Bispecific Antibody Market USD 30 Billion Opportunity 600 Antibodies In Clinical Trials
"Global Bispecific Antibody Market Opportunity, Drug Sales, Price and Clinical Trials Insight 2028" Report Highlights:
- Global Bispecific Antibody Market Opportunity Assessment: > US$ 30 Billion
- Global Bispecific Antibody Market Cumulative Sales Since 2016: > 8 Billion
- Global Bispecific Antibody Market Growth Rate: 100% CAGR (2016 -2021)
- Approved Bispecific Antibodies In Market: 7 Antibodies
- Comprehensive Clinical Trials Insight On More Than 600 Bispecific Antibodies In Clinical Trials
- Comprehensive Clinical Trials Insight By Phase, Indications, Organization, Patent
- Detailed Market Sales and Trends Insight Till 2028
- Quarterly & Yearly Sales Insight Of Approved Antibodies From 2066 Till Q2 2022
- Global & Regional Market Analysis
Several advances in the field of biotechnology, particularly antibody engineering has led to designing of next generation therapeutics with more enhanced efficacy and safety. Bispecific antibodies are novel antibody constructs which can recognize two different antigens in one construct has emerged out to be promising drug candidates for the management of wide range of chronic diseases including cancer. In comparison to traditional therapies, bispecific antibodies have shown enhanced efficacy, ability to cross blood brain barrier, and ease in manufacturing due to its small size. The large number of benefits associated with bispecific antibody has gained considerable interest from scientists to utilize its potential in the management of chronic diseases.
Recently in July 2022, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced positive opinion and granted condition marketing approval to Tecvayli (teclistamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Tecvayli developed by Janssen Pharmaceutical is fully humanised, T-cell redirecting, IgG4 bispecific antibody targeting both BCMA and CD3, on T-cells.
Currently, the novel bispecific construct is being evaluating in large number of clinical studies as monotherapy or combination therapy. In 2020, US FDA has also granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. Further in December 2021, Janssen Pharmaceutical has also submitted Biologics License Application (BLA) to the FDA seeking approval of teclistamab for the treatment of patients with RRMM. Therefore, it is expected that the novel bispecific antibody will also gain approval in US and other prominent markets during the forecast period which will drive the growth of market in the coming years.
Apart from this, few other bispecific antibodies including Blincyto, Hemlibra, Rybrevant, Vabysmo, and Lunsumio have also gained market authorization from regulatory bodies. The introduction of bispecific antibodies has totally transformed the overall therapeutic market by significantly enhancing survival rates and overcoming the limitations of already approved drugs. Apart from this, several others bispecific antibodies are also awaiting approval. For instance, US FDA has accepeted Genentech Biologics License Application (BLA) and granted Priority Review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. The regulatory body will take final decision in December 2022.
The encouraging response of bispecific antibodies across wide range of complex diseases in short span of time has led to large investments in this domain. The key players in the market are also adopting strategic alliances to launch next generation bispecific antibody construct for the managemet of cancer. For instance, F Star Therapeutics entered into license agreement with Takeda Pharmaceutical. Under the terms of agreement, Takeda received worldwide, exclusive oyalty-bearing license to research, develop, and commercialize a bispecific antibody against an immuno-oncology target using F-star’s proprietary Fcab and mAb2 platforms. These trends among the pharmaceutical giants will have a positive impact on the growth of market.
As per our report findings, the global bispecific antibody market is expected to surpass US$ 30 Billion by 2028. The high growth rates in the market are mainly attributed to rapid approval of bispecific antibodies ad their high adoption rates among population. Further, the market is also driven by several factors including high research and development activities, large patient pool, and favorable reimbursement policies. The major companies in the market are Genmab, Roche, Pfizer, GlaxoSmithKline, Janssen Pharmaceutical, Amgen, and others.