Danyelza Patent, Sales & Clinical Trials Outlook 2028 Report Analysis & Data Highlights:
- Danyelza Patent Insight
- Danyelza Dosage & Price
- Danyelza Sales Forecast 2028: > USD 400 Million
- Danyelza Role in Neuroblastoma & Osteosarcoma Therapy
- Danyelza Structure & Pharmacokinetics Properties
- Danyelza Ongoing Clinical Trials: 10 Clinical Studies
- Danyelza Reimbursement Scenario
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.
Table of Contents
1. Danyelza (Naxitamab) - GD2 Targeting Antibody
1.1 Clinical Overview
1.2 Clinical Efficacy
2. Danyelza - Approval & Patent Insights
2.1 Orphan Designation & Approval
2.2 Patents & Assignees
3. Danyelza Commercial Insights
3.1 Pricing & Dosage Analysis
3.2 Sales Analysis
4. Danyelza Mechanism of Action
5. Danyelza Role in Neuroblastoma
6. Danyelza Role in Osteosarcoma
7. Danyelza - Supplementary Information
7.1 Pharmacodynamics & Pharmacokinetics Properties
7.2 Adverse Drug Reactions
7.3 Use in Specific Population
8. Global Market Analysis
8.1 Current Market Scenario
8.2 Future Market Opportunity
9. Danyelza Sales Forecast Till 2028
10. Danyelza Clinical Trial Insights
10.1 By Phase
10.2 By Region
10.3 By Status
10.4 Ongoing Clinical Trials
11. Danyelza Reimbursement Policy
12. Competitive Landscape
12.1 Autolus Therapeutics
12.2 Beigene
12.3 Bellicum Therapeutics
12.4 Kurr Therapeutics
12.5 SciClone Therapeutics
12.6 Sorentto Therapeutics
12.7 Swixx Biopharma
12.8 Takeda Pharmaceuticals
12.9 United Therapeutics Corporation
12.10 Y-Mab Therapeutics
List of Figures
Figure 2-1: Danyelza - Orphan Drug Designation by Region
Figure 2-2: US - Danyelza Orphan Drug Designation & Exclusivity End Year
Figure 2-3: US - Danyelza Orphan Drug Designation & FDA Approval Year
Figure 2-4: Global - Danyelza Number of Patents Approved by Family
Figure 2-5: Danyelza - First Family Patents by Region
Figure 2-6: Danyelza - Second Family Patents by Region
Figure 2-7: Global - Danyelza Patents Expiration Year by Family
Figure 3-1: Danyelza - Cost of Supply of 4ml & Per Unit Cost of 4mg/ml Intravenous Solution (US$), October’2021
Figure 3-2: Danyelza - Recommended Initial Dose & Reduce Dose for Neuroblastoma (mg/kg/day)
Figure 3-3: Danyelza - Cost of Daily Treatment & One Cycle Treatment for Neuroblastoma (US$), October’2021
Figure 3-4: Danyelza - Cost of Treatment Cycles in Neuroblastoma (US$), October’2021
Figure 3-5: Danyelza - Initial Treatment Duration & Subsequent Cycles Duration in Neuroblastoma (weeks)
Figure 3-6: Global - Danyelza Quarterly Sales (US$ Million), Q1 & Q2’2021
Figure 4-1: Proposed Mechanism of Action of Danyelza
Figure 4-2: Danyelza - Mechanism of Action
Figure 5-1: Role of Danyelza in Neuroblastoma
Figure 7-1: Adverse Drug Reactions with Danyelza
Figure 8-1: Global - Neuroblastoma Incidences, 2020 & 2028
Figure 8-2: Global - GD2 Targeting Antibody Market by Product (US$ Billion), H1’2021
Figure 8-3: Global - GD2 Targeting Antibody Market by Product (%), H1’2021
Figure 8-4: Global - Estimated Neuroblastoma Cases, 2021 - 2028
Figure 8-5: Global - Expected Adoption Rate of Danyelza in Neuroblastoma (Number of Patients), 2021-2028
Figure 8-6: Global - Danyelza Market Opportunity in Neuroblastoma by 1% Adoption Rate (US$ Million), 2021 - 2028
Figure 8-7: Global - Danyelza Market Opportunity in Neuroblastoma by 2% Adoption Rate (US$ Million), 2021 - 2028
Figure 8-8: Global - Danyelza Market Opportunity in Neuroblastoma by 3% Adoption Rate (US$ Million), 2021 - 2028
Figure 8-9: Global - Danyelza Market Opportunity in Neuroblastoma by 4% Adoption Rate (US$ Million), 2021 - 2028
Figure 8-10: Global - Danyelza Market Opportunity in Neuroblastoma by 5% Adoption Rate (US$ Million), 2021 - 2028
Figure 8-11: Global - Expected Osteosarcoma Cases, 2021 - 2028
Figure 8-12: Global - Expected Adoption Rate of Danyelza in Osteosarcoma (Number
of Patients), 2021-2028
Figure 9-1: Danyelza - Expected Sales Forecast (US$ Million), 2021 - 2028
Figure 10-1: Daryelza - Number of Clinical Trials by Phase, October’2021
Figure 10-2: Daryelza - Number of Clinical Trials by Phase (%), October’2021
Figure 10-3: Daryelza - Number of Clinical Trials by Region, October’2021
Figure 10-4: Daryelza - Number of Clinical Trials by Status, October’2021
Figure 10-5: Daryelza - Number of Clinical Trials by Status (%), October’2021
Figure 10-6: Danyelza - Study 201 Start & Primary Completion Year in Neuroblastoma
Figure 10-7: Danyelza - Start & Primary Completion Year of Naxitamab in Combination with IT in Neuroblastoma
Figure 10-8: Danyelza - Start & Primary Completion Year of Naxitamab in Combination with Isotretinoin in Neuroblastoma
Figure 10-9: Danyelza - Start & Primary Completion Year of Naxitamab in Osteosarcoma
Figure 11-1: Danyelza - Total Treatment Cost & Reimbursement Cost
Figure 11-2: Danyelza - In Pocket & Out of Pocket Cost of Treatment
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Autolus Therapeutics
- Beigene
- Bellicum Therapeutics
- Kurr Therapeutics
- SciClone Therapeutics
- Sorentto Therapeutics
- Swixx Biopharma
- Takeda Pharmaceuticals
- United Therapeutics Corporation
- Y-Mab Therapeutics
