Bispecifics/BiTE Market Anticipates Impressive Growth Trajectory During the Forecast Period (2025-2034) Across 7MM Due to Their Expansion Beyond Oncology

Malaysian Reserve

08-07-2025

The bispecific antibody and BiTE market is witnessing robust growth driven by advances in immuno-oncology and rising demand for targeted cancer therapies. Key factors include increasing clinical success, regulatory approvals, and the ability of these therapies to engage immune cells directly against tumors. Partnerships and investments from major pharmaceutical players are accelerating pipeline development. The bispecific antibody and BiTE market is also expanding beyond oncology into autoimmune and infectious diseases.
LAS VEGAS, July 8, 2025 /PRNewswire/ — DelveInsight's Bispecifics/BiTE Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging bispecifics/BiTE, market share of individual therapies, and current and forecasted bispecifics/BiTE market size from 2020 to 2034, segmented into 7MM.
Key Takeaways from the Bispecifics/BiTE Market Report
As per DelveInsight's analysis, the total market size of bispecifics/BiTE in the 7MM is expected to surge significantly by 2034.
The report provides the total potential number of patients in the indications, such as Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others.
Leading bispecifics/BiTE companies, such as Aurigene Oncology, Curis, Zenas BioPharma, I-MAB Biopharma, ABL Bio, Bristol Myers Squibb, IMBiologics, Y-Biologics, HK Innoen, Sanofi, Regeneron Pharmaceuticals, and others, are developing novel bispecifics/BiTE that can be available in the bispecifics/BiTE market in the coming years.
Some of the key bispecifics/BiTE therapies in the pipeline include CA-170, Obexelimab, Givastomig, IMB-101, SAR446422, Linvoseltamab, and others.
Based on pipeline activities, most of the bispecific antibodies are developed in multiple myeloma, followed by NSCLC.
In June 2025, BioNTech and Bristol Myers Squibb agreed on the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.
According to Zenas BioPharma's Q1 2025 report published in May 2025, the company anticipates reporting topline Phase III results for Obexelimab in IgG4-related disease by the end of 2025, 12-week primary endpoint data in RMS in the third quarter of 2025, and 24-week primary endpoint data in SLE in the first half of 2026.
In February 2025, Regeneron Pharmaceuticals announced that the US FDA the resubmission of the Biologics License Application (BLA) for linvoseltamab accepted for review for the treatment of adult patients with Relapsed/Refractory multiple myeloma who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. The target action date for the FDA decision is July 10, 2025.
According to I-MAB Biopharma's Q1 2025 report published in May 2025, the company anticipates presenting data from the givastomig dose expansion cohorts (n = 40) in the first half of 2026, with further development initiatives and data readouts from the Phase Ib study expected through 2027. Additionally, new data from the givastomig dose escalation combination study in US patients will be presented at the European Society of Medical Oncology Gastrointestinal (ESMO GI) Cancers Congress 2025, scheduled for July 2–5 in Barcelona, Spain.
In May 2025, Genentech announced two-year follow-up data from the Phase III STARGLO study. The updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with R/ DLBCL who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT).
Discover which indication is expected to grab the major bispecifics/BiTE market share @ Bispecifics/BiTE Market Report
Bispecifics/BiTE Market Dynamics
The bispecific antibody and BiTE market is experiencing strong momentum, driven by rapid advancements in immuno-oncology and increasing demand for precision biologics. These modalities are designed to simultaneously bind two different antigens or epitopes, commonly one on a tumor cell and the other on an immune effector cell, such as a T-cell, thereby redirecting immune activity toward malignant cells. Their ability to provide targeted immune activation while minimizing systemic toxicity positions them as highly attractive therapeutic options, particularly for difficult-to-treat cancers and hematological malignancies.
Market growth is being fueled by a combination of technological innovation and clinical validation. Companies are investing heavily in next-generation bispecific platforms that offer improved stability, manufacturability, and half-life extension. Major pharmaceutical players, as well as emerging biotech firms, are advancing robust pipelines of bispecifics and BiTEs, with several candidates achieving regulatory approvals in recent years. The entry of these agents has set a precedent, increasing investor confidence and accelerating deal-making activity, including strategic collaborations and licensing agreements.
