Unituxin Patent, Sales & Clinical Trials Outlook 2028
Unituxin Patent, Sales & Clinical Trials Outlook 2028
Abstract
Unituxin Patent, Sales & Clinical Trials Outlook 2028 Report Analysis & Data Highlights:
• Unituxin Patent Insight
• Unituxin Dosage & Price
• Unituxin Sales Forecast 2028: > USD 500 Million
• Unituxin Role in Cancer Therapy
• Unituxin Structure & Pharmacokinetics Properties
• Unituxin Ongoing Clinical Trials: > 10 Clinical Studies
• Unituxin Reimbursement Scenario
Neuroblastoma is an embryonic cancer of the post-ganglionic sympathetic nervous system. The treatment with conventional cancer therapies are associated with poor survival outcomes, thus possing high medical needs for the development of targeted therapies. Genomic analysis of neuroblastoma has revealed high expression of GD2 on cancer cells. Owing to its restriced expression in normal cells, targeting GD2 has proven to be effective for the treatment of cancer. Researchers have developed GD2 targeting antibodies which work by targeting GD2 receptor on cancer cells.
Unituxin (dinutuximab) is first approved disialoganglioside, GD2-binding chimeric monoclonal antibody. The drug was develoed by United Therapeutics Corporation and is indicated for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). Owing to its targeted mechanism of action, the drug has shown high adoption rates in the market. The drug was also approved in Europe, but it was later discontinued due to short- and intermediate- term inability to supply Unituxin in sufficient quantities for meeting current global demands.
Recently, scientists have also developed dinutuximab beta which is another version of dinutuximab. The dinutuximab was developed is manufactured using mouse cells, whereas dinutuximab beta is manufactured using hamster cells. Following withdrawal of Unituxin, European Medicines Agency has rapidly approved Qarbiza (dinutuximab beta) for the treatment of neuroblastoma. More recently, China National Medical Products Administration (NMPA) has granted Qarbiza conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above.
Currently the drug Unituxin is mainly indicated for the management of neuroblastoma. However, ongoing clinical trials are also evaluating the role of these drugs in the treatment of other cancers also including osteosarcoma and small cell lung cancer. In addition, several ongoing clinical trials are also evaluating the role of drug in combination with other cancer targeting regimens. The coming years will witness rapid approval of drug as monotherapy or combinational therapy in wide range of cancers, which will further propel the growth of market during the forecast period.
As per report findings, the global Unituxin market is currently present at nascent stage and will grow slow growth rates during the forecast period. Several factors including increase in prevalence of cancer, no competition from generic drugs, rising awareness about the availability of drug and robust sales of Unituxin in global market will boost the growth of market. In addition to this, the high adoption rates of novel therapy as well as rising initiative by government to initiate research and development activities will also drive the future of the market. In addition, it will also face competition from novel emerging GD2 taregting drugs which are expected to enter the market during forecast period.
Presently, US holds the top position in the market and is expected to maintain its position during the forecast period due to to the presence of large pharmaceutical sector which actively invest in research and development activities as well as increasing funding by the government to promote research and development. In addition to this, the rise in prevalence of cancer and the increase awareness for the acceptance of novel therapies is also going to drive the future of the market. Moreover, the global market will be driven the rising approval of these drugs in other regions such as Europe, China and Asia and their increasing applications in other cancers. Our report provides detailed analysis on Unituxin 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 small cell lung cancer has been established.
Content
1. Unituxin (Dinutuximab) First Approved Anti-GD2 Targeting Immunotherapy
1.1 Overview
1.2 Approval & Patent Insight
2. Unituxin Commercial Information
2.1 Dosage & Price Analysis
2.2 Sales Analysis
3. Dinutuximab - Structure, Description & Pharmacokinetics
4. Unituxin Mechanism of Action
5. Role of Unituxin in Neuroblastoma
6. Role of Unituxin in SCLC
7. Unituxin - Supplementary Information
7.1 Adverse Drug Reactions
7.2 Application in Specific Population
7.3 Nonclinical Toxicology
8. Unituxin Market Analysis
8.1 Current Market Scenario
8.2 Future Market Opportunity
9. Unituxin Sales Forecast
10. Unituxin Reimbursement Policy
11. Unituxin Clinical Trial Insight
11.1 By Phase
11.2 By Development Status
11.3 By Region
12. Companies Developing GD2 Targeting Immunotherapies
12.1 Bellicum Therapeutics
12.2 MabVax Therapeutics
12.3 Shanghai Yake Biotechnology
12.4 Sinobioway Cell Therapy
12.5 Sorentto Therapeutics
12.6 United Therapeutic Corporation
12.7 Y-mAbs Therapeutics
List of Figures
Figure 1-1: Unituxin – Approval Year by Region
Figure 1-2: Unituxin – Orphan Designation Year by Region
Figure 1-3: US – Unituxin FDA Approval & Patent Exclusivity Year
Figure 1-4: US – Unituxin Orphan Approval & Exclusivity Expiration Year
Figure 1-5: Europe – EMA Approval & Market Withdrawal Year
Figure 2-1: Unituxin – Cost of Supply of 5ml & Per Unit Cost of Intravenous Solution (US$), October’2021
