Barriers to Biomarker-Guided Advanced Breast Cancer Care in India: Diagnostic, Economic, and Implementation Challenges

Breast cancer is the leading cancer among women in India, with a high proportion of cases presenting at advanced or metastatic stages. While precision oncology has transformed global breast cancer care through biomarker-guided therapies, including those targeting human epidermal growth factor receptor 2 (HER2)-positive, HER2-low, and hormone receptor (HR)-positive/HER2-negative subtypes, India continues to face substantial gaps in diagnosis, access, and clinical implementation of these advances. These disparities indicate persistent gaps in access to tailored treatments and the effective implementation of precision oncology in India. This review outlines the clinical, economic, and psychosocial consequences of limited access to precision oncology for breast cancer in India. Limited availability and inconsistent biomarker testing (e.g., HER2, HR, BRCA1/2), high out-of-pocket costs, fragmented referral systems, and poor adherence to international treatment guidelines contribute to suboptimal care and avoidable morbidity. Limited access to biomarker-guided therapies has been associated with higher toxicity, diminished quality of life, and greater psychosocial distress. National health initiatives aimed at expanding insurance coverage and enhancing digital health infrastructure have the potential to improve access through policy reforms; however, substantial financial and infrastructural barriers persist. Evidence suggests that standardization of diagnostic protocols, broader insurance coverage for therapies such as cyclin-dependent kinase 4/6 (CDK4/6) inhibitors and trastuzumab deruxtecan (T-DXd), and expanded continuing medical education could address existing gaps in care. Emerging evidence suggests that patient advocacy initiatives, AI-assisted pathology tools, and regionally integrated care models may help improve diagnostic consistency and address urban-rural disparities in access to care. Alignment with global precision oncology standards requires coordinated action across public health policy, clinical practice, and diagnostic infrastructure. Addressing these barriers may improve the delivery of biomarker-guided care and contribute to better outcomes for patients with breast cancer in India.