The Global Hepatitis B Infectious Disease Tests Market was valued at USD 2.45 billion in 2023 and is projected to reach USD 3.80 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.0% during the forecast period (2023-2032). This growth is fueled by increasing global HBV prevalence, rising awareness of early diagnosis, and advancements in molecular diagnostic technologies across healthcare settings.
As hepatitis B remains a significant global health threat affecting approximately 296 million people worldwide, diagnostic innovators are developing faster, more accurate testing solutions. In this analysis, we examine the Top 10 Companies in the Hepatitis B Infectious Disease Tests Market—industry leaders combining scientific excellence with technological innovation to combat viral hepatitis.
🔟 1. Abbott Laboratories
Headquarters: Abbott Park, Illinois, USA
Key Offering: ARCHITECT HBsAg Qualitative, HBsAg Next Qualitative/Quantitative
Abbott dominates the HBV diagnostics space with its automated immunoassay systems, serving over 100,000 laboratories globally. The company’s fourth-generation HBsAg assays demonstrate 99.9% specificity and detect emerging HBV variants.
Innovation Highlights:
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First FDA-approved hepatitis B surface antigen (HBsAg) quantitative assay
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Highly sensitive chemiluminescent microparticle immunoassay (CMIA) technology
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Integration with Alinity laboratory automation systems
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9️⃣ 2. Roche Diagnostics
Headquarters: Basel, Switzerland
Key Offering: Elecsys HBsAg II, cobas HBV tests
Roche’s molecular and serological HBV testing portfolio runs on its cobas modular platforms, processing up to 960 tests/hour. The company leads in viral load monitoring with WHO-standardized cobas HBV assays.
Innovation Highlights:
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Fully automated HBV DNA quantification
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Point-of-care molecular testing solutions
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AI-powered result interpretation algorithms
8️⃣ 3. Bio-Rad Laboratories
Headquarters: Hercules, California, USA
Key Offering: BioPlex 2200 HBsAg, GS HBsAg EIA 3.0
Bio-Rad provides both multiplexed and traditional ELISA solutions for HBV detection, with particular strength in blood screening applications and confirmatory testing workflows.
Innovation Highlights:
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Multiplex testing for HBV/HCV/HIV in single run
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Adaptable for high-volume blood center testing
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WHO-prequalified assays
7️⃣ 4. Siemens Healthineers
Headquarters: Erlangen, Germany
Key Offering: ADVIA Centaur HBsAg II, Atellica IM HBsAg
Siemens delivers comprehensive HBV serology solutions across its automated platforms, processing 4 million HBV tests annually in the US alone through its laboratory network.
Innovation Highlights:
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Rapid stat testing capabilities (results in 18 minutes)
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Integrated HBV reflex testing protocols
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Cloud-based data management solutions
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6️⃣ 5. DiaSorin
Headquarters: Saluggia, Italy
Key Offering: LIAISON XL HBsAg, LIAISON Anti-HBs II
DiaSorin specializes in chemiluminescence immunoassays with WHO-compliant HBV markers, serving reference laboratories across Europe and emerging markets.
Innovation Highlights:
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Automated infectious disease testing menu
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Focus on blood donor screening compliance
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High-throughput (400 tests/hour) capabilities
5️⃣ 6. bioMérieux
Headquarters: Marcy-l’Étoile, France
Key Offering: VIDAS HBs Ag Ultra, EPISEQ HBV assay
bioMérieux combines ELISA and molecular diagnostics with AI-driven interpretive software, particularly strong in European hospital laboratories and public health systems.
Innovation Highlights:
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Automated HBV genotyping solutions
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Integrated antibiotic resistance profiling for HBV
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CE-IVD marked assays
4️⃣ 7. Thermo Fisher Scientific
Headquarters: Waltham, Massachusetts, USA
Key Offering: TaqMan HBV assays, HBsAg ELISA kits
Thermo Fisher provides comprehensive molecular diagnostic solutions from sample prep to real-time PCR detection, serving pharmaceutical researchers and clinical labs globally.
Innovation Highlights:
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ISO 15189-accredited viral load assays
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High-precision quantification down to 10 IU/mL
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Scalable automation solutions
3️⃣ 8. Qiagen
Headquarters: Venlo, Netherlands
Key Offering: artus HBV RG PCR kit, QIAstat-Dx Hepatitis Profile
Qiagen delivers sample-to-result molecular testing solutions with particular strength in decentralized diagnostics and low-resource settings through its syndromic testing panels.
Innovation Highlights:
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Point-of-care molecular HBV detection
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Room-temperature stable reagents
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Multiplex detection of HBV genotypes
2️⃣ 9. Griffols Diagnostics
Headquarters: Barcelona, Spain
Key Offering: Procleix Ultrio Elite HBV assay
Griffols focuses on nucleic acid testing (NAT) solutions for blood screening, processing over 80 million annual tests through its global transfusion medicine network.
Innovation Highlights:
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Ultra-sensitive HBV DNA detection (95% LOD: 2.4 IU/mL)
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Fully automated blood screening platforms
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Integrated donor management systems
1️⃣ 10. Wantai Biological Pharmacy
Headquarters: Beijing, China
Key Offering: ELISA HBsAg, Real-Time PCR HBV kits
Wantai dominates the Asian HBV diagnostics market with cost-effective solutions, processing over 50 million annual tests across China’s healthcare system.
Innovation Highlights:
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PreS1 antigen detection technology
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High-capacity assay production
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CE Marked and NMPA-approved tests
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🌍 Market Outlook: Precision Diagnostics and Decentralized Testing Drive Growth
The HBV diagnostics landscape is evolving rapidly, transitioning from traditional laboratory testing to integrated, data-driven solutions. Emerging technologies are enabling earlier detection, better monitoring, and more personalized management of chronic HBV infections.
📈 Key Market Trends:
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Expanding adoption of multiplex molecular panels in clinical practice
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Growth of point-of-care rapid diagnostic tests in resource-limited settings
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Increasing demand for HBV viral load monitoring during antiviral therapy
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Integration of artificial intelligence in test interpretation and reporting
The companies profiled above are not only transforming HBV diagnostics—they’re shaping the future of viral hepatitis management through continuous innovation and global accessibility initiatives.