The global sales of HBsAg testing are estimated to be worth USD 1,436.5 million in 2024 and are anticipated to reach a value of USD 2,188.5 million by 2034. Sales are projected to rise at a CAGR of 4.7% over the forecast period between 2024 and 2034. The revenue generated by HBsAg testing in 2023 was USD 1,372.0 million.
The rapid growth of the diagnostic technologies is driving the growth of the HBsAg testing market. RDTs have greatly increased the speed and convenience of HBsAg testing. Such tests are designed for results within minutes and, therefore, are very suitable in a point-of-care setup where quick diagnosis is needed.
Advancements in automated immunoassays have increased the precision and efficiency of the process of testing HBsAg. which include integrated platforms developed by leading firms such as Thermo Fisher Scientific and BD Biosciences. The sample processing, analysis, and result reporting in these platforms have been automatically integrated into a continuous workflow process that smoothes the course of testing, be it in research or clinical applications.
This continuous innovation in the technologies makes diagnosis among patients more precise, accessible, and expands the screening programs. All this contributes to the finding of hepatitis B infection early and managing it. The rise in prevalence of these tests as mainstream tests will probably increase the HBsAg testing market significantly, since it responds to acute needs in healthcare internationally and facilitates the fight against the disease.
Global HBsAg Testing Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 1,372.0 million |
| Estimated Size, 2024 | USD 1,436.5 million |
| Projected Size, 2034 | USD 2,188.5 million |
| Value-based CAGR (2024 to 2034) | 4.7% |
Hepatitis B is a global health challenge of enormous proportions since the World Health Organization estimated that a total of 296 million people are living with the virus worldwide. In 2019 alone, hepatitis B caused an estimated 820,000 deaths, most of which were due to serious complications related to cirrhosis and hepatocellular carcinoma.
Prevalence is rather different across regions. The highest prevalence is in the African and Western Pacific regions, where 6.1% and 6.2% of adults have the infection, respectively. In this respect, there is a great need for regional public health intervention and diagnostic activity. Chronic infection due to hepatitis B is associated with significant long-term complication risks and increased mortality.
It is estimated that a very big percentage, 80-90% of newborns who get infected with hepatitis B within the first year of life, develop chronic infections; this calls for early detection and interventions. Due to increasing urbanization and alteration in lifestyle, new cases of hepatitis B will definitely rise, which in turn shifts the global health dynamics.
The growing prevalence creates more demand for advanced diagnostic tools and comprehensive screening programs. This, in turn, fosters a better market position for hepatitis B diagnostic test manufacturers. Furthermore, the increasing prevalence, coupled with an emergent need for detection and intervention strategies, provides a significant opportunity for innovation and growth in the hepatitis B diagnostics market.
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Increasing Awareness and Screening Initiatives driving the market growth
The market for HBsAg testing is growing well because of increased awareness and several screening programs. Increased efforts by the government and agencies of health around the world in raising awareness about hepatitis B and its early detection also affect the market. Public health campaigns highlight the dangers of hepatitis B and, at the same time, point out the benefits of routine screening, which, in turn, raises demand for advanced HBsAg testing solutions.
These initiatives will carry greater significance in those regions where hepatitis B prevalence is high, and where governments and other non-governmental organizations are undertaking large-scale screening programs.
Such programs, targeting high-risk populations, ensure that the emphasis on accurate and reliable HBsAg tests is increasingly felt to ensure timely diagnosis and proper management of the disease. Moreover, heightened awareness of hepatitis B and its potential complications will ensure greater participation by patients themselves and proactive health checks.
Overall, increasing awareness about hepatitis B and extension of testing campaigns are driving demanding levels for HBsAg testing. These contribute to the growth of the market by ensuring more extensive testing is done, leading to the early detection of the disease and hence managing it better and improving patient outcomes.
High Prevalence in Endemic Regions Creating Growth Opportunities
The demand for HBsAg testing is immense in the high endemicity areas of hepatitis B, particularly in the regions of Asia Pacific and Africa. WHO estimates that 68% of the total burden in the world of hepatitis B is borne by the combined Western Pacific and African regions. Around 6.1% of adults in sub-Saharan Africa live with chronic hepatitis B, yet the region shows great inequality with regards to access to testing and treatment services.
