Osimertinib,Markets and News,API,Osimertinib,1421373-66-1,ANQING CHICO PHARMACEUTICAL
Abstract
Osimertinib, marketed as Tagrisso, is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor developed by AstraZeneca for the treatment of non-small-cell lung cancer (NSCLC) with specific EGFR mutations. Since its approval in 2015. it has significantly impacted NSCLC therapy. This paper provides an in-depth analysis of osimertinib, including its chemical properties, development history, approval timeline, market presence, competitive landscape, and the emergence of generic formulations. Additionally, it offers speculative sales figures from 2020 to 2024 based on available data and market trends.
Keywords
Osimertinib, Tagrisso, EGFR tyrosine kinase inhibitor, chemical properties, market analysis, global sales, generics.
Introduction
Osimertinib is an oral EGFR tyrosine kinase inhibitor designed to selectively target both activating and resistance mutations of the EGFR protein, including the T790M mutation. Its development offers a therapeutic option for patients with advanced stages of NSCLC harboring these mutations.
Chemical Properties
Osimertinib has the chemical formula C28H33N7O2 and a molar mass of approximately 499.62 g·mol−1. Its IUPAC name is N-(2-{2-(dimethylamino)ethylamino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide. The compound's structure enables selective and irreversible inhibition of EGFR mutations, contributing to its efficacy in treating NSCLC.
Development and Approval Timeline
November 2015: The U.S. FDA granted accelerated approval to osimertinib for treating EGFR T790M mutation-positive NSCLC.
February 2016: The European Medicines Agency (EMA) provisionally approved osimertinib under an accelerated process—the first approval under the program.
December 2020: FDA approved osimertinib for adjuvant treatment of patients with EGFR-mutated NSCLC following tumor resection.
February 2024: FDA approved osimertinib, in combination with platinum-based chemotherapy, for treating EGFR-mutated NSCLC.
September 2024: FDA approved osimertinib for adults with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following chemoradiation therapy.
Time on the Market
Since its initial approval in 2015. osimertinib has been available for over a decade. Its sustained presence in the market underscores its significance in treating EGFR-mutated NSCLC, with ongoing research potentially expanding its therapeutic applications.
Global Sales and Market Competition
In 2024. AstraZeneca reported significant sales for osimertinib:
China Market Sales: Osimertinib achieved sales of USD 6.6 billion in China.
The global osimertinib market is experiencing robust growth, with projections indicating a compound annual growth rate (CAGR) of 16.1% from 2024 to 2028. This growth is attributed to factors such as increasing lung cancer incidence and the drug's efficacy.
The EGFR-TKI market is competitive, with osimertinib facing competition from other EGFR inhibitors like erlotinib and gefitinib. However, osimertinib's efficacy, particularly against the T790M resistance mutation, has solidified its market position.
Generics and Related Developments
As of February 2024. generic versions of osimertinib have not significantly penetrated the market. The introduction of generics is anticipated to increase market competition and potentially impact pricing strategies.
Speculated Sales Figures (2020–2024)
Based on available data and market trends, estimated global sales of osimertinib are as follows:
2020: Approximately $3 billion.
2021: Approximately $4.5 billion.
2022: Approximately $5.5 billion.
2023: Projected around $6.5 billion.
2024: Projected around $7 billion.
The consistent growth from 2020 to 2024 is attributed to expanded approvals, increased market adoption, and effective marketing strategies. The projections for 2023 and 2024 anticipate continued growth as osimertinib gains further acceptance in the oncology community and additional indications are explored.
Conclusion
Osimertinib has substantially impacted the treatment landscape for EGFR-mutated NSCLC since its introduction, offering patients effective therapeutic options. Its market trajectory reflects both its clinical value and the evolving dynamics of the pharmaceutical industry, including competition, pricing strategies, and the potential emergence of generic alternatives in the future. Ongoing research and market adaptations will continue to shape its role in oncology therapeutics.
References
Osimertinib - Wikipedia
AstraZeneca 2024 Financial Report
Osimertinib Drugs Global Market Report
Active Pharmaceutical Ingredient
1421373-66-1
Osimertinib, (chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!
Disclaimer:Products are only available to countries where there is no valid patent protection. Products still covered by patents rights are available exclusively for experimental or registration purpose pursuant to national applicable law, and shall be sold in strict accordance with the laws of the People's Republic of China and the laws of the Buyer's country. All products are not for human use. Buyer is obligated for evaluation of the patent situation in its domestic market and shall be held liable for uses which do not fall within the scope of the experimental or registration use exception and are not permitted by national applicable law.
References or other information:
FDA、Wikipedia、Chatgpt、DeepSeek、chemicalbook
If there is any infringement, please apologize and delete. If there are any errors, welcome to criticize and correct.
Under no circumstances shall the information or opinions expressed herein be construed as investment advice for any person.
International Department:
Copyright(C)2018 Anqing Chico Pharmaceutical Co., Ltd.
Supported byChinaChemNet
