Point of Care Testing for Hepatitis B Virus (HBV) Market Size and Overview:

The Global Point of Care Testing for Hepatitis B Virus (HBV) Market was valued at USD 1.5 billion in 2024 and will grow at a CAGR of 9% from 2025 to 2030. The market is expected to reach USD 2.6 billion by 2030.

The Point of Care Testing for HBV Market focuses on rapid diagnostic solutions that can detect Hepatitis B infections at or near the site of patient care. This market is driven by the global demand for accessible, affordable, and quick diagnostic tools, especially in regions with high HBV prevalence. Increasing government initiatives for early diagnosis, rising awareness of liver-related health issues, and advancements in portable diagnostic technologies contribute significantly to market growth. Point of care solutions reduce reliance on centralized laboratories, making testing available in resource-limited settings and improving patient outcomes through faster clinical decisions.

Key Market Insights:
Rising prevalence of HBV worldwide, with an estimated 250 million people chronically infected, is creating sustained demand for point of care testing solutions.

Portable and rapid diagnostic kits account for nearly 45% of the current market share, highlighting the shift toward decentralized healthcare delivery.

North America represents about 35% of the global revenue due to advanced healthcare infrastructure and early adoption of innovative testing technologies.

Asia-Pacific is projected to witness the fastest growth with a CAGR of over 10% during 2025–2030 due to large HBV patient pools and increased screening programs.

Test kits priced below USD 10 are driving adoption in low- and middle-income countries, where affordability is critical to wider implementation.

Partnerships between diagnostic companies and government health programs are expanding testing accessibility in rural areas, particularly in Africa and Asia.

Digital connectivity and integration with telemedicine platforms are enhancing the role of point of care testing in remote monitoring and follow-up care.

The market is seeing a rise in multiplex assays that allow simultaneous testing for HBV and other infectious diseases, improving efficiency in clinical settings.

Global Point of Care Testing for Hepatitis B Virus (HBV) Market Drivers

Rising global burden of Hepatitis B infection is driving the market growth
The most significant driver for the market is the rising global burden of Hepatitis B infections. According to international health estimates, over 250 million people worldwide are chronically infected with HBV, with millions more at risk of acquiring the infection. This persistent prevalence creates an urgent need for faster and more accessible diagnostic solutions. Traditional laboratory testing is often expensive, requires trained personnel, and may take days to deliver results, making it unsuitable for many regions with high HBV incidence. Point of care testing (POCT) provides a viable solution by offering accurate and rapid detection of HBV antigens and antibodies directly at healthcare centers, community clinics, or even at the patient’s bedside. The ability to obtain results within minutes not only improves patient outcomes but also facilitates early decision-making for treatment initiation, vaccination, and further diagnostic evaluation. Governments and non-governmental organizations are increasingly advocating for mass screening programs to control the spread of HBV, particularly in Asia-Pacific and Africa where prevalence rates are highest. These initiatives often rely heavily on POCT kits due to their affordability, portability, and ease of use. Additionally, the rise in awareness campaigns regarding liver health, coupled with improved availability of HBV vaccines, has boosted demand for diagnostic tools that can identify at-risk populations. As healthcare providers continue to prioritize cost-effective solutions that increase testing coverage, the role of point of care diagnostics in managing HBV is expected to expand significantly, making it a central driver of market growth.

Technological advancements and product innovation is driving the market growth
Another crucial factor fueling the growth of the HBV point of care testing market is the rapid advancement of technology and product innovation. Modern POCT devices have evolved to provide higher sensitivity and specificity, rivaling traditional laboratory-based tests while significantly reducing turnaround time. Manufacturers are increasingly developing portable, user-friendly kits that require minimal training, allowing their use in both advanced hospitals and resource-limited rural areas. One of the notable innovations is the rise of lateral flow immunoassays, which provide rapid detection of HBV markers at affordable costs. These innovations are further being integrated with digital platforms and mobile applications, allowing results to be shared electronically with healthcare professionals for immediate consultation and treatment planning. The development of multiplex assays, which can simultaneously test for HBV along with other blood-borne infections like HIV and Hepatitis C, is another advancement reshaping the industry by saving time and resources. In addition, miniaturization and microfluidics technology are making devices smaller, faster, and more efficient. These advancements also support home-based testing, where patients can conduct self-tests and receive guidance through telemedicine platforms, thus expanding accessibility and reducing the burden on centralized laboratories. The rise in collaborations between diagnostic companies, governments, and NGOs is also accelerating product innovation by funding research and development and creating opportunities for scaling up affordable solutions. Together, these technological improvements are driving the expansion of the POCT for HBV market by making testing more reliable, accessible, and convenient for diverse patient populations worldwide.

