Hepatitis Diagnostic Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Blood Tests {By Blood Tests {Liver Function Tests, Immunoassays, Nucleic Acid Tests}, Imaging Test, Liver Biopsy), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.72 Billion
CAGR (2026-2031)	6.66%
Fastest Growing Segment	Blood Tests
Largest Market	North America
Market Size (2031)	USD 6.95 Billion

Market Overview

The Global Hepatitis Diagnostic Test Market is projected to grow from USD 4.72 Billion in 2025 to USD 6.95 Billion by 2031 at a 6.66% CAGR. Hepatitis diagnostic tests encompass a range of serological immunoassays and nucleic acid amplification technologies designed to detect viral antigens, antibodies, or genetic material in patient samples. The sector is primarily propelled by the escalating global prevalence of viral infections and the rigorous implementation of national screening mandates aimed at eliminating transmission. Furthermore, the strategic integration of testing protocols into routine primary healthcare services serves as a fundamental driver, significantly expanding patient access and testing volumes. According to the World Hepatitis Alliance, in 2025, hepatitis delta affects an estimated 12 million people worldwide, creating a critical demand for specialized diagnostic panels to identify this severe form of the disease.

Despite these strong growth catalysts, the market faces a significant challenge regarding the financial accessibility of molecular testing platforms in developing regions. The substantial acquisition and operational costs associated with automated diagnostic systems often restrict their deployment in resource-limited settings, creating a disparity in diagnostic capabilities. This economic constraint limits the widespread adoption of high-sensitivity assays and impedes market penetration in geographies that currently bear the highest burden of chronic infection.

Key Market Drivers

The rising global prevalence of viral hepatitis infections acts as a primary catalyst for market expansion, necessitating robust diagnostic interventions to curb transmission and mortality rates. As the disease burden intensifies, healthcare systems are prioritizing early detection strategies to manage the escalating number of chronic cases and prevent liver-related complications such as cirrhosis and cancer. This urgent clinical demand is underscored by recent mortality data indicating a disturbing upward trend despite the availability of treatments. According to the World Health Organization, April 2024, in the 'Global Hepatitis Report 2024', the estimated number of deaths from viral hepatitis increased from 1.1 million in 2019 to 1.3 million in 2022, highlighting the critical need for scaled diagnostic accessibility to reverse these outcomes.

Concurrently, advancements in molecular and rapid diagnostic technologies are revolutionizing testing workflows by shifting complex procedures from centralized laboratories to point-of-care settings. These innovations significantly reduce turnaround times, enabling 'test-and-treat' models that are crucial for reaching undiagnosed populations in decentralized environments. According to the U.S. Food and Drug Administration (FDA), June 2024, in the 'FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test' announcement, the newly authorized Xpert HCV test detects hepatitis C virus RNA and delivers results in approximately one hour using a fingerstick sample. These decentralized solutions are essential to bridge the massive diagnostic gap, as according to the World Health Organization, in 2024, only 13% of people living with chronic hepatitis B infection had been diagnosed globally. By simplifying sample collection and expediting results, these technological strides facilitate immediate clinical decision-making and support global elimination targets.

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Key Market Challenges

The high acquisition and operational costs associated with molecular testing platforms constitute a primary restraint on the growth of the global hepatitis diagnostic test market. In many developing regions, the financial burden of procuring automated diagnostic systems prevents healthcare facilities from upgrading their laboratory infrastructure. This economic barrier limits the adoption of high-sensitivity assays, causing a reliance on less expensive but less accurate testing methods. Consequently, manufacturers face difficulties penetrating these high-burden geographies, restricting the overall addressable market and slowing revenue generation from equipment sales and reagent usage.

This lack of financial accessibility directly correlates with low diagnostic coverage, as public health programs often cannot afford the volume of testing required for effective disease management. The inability to deploy advanced testing widely results in a vast number of undiagnosed cases, thereby capping the potential market size. According to the World Health Organization, in 2024, only 13 percent of people living with chronic hepatitis B infection had been diagnosed globally. This low diagnosis rate reflects the persistent inability of resource-limited healthcare systems to fund widespread testing, directly hampering the expansion of the diagnostic market.

Key Market Trends

The integration of Artificial Intelligence (AI) for enhanced disease stratification is reshaping the market by advancing capabilities beyond simple pathogen detection. Machine learning algorithms now analyze complex biomarkers to assess liver fibrosis severity non-invasively, reducing the need for traditional biopsies. This technological leap enables clinicians to tailor treatment based on disease progression, driving the adoption of computational models for improved decision-making. According to IEEE Xplore, May 2025, in the 'AI and Machine Learning Applications in Hepatitis B Diagnosis: An Exploration of Techniques and Outcomes' conference paper, advanced machine learning techniques achieved a maximum diagnostic accuracy rate of 99.35%.

