Hepatitis Testing Market By Test Type (Hepatitis B, Hepatitis C, Hepatitis A/D/E); By Technology (ELISA, Rapid Diagnostic Tests, PCR, Others); By End User (Hospitals & Laboratories, Blood Banks, Public Health Agencies, Home Settings); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Hepatitis Testing Market will witness a robust CAGR of 6.9% , valued at $5.74 billion in 2024 , and is expected to appreciate and reach $8.6 billion by 2030 , confirms Strategic Market Research.

 

Hepatitis testing comprises a range of diagnostic solutions used to detect hepatitis viruses (A, B, C, D, E), assess liver function, and monitor disease progression. These solutions are vital for early detection, treatment planning, and infection control across healthcare systems. As global healthcare frameworks prioritize early diagnostics and preventive medicine, hepatitis testing has emerged as a key pillar of infectious disease management, particularly in regions with high viral prevalence.

 

Several macro-level forces are converging to fuel this market’s growth trajectory:

• Public Health Policies and WHO Targets: Global targets such as the WHO’s 2030 hepatitis elimination plan have intensified the demand for screening and surveillance infrastructure.

• Rising Incidence and Chronic Carriage: Approximately 296 million people live with chronic hepatitis B, while 58 million are chronically infected with hepatitis C, underscoring a growing testing burden.

• Technological Advancements: Point-of-care (PoC) diagnostic tools, multiplex testing panels, and molecular assays with higher specificity and sensitivity are expanding use in remote and underserved regions.

• Decentralized Testing & Home Diagnostics: Innovations in self-testing and mobile diagnostic platforms are improving access, especially in LMICs (low- and middle-income countries).

• Global Health Crises and Co-Infection Surveillance: The COVID-19 pandemic has accelerated investment in infectious disease diagnostics and highlighted the need for integrated testing systems.

Key stakeholders shaping the hepatitis testing ecosystem include original equipment manufacturers (OEMs) of diagnostic kits and systems, reference laboratories , public health authorities , government screening programs , non-profits and NGOs , private clinics , and healthcare investors . Pharmaceutical companies also influence testing demand through treatment programs requiring baseline and ongoing viral load monitoring.

As healthcare moves toward outcome-based reimbursement and universal screening, hepatitis testing serves as a frontline defense in global health security.

 

Market Segmentation And Forecast Scope

The hepatitis testing market is multifaceted and structured along the lines of test type , technology , end user , and region . Each dimension reflects unique drivers of demand and operational dynamics across the diagnostic landscape.

By Test Type

• Hepatitis B Testing

• Hepatitis C Testing

• Hepatitis A, D, and E Testing (Combined)

Hepatitis B testing currently dominates the market, accounting for approximately 45% of the global revenue share in 2024 , owing to high global prevalence, mandatory prenatal and blood bank screening, and availability of rapid and serological diagnostics. However, Hepatitis C testing is anticipated to be the fastest-growing segment during 2024–2030, driven by expanding treatment accessibility and WHO’s direct-acting antiviral (DAA) therapy guidelines.

 

By Technology

• Enzyme-Linked Immunosorbent Assay (ELISA)

• Rapid Diagnostic Tests (RDTs)

• Polymerase Chain Reaction (PCR)

• Other Molecular Diagnostics

ELISA-based tests have been the backbone of laboratory-based hepatitis diagnostics. They are highly reliable for screening large populations, especially in blood donation and public health programs. Rapid Diagnostic Tests (RDTs) , however, are projected to gain rapid momentum due to their affordability, minimal infrastructure requirements, and applicability in community-based and point-of-care settings .

 

By End User

• Hospitals and Diagnostic Laboratories

• Blood Banks

• Public Health Agencies

• Home Care Settings

Hospitals and diagnostic labs remain the principal testing environments, comprising the largest revenue contributor. However, public health agencies and home care settings are emerging as strategic growth channels. The increasing shift toward decentralized screening and national hepatitis elimination campaigns is pushing governments to expand community-level diagnostics.

 

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

Asia Pacific leads the global hepatitis testing market in volume due to high endemic rates of hepatitis B and C, particularly in China, India, and Southeast Asia. However, North America generates significant revenue due to its higher test pricing, insurance reimbursement infrastructure, and awareness levels. Sub-Saharan Africa and parts of Southeast Asia remain critical frontiers for large-scale testing rollouts supported by global health initiatives.

 

Market Trends And Innovation Landscape

The hepatitis testing market is undergoing a paradigm shift, catalyzed by disruptive technologies, shifting care models, and the global urgency for faster, decentralized diagnostics. Innovation in this market extends beyond just product development—it includes delivery formats, digital integration, and ecosystem collaboration.

