The bispecifics market is anticipated to experience substantial growth in the coming years. This growth is driven by the rising incidence of chronic diseases, technological advancements, increasing regulatory approvals, strategic collaborations, and high market demand. Additionally, the expected launch of emerging therapies such as CA-170 (Aurigene Oncology and Curis), AUR107 and AUR109 (Aurigene Oncology), Givastomig (NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, and Bristol Myers Squibb), Linvoseltamab (Regeneron Pharmaceuticals), and others will further propel the market growth.
LAS VEGAS, Sept. 14, 2026 /PRNewswire/ -- DelveInsight's Bispecifics 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), Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging bispecifics, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the Bispecifics Market Report
- The total bispecific treatment market size is expected to grow positively by 2036 in the leading markets.
- The United States accounted for the largest bispecifics market size of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- 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), Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), and others.
- The total incident cases of multiple myeloma in the 7MM comprised approximately 70,000 cases in 2025 and are projected to increase during the forecast period.
- Leading bispecific companies, such as Aurigene Oncology, Curis, NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, Bristol Myers Squibb, Regeneron Pharmaceuticals, Zenas BioPharma, AstraZeneca, AkesoBio, Summit Therapeutics, BioNTech, Roche, IMBiologics, Y Biologics, inno.N, Astellas, Immunocore, Janux Therapeutics, Compass Therapeutics, and others, are developing novel Bispecifics that can be available in the bispecifics market in the coming years.
- Some of the key bispecifics in clinical trials include CA-170, AUR107, AUR109, Givastomig, Linvoseltamab, Obexelimab, Volrustomig, Ivonescimab, BNT327, Cevostamab, Gefurulimab, IMB-101, ASP2138, Brenetafusp (IMC-F106C), JANX007, JANX014, Tovecimig, and others.
Discover a clear picture of what diseases do bispecific antibodies target @ https://www.delveinsight.com/report-store/bispecifics-market-forecast
Key Factors Driving the Bispecifics Market
- Rising Prevalence of Cancer and Chronic Diseases: The increasing burden of cancer and other chronic diseases is driving demand for advanced targeted therapies. Bispecifics offer the potential to address complex disease mechanisms and improve treatment outcomes.
- Advancements in Antibody Engineering Technologies: Innovations in antibody engineering, protein design, and manufacturing are enabling the development of more effective and stable bispecific molecules. These advances are helping overcome earlier challenges related to efficacy, safety, and production.
- Demand for Targeted and Personalized Therapies: The shift toward precision medicine is increasing interest in therapies capable of selectively targeting disease-driving pathways or specific immune cells. Bispecifics can simultaneously engage two biological targets, offering greater therapeutic specificity.
- Growing Pipeline of Bispecific Antibodies: Pharmaceutical and biotechnology companies are rapidly expanding bispecific antibody pipelines across oncology, hematology, autoimmune diseases, and other therapeutic areas. Increasing clinical-stage programs, including CA-170 (Aurigene Oncology and Curis), AUR107 and AUR109 (Aurigene Oncology), Givastomig (NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, and Bristol Myers Squibb), Linvoseltamab (Regeneron Pharmaceuticals), Obexelimab (Zenas BioPharma), Volrustomig (AstraZeneca), and others, are expected to support market growth.
Sadaf Javed, Functional Head of Forecasting & Analytics at DelveInsight, said that the versatility of bispecific drugs opens doors for exploring new therapeutic areas and expanding treatment options for various diseases.
Bispecifics Market Analysis
- REMOVAB was the world's first approved bispecific antibody, developed for the treatment of malignant ascites associated with solid tumors. It received approval from the European Medicines Agency (EMA) but was subsequently withdrawn from the market in 2017 due to commercial considerations.
- The three major bispecific antibody fragment formats include bispecific T-cell engagers (BiTEs), dual-affinity re-targeting proteins (DARTs), and tandem diabodies (TandAbs).
- Based on current pipeline activity, multiple myeloma represents the leading therapeutic area for bispecific antibody development, followed by non-small-cell lung cancer (NSCLC).
- Johnson & Johnson Innovative Medicine is among the leading players in the bispecific antibody landscape, with three approved products, RYBREVANT, TECVAYLI, and TALVEY. Other prominent companies include AbbVie/Genmab, Roche/Biogen, Pfizer, Amgen, and Akeso Biopharma.
- Several emerging players have advanced bispecific antibody candidates into late-stage development, including AstraZeneca in generalized myasthenia gravis, Zenas BioPharma in IgG4-related disease, relapsing multiple sclerosis (RMS), and systemic lupus erythematosus (SLE), Merus in pancreatic cancer and head and neck squamous cell carcinoma (HNSCC), Regeneron in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, Sichuan Baili Pharmaceutical in NSCLC, and Alphamab in pancreatic cancer. AstraZeneca is also advancing bispecific candidates in biliary tract cancer (BTC), NSCLC, and HNSCC, alongside other emerging developers.
- Odronextamab has demonstrated robust efficacy as a monotherapy with a manageable safety profile, supporting its potential as an off-the-shelf treatment option for patients whose disease progresses following CAR-T therapy.
