Abstract
Acalabrutinib, marketed as Calquence, is a second-generation Bruton's tyrosine kinase (BTK) inhibitor developed by AstraZeneca for the treatment of various B-cell malignancies. Since its approval in 2017, it has shown significant clinical efficacy and has been introduced into multiple global markets. This paper provides a comprehensive analysis of acalabrutinib, covering 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
Acalabrutinib, Calquence, Bruton's tyrosine kinase inhibitor, chemical properties, market analysis, global sales, generics.
Introduction
Acalabrutinib is an oral BTK inhibitor designed to provide sustained inhibition of the BTK protein, crucial for the proliferation and survival of malignant B cells. Its development offers a therapeutic option for patients with various hematologic cancers, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
Chemical Properties
Acalabrutinib has the chemical formula C26H23N7O2 and a molar mass of approximately 465.52 g·mol−1. Its IUPAC name is 4-{8-Amino-3-[(2S)-1-(2-butynoyl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl}-N-(2-pyridinyl)benzamide. The compound's structure enables selective and irreversible inhibition of BTK, contributing to its efficacy in treating B-cell malignancies.
Development and Approval Timeline
October 2017: The U.S. FDA approved acalabrutinib (Calquence) for treating adults with MCL who have received at least one prior therapy.
January 2019: FDA approved acalabrutinib for treating adults with CLL or small lymphocytic lymphoma (SLL).
November 2020: European Medicines Agency (EMA) approved acalabrutinib for treating CLL and MCL in the European Union.
January 2025: FDA granted traditional approval to acalabrutinib, in combination with bendamustine and rituximab, for treating adults with previously untreated MCL who are ineligible for autologous hematopoietic stem cell transplantation. FDA also approved acalabrutinib as a single agent for adults with previously treated MCL.
Time on the Market
Since its initial approval in 2017, acalabrutinib has been available for over seven years. Its sustained presence in the market underscores its significance in treating B-cell malignancies, with ongoing research potentially expanding its therapeutic applications.
Global Sales and Market Competition
In 2022, Calquence achieved notable sales milestones:
Global Sales: Totaled $2.057 billion for the year, reflecting a 66% increase compared to 2021.
Fourth Quarter Sales: Reached $558 million, marking a 49% year-over-year growth.
The BTK inhibitor market is competitive, with alternatives like ibrutinib (Imbruvica) present. Calquence differentiates itself with its unique pharmacokinetic profile, offering once or twice daily dosing options. The increasing adoption of Calquence is attributed to its efficacy and improved safety profile compared to first-generation BTK inhibitors.
Generics and Related Developments
As of February 2024, there is no publicly available information regarding generic versions of acalabrutinib entering the market. The patent protection and exclusivity rights held by AstraZeneca are expected to delay the introduction of generic formulations for several years.
Speculated Sales Figures (2020–2024)
Based on available data and market trends, estimated global sales of acalabrutinib are as follows:
2020: Approximately $500 million.
2021: Approximately $1.2 billion.
2022: Approximately $2.057 billion.
2023: Projected around $2.5 billion.
2024: Projected around $3 billion.
The significant growth from 2020 to 2022 is attributed to expanded approvals, increased market adoption, and effective marketing strategies. The projections for 2023 and 2024 anticipate continued growth as Calquence gains further acceptance in the oncology community and additional indications are explored.
Conclusion
Acalabrutinib has substantially impacted the treatment landscape for B-cell malignancies 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
[FDA Approves Calquence with Bendamustine and Rituximab for MCL](https://www.fda.gov/news-events/press-announcements/fda-approves-calquence-bendamust
Active Pharmaceutical Ingredient
1420477-60-6
Acalabrutinib, (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
