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Hepatitis Diagnostic Testing Market to Hit $5.40B by 2033, Driven by POC and Universal Screening | DataM Intelligence

Hepatitis Diagnostic Testing Market

Hepatitis Diagnostic Testing Market

The hepatitis diagnostic testing market is growing with tech advances, universal screening &rising awareness driving global demand for accurate, fast testing.

A CAGR of 5.8% from 2025–2033 highlights strong momentum in hepatitis diagnostics, powered by new technologies, universal screening, and rising global awareness. ”
— DataM Intelligence

AUSTIN, TX, UNITED STATES, July 1, 2025 /EINPresswire.com/ -- The hepatitis diagnostic testing market size reached US$ 3.26 billion in 2024 and is expected to grow steadily to US$ 5.40 billion by 2033, registering a CAGR of 5.8% during the forecast period 2025–2033. This consistent growth reflects the increasing global burden of hepatitis infections, rising awareness about early detection, and a shift toward advanced diagnostic technologies that are faster, more reliable, and more accessible.

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Key Market Drivers

One of the main factors driving this market is the rising prevalence of viral hepatitis, especially hepatitis B and C. These infections are often asymptomatic in the early stages, making accurate and timely diagnosis critical to preventing liver damage and associated complications like cirrhosis or liver cancer.

In addition, technological advancements in molecular diagnostics such as PCR-based tests and next-generation sequencing are transforming the testing landscape. These innovations have significantly improved the speed and accuracy of hepatitis diagnosis and are increasingly being deployed in both centralized laboratories and decentralized point-of-care (POC) settings.

The global push for universal screening has also accelerated market expansion. Healthcare authorities in multiple regions have revised their guidelines to recommend routine hepatitis testing for all adults, not just high-risk populations. Combined with increasing investments in healthcare infrastructure, particularly in emerging economies, this is expected to fuel demand for diagnostic kits, reagents, and testing platforms.

Major Companies in the Market

Abbott Laboratories

Danaher Corporation (Beckman Coulter Inc)

BioMerieux SA

Bio-Rad Laboratories Inc

Diasorin S.p.A

F. Hoffmann-La Roche AG

Hologic Inc

MedMira Inc

Qaigen Inc

Siemens Healthineers

These players are heavily investing in R&D and forming strategic partnerships to enhance their market presence and expand their technological capabilities.

Market Segmentation

By Type of Test Segment: Imaging Tests, Blood Tests, Liver Function Tests, Immunoassays, Nucleic Acid Tests, Liver Biopsy, Others.

By Diagnostic Tool: Paracentesis, Elastography, Surrogate markers, Others.

By End User: Diagnostic Laboratories, Hospitals, Others.

By Region: North America, South America, Europe, Asia-Pacific, Middle East and Africa.

Regional Outlook

North America
North America holds a significant share of the global hepatitis diagnostic testing market. Strong healthcare infrastructure, advanced laboratory capabilities, and favorable reimbursement policies make it a leader in terms of both adoption and innovation. In the United States, initiatives to eliminate hepatitis C as a public health threat have led to expanded screening recommendations and greater access to diagnostic services. Moreover, regulatory changes are streamlining the approval of POC diagnostics, accelerating market penetration.

Europe
Europe follows closely, with robust public health initiatives, especially in Western Europe. Many countries have implemented national hepatitis action plans that include widespread testing, vaccination programs, and education campaigns. The integration of hepatitis screening into routine healthcare checkups is helping to identify and treat infections earlier, boosting demand for diagnostic products.

Asia-Pacific
The Asia-Pacific region is projected to witness the fastest growth over the forecast period. Countries like China, India, and Japan are investing heavily in healthcare infrastructure and public health surveillance. High disease burden, particularly in rural and underserved areas, is driving the need for affordable and scalable testing solutions. Partnerships between government agencies and private companies are helping to improve access to diagnostics in even the most remote locations.

Latin America and Middle East & Africa
These regions are gradually scaling up hepatitis testing efforts. Although challenges such as lack of awareness and limited resources persist, initiatives from international health organizations and donor-funded programs are helping to bridge the gap and increase diagnostic coverage.

Latest News – USA

In the United States, recent developments reflect a renewed commitment to tackling hepatitis infections through improved diagnostics. The FDA has approved several new point-of-care hepatitis testing devices that provide results within minutes, especially for hepatitis C viral load detection. These tests are particularly valuable in community health centers, emergency rooms, and harm reduction facilities, where immediate diagnosis can facilitate faster treatment initiation.

Additionally, health authorities have updated guidelines recommending universal screening for hepatitis B for all adults at least once in their lifetime, regardless of risk factors. This move is expected to dramatically increase the demand for diagnostic tests, especially as more people become aware of their hepatitis status.

However, there are concerns about public health funding cuts affecting disease surveillance. Some testing programs have been scaled back, raising fears that early detection efforts could be compromised, particularly among marginalized communities. Despite this, the private sector continues to step in, with biotech companies launching accessible diagnostic solutions designed for broad deployment across healthcare settings.

Latest News – Japan

Japan has also made headlines with recent advancements in hepatitis diagnostics and healthcare policy. The government continues to provide financial support for hepatitis B and C treatment, covering a significant portion of diagnostic and medication costs under its universal health insurance scheme.

Recently, Japan has started to integrate more advanced serologic and molecular testing technologies in public health facilities. Hepatitis E diagnosis, which traditionally lacked standardized testing, has seen significant progress with the adoption of specific immunoglobulin assays that now form part of routine diagnostics in suspected cases.

Moreover, public health initiatives continue to focus on screening programs during workplace health exams. Despite government efforts, participation rates have room for improvement. Authorities are therefore exploring incentives and policy enhancements to boost screening uptake, particularly among younger and working-age populations.

With a highly aging demographic and one of the highest life expectancies globally, Japan is prioritizing early detection and treatment to reduce the long-term burden of hepatitis-related liver disease.

Conclusion

The hepatitis diagnostic testing market is on a steady upward trajectory. Fueled by increasing disease awareness, technological innovations, and government-backed screening initiatives, the market is expanding across both developed and developing regions. The next few years will likely see an acceleration in the adoption of point-of-care technologies, wider testing access, and greater integration of diagnostics into public health programs.

With the right combination of policy support, technological breakthroughs, and collaborative public-private partnerships, the global community is well-positioned to improve hepatitis diagnosis and ultimately, reduce the disease’s global impact.

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Sai Kumar
DataM Intelligence 4market Research LLP
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