Despite the enthusiasm, the bispecifics/BiTE market faces key challenges. Manufacturing complexities, immunogenicity risks, and potential for cytokine release syndrome remain technical and clinical hurdles. Additionally, the crowded competitive landscape necessitates differentiation, either through novel targets (e.g., B7-H3, DLL3, CLDN6) or superior clinical outcomes. Pricing pressures and reimbursement considerations also loom large, particularly as more therapies enter the market and stakeholders demand cost-effective value delivery.
In summary, the bispecific and BiTE market represents one of the most dynamic frontiers in biologics. With many candidates in preclinical and clinical development globally, the next decade is likely to see continued maturation of the field, consolidation among players, and deeper integration of bispecifics into standard-of-care treatment paradigms. Strategic investments, patient-centric development, and continuous innovation will be critical to sustaining long-term growth.
Bispecifics/BiTE Treatment Market
Bispecific antibodies are designed to address complex, multifactorial diseases by simultaneously targeting two distinct disease-related molecules with a single therapeutic agent. Most approved bispecifics are used in oncology, particularly for conditions like multiple myeloma and diffuse large B-cell lymphoma (DLBCL). Outside of oncology, only two, HEMLIBRA and VABYSMO, have been approved for treating hemophilia A, neovascular (wet) age-related macular degeneration, and diabetic macular edema.
Additionally, KIMMTRAK, a bispecific molecule, has received approval specifically for uveal melanoma. REMOVAB, the world's first approved bispecific antibody, was developed to treat malignant ascites associated with solid tumors and received approval from the EMA. However, it was withdrawn from the market in 2017 due to commercial considerations.
ZIIHERA is a bispecific antibody that targets HER2 by binding to two distinct extracellular domains on the receptor. In November 2024, the U.S. FDA granted accelerated approval for ZIIHERA (50 mg/mL for IV injection) for use in adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).
Zanidatamab, the molecule behind ZIIHERA, is also under evaluation in various clinical trials as a targeted therapy for solid tumors. These include Phase III studies for gastroesophageal adenocarcinoma (GEA) and metastatic breast cancer (mBC), as well as Phase II trials for colorectal and breast cancers. The drug was originally developed by Zymeworks and is now being advanced by Jazz Pharmaceuticals and BeiGene through licensing agreements. Jazz holds commercialization rights for the U.S., Europe, Japan, and all regions except Asia-Pacific territories already licensed by Zymeworks to BeiGene (excluding Japan, but including the rest of Asia, Australia, and New Zealand).
In April 2025, Jazz announced its participation at the ASCO annual meeting, where three abstracts related to zanidatamab were accepted for presentation. Furthermore, the European Medicines Agency's CHMP issued a positive opinion recommending conditional marketing authorization of zanidatamab monotherapy for adults with previously treated, unresectable, locally advanced or metastatic HER2-positive (IHC 3+) BTC.
COLUMVI is a bispecific antibody designed to engage CD20 and CD3, featuring a unique 2:1 structural configuration. It brings T cells into proximity with malignant B cells, making it effective in targeting cancers such as diffuse large B-cell lymphoma (DLBCL). In June 2023, the FDA granted accelerated approval to COLUMVI for use in patients with relapsed or refractory DLBCL (not otherwise specified) or large B-cell lymphoma (LBCL) that has transformed from follicular lymphoma, following at least two prior systemic treatments.
Learn more about the FDA-approved bispecifics/BiTE therapies @ Bispecifics/BiTE Drugs
Key Emerging Bispecifics/BiTE and Companies
Several key players, including Aurigene Oncology/Curis (CA-170), I-MAB Biopharma/ABL Bio/Bristol Myers Squibb (Givastomig), IMBiologics/Y-Biologics/HK Innoen (IMB-101), Regeneron Pharmaceuticals (Linvoseltamab), Sanofi (SAR446422), Zenas BioPharma (Obexelimab), and others, are involved in developing drugs for Bispecifics/BiTE for various indications such as NSCLC, Bladder and Kidney Cancers, IgG4-RD, RMS, SLE, multiple sclerosis, and others.
CA-170 is an orally administered, first-in-class small molecule with strong activity. It selectively inhibits PD-L1 and VISTA, both of which are immune checkpoint proteins that suppress immune responses. The compound is currently undergoing Phase III clinical trials for non-small cell lung cancer (NSCLC) as well as bladder and kidney cancers.
