Hepatitis B Diagnostic Tests Market By Product Type (Enzyme Immunoassay Kits, Point-of-Care Testing Kits), End User (Hospitals, Clinics, Diagnostic Centres, Home Care) & Region - Forecast 2017 - 2027

Hepatitis B Diagnostic Tests Market Outlook – 2022-2028

[218 Pages Report] Despite the COVID-19 impact, global Hepatitis B Diagnostic Tests Market experienced a healthy year-on-year (YoY) growth, reaching a valuation of around US$ 872.5 Mn in 2022. With increasing prevalence of hepatitis B worldwide, the overall market is anticipated to register a CAGR of 6.4% between 2022 and 2028, surpassing a valuation of US$ 1.26 Mn by the end of 2028.

Enzyme immunoassay (EIA) will continue to remain the most preferred diagnostic test for the detection of hepatitis B, accounting for a massive share of 89.9% in 2022. Various benefits of enzyme immunoassay kits such as reduced assay time, requirement of small sample size, and quick and accurate results.

Regionally Asia Pacific is projected to emerge as the most lucrative market for hepatitis B diagnostic tests, holding around 30.3% share of the global market in 2022. Growth in the region is driven by increasing patient pool and rising government support.

2017-2021 Hepatitis B Diagnostic Tests Market Outlook Compared to 2022-2028 Forecast

The hepatitis B diagnostic tests market is set to register a robust CAGR of 6.4% between 2022 and 2028 in comparison to 6.2% CAGR registered from 2017 to 2021.

According to Future Market Insights (FMI), increasing prevalence of hepatitis B, growing government support, advancement in diagnostic technology, higher blood transfusion rates and rising need for early diagnosis of hepatitis B are some of the major factors driving the hepatitis B diagnostic tests market.

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). It has become a major global healthcare concern over the last few decades.

Rising incidence of hepatitis B across the globe is a major factor driving the hepatitis B diagnostic tests market. According to the World Health Organization (WHO), an estimated 296 million people were diagnosed with chronic hepatitis B infection in 2019. Furthermore, around 1.5 million new infections of hepatitis B occur each year.

Early detection of hepatitis B becomes a crucial step in treating the disease as well as in curbing its spread. Hepatitis B is a “silent epidemic” because it does not manifest symptoms in majority of the newly infected or chronically infected people. If it remains undetected in the earlier stages, it can transform from acute to chronic form which is untreatable and fatal. As a result, People are opting for regular diagnostic tests for the detection of hepatitis at earlier stages.

When identified in earlier stages, hepatitis B is more likely to respond to treatment and thus enhance the chances of survival. As per WHO’s study, around 4.5 million premature deaths due to hepatitis can be prevented in low- and middle-income countries by 2030 through diagnostic tests, education campaigns, vaccination and medicines. Increase in diagnostic procedures will continue to boost the sales of hepatitis B diagnostic test kits during the forecast period.

Growing awareness among people about hepatitis B and its consequences is fostering the demand for hepatitis B diagnostic tests. Governments across the world are continuously launching initiatives to educate people about the benefits of hepatitis B diagnostic testing. Huge investments are being made to counter the global burden of hepatitis B.

As hepatitis B spread through body fluids, continuous testing is being highly recommended before blood donations, blood transfusion and during pregnancy. This is boosting the sales of hepatitis B diagnostic solutions.

Moreover, the growing popularity of point of care testing is further accelerating the growth of the market and the trend is likely to continue in the future.

A total valuation of US$ 1.26 Bn has been projected for the global hepatitis B diagnostic tests market by FMI through 2028.

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How Will The Government Initiatives Spur Hepatitis B Diagnostic Tests Market Growth?

Rising mortality rate of hepatitis B has compelled government and other international organization to launch various initiatives and programs. Huge funds are being directed towards educating people about the hepatitis B, its prevention and the importance of diagnostic tests.

It has been found that delay in treatment of hepatitis B can lead to serious health issues such as liver cancer, liver cirrhosis and even death. Early diagnosis remains a key aspect for managing the hepatitis B disease.

Various action plans and programs are being launched to promote the adoption of hepatitis B diagnostic testing. For instance, in July 2018 Ministry of Health and Family Welfare, Government of India launched the National Viral Hepatitis Control Program to eliminate hepatitis by 2030 and achieve significant reduction in the infected population, morbidity and mortality associated with hepatitis B and C.

One of the main objectives of the program is to provide early diagnosis and management of viral hepatitis at all levels of healthcare.

In June 2021, WHO launched first-ever global guidance for country validation of viral hepatitis B and C elimination. Similarly, a growing number of hepatitis elimination projects are being established across the United States to promote hepatitis B diagnostic testing.

Furthermore, various voluntary and nonprofit organizations are being formed across the world to educate people about hepatitis B and importance of early diagnosis.

Spurred by these programs, the hepatitis B diagnostic tests market is set to expand 1.45X through 2028.

Country-wise Insights

What Is Driving The Demand For Hepatitis B Diagnostic Tests In The U.S.?

