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封面
市场调查报告书
商品编码
1555006

双特异性抗体药物复合体的全球市场:临床试验，药事核准，今后的市场机会预测(2029年)

Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals & Future Market Opportunity Outlook 2029
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

双特异性抗体-药物偶联物 (BsADC) 是一类令人兴奋的新型标靶癌症治疗药物，它将化疗药物的强大细胞毒性与双特异性抗体的特异性结合在一起。透过与免疫效应细胞同时作用，靶向癌细胞上的两种不同抗原，或靶向同一抗原上的两个非重迭区域，这些创新方法可与传统的抗体-药物缀合物相比，寻求提高治疗范围和疗效。儘管全球 BsADC 产业仍处于起步阶段，但随着更多候选药物接受临床试验并投入商业化，预计未来几年将显着成长。

双特异性抗体-药物偶联物与传统的单特异性抗体-药物偶联物相比具有许多潜在优势。双特异性抗体-药物偶联物可以透过结合两个不同的抗原表位来更有选择性地靶向肿瘤。双特异性结合可以促进癌细胞中药物的摄取和释放。标靶药物给药和免疫活化可以与某些双特异性抗体-药物缀合物结合肿瘤抗原并将免疫细胞（例如 T 细胞和 NK 细胞）吸引到肿瘤微环境的能力相结合。

研究中的双特异性抗体-药物偶联物的安全性和初步疗效在早期临床数据中显示出有希望的结果。例如，BVX002（针对未公开的抗原对）和VBC103（针对TROP2 和Nectin-4）等候选药物已在癌细胞系和实体瘤动物模型中显示出良好的抗肿瘤活性，并表现出可控的毒性特征。为了充分了解双特异性抗体-药物偶联物与其他可用治疗方法以及其他创新治疗方法相比的治疗益处和潜在缺点，需要进一步研究。

从商业角度来看，全球製药公司对双特异性抗体药物偶联物的临床开发表现出了极大的兴趣和投资。安进（Amgen）、信达生物（Innovent Biologics）和阿斯特捷利康（AstraZeneca）等抗体药物偶联物市场的主要参与者正在积极将双特异性抗体药物偶联物候选物添加到其管道中。同时，专业生物技术公司正在利用其专有平台开发尖端的双特异性抗体药物偶联疗法。

本报告提供全球双特异性抗体药物复合体市场相关调查，提供市场概要，以及药物趋势，临床试验趋势，各地区趋势，及加入此市场的主要企业的竞争情形等资讯。

目录

第1章 双特异性抗体药物复合体的构想与开发的继续

  • 概要
  • 双特异性抗体药物复合体及其他免疫疗法的比较

第2章 双特异性抗体药物复合体的必要性

第3章 双特异性抗体药物复合体- 设计和作用机制

  • 双特异性抗体药物复合体的一般结构与设计
  • 作用机制

第4章 全球双特异性抗体药物复合体的临床试验概要

  • 各企业
  • 各国
  • 各适应症
  • 各期
  • 各目标

第5章 全球双特异性抗体药物复合体市场洞察

  • 目前市场情势
  • 未来市场机会

第6章 双特异性抗体药物复合体市场分析，各地区

  • 中国
  • 美国
  • 欧洲
  • 韩国

第7章 双特异性抗体药物复合体- 各适应症的应用与开发

  • 乳癌
  • 消化器官癌症
  • 肺癌症
  • 泌尿系统癌症
  • 妇产科癌症

第8章 双特异性抗体药物复合体的临床试验相关企业，国家，适应症，各期的考察

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

第9章 双特异性抗体药物复合体的开发所使用的平台技术

第10章 竞争情形

  • Alphamab Oncology
  • Amgen
  • AstraZeneca
  • Beijing Biocytogen
  • BiVictriX Therapeutics
  • Corellia AI
  • Debiopharm
  • Doma Bio
  • Genmab
  • Innovent Biologics
  • ProEn Therapeutics

Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals & Future Market Opportunity Outlook 2029 Report:

  • Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates
  • First Bispecific Antibody Drug Conjugate Commercial Approval Expected By 2029
  • Insight On Bispecific Antibody Drug Conjugates In Clinical Trials : > 60 Drug Conjugates
  • China Dominating Bispecific Antibody Drug Conjugates Clinical Trials: > 35 Drug Conjugates
  • Majority Of Bispecific Antibody Drug Conjugates For Breast Cancer
  • Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase
  • Bispecific Antibody Drug Conjugates In Combination Therapy By Indication & Clinical Phase
  • Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates

Bispecific antibody drug conjugates (BsADCs) are a novel and exciting class of targeted cancer therapies that combine the potent cytotoxicity of chemotherapeutic drugs with the specificity of bispecific antibodies. Through simultaneous engagement of immune effector cells, targeting of two distinct antigens on cancer cells, or targeting two non-overlapping areas on the same antigen, these innovative modalities seek to improve the therapeutic window and efficacy of conventional antibody drug conjugates (ADCs). Although the global BsADC industry is still in its early stages, it is expected to grow significantly over the next several years as additional candidates undergo clinical studies and become commercially available.

Comparing bispecific antibody drug conjugates to traditional monospecific antibody drug conjugates, there are a number of potential benefits. Bispecific antibody drug conjugates can target tumors more selectively by binding two different epitopes, which may lessen off-target damage while preserving or enhancing efficiency. Bispecific binding has the potential to promote drug uptake and release in cancer cells. Targeted drug administration and immune activation can be combined with the ability of certain bispecific antibody drug conjugates to bind tumor antigen and attract immune cells such as T cells or NK cells to the tumor microenvironment.

The safety and preliminary efficacy of Bispecific antibody drug conjugates in development have showed encouraging outcomes in early clinical data. In cancer cell lines and animal models of solid tumors, for instance, candidates such as BVX002 (targeting an undisclosed pair of antigens) and VBC103 (targeting TROP2 and Nectin-4) have shown encouraging antitumor activity and manageable toxicity profiles. To fully comprehend the therapeutic advantages and potential drawbacks of Bispecific antibody drug conjugates in comparison to other available therapy choices, more research is necessary, as with any innovative therapeutic approach.

Pharmaceutical companies are showing a great deal of interest in and investment in the global bispecific antibody drug conjugates clinical development landscape from a commercial standpoint. Major players in the antibody drug conjugate market, like Amgen, Innovent Biologics, and AstraZeneca, are actively adding bispecific antibody drug conjugates candidates to their pipelines. Meanwhile, specialist biotechnology firms are using proprietary platforms to create cutting edge bispecific antibody drug conjugate treatments. Examples of these companies are Zymeworks, Doma Bio, and Beijing Biocytogen.

Bispecific antibody drug conjugates development is still primarily focused on oncology; candidates are now undergoing clinical trials to treat hematological and solid malignancies. The research community is becoming more interested in using bispecific antibody drug conjugates to treat inflammatory and autoimmune diseases, among other therapeutic areas. Future market development and diversification may be further fueled by this expansion into new indications.

The potential for better clinical outcomes when compared to traditional antibody drug conjugate or monoclonal antibodies, rising investments in research and development, and developments in antibody engineering and conjugation technologies are all expected to fuel the significant growth of the bispecific antibody drug conjugates segment in the upcoming years.

Nonetheless, a number of technological hurdles must be overcome before bispecific antibody drug conjugates can be developed, and companies and researchers are working relentlessly to uncover solutions. These include choosing appropriate linker chemistries and payloads, fine-tuning the drug-to-antibody ratio, and optimizing the stability and manufacturing of complicated bispecific antibody complexes. Furthermore, efforts are being made to create new bispecific formats and screening methods in order to determine the best antigen pairings and binding affinities for the greatest possible therapeutic impact.

Consequently, the bispecific antibody drug conjugates market is highly dependent on intellectual property considerations, as firms and researchers strive to safeguard their proprietary technologies, conjugation techniques, antibody forms, and development procedures. Due to their complexity, bispecific antibody drug conjugates frequently entail several layers of intellectual property, such as patents covering the payload medications, linker chemistries, specific antigen combinations, and bispecific antibody constructions. As the market grows, this complex IP landscape might result in partnerships and licensing deals, as shown by a number of recent agreements and partnerships made by Biocytogen around its exclusive RenLite(R) Common Light Chain Mouse Platform.

