Acute Myeloid Leukemia (AML) - Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026

Acute Myeloid Leukemia (AML) Emerging Therapy and TPP Insights

Thelansis's "Acute Myeloid Leukemia (AML) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Acute Myeloid Leukemia (AML) Overview

Acute myeloid leukemia (AML) is an aggressive hematologic malignancy characterized by clonal expansion of abnormal myeloid precursors that disrupt blood-cell production. Patients may develop cytopenias, infection, and bleeding, with prognosis shaped by age, fitness, molecular features, and measurable residual disease. Treatment ranges from intensive induction chemotherapy to regimens such as azacitidine or decitabine with venetoclax, followed by consolidation or allogeneic stem-cell transplantation in selected patients. Targeted therapy includes FLT3, IDH1/2, and menin-directed agents. Revumenib and ziftomenib are FDA-approved for relapsed/refractory NPM1-mutated AML, while revumenib is approved for KMT2A-translocated acute leukemia. In 2026 oral decitabine/cedazuridine plus venetoclax was approved for newly diagnosed patients unable to receive intensive induction. Priorities include measurable residual disease, resistance, relapse prevention, and durable remission with lower toxicity.

Key Highlights

• In Spain, AML incidence cases are projected to remain broadly stable, from 2,380 in 2026 to 2,368 by 2036.
• AML is an aggressive hematologic malignancy characterized by rapid disease progression and substantial mortality risk.
• Despite advances in targeted therapies and combination regimens, relapse and treatment resistance remain major challenges.
• Significant unmet need remains for therapies that improve durable remission and long-term survival.

Market Overview

• The Germany AML market is projected to grow from $305M in 2026 to $690M by 2036.
• Market growth is driven by:
• Increasing adoption of targeted therapies and novel combination regimens
• Continued development of next-generation AML treatments
• Future growth will depend on therapies that overcome treatment resistance and deliver durable clinical responses.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Syndax Pharmaceuticals
• Ipsen
• Hikma Pharmaceuticals LLC
• Moleculin Biotech, Inc.
• Janssen Research & Development, LLC
• Hutchmed
• AbbVie
• Bristol-Myers Squibb
• Akeso
• Novartis Pharmaceuticals
• PrECOG, LLC.
• Allotera Therapeutics
• Taiho Oncology, Inc.
• OncoVerity, Inc.
• PedAL BCU, LLC
• Daiichi Sankyo Co., Ltd.
• Actinium Pharmaceuticals
• Celgene
• AstraZeneca
• Boehringer Ingelheim
• Astellas Pharma Inc.
• Amphista Therapeutics Ltd
• Pfizer
• Kyowa Kirin Co., Ltd.
• Oryzon Genomics S.A.
• Aptevo Therapeutics
• Charm Therapeutics
• Takeda
• Cullinan Therapeutics Inc.
• Kura Oncology, Inc.
• GluBio Therapeutics Inc.
• Solu Therapeutics, Inc.
• Crossbow Therapeutics, Inc.
• Remix Therapeutics
• Aprea Therapeutics
• Auron Therapeutics, Inc.
• BeOne Medicines
• NovaOnco Therapeutics Co., Ltd.
• Rigel Pharmaceuticals
• Aptose Biosciences Inc.
• Eli Lilly and Company
• Aspera Biomedicines, Inc.