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市場調查報告書
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1763117

全球 CD123 標靶治療市場：市場趨勢、臨床試驗、技術平台、未來展望 (2025)

Global CD123 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025
出版日期: | 出版商: KuicK Research | 英文 100 Pages | 商品交期: 最快1-2個工作天內

價格

報告重點：

  • 研究方法
  • 全球 CD123 標靶治療市場分析
  • 全球 CD123 標靶治療發展趨勢（依適應症劃分）
  • 已核准的 CD123 標靶治療藥物：1 個
  • 正在進行臨床試驗的 CD123 標靶治療藥物：10+ 個
  • 最高開發階段：II 期
  • 公司、國家、適應症和階段劃分的 CD123 標靶治療臨床試驗洞察
  • CD123 標靶治療開發技術平台

CD123 標靶治療市場受 Elzolis (Tagraxofusp) 藥物獲批的推動，CD123 療法的應用範圍已從罕見的母細胞性漿細胞樣樹突狀細胞瘤 (BPDCN) 擴展到更廣泛的血液系統癌症領域。 Elzonris 是一種與 IL-3 融合的截短型白喉毒素，是 2018 年底核准的首個 CD123 標靶藥物。該藥物的獲批為 CD123 作為標靶實體開創了先例，但其應用主要限於少數 BPDCN 患者。

目前的重點是利用該平台治療更常見和更致命的癌症，例如急性髓系白血病 (AML) 和骨髓增生異常綜合徵 (MDS)。目前正在研究將 Tagraxofusp 與去甲基化藥物和維奈克拉聯合使用，目標是基於分子進化的深化反應和克服抗藥性。這些初步結果凸顯了CD123療法超越罕見疾病適應症，進入更廣泛癌症領域的潛力。

幾家大型製藥公司正在重塑投資格局。艾伯維在收購ImmunoGen後，又收購了pivekimab sunirine。 pivekimab是一種高效的靶向CD123的抗體-藥物偶聯物，於2020年獲得孤兒藥和突破性療法認定，用於治療BPDCN和其他表達CD123的惡性腫瘤。同時，Innate Pharma正與賽諾菲共同開發IPH6101/SAR443579，這是一款一流的三功能NK細胞銜接劑，可同時結合CD123、NKp46和CD16受體。這種新穎的機制可實現高效的NK細胞募集並產生良好的安全訊號，復發或難治性患者的早期和長期完全緩解證實了這一點。急性骨髓性白血病 (AML)。

除了淋巴細胞介導療法外，開發人員還專注於先進的工程方法以提高選擇性。 Innate 的 ANKET® 平台增強了 IPH6101 的功能，使其能夠活化 NK 細胞發揮抗白血病作用，同時最大限度地減少細胞因子的釋放。同時，生技公司正在研究具有安全開關和親和力調節功能的 CAR-T 構建體，以區分癌細胞和健康祖細胞，這項策略的靈感來自 CD123 的常見表達。

私人資本注入進一步推動了創新。 AvenCell 療法公司於 2024 年 10 月完成 1.12 億美元的 B 輪融資，顯示投資者對其可編程、可切換的 CD123 CAR 平台充滿信心。 AvenCell 的抗體藥物偶聯物採用外部控制分子切換 CAR-T 作用的控制方案，可能為劑量限制性毒性帶來解決方案，並有望實現真正的個人化免疫療法。

然而隨著細胞療法的進步，非細胞療法也正在取得進展。採用不同連接體、有效載荷和雙特異性抗體設計的雙特異性抗體和抗體-藥物偶聯物已顯示出更高的耐受性和靶向活性。這些改進旨在維持正常的造血功能，同時提高治療指數。這些改進是第二代CD123標靶藥物，旨在限制脫靶效應，例如細胞激素釋放和毛細血管滲漏。

適應症擴展也推動了市場發展動能。由於CD123過度表現見於多種血液系統癌症，包括AML、MDS、高風險MDS和毛細胞白血病，該子公司正致力於開發適應症驅動和適應性臨床計畫。 CD123平台在更廣泛的治療領域備受青睞。

在這些趨勢的推動下，精準腫瘤學技術正在促進更聰明的開發。能夠測量CD123抗原密度並表徵患者特異性表達譜的精細診斷方法為臨床試驗提供資訊。入組和療效預測。這種精準策略降低了開發風險，並有助於定位更有效的療法。