In February 2020, Curis revised its collaboration and licensing agreement with Aurigene Discovery Technologies. The updated terms granted Aurigene development and commercialization rights for CA-170 across Asia, expanding on its original rights in India and Russia. Curis retained exclusive rights to the drug in the United States, Europe, and other global markets and is eligible to receive royalties from sales in Asia. The original partnership between Curis and Aurigene began in 2015.
Givastomig (also referred to as TJ-CD4B/ABL111 or TJ033721) is a bispecific antibody engineered to target Claudin 18.2 (CLDN18.2) on tumor cells and activate T-cells through 4-1BB in a tumor-restricted manner. It is designed to engage tumor cells expressing varying levels of CLDN18.2, commonly found in gastric and pancreatic cancers, and locally stimulate T-cell activity within the tumor microenvironment.
In September 2024, I-Mab Biopharma shared results from a Phase I trial of givastomig in patients with CLDN18.2-positive advanced gastroesophageal cancer. The therapy was well tolerated at doses up to 15 mg/kg administered biweekly and showed promising clinical activity in patients who had previously undergone multiple treatments. These patients exhibited a broad range of CLDN18.2 expression. Earlier, in March 2022, the FDA granted givastomig Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancers.
The anticipated launch of these emerging therapies are poised to transform the bispecifics/BiTE market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the bispecifics/BiTE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about bispecifics/BiTE clinical trials, visit @ Bispecifics/BiTE Treatment Drugs
Bispecifics/BiTE Overview
Bispecific antibodies, including Bispecific T-cell Engagers (BiTEs), represent an innovative class of immunotherapies designed to harness the immune system to target and destroy cancer cells more precisely. Unlike conventional monoclonal antibodies, bispecifics are engineered to recognize and bind to two different antigens simultaneously. One arm typically targets a tumor-associated antigen on cancer cells, while the other engages a molecule on immune cells, most commonly CD3 on T cells. This dual targeting brings T cells into close proximity with tumor cells, triggering T-cell activation and cytotoxicity, even without the need for antigen presentation or co-stimulation.
BiTEs are a specific subset of bispecifics characterized by their compact size and lack of an Fc region, enabling better tissue penetration and faster pharmacokinetics. The most well-known example is blinatumomab, approved for treating certain types of B-cell acute lymphoblastic leukemia. As research expands, next-generation BiTEs and bispecifics are being developed to improve half-life, reduce off-target effects, and address solid tumors, traditionally more challenging for immunotherapy. Their modular design also enables customization to different tumor types and immune targets, making them a versatile and rapidly advancing segment of oncology therapeutics.
Bispecifics/BiTE Epidemiology Segmentation
The bispecifics/BiTE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total Cases in Selected Indications for Bispecifics/BiTE
Total Eligible Patient Pool in Selected Indications for Bispecifics/BiTE
Total Treated Cases in Selected Indications for Bispecifics/BiTE
Bispecifics/BiTE Report Metrics
Details
Study Period
2020–2034
Bispecifics/BiTE Report Coverage
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key Indications Covered in the Report
Acute Lymphocytic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma, Multiple Myeloma, Non-small-cell Lung Cancer (NSCLC), Small-cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Psoriasis, Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus Erythematosus (SLE), Wet Age-related Macular Degeneration (AMD), and others
Key Bispecifics/BiTE Companies