- IMDELLTRA is expected to experience broader adoption across the U.S., supported by the substantial incidence of small cell lung cancer.
- As the use of IMDELLTRA and other bispecific antibodies expands, oncologists and healthcare providers will increasingly require specialized tools, expertise, and administration techniques to ensure these therapies are delivered safely and effectively.
Learn more about the FDA-approved bispecific antibodies complete list @ FDA Approved Bispecifics
Bispecifics Competitive Landscape
Some of the bispecifics under development include CA-170 (Aurigene Oncology and Curis), AUR107 and AUR109 (Aurigene Oncology), Givastomig (NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, and Bristol Myers Squibb), Linvoseltamab (Regeneron Pharmaceuticals), Obexelimab (Zenas BioPharma), Volrustomig (AstraZeneca), Ivonescimab (AkesoBio/Summit Therapeutics), BNT327 (BioNTech), Cevostamab (Roche), Gefurulimab (AstraZeneca), IMB-101 (IMBiologics/Y Biologics/inno.N), ASP2138 (Astellas), Brenetafusp (IMC-F106C; Immunocore), JANX007 and JANX014 (Janux Therapeutics), Tovecimig (Compass Therapeutics), and others.
Zenas BioPharma's Obexelimab is a bifunctional monoclonal antibody engineered to simultaneously target CD19 and Fc?RIIb, which are widely expressed across the B-cell lineage. By targeting these receptors, obexelimab is designed to suppress the activity of disease-associated B cells implicated in various autoimmune disorders without causing B-cell depletion. Zenas is currently conducting a fully enrolled Phase III trial in Immunoglobulin G4-Related Disease (IgG4-RD), along with Phase II trials evaluating obexelimab in Relapsing Multiple Sclerosis (RMS) and systemic lupus erythematosus (SLE).
In November 2025, Zenas BioPharma indicated that topline results from its pivotal Phase II SLE trial were expected in mid-2026. In October 2025, Zenas BioPharma reported positive results from the Phase II MoonStone trial evaluating obexelimab in patients with RMS.
NovaBridge Biosciences' Givastomig, also known as TJ-CD4B, ABL111, or TJ033721, is a bispecific antibody designed to target Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-cell activator. The US FDA has granted givastomig Orphan Drug Designation for the treatment of gastric cancer.
On February 17, 2026, NovaBridge Biosciences announced that the first patient had been enrolled in a global Phase II study evaluating givastomig in combination with nivolumab and mFOLFOX6 as a first-line treatment for HER2-negative metastatic gastric cancer. Topline results from the study are expected in 2027.
In October 2025, NovaBridge Biosciences announced that updated data from the Phase I study (NCT04900818), which evaluated givastomig monotherapy in heavily pretreated patients with gastroesophageal carcinoma, had been presented at the 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference.
AstraZeneca's Volrustomig (MEDI5752) is a monovalent PD-1/CTLA-4 bispecific humanized IgG1 monoclonal antibody designed to inhibit PD-1 while providing enhanced CTLA-4 blockade on activated PD-1-positive T cells compared with PD-1-resting peripheral T cells. This mechanism is intended to enable greater CTLA-4 inhibition at tolerable doses than may be achievable with conventional PD-1/CTLA-4 combination therapies. Volrustomig represents one of the early molecules developed using this approach.
The anticipated launch of these emerging therapies are poised to transform the bispecifics 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 market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about leading bispecific antibody companies, visit @ Bispecifics Antibody Applications
Recent Developments in the Bispecifics Market
- In August 2026, AstraZeneca has discontinued a Phase 3 trial of volrustomig in lung cancer following interim efficacy results, limiting the potential of the bispecific antibody as an alternative to existing immune checkpoint inhibitors.
- In July 2026, Johnson & Johnson announced another positive Phase III result in relapsed or refractory multiple myeloma, reporting that its dual bispecific regimen combining Tecvayli (teclistamab) and Talvey (talquetamab) significantly improved both progression-free survival (PFS) and overall survival (OS) among patients who had received one to four prior lines of therapy.
- In July 2026, AbbVie and Genmab announced that the European Commission (EC) has granted marketing authorization for epcoritamab, marketed as Tepkinly, in combination with lenalidomide and rituximab (R2) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.
- In June 2026, Talawar Therapeutics and JATT II announced a definitive merger agreement to create a public biotech focused on next-generation bispecifics for I&I diseases.
- In June 2026, Memento Medicines raised $93 million in Series A funding, which the Boston-based biotech plans to use to advance a newly licensed asset targeting retinal disorders.
- In June 2026, CytomX Therapeutics, Inc. announced an expanded collaboration and licensing agreement with Regeneron Pharmaceuticals, Inc. to develop conditionally activated bispecific cancer therapies by combining CytomX's Probody therapeutic platform with Regeneron's Veloci-Bi bispecific antibody development platform.