簡而言之，CD123 標靶治療市場正在經歷革命性的變化。在早期臨床驗證的支持下，以及如今戰略性製藥合作、尖端平台、廣泛的投資者支持和多樣化適應症的推動下，該類別正從狹窄的 BPDCN 領域擴展到血液學領域。隨著先進療法的不斷成熟和聯合治療策略的實現，CD123 將成為下一代標靶腫瘤治療的支柱。

本報告提供全球CD123標靶治療藥市場相關調查，市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及加入此市場的主要企業競爭情形等資訊。

目錄

第1章 調查手法

第2章 CD123標靶治療藥的簡介

第3章 科學性·生物學的洞察

  • CD123 (IL-3Ra) 的結構、生物學與意義
  • 靶向 CD123 的原理
  • CD123 作為生物標記

第4章 把CD123作為標的治療方法

  • 融合蛋白品質
  • 抗體
  • 抗體藥物複合體
  • 細胞療法
  • 治療用胜肽

第5章 全球CD123標靶治療藥的開發趨勢，各適應症

  • 白血病
  • 芽球性漿細胞先生樹突狀細胞腫瘤
  • 骨髓增生性腫瘤
  • 其他

第6章 CD123標靶治療藥的開發技術平台

第7章 全球CD123標靶治療藥市場分析

  • 目前市場Scenario
  • 未來市場機會

第8章 Elzonris臨床及商業性洞察

  • 概要
  • 價格和劑量
  • 涵蓋範圍和報銷方案

第9章 CD123標靶治療藥的臨床試驗概要

  • 各企業
  • 各國
  • 各適應症
  • 各相
  • 各優先狀態

第10章 CD123標靶治療藥的世界臨床實驗平台概要(企業，國家，適應症，各相)

  • 前臨床
  • 第一階段
  • 第一/二階段
  • 第二階段

第11章 已上市CD123標靶治療藥的臨床性洞察

第12章 全球CD123標靶治療藥市場動態

  • 推動市場要素和機會
  • 市場課題與阻礙因素

第13章 競爭情形

  • AbbVie
  • Affimed
  • Aptevo Therapeutics
  • Arcellx
  • AstraZeneca
  • AvenCell Therapeutics
  • CSL Limited
  • Essen Biotech
  • Innate Pharma
  • Lava Therapeutics
  • Macrogenics
  • Molecular Partners
  • Stemline Therapeutics
  • Vincerx Pharma

Global CD123 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025 Report Highlights:

  • Research Methodology
  • Global CD123 Targeting Therapies Market Analysis
  • Global CD123 Targeting Therapies Development Trends By Indication
  • Approved CD123 Targeting Therapies: 1
  • CD123 Targeting Therapies In Clinical Trials: > 10 Therapies
  • Highest Phase Of Development: Phase-II
  • CD123 Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase
  • CD123 Targeting Therapies Development Technology Platforms

The market for CD123 directed therapies, anchored by the approval of Elzonris (tagraxofusp erzs), is undergoing a vibrant transition into the broader space of hematologic cancers beyond the rare indication of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Elzonris, a truncated diphtheria toxin fused to IL 3, was the first CD123 directed agent approved in late 2018. Its approval set a precedent for CD123 as a targetable entity, but its use has largely been limited to a minor cohort of patients with BPDCN.

Focus is now shifting to using this foundation to treat more common and deadly cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Tagraxofusp is being investigated in combination with hypomethylating agents and venetoclax, with the goal of enhancing depth of response and overcoming resistance based on molecular evolution. These initial results highlight the ability of CD123 therapies to break into the wider oncology space beyond orphan indications.

Several pharma giants are reshaping the investment scene. AbbVie, following its ImmunoGen acquisition, took over pivekimab sunirine, a highly effective CD123 targeting antibody drug conjugate that has received orphan drug and Breakthrough Therapy designations in 2020 to treat BPDCN and other CD123 expressing malignancies. Innate Pharma, on the other hand, is developing IPH6101/SAR443579, a trifunctional NK cell engager of first-in-class type that binds CD123, NKp46, and CD16 receptors simultaneously, with Sanofi as a collaborator. This new mechanism provides highly effective NK cell recruitment and good safety signals, demonstrated by early long-lasting complete remissions in patients with relapsed or refractory AML.

Expanding beyond lymphocyte mediated treatments, developers are focusing on sophisticated engineering to enhance selectivity. Innate's ANKET(R) platform powers IPH6101, activating NK cells to generate anti-leukemic actions with minimal cytokine release, a possible means to avoid some of the toxicity linked with CD3 based treatments. At the same time, biotech companies are investigating CAR T constructs with safety switches and affinity tuning to distinguish between cancerous and healthy progenitor cells, a strategy conceived from shared expression of CD123.