Some countries, for example, Nigeria, in response to this have committed to wide, community-based screening programs, whereas the Nigerian government has set a target of bringing hepatitis B prevalence to less than 1% by the year 2030. The free or subsidized testing of HBsAg in all primary health care centers has led to a significant rise up to 25% in the rate of screening from 2018 to 2023.
Inclusion of hepatitis B testing in the national health insurance package in the Philippines has improved testing rates by 30% in the year 2023. In Vietnam, a few years ago, the government launched a hepatitis B screening drive for 60% of its population by 2025.
Therefore, such initiatives create attractive growth opportunities for the HBsAg testing market, proving the very existence of urgent needs for scalable, cost-effective diagnostic solutions in such high-burden settings.
Advances in Rapid Testing Methods as a major trend in this market
New advances in RDT methods and automated immunoassays have transformed the face of testing HBsAg, with much improved precision and speed in diagnosis. Tests for HBsAg, among others using lateral flow immunoassay technology, can have results in under 30 minutes with high sensitivity and specificity.
In 2022, a study published by the Lancet Infectious Diseases Journal documented that the sensitivity of the new generation of rapid tests reached 98.7%, and specificity attained 99.5%, thus making them a potential substitute for use in resource-limited settings and extra-clinical environments.
These include automated immunoassays such as chemiluminescent immunoassays and enzyme-linked immunosorbent assays that present higher throughputs, hence capable of handling hundreds of samples at any given time, with very minimal human intervention.
As early as 2024, Roche Diagnostics had come up with a next-generation HBsAg test possessing a fivefold increased sensitivity for the detection of the virus even at its lowest levels to further support early intervention strategies. In addition, POCT devices are gaining momentum, especially in rural or remote areas where laboratory infrastructure is at a minimal level.
For example, the introduction of mobile POCT testing units has seen a 40% increase in hepatitis B screening rates in the last two years in India's countryside. These technological advances are very important in expanding access to the testing services of HBsAg, and when timely diagnosis of hepatitis B infection is accurately done, they contribute to the growth of the market.
High Cost and Limited Access in Low-Income Regions may Restrict Market Growth
High costs associated with advanced testing methodologies; on the other, limited access to healthcare infrastructure hampers growth in the HBsAg testing market in low-income settings. Anecdotal evidence suggests that in many low-income countries, test prices for a single HBsAg RDT are likely to range between USD 5 and USD 10, while for more sophisticated tests, such as ELISAs, the cost might stand in the range of USD 25-USD 50 per test.
For example, the International Journal of Infectious Diseases said in 2023, "The mean laboratory-based cost of an HBsAg ELISA test performed in sub-Saharan Africa is USD 35, beyond what most individuals and public health systems in the region can pay for.”
In such areas, the infrastructures required, like good laboratory and trained personnel, are usually lacking. Even by 2022, it was estimated in a report from WHO that only 13% of health facilities from low-income countries have the capacity at the laboratory level for carrying out even routine hepatitis B testing.
Added to this rather poor access to facilities is the insufficiency of available funds for programs covering hepatitis B screening. In many countries in the sub-Saharan African region, less than 10% of the total health expenditure is put into communicable diseases, among them hepatitis B.
Lack of awareness among the at-risk populations remains a high barrier. For instance, a survey conducted by the Coalition for Global Hepatitis Elimination in 2021 estimated that less than 30% of people in the high-prevalence, low-income countries were aware of hepatitis B and the requirement to be tested, thereby further restraining market growth.
The global HBsAg testing industry recorded a CAGR of 4.3% during the historical period between 2019 and 2023. The growth of HBsAg testing industry was positive as it reached a value of USD 2,188.5 million in 2034 from USD 1,436.5 million in 2024.
The global HBsAg testing market has shown steady growth from 2019-2023, as there is an ever-growing need to address the infection burden of hepatitis B and there are continuous advancements in diagnostic methodologies. This growth was perhaps underpinned by enhanced screening programs and awareness campaigns arising from high-prevalence regions in Southeast Asia and Sub-Saharan Africa, which account for about 68% of the global hepatitis B burden.
In China, with one of the highest prevalence rates for hepatitis B globally. The large-scale screening from 2019 to 2023 increased demand for testing of HBsAg. According to the Chinese Center for Disease Control and Prevention, this has seen the number of tests for hepatitis B in the country grow at about 12% annually during the same period.