Bispecifics Epidemiology Segmentation
The bispecifics market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2022-2036 across the leading markets. In biomarker-specific cases, the highest number of cases is from PD-L1, followed by KRAS and EGFR. On the other hand, NTRK accounted for the fewest cases, whereas BRAF and ROS 1 accounted for approximately 5% and 2% of cases, respectively.
The bispecifics target patient pool is segmented into:
- Total Cases of Selected Indications for Bispecifics
- Total Eligible Patient Pool for Bispecifics in Selected Indications
- Total Treated Cases in Selected Indications for Bispecifics
Bispecifics Report Metrics | Details |
Study Period | 2022-2036 |
Bispecifics 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), Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), and others |
Bispecifics Target Patient Pool Analysis | Total Cases of Selected Indications for Bispecifics, Total Eligible Patient Pool for Bispecifics in Selected Indications, and Total Treated Cases in Selected Indications for Bispecifics |
Key Bispecific Companies | Aurigene Oncology, Curis, NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, Bristol Myers Squibb, Regeneron Pharmaceuticals, Zenas BioPharma, AstraZeneca, AkesoBio, Summit Therapeutics, BioNTech, Roche, IMBiologics, Y Biologics, inno.N, Astellas, Immunocore, Janux Therapeutics, Compass Therapeutics, and others |
Key Bispecifics | CA-170, AUR107, AUR109, Givastomig, Linvoseltamab, Obexelimab, Volrustomig, Ivonescimab, BNT327, Cevostamab, Gefurulimab, IMB-101, ASP2138, Brenetafusp (IMC-F106C), JANX007, JANX014, Tovecimig, and others |
Scope of the Bispecifics Market Report
- Bispecifics Patient Population Forecast
- Bispecifics Therapeutics Market Size
- Bispecifics Pipeline Analysis
- Bispecifics Market Size and Trends
- Bispecifics Market Opportunity
- Bispecifics Market Unmet Needs
- KOL's Views on Bispecifics
- Bispecifics Market Access and Reimbursement
Discover bispecifics latest developments 2026 @ Bispecifics Antibodies Clinical Trials
Table of Contents
1 | Bispecifics Market Key Insights |
2 | Bispecifics Market Report Introduction |
3 | Key Highlights |
4 | Executive Summary of Bispecifics |
5 | Key Events |
6 | Epidemiology and Market Forecast Methodology |
7 | Bispecifics Market Overview at a Glance in the 7MM |
7.1 | Clinical Landscape Analysis (By Phase, RoA, and Molecule Type) |
7.2 | Market Share (%) Distribution of Bispecifics by Therapy in 2025 |
7.3 | Market Share (%) Distribution of Bispecifics by Therapies in 2036 |
8 | Background and Overview |
8.1 | Introduction |
9 | Treatment |
10 | Target Patient Pool |
10.1 | Key Findings |
10.2 | Assumptions and Rationale: 7MM |
10.3 | Epidemiology Scenario in the 7MM |
10.3.1 | Total Cases of Selected Indication for Bispecifics in the 7MM |
10.3.2 | Total Eligible Patient Pool for Bispecifics in Selected Indication in the 7MM |
10.3.3 | Total Treated Cases in Selected Indication for Bispecifics in the 7MM |
11 | Marketed Therapies |
11.1 | Key Competitors |
11.2 | ZIIHERA (zanidatamab): Zymeworks |
11.2.1 | Product Description |
11.2.2 | Regulatory Milestone |
11.2.3 | Other Developmental Activities |
11.2.4 | Summary of Pivotal Clinical Trial |
11.2.5 | Clinical Development |
11.2.5.1 | Clinical Trial Information |
11.2.6 | Safety and Efficacy of Ongoing Trial |
11.2.7 | Analyst Views |
List to be continued in the full report… | |
12 | Emerging Therapies |
12.1 | Key Competitors |
12.2 | Volrustomig: AstraZeneca |
12.2.1 | Product description |
12.2.2 | Other developmental activities |
12.2.3 | Clinical development |
11.2.3.1 | Clinical Trial Information |
12.2.4 | Safety and efficacy |
12.2.5 | Analyst Views |
12.3 | Obexelimab: Zenas BioPharma |
12.4 | Givastomig: I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb |
List to be continued in the full report… | |
13 | Bispecifics Market: 7MM analysis |
13.1 | Key Findings |
13.2 | Bispecifics Market Outlook |
13.3 | Conjoint Analysis |
13.4 | Key Bispecifics Market Forecast Assumptions |
13.5 | Total Market Size of Bispecifics in the 7MM |
13.6 | The United States Bispecifics Market Size |
13.6.1 | Market Size of Bispecifics in Selected Indications in the US |
13.6.2 | Market Size of Bispecifics by Therapies in the US |
13.7 | EU4 and the UK Bispecifics Market Size |
13.8 | Japan Bispecifics Market Size |
14 | Unmet Needs |
15 | SWOT Analysis |
16 | KOL Views |
17 | Market Access and Reimbursement |
17.1 | United States |
17.2 | EU4 and the UK |
17.3 | Japan |
17.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
17.5 | Bispecifics Market Access and Reimbursement |
18 | Bibliography |
19 | Bispecifics Market Report Methodology |
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