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Acute Myeloid Leukemia (AML) –KOLs Insight | Competitive Intelligence | Market Forecast 2033

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The research study conducted by Mellalta Meets provides insights into the AML market dynamics, treatment trends, and key opportunities in the G7 regions. It highlights the need for novel targeted therapies, the potential of biomarker strategies, and the significant market opportunity for drug developers targeting the AML population. The study serves as a comprehensive resource for understanding the current landscape and future prospects of AML treatment.

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Description

AML definition: Mellalta MeetsAcute myeloid leukemia (AML) and its management are a major health and economic burden globally. AML cases are on the rise across regions and countries. With over 41,090 cases in 2023 in G7 (US, EU5 and Japan) regions, it is expected to grow with a CAGR of 0.5% by 2033.

There were no approved treatments for decades for acute myeloid leukaemia (AML) other than chemotherapies. The past six years has witnessed the approval of eleven new therapies for AML; Rydapt / midostaurin (Novartis), Vyxeos (CPX-351) / cytarabine/daunorubicin liposomal formulation (Jazz, Nippon Shinyaku), Idhifa / enasidenib (BMS, Servier), Mylotarg / gemtuzumab ozogamicin (UCB, PDL, Pfizer), Tibsovo / ivosidenib (Servier), Venclexta / venetoclax (Roche, AbbVie), Xospata / gilteritinib (Astellas), Daurismo / glasdegib (Pfizer), Vanflyta / quizartinib (Daiichi Sankyo), Onureg (azacitidine oral) and Rezlidhia / olutasidenib (Forma Therapeutics).

How are these agents faring on the market so far and will more personalised treatments follow their lead? All the drugs above form part of a rich pipeline, but which drugs stand out to key opinion leaders (KOLs)? Learn how AML’s market is evolving, and how our analyst expects developers to differentiate their pipeline therapies in the Slide Deck: Acute Myeloid Leukaemia.

We have also interviewed KOLs and they have provided their candid views on the potential of existing and upcoming molecules in the first line and second-line therapies in fit and unfit patient groups.

Mellalta Meets performed a Competitive Landscape and Competitive Intelligence study in the first quarter of 2023.  This research study aimed to analyze the dynamics of the Acute Myeloid Leukemia (AML) market in the G7 regions, identify current treatment trends, explore disruptive events, and highlight critical opportunities driving the AML market.

In addition to the full report, licensed users have access to the Market Forecast Model

Key findings:

  1. AML and its management pose a significant health and economic burden globally, with rising cases across regions and countries. In the G7 regions (US, EU5, and Japan), there were over 41,090 cases in 2023, projected to grow at a CAGR of 0.5% by 2033.
  2. High unmet needs in AML contribute to a competitive environment in research and development activities and new drug launches. Key unmet needs identified by experts and Key Opinion Leaders include high treatment costs, minimal residual disease (MRD) detection, high relapse rates, and unresponsiveness in the TP53 mutant patient population.
  3. Over the years, numerous innovative drugs have been approved, offering new treatment options for AML patients. Treatment guidelines have also evolved to maximize the benefits of these treatments.
  4. The standard of care for AML has traditionally been 7+3 therapy (cytarabine for 7 days + anthracycline for 3 days). However, recent drug approvals have focused on genetic alterations or tumor markers on AML cells, leading to targeted therapies in both frontline and relapsed/refractory settings for unfit patient groups.
  5. Despite advancements, AML remains a challenging area for research and development, necessitating novel targeted therapies for relapsed/refractory AML. There is potential for drug developers to pursue novel biomarker strategies for low-intensity and effective treatments, including expedited approval through single-arm studies.
  6. The current sales opportunity in AML focuses on three drugs (FLT3, IDH1, and IDH2 inhibitors) addressing approximately half of relapsed/refractory AML patients, leaving the remaining 50% in need of targeted therapies. Efforts are underway to expand the market by targeting additional biomarkers such as TP53 mutations, NPM1 mutations, and KMT2A rearrangements.
  7. As treatment options increase, spending levels have become a focal point worldwide, with projected growth expected to continue over the next five years. The AML treatment market is anticipated to grow at a CAGR of 9.5%, reaching USD $7.4 billion by 2033. This growth will be driven by increased uptake of recently approved therapies and the anticipated approval of six treatments considered in the forecast. Future opportunities for drug developers lie in treatment regimens targeting larger portions of the AML population, indicating a fragmented market.

