Acute myeloid leukemia (AML) is the most common form of leukemia in adults and has historically been associated with poor five-year overall survival rates. In recent years, the AML treatment armamentarium has expanded with the regulatory approval of several targeted agents and drug reformulations. This has shifted the treatment paradigm from chemotherapy-based approaches towards targeted and personalized therapies. The most recent addition is Bristol Myers Squibb’s Onureg (oral azacitidine) as a maintenance treatment after the first remission. In addition, the early- and late-phase AML pipeline is active and spans several drug classes including novel chemotherapies, novel antibody technologies, CAR T-cell therapies, and small molecules. With the uptake of new therapies and label expansions, we expect the AML market to grow substantially over the ten-year forecast period.

Questions Answered:

  • How will Roche / AbbVie’s Venclexta / Venclyxto perform in the highly lucrative newly diagnosed patient population ineligible for intensive treatment? Will its prescribing expand beyond this population?
  • What uptake and patient share can Onureg expect to capture as a maintenance treatment in AML? How do KOLs view this agent?
  • How will second-generation FLT3 inhibitors (Astellas’s Xospata, Daichii Sankyo’s Vanflyta) vie for a share of the FLT3-mutation-positive market?
  • How do physicians view Jazz Pharmaceuticals’ Vyxeos, and how will the liposomal chemotherapy agent perform in AML?

Product Description

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Solution Enhancement

Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.

Geographies: United States, EU5, Japan.

Primary research: 20 country-specific interviews with thought-leading hematologist-oncologists. Supported by survey data collected for this and other DRG research.

Epidemiology: Diagnosed incident cases of AML by country; clinically and commercially relevant drug-treatable populations.

Forecast: 10-year, annualized drug-level sales and patient shares of key AML therapies through 2029, segmented by brands/generics, age, and line of therapy.

Emerging therapies: Phase III/PR: 11 drugs; coverage of selected Phase II and Phase I products.

