Hepatitis Diagnostic Test Market Size and Share
Hepatitis Diagnostic Test Market Analysis by Mordor Intelligence
The hepatitis diagnostic test market stands at USD 4.73 billion in 2025 and is forecast to climb to USD 6.24 billion by 2030, reflecting a 5.70% CAGR. Demand is rising as governments race to meet the WHO goal of eliminating viral hepatitis as a public-health threat by 2030. Yet, diagnosis gaps remain wide—only 13% of chronic hepatitis B and 36% of hepatitis C cases are identified today. Technology is shifting fast toward molecular and AI-enabled platforms, exemplified by the FDA-cleared Cepheid Xpert HCV RNA finger-stick test that delivers results in about one hour. Regional growth imbalances are stark: North America leads with 40.34% 2024 revenue, while Asia-Pacific is the growth engine at 6.46% CAGR to 2030. Competitive intensity is moderate as global leaders leverage scale in molecular diagnostics and smaller firms push microfluidic and AI-driven point-of-care systems.
Key Report Takeaways
- By product type, reagents and kits led with 62.51% of the hepatitis diagnostic test market share in 2024, whereas software and services are projected to expand at a 6.34% CAGR through 2030.
- By disease type, hepatitis B testing captured 48.72% of the hepatitis diagnostic test market size in 2024; the “other hepatitis” segment (A, E, and D) is forecast to register a 6.65% CAGR to 2030.
- By technology, serology accounted for 46.38% of the hepatitis diagnostic test market in 2024, while next-generation sequencing panels are expected to advance at a 6.81% CAGR between 2025 and 2030.
- By sample type, blood testing commanded an 88.94% share of the hepatitis diagnostic test market in 2024, and saliva/oral fluid collection is set to grow at a 7.70% CAGR to 2030.
- By test setting, hospital laboratories held 54.06% revenue share in 2024; home testing and self-collection is anticipated to rise at 6.52% CAGR during the forecast period.
- By geography, North America dominated with 40.34% revenue share in 2024, whereas Asia-Pacific remains the fastest-growing region at 6.46% CAGR to 2030.
Global Hepatitis Diagnostic Test Market Trends and Insights
Drivers Impact Analysis
Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
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Escalating Global HBV & HCV Prevalence | +1.2% | Global, with highest impact in Asia-Pacific and sub-Saharan Africa | Long term (≥ 4 years) |
Rapid Migration from Serology to High-Sensitivity Molecular Platforms | +1.0% | Global, led by developed markets, expanding to emerging economies | Medium term (2-4 years) |
Expansion of Government-Funded Screening & Vaccination Programs | +0.8% | North America, Europe, with emerging impact in Asia-Pacific | Medium term (2-4 years) |
Emergence of Microfluidic POC Viral-Load Analyzers | +0.6% | Global, with early adoption in North America and Europe | Short term (≤ 2 years) |
AI-Assisted Elastography Improving Non-Invasive Liver Assessment | +0.4% | North America, Europe, with gradual expansion to Asia-Pacific | Long term (≥ 4 years) |
Adoption of Self-Collection Dried-Blood-Spot Kits for Remote Testing | +0.3% | Global, particularly relevant for rural and underserved populations | Medium term (2-4 years) |
Source: Mordor Intelligence
Escalating Global HBV & HCV Prevalence
More than 254 million people live with chronic hepatitis B and 50 million with hepatitis C, with Asia-Pacific bearing 75% of chronic HBV cases. Rising incidence keeps diagnostic demand high, particularly in China where new HCV infections are projected to reach 17.92 per 100,000 by 2030[1]Guo Tian, “Epidemiological trends of hepatitis C incidence and death in Mainland China between 2004 and 2018 and its predictions to 2030,” BMC Infectious Diseases, bmcinfectdis.biomedcentral.com. Regional disparities linger—southern Korea still reports elevated HCV prevalence[2]Hwa Young Choi, “Temporal and geospatial patterns of hepatitis C virus prevalence: a longitudinal examination using national health insurance service data in the Republic of Korea (2005–2022),” BMC Public Health, bmcpublichealth.biomedcentral.com despite national declines. Uncommon genotypes such as HCV 1c dominate among chronic kidney-disease patients in West Bengal[3]Sagnik Bakshi, “Impact of hepatitis C virus genotype on the efficacy of the direct-acting antivirals in chronic kidney disease patients in West Bengal, India,” BMC Infectious Diseases, bmcinfectdis.biomedcentral.com, India, underscoring the need for robust genotyping. Combined, these patterns ensure a sustained base of at-risk patients requiring accurate and repeat testing.
