The U.S. is experiencing a substantial rise in breast cancer & prostate cancer cases, along with immersive efforts in the exploration of combination therapies, which drive the overall market growth.
Market Glimpse
The emergence of an oral, targeted anti-cancer drug & potent pan-AKT kinase inhibitor that binds to & inhibits all three AKT isoforms, i.e. AKT1, AKT2, AKT3, is known as capivasertib. The U.S. capivasertib market has a key scope in patients with one or more PIK3CA/AKT1/PTEN alterations, as found by an FDA-approved test, & have expanded on at least one endocrine-based regimen. Additionally, the FDA has authorized the FoundationOne CDx assay to determine patients with specific biomarker changes.
Global Market Growth
The global capivasertib market size was estimated at USD 485.7 million in 2025 and is predicted to increase from USD 584.78 million in 2026 to approximately USD 3109.09 million by 2035, expanding at a CAGR of 21.05% from 2026 to 2035.
Market Prospects
Ongoing and upcoming studies of the U.S. capivasertib market will present robust opportunities, as the U.S. manufacturer is completing trials to assess capivasertib in patients with moderate hepatic impairment by December 2026. Another study evaluating interactions with transporter substrates is also scheduled for completion in December 2026. The future efforts will highly leverage Next-Generation Sequencing (NGS) assays to detect patients with PIK3CA, AKT1, or PTEN alterations.
Approximate Predicted Diagnosis Cases of Breast Cancer & Prostate Cancer in 2026
The graph represents the number of new cases of breast cancer & prostate cancer, where the U.S. has prioritized capivasertib + fulvestrant as second-line treatment for HR+/HER2- metastatic breast cancer with PIK3CA/AKT1/PTEN alterations. In the cases of prostate cancer, the FDA has recommended Capivasertib in combination with abiraterone & androgen deprivation therapy (ADT).
Market Segmentation Overview
- By indication, the breast cancer segment led with 58.00% share of the capivasertib market in 2025. Its prominent catalyst is the FDA approval for hormone receptor (HR)-positive, HER2-negative advanced breast cancer with specific biomarker alterations. Also, the widespread adoption & broadening clinical evidence are boosting the overall development & physician confidence. Whereas regulatory approvals are surging, with commercial penetration across the U.S.
- By therapy type, the combination therapy segment dominated with a 69.00% share of the market in 2025. Dominance is fueled by enhanced progression-free survival in advanced cancers, & synergistic purpose with endocrine & targeted therapies, which raises clinical adoption. The emergence of ecology treatment protocols is supporting multi-drug approaches.
- By route of administration, the oral segment held a dominant share of 82.00% of the capivasertib market in 2025. Dosing of this ROA boosts patient convenience & compliance. Additionally, the oral route offers home-based treatment, which lowers the need for hospitalization or hospital visits. Many pharmaceutical innovations are spurring advanced oral oncology formulation.
- By end user, the hospitals segment captured a major share of 48.00% in 2025, due to the rigorous management of a huge volume of advanced oncology patients. Alongside, hospitals facilitate various integrated diagnostic & therapeutic services, with robust reimbursement systems, which foster hospitals' oncology treatments.
- By biomarker type, the PIK3CA mutation segment registered dominance with 39.00% share of the capivasertib market in 2025. The growing prevalence of breast cancer is widely demanding robust diagnostics, which impacts the segmental progression. Developing precision oncology programs that extensively support biomarker testing. However, clinical evidence verifies pathway-targeted treatment effectiveness.
Top Companies in the U.S. Capivasertib Market
AstraZeneca, Astex Pharmaceuticals, MSD, and the Institute of Cancer Research (ICR) are four major and leading firms of the market that are involved in different stages of the development of Truqap. Whereas AstraZeneca is perceiving dominance in the U.S., as it unveiled the first AKT inhibitor, i.e. Truqap, to gain regulatory approval. Also, it is stepping towards the revolution of biomarker-driven tailored medicine.
Segments Covered in the Report
By Indication
- Breast Cancer
- HR-positive/HER2-negative Breast Cancer
- Triple-negative Breast Cancer (TNBC)
- HER2-positive Breast Cancer
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Hormone-sensitive Prostate Cancer
- Ovarian Cancer
- Endometrial Cancer
- Other Solid Tumors
- Lung Cancer
- Gastric Cancer
- Pancreatic Cancer
- Colorectal Cancer
By Therapy Type
- Monotherapy
- Combination Therapy
- With Hormonal Therapy
- With Chemotherapy
- With Immunotherapy
- With Targeted Therapy
By Route of Administration
- Oral
- Hospital-administered Combination Regimens
By End User
- Hospitals
- Specialty Cancer Centers
- Academic & Research Institutes
- Ambulatory Surgical Centers
By Biomarker Type
- PIK3CA Mutation
- AKT Mutation
- PTEN Deficiency
- Other PI3K/AKT Pathway Alterations
By Distribution Channel
- Hospital Pharmacies
- Specialty Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Line of Treatment
- First-Line Therapy
- Second-Line Therapy
- Third-Line & Later Therapy
