Bispecific antibodies (BsAbs) are antibodies with two binding sites, directed against two different antigens or two different epitopes on the same antigen. Bispecific antibodies act through four main mechanisms of action and those are, the recruiting and activating of immune cells to exert their killing effect by targeting CD3 and CD19, blocking of dual signaling pathways by targeting growth factors, blocking of immune checkpoints such as PD-1, PD-L1, and CTLA-4, and forcing association of protein complexes such as by bridging factor FIXa and FX to facilitate effective haemostasis. Bispecific antibodies are used in tumor immunotherapy, other diseases such as haemophilia A, diabetes, Alzheimer’s disease and ophthalmological diseases. Amgen, Roche, J&J, Genentech, Akeso, Inc., Taisho Pharmaceutical, and Genmab are some of the major players in the bispecific antibodies market.
Approved Drug Molecules and Brand Names for Bispecific Antibodies Market:
- Blinatumomab (Blincyto)
- Emicizumab (Hemlibra)
- Amivantamab-vmjw (Rybrevant)
- Tebentafusp-tebn (Kimmtrak)
- Faricimab-svoa (Vabysmo)
- Cadonilimab
- Mosunetuzumab (Lunsumio)
- Teclistamab (Tecvayli)
- Ozoralizumab (Nanozora)
- Glofitamab (COLUMVI)
- Epcoritamab (EPKINLY)
Drugs under the Pipeline for Bispecific Antibodies Market:
- Elranatamab
- Erfonrilimab
- Tebotelimab
- Ivonescimab
- Navicixizumab
- SI-B001
- Zanidatamab
- Catumaxomab
- Bintrafusp alfa
- SHR-1701
- Odronextamab
- Talquetamab
- Flotetuzumab
- AFM13
- KN026
- Tralatamab
- REGN5458
- Zenocutuzumab
- TNB-383B
Clinical Activity and Developments of Bispecific Antibodies:
- Currently, there are 30 drug products in the bispecific antibodies, including 11 approved drug products and the rest of them are in the clinical development phases.
- In Feb 2023, MacroGenerics completed a phase-I trial for solid tumors and hematological malignancies in the USA, Australia, Bulgaria, Hong Kong, Poland, Spain, Thailand, and Ukraine
- In Jul 2023, Genentech planned a phase-I trial in multiple myeloma for Elranatamab as a second-line combination therapy.
Key Market Developments:
- In Mar 2023, Health Canada authorized Roche’s Columnvi (Glofitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
- In May 2023, the US FDA granted accelerated approval to Genmab’s Epkinly (Epcoritamab) for relapsed or refractory diffuse large B-cell lymphoma.
Target Indication Analysis of Bispecific Antibodies
Bispecific antibodies such as Glofitamab and Epcoritamab are indicated for the treatment of diffuse large B-cell lymphoma. Blinatumomab for relapsed or refractory precursor B-cell acute lymphoblastic leukemia, Emicizumab for bleeding due haemophllia A, Amivantamab for non-small cell lung cancer. Other bispecific antibodies are in the investigational development phases for pancreatic cancer, malignant thymoma, gastric cancer, liver cancer, and others.
Regional Analysis of Bispecific Antibodies
Bispecific Antibodies Market
Amgen, Blincyto, had a total sale of USD 336 million in the USA and USD 247 million in the rest of the world in 2022 and will witness all of its patents expiring by 2030. Roche, Hemlibra gained USD 4,445 million in product sales in 2022, a 27% increase from 2021. According to the World Health Organization, China had the highest new cases of leukemia (85,404), followed by the USA (61,252), and India (48,419) in 2020. According to the World Federation of Hemophilia report on the Annual Global Survey 2021, a total of 3,86,966 patients with hemophilia were identified, including 1,85,318 people with hemophilia A and the highest incidence rates were in Europe, followed by America and Africa. According to the Global Burden Disease Study 2017, acute lymphoblastic leukemia cases have increased by 30.81% from 1990 to 2017, with the highest incidence rate in Asia-Pacific and South American countries. The growing number of disease cases and their application in various disease areas will contribute to the growth of the bispecific antibodies market over the forecast period.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Blinatumomab (Blincyto), Emicizumab (Hemlibra), Amivantamab-vmjw (Rybrevant), Tebentafusp-tebn (Kimmtrak), and Faricimab-svoa (Vabysmo) are some of the approved bispecific antibodies.
Amgen, Roche, J&J, Genentech, Akeso, Inc., Taisho Pharmaceutical, and Genmab are some of the major players in the bispecific antibodies market.
Major indications for bispecific antibodies are diffuse large B-cell lymphoma, relapsed or refractory precursor B-cell acute lymphoblastic leukemia, haemophllia A, and non-small cell lung cancer.
There are a total of 19 molecules in the clinical development phases for bispecific antibodies.
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
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- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
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- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
- Amgen
- Roche
- J&J
- Genentech
- Akeso, Inc.
- Taisho Pharmaceutical
- Genmab
- Pfizer