment

9.1Overview

9.2Drugs in Late-Stage Clinical Development

9.2.1CC-486 (oral azacitidine)

9.2.2Guadecitabine (SGI-110)

9.2.3Vyxeos (CPX-351)

9.2.4Qinprezo (vosaroxin)

9.2.5Sapacitabine (CYC682)

9.2.6Gilteritinib (ASP2215)

9.2.7Midostaurin (PKC412)

9.2.8Quizartinib (AC220)

9.2.9Volasertib (BI 6727)

9.2.10Ganetespib (STA-9090)

9.3Innovative Early-Stage Approaches

9.3.1Biologic-Targeted Therapies

9.3.2Immunotherapies

9.3.3Epigenetic Approaches

9.3.4Stem Cell Therapies and other Cell-Based Regimens

10Pipeline Valuation Analysis

10.1Clinical Benchmark of Key Pipeline Drugs

10.2Commercial Benchmark of Key Pipeline Drugs

10.3Competitive Assessment

10.4Top-Line -Year Forecast

10.4.1US

10.4.25EU

10.4.3Japan

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed AML Patients

11.4.2Percent Drug-treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6General Forecast Assumptions

11.4.7Individual Drug Assumptions

11.4.8Generic Erosion

11.4.9Pricing of Pipeline Agents

11.5Physicians and Specialists Included in this Study

11.5.1Primary Research – Prescriber Survey

11.6About the Authors

11.6.1Authors

11.6.2Epidemiologist

11.6.3Global Head of Healthcare

11.7About GlobalData

11.8Disclaimer

Figure 1: Comparison of Normal and Leukemia Blood Cell Differentiation

Figure 2: 7MM, Adjusted Diagnosed Incident Cases of AML, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 3: 7MM, Adjusted Diagnosed Incident Cases of AML by Age, Both Sexes, Ages =20 Years, N, 2014

Figure 4: 7MM, Adjusted Diagnosed Incident Cases of AML by Sex, Ages =20 Years, N, 2014

Figure 5: 7MM, Age-Standardized Adjusted Diagnosed Incidence of AML, Ages =20 Years, 2014

Figure 6: 7MM, Diagnosed Incident Cases of APL, and MDS/tAML, Both Sexes, Ages =20 Years, N, 2014 and 2024

Figure 7: 7MM, Diagnosed Incident Cases of AML Subtypes by Age, Both Sexes, N, 2014

Figure 8: 7MM, Diagnosed Incident Cases of AML by Risk Group Classification, Both Sexes, Ages =20 Years, N, 2014

Figure 9: US, Risk Group Classification of AML Incident Cases by Age, Both Sexes, N, 2014

Figure 10: 7MM, Five-Year Diagnosed Prevalent Cases of AML, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 11: Dacogen’s Development in AML

Figure 12: Vidaza’s Development in AML

Figure 13: Mylotarg’s Development in AML

Figure 14: CC-486’s Development in AML

Figure 15: Guadecitabine’s (SGI-110) Development in AML

Figure 16: Vyxeos’ Development in AML

Figure 17: Qinprezo’s (vosaroxin) Development in AML

Figure 18: Sapacitabine’s Development in AML

Figure 19: Gilteritinib’s (ASP2215) Development in AML

Figure 20: Midostaurin’s (PKC412) Development in AML

Figure 21: Quizartinib’s Development in AML

Figure 22: Volasertib’s Development in AML

Figure 23: Ganetespib’s Development in AML

Figure 24: Competitive Assessment of Late-Stage Pipeline Agents in AML, 2014–2024

Figure 25: Global Sales for AML by Region, 2014–2024

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

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