Commercialization of Elastography in India: A Critical Analysis of Screening Practices and Healthcare Policy Implications

<i>Background:</i> 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. <i>Objective:</i> 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. <i>Methods:</i> 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. <i>Results:</i> 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 <i>Conclusions:</i> 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.

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Publication Details

Journal
International Journal of Gastroenterology
Published
2025-09-26
DOI
https://doi.org/10.11648/j.ijg.20250902.15
Primary Topic
Liver Disease Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00
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article

Commercialization of Elastography in India: A Critical Analysis of Screening Practices and Healthcare Policy Implications

Atul Kapoor
International Journal of Gastroenterology
Liver Disease Diagnosis and Treatment
article

Commercialization of Elastography in India: A Critical Analysis of Screening Practices and Healthcare Policy Implications

Atul Kapoor
article en

Abstract

<i>Background:</i> 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. <i>Objective:</i> 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. <i>Methods:</i> 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. <i>Results:</i> 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 <i>Conclusions:</i> 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.

International Journal of GastroenterologyVol. 9(2)
Government Medical College, Amritsar (IN)
Openalex Percentile: Top 64%
Liver Disease Diagnosis and Treatment
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