AML Market Forecast 2033

Key coverage and questions answered…

  1. Insights into the AML treatments and relapse patterns observed across G7 countries. Specifically, what are the similarities and differences in epidemiology and treatment patterns between the US, EU, and Japan!
  2. As per KOLs, the major unmet needs they have highlighted in the current treatment landscape and specific areas where advancements or improvements are needed?
  3. An understanding of the future landscape in the next 3-7 years based on the insights and opinions shared by KOLs. The emerging trends, technologies, or treatment approaches that are expected to have a significant impact in AML space.
  4. What is the input provided by KOLs regarding key molecules or drugs in the field? Which specific molecules are generating the most interest and discussion among KOLs, and what potential benefits or challenges do they present?
  5. What is the latest data regarding the combination of Venetoclax (Venclexta) and Azacitidine? The notable findings or advancements in this treatment approach.
  6. In KOLs opinion, do they foresee VenAza (Venetoclax + Azacitidine) being used as a potential alternative to chemotherapy for fit patients.
  7. Insights into the future use of VenAza in the post-HSCT (hematopoietic stem cell transplantation) setting.
  8. Ongoing or upcoming trials exploring VenAza triplet combinations. What is the rationale behind investigating this treatment strategy, and what are the potential advantages it offers?
  9. What are the current developments and progress in frontline Magrolimab combination trials? Are there any early findings or trends that are worth noting?
  10. Regarding targeted radiotherapies, specifically the Actimab-A CLAG-M combination, what is the current understanding of its efficacy and safety profile? Are there any notable clinical outcomes or patient responses?
  11. An overview of the e-selectin antagonist, Uproleselan (Glycomimetics). What is the rationale behind targeting e-selectin, and what are the potential therapeutic implications?
  12. What is the latest data or updates on the CXCL12/CXCR4 inhibitor, Dociparstat sodium (DSTAT, CX-01)? The notable findings or clinical implications that have emerged.
  13. Shedding light on the current status and potential of Menin inhibitors, such as revumenib (SNDX-5613) and ziftomenib (KO-539). The promising data supporting their use in AML.
  14. What are the new mechanisms that are being explored? What are the potentially actionable targets?

Patients that are really elderly unfit and I think the TP53 mutant patient population is really a problem for us because they don’t respond to any of our targeted therapies. And we are seeing an increasing number of those patients who are failing all of our treatment regiments on a regular basis. I think many of us are moving away from seven plus three induction therapy, but it is still curative for some of our patients.”Haematologist, Department of Hematology, Cardiff University, UK

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Table of Contents

  1. Executive Summary
    • Summary of future trends
    • Potential opportunities to explore
    • Drivers/barriers for entry
    • Unmet needs
  2. Acute Myeloid Leukemia Overview
    • AML etiology, pathophysiology
    • Cytogenetics and molecular subsets
    • Key mutations and risk groups
  3. Acute Myeloid Leukemia Definition & Diagnosis
    • Diagnostic Algorithm
    • ICC and WHO AML definition
    • Classifications of AML and MDS as a predictive biomarker
  4. Acute Myeloid Leukemia Epidemiology
    • Incidence rates by countries
  5. Acute Myeloid Leukemia Treatment Practices
    • Current treatment practices
    • Treatment algorithms
    • Summarized version of NCCN and ESMO treatment guidelines
    • Acceptable endpoints for accelerated approval?
  6. AML Approved Targeted Treatments
    • Quick overview of targeted therapies
  7. Venetoclax Clinical Landscape
    • Clinical trial data supporting treatment recommendations
  8. Pipeline clinical trials
    • AML Pipeline Treatments
    • AML pipeline landscape overview and analysis
    • Currently actionable and potentially actionable molecules
    • Key molecules in clinical trials and results
    • Timeline of key drug approvals and launches
  9. Phase III Assets
    • Clinical trials and results
  10. Phase II Assets
    • Clinical trials and results
  11. Phase I Assets
    • Clinical trials and results
  12. AML Pipeline Latest Results from Conferences
    • Key molecules and their latest results from conferences ASH 2022, ESMO 2022, ASCO 2022, and AACR 2022
  13. AML Pipeline Early-Stage Molecules
    • Phase 1 and Phase I/II molecules
    • Mechanism of action, trial dates, and topline results
  14. AML Pipeline Non-clinical Molecules
    • Pre-clinical molecules
    • Mechanism of action, catalyst dates, and events
  15. Physicians/KOLs Input
    • Insights from 4 KOLs in the US, EU, and Japan
  16. Key Catalyst Events in AML
    • First-Generation FLT3i replacement in front-line treatment
    • Expansion of approved targeted therapies
    • Creation of new actionable targets
  17. AML Market Forecast -2033
    • Market Forecast and patient share by key drugs
  18. Appendix

