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The hepatitis B and C diagnostics market size is estimated to increase by USD 2,055.79 million between 2022 and 2027, at a CAGR of 6.12%. The growth of the market depends on several factors, including growing demand for molecular diagnostics in the diagnosis of HBV and HCV, strategies of healthcare organizations toward simplifying the diagnostic process, and rising demand for POC diagnostics.
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The reports categorize global market as a part of the global life sciences tools and services market. The parent, global life sciences tools and services market covers products and companies engaged in research and development (R&D) of a variety of product categories, including capital equipment, instruments, accessories, and consumables that are used for R&D on pharmaceuticals and biotechnology products and laboratory diagnosis of various diseases. Our market research report has extensively covered external factors influencing the parent market growth during the forecast period.
The growing demand for molecular diagnostics in the diagnosis of HBV and HCV is notably driving the market growth, although factors such as low penetration of HBV and HCV diagnostic tests may impede the market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The growing demand for molecular diagnostics in the diagnosis of HBV and HCV is notably driving market growth. Globally, nearly 600 hospital laboratories and 200 independent laboratories undertake high-volume testing that requires automated molecular diagnostic testing platforms to simplify and facilitate sample preparation. The popular applications of molecular diagnostics include the identification and profiling of causative agents of infection and the quantification of pathogens to monitor the durability of therapy.
The sales of molecular diagnostics for infectious diseases, such as HBV and HCV, hold a major share of the overall molecular diagnostics market. Real-time polymerase chain reaction (PCR) is the standard recommended molecular diagnostics method for HCV RNA and HBV DNA in clinical samples. Hence, the huge potential for the application of molecular biology techniques in the clinical diagnosis of HBV and HCV will drive the growth of the market during the forecast period.
High demand for biomarker-based tests is the primary trend in the market. Biomarkers are proteins, genes, hormones, and other molecular entities that detect the absence or presence of a disease. Sophisticated R&D in proteomics, nucleic acid expression, and genome sequencing has led to the emergence of molecular biomarkers. Technological advancements are driving manufacturers to develop assays that identify biomarkers in high-growth clinical areas such as infectious diseases, including hepatitis and retroviruses.
Biomarker-based tests will likely replace conventional drug therapeutics and account for increased revenue and sales from personalized test devices. To better reach the market, companies are developing cost-effective biomarker-based tests. Increased approvals for medical devices and a rise in product launches are expected to propel the market growth during the forecast period.
Low penetration of HBV and HCV diagnostic tests is one of the challenges impeding market growth. The presence of a large population of undiagnosed individuals with hepatitis C infections indicates a low penetration of the diagnostics. According to the World Hepatitis Alliance, only around 5% of individuals with the conditions in low-income countries are diagnosed.
The low penetration could be due to the lack of awareness and appropriate tools, as well as delivery issues. For instance, less than 1% of these individuals are likely to be aware of their diagnosis. Some other major issues are the absence of government policies and the lack of funding from government agencies. Furthermore, these diagnostics are costly, which affects their adoption rate in low-income countries. Also, treatment regimens are complex, affecting the diagnosis rates. Such issues will hinder the growth of the market during the forecast period.
The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Abbott Laboratories - The company offers hepatitis B and C diagnostics solutions under its brands Alinity and ARCHITECT under the medical devices and pharmaceuticals segment. The company offers products for rhythm management, electrophysiology, heart failure, vascular, structural heart, and neuromodulation.
The market report also includes detailed analyses of the competitive landscape of the market and information about 15 market players, including:
Qualitative and quantitative analysis of vendors has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize vendors as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize vendors as dominant, leading, strong, tentative, and weak.
The market share growth of the immunodiagnostics segment will be significant during the forecast period. Immunodiagnostics are diagnostic tests that detect antigens or antibodies by producing an enzyme-triggered color change. Immunodiagnostics have the highest adoption rates for the diagnosis of the virus (HCV) and the B virus (HBV), owing to their established presence for an extended period.
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The immunodiagnostics segment was valued at USD 3,424.50 million in 2017 and continued to grow until 2021. There is an increased need for quantification diagnostic tests owing to their ability to determine the stage of infection. The higher demand for viral core antigen testing, which is essential for effective and accurate diagnosis, is expected to fuel market growth for HCV and HBV immunodiagnostics market.
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North America is estimated to contribute 47% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
The market in North America is witnessing high adoption of these tests for HBV. Increasing blood transfusions in North America has driven the need for the diagnosis of the B variant. Around 4.5 million people living in the US and Canada need blood transfusions each year. The implementation of POC testing methods has also increased in the region, as these products are highly accessible and easy to use. Biomarker-based POC tests and initiatives by non-profit and government institutes, such as the National Institute of Health (NIH), are expected to drive market growth.
The report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
The Hepatitis B and C Diagnostics Market is experiencing significant growth, driven by advancements in technology and a rising demand for efficient diagnostic tools. The market encompasses a range of test types, including blood tests, imaging tests, and liver biopsies, catering to various diagnostic needs. Geographically, North America, Europe, Asia-Pacific, Middle East and Africa, and South America are key regions witnessing substantial market growth. Key industry players such as Transasia Bio-Medicals, Danaher Corporation, and Siemens Healthineers are at the forefront of innovation, with products like the ErbaLisa HCV Gen 4 Ag+Ab testing kit and Elecsys HCV Duo immunoassay. These companies are also actively engaged in partnerships, acquisitions, and product approvals to enhance their market presence.
World Hepatitis Day, recognized by WHO and supported by organizations like the Pan American Health Organization, is pivotal in raising awareness about HBV and HCV. Public Health agencies, including the National Institute of Biologicals (NIB) and the Partnership for Health Advancement in Vietnam (HAIVN), play crucial roles in advancing healthcare infrastructure and promoting diagnostic services.
The competitive landscape includes industry giants such as Gilead Sciences, Inc., Abbott, and Bio-Rad Laboratories Inc., driving market trends through technology innovation and strategic collaborations with institutions like Brigham and Women's Hospital, Harvard Medical School, and Beth Israel Deaconess Medical Center. Overall, the hepatitis diagnostic test market is thriving, with a diverse range of players and technologies contributing to its growth and development, estimated to be in the range of USD million, particularly in regions like India, where healthcare technology and infrastructure are rapidly evolving.
Market Scope |
|
Report Coverage |
Details |
Page number |
161 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Decelerate at a CAGR of 6.12% |
Market growth 2023-2027 |
USD 2,055.79 million |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
6.92 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 47% |
Key countries |
US, Germany, UK, Japan, and China |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
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., PerkinElmer Inc., QIAGEN NV, Quidel Corp., Randox Laboratories Ltd., Siemens AG, Sysmex Corp., and Xiamen Innovax Biotech Co. Ltd. |
Market dynamics |
Parent market analysis, Market forecasting, Market growth inducers and obstacles, segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period. |
Customization purview |
If our market growth and trends report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Type
7 Market Segmentation by Disease Type
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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