DelveInsight, a prominent life sciences–focused market research and business consulting firm, has announced the launch of its newest report titled “Bispecific Antibody – Competitive Landscape” The comprehensive analysis delivers in-depth strategic insights into the rapidly evolving bispecific antibody domain, profiling more than 180 companies and over 250 drug candidates. The report evaluates therapies across multiple dimensions, including product classification, development stage, route of administration, and molecular format, while also identifying discontinued and inactive assets—offering stakeholders a holistic understanding of the global bispecific antibody competitive environment.
Gain access to the most exhaustive analysis of the bispecific antibody space, featuring 180+ organizations and 250+ drug programs. Download the Report: Bispecific Antibody Pipeline Insight
Bispecific Antibodies in Oncology: Pipeline Overview
- Biopharmaceutical companies worldwide continue to advance innovative bispecific antibody–based therapies, achieving notable developmental progress over recent years.
- The oncology-focused bispecific antibody pipeline assessment estimates the addressable patient population across multiple indications, including Acute Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Multiple Myeloma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Cancer, Breast Cancer, Gastric and Esophageal Cancers, Pancreatic Cancer, Colorectal Cancer, and other malignancies.
- In the United States alone, approximately 895,000 oncology patients were estimated to be eligible for treatment with bispecific antibody therapies.
- Major players developing next-generation oncology bispecific antibodies include I-MAB Biopharma, Bristol Myers Squibb, AstraZeneca, BioNTech, Genmab, Compass Therapeutics, Innovent, Regeneron Pharmaceuticals, Aurigene Oncology, Curis, Akeso, Summit Therapeutics, Roche, Merus, Adimab, Creative Biolabs, Amgen, Zymeworks, Xencor, Novo Nordisk, MacroGenics, among others, with several candidates expected to enter the market in the coming years.
- Prominent bispecific antibody candidates currently undergoing clinical evaluation include Givastomig, Volrustomig, BNT327, Acasunlimab, Rilvegostomig, CTX-009, IBI363, REGN5459, CA-170, Ivonescimab, Odronextamab, MCLA-129, MIM8, MGD024, COLUMVI, RYBREVANT, and others.
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Bispecific Antibodies: Scientific Overview
Antibody Biology Explained
Antibodies, also known as immunoglobulins (Abs), are essential components of the adaptive immune system, protecting the body from pathogens and external threats. Among the various classes, IgG antibodies composed of two heavy and two light chains—are the most prevalent, traditionally designed with two identical antigen-binding sites. The development of bispecific antibodies has revolutionized antibody engineering by enabling a single molecule to bind two different targets simultaneously.
Mechanism of Action of Bispecific Antibodies
Bispecific antibodies enable precise immune redirection by simultaneously engaging CD3 receptors on cytotoxic T cells and tumor-associated antigens such as CD19, CD20, HER2, BCMA, CEA, and EpCAM. This dual-binding strategy enhances immune-mediated tumor destruction while amplifying endogenous anti-cancer immune responses.
Beyond oncology, bispecific antibodies are demonstrating therapeutic promise in several non-cancer indications, including osteoporosis, hemophilia, Alzheimer’s disease, and autoimmune disorders. Examples include:
- ACE910 (Hemophilia A): Lowers bleeding frequency by bridging coagulation factors IX and X.
- Osteoporosis programs: Target Wnt signaling modulators like sclerostin and Dkk1 to stimulate bone formation.
- Neurological candidates: Combine transferrin receptor engagement with BACE1 inhibition to facilitate blood–brain barrier penetration and reduce amyloid-beta accumulation in Alzheimer’s disease.
Benefits Compared to Monospecific Antibodies
Bispecific antibodies offer several advantages over conventional monoclonal antibody therapies, including:
- Enhanced precision and potency: Simultaneous dual-target engagement improves therapeutic outcomes.
- Reduced development costs: A single bispecific molecule can replace combination regimens involving multiple monoclonals.
- Lower resistance risk: Multi-receptor targeting decreases the likelihood of tumor escape mechanisms.
- Expanded clinical applications: Enables therapeutic use across oncology, inflammatory conditions, autoimmune diseases, and rare disorders.
Explore comprehensive scientific, clinical, and commercial insights into the bispecific antibody landscape. Access the Full Report: Bispecific Antibody Clinical Trials and FDA Approvals
Key Players in the Bispecific Antibody Competitive Landscape
- Janssen
- Amgen
- Akeso
- Zymeworks
- Roche
- IGM Biosciences
- MacroGenics
- Provention Bio
- Jiangsu Alphamab Biopharmaceuticals
- Sichuan Baili Pharmaceutical
- Regeneron Pharmaceuticals
- Boehringer Ingelheim
Market Highlights: Strategic Partnerships and Industry Developments
The “Bispecific Antibody – Competitive Landscape, 2025” report monitors critical scientific advances and corporate activities shaping the competitive ecosystem:
- LAVA Therapeutics & Merck & Co. (Jan 2024): Joint evaluation of LAVA-1207 in combination with KEYTRUDA® for metastatic prostate cancer.
