"Global Bispecific Antibody Market Opportunity, Drug Sales, Price and Clinical Trials Insight 2028" Report Highlights:
The use of antibodies as therapeutic drugs has significantly shifted the landscape of treatment in many areas of medicine including oncology, viral infections and auto-immune diseases. Over last two decades, the idea of bispecific antibody was developed and is used extensively to overcome the limitation of monoclonal antibodies. Bispecific antibodies are dual targeting modalities and can simultaneously combine two epitopes. Their novel binding efficacy has prompted significant interest for a number of therapeutic conditions, both in cancer as well as other diseases. The growing interest in the therapeutic antibodies along with the rapid progress in antibody engineering has enabled the development of wide range of bispecific formats.
Recently, Janssen Pharmaceutical has developed Teclistamab which is an investigational, fully humanized, T-cell redirecting, IgG4 bispecific antibody targeting both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. Preclinical studies have shown that Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells. In July 2022, company has announced that it has received conditional marketing approval from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Teclistamab in patients with multiple myeloma. In addition to this, the company has also submitted Biologics License Application (BLA) to US FDA seeking approval for its novel drugs. The approval is based on the positive results of late stage clinical trial which has suggested enhancing its survival rates. It is expected that the drug will be available in the market by end of 2022 and will be sold under the brand name Tecvalyi.
Currently, the novel bispecific antibody is present in various monotherapy and combination studies. For instance, researchers are currently conducting phase-I clinical trial evaluating the role of Teclistamab in combination with Darzalex Faspro in patients with relapsed or refractory multiple myeloma (RRMM). The result from the study has demonstrated safety and encouraging response of the novel combination, which led to initiation of further clinical trials. The coming years is expected to witness rapid approval of the drug in various regions as monotherapy or combination therapy which will have a positive impact on the growth of market.
Apart from this, 6 other bispecific antibodies have gained market authorization for various indications including Hemlibra for hemophilia, Blincyto for acute lymphoblastic leukemia, Rybrevant for non-small cell lung cancer, Vabysmo for Neovascular (Wet) Age‑related Macular Degeneration (AMD) and Diabetic Macular Edema (DME), Cadonilimab for cervical cancer, and Lunsmio for follicular lymphoma. Since 2017, bispecific antibodies have rapid been developed and granted approval to target the chronic diseases owing to their high efficacy and ability to target the multifactorial nature of the disease. In short span of time, the cumulative sales of the bispecific antibodies have surpassed US$ 9 Billion by first quarter of 2022, thus showing high adoption rates.
The encouraging response of bispecific antibodies has also gained a lot of investment from the pharmaceutical companies. In last few years, there has been upsurge in the number of pharmaceutical deals which will have a positive impact on the growth of market. For instance, Xencor and Janssen Biotech have entered an exclusive collaboration and global license agreement for the development and commercialization of plamotamab and XmAb CD28 bispecific antibody combinations to treat patients with B-cell malignancies. As per our report findings, the global bispecific antibody market is expected to surpass US$ 30 Billion and the cumulative sales are expected to surpass US$ 90 Billion by 2028. This is mainly attributed to increasing adoption of bispecific antibodies and lack of competition from the biosimilar drugs. Moreover, 3-5 bispecific antibodies are expected to gain approval during the forecast period which will drive the market.