In the future, the clinical validation of this treatment in large-scale trials and practical applications will be crucial to the bispecific antibody drug conjugates market's success. The ability to address unmet medical needs in cases of difficult-to-treat cancers and other diseases, cost-effectiveness, and the demonstration of superior performance and safety profiles compared to current treatments are important aspects that will affect the expansion of the market.

In conclusion, bispecific antibody-drug conjugates (BsADCs), which combine the advantages of bispecific antibodies and ADCs, constitute a state-of-the-art strategy in targeted therapies. The global BsADC market is still in its early stage but it has a lot of potential for expansion and innovation. BsADCs have the ability to profoundly alter cancer treatment paradigms and delve into new therapeutic domains as clinical development advances and technological obstacles are resolved.

Table of Contents

1. Conception & Ongoing Development Of Bispecific Antibody Drug Conjugates

  • 1.1 Overview
  • 1.2 Comparison of Bispecific Antibody Drug Conjugates With Other Immunotherapies

2. Need For Bispecific Antibody Drug Conjugates

3. Bispecific Antibody Drug Conjugates - Design & Mechanism Of Action

  • 3.1 General Structure & Design Of Bispecific Antibody Drug Conjugates
  • 3.2 Mechanism Of Action

4. Global Bispecific Antibody Drug Conjugates Clinical Trials Overview

  • 4.1 By Company
  • 4.2 By Country
  • 4.3 By Indication
  • 4.4 By Phase
  • 4.5 By Target

5. Global Bispecific Antibody Drug Conjugate Market Insight

  • 5.1 Current Market Scenario
  • 5.2 Future Market Opportunity

6. Bispecific Antibody Drug Conjugates Market Analysis by Region

  • 6.1 China
  • 6.2 US
  • 6.3 Europe
  • 6.4 South Korea

7. Bispecific Antibody Drug Conjugates - Application & Development By Indication

  • 7.1 Breast Cancer
  • 7.2 Gastrointestinal Cancer
  • 7.3 Lung Cancer
  • 7.4 Urologic Cancers
  • 7.5 Gynecologic Cancers

8. Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase

  • 8.1 Research
  • 8.2 Preclinical
  • 8.3 Phase I
  • 8.4 Phase II
  • 8.5 Phase III

9. Platforms Technologies Used to Develop Bispecific Antibody Drug Conjugates

  • 9.1 ABL Bio - ADC Strategy
  • 9.2 Alphamab Oncology - Proprietary ADC Platform
  • 9.3 Biocytogen - RenLite mice
  • 9.4 BiVictriX - Bi-Cygni Therapeutics
  • 9.5 Debiopharm - Multilink
  • 9.6 Debiopharm - AbYlink(TM)
  • 9.7 Duality Biologics - Duality Novel Platforms
  • 9.8 Enduring Biotech - PEGylated Bispecific ADC Technology
  • 9.9 Innovent Biologics - Unnamed Proprietary ADC technology
  • 9.10 Medilink - TMALIN technology platform
  • 9.11 ProEn Therapeutics - ArtBody(TM) ADC technology
  • 9.12 Sichuan Baili Pharmaceutical/SystImmune - HIRE-ADC
  • 9.13 Zymeworks - Unnamed Technology

10. Competitive Landscape

  • 10.1 Alphamab Oncology
  • 10.2 Amgen
  • 10.3 AstraZeneca
  • 10.4 Beijing Biocytogen
  • 10.5 BiVictriX Therapeutics
  • 10.6 Corellia AI
  • 10.7 Debiopharm
  • 10.8 Doma Bio
  • 10.9 Genmab
  • 10.10 Innovent Biologics
  • 10.11 ProEn Therapeutics

