Release Date: 02-Feb-2023
"Global Bispecific Antibody Market Opportunity, Drug Sales, Price and Clinical Trials Insight 2028" Report Highlights:
Acute lymphocytic leukemia (ALL) is a rare cancer of the blood which has a significant patient base globally if not equal to the other forms of leukemia. For years, treatment with chemotherapeutics has been the standard of care but the associated adverse effects and low success rates called for better treatment options as a result of which, immunotherapy and especially bispecific antibodies were greatly explored for their inventive mechanisms of exertive therapeutic effects. In 2014, Blincyto became the first-in-class bispecific antibody to be approved for the treatment of acute lymphocytic leukemia and has emerged as a new standard of care for the disease.
Blincyto (blinatumomab) was developed by Micromet, which has been acquired by Amgen, in collaboration with Lonza, and has emerged as a highly successful treatment modality which is obvious from its growing sales. When it was introduced in the market in 2015, its global sales amounted to only US$ 77 Million which has now increased to US$ 583 Million for the year 2022. All through the years, the US has been able to maintain its position as the largest regional contributor to the annual global sales of Blincyto and this trend is expected to continue in the future as well seeing high acceptance the country has showed to Blincyto all these years. The approval and use of Blincyto has definitely caused a shift in the paradigm in the management of B-cell acute lymphoblastic leukemia which is also evident by the successful real-world data being comparable to results from clinical trials.
Apart from offering an immunotherapeutic approach for the management of treatment of acute lymphocytic leukemia, the success of Blincyto was also a turning point in the research and development activities. It triggered the development of more efficient bispecific antibodies for the treatment of different forms of cancer, mainly hematological cancer for the easy access to tumor antigens. As a result of this, more than 8 bispecific antibodies are now available in the global market for treating conditions such as uveal melanoma, hemophilia A and inflammatory diseases.
In spite of its successful tenure in the market, Blincyto is still an agent widely used in clinical trials around the world and is still being evaluated in different forms of acute lymphocytic leukemia such as B-cell precursor acute lymphoblastic leukemia, mixed phenotype acute leukemia as well as acute lymphoblastic lymphoma, all these trials being in their third phases. Consequently, it is also been granted approvals newly. In May 2022, Amgen’s partner in China, BeiGene announced the approval of Blincyto by China’s drug regulatory authority National Medical Products Administration (NMPA) for the treatment of pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, which marked the second approval for Blincyto in China. Additionally, Amgen is also in the process of seeking regulatory approval from the US FDA for Blincyto for the treatment of minimal residual disease (MRD)-negative acute lymphoblastic leukemia based on positive data from a phase 3 clinical trial.
The ultimate success of Blincyto and other bispecific antibodies have also fueled the development of multispecific antibodies like tri- and tetra- specific antibodies, which are being hailed as the future of immunotherapy with antibodies. Being a bispecific T-cell engager (BiTEs), it also helped bring this novel class of drugs into the limelight for their innovative way to treat cancer and other diseases. Recently, the FDA approved Tecvayli (teclistamab-cqyv), another BiTE for the treatment of relapsed or refractory multiple myeloma, making it the first-in-class BiTE to be used for treating the indication.
Recently, data from a clinical trial evaluating the combinatorial effect of Blincyto with chemotherapy was revealed wherein the overall survival of patients upon administering a chemotherapy regimen with Blincyto was improved greatly. This caused a commotion in the research segment because no useful breakthroughs were being observed for the treatment of adult ALL patients, and results from this trial could be used to design a new standard of treatment for newly diagnosed ALL patients. Though this new regimen is expected to increase the annual cost of treatment, steps need to be taken to make it more affordable.
The approval of Blincyto sparked an interest in the RandD sector which was fueled further by the favorable monetary results from the global pharmaceutical market. Several bispecific antibodies are now commercially available for the treatment of cancers and some inflammatory and autoimmune diseases. There are many favorable market factors which are driving the market growth and helping in expansion of the indications, which will play a critical role in fulfilling the unmet need for efficient therapies. Therefore, Blincyto as one of the earliest approval bispecific antibody has helped greatly in transforming the treatment of several diseases by being based on a novel idea.