Commercialization of Elastography in India: A Critical Analysis of Screening Practices and Healthcare Policy Implications
Year: 2025
Type: article
Abstract: Background: The elastography market in India has experienced unprecedented growth and is projected to reach significant valuations by 2030 as part of the broader Asia-Pacific expansion. This growth coincides with India's integration of NAFLD screening into the National Programme for Non-Communicable Diseases (NP-NCD), creating opportunities for both appropriate clinical use and commercial exploitation of these devices. Objective: This review critically examines the commercialization of elastography in the Indian healthcare context, focusing on the disconnect between evidence-based guidelines and current screening practices, particularly in corporate wellness programs and pharmaceutical industry partnerships. Methods: We conducted a systematic analysis of Indian clinical studies, market data, government health policies, and commercial screening programs, with specific attention to the prevalence of NAFLD, regulatory frameworks, and healthcare accessibility challenges unique to India. Results: Indian validation studies established a FibroScan cutoff of 12 kPa for F3/4 fibrosis (AUROC 0.93-0.95). However, primary screening using the Community-Based Assessment Checklist (CBAC) showed poor performance (AUC 0.59), creating implementation gaps exploited by commercial screening programs. Pharmaceutical partnerships following NorUDCA approval have intensified patient-identification schemes often exceeding evidence-based indications Conclusions: Successful elastography implementation in India requires strengthening regulatory oversight, improving healthcare worker training, and establishing clear guidelines that distinguish between appropriate clinical use and commercial patient-identification schemes.
Author: Atul Kapoor
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414584493