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VERZENIO's Market Potential Soars as Demand for CDK4/6 Inhibitors Grows | DelveInsight
VERZENIO (abemaciclib) is a prescription medication used to treat adults with HR-positive, HER2-negative breast cancer that has metastasized (spread to other parts of the body). It is administered orally and is prescribed in combination with an aromatase inhibitor as an initial endocrine-based therapy. Additionally, the drug is being developed for the treatment of prostate cancer.
VERZENIO is approved for the following indications:
Learn more about VERZENIO projected market size for breast cancer @
HR+/HER2- breast cancer is the most common subtype of breast cancer, defined by the presence of estrogen and progesterone hormone receptors but lacking HER2 overexpression. This form of breast cancer generally has a favorable prognosis and is primarily managed with hormone therapy to suppress hormone-driven tumor growth.
According to DelveInsight's estimates, around new cases of HR+/HER2− breast cancer were reported in the US in 2024. Over the past decade, endocrine therapy has remained the cornerstone of treatment, including for cases with visceral involvement. The current preferred approach involves combining endocrine therapy—using aromatase inhibitors or fulvestrant—with CDK4/6 inhibitors.
The approval of CDK4/6 inhibitors has significantly transformed the treatment landscape for HR+/HER2− breast cancer. Currently, five selective CDK4/6 inhibitors— —are used in combination with endocrine therapy. In November 2023 , the FDA approved TRUQAP (capivasertib) in combination with FASLODEX for patients with advanced HR+/HER2− breast cancer harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN).
The NCCN Guidelines have designated KISQALI as the only Category 1 Preferred CDK4/6 inhibitor for first-line treatment in combination with an aromatase inhibitor, strengthening its position in the U.S. market. This led to KISQALI recovering its lost market share, with its U.S. revenue contribution rebounding to 50%, following declines to 46% in 2020, 36% in 2021, and 38% in 2022.
In January 2025 , the FDA approved DATROWAY for patients with unresectable or metastatic HR+/HER2- breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) who had previously received endocrine-based therapy and chemotherapy. Additionally, ENHERTU was approved for patients with unresectable or metastatic HR+, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that had progressed after at least one prior endocrine therapy in the metastatic setting.
Also, in January 2025 , Roche reported positive topline results from its Phase III INAVO120 trial, assessing ITOVEBI in combination with IBRANCE and fulvestrant for patients with PIK3CA-mutated HR+/HER2−, endocrine-resistant, locally advanced, or metastatic breast cancer.
Among the seven major markets, the US accounted for the largest market share in HR+/HER2− breast cancer, generating in revenue in 2023. The market is expected to experience substantial growth from 2025 to 2034, driven by the introduction of novel therapeutic options.
Discover more about the breast cancer market in detail @
Some of the competing emerging key players in HR+/HER2- breast cancer market are, (KEYTRUDA), (ARV-471 (vepdegestrant)), (OP1250 (palazestrant)), (Gedatolisib), (Giredestrant (RG6171, GDC-9545); Inavolisib), (Datopotamab Deruxtecan (Dato-DXd)), (Camizestrant (AZD9833); Capivasertib), (LY3484356/Imlunestrant), (Lasofoxifene), (Enobosarm), (DB-1303), (SFX-01), (Samuraciclib (CT-7001)), (Lerociclib), (Eftilagimod Alpha (LAG-3lg/IMP321)), and others.
To know more about the number of competing drugs in development, visit @
Discover how VERZENIO is shaping the breast cancer treatment landscape @
The of VERZENIO enhances patient convenience, while its of adult patients with HR+/HER2- early breast cancer highlights its role as a differentiated CDK4/6 inhibitor in reducing the risk of recurrence. The is driving market demand for effective treatments like VERZENIO. Additionally, its demonstrated and its ability to penetrate the central nervous system further strengthen its market position. and among healthcare providers also contribute to its adoption.
However, its adoption may be hindered by , including severe or life-threatening lung inflammation and serious liver problems. in certain regions could also limit market penetration. Competition from other CDK4/6 inhibitors such as poses a challenge, along with concerns over long-term safety data. Additionally, the to meet primary endpoints in mCRPC, which may impact its broader clinical prospects and investor confidence.
Dive deeper to get more insight into VERZENIO's strengths & weaknesses relative to competitors @
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including among others.
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Shruti Thakur
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