A. Rise of Multiplexed and Integrated Testing Platforms

Modern diagnostic systems increasingly combine multiplex capabilities , allowing simultaneous detection of multiple hepatitis virus strains (A–E) or co-infections such as HIV or syphilis. This approach is particularly transformative in low-resource settings where testing access is limited.

According to laboratory directors in emerging markets, bundled diagnostic panels have reduced screening time by 40%, enabling quicker treatment initiation and epidemiological surveillance.

 

B. Miniaturization and Point-of-Care (PoC) Diagnostics

Rapid diagnostic tests (RDTs) are no longer limited to basic lateral flow assays. Next-generation PoC devices are now incorporating isothermal amplification and microfluidic chip technology , enabling real-time detection without thermal cycling. These devices are battery-operated, smartphone-compatible, and ideal for rural deployments.

Experts forecast that PoC solutions will account for over 60% of new hepatitis testing installations in Africa and South Asia by 2030, revolutionizing access and real-time disease mapping.

 

C. Digital Health and Remote Monitoring Integration

With growing emphasis on digital transformation, several companies are embedding connectivity features into diagnostic tools. Mobile-linked hepatitis testing devices can now automatically log results, sync with patient records, and alert public health authorities about outbreaks in real time.

Digital epidemiology tools are enabling early outbreak detection and improving longitudinal care through electronic reporting platforms in countries like Brazil and Thailand.

 

D. Strategic Collaborations and Diagnostic Alliances

Noteworthy developments include global partnerships between diagnostic firms , public health agencies , and pharmaceutical manufacturers . These alliances aim to scale access to testing in hard-to-reach areas and support DAA drug rollouts with diagnostic support.

Examples include:

• Co-deployment of hepatitis C testing kits with DAA treatment access programs in Central Asia.

• WHO-prequalified testing platforms backed by global funding mechanisms such as Unitaid and The Global Fund .

 

E. Pipeline Innovation and Regulatory Acceleration

Global regulatory bodies are now fast-tracking innovative hepatitis diagnostics, particularly those with AI-driven image interpretation, cloud-based analytics, and telehealth integration . Future market entrants include self-testing kits under validation for CE and FDA clearance, promising increased autonomy and privacy for at-risk populations.

As one virologist from a leading APAC research institute noted, “We’re approaching a phase where hepatitis diagnostics will evolve from facility-based interventions to fully patient-activated tools, much like pregnancy or HIV self-tests.”

 

Competitive Intelligence And Benchmarking

The hepatitis testing market is moderately consolidated, with a blend of multinational diagnostics giants and niche innovators competing across different technology tiers and geographic markets. Players are differentiating themselves through test accuracy, speed, pricing strategies, and global deployment networks.

Key Market Players

1. Abbott Laboratories A global diagnostics leader, Abbott offers a diverse hepatitis test portfolio encompassing ELISA kits, RDTs, and high-throughput molecular assays. The company's m2000 RealTime System is widely adopted in centralized labs for HBV and HCV detection. Abbott's competitive strength lies in global presence , integrated testing systems, and cost-effective test panels adapted for LMICs .

 

2. Roche Diagnostics Roche commands a significant share in molecular hepatitis testing through its cobas ® systems. Its PCR-based viral load tests for hepatitis B and C are recognized for high sensitivity and speed. Roche emphasizes automated workflow solutions , targeting large hospital labs and public health labs involved in longitudinal disease monitoring.

 

3. Siemens Healthineers Siemens has built a stronghold in serological testing for hepatitis through its ADVIA Centaur platforms. The company focuses on accuracy-driven innovations and strategic hospital partnerships in Europe and North America. Its dual-infection detection panels are gaining ground in universal screening programs.

 

4. Bio-Rad Laboratories Specializing in infectious disease diagnostics, Bio-Rad provides a suite of hepatitis test kits, particularly for blood banks and surveillance programs. Its competitive edge lies in customizable platforms and affordable pricing , especially in emerging markets.

 

5. Cepheid (a Danaher company) Cepheid is a game-changer in the rapid molecular testing space. Its Xpert ® HCV Viral Load system delivers PCR-grade diagnostics in under 90 minutes, even in mobile clinics. Its cartridge-based design and user simplicity are ideal for decentralized or rural deployments.

 

6. OraSure Technologies A niche innovator, OraSure is developing oral fluid-based rapid tests for hepatitis C, modeled after its successful HIV self-test. While still under regulatory evaluation in some markets, these non-invasive kits could revolutionize community-based and at-home screening in high-risk populations.

 

7. DiaSorin S.p.A. Known for its specialty immunoassays, DiaSorin has expanded its hepatitis test menu across the LIAISON® XL platform. Its European and Latin American market penetration is supported by clinical partnerships and R&D investments in multiplex assay development .

 

Strategic Takeaways:

• Most global leaders offer integrated systems , combining serological and molecular testing.