Private capital infusion drives innovation even further. October 2024's Series B funding of US$ 112 million for AvenCell therapeutics is an indicator of investors' confidence in programmable, switchable CD123 CAR platforms. AvenCell's antibody drug conjugates style control scheme, in which external regulator molecules will switch CAR T action, has the potential to bring a solution to dose limiting toxicities, trending towards truly individualized immunotherapies.

While cell therapies improve, non-cellular modalities make inroads. Bispecific and antibody drug conjugates modalities, designed with altered linkers, payloads, or bi-specificity, are showing enhanced tolerability and targeted activity. Such improvements intend to maintain normal hematopoiesis while enhancing therapeutic indices. These engineered forms are second generation CD123 targeting agents intended to limit off-target activities, including cytokine release and capillary leak.

Market momentum is also fueled by expanding indications. CD123 overexpression is seen in various hematologic cancers, including AML, MDS, high-risk MDS, and hairy cell leukemia, leading subsidiaries to develop adaptable clinical programs that can pivot indications. The variety increases return potential for developers, and CD123 platforms are coveted across a broader therapeutic spectrum.

Backed by these trends, precision oncology technologies facilitate smarter development. Sophisticated diagnostics measuring CD123 antigen density and characterizing patient-specific expression profiles inform trial enrollment and response prediction. This precision strategy de-risks development and facilitates more effective therapeutic positioning.

In short, the CD123 targeted therapy market is at a period of revolutionary change. Tethered by early clinical validation, now boosted by strategic pharma engagement, cutting edge platforms, expansive investor support, and indication diversification, this category is evolving from a narrow BPDCN niche to expanding hematologic reach. As advanced therapies continue to mature and combination strategies are realized, CD123 is set to be an anchor pillar in next generation targeted oncology.

Table of Contents

1. RESEARCH METHODOLOGY

2. Introduction To CD123 Targeting Therapies

  • 2.1 Introduction
  • 2.2 History & Evolution

3. Scientific & Biological Insight

  • 3.1 Structure, Biology & Significance Of CD123 (IL-3Ra)
  • 3.2 Rationale For Targeting CD123
  • 3.3 CD123 As Biomarker

4. Therapeutic Approaches Targeting CD123

  • 4.1 Fusion Proteins
  • 4.2 Antibodies
  • 4.3 Antibody Drug Conjugates
  • 4.4 Cell Therapies
  • 4.5 Therapeutic Peptides

5. Global CD123 Targeting Therapies Development Trends By Indication

  • 5.1 Leukemia
  • 5.2 Blastic Plasmacytoid Dendritic Cell Neoplasm
  • 5.3 Myeloproliferative Neoplasms
  • 5.4 Other Indications

6. CD123 Targeting Therapies Development Technology Platforms

7. Global CD123 Targeting Therapies Market Analysis

  • 7.1 Current Market Scenario
  • 7.2 Future Market Opportunity

8. Elzonris Clinical & Commercial Insight

  • 8.1 Overview
  • 8.2 Pricing & Dosage
  • 8.3 Coverage & Reimbursement Scenario

9. CD123 Targeting Therapies Clinical Trials Overview

  • 9.1 By Company
  • 9.2 By Country
  • 9.3 By Indication
  • 9.4 By Phase
  • 9.5 By Priority Status

10. Global CD123 Targeting Therapies Clinical Pipeline Overview By Company, Country, Indication & Phase

  • 10.1 Preclinical
  • 10.2 Phase I
  • 10.3 Phase I/II
  • 10.4 Phase II

11. Marketed CD123 Targeting Therapy Clinical Insight

12. Global CD123 Targeting Therapies Market Dynamics

  • 12.1 Market Drivers & Opportunities
  • 12.2 Market Challenges & Restraints

13. Competitive Landscape

  • 13.1 AbbVie
  • 13.2 Affimed
  • 13.3 Aptevo Therapeutics
  • 13.4 Arcellx
  • 13.5 AstraZeneca
  • 13.6 AvenCell Therapeutics
  • 13.7 CSL Limited
  • 13.8 Essen Biotech
  • 13.9 Innate Pharma
  • 13.10 Lava Therapeutics
  • 13.11 Macrogenics
  • 13.12 Molecular Partners
  • 13.13 Stemline Therapeutics
  • 13.14 Vincerx Pharma

