Delhi, June 26, 2023 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Market Opportunity & Clinical Trials Insight 2023 Report Highlights:
- Yearly & Quarterly Sales Insight (2018 till Q1’2023)
- Global & Regional Sales Insights
- Global Market Forecast Till 2028
- Approved Bispecific Antibodies: 9
- Insight On Bispecific Antibodies In Clinical Trials: > 700 Bispecific Antibodies
- Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase
- Fast Track Approval, Orphan Designation & Priority Status Insights
- Approved Bispecific Antibodies Pricing & Dosage Analysis
- Competitive Landscape: Top 50 Companies Developing Bispecific Antibodies
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The development of bispecific antibodies has presented researchers the opportunity to improve the current treatment approaches for a number of diseases for which the conventional treatment approaches have not resulted in satisfactory results. For instance, the development and approval of Hemlibra, a bispecific antibody created by Roche, which has been highly received by the patient community worldwide, has significantly improved the therapy for hemophilia A. The market for bispecific antibodies has advanced in recent years, and this trend is anticipated to continue in the years to come, thanks in large part to the clinical and commercial success of Hemlibra and other marketed bispecific antibodies.
Removab was the first bispecific antibody to receive clinical approval; nevertheless, after it was pulled off the market, Blincyto was the only bispecific antibody ever to be commercially available worldwide until Hemlibra was introduced in 2017. Blincyto and Hemlibra both served as the leading drugs in the budding market for bispecific antibodies and were instrumental in the creation of contemporary bispecific antibodies. Glofitamab, which is sold under the brand name Columvi, was the most recent bispecific antibody to receive clinical use approval in 2023. However, Health Canada became the first drug regulating agency to approve Glofitamab, not the FDA or EMA.
At present, 9 bispecific antibodies, which have received approvals globally or regionally, and some more are in the process of getting regulatory approvals from different drug approval bodies. The development and clinical pipelines of bispecific antibodies are slowly becoming populated with more candidates as more pharmaceutical and biotechnology companies have been developing and introducing their candidates in clinical trials. It is estimated that over 700 bispecific antibodies are currently undergoing clinical evaluation globally, which suggests a promising future for this growing drug class.
Bispecific antibodies developed for different cancer indications are currently dominating the pipeline as understood from the growing incidence and mortality rates of cancer in different regions. Due to increasing urbanization and lifestyles shifting to a more unhealthy routine, cancer cases have been spiking up in highly populated regions such as the USA, UK and China. As a result, these countries have also emerged as the countries hosting the majority of the clinical trials. In addition, a huge number of pharmaceutical companies currently involved in the development of bispecific antibodies are also located in these regions, which make them hotspots for conducting clinical trials.
Bispecific antibodies are being generated increasingly frequently thanks to the rising use of cutting-edge technology platforms, and these newer antibodies have traits that make them therapeutically more promising. For instance, the proprietary CAB (Conditionally Active Biologics) technology of BioAtla has enabled the company to develop bispecific antibodies that are conditionally active, increasing their tumor specificity. In a nutshell, these antibodies use the tumor's acidic milieu to their advantage to produce therapeutic effects. This minimizes the possibility of negative consequences from off-site interactions by ensuring that the bispecific antibodies are not activated off-target. BA3182, a bispecific candidate targeting EpCAM & CD3, was created for the treatment of advanced adenocarcinoma using the CAB platform. Additionally, two other bispecific compounds created using the CAB platform that are presently in IND-enabling trials for solid tumors are included in BioAtla's portfolio: BA3142 and BA3311.
Drug regulatory bodies approved the IND applications of a number of newly developed candidates in the last six months, which has further contributed to the ever-expanding pipeline of bispecific antibodies. Recently, Alphamab Oncology announced the acceptance of the IND application it had filed for its anti-HER2 bispecific antibody KN026 by China’s Center for Drug Evaluation. The company plans on conducting clinical trials for the candidate in combination with the chemotherapy drug Docetaxel as a first-line treatment of metastatic breast cancer patients expressing HER2.
The market for bispecific antibodies is quite vibrant considering the number of candidates entering the developmental and clinical trials pipelines in the past few years. The bispecific antibody market was valued at US$ 5.7 Billion in 2022, which is anticipated to increase rapidly in the coming years as more candidates gain market entry thanks to the expedited approval process of the drug regulatory authorities. Bispecific antibodies have gained a lot of traction in the past few years with the development of drugs having novel mechanisms of action, and more innovations are expected in the coming years.
