Ayvakit Patent, Sales & Clinical Trials Insight 2028 Report Analysis & Data Highlights:
- Ayvakit Patent Insight
- Ayvakit Dosage & Price
- Ayvakit Sales Forecast 2028: > USD 1 Billion
- Ayvakit Role in Cancer Therapy
- Ayvakit Structure & Pharmacokinetics Properties
- Ayvakit Ongoing Clinical Trials: > 10 Clinical Studies
- Ayvakit Reimbursement Scenario
Avapritinib (formerly BLU-285) developed by Blueprint Medicines Corporation is a selective and potent inhibitor of KIT and PDGFRA that shows activity against resistance mutations in the activation loop of each kinase (exons 17/18 and exon 18, respectively) in addition to other well-characterized disease-driving KIT mutants. The drug is sold under the brand name Ayvakit (US)/ Ayvakyt (Europe). Initially, the drug was granted orphan status by US FDA. However in January 2020, US FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. In June 2021, the drug was further granted approval for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL).
Apart from US, the drug was also granted approval by European Commission in 2020. In China, the drug was market by Cstone Therapeutics and was recently granted approval in 2021 for the management of GIST only. The rapid approval of the drug in different regions of the world will propel the market during the forecast period. Owing to its specific mechanism of action, it has been shown that the drug Ayvakit has superior efficacy than approved drugs of this class. In addition, it has the ability to overcome the limitations of other conventional cancer therapies which will further boost the growth of market.
Apart from approved indications, several ongoing studies are evaluating the role of Ayvakit in the management of other cancers including colorectal cancer, breast cancer, lung cancer, melanoma, and others. The majority of these studies are present in phase-II clinical trials. Therefore, this report suggests that coming years will witness extended approval of drug in wide range of cancers, which will boost the market growth. In addition, the drug will not face any competition from generic drug, which will also have a positive impact on the growth of market.
Despite several favorable parameters, the overall market will mainly be restricted by high cost of therapy, long duration of drug development, and stringent regulatory norms. However, advancement in the field of science and innovation has led to the development of new technologies which will ease the drug designing process. Moreover, rising initiatives by government and pharmaceutical giants has led to development of favorable reimbursement policies which enhance their uptake in market. For instance, YourBlueprint program was initiated to provide coverage for patients using Ayvakit.
Keeping in mind the sales in previous years and ongoing clinical trials, the report analyzes that the global sales will reach US$ 1 Billion by 2028. The overall market for PDGFR inhibitor is highly competitive and includes several potential candidates in development pipelines. The rapid approval of drugs from this class will have a negative impact on the growth of Ayvakit market. Geographically, US will continue to dominate the market owing to high adoption rates of approved Ayvakit. In addition, the presence of well-developed technology, increase patient base, robust research and development activities, and high investment in the healthcare sectors is aiding to promote the growth of market in the region.
Table of Contents
1. Ayvakit (Avapritinib) - Approval & Patents
1.1 Overview
1.2 Patents & Assignees
2. Ayvakit Commercial Insight
2.1 Price & Dosage
2.2 Sales Analysis
3. Ayvakit Mechanism of Action
4. Ayvakit Role in Cancer
5. Ayvakit Role in Other Therapeutic Indications
6. Ayvakrit Supplementary Information
6.1 Use in Specific Population
6.2 Adverse Reactions
6.3 Drug Interactions
7. Ayvakit Structure & Pharmacokinetics Properties
8. Global Ayvakit Market Analysis
9. Ayvakit Future Market Opportunity by Indication
9.1 Gastrointestinal Tumors
9.2 Mastocytosis
9.3 Lung Cancer
9.4 Colorectal Cancer
10. Ayvakit Sales Forecast 2028
11. Ayvakit Clinical Trial Insights
11.1 By Phase
11.2 By Region
11.3 By Status
11.4 Ongoing Clinical Trials
12. Ayvakit Reimbursement Scenario
13. Competitive Landscape
13.1 Arog Pharmaceuticals
13.2 AstraZeneca
13.3 Bayer
13.4 Blueprint Medicine
13.5 Boehringer Ingelheim
13.6 Clovis Oncology
13.7 Deciphera Pharmaceuticals
13.8 Eli Lilly
13.9 Gilead Sciences
13.10 Pfizer
13.11 Tyrogenex
13.12 Zai Lab
List of Figures
Figure 1-1: Ayvakit - US & Europe Orphan Drug Designation Approval
Figure 1-2: US - Ayvakit FDA Approval Year by Indication
Figure 1-3: Ayvakit - Approval Year by Region
Figure 1-4: US - Avyakit Patent Approval & Expiration Year
Figure 2-1: US - Cost of Supply of 30 Tablets & Per Unit Cost of Ayvakit Oral Tablet (US$), October’2021
Figure 2-2: Europe - Cost of Supply of 30 Tablets & Per Unit Cost of Ayvakit Oral Tablet (Euro/US$), October’2021
Figure 2-3: Ayvakit - Recommended Initial & Minimum Dose by Indication (mg/day)
Figure 2-4: Ayvakit - Recommended Initial & Reduced Dose in Patients with GIST (mg/day)
Figure 2-5: Ayvakit - Recommended Initial & Reduced Dose in Patients with Mastocytosis (mg/day)
Figure 2-6: US - Average Cost of Daily, Monthly & Annual Treatment with Ayvakit (US$)
Figure 2-7: Global - Ayvakit Quarterly Sales (US$ Million), 2020
Figure 2-8: Global - Ayvakit Quarterly Sales (US$ Million), Q1 & Q2’2021
Figure 3-1: PDGFR’s Pathway, Receptors, Ligands & Functions
Figure 3-2: PDGFR Stimulated Effectors, Biomarkers & Cell Signaling Pathways
Figure 3-3: PDGFR Inhibitors - Mechanism of Action
Figure 3-4: Ayvakit - Mechanism of Action
Figure 4-1: PDGF Signaling in Cancer Progression
Figure 5-1: Role of PDGFR Inhibitors in Neurological Disorders
Figure 5-2: Potential Role of PDGFR Inhibitors in Asthma
