Acute Myeloid Leukemia – Landscape & Forecast – Disease Landscape & Forecast
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. These new therapies have diversified the treatment paradigm from chemotherapy-based approaches to safer and more-effective targeted or personalized therapies. The approval of Bristol Myers Squibb’s Onureg has paved the way for drug development in the commercially lucrative maintenance setting. In addition, the early- and late-phase AML pipeline is active and spans several drug classes, including novel CD47-targeting agents, E-selectin inhibitors, vaccines, kinase inhibitors, small molecules, novel antibody technologies, and CAR T-cell therapies. With the uptake of new therapies and label expansions, we expect the AML market to grow substantially over the 10-year forecast period.
Questions answered:
- What uptake and patient share can Onureg expect to capture as maintenance treatment in AML, and what competition will it face?
- 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?
- How will second-generation FLT3 inhibitors (Astellas’s Xospata, Daiichi Sankyo’s Vanflyta) vie for a share of the FLT3-mutation-positive market?
- Which emerging therapies are the most promising in AML? Which therapies could help address the unmet need for better treatments for TP53-mutated patients?
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 continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Geographies: United States, EU5, Japan.
Primary research: 19 country-specific interviews with thought-leading hematologist-oncologists. Supported by survey data collected for this and other Clarivate research.
Epidemiology: Diagnosed incidence cases of AML by country, clinically, and market-relevant drug-treatable populations.
Forecast: 10-year, annualized, drug- and regimen-level sales and patient share of key AML therapies through 2031, segmented by brands / generics / biosimilars and drug-treatable subpopulations.
Emerging therapies: Phase III: 9 drugs; coverage of selected Phase II and Phase I products.
Table of contents
- Acute Myeloid Leukemia - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Acute myeloid leukemia - key findings - October 2022
- Key updates
- January 2023
- Q4 2022
- December 2022
- October 2022
- Q3 2022
- July 2022
- Q2 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Market outlook
- Key findings
- Market share of drug classes for AML: 2021
- Market share of drug classes for AML: 2031
- Drug-treatable population share and major-market sales share in AML: 2021
- Drug-treatable population share and major-market sales share in AML: 2031
- Major-market sales of key agents in AML (venetoclax, FLT3 inhibitors, and hypomethylating agents): 2021-2031
- Major-market sales of key agents in AML (excluding venetoclax, FLT3 inhibitors, and hypomethylating agents): 2021-2031
- Population positioning of current therapies in AML
- Population positioning of emerging therapies in AML
- AML SWOT analysis
- Market drivers and constraints
- What factors are driving the market for AML?
- What factors are constraining the market for AML?
- Segment-specific trends
- Patient-share dynamics of key regimens for first-line younger AML patients (aged < 60), United States: 2021-2031
- Patient-share dynamics of key regimens in first-line AML patients (aged u2265 60), United States: 2021-2031
- Patient share dynamics of key regimens in second-line younger AML patients (aged < 60), United States, 2021-2031
- Patient share dynamics of key regimens in second-line older AML patients (aged u2265 60), United States, 2021-2031
- Patient share dynamics of key regimens in third-line AML, United States, 2021-2031
- Key findings
- 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
- 2017 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
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition
- Methods
- Sources used for diagnosed incidence of acute myeloid leukemia
- Diagnosed incident cases of acute myeloid leukemia: 2021-2031
- Acute myeloid leukemia patient flow
- Drug-treatable cases of acute myeloid leukemia: 2021-2031
- Drug-treated cases of acute myeloid leukemia: 2021-2031
- Key findings
- 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 injectable azacitidine for the treatment of AML
- Expert insight: injectable azacitidine
- 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 decitabine for the treatment of AML
- Key results from select clinical trials investigating Mylotarg for the treatment of AML
- Ongoing clinical development of Mylotarg
- 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
- Key results from select clinical trials investigating Vanflyta for the treatment of AML
- 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 Rezlidhia for the treatment of AML
- Analysis of the clinical development program for Rezlidhia
- 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 u2265 60)
- Relapsed / refractory AML
- 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
- Key findings
- Unmet need overview
- Current and future attainment of unmet needs in AML
- Top unmet needs in acute myeloid leukemia: current and future attainment
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- 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 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 ASTX-727 for the treatment of AML
- Analysis of the clinical development program for ASTX-727
- Expert insight: ASTX-727
- Expectations for market authorization and sales opportunity of ASTX-727 in AML
- Analysis of the clinical development program for ASTX-030
- Key ongoing clinical trials of ASTX-030 in the treatment of AML
- Expectations for market authorization and sales opportunity of ASTX-030 in AML
- Key results from select clinical trials investigating galinpepimut-S for the treatment of AML
- Analysis of the clinical development program for galinpepimut-S
- Key ongoing clinical trials of galinpepimut-S in the treatment of AML
- Expert insight: galinpepimut-S
- Expectations for market authorization and sales opportunity of galinpepimut-S in AML
- Key results from select clinical trials investigating radgocitabine for the treatment of AML
- Analysis of the clinical development program for radgocitabine
- Key ongoing clinical trials of radgocitabine in the treatment of AML
- Expert insight: radgocitabine
- Expectations for market authorization and sales opportunity of radgocitabine 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
- Expert insights: magrolimab
- Expectations for market authorization and sales opportunity of magrolimab in AML
- Key results from select clinical trials investigating OmnImmune for the treatment of AML
- Analysis of the clinical development program for OmnImmune
- Key ongoing clinical trials of OmnImmune in the treatment of AML
- Expectations for market authorization and sales opportunity of OmnImmune in AML
- Key results from select clinical trials investigating Iomab-B for the treatment of AML
- Analysis of the clinical development program for Iomab-B
- Key ongoing clinical trials of Iomab-B in the treatment of AML
- Expert insight: Iomab-B
- Expectations for market authorization and sales opportunity of Iomab-B in AML
- Early-phase pipeline analysis
- Select compounds in early-phase development for AML
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviation table
- Acute myeloid leukemia bibliography
- Key findings
Joan Tur, M.Sc., Ph.D., Healthcare Research & Data Analyst, Oncology. Dr. Tur conducts market research and forecasting in a range of oncology indications. He has several years of experience as a pharmaceutical industry analyst with the Cortellis Competitive Intelligence group, serving as the team’s immuno-oncology expert. Prior to joining Clarivate, Dr. Tur was a researcher in inflammation and macrophage biology at the Barcelona Science Park. He holds a Ph.D. in biomedicine, an M.Sc. in immunology, and a B.Sc. in biology from the University of Barcelona.
Pramilesh Tekchand Suryawanshi, M.P.H., is an associate epidemiologist at Clarivate. His focus is on hematological malignancies and solid tumors. Previously, Mr. Suryawanshi worked with Pathfinder International in Lepra, the Netherlands Leprosy Relief Foundation, and the National Health Mission. He received his M.P.H. from the Tata Institute of Social Sciences in Mumbai, where he worked on several public health projects, including an assessment of social health insurance schemes. He holds a bachelor’s degree in the Indian system of medicine (Ayurveda) from Rajiv Gandhi University of Health Sciences in Karnataka.