Hepatitis B Diagnostics Market

Market Scope

The Hepatitis B diagnostics market, HSI (High Sensitivity Immunoassay) technologies includes a range of serological and molecular tests used to detect, monitor, and manage hepatitis B virus (HBV) infections. These diagnostics cover blood-based assays such as HBsAg (Hepatitis B surface antigen) detection, anti-HBc, and HBeAg testing, along with molecular techniques like PCR-based HBV DNA quantification that measure viral load and replication activity. Together, these tools enable clinicians to identify acute and chronic hepatitis B infections, assess infectivity, and distinguish HBV from other types of viral hepatitis. Chronic infection is clinically defined by the persistence of HBsAg for more than six months, making sensitive and accurate diagnostic testing essential for long-term disease management.

The evolution of hepatitis B diagnostics began in the 1970s with early radioimmunoassays such as Ausria-125 and progressed to safer, automated enzyme immunoassays (EIA) and chemiluminescent immunoassays (CLIA) widely used today. More recently, high sensitivity immunoassays (HSI) and advanced nucleic acid amplification tests have significantly improved the detection of low-level viral antigens and DNA, enabling earlier diagnosis and reducing the risk of false-negative results — particularly in patients with occult or low-replicating HBV infection.

These diagnostics are widely applied in prenatal screening, blood donor testing, occupational health programs, and population-level surveillance, as well as in the ongoing monitoring of the estimated 257 million people living with chronic hepatitis B worldwide. Clinicians use serial measurements of ALT, AST, and HBV DNA levels to track disease progression and treatment response, and to guide antiviral therapy in patients at risk of cirrhosis and hepatocellular carcinoma. By enabling earlier detection and more precise monitoring, HSI-based hepatitis B diagnostic technologies play a critical role in reducing disease transmission, improving clinical outcomes, and addressing the global burden of hepatitis B, which is responsible for approximately 620,000 deaths annually.

Key Highlights:

The global Hepatitis B diagnostics market was valued at approximately USD 1,648 million in 2023 and is projected to reach around USD 2,022 million by 2032, growing at a compound annual growth rate (CAGR) of 2.3% over the forecast period. This steady growth is being supported by the increasing adoption of high sensitivity immunoassays (HSI), which enhance diagnostic precision by detecting low concentrations of viral antigens and improving early-stage identification of hepatitis B infections.

North America currently leads the global market, accounting for nearly 49% of total revenue, driven by its advanced diagnostic infrastructure, widespread availability of automated laboratory platforms, and screening recommendations from public health authorities such as the CDC. In contrast, the Asia-Pacific region is expected to witness the fastest growth, with a projected regional CAGR of approximately 6.4%, supported by a high hepatitis B disease burden and increasing government and private investments in diagnostic capacity. The Western Pacific region alone accounts for nearly 47% of hepatitis B–related deaths globally, reinforcing the urgent need for expanded screening and monitoring programs.

At the country level, Japan is emerging as one of the fastest-growing markets, with regions such as Kyushu and Okinawa showing growth rates of around 6.1% CAGR, reflecting strong preventive healthcare policies, routine screening initiatives, and high adoption of advanced diagnostic technologies.

From a segmentation perspective, enzyme immunoassay (EIA) kits represent the largest product segment, capturing approximately 47.6% of market revenue due to their scalability, automation compatibility, and cost-effectiveness in high-volume testing environments. In terms of end users, hospitals account for about 53.2% of total diagnostic testing demand, supported by well-established laboratory infrastructure, integrated patient management systems, and their central role in screening, diagnosis, and long-term disease monitoring.

Market Dynamics:

The growth of the hepatitis B diagnostics market is strongly driven by the rising global prevalence of hepatitis B virus infection, which affects an estimated 254 million people worldwide, of whom only 13% have been formally diagnosed, according to the World Health Organization. This large undiagnosed population is prompting governments to expand screening and surveillance programs, particularly in high-burden regions. The Western Pacific region alone accounts for approximately 47% of global hepatitis B–related deaths, driving national public health initiatives to strengthen early testing and disease monitoring. Expanded screening has been shown to improve early intervention and can reduce disease progression to cirrhosis and liver cancer by 30–50% through timely antiviral treatment, thereby increasing the clinical and economic value of early diagnosis.

Technological advancements, particularly in high sensitivity immunoassays (HSI) integrated with artificial intelligence (AI) and machine learning (ML) algorithms, are further accelerating market growth. These innovations enhance biomarker interpretation, improve result accuracy, and reduce turnaround times, with some diagnostic platforms reporting 20–30% faster detection and reporting workflows compared to conventional systems. This is especially impactful in high-prevalence and resource-limited settings, where early and reliable detection is essential for disease control. Despite these drivers, the market faces notable restraints. Regulatory complexity under agencies such as the EMA and national authorities can extend product approval timelines, delaying the introduction of innovative diagnostics. In parallel, constrained public healthcare budgets in many low- and middle-income countries limit large-scale procurement, with rural and underserved populations experiencing up to 40% lower access to diagnostic services, which restricts market penetration.

