Bispecific Antibody Drug Conjugates Clinical Trials FDA Approval Market Trends Report

First Bispecific Antibody Drug Conjugates Commercial Approval Expected By 2029 Says Kuick Research

Delhi, July 11, 2025 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals and Future Market Opportunity Outlook 2029 Report:

Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates
First Bispecific Antibody Drug Conjugates 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 and Phase
Bispecific Antibody Drug Conjugates In Combination Therapy By Indication and Clinical Phase
Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates

Download Report: https://www.kuickresearch.com/report-bispecific-antibody-drug-conjugates

The global bispecific antibody drug conjugates (bispecific ADCs) market is emerging as one of the most promising frontiers in next generation targeted therapies. By combining the tumor-targeting precision of bispecific antibodies with the potent cell-killing payloads of ADCs, this modality offers the potential to overcome resistance mechanisms and deliver superior efficacy compared to traditional single-target ADCs or bispecific antibodies alone. As cancer biology becomes increasingly understood, bispecific ADCs are positioned to transform the therapeutic landscape across solid tumors and hematologic malignancies. The first commercial approval of a bispecific ADC is anticipated by 2029, marking a major inflection point for the modality’s clinical and commercial potential.

Currently, more than 60 bispecific ADCs are under clinical investigation globally, with China leading the research landscape. Over 35 of these bispecific ADCs are being evaluated in Chinese clinical trials, demonstrating the country’s rapidly advancing capabilities in next-generation biologics and targeted oncology therapeutics. This dominance is driven by a strong innovation ecosystem, regulatory support for accelerated oncology development, and a growing number of homegrown companies pioneering the space. While the US and Europe also have active pipelines, the sheer scale of China’s development efforts provides a competitive edge in candidate volume and trial diversity.

Breast cancer remains the primary indication of interest, accounting for the majority of bispecific ADC clinical trials. The focus on breast cancer stems from the availability of well-defined molecular targets such as HER2, HER3, and TROP2, as well as a large patient population with significant unmet clinical needs. Many of these trials are evaluating monotherapy and combination therapy strategies, including checkpoint inhibitors, chemotherapy, and other ADCs, to enhance response rates and prolong survival. Clinical development insights reveal a distribution across early and mid-stage trials, with several assets now progressing from Phase I to Phase II.

Our report offers detailed insight into the ongoing clinical trials by company, country, indication, and phase. The July 2025 initiation of Avenzo Therapeutics' first-in-human trial of AVZO-1418/DB-1418 represents a major milestone. Developed in collaboration with DualityBio, this novel EGFR/HER3-targeted bispecific ADC is positioned as a potential best-in-class therapy for advanced solid tumors. The trial underscores growing interest in dual-receptor targeting to overcome tumor heterogeneity and improve therapeutic precision.

Another significant update is the July 2025 partnership between Adagene and ConjugateBio. Under this collaboration, Adagene will supply a proprietary antibody for ConjugateBio’s bispecific ADC programs, while retaining non-ADC rights. This reflects a growing trend of strategic alliances between antibody innovators and ADC technology companies aimed at accelerating clinical development and enhancing commercial scalability.

The competitive landscape is rich and evolving, with companies such as DualityBio, Debiopharm, Adagene, Innovent Biologics, and others at the forefront. Each of these players is leveraging proprietary antibody engineering platforms, novel linker technologies, and high-potency payloads to develop differentiated assets with improved safety and efficacy profiles. The industry is also witnessing increased interest from large pharma companies seeking to co-develop or license bispecific ADC assets to strengthen their oncology portfolios.

Our report delivers a comprehensive and strategic analysis of this high-potential market segment. It provides detailed insights into clinical development pipelines, regional dynamics, company-level strategies, technology platforms, and indication-wise trends. With the first approval expected by 2029 and an expanding portfolio of novel assets, the global bispecific antibody-drug conjugate market is poised to play a transformative role in precision oncology.

Neeraj Chawla
Research Head
Kuick Research
neeraj@kuickresearch.com
https://www.kuickresearch.com/
+91-11-47067990

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