Hepatitis Test Solution & Diagnosis Market to Reach USD 6.4 Billion

Pune, India, November 11, 2025 - The global Hepatitis Test Solution & Diagnosis Market is projected to expand from USD 3.8 billion in 2024 to USD 6.4 billion by 2034, registering a CAGR of 5.6%, according to Exactitude Consultancy. The increasing global burden of hepatitis B and C infections, combined with the expansion of point-of-care diagnostic technologies and government screening initiatives, is fueling strong market growth.

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Key Takeaways
• Market Size (2024): USD 3.8 billion
• Forecast (2034): USD 6.4 billion
• CAGR (2025-2034): 5.6%
• Leading Companies: Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Bio-Rad Laboratories, DiaSorin S.p.A, Thermo Fisher Scientific, Ortho Clinical Diagnostics, Grifols S.A., and Hologic Inc.
• Primary Applications: Hepatitis A, B, C, D, and E detection through ELISA, rapid test kits, and molecular assays.

Market Story
Hepatitis infections continue to pose a major global health challenge, affecting over 350 million people worldwide. The growing awareness around early diagnosis and treatment monitoring has led to an unprecedented demand for accurate, cost-effective, and rapid testing solutions.

Emerging molecular diagnostic technologies, such as PCR-based assays, chemiluminescence immunoassays (CLIA), and microfluidic point-of-care devices, are transforming detection capabilities in both clinical and remote settings. Public-private collaborations and WHO-backed hepatitis elimination programs are further driving adoption of screening tools in developing regions.

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Market Segmentation

• By Test Type:
o ELISA (Enzyme-Linked Immunosorbent Assay)
o Rapid Diagnostic Tests (RDTs)
o Nucleic Acid Testing (NAT)
o Immunoassays
o Others

• By Disease Type:
o Hepatitis A
o Hepatitis B
o Hepatitis C
o Hepatitis D
o Hepatitis E

• By End User:
o Hospitals & Diagnostic Laboratories
o Blood Banks
o Research Centers
o Public Health Agencies

• By Region:
o North America: Largest market due to advanced screening infrastructure and strong government surveillance programs.
o Europe: Increased early detection through national health systems and blood-safety regulations.
o Asia Pacific: Fastest-growing market driven by high hepatitis incidence in China, India, and Southeast Asia.
o Latin America & MEA: Expanding immunization coverage and growing healthcare access.

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Recent Developments
• 2025: Abbott launched ARCHITECT Hepatitis E IgM/IgG assays to strengthen its viral diagnostics portfolio.
• 2024: Roche Diagnostics introduced COBAS® HBV Quant II assay, offering enhanced viral-load accuracy.
• 2023: Siemens Healthineers expanded its Atellica® immunoassay range with hepatitis A and E diagnostic panels.
• 2022: Bio-Rad Laboratories acquired GenScreen Technologies to broaden its rapid test development pipeline.

Expert Quote
"Early and accurate diagnosis is the cornerstone of global hepatitis elimination goals. Continuous innovation in molecular diagnostics and portable testing devices is making screening more accessible and efficient worldwide," said Irfan Tamboli, Business Development Executive at Exactitude Consultancy.

Market Drivers
1. Growing Global Prevalence of Hepatitis B & C: Increased screening efforts in high-burden countries.
2. Advancements in Point-of-Care Testing (POCT): Portable analyzers and rapid assays enhance field diagnostics.
3. Government & WHO Programs: Global campaigns promoting mass screening and vaccination.
4. Technological Integration: AI-based data interpretation and digital connectivity for surveillance.

Forecast Outlook
The market will continue to expand as healthcare systems adopt next-generation molecular testing, integrated diagnostic workflows, and AI-enabled disease monitoring. Emerging economies are expected to witness rapid penetration of low-cost rapid test kits and automated immunoassay platforms by 2034.

Conclusion
The Hepatitis Test Solution & Diagnosis Market is evolving toward greater accessibility, speed, and diagnostic precision. Supported by strong public health initiatives and innovation in molecular testing, this market is set to play a pivotal role in achieving WHO's 2030 hepatitis elimination targets.

This report is also available in the following languages : Japanese (肝炎検査ソリューション診断), Korean (간염 검사 용액 진단), Chinese (肝炎检测方案诊断), French (Solution de test de dépistage de l'hépatite et diagnostic), German (Hepatitis-Testlösung zur Diagnose), and Italian (Diagnosi della soluzione del test dell'epatite), etc.

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