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市场调查报告书
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1858511

全球人类白血球抗原(HLA)标靶治疗，临床试验，治疗方法，市场机会的洞察(2026年)

Global Human Leukocyte Antigen (HLA) Targeted Therapy, Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2026
出版日期: | 出版商: KuicK Research | 英文 120 Pages | 商品交期: 最快1-2个工作天内

价格

全球人类白血球抗原 (HLA) 标靶疗法、临床试验、治疗方案及市场机会洞察 (2026) 研究结果及亮点

  • 首个人类白血球抗原 (HLA) 标靶疗法预计将于 2030 年前获批
  • 按公司、适应症和阶段划分的人类白血球抗原 (HLA) 标靶疗法临床试验的全面洞察
  • 正在进行临床试验的 HLA 标靶疗法：超过 10 种
  • 人类白血球抗原 (HLA) 标靶疗法的适应症
  • HLA 标靶疗法治疗方案的洞察
  • 竞争格局概览

HLA标靶疗法的需求及本报告的意义

免疫疗法的进展凸显了人类白血球抗原 (HLA) 系统在免疫辨识中的作用，它不再只是背景因素，而一些HLA分子本身已成为直接的治疗标靶。随着研究的深入，人们越来越需要策略指导，以了解如何设计、测试HLA标靶策略并将其转化为临床应用。

本报告旨在满足这一日益增长的需求，为包括生物技术公司、投资者、医疗保健规划者和监管机构在内的利益相关者提供关于新兴的HLA靶向疗法领域的真实世界见解。随着许多候选化合物进入临床试验并接近转化里程碑，了解科学现状和发展方向对于做出明智的决策至关重要。

本报告包​​含的临床试验及临床试验洞察

透过监测全球范围内涉及HLA分子标靶疗法的当前和近期临床试验，可以追踪HLA标靶治疗计画的趋势。本报告详细分析了按临床试验阶段、疾病类型、HLA分子标靶以及申办方/合作方所在地区划分的研发管线。例如，近期研究表明，非经典分子HLA-G正在一项针对实体瘤的首次人类体外泌体递送试验中进行研究。此外，大阪大学的研究小组阐述如何针对HLA-DRB1治疗异体造血干细胞移植后復发的急性骨髓性白血病。

透过汇总这些项目，本报告使用户能够评估哪些HLA分子正在获得关注，哪些疾病适应症正在被重点关注，主要申办方是谁，以及地域覆盖范围和试验强度如何影响该领域。

从事人类白血球抗原 (HLA) 标靶疗法研发的主要公司

多家公司正在开发针对 HLA 分子的新型标靶疗法平台。例如，Quell Therapeutics 正在开发 QEL-001，这是一种首创的抗原特异性 CAR-Tr​​eg 细胞疗法，针对 HLA-A2，用于治疗接受肝臟移植的 HLA-A2 不匹配患者，并促进免疫耐受性。同样，第一三共株式会社 (Daiichi Sankyo) 正在开发 DS-2243a，这是一种针对 HLA-A*02 复合物的双特异性 T 细胞衔接器，旨在引导细胞毒性 T 淋巴细胞杀伤 NY-ESO-1 阳性肿瘤细胞。这些图示显示瞭如何利用 HLA 分子开发针对癌症和移植的新型免疫疗法，突显了 HLA 在新型生物学计画中的核心地位。

报告展望人类白血球抗原 (HLA) 标靶治疗领域未来发展方向

展望未来，HLA 标靶治疗领域正朝着几个重要的策略方向发展。其中之一是拓宽 HLA 分子的研究范围，从经典的 I 类等位基因扩展到非经典 HLA 分子，例如 HLA-G 和 HLA-DRB1，这些分子可能在恶性肿瘤中选择性上调。最近的一项综述表明，HLA-G 作为一种免疫抑制检查点分子，具有作为目标和生物标记的双重价值。另一个未来发展方向是将诊断、病患分层和 HLA 表现谱分析整合到早期研发阶段，以确保治疗能精准地针对合适的病患群体。