Migration from Serology to High-Sensitivity Molecular Platforms
Targeted next-generation sequencing (NGS) now detects hepatitis viruses even in extra-hepatic tissue where classical assays fail. High-throughput sequencing also tracks resistance-associated variants such as A1343V in hepatitis E during treatment. Artificial-intelligence tools like GPT-4o deliver physician-level accuracy in liver-disease diagnosis yet operate faster and at lower cost. Regulatory support accelerates adoption: the FDA reclassified HBV assays from Class III to Class II, streamlining the 510(k) pathway. As platforms migrate to clinics and community settings, the hepatitis diagnostic test market gains a clear uplift.
Government-Funded Screening & Vaccination Programs
The U.S. Viral Hepatitis National Strategic Plan proposes USD 12.3 billion in elimination funding, including universal HCV screening for adults aged 18-79. The WHO’s 2024 HBV guidance[4]World Health Organization, “WHO Publishes Updated Guidelines on Hepatitis B,” World Health Organization, who.int expands treatment eligibility and stresses point-of-care viral-load testing to close diagnosis gaps. Egypt’s previous HCV elimination model achieved a 90% drop in active infections via mass testing, providing a playbook for emerging economies. Funding boosts and policy alignment collectively advance testing volumes, reinforcing long-term growth in the hepatitis diagnostic test market.
Emergence of Microfluidic Point-of-Care Viral-Load Analyzers
Palm-sized wireless elastography devices now correlate strongly (r = 0.975) with conventional systems while boosting portability. Integrated microfluidic instruments like iPonatic cut total processing time to 30 minutes and deliver AUC > 0.98 for pathogen detection. In Ghanaian clinics, Bioline HCV point-of-care tests scored 88.7 on the System Usability Scale, showing readiness for routine use. Wearable bioadhesive ultrasound devices even enable 48-hour liver stiffness monitoring in preclinical models. These innovations shorten diagnostic turnaround and open new decentralized channels for the hepatitis diagnostic test market.
Restraints Impact Analysis
Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
---|---|---|---|
High Per-Test Cost of Molecular Assays in Low-Income Settings | -0.9% | Sub-Saharan Africa, South Asia, rural areas in emerging markets | Long term (≥ 4 years) |
Regulatory Ambiguity Around Direct-To-Consumer Viral-Load Kits | -0.8% | North America, Europe, developed markets with established DTC frameworks | Short term (≤ 2 years) |
Undetected Occult Infections Causing False-Negatives in Immunocompromised Patients | -0.7% | Global, with higher impact in regions with high HIV prevalence and organ transplant centers | Medium term (2-4 years) |
Weak Cold-Chain Logistics for Sample Transport in Remote Areas | -0.6% | Rural areas globally, particularly in tropical and sub-tropical regions | Medium term (2-4 years) |
Source: Mordor Intelligence
High Per-Test Cost of Molecular Assays in Low-Income Settings
Surveys across 23 low- and middle-income countries confirm that many programs still limit hepatitis testing to blood donors because virological assays remain unaffordable. Complex confirmation algorithms push per-patient costs well beyond those of single-step serology. Product developers face an innovation-to-access gap, as environmental factors and regulatory fragmentation raise validation expenses. Until tiered pricing, pooled procurement or subsidy models expand, penetration of advanced platforms will lag in high-burden but cash-strapped markets.
Weak Cold-Chain Logistics for Sample Transport in Remote Areas
Audits in Ghana showed 53.8% of primary clinics experienced stock-outs of essential diagnostics due to supply-chain weaknesses, with compliance scoring just 53.5%. Molecular assays are especially temperature-sensitive, and tropical climates undermine sample integrity during transport, risking false results. While dried-blood-spot methods ease the burden, sensitivity gaps persist for some hepatitis markers. Absent sustained investment in integrated specimen-referral networks, cold-chain bottlenecks will continue to constrain the hepatitis diagnostic test market.
Segment Analysis
By Product Type: Software Integration Drives Service Growth
Reagents and kits generated the largest slice of the hepatitis diagnostic test market size in 2024 with 62.51% revenue, underscoring the recurrent-consumables model that underpins laboratory workflows. Instruments benefited from miniaturization trends such as palm-sized elastography, yet capital budgets remained cyclical. Software and services, though still a smaller base, are on track for a 6.34% CAGR to 2030 as laboratories embed AI engines that streamline interpretation and automate reporting. Vendors that link cloud-based analytics to their reagent franchises lock-in customers while creating incremental subscription income.