As per FMI, hepatitis B diagnostic tests market in the U.S. will accelerate at a steady CAGR of 4.3% between 2022 and 2028. Growth in the country is attributed to the rising health awareness, well established healthcare sector, and presence of leading players and increasing prevalence of hepatitis B

Over the years, diagnostic screening for hepatitis B has risen drastically across the U.S. Rising health awareness and involvement of government and other healthcare organizations is boosting the hepatitis B diagnostic tests market in the country.

According to the U.S. Department of Health and Human Services, around 850,000 people in the U.S. are living with hepatitis B. However, the actual number may be as high as 2.2 million or as low as 730,000.

Majority of the persons living with hepatitis B do not know that they have virus. Almost around 67% of persons living with hepatitis B infection in the U.S do not know they have the virus. As a result, early diagnosis is important to prevent the spread and reduce the mortality rate.

What Are The Growth Projections For India Hepatitis B Diagnostic Tests Market?

As per FMI, India is set to register the fastest growth in the hepatitis B diagnostic tests market, growing at a robust CAGR of 7.7% between 2022 and 2028. Expanding healthcare infrastructure, increasing government support, surging diagnostic rates and rising cases of hepatitis B.

Hepatitis B has become a public health problem in India, with a high mortality rate. According to a report by WHO, it is estimated that there are around 40 million people chronically infected with hepatitis B in India.

Various steps are being taken to control the spread of this disease. Hepatitis B generally spread through body fluids; any negligence can lead to serious consequences. Proper diagnosis becomes vital for curbing its spread. As a result, government is providing sufficient testing solutions across hospitals and other healthcare setups to increase the diagnostic rates. This is spurring the growth of hepatitis B diagnostic tests market.

How Will The Growth Unfold In China Hepatitis B Diagnostic Tests Market?

China will continue to remain one of the most lucrative markets for hepatitis B diagnostic tests, expanding at a healthy CAGR of 6.5% over the forecast period. Market in the country is mainly driven by rapidly rising population, increasing prevalence of hepatitis B and increasing diagnostic rates.

According to the WHO, China has the largest burden of hepatitis B cases in the world. There are around 70 million HBV-infected people in China right now. To tackle this burden, vaccination, counselling and early diagnosis will play a crucial role.

The government of China has also launched various initiatives to eradicate this fatal disease by 2030. It works closely with international organizations such as WHO to achieve its goal.

FMI, predicts a market share of 30.3% for Asia Pacific Excluding Japan (APEJ) in 2022, with China leading at the forefront.

Category-wise Insights

Which Product Type Dominates The Hepatitis B Diagnostic Tests Market?

According to FMI’s latest report, the enzyme immunoassay kits will continue to remain the most preferred products for the diagnosis of hepatitis B. A gigantic market share of 89.9% has been predicted for enzyme immunoassay kits segment by FMI.

Enzyme immunoassay (EIA) tests are being extensively employed for the detection of surface antigen (HBsAg) as well as for measurement of antibodies in blood. Enzyme immunoassay tests such as ELISA (enzyme-linked immunosorbent assay) have gained significant traction for the detection of hepatitis B due to their high sensitivity and specificity. These tests are more simpler, accurate and reliable than other diagnostic tests.

Rising adoption of enzyme immunoassay tests for the early detection of hepatitis B will continue to fuel the sales of EIA test kits.

Which Is The Leading End User Of Hepatitis B Diagnostic Tests?

Based on end user, the hepatitis B diagnostic tests market has been segmented into hospitals, clinics, diagnostic centres and home care.

Hospitals segment is anticipated to remain the most lucrative end user for hepatitis B diagnostic tests, growing at a CAGR of around 6.1% between 2022 and 2028.

Rising number of hospitals worldwide and increasing government investments to provide better diagnostic products are boosting the sales of hepatitis B diagnostic testing products. As diagnostic tests are offered free of cost at hospitals, majority of people usually opt for them.

Competitive Landscape

Leading players operating in the hepatitis B diagnostic tests market are investing vigorously in research activities for the development of low cost and efficient diagnostic tests. Besides this, they are leveraging various growth strategies such as partnerships, acquisitions, collaborations and advanced product launches & approvals to dominate the market.

• In May 2021, Biosynex SA, a leading designer and distribution of rapid diagnostic tests   acquired Avalun SAS to become the European leader in rapid diagnostic testing. The acquisition will help the company to further expand its presence.

• In December 2021, Roche launched first infectious disease tests on the Cobas 5800 system, a molecular laboratory instrument. The new tests will support patient management of human immunodeficiency virus, hepatitis B and C virus.

In February 2019, Abbott received the CE mark for the world's most sensitive point of care rapid diagnostic test for the detection of hepatitis B.

Scope Of The Report

Hepatitis B Diagnostic Tests Market By Category

Product Type:

• Enzyme Immunoassay Kits
  • Hepatitis B Surface Antigen Test
  • Anti-Hepatitis B Surface Antibody Test
  • Anti-Hepatitis B Core Antibody Test
• Point-of-Care Testing Kits
  • Strips
  • Cassettes/Cards

 End User:

• Hospitals
• Clinics
• Diagnostic Centres
• Home Care

Region:

• North America
• Western Europe
• Eastern Europe
• Latin America
• Asia-Pacific excluding Japan
• Japan
• Middle East and Africa