Table of contents

  • Acute Myeloid Leukemia - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
      • Q3 2020
        • August 2020
      • Q2 2020
        • April 2020
      • Q4 2019
        • December 2019
    • Key Findings
      • Acute Myeloid Leukemia - Key Findings
        • December 2019
    • Market Outlook
      • Key Findings
        • Market Share of Drug Classes for Acute Myeloid Leukemia: 2019
        • Market Share of Drug Classes for Acute Myeloid Leukemia: 2029
        • Drug-Treatable Population Share and Major-Market Sales Share in Acute Myeloid Leukemia: 2019
        • Drug-Treatable Population Share and Major-Market Sales Share in Acute Myeloid Leukemia: 2029
        • Major-Market Sales of Key Agents in Acute Myeloid Leukemia (Venetoclax, FLT3 Inhibitors, Hypomethylating Agents), 2019-2029
        • Major-Market Sales of Key Agents in Acute Myeloid Leukemia (Excluding Venetoclax, FLT3 Inhibitors, Hypomethylating Agents), 2019-2029
        • Population Positioning of Therapies in Acute Myeloid Leukemia
        • Acute Myeloid Leukemia SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Acute Myeloid Leukemia?
          • What Factors Are Constraining the Market for Acute Myeloid Leukemia?
        • Segment-Specific Trends
          • Patient Share Dynamics of Key Regimens in First-Line Younger AML Patients (Aged <60 Years), United States, 2019-2029
          • Patient Share Dynamics of Key Regimens in First-Line Older AML Patients (Aged ≥60 Years), United States, 2019-2029
          • Patient Share Dynamics of Key Regimens in Second-Line Younger AML Patients (Aged <60 Years), United States, 2019-2029
          • Patient Share Dynamics of Key Regimens in Second-Line Older AML Patients (Aged ≥60 Years), United States, 2019-2029
          • Patient Share Dynamics of Key Regimens in Third-Line AML, United States, 2019-2029
      • Forecast
        • Market Forecast Downloads
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Etiology
            • Risk Factors Associated with AML
          • Disease Pathophysiology
            • Select Molecular Mutations in AML
          • Staging Systems in AML
            • FAB Classification System
            • 2016 WHO Classification of AML and Related Neoplasms
          • Risk Stratification in AML
            • NCCN and ELN Risk Stratification Systems for AML
          • Key Pathways and Drug Targets
            • Select Pathways and Drug Targets
        • Epidemiology
          • Key Findings
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Incidence of Acute Myeloid Leukemia
              • Diagnosed Incident Cases of Acute Myeloid Leukemia: 2019-2029
              • Acute Myeloid Leukemia Patient Flow
              • Drug-Treatable Cases of Acute Myeloid Leukemia: 2019-2029
              • Drug-Treated Cases of Acute Myeloid Leukemia: 2019-2029
          • Current Treatment
            • Key Findings
              • Treatment Goals
                • Key Endpoints Used in Clinical Trials for AML
              • Key Current Therapies
                • Overview
                • Mechanism of Action of Key Current Drugs Used for AML
                • Current Treatments Used for AML
                • Market Events Impacting the Use of Key Current Therapies for AML
                • Key Results from Select Clinical Trials Investigating Vidaza for the Treatment of AML
                • Expert Insight: Vidaza
                • Key Results from Select Clinical Trials Investigating Onureg (Oral Azacitidine) for the Treatment of AML
                • Ongoing Clinical Development of Onureg (Oral Azacitidine)
                • Key Ongoing Clinical Trials of Onureg (Oral Azacitidine) in the Treatment of AML
                • Expert Insight: Onureg (Oral Azacitidine)
                • Key Results from Select Clinical Trials Investigating Dacogen for the Treatment of AML
                • Expert Insight: Dacogen
                • Key Results from Select Clinical Trials Investigating Mylotarg for the Treatment of AML
                • Key Ongoing Clinical Trials of Mylotarg in the Treatment of AML
                • Expert Insight: Mylotarg
                • Key Results from Select Clinical Trials Investigating Rydapt for the Treatment of AML
                • Ongoing Clinical Development of Rydapt
                • Key Ongoing Clinical Trials of Rydapt in the Treatment of AML
                • Expert Insight: Rydapt
                • Key Results from Select Clinical Trials Investigating Xospata for the Treatment of AML
                • Ongoing Clinical Development of Xospata
                • Key Ongoing Clinical Trials of Xospata in the Treatment of AML
                • Expert Insight: Xospata
                • Ongoing Clinical Development of Vanflyta
                • Key Ongoing Clinical Trials of Vanflyta in the Treatment of AML
                • Expert Insight: Vanflyta
                • Key Results from Select Clinical Trials Investigating Vyxeos for the Treatment of AML
                • Ongoing Clinical Development of Vyxeos
                • Key Ongoing Clinical Trials of Vyxeos in the Treatment of AML
                • Expert Insight: Vyxeos
                • Key Results from Select Clinical Trials Investigating Idhifa for the Treatment of AML
                • Ongoing Clinical Development of Idhifa
                • Key Ongoing Clinical Trials of Idhifa in the Treatment of AML
                • Expert Insight: Idhifa
                • Key Results from Select Clinical Trials Investigating Tibsovo for the Treatment of AML
                • Ongoing Clinical Development of Tibsovo
                • Key Ongoing Clinical Trials of Tibsovo in the Treatment of AML
                • Expert Insight: Tibsovo
                • Key Results from Select Clinical Trials Investigating Venclexta / Venclyxto for the Treatment of AML
                • Ongoing Clinical Development of Venclexta / Venclyxto
                • Key Ongoing Clinical Trials of Venclexta / Venclyxto in the Treatment of AML
                • Expert Insight: Venclexta / Venclyxto
                • Key Results from Select Clinical Trials Investigating Daurismo for the Treatment of AML
                • Ongoing Clinical Development for Daurismo
                • Key Ongoing Clinical Trials of Daurismo in the Treatment of AML
                • Expert Insight: Daurismo
              • Medical Practice
                • First-Line AML, Younger Patients (Aged < 60)
                • First-Line AML, Older Patients (Aged ≥ 60)
                • Relapsed/Refractory AML
                • AML Treatment Guidelines by Region
                • Patient Characteristics Influencing Drug Selection in AML
                • Treatment Decision Tree for Acute Myeloid Leukemia: United States
                • Treatment Decision Tree for Acute Myeloid Leukemia: Europe