Global Point of Care Testing for Hepatitis B Virus (HBV) Market Challenges and Restraints

Accuracy and affordability challenges in low-resource regions is restricting the market growth
While the market for point of care testing for HBV is growing rapidly, one of the most pressing challenges is balancing accuracy with affordability, particularly in low- and middle-income regions. Many rapid diagnostic kits available in the market today face limitations in terms of sensitivity and specificity when compared to traditional laboratory methods. False positives or negatives not only impact patient care but also undermine trust in point of care solutions. In regions where HBV is endemic, even a small margin of error can have significant consequences for public health strategies. Furthermore, while POCT kits are more affordable than centralized laboratory testing, consistent access to quality kits at a sustainable price point remains a challenge. Governments and healthcare systems in resource-limited settings often operate with constrained budgets, making it difficult to scale mass testing programs. Additionally, the lack of standardized regulatory frameworks in some countries raises concerns regarding the quality and reliability of products circulating in the market. Another restraint is the limited awareness and training among healthcare workers in remote areas, where the majority of POCT kits are most needed. Without proper guidance, even accurate test kits may be misused or underutilized. The distribution and supply chain also present challenges, as ensuring the availability of POCT kits in rural regions requires efficient logistics and cold-chain infrastructure in some cases. Addressing these affordability and accuracy-related barriers will be crucial for the sustainable growth of the HBV point of care testing market in the coming years.

Market Opportunities
The global point of care testing for HBV market is poised for considerable expansion as healthcare systems prioritize rapid and decentralized diagnostic solutions. One of the greatest opportunities lies in the integration of POCT with large-scale government and international health organization initiatives aimed at eliminating viral hepatitis as a major public health threat by 2030. With the World Health Organization calling for widespread HBV testing, opportunities exist for diagnostic companies to partner with public health programs to scale up affordable and accessible testing solutions. The growing prevalence of home-based care and the rise of telemedicine create additional opportunities for manufacturers to develop self-testing kits integrated with digital platforms that allow real-time consultation and monitoring. Moreover, multiplex technologies offer prospects to expand the scope of POCT beyond HBV alone, allowing simultaneous testing for other infectious diseases, which increases cost-effectiveness and clinical utility. In terms of market potential, emerging economies in Asia-Pacific, Africa, and South America provide vast opportunities due to large patient pools, high infection rates, and growing investments in healthcare infrastructure. Companies that can deliver cost-effective yet highly accurate solutions tailored to these markets are expected to gain a competitive edge. Furthermore, ongoing advancements in nanotechnology and microfluidics could pave the way for next-generation devices that are even more compact, faster, and easier to use. As demand for preventive healthcare rises globally, the opportunity for POCT manufacturers to position themselves as key contributors to HBV elimination and liver disease prevention programs will be one of the most defining growth avenues in the years ahead.

POINT OF CARE TESTING FOR HEPATITIS B VIRUS (HBV) MARKET REPORT COVERAGE:

Point of Care Testing for Hepatitis B Virus (HBV) Market Segmentation

Point of Care Testing for Hepatitis B Virus (HBV) Market By Product

• Lateral flow assays
• Immunoassay analyzers
• Test strips and dipsticks
• Portable molecular diagnostic devices
• Others

The dominant product segment in the global point of care testing for HBV market is lateral flow assays. These tests are inexpensive, portable, and capable of delivering results within minutes, making them particularly valuable in resource-limited settings. Their ease of use requires minimal training, which facilitates adoption in rural clinics, outreach programs, and large-scale screening initiatives. With continued innovation, lateral flow assays have also achieved improved accuracy and sensitivity, further boosting their credibility among healthcare providers. The scalability and affordability of these kits ensure they remain the backbone of HBV POCT solutions globally.