- Biocytogen & Radiance Biopharma (Jan 2024): Exclusive licensing agreement for a novel HER2/TROP2 bispecific antibody-drug conjugate.
- Debiopharm & SunRock Biopharma (Jan 2024): Expanded licensing collaboration focused on HER3-EGFR bispecific ADCs.
- Pfizer & Seagen (Dec 2023): Pfizer’s USD 43 billion acquisition significantly expanded its oncology portfolio, including bispecific antibody assets.
- NAYA Biosciences & ONK (Dec 2023): Research alliance exploring NK-cell–based combinations with FLEX-NK™ bispecific platforms.
- I-Mab (Nov 2023): Presentation of preclinical data on CD4/4-1BB bispecific antibodies at SITC.
- Cantai Therapeutics (Nov 2023): Launch of a biotechnology company dedicated to cytokine-targeted bispecific antibodies for autoimmune diseases.
- Lonza & ABL Bio (Apr 2023): Partnership for the development and manufacturing of bispecific antibodies in oncology and neurodegenerative indications.
Understand how industry leaders such as Amgen, Roche, AstraZeneca, and Regeneron are shaping the future of bispecific antibodies. Request Sample Access: Bispecific Antibody Companies and Manufacturers
Marketed Bispecific Antibody Therapies: Company Snapshots
Janssen (Johnson & Johnson) – Amivantamab (RYBREVANT®)
- Targets: EGFR and MET
- Indication: Non-small cell lung cancer with EGFR Exon 20 insertion mutations
- Milestone: First FDA-approved therapy developed using Genmab’s DuoBody® platform
Amgen – Blinatumomab (BLINCYTO®)
- Targets: CD19 and CD3 (BiTE® technology)
- Indications: Acute lymphoblastic leukemia and B-cell lymphomas
- Significance: First-in-class BiTE antibody approved for multiple hematologic cancers with orphan drug status
Pipeline Therapy Highlights
AstraZeneca – Gefurulimab
- Humanized bispecific antibody targeting C5 and albumin
- Investigated for autoimmune disorders via complement system modulation
Sichuan Baili Pharmaceutical – SI-B001
- Targets: EGFR and HER3
- Development Stage: Phase III
- Demonstrated robust anti-tumor activity in early-stage studies
Innovent Biologics – IBI322
- Targets: CD47 and PD-L1
- Stage: Phase II
- Dual immune-activating mechanism across hematologic and solid malignancies
IGM Biosciences – Imvotamab
- IgM-based CD20 × CD3 bispecific antibody
- Designed for enhanced binding strength with reduced cytokine release risk
MacroGenics – MGD024
- Targets: CD123 × CD3 (DART® technology)
- Engineered to limit cytokine release syndrome while preserving anti-leukemic efficacy
Evaluate your organization’s position within the global bispecific antibody pipeline. Download the Report: Bispecific Antibody Competitive Landscape
DelveInsight’s Analytical Viewpoint
The report extends beyond scientific profiling to deliver actionable commercial intelligence, including: • Trends in collaborations and licensing agreements across academia and industry • Merger and acquisition activities redefining competitive dynamics • Comparative analysis of companies by therapeutic focus, clinical maturity, and technology platforms • Identification of unmet needs and emerging growth opportunities
Key Questions Addressed in the Report
The bispecific antibody pipeline analysis answers several critical market questions, such as:
- How many companies are actively developing bispecific antibody therapies?
- How are pipeline assets distributed across early, mid, and late development stages?
- Which partnerships, licensing deals, and acquisitions are accelerating innovation?
- What novel platforms are addressing the limitations of traditional antibody therapies?
- Which clinical trials are ongoing, and what is their current status?
- Which bispecific antibodies have secured regulatory approvals or special designations?
Future Outlook for Bispecific Antibodies
The bispecific antibody market spans major global regions, with strong R&D activity concentrated in the United States, Europe, and the Asia-Pacific region. As regulatory pathways mature and next-generation modalities emerge, bispecific antibodies are expected to transform oncology care while expanding into autoimmune, neurological, and rare disease indications. DelveInsight anticipates that sustained innovation, strategic alliances, and broader clinical adoption will fuel significant market expansion over the next decade.
About DelveInsight
DelveInsight is a specialized market research and business consulting firm dedicated exclusively to the life sciences sector. Through expertise in market forecasting, pipeline analysis, competitive intelligence, and strategic advisory services, DelveInsight supports pharmaceutical companies, biotechnology firms, and investors with data-driven insights to guide critical business decisions.
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