Danyelza Patent, Sales and Clinical Trials Outlook 2028 Report Analysis and Data Highlights:
The introduction of more comprehensive, clinical grade sequencing platforms has promoted recognition of targetable genomic alterations across multiple tumor types. Recently, researchers have identified high expression of GD2 ganglioside on majority of neuroblastoma, and thus suggested that targeting GD2 may emerge as potential treatment in neuroblastoma. GD2 has emerged out to be potential therapeutic target owing to its limited expression in normal cells tissues and extensive expression by a number of tumors including neuroblastoma, small cell lung cancer, melanoma, osteosarcoma, and others.
In recent times, therapeutic monoclonal antibodies are considered as one of the most promising approach for cancer immunotherapy. Researchers have developed several monoclonal antibodies which are directed against tumor-associated molecules including ganglioside GD2. Investigators have developed Naxitamab which is first humanized GD2 targeting monoclonal antibody. It was originated and was developed by the Memorial Sloan Kettering Cancer Center (MSKCC), with commercial rights licenced to Y-mAbs therapeutics (Y-mAbs). Naxitamab received its frst approval on 24 November 2020 in the USA for the treatment of neuroblastoma in children at least 1 year of age and adults.
As of now, the drug Danyelza has gained approval only in US. However, it is expected that in coming years the drug will gain approval in other regions also including China, Europe, and Japan. For instance, CHMP has recently given positive opinon of the drug and thus, it is expected that Danyelza will gain approval in Europe by 2022, thus further boosting the growth of market. As per report findings, it is suggested that sales of the drug will follow trajectory growth rates during the forecast period and is expected to reach US$ 400 Million by 2028.
Apart from neuroblastoma, researchers are also evaluating further indications s in children and adults include osteosarcoma and other GD2-positive cancers. Apart from this, ongoing clinical trials are also evaluating naxitamab in combination with allogenic natural killer cells and in combination with GM-CSF, irinotecan and temozolomide for the management of neuroblastoma. The coming years will see a dominance of combinational therapy in neuroblastoma which will enhance the efficacy of treatment in cancer patients. The majority of clinical trials are present in phase-I/II clinical stage, suggesting that forecast period will see rapid approval of Danyelza as monotherapy or combinational therapy in wide range of GD2 positive cancers.
The overall Danyelza market will be mainly restricted by the high cost of therapy, lack of biomarkers, and the increasing investment in research and development sector. Currently, the drug is available as branded molecule and it will not face any competition from the generic drug during the forecast period. The high cost of the therapy is generally unaffordable to majority of patients, thus restraining the growth of the market. To overcome this, several reimbursement policies have been developed which aim to reduce the out-of pocket cost by patients, thus decreasing financial toxicity. For example, y-Mab Connect co-pay program has been developed which provide a maximum benefit of US$ 15,000 per enrolment period.
The Danyelza market will witness high adoption rates of the drug during the forecast period. Owing to its superior mechanism of action, limited side effects, and ability to specifically target the receptors which are expressed on cancer cells, the drug Danyelza is expected show high adoption rates at a global level. Our report provides detailed analysis on Danyelza including its price, sales, dosage, and clinical trial insights. On the basis of this, the future sales of the drug have been forecasted and market opportunity of drug in neuroblastoma as well as osteosarcoma has been established.