At the same time, significant opportunities are emerging through the development of multiplex testing platforms, point-of-care (POC) diagnostic kits, and next-generation sequencing (NGS)–based solutions, which are expanding the reach of hepatitis B testing beyond centralized laboratories. With NGS technologies projected to grow at a 6.81% CAGR, decentralized testing models are enabling earlier diagnosis and are estimated to increase detection rates by approximately 25% in remote and underserved areas. Collectively, these dynamics highlight how demand drivers improve efficiency and disease outcomes, regulatory and budgetary restraints limit short-term expansion, and technological innovation — particularly the integration of HSI-based diagnostics — is unlocking new growth opportunities across global healthcare systems.

Market Trends

• Current trends in the hepatitis B diagnostics market are increasingly shaped by the rising adoption of point-of-care (POC) testing, driven by the need for faster results and expanded access in underserved regions. POC diagnostics enable rapid screening and same-day clinical decisions, helping reduce hospital stays by 20–30% in resource-limited settings, according to public health evaluations. This shift is transforming healthcare delivery by bringing hepatitis B testing closer to patients and improving early intervention rates.
• At the same time, laboratories are accelerating the adoption of high sensitivity immunoassays (HSI), including advanced enzyme immunoassays (EIA) and PCR-based molecular diagnostics, which significantly enhance analytical sensitivity and diagnostic reliability. These technologies are now achieving detection accuracy exceeding 95%, supporting better clinical outcomes through earlier and more precise identification of infection status.
• Looking ahead, artificial intelligence (AI)-enabled diagnostics and automated laboratory platforms are emerging as key future trends, improving both processing speed and result interpretation. Innovations in automated workflows and AI-supported pattern recognition are reported to enhance operational efficiency and diagnostic accuracy by approximately 25%, reducing manual error and increasing throughput in high-volume testing environments.
• A major technological shift is also underway toward molecular and next-generation sequencing (NGS)–based diagnostics, which are growing at an estimated 6.81% CAGR. These platforms allow for viral genotyping and resistance mutation monitoring, enabling clinicians to tailor antiviral therapy more precisely and improving long-term disease management.
• From a customer perspective, demand is rising for integrated prenatal screening and HIV–hepatitis B co-testing, driven by maternal health programs and infectious disease control strategies. Government-led campaigns are increasing screening volumes by 15–20%, particularly in high-burden regions.
• Product innovation is further supporting market expansion, with manufacturers developing low-cost rapid diagnostic kits designed for use in low-resource and decentralized settings. These affordable and easy-to-use products are improving early detection and supporting broader population-level screening. Collectively, these trends demonstrate how HSI-enabled diagnostic technologies, decentralization, automation, and policy-driven demand are reshaping the hepatitis B diagnostics landscape by improving efficiency, accuracy, and accessibility — without relying on market size or revenue growth metrics.
  

Market Segmentation

By Diagnostic Purpose

• Screening
• Blood donor screening
• Antenatal (pregnancy) screening
• Community / population screening
• Occupational screening (healthcare workers)
• Diagnosis / Confirmation
• Acute HBV diagnosis
• Chronic HBV diagnosis
• Differentiation from other hepatitis causes
• Disease Monitoring
• Viral load monitoring during treatment
• Treatment response monitoring
• Liver disease progression risk assessment (with HBV markers)
• Others

By Biomarker / Test Target (HBV markers)

• HBsAg (screening/diagnosis)
• Anti-HBs (immunity / vaccine response)
• Total Anti-HBc (past or current infection)
• IgM Anti-HBc (acute/recent infection)
• HBeAg
• Others

By Test Modality / Technology

• Immunoassays (Serology)
• Rapid Diagnostic Tests (RDTs)
• ELISA / EIA
• CLIA / ECLIA
• Chemiluminescent microparticle immunoassay (CMIA) (platform-based)
• Others
• Molecular / Nucleic Acid Testing (NAT)
• Real-time PCR (qPCR) (quantitative viral load)
• Digital PCR (niche/advanced)
• Isothermal amplification (e.g., LAMP)
• Others
• C) Sequencing & Advanced Methods)
• Sanger sequencing
• Next-Generation Sequencing (NGS)
• Multiplex molecular panels (HBV + HCV + HIV, etc.)

By Product Type

• Instruments / Analyzers
• Immunoassay analyzers
• Molecular platforms (PCR/NAT systems)
• Reagents & Kits
• Serology reagent kits
• HBV DNA quantification kits
• Genotyping/resistance kits
• Consumables
• Cartridges, assay strips, tubes, tips, extraction kits
• Software / Informatics
• Viral load analysis/reporting modules
• LIS integration, QC analytics

By Sample Type

• Whole blood
• Serum
• Plasma
• Dried blood spot (DBS)
• Others

By End User / Testing Site

• Hospitals & hospital laboratories
• Independent / private diagnostic laboratories
• Blood banks / transfusion centers
• Public health laboratories
• Clinics & primary care centers
• Research institutes / academic labs
• Others

By Patient / Risk Group

• Pregnant women
• Newborns/infants
• General adult population 
• Healthcare workers
• Hemodialysis patients
• Immunocompromised patients
• People living with HIV
• Household/sexual contacts of HBV-positive individuals
• Migrants from high-prevalence regions
• Others

Market Players

• Hoffmann-La Roche Ltd.
• Abbott Laboratories
• DAAN Gene Co. Ltd.
• Bio-Rad Laboratories Inc.
• DiaSorin SpA
• Siemens AG/Healthineers
• QIAGEN NV
• bioMérieux SA
• Xiamen Innovax Biotech Co. Ltd.
• MedMira Inc.
• Grifols SA
• Hologic Inc.
• Others