PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930130
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930130
The global bispecific antibody market is witnessing robust growth due to its therapeutic potential in oncology, hematology, and other complex diseases. According to Fortune Business Insights, the market was valued at USD 31.17 billion in 2025, projected to grow to USD 34.72 billion in 2026, and reach USD 91.09 billion by 2034, reflecting a CAGR of 12.8%. In 2025, North America dominated the market with a 51.8% share, driven by advanced biotechnology infrastructure, extensive clinical trials, and supportive reimbursement frameworks.
Bispecific antibodies are bioengineered proteins capable of simultaneously targeting multiple antigens. Their unique mechanism allows for more precise targeting of tumor cells or immune modulation compared with conventional monoclonal antibodies. The rising prevalence of cancer, increasing FDA and EMA approvals, and growing investment in clinical trials are significantly fueling the demand for bispecific antibodies. Key industry players, including AbbVie Inc., Pfizer Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals, are actively developing pipeline candidates to meet rising therapeutic demand.
Market Dynamics
Drivers
The increasing cancer burden coupled with advancements in antibody engineering is a primary growth driver. Conventional therapies often have limitations in relapsed or refractory patient populations, creating demand for novel modalities such as bispecific antibodies. Collaborative research initiatives are enhancing therapeutic applications globally. For instance, in March 2025, Harbour BioMed partnered with AstraZeneca to develop next-generation multi-specific antibodies, supported by a USD 105 million equity investment.
Restraints
High manufacturing complexity and production costs remain major restraints. Bispecific antibodies require sophisticated engineering to maintain dual target specificity, structural stability, and batch consistency. Regulatory quality standards and advanced purification techniques further increase production costs, limiting broader adoption. In August 2025, the U.S. FDA declined approval of Regeneron's odronextamab for follicular lymphoma due to manufacturing issues.
Opportunities
The expansion into earlier lines of therapy presents a significant opportunity. Currently approved mainly for relapsed or refractory cancers, bispecific antibodies may be used in larger patient populations when combined with standard regimens. In December 2024, Janssen-Cilag (Johnson & Johnson) showcased frontline data for TECVAYLI (teclistamab) in multiple myeloma, highlighting potential for early-line combination therapy.
Challenges
Cytokine Release Syndrome (CRS) and neurotoxicity are critical safety challenges, particularly with T-cell engagers. These adverse effects require careful clinical management and step-up dosing, increasing treatment complexity and cost. In November 2024, the American Society of Hematology reported multi-institution rates of CRS and ICANS associated with lymphoma-targeted bispecific antibodies.
Market Trends
A major trend is the shift from intravenous (IV) infusions to subcutaneous (SC) formulations, enhancing patient convenience, compliance, and reduced hospital dependency. Companies are developing stable, low-viscosity, high-concentration SC formulations to maintain efficacy and safety. In November 2024, Alphamab Oncology reported clinical trial data for JSKN033, a subcutaneous co-formulation combining an anti-HER2 bispecific ADC and a PD-L1 inhibitor.
By Mechanism of Action
The market is divided into T-cell engaging, dual blockers/inhibitors, co-factor mimetics, and others. The T-cell engaging segment is expected to dominate due to its potent anti-tumor activity and ability to overcome resistance in heavily pretreated cancers. In February 2023, Atreca, Inc. collaborated with Xencor, Inc. to launch a T-cell engager program using XmAb bispecific Fc technology.
By Application
Applications include oncology, hematology, ophthalmology, and others. Oncology held the largest market share in 2025 and is projected to account for 41.99% in 2026. The hematology segment is growing at a CAGR of 6.43%.
By Route of Administration
The market is segmented into intravenous (IV), subcutaneous (SC), and others. IV administration dominated in 2025, with a 58.90% share in 2026. SC administration is anticipated to grow at 14.05% CAGR, driven by convenience and improved patient compliance.
By Distribution Channel
Hospital pharmacies dominate due to controlled settings for IV biologics, cold chain storage, and sterile compounding. The segment is expected to hold 67.19% share in 2026. Retail pharmacies are growing at a CAGR of 11.94%, expanding patient access.
North America leads due to advanced biotechnology infrastructure, clinical trials, early regulatory approvals, and strong reimbursement systems.
Competitive Landscape
Key players include Bristol-Myers Squibb, Pfizer, Merck, Genentech, AbbVie, Hoffmann-La Roche, Regeneron, and Harbour BioMed. Strategic collaborations, acquisitions, and R&D investments are driving growth. For example, in June 2025, BioNTech SE collaborated with Bristol-Myers Squibb to co-develop investigational bispecific antibodies for solid tumors.
Conclusion
The global bispecific antibody market is expected to grow from USD 31.17 billion in 2025 to USD 91.09 billion by 2034, driven by rising cancer prevalence, advanced antibody engineering, pipeline expansion, and regulatory approvals. Despite manufacturing complexity, high costs, and safety concerns, innovations in subcutaneous formulations, early-line therapy expansion, and strategic collaborations are set to enhance adoption and market growth globally.
Segmentation By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Region
By Mechanism of Action * T-Cell Engaging
By Application * Oncology
By Route of Administration * Intravenous
By Distribution Channel * Hospital Pharmacies
By Region * North America (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country)