整体而言，市场似乎正朝着模组化平台发展，这些平台可重复利用框架，针对多种适应症（包括细胞疗法、双特异性抗体和基于外泌体的递送系统）靶向 HLA 分子。透过描绘这一发展轨迹，本报告旨在帮助读者预测该领域的未来走向、投资和合作机会，以及 HLA 标靶治疗市场未来的发展趋势。

目录

第1章 人类白血球抗原(HLA)标靶治疗的简介

  • 概要
  • 历史，出现，发展

第2章 人类白血球抗原(HLA)系统概要

  • HLA的结构与机能
  • 免疫反应的HLA所扮演的角色
  • 标靶治疗的关联性

第3章 人类白血球抗原(HLA)标靶治疗的治疗适应

  • 癌症
    • 固态肿瘤
    • 血液癌症
  • 器官移植
  • 感染疾病
  • 自体免疫疾病
  • 其他

第4章 人类白血球抗原(HLA)标靶治疗方法

  • 抗体为基础的治疗方法
  • 细胞为基础的治疗方法
  • 遗传基因编辑和基因治疗
  • 低分子抑制剂
  • [月太]为基础的治疗方法
  • 其他

第5章 人类白血球抗原(HLA)基因学和精密医疗

  • HLA型检测和筛检
  • 个人化医疗和生物标誌物的发现
  • HLA标靶治疗的伴随式诊断

第6章 全球人类白血球抗原(HLA)临床试验概要

  • 各企业
  • 各国
  • 各适应症
  • 各期

第7章 全球人类白血球抗原(HLA)标靶治疗临床试验(企业，适应症，各期)

  • 研究
  • 前临床
  • 第一阶段
  • 第一/二阶段
  • 第二阶段
  • 第三阶段

第8章 全球人类白血球抗原(HLA)市场分析

  • 目前市场Scenario
  • 未来市场机会

第9章 全球人类白血球抗原(HLA)市场动态

  • 促进因素和机会
  • 课题与解决的办法

第10章 竞争情形

  • BlueSphere Bio
  • Diamyd Medical
  • Grey Wolf Therapeutics
  • IMBiologics
  • Invectys
  • Quell Therapeutics
  • Rheumagen
  • Sangamo Therapeutics
  • Tizona Therapeutics
  • TScan Therapeutics

Global Human Leukocyte Antigen (HLA) Targeted Therapy, Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2026 Report Findings & Highlights:

  • First Human Leukocyte Antigen (HLA) Targeted Therapy Approval Expected By 2030
  • Comprehensive Insight On Human Leukocyte Antigen (HLA) Targeted Therapies Clinical Trials By Company, Indication & Phase
  • Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials: > 10 Therapies
  • Therapeutic Indications For Human Leukocyte Antigen (HLA) Targeted Therapy
  • Insight On Human Leukocyte Antigen (HLA) Targeted Therapy Approaches
  • Competitive Landscape

Human Leukocyte Antigen (HLA) Targeted Therapy Need & Why This Report?

Advances in immunotherapy have highlighted the role of the human leukocyte antigen (HLA) system beyond that of a background component of immune recognition: some HLA molecules themselves are becoming direct therapeutic targets. As investigation moves forward, there is an increasing demand for strategic guidance on how HLA directed strategies can be formulated, tested and steered toward clinical application.

This report seeks to serve that growing demand by providing stakeholders, such as biotech companies, investors, healthcare planners and regulators, with real world insight into the emerging HLA targeted therapy space. With many candidates now reaching trials and approaching translational milestones, current understanding of where the science is and where the space is going is needed for informed decision making.

Clinical Studies & Trials Insight Included In Report

The development of HLA targeted therapy programs can be tracked by monitoring current and recent trials worldwide involving HLA molecule approaches. The report includes a detailed analysis of the development pipeline by trial stage, disease type, HLA molecule target and sponsor/collaborator geography. For instance, recent studies have indicated that the non-classical molecule HLA G is being investigated in a first in human exosome delivery study in solid tumors. In a further example, a research group at Osaka University explained how HLA DRB1 can be a target in relapsed acute myeloid leukaemia following allogeneic stem cell transplantation.

By aggregating such programmes, the report provides users with the capacity to measure which HLA molecules are gaining momentum, what disease indications are being focused on, who the lead sponsors are, and how geographic spread and trial intensity are influencing the field.

