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As a leading expert in life sciences market research, I'm excited to share insights from DelveInsight’s comprehensive report on the Bispecifics/BITE market. This innovative field focuses on bispecific antibodies and BiTEs (Bispecific T-cell Engagers), revolutionizing treatments for oncology, autoimmune disorders, and rare diseases by targeting multiple pathways simultaneously. In this LinkedIn article, I'll explore the market dynamics, competitive landscape, and forecast to 2034 across the 7MM (US, EU4, UK, Japan). Let's delve into the transformative potential!
Bispecifics/BITE Market Overview and Projections
The Bispecifics/BITE market size is estimated to grow with a significant CAGR during the study period (2020-2034). Bispecific antibodies (BsAbs) have emerged as a transformative class of biologics, offering dual-targeting mechanisms that enhance therapeutic efficacy across oncology, autoimmune disorders, and rare diseases. Bispecific antibodies aim to treat multifaceted, complex diseases by engaging two disease targets with one molecule. The majority approved for oncology indications (mainly multiple myeloma and Diffuse Large B-cell Lymphoma). Only two bispecific antibodies, HEMLIBRA and VABYSMO, are authorized for non-oncology indications such as hemophilia A, neovascular (wet) age-related macular degeneration, and diabetic macular edema, and a bispecific molecule named KIMMTRAK, approved for uveal melanoma.
DelveInsight’s “Bispecifics/BITE Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the Bispecific T-cell engager, historical and Competitive Landscape as well as the Bispecific T-cell engager therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Some facts of the Bispecifics/BITE Market Report are:
According to DelveInsight, Bispecifics/BITE market size is expected to grow at a significant CAGR by 2034.
According to DelveInsight’s analysis, the Bispecifics/BITE Market in the 7MM was valued at approximately USD XX million in 2023. Over the forecast period from 2025 to 2034, this Bispecifics/BITE Market is projected to reach USD XX billion.
Leading Bispecifics/BITE companies working in the market are Zymeworks, Genentech, Genmab, Pfizer, Johnson & Johnson Innovative Medicine, AstraZeneca, Aurigene Oncology and Curis, I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb, IMBiologics, Y-Biologics, and HK Innoen, Regeneron Pharmaceuticals, Sanofi, Zenas BioPharma, BioNTech, Bristol Myers Squibb, and others.
Key Bispecifics/BITE Therapies expected to launch in the market are ZIIHERA, COLUMVI, EPKINLY, LUNSUMIO, ELREXFIO, VABYSMO, TECVAYLI, SAPHNELO, OCREVUS, CA-170, Givastomig, IMB-101, Linvoseltamab, SAR446422, Obexelimab, BNT327, and Others.
The Bispecifics/BITE market is expected to surge due to the increasing prevalence of targeted indications and the launch of innovative therapies during the forecast period. Furthermore, multiple-stage Bispecifics/BITE pipeline products will significantly revolutionize the Bispecifics/BITE market dynamics.
In May 2024, the FDA granted accelerated approval to IMDELLTRA (tarlatamab-dlle) for the treatment of patients with SCLC that has progressed on or after platinum-based chemotherapy, making it the first BiTE approved for a major solid tumor and the first therapeutic option for the treatment of extensive-stage SCLC.
In June 2025, BioNTech and Bristol Myers Squibb entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.
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.
Bispecifics/BITE Overview
Bispecific antibodies (also known as T cell engagers) are a type of immunotherapy that help the immune system to recognise and kill cancer cells. There are several bispecific antibodies for myeloma at different stages of development. Bispecific antibodies are produced in a laboratory and they are specifically created to bind to proteins on two different types of cells – myeloma cells and a person’s own T cells. Three main bispecific antibody fragments include Bispecific T-cell engager (BiTE), Dual-affinity re-targeting proteins (DARTs), and Tandem diabodies (TandAbs). In May 2024, the FDA granted accelerated approval to IMDELLTRA (tarlatamab-dlle) for the treatment of patients with SCLC that has progressed on or after platinum-based chemotherapy, making it the first BiTE approved for a major solid tumor.
Do you know what will be the Bispecifics/BITE market share in 7MM by 2034 – Bispecifics/BITE Market Dynamics and Trends
Bispecifics/BITE Market
In 2023, the Bispecifics/BITE market across the 7MM was valued at USD XX billion, with the U.S. contributing significantly. The EU4 and the UK generated substantial shares, while Japan accounted for a smaller portion. Emerging therapies dominated the market, with BiTEs and bispecific antibodies leading. Key companies—including Johnson & Johnson Innovative Medicine, AbbVie/Genmab, Roche/Biogen, Pfizer, Amgen, and Akeso Biopharma—are driving innovation, supporting a projected high CAGR from 2025 to 2034.
Market growth is fueled by advancements in dual-targeting modalities aimed at complex diseases. Current approaches include approved BiTEs and bispecifics, while pipeline therapies such as CA-170 and Givastomig target immune activation and tumor engagement. Combination with other therapies remains vital for enhancing responses.