The reagents segment faces mounting price transparency and generics, but demand persists through continuous innovation in lyophilized molecular master mixes and multiplex point-of-care kits. Instrument vendors increasingly bundle connectivity and decision-support dashboards, transforming once-stand-alone analyzers into networked devices. BioMérieux’s January 2025 purchase of SpinChip Diagnostics for EUR 111 million illustrates the race to secure ultra-fast sample-to-answer platforms that fit primary-care settings. As software layers expand, service models shift toward outcome-based contracts, giving the hepatitis diagnostic test market a new revenue vector tied to digital performance.
Note: Segment shares of all individual segments available upon report purchase
By Disease Type: Hepatitis B Dominance Faces C Elimination Push
Hepatitis B dominated 2024 revenue with a 48.72% of the hepatitis diagnostic test market share in 2024, mirroring its 254 million-patient prevalence. Testing panels remain complex—pregnant women require HBsAg, anti-HBc and anti-HBs screening every pregnancy under CDC guidance. Hepatitis C volumes are scaling quickly as elimination programs simplify algorithms; the Cepheid finger-stick RNA test enables single-visit diagnosis in primary care. “Other hepatitis” (A, E, D) is the fastest-growing group at 6.65% CAGR, propelled by increasing HAV and HEV outbreaks and new sequencing data confirming wider geographic spread.
Emerging data link specific HAV genotype IIIA and HEV-1 strains to more severe outcomes, pressuring hospitals to upgrade to molecular assays and genotyping. In parallel, hepatitis C elimination funding in the U.S. supports universal screening, driving consistent reagent pull-through. As novel therapies for hepatitis D roll out, demand for HDV reflex testing is likely to rise. This mix of chronic HBV burden, HCV elimination acceleration and broader recognition of other viral hepatitides secures long-term breadth for the hepatitis diagnostic test market.
By Technology: Molecular Platforms Accelerate NGS Adoption
Serology retained 46.38% of the hepatitis diagnostic test market size in 2024, reflecting its role as the first-line screen in many health systems. However, molecular assays and next-generation sequencing are eclipsing serology for confirmation and resistance monitoring, giving NGS the fastest forecast CAGR at 6.81%. The hepatitis diagnostic test market size attached to molecular workflows is set to expand further as 510(k) reclassification lowers U.S. entry barriers for HBV assays. Rapid tests keep traction where budgets are tight, but microfluidic advances now deliver molecular-grade sensitivity in decentralized devices.
NGS adds clinical value by detecting occult infections and characterizing mixed-genotype cases in a single run. Laboratories that already own high-throughput sequencers leverage the same platforms for oncology and microbiology, improving asset utilization. Vendors are bundling AI-curated resistance-variant reports, reducing bioinformatics friction for clinicians. Serology technology is also improving through full automation and higher throughput, ensuring it remains pivotal at massive scale. This dual track keeps every major modality relevant while shifting revenue toward data-rich molecular assays.
By Sample Type: Blood Dominance Challenged by Alternative Matrices
Blood specimens generated 88.94% of the hepatitis diagnostic test market share in 2024, cementing their role as the high-sensitivity standard. Saliva and oral fluid sampling, despite a low base, is projected to grow 7.70% CAGR owing to patient preference and easier logistics. Finger-stick capillary sampling, as used in the Cepheid Xpert HCV test, demonstrates that blood-based diagnostics can also migrate outside conventional phlebotomy fda.gov. Dried-blood-spot innovations directly address transport hurdles, although some assays show only 80% sensitivity for HCV.
Saliva testing still faces lower viral load challenges, particularly for HBV detection, but diagnostic yields for certain antibodies are improving. Urine remains niche yet gains research traction for monitoring adherence and screening populations unwilling to provide blood. As alternative matrices mature, multiplex assays may combine blood and saliva inputs, creating more versatile sampling workflows. Nonetheless, until analytical sensitivity converges, blood will stay the anchor sample type within the hepatitis diagnostic test market.

