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Trikafta Patent, Sales & Clinical Trials Outlook 2028

Trikafta Patent, Sales & Clinical Trials Outlook 2028

The successful mapping of human genome and advances in molecular technology has led to evolution of targeted therapies. The identification of cystic fibrosis transmembrane conductor regulator (CFTR) gene and its potential role in the progression of cystic fibrosis has surged the research and development of targeted drugs towards CFTR genes. Researchers have developed CFTR modulator agents which are small molecules which modulate the function of abnormal CFTR protein. To date, four CFTR modulators have been approved for the treatment of cystic fibrosis.

Trikafta is the first triple combinational therapy involving elexacaftor, tezacaftor, and ivacaftor. The Trikafta drug is indicated for the management of cystic fibrosis in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The novel drug Trikafta was designed to increase the quantity and function of the F508del-CFTR protein at the cell surface. The drug has gained approval in US and Europe. It is expected that the Trikafta drug will also be approved in China and Japan during the forecast period, which will further propel the market.

The approval of drug Trikafta was supported by the positive results of two global Phase 3 studies in people ages 12 years and older with cystic fibrosis including a 24-week Phase 3 study in 403 people with one F508del mutation and one minimal function mutation (F/MF) and a 4-week Phase 3 study in 107 people with two F508del mutations (F/F). The results from the trial indicated that clinically meaningful improvements were seen in patients and the drug has demonstrated safety and tolerability in cystic fibrosis patients.

The entrance of the drug Trikafta has greatly revolutionized the overall cystic fibrosis treatment as it combines the properties of all three previously approved CFTR modulators. Owing to its high specificity towards of cystic fibrosis transmembrane conductor regulator (CFTR) gene and ability to overcome the resistance limitations of already approved drugs, the report analyzes that the coming years will witness high growth rates in the global sales of Trikafta.

Important advances in the clinical outcomes have been shown since the introduction of Trikafta. Unfortunately, the therapy is currently associated with substantial cost and as results is not available for all eligible patients. However, considerable initiatives by government and public sectors have led to the development of favorable reimbursement policies which aim to enhance their uptake in market. For instance, Vertex GPS program was developed which provide financial support services, reimbursement support, and ongoing product-related materials for eligible enrolled patients who have been prescribed Trikafta.

The report offers compressive analysis on the growth of Trikafta market during the forecast period 2021-2028 by taking into considerations several parameters including previous sales, competition from other drugs, increasing prevalence of cystic fibrosis, and unmet need of targeted drugs. The overall CFTR modulator market is highly competitive and consists of several pharmaceutical companies including Vertex Pharmaceuticals, Eloxx, Recode Therapeutics and Corbus Pharma which are investing huge amount in the development of novel CFTR modulators in the management of disease.

As per report findings, the global Trikafta market is estimated to surpass USD 5 Billion by 2028. The high growth rate during the forecast period can be justified by the high adoption rates in US and Europe. In addition, several ongoing clinical trials are also evaluating the role of drug in other mutations in different age groups, which are expected to gain approval in coming years.

• Trikafta Patent Insight
• Trikafta Dosage & Price
• Trikafta Sales Forecast 2028: > USD 5 Billion
• Trikafta Chemistry & Pharmacokinetic Properties
• Trikafta Ongoing Clinical Trials: > 15 Clinical Studies
• Role in Cystic Fibrosis
• Trikafta Reimbursement Scenario

1. Elexacaftor/Ivacaftor/Tezacaftor (Trikafta/Kaftrio)
1.1 Overview
1.2 Patent & Assignees

2. Trikafta Commercial Information
2.1 Pricing & Dosage Analysis
2.2 Sales Analysis

3. Role in Cystic Fibrosis

4. Trikafta Mechanism of Action

5. Trikafta: Chemistry & Pharmacokinetic Properties

6. Trikafta Sales Forecast 2028

7. Trikafta Supplementary Information
7.1 Drug Interactions
7.1.1 Potential for other drugs to affect elexacaftor/tezacaftor/ivacaftor
7.1.2 Potential for elexacaftor/tezacaftor/ivacaftor to affect other drugs
7.2 Adverse Events
7.3 Use in Specific Population

8. Trikafta Reimbursement

9. Trikafta Clinical Trial Insights
9.1 By Phase
9.2 By Region
9.3 By Status


10. Global Market Analysis
10.1 Current Market Scenario
10.2 Future Market Opportunity

11. Ongoing Clinical Trials

12. Competitive Landscape
12.1 Abbvie
12.2 Eloxx Pharmaceuticals
12.3 GlaxoSmithKline
12.4 Mylan
12.5 Recode Therapeutics
12.6 Roche
12.7 Southern Research Institute
12.8 Spirovant Sciences
12.9 Translate Bio
12.10 Vertex Pharmaceuticals

List of Figures
Figure 1-1: US - Trikafta Orphan Drug Designation & FDA Approval Year
Figure 1-2: Europe - Trikafta Orphan Drug Designation & EMA Approval Year
Figure 1-3: US - Trikafta FDA Approval History by Mutation
Figure 1-4: US - Trikafta FDA Approval History in F508del Mutation by Age
Figure 1-5: Trikafta/Kaftrio - Initial Approval Year by Region
Figure 1-6: Europe - Kaftrio Approval & Patent Expiration Year
Figure 1-7: US - Trikafta Approval & Patent Expiration Year
Figure 1-8: US - Trikafta Patent Approval & Expiration Year