List of Figures

  • Figure 2-1: Evolution of CD123-Targeted Therapies
  • Figure 3-1: CD123 - Expression Levels Across Cell Types
  • Figure 3-2: CD123 - Expression In Normal vs. Malignant Stem Cells
  • Figure 3-3: CD123 Targeted Therapies - Overview
  • Figure 3-4: CD123 As Biomarker For Patient Stratification
  • Figure 4-1: CD123 Targeting Fusion Protein - Structure
  • Figure 4-2: CD123 Fusion Proteins - Mechanism Of Action
  • Figure 4-3: CD123 Targeting Antibodies - Mechanism Of Action
  • Figure 4-4: CD123 Targeting ADCs - Structure & Mechanism Of Action
  • Figure 4-5: CD123 CAR T Cells
  • Figure 4-6: Therapeutic Peptides - Mechanism of Action
  • Figure 5-1: Leukemia - CD123 Driven Signaling Pathway
  • Figure 5-2: CD123 - Expression Across Leukemia Subtypes
  • Figure 5-3: AFM28-101 Phase 1 (NCT05817058) Trial - Study Initiation & Completion Year
  • Figure 5-4: Vibecotamab Phase 2 (NCT05285813) Trial - Study Initiation & Completion Year
  • Figure 5-5: CART123 Phase 1 (NCT03766126) Trial - Study Initiation & Completion Year
  • Figure 5-6: VNC-943-101 Phase 1 (NCT06034275) Trial - Study Initiation & Completion Year
  • Figure 5-7: CP-MGD024-01 Phase 1 (NCT05362773) Trial - Study Initiation & Completion Year
  • Figure 5-8: TAGVEN Phase 2 (NCT07007052) Trial - Study Initiation & Completion Year
  • Figure 5-9: Tagraxofusp Phase 2 (NCT04216524) Trial - Study Initiation & Completion Year
  • Figure 5-10: IMGN632-0801 Phase 1/2 (NCT03386513) Trial - Study Initiation & Completion Year
  • Figure 5-11: UHKT-CAR123-01 Early Phase 1 (NCT06765876) Trial - Study Initiation & Completion Year
  • Figure 5-12: PBC065 Phase 1 (NCT06690827) Trial - Study Initiation & Completion Year
  • Figure 5-13: STUDY00160238 Phase 1 (NCT06414681) Trial - Study Initiation & Completion Year
  • Figure 5-14: HSR210434 Phase 1 (NCT05233618) Trial - Study Initiation & Completion Year
  • Figure 5-15: Tagraxofusp Phase 1/2 (NCT05038592) Trial - Study Initiation & Completion Year
  • Figure 5-16: IMGN632-0801 Phase 1/2 (NCT03386513) Trial - Study Initiation & Completion Year
  • Figure 5-17: Flotetuzumab Phase 1 (NCT04681105) Trial - Study Initiation & Completion Year
  • Figure 6-1: ICE Platform - Affimed
  • Figure 6-2: ADAPTIR - Aptevo Therapeutics
  • Figure 6-3: ARC-SparX - Arcellx
  • Figure 6-4: Universal Targeting Platform - AvenCell
  • Figure 6-5: ANKET - Innate Pharma
  • Figure 6-6: GAMMABODY(R) Platform - LAVA Therapeutics
  • Figure 6-7: GAMMABODY(R) Platform Mechanism - LAVA Therapeutics
  • Figure 6-8: DART Platform - MacroGenics
  • Figure 6-9: VersAptx - Vincerx Pharma
  • Figure 7-1: CD123 Targeted Therapy Market - Future Opportunities
  • Figure 8-1: Elzonris - Price Per Vial By Region (US$), July'2025
  • Figure 9-1: Global - CD123 Targeting Therapy Clinical Pipeline By Company (Number Of Therapies), 2025
  • Figure 9-2: Global - CD123 Targeting Therapy Clinical Pipeline By Country (Number Of Therapies), 2025
  • Figure 9-3: Global - CD123 Targeting Therapy Clinical Pipeline By Indication (Number Of Therapies), 2025
  • Figure 9-4: Global - CD123 Targeting Therapy Clinical Pipeline By Phase (Number Of Therapies), 2025
  • Figure 9-5: Global - CD123 Targeting Therapy Clinical Pipeline By Priority Status (Number Of Therapies), 2025
  • Figure 12-1: CD123 Targeted Therapy Market - Drivers & Opportunities
  • Figure 12-2: CD123 Targeted Therapy Market - Challenges & Restraints

List of Tables

  • Table 8-1: Elzonris - Recommended Dosage Modifications
  • Table 8-2: Elzonris - CLS Management Guidelines