急性骨髄性白血病（AML）市場：機会評価、疫学、臨床試験、アンメットニーズ、2032年までの予測

急性骨髄性（または骨髄原性または骨髄球性）白血病（AML）は、骨髄および末梢血中の骨髄系前駆細胞の異常増殖または分化によって引き起こされる造血系の悪性腫瘍です。希少な血液がんであるにもかかわらず、AMLはブロックバスター市場であり、2022年の売上高23億米ドルからCAGR3.7％で拡大し、2032年には37億米ドルに成長すると予測されています。主要8ヶ国のAMLに対する現在の治療パラダイムは、虚弱な患者にはVenclextaとHMAまたはLDACレジメンを併用し、体力のある患者には7+3化学療法を行うことに大きく依存しています。AMLには、治療選択肢の拡大や、患者の全生存期間を延長するための移植転帰の改善を求めるアンメットニーズがいくつか存在します。

当レポートでは、主要8ヶ国市場（米国、フランス、ドイツ、イタリア、スペイン、英国、日本、カナダ）における急性骨髄性白血病（AML）の危険因子、併存疾患、世界および過去の疫学動向について概説し、急性骨髄性白血病（AML）の診断済み発症例と診断済み有病率に関する10年間の疫学予測などをまとめています。

目次

第1章 序文

第2章 エグゼクティブサマリー

第3章 病気の概要

• 急性骨髄性白血病の概要
• 急性骨髄性白血病市場の強み、弱み、機会、脅威の分析
• 急性骨髄性白血病の分類

第4章 疫学

• 急性骨髄性白血病と診断済み症例数、（男女）18歳以上、2022～2032年
• 急性骨髄性白血病の診断症例数の年齢別動向（男女）、2022年
• 急性骨髄性白血病の性特異的診断済み症例数、（男女）18歳以上、2022年
• 急性骨髄性白血病の発生源と調査手法

第5章 現在の治療選択肢

• 治療パラダイム- 第一選択の導入療法
• 治療パラダイム- 地固め、維持、再発/難治性治療
• 急性骨髄性白血病の治療アルゴリズム
• 市販製品の概要
• 製品概要：抗体薬物複合体（Mylotarg）
• 製品プロファイル：BCL-2阻害剤（ベンクレスタ）
• 製品プロファイル：FLT3阻害剤（Rydapt、Vanflyta、Xospata）
• 製品概要：ヘッジホッグ経路阻害剤（ダウリズモ）
• 製品プロファイル：IDH1/2阻害剤（Tibsovo、Idhifa、Rezlidhia）
• 製品概要：細胞療法（オミシルジ）
• 製品プロファイル：低メチル化剤（Dacogen、Onureg、およびVidaza）
• 製品プロファイル：低メチル化剤（Inaqovi）
• 製品プロファイル：ブランド化学療法（Vyxeos）

第6章 アンメットニーズと機会

• 急性骨髄性白血病におけるアンメットニーズ
• 完全寛解を持続的な全生存期間に変換
• セカンドライン以降の治療
• 治療困難な患者の治療選択肢の改善
• 患者のアクセスとHSCTの結果を改善

第7章 研究開発戦略

• 急性骨髄性白血病における臨床試験デザインの動向
• 治験スポンサー別急性骨髄性白血病の臨床試験
• 急性骨髄性白血病における取引の動向

第8章 パイプラインの評価

• AMLパイプラインの概要
• 急性骨髄性白血病に対する後期パイプライン薬剤
• 製品プロファイル：ブランド化学療法（ラドゴシタビン）
• 製品概要：E-セレクチン阻害剤（ウプロレセラン）
• 製品プロファイル：FLT3阻害剤（クリフチニブ、クレノラニブ、SKLB-1028）
• 製品概要：低メチル化剤（ASTX030）
• 製品プロファイル：メニン阻害剤（レブメニブ、ジフトメニブ）
• 製品概要：モノクローナル抗体（マグロリマブ）
• 製品概要：ペプチドワクチン（ガリンペピムット-S）
• 製品プロファイル：放射性免疫複合体（ヨウ素-131-アパミスタマブ）
• 製品プロファイル：S1PRアゴニスト（モクラビモド）
• 製品プロファイル：細胞療法（OmnImmune、Orca-T）

第9章 市場の見通し

• 急性骨髄性白血病の市場予測
• 急性骨髄性白血病市場の促進要因と抑制要因

第10章 付録

第11章 お問い合わせ

Abstract

This report covers the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) and includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 8MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Acute Myeloid Leukemia (AML).

These sales forecasts leverage data on pharmaceutical sales and drug availability from GlobalData's World Markets Healthcare (WMH) and POLI Price Intelligence databases.

This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 8MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Acute Myeloid Leukemia (AML). These sales forecasts leverage data on pharmaceutical sales and drug availability from GlobalData's World Markets Healthcare (WMH) and POLI Price Intelligence databases.

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. Despite being a rare blood cancer, AML is a blockbuster market and is expected to grow from sales of $2.3 billion in 2022 to $3.7 billion in 2032 at a compound annual growth rate (CAGR) of 3.7%. The current treatment paradigm for AML across the 8MM relies heavily on the use of Venclexta plus HMA or LDAC regimen for frail patients, and 7+3 chemotherapy for fit patients. There are several unmet needs in AML that call for more treatment options and improving transplant outcome for extending overall survival in patients.

Major drivers of growth in the AML market across the 8MM over the forecast period include the following -

• Approval of 14 new late-stage pipeline agents
• 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
• Growing patient population to 2032

Major barriers to growth in the AML market across the 8MM over the forecast period include the following:

• Patent expiries and subsequent genericization of the most lucrative agents that are part of the standard of care, principally Roche/AbbVie's Venclexta
• Limited launches of novel pipeline agents in Asian markets
• Continued dominance of the traditional 7+3 chemotherapy regimen in the newly-diagnosed setting

Key Highlights

• Report deliverables include a Pdf and Excel-based forecast model
• Forecasts includes the 8MM
• Forecasts covers from 2022-2032
• GlobalData valued the Acute Myeloid Leukemia market in the 8MM at $2.3 billion and expects the market to increase to $3.7 billion by 2032
• Syndex Pharmaceuticals, Gamida Cell, and GlycoMimetics are expected to take market-leading position in 2032
• A high level of unmet need will remain for most Acute Myeloid Leukemia patient populations during the forecast period
• The AML late-stage R&D pipeline is diversified in addressing different pain points throughout the treatment journey

Scope

• Overview of Acute Myeloid Leukemia, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized Acute Myeloid Leukemia therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2022 to 2032.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the Acute Myeloid Leukemia therapeutics market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for Acute Myeloid Leukemia treatment. The most promising candidates in Phase III and Phase IIb development are profiled.
• Analysis of the current and future market competition in the global Acute Myeloid Leukemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

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 global Acute Myeloid Leukemia therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Acute Myeloid Leukemia 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 counter-strategies 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

Table of Contents

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