Acute Myeloid Leukemia (AML) Market Opportunity Assessment, Epidemiology, Clinical Trials, Unmet Needs and Forecast to 2032

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Acute Myeloid Leukemia (AML) Market Report Overview

The acute myeloid leukemia (AML) market in the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China) was $2.3 billion in 2022. Steady growth is anticipated at a CAGR of more than 4% throughout the forecast period as the number of AML patients continues to climb and new therapies arrive in the 8MM. The AML market research report offers an overview of AML, including epidemiology, symptoms, diagnosis, and disease management. The report offers key topics covered including strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications for the AML therapeutics market.

AML Market Outlook 2022-2032 ($ Billion)

AML Market Outlook 2022-2032 ($ Billion)

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Acute myeloid (or myelogenous or myelocytic) leukemia (AML) is a malignancy of the hematopoietic system caused by abnormal proliferation or differentiation of myeloid progenitors in the bone marrow and peripheral blood. AML is relatively rare and has a poor prognosis, particularly in elderly patients.

Market Size (2022) $2.3 billion
CAGR (2022-2032) >4%
Key Countries (8MM) ·        The US

·        The UK

·        Germany

·        France

·        Italy

·        Spain

·        Japan

·        Urban China

Key Drug Classes ·        Targeted Therapies – Small Molecule

·        Cell Therapies

·        Targeted Therapies – Biologics

·        Branded Chemotherapy

·        Hypomethylating Agents

·        Generic Chemotherapy

Key Sponsors ·        CSPC Pharmaceutical Group

·        Astex Pharmaceuticals Inc

·        Zhejiang University

·        Novartis AG

·        Daiichi Sankyo Co Ltd

·        Celgene Corp

·        AbbVie Inc

·        Dana-Farber Cancer Institute Inc

·        Bristol Myers Squibb Co

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AML Market Dynamics

  • The sales of two menin inhibitors, revumenib and ziftomenib, represent the most high-profile driver as highlighted by KOLs, totaling $393 million in 2032. Targeting a new segment of difficult-to-treat patients, both inhibitors are anticipated to be launched in the US and 5EU.
  • Pipeline agents to be used as therapies for improving HSCT outcomes are important market drivers as they create a brand-new market segment as HSCT aids. Orca-T is heading towards the US and 5EU, while mocravimod targets the US, 5EU, and Japan.
  • The anticipated launch of iodine-131-apamistamab in the markets of the US and 5EU contributes to the robust growth of the AML market, thanks to its potentially higher price tag as a radiopharmaceutical, and its robustness in clearing blasts in a wider population of patients for conducting effective HSCT.
  • Several late-stage pipeline drugs with novel MOAs have received orphan drug designation from the FDA. As such, they are granted a potential seven years of market exclusivity after approval.

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AML Market Segmentation by Country

The key countries in the AML market are the United States, France, Germany, Italy, Spain, the UK, Japan, and Urban China. In 2022, the US dominated the total AML market in the 8MM occupying over 60% of the market share. The dominance of the US within the 8MM is due to higher drug prices and the market entries of a greater range of novel therapies.

AML Market Analysis by Country, 2022 (%)

AML Market Analysis by Country, 2022 (%)

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AML Market Segmentation by Drug Classes

The key drugs in the AML market are targeted therapies – small molecule, cell therapies, targeted therapies – biologics, branded chemotherapy, hypomethylating agents, and generic chemotherapy. In 2022, small molecule drugs in the class of targeted therapy contributed the highest AML market sales.

AML Market Analysis by Drug Classes, 2022 (%)

AML Market Analysis by Drug Classes, 2022 (%)

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AML Market Segmentation by Sponsors

The key sponsors conducting Phase I to III clinical trials in the AML market are CSPC Pharmaceutical Group, Astex Pharmaceuticals Inc, Zhejiang University, Novartis AG, Daiichi Sankyo Co Ltd, Celgene Corp, AbbVie Inc, Dana-Farber Cancer Institute Inc, and Bristol Myers Squibb Co among others. As of September 2023, CSPC Pharmaceutical Group from China has been the most active sponsor of clinical trials in AML. The company is developing the FLT3 inhibitor SKLB-1028, gearing towards the R/R setting in the domestic market.

AML Market Analysis by Sponsors, 2023 (%)

AML Market Analysis by Sponsors, 2023 (%)

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Segments Covered in this Report

AML Country Outlook ($ Billion, 2022-2032)

  • The US
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Japan
  • Urban China

AML Drugs Outlook (%, 2022-2032)

  • Targeted Therapies – Small Molecule
  • Cell Therapies
  • Targeted Therapies – Biologics
  • Branded Chemotherapy
  • Hypomethylating Agents
  • Generic Chemotherapy


  • Annualized AML therapeutics market revenue in 8MM (the US, Germany, and the UK), the annual cost of therapy and treatment usage pattern in 2022 and forecast for 10 years to 2032 covering three-time points: base year, 5-year, and 10-year.
  • Pipeline analysis, comprehensive data assessing emerging trends and mechanisms of action under development for AML treatment. The most promising candidates in late-stage development are profiled.
  • Analysis of the current and future market competition in the 8MM AML therapeutics market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide a qualitative analysis of its implications.