Figure 2-2: Unituxin – Duration of Treatment (Days)
Figure 2-3: Unituxin – Cost of Single Cycle & Full Treatment Cost (US$)
Figure 2-4: Global – Unituxin Annual Sales (US$ Million), 2017-2020
Figure 2-5: Global – Unituxin Quarterly Sales (US$ Million), 2020
Figure 2-6: Global – Unituxin Quarterly Sales (US$ Million), 2020
Figure 2-7: Global – Unituxin Quarterly Sales (US$ Million), Q1 & Q2, 2021
Figure 2-8: Global – Unituxin Half Yearly Sales (US$ Million), H1, 2020 & 2021
Figure 4-1: Role of GD2 in Cancer
Figure 4-2: General Pathways of GD2 Targeting Immunotherapies
Figure 4-3: Interaction of GD2 & Unituxin
Figure 4-4: Unituxin – Mechanism Of Action
Figure 5-1: Global – Newly Diagnosed Cases of Neuroblastoma, 2020 & 2028
Figure 5-2: Impact of GD2 Targeting Immunotherapies on Lung Cancer
Figure 6-1: Global – Newly Diagnosed Cases & Deaths Related to Lung Cancer (Million), 2020
Figure 6-2: Global – Lung Cancer Incidence by Type (%), 2020
Figure 6-3: Impact of GD2 Targeting Therapy on SCLC
Figure 7-1: Unituxin Associated Adverse Events
Figure 8-1: Global – Newly Diagnosed Cases of Neuroblastoma, 2020-2028
Figure 8-2: Global – Unituxin Market Opportunity by 2% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-3: Global – Unituxin Market Opportunity by 4% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-4: Global – Unituxin Market Opportunity by 6% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-5: Global – Unituxin Market Opportunity by 8% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-6: Global – Unituxin Market Opportunity by 10% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-7: Global – Estimated SCLC Population for Unituixin, 2021-2028
Figure 9-1: Global – Unituxin Sales Forecast (US$ Million), 2020-2028
Figure 10-1: Global – Unituxin Reimbursed Sales (%)
Figure 10-2: Global – Unituxin Incremental Budget Impact (US$/3 Years)
Figure 11-1: Global – Number of Unituxin Related Clinical Trials by Phase, October’2021
Figure 11-2: Global – TROP2 Related Clinical Trials by Phase (%), October’2021
Figure 11-3: Global – Number of Unituxin Related Clinical Trials by Development Status, October’2021
Figure 11-4: Global – Number of Unituxin Related Clinical Trials by Development Status (%), October’2021
Figure 11-5: Global – Number of Unituxin Related Clinical Trials by Region, October’2021
• Unituxin Patent Insight
• Unituxin Dosage & Price
• Unituxin Sales Forecast 2028: > USD 500 Million
• Unituxin Role in Cancer Therapy
• Unituxin Structure & Pharmacokinetics Properties
• Unituxin Ongoing Clinical Trials: > 10 Clinical Studies
• Unituxin Reimbursement Scenario
Neuroblastoma is an embryonic cancer of the post-ganglionic sympathetic nervous system. The treatment with conventional cancer therapies are associated with poor survival outcomes, thus possing high medical needs for the development of targeted therapies. Genomic analysis of neuroblastoma has revealed high expression of GD2 on cancer cells. Owing to its restriced expression in normal cells, targeting GD2 has proven to be effective for the treatment of cancer. Researchers have developed GD2 targeting antibodies which work by targeting GD2 receptor on cancer cells.
Unituxin (dinutuximab) is first approved disialoganglioside, GD2-binding chimeric monoclonal antibody. The drug was develoed by United Therapeutics Corporation and is indicated for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). Owing to its targeted mechanism of action, the drug has shown high adoption rates in the market. The drug was also approved in Europe, but it was later discontinued due to short- and intermediate- term inability to supply Unituxin in sufficient quantities for meeting current global demands.
Recently, scientists have also developed dinutuximab beta which is another version of dinutuximab. The dinutuximab was developed is manufactured using mouse cells, whereas dinutuximab beta is manufactured using hamster cells. Following withdrawal of Unituxin, European Medicines Agency has rapidly approved Qarbiza (dinutuximab beta) for the treatment of neuroblastoma. More recently, China National Medical Products Administration (NMPA) has granted Qarbiza conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above.
Currently the drug Unituxin is mainly indicated for the management of neuroblastoma. However, ongoing clinical trials are also evaluating the role of these drugs in the treatment of other cancers also including osteosarcoma and small cell lung cancer. In addition, several ongoing clinical trials are also evaluating the role of drug in combination with other cancer targeting regimens. The coming years will witness rapid approval of drug as monotherapy or combinational therapy in wide range of cancers, which will further propel the growth of market during the forecast period.
As per report findings, the global Unituxin market is currently present at nascent stage and will grow slow growth rates during the forecast period. Several factors including increase in prevalence of cancer, no competition from generic drugs, rising awareness about the availability of drug and robust sales of Unituxin in global market will boost the growth of market. In addition to this, the high adoption rates of novel therapy as well as rising initiative by government to initiate research and development activities will also drive the future of the market. In addition, it will also face competition from novel emerging GD2 taregting drugs which are expected to enter the market during forecast period.