By Test Setting: Home Testing Disrupts Traditional Laboratory Models
Hospital laboratories controlled 54.06% of the hepatitis diagnostic test market size in 2024, reflecting comprehensive test menus and tight links to clinical decision-making. Reference labs retain high throughput for genotyping and resistance panels but face margin squeeze from payer price cuts. Home testing and self-collection, though nascent, carries the highest growth at 6.52% CAGR, propelled by consumer demand for privacy and convenience within CLIA-waived frameworks. Point-of-care platforms are gaining share in physician offices and community clinics as one-step molecular cartridges go mainstream.
Digital-first players bundle subscription telehealth for result interpretation, potentially detaching some volume from hospital labs. Blood bank screening remains a regulatory mandate, ensuring a stable, though mature, revenue stream. Physician offices benefit from palm-sized elastography that brings liver fibrosis evaluation closer to primary care. The net effect is a diversifying channel mix where decentralized models grow fastest, pressuring traditional lab operators to add connectivity, same-day turnaround and patient-friendly reporting to protect share.
Geography Analysis
North America held 40.34% of the global hepatitis diagnostic test market share in 2024 due to structured government screening and early adoption of molecular platforms. U.S. policy momentum, including the proposed USD 12.3 billion hepatitis C elimination budget, ensures a steady 5.02% CAGR for the regional hepatitis diagnostic test market. FDA approvals, such as Cepheid’s HCV point-of-care RNA test, accelerate decentralized uptake. Laboratory networks integrate AI-enhanced interpretation pathways like iLFT to boost chronic liver-disease detection, demonstrating a mature ecosystem that rapidly scales innovation.
Europe posts a 5.38% CAGR as harmonized regulations and robust clinical guidelines sustain investment. EASL’s updated hepatitis B management protocol mandates advanced diagnostics, reinforcing demand for molecular panels. Roche’s 18-minute Elecsys PRO-C3 fibrosis test exemplifies the region’s appetite for rapid, non-invasive tools. Yet, care gaps remain, with only 70% of Spanish hospitals performing reflex tests for HBV and under 50% for HDV, spotlighting workflow opportunities. Innovation in wearable ultrasound monitoring further differentiates European offerings.
Asia-Pacific is the fastest-expanding territory at 6.46% CAGR to 2030, fueled by its disproportionate hepatitis burden and rising healthcare investment. China, Japan, and South Korea host half of all chronic HBV patients, creating unparalleled testing demand. China’s HCV incidence is projected to reach 17.92 per 100,000 by 2030, urging an upgrade to high-throughput diagnostics. Japan’s reimbursement for the Enhanced Liver Fibrosis score underscores policy support for advanced tools. Sophisticated genotyping needs are rising in India due to uncommon subtypes like HCV 1c. Regulatory collaboration across ASEAN and East-Asia regulators is improving device approval timelines, fostering broader market access.

Competitive Landscape
The hepatitis diagnostic test market is moderately consolidated. Roche, Abbott and Danaher together generate multibillion-dollar diagnostics revenue and command significant molecular and immunoassay portfolios. Roche’s USD 16.76 billion diagnostics sales in 2023 evidence scale-driven advantages, while Abbott leverages its Alinity and m2000 systems globally. Danaher’s Cepheid earned first-mover status in point-of-care HCV RNA testing after FDA clearance, underscoring the value of cartridge-based molecular leadership.
Acquisition activity centers on speed and ease-of-use. BioMérieux’s EUR 111 million purchase of SpinChip Diagnostics added 10-minute microfluidic capability aimed at community clinics. Partnerships marry complementary assets: IBL International and Grifols collaborate on single-molecule counting biomarker panels to raise sensitivity thresholds. Vendors also invest heavily in AI algorithms that interpret elastography and serology in real time.
Emerging challengers exploit regulatory tailwinds. FDA reclassification of high-risk hepatitis assays from Class III to Class II reduces time-to-market and compliance costs, opening doors for nimble microfluidic and AI-first entrants. White-space remains in wearable diagnostics and remote-monitoring ecosystems; early-stage firms developing bioadhesive ultrasound platforms illustrate the shift toward continuous liver assessment. As incumbents defend share with full-suite offerings and service contracts, competitive pressure will pivot on speed of innovation adoption and footprint in fast-growing Asia-Pacific markets.
Hepatitis Diagnostic Test Industry Leaders
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Abbott Laboratories
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bioMérieux SA
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Bio-Rad Laboratories
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Danaher Corporation
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F. Hoffmann-La Roche AG
- *Disclaimer: Major Players sorted in no particular order

Recent Industry Developments
- May 2025: Médecins Sans Frontières expanded its hepatitis C “test and treat” campaign in Rohingya refugee camps, targeting treatment for 30,000 people by 2026.