In Africa, too, countries like South Africa showed an increase in volume due to international funding for hepatitis B transmission control and due to efforts within their own respective governments.
This historical trend exhibits the rise in demand due to increased awareness by organizations such as the World Health Organization and several national governments. The WHO initiative to reduce hepatitis B infections increased testing efforts, especially within high-prevalence regions of the Asia-Pacific and Africa.
Rapid diagnostic tests and the expansion of point-of-care facilities reached more people and thus contributed to higher growth in testing because it increased accessibility and affordability.
In the forecasted years, it is expected that demand for HBsAg testing will progress with growth at a 4.7% CAGR from 2024 to 2034. Improved access to advanced technologies and expanded testing efforts are expected to be contributed. Accessibility and affordability for HBsAg testing have been increased by next-generation RDTs and automated immunoassays.
Continued innovation in testing technologies and expanded global screening programs are anticipated to drive this growth, ultimately improving hepatitis B management and early detection on a worldwide scale.
Principal Consultant
The Tier 1 firms are the undisputed leaders, with a dominating market share of 71.8% in the global HBsAg testing market. Their broad product portfolio and large production capacity help these firms amass revenues of more than USD 130 million. They have been identified to have wide geographical reach, strong customer dependency, and substantial experience in manufacturing and product innovations.
This leadership is reflected in the broad range of products and services offered by the Tier 1 companies, aside from keeping such offerings presented under strict legal requirements and at the best quality standards.
Key Tier 1 companies in the HBsAg testing market are Abbott, Bio-Rad Laboratories Inc., Siemens Healthineers, QIAGEN, and F. Hoffmann-La Roche AG. These industry behemoths are known for their advance technologies and global presence, making them the leading companies in the market.
Mid-size businesses with revenues between USD 50 and USD 80 million annually capture a value share of 17.1% in the global HBsAg testing market. Tier 2 companies, while significant in their own right, are usually region-based and have a considerable impact in the local markets. They feature deep industry expertise combined with a global presence.
These companies are typified by investment in newer technologies and adherence to good manufacturing practices. Some of the prominent Tier 2 companies include CTK Biotech Inc., Biopanda Reagents Ltd., and Avecon Healthcare Pvt Ltd. These firms create value in the market with specialized products and regional strengths, which have helped them grow and their influence increase in the industry.
While smaller in scale, Tier 3 companies play an important role within the HBsAg testing market through their specializations in specific product areas and niche markets. Their focused areas of expertise give diversity to the industry. Companies that would fall under this category are Bio-Rad Laboratories Inc. and Cytek Biosciences, Inc. These firms offer specialized solutions for specific needs in the market, hence helping develop the growth and variety of the landscape for HBsAg testing.
The section below covers the industry analysis for the HBsAg testing market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Asia Pacific, Europe, and others, is provided. The United States is anticipated to remain at the forefront in North America, with a CAGR of 1.3% through 2034. In Asia Pacific, China is projected to witness a CAGR of 5.3% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| USA | 1.3% |
| Germany | 1.4% |
| France | 2.1% |
| UK | 1.7% |
| China | 5.3% |
| India | 5.6% |
| South Korea | 4.2% |
Germany’s HBsAg testing market is expected to exhibit a CAGR of 1.4% between 2024 and 2034. The Germany holds highest market share in European market.
Germany is one of the major markets for HBsAg testing within the European continent. Overall, the country has a very well-developed healthcare infrastructure, focusing on precautionary health check-ups. Robust healthcare policies by the German government have thereby given importance to early detection and prevention of any disease, which has significantly enhanced demand for HBsAg testing.
Healthcare expenditure in Germany reached a value of more than €440 billion in 2023, of which a considerable proportion has been entrusted with precautionary care programs, for hepatitis B screening initiatives.
The strategic partnerships of pharmaceutical companies and diagnostic manufacturers with Germany continue to drive growth within the HBsAg testing market. For instance, most of the leading biotech and diagnostic firms of the country, including Siemens Healthineers and Qiagen, are investing high amounts in research and development in order to bring up new technologies in testing. Such factors have given rise to the uptake of innovative solutions for testing, such as molecular diagnostic tools.
USA market is anticipated to grow at a CAGR of 1.3% throughout the forecast period. The United States remains one of the largest markets for HBsAg testing, owing to a high prevalence of hepatitis B infections and strong government action.