• M&A activity is moderate but growing, particularly in the PoC and digital diagnostics segments.

• Regional players in Asia and Latin America are rising through government tenders and NGO-backed deployments .

Competitive advantage in this market hinges not only on technical performance but on scalability, funding alignment, and adaptability to local infrastructure.

 

Regional Landscape And Adoption Outlook

The regional performance of the hepatitis testing market is shaped by a complex interplay of disease prevalence, government policy, healthcare infrastructure, and testing affordability. While global in reach, the market’s maturity and focus areas differ sharply across continents.

North America

Market Position: High-revenue, moderate-volume market North America—especially the United States —hosts a well-established hepatitis testing infrastructure. The region benefits from:

• Strong payer reimbursement frameworks

• CDC-driven screening mandates for baby boomers and high-risk groups

• Integration of molecular diagnostics in mainstream care

Advanced laboratory automation and real-time PCR adoption are widespread in hospitals and public health labs. Moreover, the rise of at-home hepatitis C test kits, particularly in urban areas, is accelerating self-initiated diagnosis.

 

Canada is seeing increased provincial investments in universal hepatitis C screening and micro-elimination programs focused on incarcerated and Indigenous populations.

 

Europe

Market Position: Regulation-driven, innovation-receptive market Western Europe, led by Germany, the UK, and France , is pushing forward with early detection programs aligned with ECDC and WHO Europe guidelines. Public-private partnerships are promoting community-based testing , especially in migrant and underserved populations.

• Germany : Strong hospital lab network and test reimbursement coverage

• UK : Active NHS hepatitis elimination campaign, aided by decentralized testing pilots

• Eastern Europe : Slower uptake due to funding gaps, but donor-supported programs are helping bridge the diagnostic divide

Europe is a hub for regulatory-clearance pilots of oral swab-based hepatitis C diagnostics and multiplex disease panels.

 

Asia Pacific

Market Position: High-volume, underpenetrated opportunity This is the largest regional market by volume , driven by China, India, Japan , and Southeast Asia . Hepatitis B is endemic in several countries, where over 7–10% of the adult population tests positive. Adoption trends vary:

• China : Government-backed neonatal HBV screening and digitized public health labs

• India : Ongoing gaps in rural diagnostic access, but growing NGO-led screening in urban slums and prisons

• Japan : Robust public health monitoring system and strong adoption of molecular diagnostics

The region presents tremendous potential for rapid tests and affordable PoC kits tailored to low-resource clinics and mobile testing units.

 

Latin America

Market Position: Growing with donor-supported programs Led by Brazil , Mexico , and Argentina , this region is investing in hepatitis C elimination through:

• Subsidized DAA therapy combined with targeted testing

• Hepatitis testing incorporated into maternal and prison health programs

• Regional collaborations with PAHO and WHO

Decentralized testing programs using mobile clinics are particularly impactful in Brazil’s Amazon and Mexico’s underserved northern states.

 

Middle East & Africa

Market Position: Critical growth frontier with infrastructure gaps The Middle East shows relatively higher diagnostic penetration—especially in Saudi Arabia, UAE, and Egypt —due to government-funded elimination programs and strategic diagnostic partnerships.

Sub-Saharan Africa , on the other hand, faces:

• Low screening coverage

• Supply chain constraints

• Heavy reliance on donor-funded diagnostics through programs like CHAI and Gavi

Despite these barriers, Africa is projected to be the fastest-growing regional market due to strong demand and global focus on equitable healthcare access.

 

White Space Opportunities

• Self-testing remains vastly underutilized in Asia and Africa.

• Bundled viral panels (HIV-HCV-syphilis) are in nascent adoption stages but offer huge cost efficiency.

• Regulatory harmonization and local test manufacturing can unlock market scale in Latin America and East Africa.

 

End-User Dynamics And Use Case

The end-user landscape in the hepatitis testing market is characterized by varying levels of diagnostic infrastructure, workflow demands, and care models. Each stakeholder segment plays a distinct role in driving adoption, influenced by technical needs, patient volume, and funding models.

Hospitals and Diagnostic Laboratories

These are the primary adopters of both serological and molecular hepatitis testing. In tertiary and urban hospitals, full-service labs typically run:

• Automated ELISA platforms for HBV/HCV screening

• Quantitative PCR tests for viral load monitoring

• Baseline genotype assays to inform treatment decisions

In high-income nations, hospital labs operate under rigorous accreditation standards, ensuring consistent testing turnaround and integrated care pathways.

 

Blood Banks

Blood transfusion safety mandates make hepatitis testing mandatory in blood donation centers . Most blood banks deploy:

• Rapid tests for preliminary screening

• Follow-up nucleic acid tests (NATs) for definitive exclusion

This segment remains a volume-heavy user of hepatitis B and C tests, especially in high-donation countries like the U.S., Brazil, and India. Any policy changes affecting blood safety regulation have a direct impact on this segment’s demand.