Figure 2-1: US - Cost of Supply of 84 Oral Tablet & Per Unit Cost of Trikafta Oral Tablet (US$), October'2021
Figure 2-2: Europe - Cost of Supply of 56 Oral Tablet & Per Unit Cost of Kaftrio Oral Tablet (Euro/US$), October'2021
Figure 2-3: UK - Cost of Supply of 56 Oral Tablet & Per Unit Cost of Kaftrio Oral Tablet (Euro/US$), October'2021
Figure 2-4: Trikafta/Kaftrio - Recommended Initial & Reduced Dose (mg/day)
Figure 2-5: Trikafta – Average Cost of Daily, Monthly & Annual Treatment of Cystic Fibrosis (US$), October'2021
Figure 2-6: Global - Trikafta/Kaftrio Annual Sales (US$ Million), 2019 & 2020
Figure 2-7: Global - Trikafta/Kaftrio Quarterly Sales (US$ Million), 2020
Figure 2-8: Global - Trikafta/Kaftrio Quarterly Sales (US$ Million), Q1 & Q2’2021

Figure 3-1: Frequency of CFTR Mutation by Class

Figure 4-1: CFTR Modulators – Specific Target for Different Approaches
Figure 4-2: Trikafta – Mechanism of Action at Molecular Level

Figure 5-1: Elexacaftor – Chemical Structure
Figure 5-2: Chemical Structure of Ivacaftor & Tezacaftor

Figure 6-1: Trikafta – Expected Sales Analysis (US$ Million), 2021 - 2028

Figure 9-1: Trikafta – Number of Clinical Trials by Phase, October’2021
Figure 9-2: Trikafta – Number of Clinical Trials by Phase (%), October’2021
Figure 9-3: Trikafta – Number of Clinical Trials by Region, October’2021
Figure 9-4: Trikafta – Number of Clinical Trials by Region (%), October’2021
Figure 9-5: Trikafta – Number of Clinical Trials by Status, October’2021
Figure 9-6: Trikafta – Number of Clinical Trials by Status (%), October’2021

Figure 10-1: Global – CFTR Modulator Market by Product (US$ Billion), 2020
Figure 10-2: Global – CFTR Modulator Market by Product (%), 2020
Figure 10-3: Global – CFTR Modulator Market by Product (US$ Billion), H1’2021
Figure 10-4: Global – CFTR Modulator Market by Product (%), H1’2021
Figure 10-5: Global – Estimated Cystic Fibrosis Incidence, 2021-2028
Figure 10-6: Global – Trikafta Market Opportunity in Cystic Fibrosis by 5% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-7: Global – Trikafta Market Opportunity in Cystic Fibrosis by 10% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-8: Global – Trikafta Market Opportunity in Cystic Fibrosis by 15% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-9: Global – Trikafta Market Opportunity in Cystic Fibrosis by 20% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-10: Global – Trikafta Market Opportunity in Cystic Fibrosis by 25% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-11: Global – Trikafta Market Opportunity in Cystic Fibrosis by 30% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-12: Global – Trikafta Market Opportunity in Cystic Fibrosis by 35% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-13: Global – Trikafta Market Opportunity in Cystic Fibrosis by 40% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-14: Global – Trikafta Market Opportunity in Cystic Fibrosis by 45% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-15: Global – Trikafta Market Opportunity in Cystic Fibrosis by 50% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-16: US – Estimated Cystic Fibrosis Incidence, 2021-2028
Figure 10-17: US – Trikafta Market Opportunity in Cystic Fibrosis by 5% Adoption Rate (US$ Million), 2021 - 2028

Figure 10-18: US – Trikafta Market Opportunity in Cystic Fibrosis by 10% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-19: US – Trikafta Market Opportunity in Cystic Fibrosis by 15% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-20: US – Trikafta Market Opportunity in Cystic Fibrosis by 20% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-21: US – Trikafta Market Opportunity in Cystic Fibrosis by 25% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-22: US – Trikafta Market Opportunity in Cystic Fibrosis by 30% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-23: US – Trikafta Market Opportunity in Cystic Fibrosis by 35% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-24: US – Trikafta Market Opportunity in Cystic Fibrosis by 40% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-25: US – Trikafta Market Opportunity in Cystic Fibrosis by 45% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-26: US – Trikafta Market Opportunity in Cystic Fibrosis by 50% Adoption Rate (US$ Million), 2021 - 2028

Figure 11-1: Trikafta – Phase-III Evaluating Long Term Efficacy in CF with F508del Mutation Initiation & Completion Year
Figure 11-2: Trikafta – Phase-III Evaluating Long Term Efficacy in CF with F/MF Mutation Initiation & Completion Year
Figure 11-3: Trikafta – Phase-III Evaluating Effect on Cough & Physical Activity Initiation & Completion Year
Figure 11-4: Trikafta – Phase-III Evaluating Glucose Tolerance in CF Initiation & Completion Year

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

Report Title: Trikafta Patent, Sales & Clinical Trials Outlook 2028


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