The Centers for Disease Control and Prevention has pointed out the immense burden of chronic hepatitis B infection in the United States, hence continuing to recommend universal screening for all adults 18 years and above. Introduced in 2022, this policy is foreseen to surge demand for the testing of HBsAg.
The broad-based funding by the USA government for the prevention and control of hepatitis is a key growth driver in the market. There has been a "Viral Hepatitis National Strategic Plan for the United States" to increase screening and better management of the disease. Awareness and access to hepatitis B testing have been on the rise especially among high-risk populations due to support from public health agency and non-profit organization.
In conclusion, federal support, strategic health initiatives, and targeted awareness campaigns are some of the factors fueling unparalleled growth in the HBsAg testing market in the United States.
The China is expected to hold dominating position in East Asia market of HBsAg testing and is anticipated to grow at a CAGR of 5.3% throughout the forecast period.
China's HBsAg testing market is driven by a combination of large government-funded screening programs and solid local production. The government has initiated several national programs aimed at reducing the hepatitis B incidence, such as the National Hepatitis B Immunization Program, which provides free hepatitis B vaccinations to newborns and has significantly reduced the incidence of new hepatitis B infections in younger demographics.
The Chinese government has also initiated hepatitis B screening programs amongst pregnant women, as a part of the efforts to reduce the risk of transmission of the virus from mother to child and thereby enhance demand for tests like HBsAg. It will now pay more attention towards health and preventive measures.
This growth certainly provides a very good market for regular health check-ups, one of which is believed to be the HBsAg testing. This means the demand for HBsAg testing will keep on increasing owing to health awareness and private demands.
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The section contains information about the leading segments in the industry. Based on kits, the cassettes/cards is expected to account for 56.2% of the global market share in 2024.
| Kits | Cassettes/Cards |
|---|---|
| Value Share (2024) | 56.2% |
Cassettes and cards are expected to continue domination in the HBsAg testing market, with a market share of 56.2% in 2024. Cassettes and cards are just a simple, low-cost method for POC testing and, therefore, are accessible in most health care settings.
Its simplicity allows for quick and sure results with little training, essential for immediate patient management and decision-making. Moreover, in comparison to more complex systems, the testing formats are inexpensive, which justifies the wide usage. Rapid diagnosis using cassette and card formats adds to their appeal, hence their leading position in the market.
| Sample | Serum |
|---|---|
| Value Share (2024) | 48.1% |
By sample types, serum is likely to capture a share of 48.1% in the market in 2024. Serum samples are in great demand due to their established sensitivity and reliability in the detection of hepatitis B surface antigens. Well-established protocols of serum testing ensure consistency and accuracy in the diagnostic outcome.
Other reasons for choosing serum in clinical diagnosis are that serum provides comprehensive information as a diagnostic specimen. These are considered gold standards in the diagnosis of hepatitis B, mainly because of high sensitivity and standardization associated with serum samples thus, it is expected to hold a considerable market share.
The HBsAg testing market is highly fragmented, with a large number of manufacturers involved in the development and refining of new advanced products to cater to various customer demands. Market growth may be endorsed by demand for advanced diagnostic solutions, which, in turn, has accelerated international expansion and strategic acquisitions amongst leading players.
Recent Industry Developments in HBsAg Testing Market
In terms of Kits, the industry is divided into cassettes/cards and strips
In terms of sample, the industry is divided into serum, plasma and whole blood
In terms of end user, the industry is segregated into hospitals, clinics, diagnostic centres, home care and others
Key countries of North America, Latin America, Europe, East Asia, South Asia & Pacific, Middle East and Africa (MEA) have been covered in the report.
The global HBsAg testing industry is projected to witness CAGR of 4.7% between 2024 and 2034.
The global HBsAg testing industry stood at USD 1,372.0 million in 2023.
The global HBsAg testing industry is anticipated to reach USD 2,188.5 million by 2034 end.
China is expected to show a CAGR of 5.3% in the assessment period.
The key players operating in the global HBsAg testing industry include CTK Biotech Inc., Biopanda Reagents Ltd., Avecon Healthcare Pvt Ltd., Abbott, Bio-Rad Laboratories Inc., Siemens Healthineers, QIAGEN and F. Hoffmann-La Roche AG
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