 

Public Health Agencies

Governments and NGOs play a critical role in mass screening efforts under national hepatitis elimination programs. These agencies prioritize:

• Low-cost PoC diagnostics

• Self-testing kits for community use

• Field-deployable platforms in mobile clinics

In countries like Vietnam, Egypt, and Rwanda , public health entities collaborate with WHO, Unitaid , and local nonprofits to carry out mass testing campaigns in high-risk populations such as prisoners, migrants, and sex workers.

 

Home Care Settings

While still nascent, this is the fastest-growing end-user segment due to rising consumer preference for self-testing. Key developments include:

• Oral-swab-based rapid hepatitis C test kits

• App-linked result interpretation for telehealth integration

• Delivery partnerships with pharmacies and e-commerce platforms

Regulatory approval for home hepatitis C testing in parts of Europe and ongoing clinical trials in the U.S. signal a major shift toward user-initiated diagnostics.

 

Use Case Spotlight: Community-Based Testing in South Korea

A tertiary care hospital in Incheon, South Korea , partnered with regional public health centers to launch a mobile hepatitis C screening initiative targeting elderly populations. The program utilized fingerstick-based RDTs administered by trained outreach nurses.

• Over 18,000 individuals were screened in 14 months.

• Positive cases were referred to the hospital's liver clinic for confirmatory PCR testing and DAA therapy initiation.

• The initiative achieved a 63% treatment uptake rate , demonstrating the power of decentralized diagnostics combined with central care navigation .

This use case highlights the critical role of flexible testing formats and public-private collaboration in achieving population-level disease control.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• FDA Clearance for Rapid HCV Test by LumiraDx (2024) LumiraDx received FDA clearance for its microfluidic-based hepatitis C rapid test capable of delivering results in under 15 minutes. The test integrates with the company's connected diagnostic platform, supporting real-time data sharing with healthcare providers.

• Roche Launches Multiplex Viral Load Panel (2023) Roche introduced a new cobas ® 5800 system panel that enables simultaneous quantification of HIV, HBV, and HCV, targeting resource-limited settings that require high-throughput with low sample volumes.

• WHO Prequalification of OraSure’s HCV Self-Test (2023) OraSure Technologies’ oral fluid-based HCV self-test received WHO prequalification, making it eligible for global procurement by donors and health agencies in LMICs.

• Partnership Between FIND and Cepheid for African Deployment (2023) The Foundation for Innovative New Diagnostics (FIND) and Cepheid expanded their partnership to roll out Xpert ® HCV Viral Load testing in sub-Saharan Africa with funding support from Unitaid .

• India’s ICMR Endorses Domestic HBV NAT Kit (2024) India’s apex research body approved the first locally manufactured nucleic acid testing kit for hepatitis B , aimed at reducing dependence on imports and cutting costs by 30%.

 

Opportunities

• Emerging Markets & National Elimination Programs Rapid scale-up of hepatitis testing in countries like Egypt, Vietnam, India , and Brazil offers a fertile ground for affordable diagnostic solutions. Public-private collaborations are key here.

• Expansion of Self-Testing and Digital Diagnostics The convergence of e-commerce, mobile health platforms, and oral fluid-based tests is opening a new frontier of patient-driven screening, especially in urban and remote populations.

• Multiplex & Syndromic Testing Panels Bundled diagnostics that detect HCV, HIV, and syphilis simultaneously are gaining traction due to cost-efficiency and better epidemiological insights, particularly for high-risk groups.

 

Restraints

• Regulatory Bottlenecks and Approvals Lag Despite promising technologies, several hepatitis diagnostics face delays in FDA and CE mark approvals , especially in the self-testing category. These hurdles slow down commercial rollout.

• Cost and Access Barriers in Low-Income Settings High-end molecular diagnostics remain out of reach for many low-resource clinics due to infrastructure and cost constraints, creating access gaps in rural Africa and South Asia.

As testing technology advances, equal attention must be paid to affordability, policy integration, and user training to ensure true market penetration.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 5.74 Billion
Revenue Forecast in 2030	USD 8.6 Billion
Overall Growth Rate	CAGR of 6.9% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Test Type, By Technology, By End User, By Geography
By Test Type	Hepatitis B, Hepatitis C, Hepatitis A/D/E
By Technology	ELISA, Rapid Diagnostic Tests, PCR, Others
By End User	Hospitals & Laboratories, Blood Banks, Public Health Agencies, Home Settings
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, Egypt
Market Drivers	1. Expansion of public health screening programs 2. Rise of home and self-testing innovations 3. WHO-backed hepatitis elimination funding
Customization Option	Available upon request