El mercado mundial de diagnóstico de enfermedades hepáticas está experimentando un crecimiento significativo. Este auge se debe a la creciente prevalencia de trastornos hepáticos, como la hepatitis viral, la EHNA (enfermedad del hígado graso no alcohólico), la EHNA (esteatohepatitis no alcohólica), la cirrosis y el carcinoma hepatocelular, así como al mayor énfasis que los sistemas sanitarios ponen en el diagnóstico precoz y mínimamente invasivo.

Se prevé que el mercado de diagnóstico de enfermedades hepáticas registre una tasa de crecimiento anual compuesta (CAGR) del 6,4% durante el período de pronóstico de 2025-2031.

Estrategias de crecimiento

Los avances tecnológicos y los diagnósticos no invasivos están dejando atrás las biopsias hepáticas para centrarse en técnicas de imagen, elastografía, biomarcadores séricos y análisis moleculares. De hecho, las técnicas no invasivas como la elastografía y los paneles de biomarcadores se han identificado como importantes motores de crecimiento.

Integración de la IA y la salud digital : Las empresas de diagnóstico están desarrollando interpretación de imágenes habilitada por IA, aprendizaje automático para el análisis de biomarcadores y formatos de monitorización remota.

Diagnóstico en el punto de atención y descentralizado : Los diagnósticos están cada vez más disponibles no solo en el entorno del laboratorio hospitalario, sino también en clínicas ambulatorias, ubicaciones remotas/rurales y entornos de uso doméstico.

Colaboraciones estratégicas, alianzas y fusiones y adquisiciones: Las empresas están colaborando con empresas de biotecnología, instituciones de investigación y startups de imagen/IA para acelerar la innovación, ampliar la cartera de productos y expandir su alcance geográfico.

Expansión geográfica en mercados emergentes : Las empresas se centran en estas regiones para su crecimiento, dado el aumento de casos de enfermedades hepáticas en Asia Pacífico, Latinoamérica y Oriente Medio y África. Por ejemplo, se prevé que la región de Asia Pacífico crezca a una tasa de crecimiento anual compuesta (TCAC) más alta, de aproximadamente el 8,5 %, entre 2025 y 2033.

Get Sample Report: https://www.theinsightpartners.com/sample/TIPRE00040724

Future Trends

Emergence of liquid biopsies and multi-omic biomarker panels: Beyond standard liver function tests, diagnostics include rapidly evolving fields of genomics, epigenetics, and metabolomics for earlier detection of fibrosis, NASH, and HCC.

Continuous monitoring and integration with telehealth: Diagnostic tools will increasingly be interfaced with telemedicine platforms and with remote monitoring systems for the longitudinal tracking of liver health.

Miniaturization of devices and testing in the home: Portable ultrasound/elastography and home testing kits for viral hepatitis, enzyme panels, and fatty liver screening will enhance access, especially in disadvantaged regions.

Metabolic-Associated Liver Disease (MASLD/NAFLD/NASH): Diagnostics related to fatty-liver diseases and associated fibrosis due to growing obesity, diabetes, and metabolic syndrome are gaining center stage globally. For instance, imaging dominated in 2024 with 30.62% share, while the NAFLD segment held the largest disease-based share of approximately 26.4% in

Regulatory change towards non-invasive diagnostics: There is a growing endorsement by regulatory bodies of non-invasive methods as first-line evaluations-such as liver fibrosis-which is likely to quicken the pace of adoption.

Opportunities

Unmet need for early detection: Most liver diseases are silent until the advanced stages; diagnostics that identify pathology early provide major clinical value and market opportunity.

Underserved areas/emerging markets: Increasing liver-disease burden with growing healthcare infrastructure (e.g., India, China, Southeast Asia) provide growth opportunities.

Integration with therapeutic markets: With the development of therapies against NASH, fibrosis, and HCC, there is an increasing need for companion diagnostics that stratify patients and monitor the response to therapy.

Cost-effective screening programs: With growing interest in preventive healthcare, population screening for fatty liver, viral hepatitis, and fibrosis is a broad area of scope.

Data & analytics value: With more tests, imaging, and longitudinal tracking, diagnostics firms can leverage big data for predictive analytics, outcome modeling, and value-based care offerings.

Key Segments

By Diagnosis Technique

Imaging

Laboratory Tests

Endoscopy

Biopsy

By Disease

NAFLD

NASH

Fibrosis

Cirrhosis

By End use

Hospitals

Laboratories

Key Players & Recent Developments

Abbott Laboratories: Abbott offers a wide menu of liver-disease relevant assays through their core laboratory segment, including liver enzyme panels and bile acids tests. They also launched the “HBsAg Next Qualitative” assay in India recently, for earlier detection of HBV infection, a major risk to liver disease. Their Alinity HCV and HBV molecular assays, such as the Alinity m HBV test, have been added for quantitative viral load monitoring.

Roche Diagnostics: Roche has launched the Elecsys® PRO-C3 test in 2025 for assessment of liver fibrosis severity in patients with MASLD. The test delivers results in just 18 minutes and integrates into their cobas analysers. They also expanded their hepatitis diagnostics portfolio with the Elecsys® HBeAg quant immunoassay for HBV in 2023.

Siemens Healthineers: Siemens continues to advance imaging and analysis in liver diagnostics. For example, its ACUSON Sequoia ultrasound system now features Auto pSWE-an advanced form of shear wave elastography-and UDFF (ultrasound-derived fat fraction) for earlier detection of steatosis and fibrosis. The company also provides advanced elastography technologies for the non-invasive assessment of liver tissue stiffness.

Conclusion

The liver disease diagnostics market reaches an important juncture: increasing disease burden, greater need for early and non-invasive testing, and technological advance combine to support rapid growth over the next decade. With a projected size of over $66 billion by 2033, and growth strategies aligned around AI-enabled imaging, biomarker innovation, decentralized testing, and emerging markets, the industry is poised for transformation.

Frequently Asked Questions (FAQs)

What is driving the growth of the liver disease diagnostics market?

The major drivers include the increasing prevalence of liver disorders, NAFLD, NASH, and viral hepatitis; early diagnosis and monitoring; advancement in technology for non-invasive diagnostics; and preventive healthcare.

Which diagnostic technique has the largest share?

Imaging techniques ultrasonography, computed tomography, magnetic resonance imaging, and elastography accounted for approximately 30.62% of the market in 2024, by diagnosis technique.

What are the major challenges in this market?

Challenges include the high cost of advanced diagnostic equipment, the shortage of skilled professionals in emerging markets, variable regulatory landscapes, and disparities in access to healthcare services.

How are the key players differentiating themselves?

Players differentiate by developing faster, more accurate assays (e.g., Roche's PRO-C3), expanding imaging features (e.g., Siemens' US elastography), and offering broad assay menus and screening solutions (e.g., Abbott's HBV/HCV assays).

Which areas should companies focus on?

Se encuentran oportunidades específicas de alto valor en los diagnósticos no invasivos de fibrosis, las pruebas descentralizadas y domiciliarias, los mercados emergentes con necesidades no satisfechas y los diagnósticos vinculados a terapias, o diagnósticos complementarios para los tratamientos de la EHNA/fibrosis.