Despite progress, gaps persist due to limited approved therapies and challenges in patient stratification. Nonetheless, ongoing research indicates strong potential for Bispecifics/BITE treatments to transform oncology and autoimmune care.
Bispecifics/BITE Epidemiology
According to DelveInsight, the target population for Bispecifics/BITE includes patients with indications like multiple myeloma, DLBCL, NSCLC, and autoimmune disorders. Among EU4 and the UK, the multiple myeloma incident cases were maximum in Germany and France, with approximately 24% of the total cases in 2024. The treatment-eligible population targeted by bispecific antibodies in oncology in the US was estimated to be approximately 895,600 cases.
Bispecifics/BITE Epidemiology Segmentation:
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
Interested to know how the emerging diagnostic approaches will be contributing in increased Bispecifics/BITE target population pool? Download report – Bispecifics/BITE Patient Pool Forecast
Bispecifics/BITE Pipeline Development Activities and Drugs Uptake
ZIIHERA – Zymeworks, Jazz Pharmaceuticals, and BeiGene
ZIIHERA is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. In November 2024, the US FDA granted accelerated approval of ZIIHERA for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive Biliary Tract Cancer.
COLUMVI – Genentech
COLUMVI is a CD20 x CD3 T-cell engaging bispecific antibody designed with a novel 2:1 structural format. COLUMVI targets both T cells and B cells, which are cancerous in DLBCL. In June 2023, the US FDA granted accelerated approval to COLUMVI for relapsed or refractory DLBCL.
Bispecifics/BITE Competitive Landscape
The Bispecifics/BITE report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stages. It also analyses Bispecifics/BITE key players involved in developing targeted therapeutics.
Bispecifics/BITE Companies and Drugs
ZIIHERA: Zymeworks, Jazz Pharmaceuticals, and BeiGene
COLUMVI: Genentech
EPKINLY: Genmab/AbbVie
LUNSUMIO: Roche
ELREXFIO: Pfizer
VABYSMO: Roche
TECVAYLI: Johnson & Johnson Innovative Medicine
SAPHNELO: AstraZeneca
OCREVUS: Roche/Biogen
CA-170: Aurigene Oncology and Curis
Givastomig: I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb
IMB-101: IMBiologics, Y-Biologics, and HK Innoen
Linvoseltamab: Regeneron Pharmaceuticals
SAR446422: Sanofi
Obexelimab: Zenas BioPharma
BNT327: BioNTech
Download report to know which TOP 3 therapies will be capturing the largest Bispecifics/BITE market share by 2034? Click here – Bispecifics/BITE Treatment Market
Bispecifics/BITE Therapeutics Assessment
Major key companies are working proactively in the Bispecifics/BITE Therapeutics market to develop novel therapies which will drive the Bispecifics/BITE treatment markets in the upcoming years are Zymeworks, Genentech, Genmab, Pfizer, Johnson & Johnson Innovative Medicine, AstraZeneca, Aurigene Oncology and Curis, I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb, IMBiologics, Y-Biologics, and HK Innoen, Regeneron Pharmaceuticals, Sanofi, Zenas BioPharma, BioNTech, Bristol Myers Squibb, and others.
Do you know how ZIIHERA and COLUMVI market launch will be impacting the Bispecifics/BITE market CAGR? Download sample report - Bispecifics/BITE Clinical Trials and Drugs Market
Bispecifics/BITE Report Key Insights
Bispecifics/BITE Target Population
Bispecifics/BITE Market Size and Trends
Key Cross Competition in the Bispecifics/BITE Market
Bispecifics/BITE Market Dynamics (Key Drivers and Barriers)
Bispecifics/BITE Market Opportunities
Bispecifics/BITE Therapeutic Approaches
Bispecifics/BITE Pipeline Analysis
Bispecifics/BITE Current Treatment Practices/Algorithm
Impact of Emerging Therapies on the Bispecifics/BITE Market
Bispecifics/BITE Clinical Trials
The report delves into ongoing and upcoming clinical trials for Bispecifics/BITE, highlighting trial designs, patient recruitment, endpoints, and key results from studies evaluating therapies like CA-170 and Givastomig.
Bispecifics/BITE Companies
Leading entities include Zymeworks, Genentech, Genmab, Pfizer, Johnson & Johnson Innovative Medicine, AstraZeneca, Aurigene Oncology and Curis, I-MAB Biopharma, ABL Bio, and Bristol Myers Squibb, IMBiologics, Y-Biologics, and HK Innoen, Regeneron Pharmaceuticals, Sanofi, Zenas BioPharma, BioNTech, Bristol Myers Squibb, and others, each advancing targeted treatments for oncology and autoimmune indications.
Bispecifics/BITE Drugs
Key therapies encompass ZIIHERA, COLUMVI, EPKINLY, LUNSUMIO, ELREXFIO, VABYSMO, TECVAYLI, SAPHNELO, OCREVUS, CA-170, Givastomig, IMB-101, Linvoseltamab, SAR446422, Obexelimab, BNT327, and Others, focusing on dual-targeting and immune engagement.
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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