Figure 7-1: Ayvakit - Chemical Structure
Figure 8-1: Global - Cancer Incidences & Deaths (Million), 2020 & 2025
Figure 8-2: Global - PDGFR Inhibitor Market by Product (US$ Million), 2020
Figure 8-3: Global - PDGFR Inhibitor Market by Product (%), 2020
Figure 8-4: Global - PDGFR Inhibitor Market by Product (US4 Million), H1’2021
Figure 8-5: Global - PDGFR Inhibitor Market by Product (%), H1’2021
Figure 9-1: Global - Estimated GIST Cancer Cases, 2021 - 2028
Figure 9-2: Global - Ayvakit Market Opportunity in GIST by 2% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-3: Global - Ayvakit Market Opportunity in GIST by 4% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-4: Global - Ayvakit Market Opportunity in GIST by 6% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-5: Global - Ayvakit Market Opportunity in GIST by 8% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-6: Global - Ayvakit Market Opportunity in GIST by 10% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-7: Global - Ayvakit Market Opportunity in GIST by 12% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-8: Global - Ayvakit Market Opportunity in GIST by 14% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-9: Global - Ayvakit Market Opportunity in GIST by 16% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-10: Global - Ayvakit Market Opportunity in GIST by 18% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-11: Global - Ayvakit Market Opportunity in GIST by 20% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-12: Global - Estimated Systemic Mastocytosis Cases, 2021 - 2028
Figure 9-13: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 2% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-14: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 4% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-15: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 6% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-16: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 8% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-17: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 10% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-18: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 12% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-19: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 14% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-20: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 16% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-21: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 18% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-22: Global - Ayvakit Market Opportunity in Systemic Mastocytosis by 20% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-23: Global - Estimated Lung Cancer Cases, 2021 - 2028
Figure 9-24: Global - Estimated PDGFR Mutated Lung Cancer Cases, 2021 - 2028
Figure 9-25: Global - Ayvakit Market Opportunity in Lung Cancer by 1% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-26: Global - Ayvakit Market Opportunity in Lung Cancer by 2% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-27: Global - Ayvakit Market Opportunity in Lung Cancer by 3% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-28: Global - Ayvakit Market Opportunity in Lung Cancer by 4% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-29: Global - Ayvakit Market Opportunity in Lung Cancer by 5% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-30: Global - Estimated Colorectal Cancer Cases, 2020-2028
Figure 9-31: Global - Estimated Metastatic Colorectal Cancer Cases, 2020-2028
Figure 9-32: Global - Ayvakit Market Opportunity in Colorectal Cancer by 1% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-33: Global - Ayvakit Market Opportunity in Colorectal Cancer by 2% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-34: Global - Ayvakit Market Opportunity in Colorectal Cancer by 3% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-35: Global - Ayvakit Market Opportunity in Colorectal Cancer by 4% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-36: Global - Ayvakit Market Opportunity in Colorectal Cancer by 5% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-37: Global - Ayvakit Market Opportunity in Colorectal Cancer by 6% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-38: Global - Ayvakit Market Opportunity in Colorectal Cancer by 7% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-39: Global - Ayvakit Market Opportunity in Colorectal Cancer by 8% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-40: Global - Ayvakit Market Opportunity in Colorectal Cancer by 9% Adoption Rate (US$ Million), 2021 - 2028
Figure 9-41: Global - Ayvakit Market Opportunity in Colorectal Cancer by 10% Adoption Rate (US$ Million), 2021 - 2028
Figure 10-1: Global - Ayvakit Sales Forecast (US$ Million), 2021 - 2028
Figure 11-1: Avapritinib - Number of Clinical Trials by Phase, October’2021
Figure 11-2: Avapritinib - Number of Clinical Trials by Phase (%), October’2021
Figure 11-3: Avapritinib - Number of Clinical Trials by Region, October’2021
Figure 11-4: Avapritinib - Number of Clinical Trials by Status, October’2021
Figure 11-5: Avapritinib - Number of Clinical Trials by Status (%), October’2021
Figure 11-6: Ayvakit - Start & Completion Year of Avapritinib in Adult Solid Tumors
Figure 11-7: Ayvakit - Start & Completion Year of Avapritinib in Pediatric Solid Tumors
Figure 11-8: Ayvakit - Start & Completion Year of Avapritinib in GIST
Figure 11-9: Ayvakit - Start & Completion Year of Drug-Drug Interaction
Figure 12-1: Ayvakit - Total Treatment Cost & Reimbursement Cost
Figure 12-2: Ayvakit - 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:
- Arog Pharmaceuticals
- AstraZeneca
- Bayer
- Blueprint Medicine
- Boehringer Ingelheim
- Clovis Oncology
- Deciphera Pharmaceuticals
- Eli Lilly
- Gilead Sciences
- Pfizer
- Tyrogenex
- Zai Lab
