雙特異性抗體藥物複合體的全球市場:臨床試驗，藥事核准，今後的市場機會預測(2029年)

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

出版日期: 2024年09月01日 | 出版商:

KuicK Research | 英文 180 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

雙特異性抗體-藥物偶聯物 (BsADC) 是一類令人興奮的新型標靶癌症治療藥物，它將化療藥物的強大細胞毒性與雙特異性抗體的特異性結合在一起。透過與免疫效應細胞同時作用，靶向癌細胞上的兩種不同抗原，或靶向同一抗原上的兩個非重疊區域，這些創新方法可與傳統的抗體-藥物綴合物相比，尋求提高治療範圍和療效。儘管全球 BsADC 產業仍處於起步階段，但隨著更多候選藥物接受臨床試驗並投入商業化，預計未來幾年將顯著成長。

雙特異性抗體-藥物偶聯物與傳統的單特異性抗體-藥物偶聯物相比具有許多潛在優勢。雙特異性抗體-藥物偶聯物可以透過結合兩個不同的抗原表位來更有選擇性地靶向腫瘤。雙特異性結合可以促進癌細胞中藥物的攝取和釋放。標靶藥物給藥和免疫活化可以與某些雙特異性抗體-藥物綴合物結合腫瘤抗原並將免疫細胞（例如 T 細胞和 NK 細胞）吸引到腫瘤微環境的能力相結合。

研究中的雙特異性抗體-藥物偶聯物的安全性和初步療效在早期臨床數據中顯示出有希望的結果。例如，BVX002（針對未公開的抗原對）和VBC103（針對TROP2 和Nectin-4）等候選藥物已在癌細胞系和實體瘤動物模型中顯示出良好的抗腫瘤活性，並表現出可控的毒性特徵。為了充分了解雙特異性抗體-藥物偶聯物與其他可用治療方法以及其他創新治療方法相比的治療益處和潛在缺點，需要進一步研究。

從商業角度來看，全球製藥公司對雙特異性抗體藥物偶聯物的臨床開發表現出了極大的興趣和投資。安進（Amgen）、信達生物（Innovent Biologics）和阿斯特捷利康（AstraZeneca）等抗體藥物偶聯物市場的主要參與者正在積極將雙特異性抗體藥物偶聯物候選物添加到其管道中。同時，專業生物技術公司正在利用其專有平台開發尖端的雙特異性抗體藥物偶聯療法。

本報告提供全球雙特異性抗體藥物複合體市場相關調查，提供市場概要，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的競爭情形等資訊。

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.

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

簡介目錄圖表

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