Release Date: 08-Apr-2022
Global Trispecific Antibody Market Opportunity And Clinical Trials Insight 2028 Report Analysis and Data Highlights:
Global Bispecific Antibody Market Insight 2028 Report Highlights:
Targeted treatment of cancer with monoclonal antibodies has shown to significantly enhance the survival rates in cancer patients. To further enhance the efficacy of monoclonal antibodies, researchers have developed multispecific antibodies which have the ability to bind to two or more different antigens simultaneously. In comparison to conventional monoclonal antibodies, multispecific antibodies show several advantages in terms of efficacy, specificity, reduced cost, and ability to cross the blood brain barrier. This has led to growing interest among pharmaceutical companies to develop novel multispecific antibodies in management of cancers.
Bispecific antibodies are novel antibody construct which has the ability to bind two different antigens or two different epitopes on same antigens. The progress in antibody engineering and recombinant DNA technology has led to development of various platforms for generating different types of bispecific antibody platforms. Researchers have developed various platforms including knob-into-holes, SEED, DEKK, DuoBody, Orthogonal Fab, bispecific T-cell engager (BiTE), and others have been developed which are widely used for the development of novel bispecific constructs.
Presently, four bispecific antibodies have entered the market for the management of cancer. Blinatumomab (Blincyto) developed by Amgen was the first bispecific antibody approved by FDA for cancer patients. Blincyto is BiTE immune-oncology therapy which targets CD19 surface antigens on B-cells and is indicated for the management of acute lymphoblastic leukemia. The entrance of Blincyto in the global market has paved the way for further research and development in bispecific antibodies market.
Recently in 2021, a novel bispecific antibody Rybrevant (Amivantamab) was granted approval by US FDA. Rybrevant is an EGF and MET directed bispecific antibody, developed by Janssen Pharmaceutical which is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EFGR) exon 20 insertion mutations.
Although only 4 bispecific antibodies have been approved in the management of cancer but several others are present in clinical development. Amgen is currently leading the global market with its BiTE platform. To increase half-life, Amgen has alunched several half-life extended BiTEs which are present in clinical trials. Acapatamab is a half-life extended BiTE immunotherapy agent which is being evaluated for the management of prostate cancer. In addition, Amgen has also collaborated with Xencor to develop and commercialize in the area of cancer immunotherapy. The research collaboration brings together Amgen’s capabilities in target discovery and protein therapeutics with Xencor Xmab bispecific technology platform.
The success of approved bispecific antibodies in market has led to increase in number of ongoing clinical trials in this sector. Scientists have identified several targets which are critical for cancer progression and can be used for the development of novel bispecific antibody constructs. B-cell maturation antigen is the tumor-associated antigen most frequently targeted, followed by CD20, CD33, CD123 and prostate-specific membrane antigen.
The promising response of bispecific antibodies in the market has increased the competition among pharmaceutical companies to actively invest in this sector. The global market has witness an increase in collaboration and partnerships to drive the research and development of bispecific antibody. Recently, F-star Therapeutics partnered with Janssen Biotech for research, development and commercialization of novel bispecific antibodies in the hopes that they can use these custom-designed antibodies as part of their immuno-oncology research.
As bispecific antibodies can bind to specific antigens and specific detection sites simultaneously, their design is flexible, sensitive, and convenient. They can reduce the harmful effects of chemical modification of enzymes or antibodies, simplify detection, and help detect infectious bacterial and viral diseases and diagnose cancer. Currently, the use of bispecific antibodies in diagnosing cancer is mainly confined to preclinical stages. However, it is believed that the coming years will witness diagnostic role of bispecific antibodies, which will further boost this segment in the market.
Further increase of antibody specificity can potentially result in even higher efficacy compared to mono- and bispecific antibodies. The novel trispecific antibody constructs have the ability to target three different antigens, with generally at least one of the three specificities intended to redirect T- or NK cells, and the other two targeting tumor associated antigens (TAA). At present, no trispecific antibody has entered the market, but a majority of them are present in clinical and preclinical stages of development.
The TriKE GTB-3550, developed by GT Biopharma, targets CD33 and is currently tested in a phase 1/2 study for relapsed or refractory high-risk myeloid malignancies. GTB-3550 represents one of the most advanced staged trispecific antibody being developed and have shown enhanced efficacy and specificity in targeting cancer. Apart from this, GT Biopharma is also developing two TriKEs against solid tumors: GTB-4550 targeting PD-1, and GTB-5550 targeting B7H3. Additional TriKEs are in preclinical stage, such as 161,533 targeting CD33, or a slightly different construct targeting B7-H3 and using an sdAb to bind CD16.
In addition to this, HPN424 developed by Harpoon Therapeutics is a trispecific T-cell engager being investigated for the treatment of prostate cancer. The agent has 3 domains targeted against PSMA for tumor binding, albumin for half-life extension, and CD3 for T-cell engagement. The novel trispecific construct was developed o enable solid tumor penetration with prolonged half-life and stability. These features were designed to increase the therapeutic index and minimize off-target toxicities compared with other T-cell engagers.
Currently, the field of trispecific antibodies is highly unexplored which further create opportunities for pharmaceutical companies to actively invest in this sector. The major key players in the market have adopted strategic alliances including collaboration, partnerships, and joint ventures to drive the research and development in this sector. Recently in 2021, Lonza has signed licensing agreement with clinical-stage biopharma, Zhejiang Doer Biologics, whereby the Hangzhou, China based biopharma company will develop multi-specific biotherapeutics using the Swiss CDMO’s XS Pichia. For instance, DR30206 is a preclinical tri-specific antibody targeting PD-1, VEGF, and TGF-beta which can be used to treat various solid tumors that may be low or non-response to conventional PD-1/PD-L1 antibodies.
In addition, the constantly increasingly knowledge with respect to the surface antigens present on the cancer cells will also open up new opportunities for the development of novel multispecific antibodies. It is further believed to develop a massive competitive landscape threat to all the other viable and commercially available cancer therapies such as old and traditional chemotherapy or radiation therapy and novel therapies such as small molecule cancer drug therapy during the forthcoming years.
Our reports findings suggest that the pipeline for novel multispecific antibodies is expected to double in next 5 years and new product launches will be seen in forthcoming years. Despite the emergence of several new classes of drugs, it is believed that multispecific antibodies will have significant share in cancer therapeutics market owing to their several conferred advantages, which will further propel the growth of market during forecast period. Apart from this, the increase in prevalence of cancer worldwide and the high medical needs for the development of targeted therapy will also boost the growth of market. The existence of significant manufacturers, strong government initiatives, advantageous reimbursement rules, and a huge patient pool are some of the main elements driving expansion of the market during the forecast period.
Amid region, US is currently dominating the global market and is expected to do so during the forecast period. This is mainly due to increase geriatric population, high acceptance to novel therapies and the rising initiatives by government sector to propel the research and development sector. Moreover, the presence of major key players also boosts the growth of market in this region.
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