Ayvakit Patent, Sales and Clinical Trials Insight 2028 Report Analysis and Data Highlights:
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, our 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.