Hepatitis Diagnostic Test Market (Updated Version Available)
Hepatitis Diagnostic Test Market Size, Share & Trends Analysis, By Test Type (Blood Test {Liver Function Tests, Nucleic Acid Amplification Testing, immunoassay} Imaging Test, Liver Biopsy), Technology (Rapid Diagnostic Tests, Point-of-care (POC), Radioimmunoassay, Polymer Chin Reaction, ELISA, and others), End Use (Hospital, Clinic, and Others) By Region, Forecast Period 2023 - 2030.
Report ID : RI_673921 | Date : July 2023 |
Format : 
Key Market Overview:
Hepatitis Diagnostic Test Market size was valued at USD 2,935.01 Million in 2022, registering a CAGR of 4.1% during the forecast period (2023-2030), and the market is projected to be worth USD 4,047.03 Million by 2030.
Hepatitis diagnostic test involves screening and diagnosis for viral hepatitis infection and evaluating the causes of inflammation in the liver, which can be done by detection of hepatitis surface antigens such as HBsAg, HCsAg, and others. Hepatitis diagnostic tests are used to diagnose, evaluate, and guide treatment for viral hepatitis infection.
The increasing prevalence of hepatitis globally is accelerating the demand for the hepatitis diagnostic test market. Testing and diagnosis of hepatitis infection is a crucial part of an effective response to the global hepatitis epidemic. For instance, in June 2022, the WHO World Hepatitis Summit 2022 urges action to eliminate viral hepatitis as unexplained hepatitis cases in children rise globally.
Additionally, according to the WHO, it is estimated 354 million people globally are still living with this life-threatening infection and at least one person dies from viral hepatitis every 30 seconds. That\'s over 1 million deaths per year. Henceforth, increasing cases of hepatitis virus infection globally forecast the growth of the hepatitis diagnostic test market.
Moreover, the increasing partnerships between the market players to ensure the development of advanced diagnostic technology for hepatitis diagnostic tests will trigger the growth of the hepatitis diagnostic test market in the upcoming years.
Hepatitis Diagnostic Test Market Report Coverage:
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Market Dynamics:
Driver:
Hepatitis is a highly prevalent public health concern. However, hepatitis is also one of the preventable and treatable diseases with easily accessible services at hospitals and clinics. For instance, in July 2022 as per the data published by WHO on World Hepatitis Day hepatitis C shows that there are 67,000 new infections in the Americas and 84,000 deaths each year. Furthermore, WHO estimates that 296 million people were living with chronic hepatitis B virus infection and 58 people with chronic hepatitis C virus infection. Globally, these infections are major causes of acute and chronic liver disease, causing around 1.1 million deaths annually in 2019.
However, about 22% of people chronically infected with Hepatitis C have been diagnosed, and just 18% of them have received treatment in the U.S. Thus, the increasing prevalence of the hepatitis infection is prompting the adoption of hepatitis diagnostic tests to minimize the occurrence of hepatitis, which in turn accelerating the market growth.
Restraint:
The high cost of diagnostics tests can hinder their widespread adoption and limit access to accurate and timely hepatitis diagnosis. For instance, as per WHO, Governments provide an average of 51% of a country\'s health spending, while more than 35% of health spending per country comes from out-of-pocket expenses. Furthermore, medical diagnostic test costs are high and growing at an unstainable rate due to continuous advancements in technology. Hence, the high cost of hepatitis diagnostic tests is restraining the growth of the market.
Opportunities:
The continuous advancement in diagnostic technologies such as pot-of-care testing (POC), molecular diagnosis, and advanced imaging technologies provide opportunities for the hepatitis diagnosis market. These advancements offer faster, more accurate, and cost-effective diagnostic solutions. Leading to improved patient management and outcomes. For instance, in March 2020, Abbott launched a molecular point-of-care test. The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test. Henceforth, strategic collaborations related to the development of advanced diagnostic technology will create opportunities for the Hepatitis Diagnostic Test Market in the forecast year.
Hepatitis Diagnostic Test Market Segmentation:
By Test Type:
The test type segment is classified into blood test, imaging test, and liver biopsy. In 2022, the blood test segment accounted for the highest market share in the hepatitis diagnostic test market. The blood test is performed to analyze the type of viral hepatitis, the severity of the infection, and whether the person is currently contagious. Also, it is the first line of diagnosis option to whether a virus is acute or chronic. The blood test segment is further divided into immunoassay, liver function tests, and nucleic acid amplification testing (NAT). Blood tests including immunoassay, liver function tests, and nucleic acid amplification testing (NAT) are crucial tests to perform and are most used to the detection and guide the treatment of viral hepatitis infection. For instance, in May 2022, the North Carolina Department of Health and Human Services (NC DHHS) encourages screening, testing, and vaccination during Hepatitis Awareness Month to Reduce the Spread of Disease. Additionally, In April 2020, the U.S. Preventive Services Task Force released updated HCV testing recommendations that promote one lifetime HCV test, screening during each pregnancy, and repeat testing for individuals who are at higher risk. Thus, the increasing adoption of blood tests is favoring market growth.