Leading Companies Engaged In R&D Of Human Leukocyte Antigen (HLA) Targeted Therapy

Multiple companies are working on platforms targeting HLA molecules in novel approaches. For example, Quell Therapeutics is progressing with QEL-001, a first-in-class antigen-specific CAR-Treg cell therapy targeting HLA-A2 to treat HLA-A2 mismatched patients undergoing liver transplantation, promoting immune tolerance. Likewise, Daiichi Sankyo is in the process of developing DS-2243a, a bispecific T-cell engager against the HLA-A*02 complex, designed to redirect cytotoxic T lymphocytes to kill NY-ESO-1-positive tumor cells. These illustrations point out the way HLA molecules are being used to develop new immunotherapies for cancer and transplantation, demonstrating their central position in novel biologic programs.

Report Indicating Future Direction Of Human Leukocyte Antigen (HLA) Targeted Therapy Segment

Looking ahead, the HLA targeted therapy segment is moving toward several key strategic orientations. One direction is broadening the spectrum of HLA molecules under investigation-moving beyond classical class I alleles toward non classical HLA molecules such as HLA G or HLA DRB1 that may be selectively up regulated in malignancy. Insights from recent reviews suggest that HLA G, as an immunosuppressive checkpoint molecule, offers dual value as both a target and a biomarker. Another future direction lies in integrating diagnostics, patient stratification and HLA expression profiling into early development so that therapies reach the right patient populations with precision.

Overall, the market appears to be gravitating toward modular platforms, be they cell therapies, bispecific antibodies, exosome based delivery systems, that reuse HLA molecule targeting frameworks across multiple indications. By mapping these trajectories, this report assists readers in anticipating where the field is headed, where investment or collaboration opportunities may lie, and how the HLA targeted therapy market may evolve in the coming years.

Table of Contents

1. Introduction To Human Leukocyte Antigen (HLA) Targeted Therapy

  • 1.1 Overview
  • 1.2 History, Emergence & Development

2. Human Leukocyte Antigen (HLA) System Overview

  • 2.1 HLA Structure & Function
  • 2.2 Role Of HLA In Immune Response
  • 2.3 Relevance To Targeted Therapies

3. Therapeutic Indications For Human Leukocyte Antigen (HLA) Targeted Therapy

  • 3.1 Cancer
    • 3.1.1 Solid Tumors
    • 3.1.2 Hematologic Cancers
  • 3.2 Organ Transplantation
  • 3.3 Infectious Diseases
  • 3.4 Autoimmune Diseases
  • 3.5 Other Indications

4. Human Leukocyte Antigen (HLA) Targeted Therapy Approaches

  • 4.1 Antibody Based Therapies
  • 4.2 Cell Based Therapies
  • 4.3 Gene Editing & Gene Therapy
  • 4.4 Small Molecule Inhibitors
  • 4.5 Peptide Based Therapies
  • 4.6 Other Novel Approaches

5. Human Leukocyte Antigen (HLA) Genomics & Precision Medicine

  • 5.1 HLA Typing & Screening
  • 5.2 Personalized Medicine & Biomarker Discovery
  • 5.3 Companion Diagnostics For HLA-Targeted Therapy

6. Global Human Leukocyte Antigen (HLA) Clinical Trials Overview

  • 6.1 By Company
  • 6.2 By Country
  • 6.3 By Indication
  • 6.4 By Phase

7. Global Human Leukocyte Antigen (HLA) Targeted Therapies Clinical Trials By Company, Indication & Phase

  • 7.1 Research
  • 7.2 Preclinical
  • 7.3 Phase I
  • 7.4 Phase I/II
  • 7.5 Phase II
  • 7.6 Phase III

8. Global Human Leukocyte Antigen (HLA) Market Analysis

  • 8.1 Current Market Scenario
  • 8.2 Future Market Opportunities

9. Global Human Leukocyte Antigen (HLA) Market Dynamics

  • 9.1 Drivers & Opportunities
  • 9.2 Challenges & Solutions

10. Competitive Landscape

  • 10.1 BlueSphere Bio
  • 10.2 Diamyd Medical
  • 10.3 Grey Wolf Therapeutics
  • 10.4 IMBiologics
  • 10.5 Invectys
  • 10.6 Quell Therapeutics
  • 10.7 Rheumagen
  • 10.8 Sangamo Therapeutics
  • 10.9 Tizona Therapeutics
  • 10.10 TScan Therapeutics