Presently, US holds the top position in the market and is expected to maintain its position during the forecast period due to to the presence of large pharmaceutical sector which actively invest in research and development activities as well as increasing funding by the government to promote research and development. In addition to this, the rise in prevalence of cancer and the increase awareness for the acceptance of novel therapies is also going to drive the future of the market. Moreover, the global market will be driven the rising approval of these drugs in other regions such as Europe, China and Asia and their increasing applications in other cancers. Our report provides detailed analysis on Unituxin 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 small cell lung cancer has been established.
1.1 Overview
1.2 Approval & Patent Insight
2. Unituxin Commercial Information
2.1 Dosage & Price Analysis
2.2 Sales Analysis
3. Dinutuximab - Structure, Description & Pharmacokinetics
4. Unituxin Mechanism of Action
5. Role of Unituxin in Neuroblastoma
6. Role of Unituxin in SCLC
7. Unituxin - Supplementary Information
7.1 Adverse Drug Reactions
7.2 Application in Specific Population
7.3 Nonclinical Toxicology
8. Unituxin Market Analysis
8.1 Current Market Scenario
8.2 Future Market Opportunity
9. Unituxin Sales Forecast
10. Unituxin Reimbursement Policy
11. Unituxin Clinical Trial Insight
11.1 By Phase
11.2 By Development Status
11.3 By Region
12. Companies Developing GD2 Targeting Immunotherapies
12.1 Bellicum Therapeutics
12.2 MabVax Therapeutics
12.3 Shanghai Yake Biotechnology
12.4 Sinobioway Cell Therapy
12.5 Sorentto Therapeutics
12.6 United Therapeutic Corporation
12.7 Y-mAbs Therapeutics
List of Figures
Figure 1-1: Unituxin – Approval Year by Region
Figure 1-2: Unituxin – Orphan Designation Year by Region
Figure 1-3: US – Unituxin FDA Approval & Patent Exclusivity Year
Figure 1-4: US – Unituxin Orphan Approval & Exclusivity Expiration Year
Figure 1-5: Europe – EMA Approval & Market Withdrawal Year
Figure 2-1: Unituxin – Cost of Supply of 5ml & Per Unit Cost of Intravenous Solution (US$), October’2021
Figure 2-2: Unituxin – Duration of Treatment (Days)
Figure 2-3: Unituxin – Cost of Single Cycle & Full Treatment Cost (US$)
Figure 2-4: Global – Unituxin Annual Sales (US$ Million), 2017-2020
Figure 2-5: Global – Unituxin Quarterly Sales (US$ Million), 2020
Figure 2-6: Global – Unituxin Quarterly Sales (US$ Million), 2020
Figure 2-7: Global – Unituxin Quarterly Sales (US$ Million), Q1 & Q2, 2021
Figure 2-8: Global – Unituxin Half Yearly Sales (US$ Million), H1, 2020 & 2021
Figure 4-1: Role of GD2 in Cancer
Figure 4-2: General Pathways of GD2 Targeting Immunotherapies
Figure 4-3: Interaction of GD2 & Unituxin
Figure 4-4: Unituxin – Mechanism Of Action
Figure 5-1: Global – Newly Diagnosed Cases of Neuroblastoma, 2020 & 2028
Figure 5-2: Impact of GD2 Targeting Immunotherapies on Lung Cancer
Figure 6-1: Global – Newly Diagnosed Cases & Deaths Related to Lung Cancer (Million), 2020
Figure 6-2: Global – Lung Cancer Incidence by Type (%), 2020
Figure 6-3: Impact of GD2 Targeting Therapy on SCLC
Figure 7-1: Unituxin Associated Adverse Events
Figure 8-1: Global – Newly Diagnosed Cases of Neuroblastoma, 2020-2028
Figure 8-2: Global – Unituxin Market Opportunity by 2% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-3: Global – Unituxin Market Opportunity by 4% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-4: Global – Unituxin Market Opportunity by 6% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-5: Global – Unituxin Market Opportunity by 8% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-6: Global – Unituxin Market Opportunity by 10% of Neuroblastoma Population (US$ Million), 2021 - 2028
Figure 8-7: Global – Estimated SCLC Population for Unituixin, 2021-2028
Figure 9-1: Global – Unituxin Sales Forecast (US$ Million), 2020-2028
Figure 10-1: Global – Unituxin Reimbursed Sales (%)
Figure 10-2: Global – Unituxin Incremental Budget Impact (US$/3 Years)
Figure 11-1: Global – Number of Unituxin Related Clinical Trials by Phase, October’2021
Figure 11-2: Global – TROP2 Related Clinical Trials by Phase (%), October’2021
Figure 11-3: Global – Number of Unituxin Related Clinical Trials by Development Status, October’2021
Figure 11-4: Global – Number of Unituxin Related Clinical Trials by Development Status (%), October’2021
Figure 11-5: Global – Number of Unituxin Related Clinical Trials by Region, October’2021
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