Aurigene Oncology, Curis, Zenas BioPharma, I-MAB Biopharma, ABL Bio, Bristol Myers Squibb, IMBiologics, Y-Biologics, HK Innoen, Sanofi, Regeneron Pharmaceuticals, Zymeworks, Genentech, Genmab, Pfizer, Johnson & Johnson Innovative Medicine, AstraZeneca, and others
Key Bispecifics/BiTE Therapies
CA-170, Obexelimab, Givastomig, IMB-101, SAR446422, Linvoseltamab, ZIIHERA, COLUMVI, EPKINLY, LUNSUMIO, ELREXFIO, VABYSMO, TECVAYLI, SAPHNELO, OCREVUS, and others
Scope of the Bispecifics/BiTE Market Report
Bispecifics/BiTE Therapeutic Assessment: Bispecifics/BiTE current marketed and emerging therapies
Bispecifics/BiTE Market Dynamics: Conjoint Analysis of Emerging Bispecifics/BiTE Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, Bispecifics/BiTE Market Access and Reimbursement
Discover more about bispecifics/BiTE therapies in development @ Bispecifics/BiTE Clinical Trials
Table of Contents
1
Key Insights
2
Report Introduction
3
Key Highlights Of The Report
4
Executive Summary Of Bispecifics/BiTE
5
Key Events
6
Epidemiology And Market Forecast Methodology
7
Bispecific/BiTE Market Overview At A Glance
7.1
Market Share (%) Distribution of Bispecifics/BiTE by Therapies in 2024
7.2
Market Share (%) Distribution of Bispecifics/BiTE by Therapies in 2034
7.3
Market Share (%) Distribution of Bispecifics/BiTE by Indications in 2024
7.4
Market Share (%) Distribution of Bispecifics/BiTE by Indications in 2034
8
Background And Overview
8.1
Introduction
8.2
Treatment
8.3
FDA-Approved Bispecifics/BiTE Antibodies
9
Epidemiology And Patient Population
9.1
Key Findings
9.2
Assumptions And Rationale
9.3
Total Cases of Selected Indication for Bispecifics/BiTE in the 7MM
9.4
The eligible pool of Indications for Bispecific/BiTE Antibodies in the 7MM
9.5
Treatable Cases by Indication for Bispecific/BiTE Antibodies in the 7MM
10
Marketed Drugs
10.1
Key Competitors
10.2
ZIIHERA (zanidatamab): Zymeworks
10.2.1
Product Description
10.2.2
Regulatory Milestones
10.2.3
Other Developmental Activities
10.2.4
Clinical Development
10.2.4.1
Clinical Trial Information
10.2.5
Safety and Efficacy
10.2.6
Analyst Views
10.3
COLUMVI (glofitamab): Roche
10.3.1
Product Description
10.3.2
Regulatory Milestones
10.3.3
Other Developmental Activities
10.3.4
Clinical Development
10.3.4.1
Clinical Trial Information
10.3.5
Safety and Efficacy
10.3.6
Analyst Views
List to be continued…
11
Emerging Drugs
11.1
Key Competitors
11.2
CA-170: Aurigene Oncology and Curis
11.2.1
Product Description
11.2.2
Other Development Activities
11.2.3
Clinical Development
11.2.3.1
Clinical Trials Information
11.2.4
Safety and Efficacy
11.2.5
Analyst Views
11.3
Givastomig: I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb
11.3.1
Product Description
11.3.2
Other Development Activities
11.3.3
Clinical Development
11.3.3.1
Clinical Trials Information
11.3.4
Safety and Efficacy
11.3.5
Analyst Views
List to be continued…
12
Bispecifics/BiTE: The 7MM Analysis
12.1
Key Findings
12.2
Market Outlook
12.3
Conjoint Analysis
12.4
Key Market Forecast Assumptions
12.4.1
Cost Assumptions and Rebates
12.4.2
Pricing Trends
12.4.3
Analogue Assessment
12.4.4
Launch Years and Therapy Uptake
12.5
Total Market Size of Bispecifics/BiTE in the 7MM
12.6
United States Market
12.6.1
Market Size of Bispecifics/BiTE By Indications in the United States
12.6.2
Market Size By Therapies in the United States
12.7
EU4 and the UK Market
12.7.1
Market Size of Bispecifics/BiTE By Indications in EU4 and the UK
12.7.2
Market Size By Therapies in EU4 and the UK
12.8
Japan Market
12.8.1
Market Size of Bispecifics/BiTE By Indications in Japan
12.8.2
Market Size By Therapies in Japan
13
Unmet Needs Of Bispecifics/BiTE
14
SWOT Analysis Of Bispecifics/BiTE
15
KOL Views Of Bispecifics/BiTE
16
Market Access and Reimbursement
16.1
United States
16.1.1
Centre for Medicare & Medicaid Services (CMS)
16.2
EU4 and the UK
16.2.1
Germany
16.2.2
France
16.2.3
Italy
16.2.4
Spain
16.2.5
United Kingdom
16.3
Japan
16.3.1
MHLW
17
Appendix
17.1
Bibliography
17.2
Report Methodology
18
DelveInsight Capabilities
19
Disclaimer
20
About DelveInsight
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