Key Highlights

Report deliverables include a PowerPoint report and Excel-based forecast model

Forecast includes 8 countries

Forecast covers 2022-2032

Reasons to Buy

  • 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 AML therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the AML therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counterstrategies 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.

Actinium Pharmaceuticals
Astellas Pharma
Astex Pharmaceuticals
Arog Pharmaceuticals
Bristol Myers Squibb
CSPC Pharmaceutical Group
Daiichi Sankyo
Delta-fly Pharma
Gamida Cell
Gilead Sciences
Jazz Pharmaceutcials
Kura Oncology
Orca Biosystems
Rigel Pharmaceuticals
SELLAS Life Sciences Group
Servier Pharmaceuticals
Sunshine Lake Pharma
Syndax Pharmaceuticals
TC BioPharm

Table of Contents

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

3. Disease Overview

3.1. Overview of Acute Myeloid Leukemia

3.2. Acute Myeloid Leukemia Market Strength, Weakness, Opportunity, and Threat Analysis

3.3. Classification of Acute Myeloid Leukemia

4. Epidemiology

4.1. Diagnosed Incident Cases of Acute Myeloid Leukemia, Both Sexes, Ages ≥18 Years, 2022-32

4.2. Age-Specific Trends in Diagnosed Incident Cases of Acute Myeloid Leukemia, Both Sexes, 2022

4.3. Sex-Specific Diagnosed Incident Cases of Acute Myeloid Leukemia, Both Sexes, Ages ≥18 Years, 2022

4.4. Sources and Methodology for Acute Myeloid Leukemia Incidence

5. Current Treatment Options

5.1. Treatment Paradigm – First-Line Induction Therapy

5.2. Treatment Paradigm – Consolidation, Maintenance, and Relapsed/Refractory Therapy

5.3. Acute Myeloid Leukemia Treatment Algorithm

5.4. Marketed Products Overview

5.5. Product Profile: Antibody-drug Conjugate (Mylotarg)

5.6. Product Profile: BCL-2 Inhibitor (Venclexta)

5.7. Product Profile: FLT3 Inhibitors (Rydapt, Vanflyta, Xospata)

5.8. Product Profile: Hedgehog Pathway Inhibitor (Daurismo)

5.9. Product Profile: IDH1/2 Inhibitors (Tibsovo, Idhifa, Rezlidhia)

5.10. Product Profile: Cell Therapy (Omisirge)

5.11. Product Profile: Hypomethylating Agents (Dacogen, Onureg, and Vidaza)

5.12. Product Profile: Hypomethylating Agents (Inaqovi)

5.13. Product Profile: Branded Chemotherapy (Vyxeos)

6. Unmet Needs and Opportunities

6.1. Unmet Needs in Acute Myeloid Leukemia

6.2. Translating Complete Remission to Durable Overall Survival

6.3. Treatments in the Second Line and Beyond

6.4. Improving Treatment Options for Difficult-to-treat Patients

6.5. Improving Patient Access and Outcome of HSCT

7. R&D Strategies

7.1. Trends in Clinical Trial Design in Acute Myeloid Leukemia

7.2. Acute Myeloid Leukemia Clinical Trials by Trial Sponsors

7.3. Trends in Deal-Making in Acute Myeloid Leukemia

8. Pipeline Assessment

8.1. AML Pipeline Overview

8.2. Late-Stage Pipeline Agents for Acute Myeloid Leukemia

8.3. Product Profile: Branded Chemotherapy (radgocitabine)

8.4. Product Profile: E-selectin Inhibitor (uproleselan)

8.5. Product Profile: FLT3 Inhibitors (clifutinib, crenolanib, SKLB-1028)

8.6. Product Profile: Hypomethylating Agents (ASTX030)

8.7. Product Profile: Menin Inhibitors (revumenib, ziftomenib)

8.8. Product Profile: Monoclonal Antibody (magrolimab)

8.9. Product Profile: Peptide Vaccine (galinpepimut-S)

8.10. Product Profile: Radioimmunoconjugate (iodine-131-apamistamab)

8.11. Product Profile: S1PR Agonist (mocravimod)

8.12. Product Profile: Cell Therapies (OmnImmune, Orca-T)

9. Market Outlook

9.1. Acute Myeloid Leukemia Market Forecast

9.2. Acute Myeloid Leukemia Market Drivers and Barriers

10. Appendix

10.1. Primary Research: Key Opinion Leader Information

10.2. Bibliography

10.3. About the Authors

11. Contact Us

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