Hence, blood tests can detect the sign of hepatitis infection and other infections, which is helpful in further treatment, thereby enabling the growth of the segment.
By Technology:
The technology segment is divided into point-of-care (POC), radioimmunoassay (RIA), polymer chain reaction (PCR), ELISA, and others. In 2022, the point-of-care (POC) segment accounted for the highest market share in the hepatitis diagnostic test market. The point-of-care (POC) technology ensures immediate and informed change in patient management, potentially facilitating a reduced number of visits leading to increased linkage to care. Additionally, collection can be performed by peers or other people who are not practitioners due to the easy accessibility and ease to use. The adoption of point-of-care (POC) technology has increased over time. For instance, In January 2023, as per a new study by WHO, hepatitis VL assays performed on point-of-care (POC) devices outside of the laboratory and in a clinic near patients receiving care are being increasingly used as an alternative approach to laboratory-based diagnosis.
Further, WHO recommended the adoption of POC HCV viral load testing as an alternative approach to laboratory-based platforms for diagnosing HCV infection and speeding up starting curative treatment. Thus, due to the above factors, the implementation of advanced technology in the hepatitis diagnostic test is accelerating the growth of the segment.
By End-use:
The end-use market is segmented into hospitals and clinics, diagnostic laboratories, and others. In 2022, hospitals and clinics segment accounted for the highest market share in the hepatitis diagnostic test market. In hospitals and clinics, the adoption of diagnostic tests such as blood tests, ultrasound, liver biopsy, and others is increasing to enable the treatment of viral hepatitis infection diseases. Also, hospitals and clinics are the first points of care for patients. For instance, as per the U.S. Department of Health & Human Services, in March 2020, approximately 90% of hospitalized where Most of the hospitalized patients had underlying conditions, some of which are recognized to be associated with severe COVID-19 disease, including chronic lung disease, cardiovascular disease, diabetes mellitus. Henceforth, the increasing adoption of hepatitis diagnostic tests to ensure prompt treatment measures is supplementing the market growth.
However, increased hospitalization rates due to several infectious diseases such as SARS-CoV-2, hepatitis, and others driving the growth of the hospital and clinic segment.
By Region:
By region, the market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. In 2022, North America accounted for the highest market share in the hepatitis diagnostic test market. The prime factors such as increasing cases, awareness about the advanced technology for hepatitis infection, and the strong presence of market players and others are some of the vital aspects accelerating the adoption of hepatitis diagnostic tests in the United States. For instance, in 2022, as per the WHO estimates of hepatitis C show that each year, there are 67,000 new infections in the Americas and 84,000 deaths, 10,000 new hepatitis B infections each year, and 23,000 deaths. Whereas, about 22% of people chronically infected with Hepatitis C have been diagnosed, and just 18% of them have received treatment. Therefore, the rising prevalence of Hepatitis C in the North America region is driving the hepatitis diagnostic test market demand.
Nevertheless, Asia Pacific is expected to be the fastest-growing region over the forecast period due to increasing research and development activities in the region.
Hepatitis Diagnostic Test Market Competitive Landscape:
The hepatitis diagnostic test market is highly competitive, with several large players and numerous small and medium-sized enterprises. These companies have strong research and development capabilities and a strong presence in the market through their extensive product portfolios and distribution networks. The market is characterized by intense competition, with companies focusing on expanding their product offerings and increasing their market share through mergers, acquisitions, and partnerships. The key players in the market include-
• Abbott Laboratories
• Bio-Rad Laboratories, Inc
• F. Hoffmann-La Roche Ltd
• bioMérieux SA
• Siemens Healthcare
• Meridian Bioscience
• Biogate Laboratories Ltd.
Recent Developments
• In May 2022, Abbott launches HBsAg Next Assay in India to accelerate early and enhanced detection of Hepatitis B. Early identification of HBV infections not only helps in preventing or delaying the progression of advanced liver diseases and also reduces the risk of transmission.
Hepatitis Diagnostic Test Market size was valued at USD 2,935.01 Million in 2022, registering a CAGR of 4.1% during the forecast period (2023-2030), and the market is projected to be worth USD 4,047.03 Million by 2030.