Simultaneously, the utilization of Next-Generation Sequencing (NGS) for viral genotyping is expanding as healthcare systems prioritize precision medicine. Unlike standard PCR, NGS platforms provide comprehensive genomic insights to identify viral genotypes and drug-resistance mutations. This capability is crucial for managing patients failing antiviral therapies, allowing for targeted second-line treatments. The high fidelity of these systems is establishing a new clinical standard. According to the Journal of Clinical Virology, January 2025, in the 'Evaluation of a next generation sequencing assay for Hepatitis B antiviral drug resistance on the Oxford Nanopore system' study, the NGS platform achieved a 97% agreement rate with established methods.

Segmental Insights

The blood tests segment represents the fastest expanding category in the global hepatitis diagnostic test market due to the increasing demand for non-invasive screening methods. Unlike liver biopsies, blood-based serological assays allow for efficient population-wide testing without significant patient discomfort. This trend is further supported by initiatives from the World Health Organization aiming to eliminate viral hepatitis, which prioritize accessible diagnostics for early detection. Consequently, laboratories and hospitals are prioritizing these assays to manage the rising disease burden, ensuring sustained developmental momentum for this market segment.

Regional Insights

North America maintains a leading position in the global hepatitis diagnostic test market, driven by established healthcare infrastructure and favorable government policies. This dominance is largely attributed to proactive screening initiatives recommended by the Centers for Disease Control and Prevention, which encourage wider testing parameters for adults to facilitate early disease management. Additionally, the region benefits from the strong presence of established diagnostic manufacturers and high public awareness regarding infectious diseases. These factors, combined with supportive reimbursement frameworks, ensure consistent demand for diagnostic solutions across the region.

Recent Developments

• In May 2025, Quest Diagnostics published the first nationwide seroprevalence study of Hepatitis Delta Virus (HDV) in the United States in the Journal of Viral Hepatitis. The researchers analyzed de-identified Hepatitis B surface antigen-positive specimens collected from all ten U.S. Department of Health and Human Services regions to estimate the burden of this severe co-infection. The study revealed an overall HDV seroprevalence of approximately 2.2% among the study population. The findings highlighted significant gaps in current screening practices and underscored the importance of implementing reflex testing protocols to identify undiagnosed patients who are at risk of rapid disease progression.
• In March 2025, Fujirebio Europe announced the availability of the INNO-LiPA HCV 2.0 Genotyping assay, a line probe assay designed for the qualitative detection and identification of Hepatitis C virus genotypes 1 to 6 and subtypes 1a and 1b in human serum or plasma. This diagnostic tool, which was previously distributed by another major healthcare company, was relaunched as part of Fujirebio’s own portfolio to ensure continued access for laboratories. The assay aids clinicians in determining the specific genotype of the virus, a critical step for selecting the most effective antiviral therapy for patients with chronic Hepatitis C infection.
• In June 2024, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System. This approval established the first point-of-care test for the Hepatitis C virus (HCV) allowed in non-traditional settings such as substance use disorder treatment facilities and correctional centers. The molecular diagnostic test detects HCV RNA from a fingertip blood sample and delivers results in approximately one hour. This rapid turnaround enables a test-and-treat model, allowing healthcare providers to diagnose patients and potentially link them to care within a single visit.
• In April 2024, Beckman Coulter Diagnostics announced the expansion of its test menu for the DxI 9000 Immunoassay Analyzer with the addition of CE-marked assays for Hepatitis B and C. The new availability included the Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays, which are designed to support accurate screening and diagnosis in high-volume laboratories. The company noted that its validated algorithm for the Hepatitis B surface antigen test could reduce the need for repeat testing on strongly positive samples, thereby improving operational efficiency and accelerating the delivery of results to clinicians.

Key Market Players

• Abbott Laboratories
• Bio-Rad Laboratories Inc
• F. Hoffmann-La Roche AG
• BioMerieux SA
• Siemens Healthineers AG
• Qiagen N.V.
• Grifols SA
• Fujirebio Inc.
• Molbio diagnostics Pvt. Ltd
• Meril LifeSciences Pvt. Ltd

By Test Type	By Region
Blood Tests {	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Hepatitis Diagnostic Test Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Hepatitis Diagnostic Test Market, By Test Type:

• Blood Tests {

• Hepatitis Diagnostic Test Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE