Hepatitis C Testing Market Expected to Reach $2.6 Billion by 2035

According to a new report published by Allied Market Research, titled, “Hepatitis C Testing Market," The hepatitis C testing market size was valued at $1.5 billion in 2023, and is estimated to reach $2.6 billion by 2035, growing at a CAGR of 4.9% from 2024 to 2035. Hepatitis C is a viral infection that primarily affects the liver, caused by the hepatitis C virus (HCV). It often lead to chronic liver diseases, including cirrhosis, liver failure, and liver cancer if left untreated. HCV is transmitted through blood-to-blood contact, often through shared needles, unregulated blood transfusions, or unsafe medical practices.

Many people with hepatitis C do not experience symptoms until significant liver damage occurs, making early detection crucial. Testing for hepatitis C typically involves antibody tests to detect the presence of HCV antibodies, indicating past exposure to the virus. If positive, a confirmatory test such as a polymerase chain reaction (PCR) test is used to detect the virus’s genetic material and assess viral load. Additional tests, such as genotype testing, determine the best treatment plan. Early diagnosis enables timely intervention, preventing complications and improving treatment outcomes.

Hepatitis C testing market trends include rise in prevalence of hepatitis C cases which significantly drives hepatitis C testing market growth, with increase in concerns about its transmission and long-term health implications. According to the Wisconsin Department of Health Services, in 2023, 58% of all new hepatitis C virus (HCV) cases among females were in women of childbearing age (15-44 years). The estimated rate of mother-to-child transmission is approximately 6%, emphasizing the urgent need for preventive interventions. Currently, the only available preventive measure is treating HCV before pregnancy, highlighting the importance of early detection and timely treatment. Surge in incidence of hepatitis C, particularly in high-risk populations, drives the need for enhanced diagnostic solutions and treatment accessibility.

In addition, rise in product approvals and adoption of strategic initiatives by key market players further contribute to hepatitis C testing market growth. In June 2024, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System. This marks a significant milestone, as it is the first HCV test approved for use in certified point-of-care settings for individuals at risk of hepatitis C. The test, which operates under a CLIA Certificate of Waiver, is used in correctional facilities, syringe service programs, doctor’s offices, emergency departments, and urgent care clinics. Unlike traditional methods requiring samples to be sent to centralized laboratories, this test detects HCV RNA from a fingertip blood sample and provides results within an hour, improving accessibility and efficiency in diagnosis.

Moreover, increase in government initiatives aimed at raising awareness about hepatitis C testing further provides hepatitis C testing market opportunity. Public health organizations are actively implementing programs to educate individuals on the importance of early detection and treatment of hepatitis C, ultimately driving demand for advanced diagnostic solutions and preventive strategies.

The hepatitis C testing market size is segmented into technique, test, end user, and region. On the basis of technique, it is segregated into immunoassay, PCR, and others. The immunoassay segment dominated the market share in 2023 owing to its cost-effectiveness, ease of use, and high throughput capabilities. It enables rapid screening for HCV antibodies, making it ideal for large-scale screenings in hospitals, blood banks, and point-of-care settings, driving widespread adoption globally.

However, the PCR test segment is expected to register the highest CAGR during the hepatitis C testing market forecast period owing to its superior sensitivity, accuracy, and ability to detect low viral loads. Surge in adoption of real-time PCR assays for early and confirmatory diagnosis, coupled with advancements in automation and portable PCR platforms, is driving demand for hepatitis C testing solutions. In addition, increase in government initiatives for early screening programs and rise in need for high-throughput diagnostic solutions further support segment expansion.

On the basis of test, the hepatitis C testing industry is divided into antibody test, genotype test, and viral load test. The antibody test segment dominated the hepatitis C testing market share in 2023. This is attributed to its cost-effectiveness, widespread availability, and ease of use in initial screening. The high adoption of hepatitis C testing solutions in blood banks, hospitals, and diagnostic centers, along with government-led screening programs, contribute to market growth. In addition, its rapid turnaround time makes it a preferred choice for large-scale testing.

However, the viral load test segment is expected to register the highest CAGR during the forecast period owing to its critical role in monitoring treatment response and disease progression. Increase in adoption of quantitative PCR based assays, advancements in automated molecular diagnostics, and surge in emphasis on personalized treatment strategies significantly drive market growth. In addition, rise in hepatitis C cases and expanded government screening initiatives further boost demand for viral load testing.

On the basis of end user, it is classified into hospital & diagnostic laboratory, blood banks, and others. The hospital & diagnostic laboratory segment dominated the hepatitis C testing market share in 2023. This is attributed to the high volume of hepatitis C tests conducted in these settings, ensuring accurate diagnosis and disease monitoring. Advanced laboratory infrastructure, availability of skilled professionals, and access to molecular testing technologies further boost the growth of this segment. In addition, government-led screening programs, increase in hospital visits, and rise in prevalance of hepatitis C infections contribute to strong market presence and growth of the segment.

However, the blood banks segment is expected to register the highest CAGR during the forecast period owing to rise in demand for safe blood transfusions and stringent screening regulations to prevent hepatitis C transmission. Increase in blood donation drives, advancements in nucleic acid testing (NAT), and government mandates for infectious disease screening further drive the growth of this segment. In addition, the expansion in number of blood banks in emerging economies supports market expansion.

Region wise, North America was the largest shareholder in the hepatitis C testing industry in 2023, owing to the presence of hepatitis C cases, advanced healthcare infrastructure, and widespread adoption of molecular diagnostics. Supportive government initiatives, strong reimbursement policies, and increased awareness programs further contribute to the region’s market dominance.

However, Asia-Pacific is anticipated to register the highest CAGR during the forecast period owing to the presence of hepatitis C cases, expansion in healthcare infrastructure, and increase in number of government screening programs. Growing awareness of early testing of hepatitis, improving access to advanced diagnostic technologies, and the presence of a large undiagnosed population further drive market growth. In addition, affordable testing solutions and rise in healthcare investments boost adoption of hepatitis C testing solutions.

Key Findings of the Study

• On the basis of technique, the immunoassay segment dominated the market share in 2023. However, the PCR segment is anticipated to grow at the highest CAGR during the forecast period. 
• On the basis of the test, the antibody test segment dominated the market share in 2023. However, the viral load test segment is anticipated to grow at the highest CAGR during the forecast period.
• On the basis of end user, the hospitals and diagnostic laboratory segment dominated the market share in 2023. However, the blood banks segment is anticipated to grow at the highest CAGR during the forecast period.
• By region, North America generated the largest revenue in 2023. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.