FDA Approved Bispecific Antibodies For Targeted Cancer Therapy

Release Date: 02-Nov-2021

Global Bispecific Antibody Market Opportunity, Drug Sales, Price and Clinical Trials Insight 2028 Report Analysis and Data Highlights:



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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 can target two antigens at the same time such as simultaneously binding target cell as well as NK or T-cell to recruit and activate immune cells to destroy the target cell. Bispecific antibodies enhance the selectivity and efficacy of antibody based human treatment due to combination of two binding specificities.


To date, three bispecific antibodies are present in market. Removab developed by Neovii Biotech was first bispecific antibody approved in 2009 but was further discontinue in 2013. Later, Blincyto (Blinatumomab) developed by Amgen was the bispecific antibody approved by US FDA in 2014. Blincyto is a novel bispecific CD19 directed CD3 T-cell engager which is indicated for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Later in 2017, Genentech developed Hemlibra which is a bispecific factor IXA and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with Hemophilia A. In 2021, Rybrevant (Amivantamab) developed by Janssen Pharmaceuticals was also granted approval.


Since their introduction into the market, they have shown high adoption rates in market owing to their high specificity and ability to overcome the limitations of monoclonal antibodies. Bispecific antibodies find their application in plethora of cancers such as lung cancer, breast cancer, colon cancer and a variety of chronic inflammatory diseases such as rheumatoid arthritis. With the advent in field of life sciences, there are more than 20 different formats available of bispecific antibodies. The great zeal of interest in bispecific antibodies can be justified by the large number of clinical trials ongoing.


The future of bispecific antibody market can be predicated from the involvement of big pharmaceutical companies as well as same participation enthusiasm by the small ventures in collaboration to them. The number of new molecules entering the clinical trials has since on ascended after the approval of Blincyto in 2014, with most of them in the Phase I and Phase II trials. Several pharmaceutical companies such as Amgen, Pfizer, Roche, Sanofi and others are investing huge amount in the development of novel bispecific antibodies. Further, it is expected that around 5 bispecific antibodies will enter the market by 2028, thus boosting the growth of market.


As per report findings, the global bispecific antibody market was valued around US$ 100 Million in 2020 which is mainly due to the robust sales of Blincyto and Hemlibra. By 2028, it is estimatedthat the market will increase expoentialllly to surpass USD 20 Billion which is mainly attributed to the high adoption rates of Amivantamab in non-small cell lung cancer patients. In addition, increase in geriatric population and subsequent chronic conditions will also enhance their uptake in market.


North America and Europe were observed to be largest bispecific antibodies treatment market due to the presence of major key players in these regions. Moreover, the high prevalence of chronic diseases including cancer and blood disorders is expected to drive the market in recent future. The favorable initiatives taken by the federal government to encourage the use of novel therapies as well as to promote research and development is also adding to the growth of market. Similarly, Asia-Pacific market is also expanding due to untapped opportunities and the growing awareness among this region. Asian market will be fuelled due to extensive increase in healthcare infrastructure and growing market penetration in the region.



Neeraj Chawla

Research Head



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