                • Treatment Decision Tree for Acute Myeloid Leukemia: Japan
            • Unmet Need Overview
              • Current and Future Attainment of Unmet Needs in AML
              • Top Unmet Needs in Acute Myeloid Leukemia: Current and Future Attainment
            • Emerging Therapies
              • Key Findings
                • Pipeline Trends in Acute Myeloid Leukemia
              • Key Emerging Therapies
                • Key Therapies in Development for AML
                • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of AML
                • Key Results from Select Clinical Trials Investigating Crenolanib for the Treatment of AML
                • Analysis of the Clinical Development Program for Crenolanib
                • Key Ongoing Clinical Trials of Crenolanib in the Treatment of AML
                • Expert Insight: Crenolanib
                • Expectations for Market Authorization and Sales Opportunity of Crenolanib in AML
                • Key Results from Select Clinical Trials Investigating Guadecitabine for the Treatment of AML
                • Analysis of the Clinical Development Program for Guadecitabine
                • Key Ongoing Clinical Trials of Guadecitabine in the Treatment of AML
                • Expert Insight: Guadecitabine
                • Expectations for Market Authorization and Sales Opportunity of Guadecitabine in AML
                • Key Results from Select Clinical Trials Investigating Uproleselan for the Treatment of AML
                • Analysis of the Clinical Development Program for Uproleselan
                • Key Ongoing Clinical Trials of Uproleselan in the Treatment of AML
                • Expert Insight: Uproleselan
                • Expectations for Market Authorization and Sales Opportunity of Uproleselan for AML
                • Key Results from Select Clinical Trials Investigating Pracinostat for the Treatment of AML
                • Analysis of the Clinical Development Program for Pracinostat
                • Key Ongoing Clinical Trials of Pracinostat in the Treatment of AML
                • Expert Insight: Pracinostat
                • Expectations for Market Authorization and Sales Opportunity of Pracinostat in AML
                • Key Results from Select Clinical Trials Investigating Idasanutlin for the Treatment of AML
                • Analysis of the Clinical Development Program for Idasanutlin
                • Key Ongoing Clinical Trials of Idasanutlin in the Treatment of AML
                • Expert Insight: Idasanutlin
                • Expectations for Market Authorization and Sales Opportunity of Idasanutlin in AML
                • Key Results from Select Clinical Trials Investigating Devimistat for the Treatment of AML
                • Analysis of the Clinical Development Program for Devimistat
                • Key Clinical Trials of Devimistat in the Treatment of AML
                • Expert Insight: Devimistat
                • Expectations for Market Authorization and Sales Opportunity of Devimistat in AML
                • Key Results from Select Clinical Trials Investigating Pevonedistat for the Treatment of AML
                • Analysis of the Clinical Development Program for Pevonedistat
                • Key Ongoing Clinical Trials of Pevonedistat in the Treatment of AML
                • Expert Insight: Pevonedistat
                • Expectations for Market Authorization and Sales Opportunity of Pevonedistat in AML
                • Key Results from Select Clinical Trials Investigating Cedazuridine for the Treatment of AML
                • Key Ongoing Clinical Trials of Cedazuridine in the Treatment of AML
                • Analysis of the Clinical Development Program for Cedazuridine
                • Expert Insight: Cedazuridine
                • Expectations for Market Authorization and Sales Opportunity of Cedazuridine in AML
                • Key Ongoing Clinical Trials of Galinpepimut-S in the Treatment of AML
                • Analysis of the Clinical Development Program for Galinpepimut-S
                • Expert Insight: Galinpepimut-S
                • Expectations for Market Authorization and Sales Opportunity of Galinpepimut-S in AML
                • Key Results from Select Clinical Trials Investigating DFP-10917 for the Treatment of AML
                • Key Ongoing Clinical Trials of DFP-10917 in the Treatment of AML
                • Analysis of the Clinical Development Program for DFP-10917
                • Expert Insight: DFP-10917
                • Expectations for Market Authorization and Sales Opportunity of DFP-10917 in AML
                • Key Results from Select Clinical Trials Investigating Magrolimab for the Treatment of AML
                • Analysis of the Clinical Development Program for Magrolimab
                • Key Ongoing Clinical Trials of Magrolimab in the Treatment of AML
                • Expectations for Market Authorization and Sales Opportunity of Magrolimab in AML
              • Early-Phase Pipeline Analysis
                • Select Compounds in Early-Phase Development for AML
            • Access & Reimbursement Overview
              • Region-Specific Reimbursement Practices
                • Key Market Access Considerations in AML: United States
                • General Reimbursement Environment: United States
                • Key Market Access Considerations in AML: EU5
                • General Reimbursement Environment: EU5
                • Key Market Access Considerations in AML: Japan
                • General Reimbursement Environment: Japan
            • Appendix
              • Key Abbreviations Related to Acute Myeloid Leukemia
              • Brands, Marketers, and Generic Availability of Key Therapies for Acute Myeloid Leukemia by Market
              • Acute Myeloid Leukemia Bibliography

          Author(s): Angela Diana; Atul Sharma, M.P.H.

          Angela Diana, Ph.D., is an analyst on the Oncology team at DRG, part of Clarivate. Previously, she was a research assistant at Stemgen, a biotech company focused on developing stem cell treatments for cancer and neurodegenerative diseases. She received a Ph.D. in radiation oncology from the University of Oxford with a thesis focused on better understanding the effects of radiotherapy on the tumor microenvironment. Her project was funded by the European Union's Horizon 2020 research and innovation program and received a Marie-Sklodowska Curie grant. She also holds M.Sc. and B.Sc. degrees from the University of Milan in Italy.

          Atul Sharma, M.P.H., is an associate epidemiologist at DRG, part of Clarivate. He holds a master’s degree in public health from the School of Public Health, Post-Graduate Institute of Medical Education and Research, and a bachelor’s degree in dental surgery from MN DAV Dental College and Hospital.


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