List of Figures

  • Figure 1-1: Human Leukocyte Antigen (HLA) System & Immune Activation
  • Figure 1-2: Managing Risks In HLA Targeted Therapy
  • Figure 1-3: Evolution Of HLA Research & Therapies
  • Figure 1-4: Development Of HLA Targeted Therapies
  • Figure 2-1: HLA System & Its Role In Immune Response
  • Figure 2-2: HLA Classes I, II, & III
  • Figure 2-3: Antigen Presentation via HLA Class I Molecules
  • Figure 2-4: Antigen Presentation via HLA Class I Molecules
  • Figure 2-5: HLA Polymorphism
  • Figure 2-6: HLA - Key Themes By Indication
  • Figure 2-7: HLA In Personalized Medicine
  • Figure 3-1: HLA Targeted Therapy To Enhance Cancer Immunity
  • Figure 3-2: SCOPE Phase 2 (NCT04079166) Study - Initiation & Completion Year
  • Figure 3-3: DENALI-1 Phase 1/2 (NCT06682793) Study - Initiation & Completion Year
  • Figure 3-4: SOB100-CL-Proto-01 Phase 1 (NCT07219940) Study - Initiation & Completion Year
  • Figure 3-5: AFNT-211 Phase 1 (NCT06105021) Study - Initiation & Completion Year
  • Figure 3-6: TSCAN-001 Phase 1 (NCT05473910) Study - Initiation & Completion Year
  • Figure 3-7: BSB1001-CL-101 Phase 1/2 (NCT06704152) Study - Initiation & Completion Year
  • Figure 3-8: HLA Targeted Transplant Therapies - Treg Gene Editing
  • Figure 3-9: HLA Sensitization In Transplantation
  • Figure 3-10: QEL-001-CLN-01 Phase 1/2 (NCT05234190) Study - Initiation & Completion Year
  • Figure 3-11: AOTCRI-102 Phase 1/2 (NCT07053488) Study - Initiation & Completion Year
  • Figure 3-12: HLA & Immune Evasion By Microbes
  • Figure 3-13: Modulating HLA For Autoimmune Disease Treatment
  • Figure 3-14: HLA Modulation In Immune Diseases
  • Figure 4-1: HLA Targeting Antibody Mechanisms
  • Figure 4-2: HLA Targeted Cell Therapies - Mechanisms & Applications
  • Figure 4-3: Off-the-Shelf & Universal HLA Directed Cell Therapies
  • Figure 4-4: Peptide Based HLA Targeted Therapy - Mechanism
  • Figure 4-5: Peptide Based HLA Therapy - Benefits
  • Figure 4-6: Novel HLA Targeted Therapy Platforms
  • Figure 5-1: HLA Typing -Technological Evolution
  • Figure 5-2: Challenges In HLA Typing & Clinical Integration
  • Figure 5-3: HLA - Role In Personalized Medicine
  • Figure 5-4: Immunopeptidomics - Role In Personalized Therapy
  • Figure 5-5: Companion Diagnostics Workflow
  • Figure 6-1: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Company, 2025 -2026
  • Figure 6-2: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Country, 2025 -2026
  • Figure 6-3: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Indication, 2025 -2026
  • Figure 6-4: Global - Number Of Human Leukocyte Antigen (HLA) Targeted Therapies In Clinical Trials By Phase, 2025 -2026
  • Figure 8-1: Global Human Leukocyte Antigen (HLA) Market - Future Opportunities
  • Figure 9-1: Global Human Leukocyte Antigen (HLA) Market - Drivers & Opportunities
  • Figure 9-2: Global Human Leukocyte Antigen (HLA) Market - Challenges & Solutions

List of Tables

  • Table 2-1: Comparison Between HLA Class I & Class II Antigen Presentation
  • Table 2-2: HLA Based Therapies - Comparison In Different Areas
  • Table 4-1: HLA Targeted Cell Therapy - Techniques For Enhancing Performance
  • Table 5-1: HLA Typing Timeline