Global Bispecific Antibody Market Opportunity and Clinical Trials Insight 2023 Report Highlights:
The introduction of antibody based therapeutics has been a game changer in the field of cancer therapy. Monoclonal antibodies have been around for decades and still there role has been ever so significant. However, with the rising clinically unmet medical needs, current efforts are focused on developing advanced forms of these biologics. The continued expansion in research and development of antibody biologics has brought in the era of bispecific antibodies.
These bispecific antibodies are capable of engaging or targeting two distinct targets and therefore are able to simultaneously perform multiple actions including; direct the immune cells to tumor cells, block two different pathways simultaneously and deliver cytotoxic payloads. Over the past few decades, there have been a number of difficulties with the production of bispecific antibodies; nevertheless, they have shown great potential as promising cancer therapeutics.
Bispecific antibodies are a fast growing engineered biologics that have significantly improved significant unmet medical needs. The fast approval of Columvi showed the urgency of this particular bispecific product. With the expansion of global pharmaceutical industry developing a robust clinical pipeline for the research and development of bispecific antibodies, there are numerous candidates currently undergoing clinical trials while several are being tested in preclinical studies.
The range of therapeutics has been increasing, similar to the rising demand of innovation in the pharmaceutical industry. This increase in the growing expansion of antibodies can be due to the increasing regulatory approvals. Recently, Roche’s Glofitamab (Columvi), a bispecific T cell engager molecule (BiTE) was approved by Health Canada for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
The approval was based on the clinical study called NP30179 where more than 30% patients who received Glofitamab showed cancer disappearance. This marked the first ever approval for this CD20 x CD3 targeting bispecific antibody. . By simultaneously engaging the CD20 receptor on B cells and CD3 on the T cells, Glofitamab facilitates the development of an immunological synapse with following proliferation of T-cells and their activation, cytokine secretion, and release of cytolytic proteins that results in the killing of tumor cells which express CD20 surface receptor.
There are several factors that are driving the growth of bispecific antibody market which include; improved regulatory framework, persistent clinical trials having promising results and increasing investment with active assets. As the global pharmaceutical industry realizes the commercial as well as therapeutic potential of bispecific antibodies, we can expect an increase in the number of possible clinical candidates in the coming years.
Moreover, as the industry develops, there is also grows the number of competitors. A few years ago, there were only a handful of pharmaceutical players in the bispecific antibody market, however, now there are multiple stakeholders that are continuously working to develop novel bispecific antibodies. Furthermore, with eagerness to enter the market, several companies have also chosen the road to collaboration.
For instance, recently, ABL Bio, a South Korea based Biotech Company and Lonza, a Swiss multinational pharmaceutical manufacturing company have entered an agreement that will focus on the development and manufacturation of the former company’s bispecific antibody product. The latter will provide ABL Bio will end to end solutions regarding early research and offer support for the potential Investigational New Drug (IND) application. With Lonza being a major leader with several bispecific and multispecific products in its pipeline, the collaboration will lead ABL Bio to a speedy road towards commercialization.
Overall, it is not hard to predict that the future of bispecific antibodies is very promising; however, more research needs to be conducted in order to fully determine the therapeutic potential and capability of this novel class of therapeutic biologics. Our report aims to provide a detailed overview about the mechanism of action of several approved bispecific antibodies in market, as well as highlights their patent, dosage and pricing in in major markets like that of the US. Additionally, the report also contains information about reimbursement policies respective to differnet bispecific antibodies and also presents information about bispecific antibodies currently in clinical pipeline.