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市场调查报告书
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1568884

PROTAC(蛋白质分解标的嵌合体)的全球市场:市场机会和临床试验趋势(2027年)

Global PROTAC Targeted Protein Degraders Market Opportunity & Clinical Trials Insight 2027

出版日期: | 出版商: KuicK Research | 英文 180 Pages | 商品交期: 最快1-2个工作天内

价格
特征 详细内容
主要市场区隔 各适应症,各地区,技术各平台
治疗领域 癌症,感染疾病,自体免疫·发炎性疾病,其他
观察对象国家 美国,中国,韩国
报告目标范围 作用机制,癌症的可能性,全面的临床药的洞察,目前趋势与未来的机会
对象企业 Arvinas,EnhancedBio,Uppthera,TYK Medicine,Axter Therapeutics等

蛋白水解靶向嵌合体 (PROTAC) 首次概念化于 2000 年代初,现已成为标靶治疗的突破性方法。透过利用人体的天然泛素蛋白酶体系统,PROTAC 选择性地去除与多种疾病相关的特定蛋白质,特别是那些历来被认为无法治疗的疾病。这种创新疗法专注于解决复杂疾病患者治疗方案的关键差距,并在学术和工业领域获得关注。

PROTAC 透过一种独特的机制发挥作用,该机制由三个基本成分组成:靶向配体、E3 连接酶配体和接头。靶向配体特异性结合目标蛋白 (POIs),这些蛋白质通常在疾病病理学中发挥重要作用。这包括与癌症和神经退化性疾病相关的蛋白质。 E3 连接酶配体将 PROTAC 连接到 E3 连接酶,E3 连接酶促进泛素分子与蛋白质的附着。当 PROTAC 同时与 POI 和 E3 连接酶结合时,PROTAC 催化泛素的转移并标记蛋白酶体降解的目标。与传统的小分子抑制剂相比,这种机制可以更有效、更精确地干预疾病过程,传统的小分子抑制剂通常只抑制蛋白质功能而不促进降解。

PROTAC 最突出的应用是癌症治疗。癌症涉及蛋白质之间的复杂相互作用,这些相互作用导致肿瘤生长、进展、转移和对现有治疗的抵抗。 PROTAC 已开发用于靶向和降解多种关键蛋白,包括 KRAS、BRAF、细胞週期蛋白依赖性激酶以及雌激素受体和雄激素受体等激素受体。在临床试验的候选药物中,由Urvinus公司开发的雌激素受体降解药物bepdegestrant(ARV-471)脱颖而出。截至2024年10月,Bepdegeslant正处于治疗雌激素受体阳性、人类表皮生长因子受体2阴性(ER+/HER2-)乳癌的3期临床试验。这可能使其成为全球管道中最先进的 PROTAC 候选产品,并为其在本十年末成为第一个上市的 PROTAC 铺平道路。

PROTAC 的商业前景正在快速成长,其特点是旨在加速基于 PROTAC 的新疗法的发现和开发的策略研究合作。 2024 年 1 月,Galapagos 和 BridGene Biosciences 宣布开展策略合作,开发针对临床验证的肿瘤标靶的新型精准药物。此次合作旨在利用两家公司的专业知识并加强 PROTAC 的开发管道。 2024 年 8 月,两家公司扩大了协议范围,纳入了在精准肿瘤学领域开发选择性口服 SMARCA2 PROTAC 的努力,突显了这一新领域的合作精神。

由于研究进展和药物开发投资的增加,PROTAC 市场预计将显着成长。 PROTAC 独特的作用机制和针对以前无法治疗的蛋白质的能力使 PROTAC 成为复杂疾病治疗方法的一个有希望的补充。

本报告调查了全球 PROTAC(蛋白水解靶向嵌合体)市场,并提供了市场概况,包括药物趋势、临床试验趋势、区域趋势以及进入市场的公司的竞争格局。

目录

第1章 PROTAC技术的简介

第2章 PROTAC疗法的癌症治疗的可能性

  • 作为标靶治疗的重要性
  • 与传统治疗方法的比较

第3章 PROTAC技术临床概要

  • PROTAC分子的成分
  • 作用机制

第4章 全球PROTAC药物市场趋势的洞察

  • 目前市场概要
  • 未来临床及商业机会

第5章 全球PROTAC药物市场趋势,各地区

  • 美国
  • 韩国
  • 中国

第6章 世界PROTAC药物临床试验概要

  • 各企业
  • 各国
  • 患者各市场区隔
  • 各相
  • 依孤儿与快速通道状态

第7章 全球PROTAC药物临床试验的洞察:各企业,各国,各适应症,各相

  • 调查
  • 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PROTAC药物市场趋势,各适应症

  • 癌症
  • 感染疾病
  • 神经退化性疾病
  • 自体免疫疾病及发炎性疾病
  • 心血管疾病

第9章 PROTAC技术平台

第10章 全球PROTAC药物市场动态与展望

第11章 竞争情形

  • Arvinas
  • Axter Therapeutics
  • Beactica
  • BioTheryX
  • EnhancedBio
  • Suzhou Kintor Pharmaceuticals
  • Monte Rosa Therapeutics
  • TYK Medicine
  • Ubix Therapeutics
  • Uppthera

"Global PROTAC Targeted Protein Degraders Market Opportunity & Clinical Trials Insight 2027" Report Finding & Inclusions:

  • First PROTAC Drug Approval Expected By 2027
  • Global & Regional PROTAC Drug Market Trends Insight
  • First 12 Months & First 5 Years Market Size Estimates Since Approval
  • Global PROTAC Drugs Clinical Trials Insight By Company, Country, Indication & Phase: > 90 Drugs
  • FDA Fast Track & Orphan Drug Status Insight By Company & Indication
  • Comprehensive Insight On PROTAC Technology Platforms: 10 Platforms
  • Global PROTAC Drug Market Trends By Indications
  • Competitive Landscape
FeaturesDetails
Key Segments:By Indication, By Region, Technology Platforms
Therapeutic Areas:Cancer, Infectious Diseases, Autoimmune & Inflammatory Diseases and others
Countries Covered:US, China, South Korea
Report CoverageMechanism of Action, Potential in Cancer, Comprehensive Clinical Drugs Insight, Current Trends and Future Opportunities
Companies Covered:Arvinas, EnhancedBio, Uppthera, TYK Medicine, Axter Therapeutics among others

First conceptualized in the early 2000s, proteolysis-targeting chimeras (PROTACs) are emerging as a transformative approach in targeted therapies. By harnessing the body's natural ubiquitin-proteasome system, PROTACs selectively eliminate specific proteins implicated in various diseases, particularly those that have been historically deemed undruggable. This innovative therapeutic modality is gaining traction in both academic and industrial settings, with a focus on addressing significant gaps in treatment options for patients with complex diseases.

PROTACs function through a unique mechanism that comprises three essential components: a targeting ligand, an E3 ligase ligand, and a linker. The targeting ligand binds specifically to the protein of interest (POI), which often plays a crucial role in disease pathology. This can include proteins associated with cancer or neurodegenerative disorders. The E3 ligase ligand links the PROTAC to an E3 ligase, an enzyme that facilitates the attachment of ubiquitin molecules to proteins. Once the PROTAC simultaneously binds to the POI and the E3 ligase, it catalyzes the transfer of ubiquitin, marking the target for degradation by the proteasome. This mechanism allows for a more effective and precise intervention in disease processes compared to traditional small molecule inhibitors, which often only inhibit protein function without promoting degradation.

The most prominent application of PROTACs is in cancer treatment. Cancer involves a complex interplay of proteins that contribute to tumor growth, progression, metastasis, and resistance to existing therapies. PROTACs are being developed to target and degrade a variety of key proteins, including KRAS, BRAF, cyclin-dependent kinases, and hormone receptors like estrogen and androgen receptors. Among the candidates in clinical trials, Vepdegestrant (ARV-471), an estrogen receptor degrader developed by Arvinas, stands out. As of October 2024, Vepdegestrant is undergoing phase 3 clinical trials for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. This makes it the most advanced PROTAC candidate in the global pipeline, potentially paving the way to become the first PROTAC on the market by the end of this decade.

In addition to Vepdegestrant, Arvinas is also conducting a Phase 1/2 clinical trial for Bavdegalutamide (ARV-110), a PROTAC targeting the androgen receptor in patients with metastatic castration-resistant prostate cancer. This dual approach highlights the potential of PROTACs to address multiple facets of cancer biology effectively.

Beyond oncology, the application of PROTACs is expanding into the realm of autoimmune and inflammatory disorders. Researchers are exploring their potential to degrade key proteins involved in inflammatory signaling pathways. Notably, proteins from the IRAK family, especially IRAK4, and BTK kinase are being targeted for PROTAC development in these areas. While most candidates in this category are still in early phases, with few like HSK-40118 and KT-474 currently in clinical trials, ongoing research promises to uncover more viable options in the future.

The commercial landscape for PROTACs is burgeoning, characterized by strategic collaborations aimed at accelerating the discovery and development of new PROTAC-based therapies. In January 2024, Galapagos and BridGene Biosciences announced a strategic partnership to develop novel precision medicines targeting clinically validated oncology targets. This collaboration aims to leverage both companies' expertise to enhance the development pipeline of PROTACs. In August 2024, they expanded their agreement to include efforts on developing a selective oral SMARCA2 PROTAC in precision oncology, underscoring the collaborative spirit in this emerging field.

The market for PROTACs is anticipated to grow significantly, driven by advancements in research and increasing investments in drug development. The unique mechanism of action and the ability to target previously undruggable proteins position PROTACs as a promising addition to the therapeutic arsenal against complex diseases.

As the PROTAC field continues to evolve, its clinical and commercial prospects look bright. The promising early results from clinical trials and the strategic partnerships being formed indicate that PROTACs could soon revolutionize treatment paradigms for various diseases, particularly cancer and autoimmune disorders. With ongoing research and development, PROTACs are set to become a cornerstone of targeted therapy, offering new hope to patients and filling critical gaps in treatment. As we move toward the latter half of this decade, the landscape of drug development is likely to be significantly reshaped by the success of PROTAC technology.

Table of Contents

1. Introduction To PROTAC Technology

  • 1.1 Overview Of PROTAC Technology
  • 1.2 Development & Evolution of PROTACs

2. PROTAC Therapies Potential In Cancer Therapeutics

  • 2.1 Importance As Targeted Therapy
  • 2.2 Comparison With Conventional Treatment Methods

3. Clinical Overview of PROTAC Technology

  • 3.1 Components Of PROTAC Molecules
  • 3.2 Mechanism Of Action

4. Global PROTAC Drug Market Trends Insight

  • 4.1 Current Market Overview
  • 4.2 Future Clinical & Commercial Opportunities

5. Global PROTAC Drug Market Trends By Region

  • 5.1 US
  • 5.2 South Korea
  • 5.3 China

6. Global PROTAC Drugs Clinical Trials Insight Overview

  • 6.1 By Company
  • 6.2 By Country
  • 6.3 By Patient Segment
  • 6.4 By Phase
  • 6.5 By Orphan & Fast Track Status

7. Global PROTAC Drugs Clinical Trials Insight By Company, Country, 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 PROTAC Drug Market Trends By Indication

  • 8.1 Cancer
  • 8.2 Infectious Diseases
  • 8.3 Neurodegenerative diseases
  • 8.4 Autoimmune & Inflammatory Diseases
  • 8.5 Cardiovascular Diseases

9. PROTAC Technology Platforms

10. Global PROTAC Drugs Market Dynamics & Outlook

  • 10.1 Drivers & Opportunities
  • 10.2 Challenges & Restraints

11. Competitive Landscape

  • 11.1 Arvinas
  • 11.2 Axter Therapeutics
  • 11.3 Beactica
  • 11.4 BioTheryX
  • 11.5 EnhancedBio
  • 11.6 Suzhou Kintor Pharmaceuticals
  • 11.7 Monte Rosa Therapeutics
  • 11.8 TYK Medicine
  • 11.9 Ubix Therapeutics
  • 11.10 Uppthera

List of Figures

  • Figure 1-1: PROTACs - Evolution Across Generations
  • Figure 1-2: PROTACs - Major Developmental Milestones Over The Years
  • Figure 2-1: PROTACs - Advantages As Cancer Target Therapy
  • Figure 3-1: PROTAC - Typical Structure
  • Figure 3-2: PROTACs - Mechanism Of Action
  • Figure 4-1: Global - PROTA Therapy Market Size: First 12 Month & First 5 Years Since Approval, (US$ Million)
  • Figure 6-1: Global - Number of PROTAC Drugs Clinical Trials By Company, 2024
  • Figure 6-2: Global - Number Of PROTAC Drugs In Clinical Trials By Country, 2024
  • Figure 6-3: Global - Number Of PROTAC Drugs In Clinical Trials By Patient Segment, 2024
  • Figure 6-4: Global - Number Of PROTAC Drugs In Clinical Trials By Phase, 2024
  • Figure 6-5: Global - Fast Track & Orphan Designated PROTAC Drugs In Clinical Trials, 2024
  • Figure 8-1: Bavdegalutamide Phase I/II (NCT03888612) Study - Initiation & Completion Year
  • Figure 8-2: Bavdegalutamide Phase I (NCT05177042) Study - Initiation & Completion Year
  • Figure 8-3: Vepdegestrant Phase I/II (NCT04072952) Study - Initiation & Completion Year
  • Figure 8-4: VERITAC-2 Phase III (NCT05654623) Study - Initiation & Completion Year
  • Figure 8-5: VERITAC-3 Phase III (NCT05909397) Study - Initiation & Completion Year
  • Figure 8-6: I-SPY-2 Phase II (NCT01042379) Study - Initiation & Completion Year
  • Figure 8-7: ARV-393 Phase I (NCT06393738) Study - Initiation & Completion Year
  • Figure 8-8: ADVANTA Phase II (NCT06058156) Study - Initiation & Completion Year
  • Figure 8-9: ZEN Phase II (NCT06028230) Study - Initiation & Completion Year
  • Figure 9-1: PROTAC(R) Discovery Engine - Arvinas
  • Figure 9-2: Degraducer Technology - Ubix Therapeutics
  • Figure 9-3: SpeedUPP Platform - UPPTHERA
  • Figure 9-4: DaTProD Platform - HealZen Therapeutics
  • Figure 10-1: Global PROTAC Drugs Market - Drivers & Opportunities
  • Figure 10-2: Global PROTAC Drugs Market - Challenges & Restraints

List of Tables

  • Table 2-1: Comparison of PROTACs With Conventional Therapies
  • Table 6-1: Cancer - Clinical Trials Assessing ARV-471