Introduction to Epirubicin Hydrochloride
Epirubicin hydrochloride, a member of the anthracycline class of drugs, is widely used in the treatment of various cancers, particularly breast cancer. It is known for its efficacy and relatively lower side effect profile compared to other anthracyclines like doxorubicin.
Clinical Trials Overview
Ongoing and Recent Trials
Several clinical trials are currently underway or have recently been completed to evaluate the efficacy and safety of epirubicin hydrochloride in different clinical settings.
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Phase I Trials: A clinical trial registered in the EU Clinical Trials Register (EudraCT Number: 2016-004269-14) is ongoing, focusing on human pharmacology (Phase I) and the first administration of epirubicin to humans. This trial aims to assess the efficacy and safety of epirubicin in its initial stages of human testing[1].
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Physiologically Based Pharmacokinetic (PBPK) Models: A study published in MDPI describes the development and evaluation of a full-body PBPK model to predict systemic and individual organ exposure to epirubicin. This model helps in understanding the pharmacokinetics of epirubicin, which is crucial for optimizing dosing regimens[3].
Specific Trials in Breast Cancer
- CompassHER2 Trials: While not exclusively focused on epirubicin, the CompassHER2 trials provide insight into the treatment landscape of HER2-positive breast cancer, a context in which epirubicin might be used. These trials compare the efficacy of trastuzumab emtansine (T-DM1) with and without tucatinib in preventing relapses in high-risk patients. Although epirubicin is not the primary drug under investigation, the trial's design and outcomes can inform strategies for adjuvant therapies in breast cancer[4].
Market Analysis
Current Market Size and Growth
The global epirubicin hydrochloride market has experienced significant growth in recent years and is projected to continue this trend.
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Market Size: As of 2021, the global epirubicin market was valued at $191.66 million. It is expected to reach $243.99 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 3.60% from 2022 to 2028[5].
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Segmentation: The market is segmented based on type (10mg/5ml, 50mg/25ml, and others) and application (primarily cancer treatment). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa are also key segments[2].
Drivers and Restraints
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Drivers: The increasing incidence of breast cancer and other cancers, combined with the preference for epirubicin over other anthracyclines due to its lower side effect profile, are driving the market growth. Advances in clinical trials and the development of more precise pharmacokinetic models also contribute to the market's expansion[3][5].
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Restraints: Despite its advantages, the market faces restraints such as the availability of alternative treatments and the potential for adverse effects, although these are generally milder compared to other anthracyclines.
Market Projections
Forecast Period
- 2023-2031: The epirubicin hydrochloride market is expected to see robust growth over the forecast period. Projections indicate a consistent upward trend in market dynamics, reflecting strong growth rates. The market is anticipated to undergo significant development, driven by increasing demand and advancements in treatment protocols[2].
Key Factors Influencing Growth
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Product Penetration: The extent of product penetration at both national and regional levels is a critical factor. The report highlights that market dynamics are influenced by product pricing, consumer behavior, and the economic, political, and social landscapes of countries[2].
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Competitive Landscape: The competitive surroundings, including key players and their strategies, play a significant role in shaping the market. The thorough segmentation of the market ensures a comprehensive analysis from various angles, aiding in optimizing ongoing marketing strategies[2].
Epirubicin Hydrochloride in Clinical Practice
FDA Approval and Use
Epirubicin hydrochloride was FDA-approved in 1999 under the trade name Ellence for adjuvant therapy in treating axillary node-positive breast cancers following resection. It is preferred over doxorubicin due to its lower cardiotoxicity and other side effects[5].
Mechanism of Action
Epirubicin hydrochloride exerts its antineoplastic effects by targeting the replication of DNA. It is an antibiotic isolated from the gram-positive bacteria Streptomyces and is commonly used as a chemotherapy agent[5].
Conclusion
Epirubicin hydrochloride remains a vital component in the treatment of breast cancer and other malignancies. The ongoing clinical trials and advancements in pharmacokinetic modeling are expected to further optimize its use. The market for epirubicin hydrochloride is poised for significant growth, driven by increasing demand and favorable market dynamics.
Key Takeaways
- Clinical Trials: Ongoing trials are focusing on the pharmacology and safety of epirubicin hydrochloride.
- Market Growth: The global market is expected to grow at a CAGR of 3.60% from 2022 to 2028.
- Segmentation: The market is segmented by type, application, and geographical region.
- Drivers and Restraints: Increasing cancer incidence and preference over other anthracyclines drive the market, while alternative treatments and potential side effects act as restraints.
- Clinical Use: Epirubicin hydrochloride is FDA-approved for adjuvant therapy in breast cancer and is preferred due to its lower side effect profile.
FAQs
What is the current market size of the epirubicin hydrochloride market?
The global epirubicin hydrochloride market was valued at $191.66 million in 2021 and is projected to reach $243.99 million by 2028[5].
What are the primary applications of epirubicin hydrochloride?
Epirubicin hydrochloride is primarily used in the treatment of breast cancers, particularly after surgical resection[5].
Why is epirubicin hydrochloride preferred over other anthracyclines?
Epirubicin hydrochloride is preferred due to its lower side effect profile, especially lower cardiotoxicity compared to doxorubicin[5].
What is the expected growth rate of the epirubicin hydrochloride market?
The market is expected to grow at a CAGR of 3.60% from 2022 to 2028[5].
Are there any ongoing clinical trials for epirubicin hydrochloride?
Yes, there are ongoing clinical trials, including Phase I trials and studies focusing on pharmacokinetic modeling[1][3].
Sources
- EU Clinical Trials Register: "EudraCT Number: 2016-004269-14"
- Market Research Intellect: "Global Epirubicin Hydrochloride Market Size, Trends and Projections"
- MDPI: "A Physiologically Based Pharmacokinetic Model to Predict Systemic and Individual Organ Exposure to Epirubicin"
- Yale Medicine: "The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer)"
- Research and Markets: "Epirubicin Market Forecast to 2028 - COVID-19 Impact and Global Analysis"