Hepatitis diagnostic test involves screening and diagnosis for viral hepatitis infection and evaluating the causes of inflammation in the liver, which can be done by detection of hepatitis surface antigens such as HBsAg, HCsAg, and others. Hepatitis diagnostic tests are used to diagnose, evaluate, and guide treatment for viral hepatitis infection.
The increasing prevalence of hepatitis globally is accelerating the demand for the hepatitis diagnostic test market. Testing and diagnosis of hepatitis infection is a crucial part of an effective response to the global hepatitis epidemic. For instance, in June 2022, the WHO World Hepatitis Summit 2022 urges action to eliminate viral hepatitis as unexplained hepatitis cases in children rise globally.
Additionally, according to the WHO, it is estimated 354 million people globally are still living with this life-threatening infection and at least one person dies from viral hepatitis every 30 seconds. That\'s over 1 million deaths per year. Henceforth, increasing cases of hepatitis virus infection globally forecast the growth of the hepatitis diagnostic test market.
Moreover, the increasing partnerships between the market players to ensure the development of advanced diagnostic technology for hepatitis diagnostic tests will trigger the growth of the hepatitis diagnostic test market in the upcoming years.
Hepatitis Diagnostic Test Market Report Coverage:
| Report Attributes | Report Details |
| Study Timeline | 2017-2030 |
| Market Size in 2030 (USD Million) | 4,047.03 Million |
| CAGR (2023-2030) | 4.1% |
| Base Year | 2022 |
| By Test Type | Blood Test (Liver Function Tests, Nucleic Acid Amplification Testing, Immunoassay), Imaging Test and liver biopsy |
| By Technology | Point-of-care (POC) HCV, Radioimmunoassay (RIA), Polymer Chin Reaction (PCR), ELISA, and Other technologies (Serologic testing of HBV) |
| By End User | Hospitals and Clinics, Diagnostic labs, and Others |
| By Geography |
|
| Key Players | Abbott Laboratories, Bio-Rad Laboratories, Inc, F. Hoffmann-La Roche Ltd, bioMérieux SA, Siemens Healthcare, Meridian Bioscience, Biogate Laboratories Ltd. |
Market Dynamics:
Driver:
Hepatitis is a highly prevalent public health concern. However, hepatitis is also one of the preventable and treatable diseases with easily accessible services at hospitals and clinics. For instance, in July 2022 as per the data published by WHO on World Hepatitis Day hepatitis C shows that there are 67,000 new infections in the Americas and 84,000 deaths each year. Furthermore, WHO estimates that 296 million people were living with chronic hepatitis B virus infection and 58 people with chronic hepatitis C virus infection. Globally, these infections are major causes of acute and chronic liver disease, causing around 1.1 million deaths annually in 2019.
However, about 22% of people chronically infected with Hepatitis C have been diagnosed, and just 18% of them have received treatment in the U.S. Thus, the increasing prevalence of the hepatitis infection is prompting the adoption of hepatitis diagnostic tests to minimize the occurrence of hepatitis, which in turn accelerating the market growth.
Restraint:
The high cost of diagnostics tests can hinder their widespread adoption and limit access to accurate and timely hepatitis diagnosis. For instance, as per WHO, Governments provide an average of 51% of a country\'s health spending, while more than 35% of health spending per country comes from out-of-pocket expenses. Furthermore, medical diagnostic test costs are high and growing at an unstainable rate due to continuous advancements in technology. Hence, the high cost of hepatitis diagnostic tests is restraining the growth of the market.
Opportunities:
The continuous advancement in diagnostic technologies such as pot-of-care testing (POC), molecular diagnosis, and advanced imaging technologies provide opportunities for the hepatitis diagnosis market. These advancements offer faster, more accurate, and cost-effective diagnostic solutions. Leading to improved patient management and outcomes. For instance, in March 2020, Abbott launched a molecular point-of-care test. The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test. Henceforth, strategic collaborations related to the development of advanced diagnostic technology will create opportunities for the Hepatitis Diagnostic Test Market in the forecast year.
