AI is Redefining the Hepatitis B and C Diagnostics Market, Set to Grow by USD 3.02 Billion from 2024-2028 with Rising Demand for Molecular Diagnostics – Technavio

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Sep 19, 2024, 17:20 ET

NEW YORK, Sept. 19, 2024 /PRNewswire/ — Report with market evolution powered by AI- The global hepatitis b and c diagnostics market size is estimated to grow by USD 3.02 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 8.09% during the forecast period. Growing demand for molecular diagnostics in diagnosis of HBV and HCV is driving market growth, with a trend towards advent of immunosensors in HBV and HCV diagnostic tests. However, low penetration of HBV and HCV diagnostic tests poses a challenge. Key market players include Abbott Laboratories, Bio Rad Laboratories Inc., bioMerieux SA, DAAN Gene Co. Ltd., DiaSorin SpA, Enzo Biochem Inc., F. Hoffmann La Roche Ltd., Grifols SA, Hologic Inc., MedMira Inc., OraSure Technologies Inc., Perkin Elmer Inc., QIAGEN NV, Quidelortho Corp., Randox Laboratories Ltd., Siemens AG, Sysmex Corp., and Xiamen Innovax Biotech Co. Ltd..

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Market Driver

The Hepatitis B and C diagnostics market is experiencing growth due to the emergence of immunosensors for the detection of HBV and HCV. Immunosensors are devices that convert specific antibody-antigen interactions into measurable signals, enabling accurate and quick diagnosis. Biosensor technology, including electrochemical, piezoelectric, acoustic, magnetic, and optical sensors, is extensively used for HCV RNA and anti-HCV detection. Nanotechnology is also a significant trend in the market, with materials like carbon nanotubes, carbon nanofibers, and carbon nanorods being used as support materials for electrochemical immunosensors. These materials offer advantages such as large surface area, electrical conductivity, chemical stability, and biocompatibility. For instance, the University of Tehran developed nanotechnology-based immunosensors for HBV detection in 2014. The increasing need for better and quicker diagnosis and ongoing research activities are expected to drive the growth of the global hepatitis B and C diagnostics market.

The Hepatitis B and C diagnostics market is witnessing significant growth due to the increasing number of diagnostic tests for these liver diseases. Blood samples are the primary source for diagnosing these conditions through various methods like molecular diagnostics, nucleic acid assays, rapid diagnostic tests, and traditional methods using antibodies, antigens, enzymes, and proteins. Hospitals and diagnostic laboratories are the major consumers of these tests, with blood donation centers and clinical laboratories also contributing. Key technologies include Enzyme-linked immunosorbent assay (ELISA), Polymerase chain reaction (PCR), and Imaging tests like liver biopsy. Hepatitis B and C are public health concerns, with chronic infections affecting millions. Vaccination coverage and blood screening are essential for prevention and early detection. Reagents and kits, instruments, and skilled laboratory technicians are crucial for sample procurement, storage, transportation, and pathogen detection. Next-Generation Sequencing and Laboratory space are emerging trends. Cross-contamination is a concern, requiring stringent safety measures. HBV and HCV affect the liver, with HBV causing chronic infection in around 257 million people and HCV in 71 million. Diagnostics play a vital role in identifying these conditions for effective treatment. 

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Market Challenges

• The global market for Hepatitis B and C diagnostics faces challenges due to low diagnosis rates, particularly in low-income countries. Approximately 95% of individuals with these viruses remain undiagnosed, according to the World Hepatitis Alliance. This situation results from several factors, including insufficient awareness, limited diagnostic tools, and delivery issues. Government policies and funding are often absent, and the costly nature of these diagnostics further hinders their adoption. Moreover, complex treatment regimens negatively impact diagnosis rates. These issues may impede the growth of the Hepatitis B and C diagnostics market during the forecast period.
• The Hepatitis B and C diagnostics market faces several challenges in ensuring accurate and timely detection of these viruses. Blood tests, such as HBsAg testing for Hepatitis B and HCV RNA detection for Hepatitis C, are common diagnostic methods. However, challenges include the need for hospital and diagnostic laboratory resources, blood transfusion and donation safety, and nucleic acid testing complexities. Public health concerns around chronic HBV and HCV infections require ongoing awareness campaigns, particularly for adolescents and children. Imaging tests, liver biopsies, and clinical laboratories play crucial roles, but face challenges like sample procurement, storage, transportation, and cross-contamination. Next-Generation Sequencing and Pathogen detection technologies offer solutions, but require skilled laboratory technicians, sufficient laboratory space, and advanced equipment. Hepatitis B and C diagnostics are essential for effective treatment and management, making it a critical market to address these challenges. Immunoassays and PCR tests are widely used, but severe acute hepatitis cases may require additional diagnostic tools.

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Segment Overview

This hepatitis b and c diagnostics market report extensively covers market segmentation by

1. Type
   • 1.1 Immunodiagnostics
   • 1.2 NAT
2. Disease Type
   • 2.1 Hepatitis B
   • 2.2 Hepatitis C
3. Geography
   • 3.1 North America
   • 3.2 Europe
   • 3.3 Asia
   • 3.4 Rest of World (ROW)

1.1 Immunodiagnostics- Immunodiagnostics, which include tests that detect antigens or antibodies through an enzyme-triggered color change, dominate the Hepatitis B and C diagnostics market. Approximately half of this market is represented by laboratory immunoassays, primarily used for detecting anti-hepatitis virus antibodies and viral surface and core antigens. The need for quantification diagnostic tests, which determine infection stages, is increasing. HCV and HBV viral core antigen testing is essential for accurate diagnosis and fuels market growth. Rapid diagnostic tests for HCV and advanced immunosensors are also driving market expansion. Immunodiagnostic tests, such as serological antibody assays, enzyme immunoassays (EIA), chemiluminescence immunoassays (CIA), and point-of-care (POC) rapid immunoassays, are used for Hepatitis B and C diagnosis. EIA is the most common initial HCV antibody test, while POC tests like the OraQuick HCV rapid antibody test offer quick diagnosis. Recombinant immunoblot assays (RIBA) help identify specific antibodies and distinguish between resolved infections and false positives. Immunoassay analyzers, which automate the testing process, and immunodiagnostic reagents, which contain all necessary materials for assay technologies, are essential instruments in the Hepatitis B and C diagnostics market. Automated immunoassay analyzers and integrated systems enable high-speed, multi-sample analysis. The market’s growth is driven by the development of advanced immunodiagnostic technologies and the increasing demand for accurate and quick diagnoses.

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Research Analysis

The Hepatitis B and C diagnostics market encompasses a range of tests used to identify the presence of these viruses in individuals. These tests primarily involve analyzing a blood sample for the presence of specific antigens and antibodies, as well as nucleic acid assays for detecting viral RNA or DNA. Molecular diagnostics, including nucleic acid tests, have become increasingly important in the diagnosis of chronic HBV and HCV infections. Rapid diagnostic tests offer quick results, making them valuable in high-risk populations and resource-limited settings. Hepatitis B and C are significant public health concerns, with vaccination coverage varying globally. Chronic HBV and HCV infections can lead to liver damage and liver disease, making early diagnosis crucial. Diagnostic tests include HBsAg testing, HBV DNA testing, and HCV RNA detection, among others. Imaging tests and liver biopsy may also be used for further evaluation. Awareness campaigns are essential to encourage regular testing, particularly for those at higher risk, such as blood donors and recipients of blood transfusions.

Market Research Overview

Hepatitis B and C diagnostics involve various tests to detect the presence of these viruses in individuals. These tests include molecular diagnostics such as nucleic acid assays and rapid diagnostic tests that use antibodies, antigens, enzymes, or proteins to identify the viruses in a blood sample. Hepatitis B and C are major public health concerns, particularly in areas with low vaccination coverage and high rates of blood donations and transfusions. Diagnostic tests are crucial for identifying chronic HBV and HCV infections, which can lead to severe acute hepatitis and long-term liver damage. Diagnostic tests can be performed in hospitals, diagnostic laboratories, and clinical settings using instruments like ELISA, PCR, and imaging tests such as liver biopsy. Reagents and kits, as well as skilled laboratory technicians, are essential for sample procurement, storage, transportation, and pathogen detection. Next-Generation Sequencing is also used for advanced diagnosis. Nucleic acid tests are increasingly being used for blood screening to prevent cross-contamination. Awareness campaigns and education for adolescents and children are crucial for early detection and treatment. Immunoassays are commonly used for HBsAg testing, HBV DNA testing, and HCV RNA detection. Chronic HBV consultations and severe acute hepatitis cases require specialized diagnostic services.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Type
  • Immunodiagnostics
  • NAT
• Disease Type
  • Hepatitis B
  • Hepatitis C
• Geography
  • North America
  • Europe
  • Asia
  • Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

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SOURCE Technavio