Point of Care Testing for Hepatitis B Virus (HBV) Market By Application

• Hospitals and clinics
• Diagnostic laboratories
• Home care settings
• Research institutes
• Others

Hospitals and clinics dominate the application segment for point of care testing of HBV. This is largely due to the high patient influx, the critical need for rapid diagnosis, and the ability to immediately integrate test results into clinical decision-making and treatment plans. Hospitals remain the primary setting for HBV testing, especially in cases involving high-risk groups, prenatal care, and pre-surgical screenings. Clinics, particularly in developing regions, also serve as critical hubs for point of care testing due to their accessibility for local populations. This makes hospitals and clinics the most influential segment driving demand for POCT solutions in HBV management.

Point of Care Testing for Hepatitis B Virus (HBV) Market Regional Segmentation

• North America
• Asia-Pacific
• Europe
• South America
• Middle East and Africa

The dominant region in the global point of care testing for HBV market is Asia-Pacific. This region carries the largest burden of Hepatitis B, with countries such as China, India, and Southeast Asian nations accounting for a significant portion of the world’s infected population. The high prevalence has driven governments to launch widespread screening and vaccination programs, many of which rely heavily on affordable and rapid POCT solutions. Additionally, increasing healthcare investments, expanding diagnostic infrastructure, and rising awareness campaigns are boosting demand for point of care testing kits across the region. Asia-Pacific also benefits from a large pool of diagnostic manufacturers offering cost-effective solutions, further enhancing market accessibility. Rural and underserved areas, which often lack centralized laboratory facilities, particularly benefit from portable and easy-to-use HBV testing devices. The combination of high disease prevalence, government support, and rapid technological adoption ensures that Asia-Pacific will continue to dominate the global market during the forecast period.

Point of Care Testing for Hepatitis B Virus (HBV) Market COVID-19 Impact Analysis
The COVID-19 pandemic had a dual impact on the point of care testing for HBV market. Initially, disruptions were evident as healthcare systems globally diverted resources, staff, and infrastructure toward managing COVID-19. Routine testing and screening for HBV declined significantly, especially during the peak of the pandemic, as hospitals prioritized emergency care and patients avoided clinical visits due to fear of infection. However, the pandemic also accelerated the adoption of rapid diagnostic technologies and decentralized testing models, which benefited the POCT market in the long term. The global emphasis on early detection, rapid diagnostics, and at-home testing created awareness about the importance of portable, user-friendly diagnostic kits. Manufacturers of POCT devices leveraged their existing technologies to innovate further, with many developing multiplex testing solutions that could eventually be adapted for HBV. Supply chain challenges were also addressed through new distribution models that emphasized local production and partnerships with regional healthcare providers. In the post-pandemic period, many governments have expanded investments in infectious disease diagnostics, ensuring that HBV testing receives renewed attention under broader public health programs. The pandemic thus served as a catalyst for innovation and adoption, establishing point of care testing as a crucial pillar of global healthcare strategies, including those focused on Hepatitis B.

Latest Trends/Developments
The market for point of care testing for HBV is witnessing a series of important developments that are shaping its trajectory. One of the most notable trends is the rise of digital integration, where POCT devices are now being linked with mobile applications and telemedicine platforms to provide real-time guidance, data recording, and remote consultation. Another significant development is the growing focus on multiplex assays that allow simultaneous detection of HBV and other blood-borne infections like HIV and HCV, improving efficiency for clinicians and healthcare workers. Portable molecular diagnostic platforms, which were once considered costly and complex, are becoming more accessible thanks to miniaturization and affordability improvements. Additionally, the trend toward self-testing has gained momentum, with several companies developing easy-to-use HBV POCT kits designed for home use. This aligns with the broader shift toward patient-centered healthcare. Partnerships between diagnostic manufacturers and governments or NGOs are increasing, enabling large-scale distribution of POCT kits, particularly in regions with high HBV prevalence. Sustainability is also emerging as a key focus, with manufacturers exploring biodegradable materials for disposable test kits to reduce medical waste. Furthermore, artificial intelligence and data analytics are being integrated into POCT solutions to enhance accuracy and interpretation, thereby supporting clinical decision-making. Collectively, these trends demonstrate that the market is not only expanding in scale but also evolving technologically and strategically to meet the dynamic demands of global healthcare.

Key Players

1. Abbott Laboratories
2. Roche Diagnostics
3. Siemens Healthineers
4. Bio-Rad Laboratories
5. Danaher Corporation
6. OraSure Technologies
7. Chembio Diagnostics
8. Fujirebio Holdings
9. Hologic Inc.
10. Meridian Bioscience