- May 2025: Medway NHS Foundation Trust launched an NIHR-backed programme to screen all Emergency Department patients aged ≥16 for HIV, HBV and HCV on an opt-out basis.
- March 2025: UK Health Security Agency initiated a genomic-surveillance programme to track resistance mutations in circulating HCV strains.
- November 2023: Roche introduced the Elecsys HBeAg quant immunoassay for simultaneous detection and quantification of HBV e-antigen.
Global Hepatitis Diagnostic Test Market Report Scope
As per the scope of the report, the term hepatitis broadly means inflammation of the liver. Heavy alcohol use, some medications, toxins, and certain medical conditions can cause hepatitis. However, hepatitis is often caused due to viral infection. The most common types of viral hepatitis are hepatitis A, hepatitis B, and hepatitis C. The Hepatitis Diagnostic Test Market is segmented by Test Type, (Blood Tests (Liver Function Tests, Immunoassays and Nucleic Acid Tests), Imaging Tests, and Liver Biopsy) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.
By Product Type | Reagents & Kits | ||
Instruments & Analyzers | |||
Software & Services | |||
By Disease Type | Hepatitis B | ||
Hepatitis C | |||
Other Hepatitis | |||
By Technology | Serology Tests | ||
Rapid Diagnostic Tests | |||
Molecular Tests | |||
Next-Gen Sequencing Panels | |||
By Sample Type | Blood | ||
Saliva / Oral Fluid | |||
Urine | |||
By Test Setting | Hospital Laboratories | ||
Reference Laboratories | |||
Blood Banks | |||
Point-of-Care / Physician Offices | |||
Home Testing & Self-Collection | |||
By Geography | North America | United States | |
Canada | |||
Mexico | |||
Europe | Germany | ||
United Kingdom | |||
France | |||
Italy | |||
Spain | |||
Rest of Europe | |||
Asia-Pacific | China | ||
Japan | |||
India | |||
Australia | |||
South Korea | |||
Rest of Asia-Pacific | |||
Middle East and Africa | GCC | ||
South Africa | |||
Rest of Middle East and Africa | |||
South America | Brazil | ||
Argentina | |||
Rest of South America |
Reagents & Kits |
Instruments & Analyzers |
Software & Services |
Hepatitis B |
Hepatitis C |
Other Hepatitis |
Serology Tests |
Rapid Diagnostic Tests |
Molecular Tests |
Next-Gen Sequencing Panels |
Blood |
Saliva / Oral Fluid |
Urine |
Hospital Laboratories |
Reference Laboratories |
Blood Banks |
Point-of-Care / Physician Offices |
Home Testing & Self-Collection |
North America | United States |
Canada | |
Mexico | |
Europe | Germany |
United Kingdom | |
France | |
Italy | |
Spain | |
Rest of Europe | |
Asia-Pacific | China |
Japan | |
India | |
Australia | |
South Korea | |
Rest of Asia-Pacific | |
Middle East and Africa | GCC |
South Africa | |
Rest of Middle East and Africa | |
South America | Brazil |
Argentina | |
Rest of South America |
Key Questions Answered in the Report
Which diagnostic technology is gaining momentum for hepatitis testing?
Molecular platforms—particularly point-of-care RNA assays—are displacing traditional serology because they deliver same-day results and enable on-the-spot treatment decisions.
Why are reagents and kits expected to retain a leading role despite rising software adoption?
Every viral-load or antibody test still requires a consumable kit, so laboratories must replenish reagents even as they add AI-driven analytics layers.
How are governments influencing demand for hepatitis diagnostics?
Expanded universal-screening policies and elimination campaigns are driving routine testing in primary care, emergency departments, and even community pharmacies.
What makes Asia-Pacific a key focus for diagnostic companies?
The region houses the world’s highest concentration of chronic hepatitis B and C cases, motivating health systems to adopt faster, more sensitive testing algorithms.
Which sample types are emerging as alternatives to venous blood draws?
Finger-stick capillary blood and saliva/oral fluid collections are gaining favor for their convenience, enabling wider outreach in remote and resource-limited settings.
How is artificial intelligence reshaping hepatitis diagnostics?
AI tools now interpret elastography and laboratory data in real time, helping clinicians detect liver fibrosis earlier and reduce manual review workloads.
Page last updated on: July 6, 2025