List of Figures

  • Figure 1-1: Limitations Of Convectional Immunotherapies Addressable By BsADCs
  • Figure 3-1: Bispecific Antibody Drug Conjugate - General Structure
  • Figure 3-2: Bispecific Antibody Drug Conjugate - General Mechanism of Action
  • Figure 4-1: Global - Bispecific Antibody Drug Conjugates Clinical Pipeline By Company (Numbers), 2024
  • Figure 4-2: Global - Bispecific Antibody Drug Conjugates Clinical Pipeline By Country (Numbers), 2024
  • Figure 4-3: Global - Bispecific Antibody Drug Conjugates Clinical Pipeline By Indication (Numbers), 2024
  • Figure 4-4: Global - Bispecific Antibody Drug Conjugates Clinical Pipeline By Phase (Numbers), 2024
  • Figure 4-5: Global - Bispecific Antibody Drug Conjugates Clinical Pipeline By Target (Numbers), 2024
  • Figure 5-1: Bispecific Antibody Drug Conjugate Market Forecast - First 12 Months & First 24 Months Of Approval Of First Drug (US$ Million)
  • Figure 7-1: BL-B01D1-306 Phase III (NCT06343948) Study - Initiation & Estimated Completion Year
  • Figure 7-2: BL-B01D1-307 Phase III (NCT06382142) Study - Initiation & Estimated Completion Year
  • Figure 7-3: BL-B01D1-204-04 Phase II (NCT06471205) Study - Initiation & Estimated Completion Year
  • Figure 7-4: BL-B01D1-SI-B003-201-04 Phase II (NCT06042894) Study - Initiation & Estimated Completion Year
  • Figure 7-5: BL-B01D1-LUNG-101 Phase I (NCT05983432) Study - Initiation & Estimated Completion Year
  • Figure 7-6: BL-B01D1-104 Phase I (NCT05470348) Study - Initiation & Estimated Completion Year
  • Figure 7-7: KM501-1001 Phase I (NCT05804864) Study - Initiation & Estimated Completion Year
  • Figure 7-8: ZWI-ZW49-101 Phase I (NCT03821233) Study - Initiation & Estimated Completion Year
  • Figure 7-9: BL-B01D1-SI-B003-201-05 Phase II (NCT06008054) Study - Initiation & Estimated Completion Year
  • Figure 7-10: BL-B01D1-103 Phase I (NCT05262491) Study - Initiation & Estimated Completion Year
  • Figure 7-11: BL-B01D1-302 Phase III (NCT06382129) Study - Initiation & Estimated Completion Year
  • Figure 7-12: BL-B01D1-301 Phase III (NCT06382116) Study - Initiation & Estimated Completion Year
  • Figure 7-13: BL-B01D1-304 Phase III (NCT06500026) Study - Initiation & Estimated Completion Year
  • Figure 7-14: DM001001 Phase II (NCT06475937) Study - Estimated Initiation & Estimated Completion Year
  • Figure 7-15: CIBI334A101 Phase I/II (NCT05774873) Study - Estimated Initiation & Estimated Completion Year
  • Figure 7-16: BL-B01D1-201 Phase II (NCT05785039) Study - Initiation & Estimated Completion Year
  • Figure 7-17: BL-B01D1-102 Phase I (NCT05393427) Study - Initiation & Estimated Completion Year
  • Figure 7-18: BL-B01D1-SI-B003-201-08 Phase II (NCT05990803) Study - Initiation & Estimated Completion Year
  • Figure 7-19: BL-B01D1-202 Phase Ib/II (NCT05803018) Study - Initiation & Estimated Completion Year
  • Figure 7-20: IMGN151-1001 Phase I (NCT05527184) Study - Initiation & Estimated Completion Year
  • Figure 7-21: JSKN003-102 Phase I/II (NCT05744427) Study - Initiation & Estimated Completion Year
  • Figure 9-1: BiVictriX - Bi-Cygni Therapeutics
  • Figure 9-2: Duality Biologics - DITAC Platform
  • Figure 9-3: Duality Biologics - DITAC Platform
  • Figure 9-4: ProEn Therapeutics - ArtBody(TM) ADC Technology

List of Tables

  • Table 5-1: Bispecific Antibody Drug Conjugate Market - Recent Collaborations
  • Table 7-1: BL-B01D1: Clinical Trials Underway For Lung Cancer, September'2024