Market Forecast for the below therapies till 2033

  1. Rydapt / midostaurin (Novartis)
  2. Vyxeos (CPX-351) / cytarabine/daunorubicin liposomal formulation (Jazz, Nippon Shinyaku)
  3. Idhifa / enasidenib (BMS, Servier)
  4. Mylotarg / gemtuzumab ozogamicin (UCB, PDL, Pfizer)
  5. Tibsovo / ivosidenib (Servier)
  6. Venclexta / venetoclax (Roche, AbbVie)
  7. Xospata / gilteritinib (Astellas)
  8. Daurismo / glasdegib (Pfizer)
  9. Vanflyta / quizartinib (Daiichi Sankyo)
  10. Onureg/oral azacitidine (BMS)
  11. Rezlidhia / olutasidenib (Forma Therapeutics)
  12. crenolanib /ARO-002 (Arog)
  13. uproleselan sodium /APL-106 (GlycoMimetics)
  14. dociparstat sodium /CX-01 (Chimerix)
  15. entospletinib /GS-9973 (Kronos Bio)
  16. Iomab-B /I-131-apamistamab (Actinium, Immedica)
  17. revumenib /SNDX-5613 (Syndax)

Key brands/drugs covered in this report…

  • Venclexta (venetoclax) [Roche, AbbVie]
  • Xospata (gilteritinib) [Astellas]
  • Vanflyta (quizartinib) [Daiichi Sankyo]
  • Daurismo (glasdegib) [Pfizer]
  • pevonedistat (MLN4924) [Takeda]
  • crenolanib (ARO-002) [AROG]
  • uproleselan sodium (APL-106) [GlycoMimetics]
  • dociparstat sodium (CX-01) [Chimerix]
  • entospletinib (GS-9973) [Kronos Bio]
  • Iomab-B (I-131-apamistamab) [Actinium, Immedica]
  • flotetuzumab (MGD006) [MacroGenics]
  • Actimab-A (lintuzumab-Ac225) [Actinium]
  • Talzenna (talazoparib) [Pfizer]
  • navtemadlin (KRT-232) [Kartos Therap]
  • Hepacid (pegargiminase) [Polaris Pharma]
  • Mavenclad (cladribine) [EMD Serono]
  • Mektovi (binimetinib) [Ono Pharma, Pierre Fabre, Pfizer]
  • iadademstat (ORY-1001) [Oryzon]
  • prexigebersen (BP1001) [Bio-Path]
  • Amnolake (tamibarotene) [Syros, Nippon Shinyaku, Zeria Pharma, RaQualia]
  • bemcentinib (BGB324) [BerGenBio]
  • tuspetinib (HM43239) [Aptose Biosciences]
  • revumenib (SNDX-5613) [Syndax Pharmaceuticals]
  • ziftomenib (KO-539) [Kura Oncology]
  • MGTA-117 [Magenta Therapeutics, Inc.]
  • Evorpacept (ALX-148) [ALX Oncology Inc.]
  • Pivekimab sunirine (IMGN-632) [ImmunoGen]
  • Lemzoparlimab (TJ-011133) AbbVie (MDS result) [I-MAb Biopharma]
  • CFI 400945 [Treadwell Therapeutics]
  • Alrizomadlin (APG-115) [Ascentage Pharma]
  • EP0042 [Ellipses Pharma]
  • BGB 11417 [BeiGene]
  • Dubermatinib (TP-0903) [Sumitomo Pharma Oncology]
  • E7820 [Eisai Co Ltd]
  • LAVA-051 [Lava Therapeutics]
  • AZD0466 [AstraZeneca]
  • DSP-5336 [Sumitomo Dainippon Pharma]
  • ONC201 [Oncoceutics]
  • SEL24 [MEN1703 (Menarini Group)]
  • SAR443579 [Sanofi]
  • DCP-001 [DCPrime]
  • Cotellic (cobimetinib) [Exelixis, Roche]
  • RG7112 [Roche]
  • bomedemstat (IMG-7289) [Imago BioSciences]
  • luxeptinib (CG-806) [Aptose Biosciences/ CrystalGenomics]
  • ACLX-002 [Arcellx]
  • Pegcrisantaspase [Jazz Pharmaceuticals Inc]
  • FT538 [Fate Therapeutics]
  • TSC 100 [TScan Therapeutics]
  • TSC 101 [TScan Therapeutics]
  • LP 108 [Newave Pharmaceuticals]
  • NTX-301 [Xennials Therapeutics]
  • PHI-101 [Pharos I&BT Co.]
  • UCART123 [Cellectis]
  • RVU120 [Ryvu Therapeutics SA]
  • PRGN-3006 [PGEN Therapeutics]
  • APVO436 [Aptevo Therapeutics]
  • GFH009 [GenFleet Therapeutics]
  • JNJ-75276617 [Janssen Research & Development, LLC]
  • LP-118 [Newave Pharmaceutical Inc]
  • MGD024 [MacroGenics]
  • MK-0482 [Merck Sharp & Dohme LLC]
  • WU-NK-101 [Wugen, Inc.]
  • BMF-219 [Biomea Fusion Inc.]
  • TTI-622-01 [Pfizer]
  • SC-DARIC33 (DARIC 33) [2seventy bio]
  • BTX-1188 [BioTheryX, Inc.]
  • CTX-712 [Chordia Therapeutics Inc.]
  • NC525 [NextCure]
  • Tegavivint [Apollomics/Iterion Therapeutics]

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