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Bispecific Antibodies in Oncology Market Forecast to Surge Over the Next Decade | DelveInsight
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The increasing global prevalence of cancer is a significant driver for the bispecific antibodies market. The WHO/IARC projects a rise to over new cancer cases by 2050, which is about a increase compared to 2022. As per DelveInsight's analysis, the total incident cases of NSCLC in the 7MM were approximately in 2024; these cases are estimated to increase by 2034.
BLINCYTO has been around for almost a decade. This therapy is the current market leader in the ALL sector, and Amgen is expanding its use to earlier stages of illness, as it was first licensed for relapsed/refractory ALL. It is also FDA authorized for MRD-positive patients. Amgen is now attempting to enter niche markets with BLINCYTO.
Amid rising industry interest in PD-(L)1 × VEGF bispecifics, Pfizer made a landmark move by acquiring for upfront, with potential milestones reaching , marking the largest deal in this emerging field. This follows acquisition of , including , and upfront payment for , underscoring the growing momentum behind dual-targeted therapies.
The bispecific antibodies in oncology clinical trials include several promising therapies such as (I-MAB Biopharma and BMS), (AstraZeneca), (BioNTech and Bristol Myers Squibb), (Genmab), (AstraZeneca), (Compass Therapeutics), (Innovent), (Regeneron Pharmaceuticals), (Aurigene Oncology and Curis), and others.
PD-1 × VEGF, PD-1 × CTLA-4, PD-L1 × 4-1BB, TIGIT × PDL1, and others are the prominent targets of bispecific antibodies in NSCLC, whereas targets such as DLL4 × VEGF-A, PD-L1 × VEGF-A, PD-1/IL-2α, Claudin 18.2 (CLDN18.2)/4-1BB, BCMA × CD3, and others are in other cancers.
Leading companies such as (CrossMAb Technology), (Multiclonics Therapeutics), (Multispecific and T-cell engager platform), (Knobs-in-holes Bispecific Antibody), (BiTE Antibody), (Azymetric), (XmAb Bispecific Fc Domain Platform), (Duobody Platform), and others are developing technologies for bispecific antibodies.
Bispecific antibodies have gained significant attention over the past decade. Although bispecific immunomodulatory antibodies have shown promising clinical activity in certain tumor types, achieving robust anti-tumor efficacy in most solid tumors remains a challenge. Numerous bispecific antibodies targeting different combinations of antigens have demonstrated strong preclinical anti-tumor effects, yet many of these positive findings have not translated successfully into clinical outcomes. As an increasing number of bispecific antibodies advance through preclinical and clinical development, a variety of challenges have emerged that complicate their progression.
(Glofitamab, Roche Group), (epcoritamab, Genmab/AbbVie), (talquetamab, Johnson & Johnson), (linvoseltamab, Regeneron Pharmaceuticals), (tarlatamab, Amgen), (odronextamab, Regeneron), (zanidatamab, Jazz Pharmaceuticals), (zenocutuzumab, Merus), and others are the approved Bispecific Antibodies in Oncology.
T cell-engaging bispecific antibodies have proven effective in treating hematological malignancies, but similar approaches have been less successful in solid tumors. Factors contributing to this reduced efficacy include limited availability of tumor-specific targets, the immunosuppressive tumor microenvironment, and physical barriers that hinder antibody penetration. Bispecific antibodies can simultaneously engage immune checkpoints such as , enabling dual modulation of key cancer pathways while enhancing specificity and reducing off-target toxicity in cancer immunotherapy.
The growing interest in PD-(L)1 x VEGF bispecifics is driving notable industry activity. Pfizer's acquisition of 3SBio's SSGJ-707 for USD 1.25 billion upfront, with up to in milestones, represents the largest deal in this emerging space. This follows acquisition of Biotheus, including BNT327, and upfront payment for , underscoring the increasing momentum and commercial potential of dual-targeted bispecific therapies.
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Some of the potential bispecific antibodies in clinical trials include (I-MAB Biopharma and BMS), (AstraZeneca), (BioNTech and Bristol Myers Squibb), (Genmab), (AstraZeneca), (Compass Therapeutics), (Innovent), (Regeneron Pharmaceuticals), (Aurigene Oncology and Curis), and others.
is a monovalent, humanized IgG1 monoclonal antibody that acts as a PD-1/CTLA-4 bispecific inhibitor. It is engineered to block PD-1 while enhancing CTLA-4 inhibition specifically on PD-1+ activated T cells, compared to resting PD-1– peripheral T cells. This selective mechanism may allow stronger CTLA-4 inhibition at tolerable doses beyond what current PD-1/CTLA-4 combinations achieve. Volrustomig is being evaluated in multiple Phase III trials across various cancers, including eVOLVE-cervical (locally advanced cervical cancer), eVOLVE-HNSCC (unresected locally advanced head and neck squamous cell carcinoma), eVOLVE-Lung02 (first-line metastatic NSCLC), and eVOLVE-Meso (first-line unresectable malignant pleural mesothelioma). According to the Q1 2025 presentation, Phase IIb eVOLVE-01 (NCT06448754) results in NSCLC are expected in H2 2025.
is a bispecific antibody that targets Claudin 18.2 (CLDN18.2) on tumor cells and 4-1BB to activate T cells within the tumor microenvironment conditionally. It binds tumor cells with varying CLDN18.2 expression, including gastric and pancreatic cancers, and selectively stimulates intra-tumoral T cells through 4-1BB. The US FDA has granted Orphan Drug Designation to givastomig for gastric cancer, including gastroesophageal junction tumors. In June 2025 , I-Mab published first-in-human monotherapy data for givastomig in . Earlier, in March 2025 , I-Mab reported that enrollment in the Phase Ib combination study's first dose expansion cohort finished ahead of schedule, with continued progress in the second cohort. In January 2025 , I-Mab outlined its 2025 strategic focus on advancing givastomig for first-line metastatic gastric cancer, while exploring its potential in other solid tumors.
is an investigational bispecific antibody combining two validated oncology mechanisms in one molecule. It simultaneously inhibits PD-L1, restoring T-cell recognition and killing of tumor cells, and neutralizes VEGF-A. Several global trials are ongoing or planned for 2025, including three with registrational potential in first-line small cell lung cancer (SCLC), first-line NSCLC, and first-line triple-negative breast cancer (TNBC).
The anticipated launch of these emerging therapies is poised to transform the bispecific antibodies in oncology market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the bispecific antibodies in oncology market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
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Bispecific antibodies in oncology are engineered to include two or more distinct antigen-binding domains, enabling them to bind selectively to multiple targets. By leveraging the flexibility of these multi-specific molecules, immunotherapy strategies can simultaneously engage different pathways or cells. This innovative class of biologics offers dual-targeting capabilities, enhancing therapeutic efficacy and demonstrating significant promise in treating cancer, autoimmune disorders, and various rare diseases.
The bispecific antibodies in oncology report provides the total potential number of patients in the indications, such as 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 Cancer/Esophageal Cancer, Pancreatic Cancer, Colorectal Cancer, and others. In the US, the population eligible for treatment with bispecific antibodies in oncology was estimated to be approximately cases. While NSCLC represents roughly of all lung cancer diagnoses, indicating it is the most common type of lung cancer.
The bispecific antibodies in oncology market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020–2040 across the leading markets. The bispecific antibodies in oncology target patient pool is segmented into:
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report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key bispecifics companies, including among others.
report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key bispecifics/BiTE companies, including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including among others.
report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including among others.
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