Hepatitis Diagnostic Test Market Segmentation:
By Test Type:
The test type segment is classified into blood test, imaging test, and liver biopsy. In 2022, the blood test segment accounted for the highest market share in the hepatitis diagnostic test market. The blood test is performed to analyze the type of viral hepatitis, the severity of the infection, and whether the person is currently contagious. Also, it is the first line of diagnosis option to whether a virus is acute or chronic. The blood test segment is further divided into immunoassay, liver function tests, and nucleic acid amplification testing (NAT). Blood tests including immunoassay, liver function tests, and nucleic acid amplification testing (NAT) are crucial tests to perform and are most used to the detection and guide the treatment of viral hepatitis infection. For instance, in May 2022, the North Carolina Department of Health and Human Services (NC DHHS) encourages screening, testing, and vaccination during Hepatitis Awareness Month to Reduce the Spread of Disease. Additionally, In April 2020, the U.S. Preventive Services Task Force released updated HCV testing recommendations that promote one lifetime HCV test, screening during each pregnancy, and repeat testing for individuals who are at higher risk. Thus, the increasing adoption of blood tests is favoring market growth.
Hence, blood tests can detect the sign of hepatitis infection and other infections, which is helpful in further treatment, thereby enabling the growth of the segment.
By Technology:
The technology segment is divided into point-of-care (POC), radioimmunoassay (RIA), polymer chain reaction (PCR), ELISA, and others. In 2022, the point-of-care (POC) segment accounted for the highest market share in the hepatitis diagnostic test market. The point-of-care (POC) technology ensures immediate and informed change in patient management, potentially facilitating a reduced number of visits leading to increased linkage to care. Additionally, collection can be performed by peers or other people who are not practitioners due to the easy accessibility and ease to use. The adoption of point-of-care (POC) technology has increased over time. For instance, In January 2023, as per a new study by WHO, hepatitis VL assays performed on point-of-care (POC) devices outside of the laboratory and in a clinic near patients receiving care are being increasingly used as an alternative approach to laboratory-based diagnosis.
Further, WHO recommended the adoption of POC HCV viral load testing as an alternative approach to laboratory-based platforms for diagnosing HCV infection and speeding up starting curative treatment. Thus, due to the above factors, the implementation of advanced technology in the hepatitis diagnostic test is accelerating the growth of the segment.
By End-use:
The end-use market is segmented into hospitals and clinics, diagnostic laboratories, and others. In 2022, hospitals and clinics segment accounted for the highest market share in the hepatitis diagnostic test market. In hospitals and clinics, the adoption of diagnostic tests such as blood tests, ultrasound, liver biopsy, and others is increasing to enable the treatment of viral hepatitis infection diseases. Also, hospitals and clinics are the first points of care for patients. For instance, as per the U.S. Department of Health & Human Services, in March 2020, approximately 90% of hospitalized where Most of the hospitalized patients had underlying conditions, some of which are recognized to be associated with severe COVID-19 disease, including chronic lung disease, cardiovascular disease, diabetes mellitus. Henceforth, the increasing adoption of hepatitis diagnostic tests to ensure prompt treatment measures is supplementing the market growth.
However, increased hospitalization rates due to several infectious diseases such as SARS-CoV-2, hepatitis, and others driving the growth of the hospital and clinic segment.
By Region:
By region, the market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. In 2022, North America accounted for the highest market share in the hepatitis diagnostic test market. The prime factors such as increasing cases, awareness about the advanced technology for hepatitis infection, and the strong presence of market players and others are some of the vital aspects accelerating the adoption of hepatitis diagnostic tests in the United States. For instance, in 2022, as per the WHO estimates of hepatitis C show that each year, there are 67,000 new infections in the Americas and 84,000 deaths, 10,000 new hepatitis B infections each year, and 23,000 deaths. Whereas, about 22% of people chronically infected with Hepatitis C have been diagnosed, and just 18% of them have received treatment. Therefore, the rising prevalence of Hepatitis C in the North America region is driving the hepatitis diagnostic test market demand.
Nevertheless, Asia Pacific is expected to be the fastest-growing region over the forecast period due to increasing research and development activities in the region.
Hepatitis Diagnostic Test Market Competitive Landscape:
The hepatitis diagnostic test market is highly competitive, with several large players and numerous small and medium-sized enterprises. These companies have strong research and development capabilities and a strong presence in the market through their extensive product portfolios and distribution networks. The market is characterized by intense competition, with companies focusing on expanding their product offerings and increasing their market share through mergers, acquisitions, and partnerships. The key players in the market include-
• Abbott Laboratories
• Bio-Rad Laboratories, Inc
• F. Hoffmann-La Roche Ltd
• bioMérieux SA
• Siemens Healthcare
• Meridian Bioscience
• Biogate Laboratories Ltd.
Recent Developments
• In May 2022, Abbott launches HBsAg Next Assay in India to accelerate early and enhanced detection of Hepatitis B. Early identification of HBV infections not only helps in preventing or delaying the progression of advanced liver diseases and also reduces the risk of transmission.
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