The Hepatitis C Virus (HCV) Testing Market is estimated to be valued at USD 0.9 billion in 2025 and is projected to reach USD 1.4 billion by 2035, registering a compound annual growth rate (CAGR) of 5.1% over the forecast period.
-testing-market-market-value-analysis.webp "Hepatitis C Virus (hcv) Testing Market Market Value Analysis")
| Metric | Value |
|---|---|
| Hepatitis C Virus (HCV) Testing Market Estimated Value in (2025 E) | USD 0.9 billion |
| Hepatitis C Virus (HCV) Testing Market Forecast Value in (2035 F) | USD 1.4 billion |
| Forecast CAGR (2025 to 2035) | 5.1% |
The hepatitis C virus (HCV) testing market is advancing steadily, supported by the rising prevalence of HCV infections and the increasing emphasis on early detection and treatment initiation. Clinical journals and public health reports have stressed the importance of scaling up testing programs to achieve the World Health Organization’s elimination targets, driving demand across both developed and emerging healthcare systems.
Pharmaceutical company disclosures and diagnostic sector press releases have highlighted investments in high-sensitivity assays and point-of-care platforms, enabling wider accessibility and faster results. Additionally, government-led screening campaigns and reimbursement support have accelerated test adoption in high-risk populations.
Technological progress in molecular diagnostics and serological testing has improved diagnostic accuracy, reducing false negatives and facilitating timely medical intervention. Looking forward, the market is expected to expand with continued innovation in rapid diagnostic tests, broader implementation of national screening policies, and the integration of testing services into routine health checkups. Segmental growth is projected to be led by immunoassay-based techniques, HCV antibody testing, and hospital-based end-user settings due to their reliability, accessibility, and established clinical utility.
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The immunoassays-based hepatitis C virus testing segment is projected to contribute 47.60% of the HCV testing market revenue in 2025, maintaining its leadership due to its widespread adoption in initial screening protocols. Growth of this segment has been supported by its high throughput, cost-effectiveness, and reliability in detecting antibodies against HCV.
Clinical studies have confirmed the strong sensitivity and specificity of immunoassays, making them essential for large-scale screening programs in both hospital and community health settings. Furthermore, the automation compatibility of immunoassays has streamlined laboratory workflows, enabling rapid processing of high sample volumes.
Health ministries and international organizations have favored immunoassays for their scalability, which has proven critical in achieving population-level screening coverage. As healthcare systems continue to prioritize early detection to improve treatment outcomes and curb transmission, immunoassays-based testing is expected to retain its dominant role in the HCV diagnostics landscape.
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The HCV antibody testing segment is projected to account for 52.10% of the HCV testing market revenue in 2025, reinforcing its role as the primary test type used globally. This segment’s strength has been shaped by its application as the first-line screening tool to identify prior or ongoing infections.
Public health programs have relied heavily on antibody testing due to its affordability, accessibility, and ability to be deployed at both central laboratories and point-of-care settings. Clinical guidelines have consistently recommended antibody testing as the initial diagnostic step before confirmatory molecular assays, driving its widespread utilization.
In addition, innovations in rapid antibody tests have expanded testing into remote and resource-limited areas, supporting equitable access to HCV care. With global initiatives promoting universal screening in high-prevalence populations, the HCV antibody testing segment is expected to remain the cornerstone of HCV detection strategies.
-testing-market-analysis-by-end-user.webp "Hepatitis C Virus (hcv) Testing Market Analysis By End User")
The hospitals segment is projected to contribute 44.80% of the HCV testing market revenue in 2025, sustaining its position as the leading end-user category. Hospitals have been prioritized as primary testing sites due to their comprehensive diagnostic capabilities, access to confirmatory molecular assays, and ability to link patients directly to treatment services.
Clinical care pathways for HCV typically begin with hospital-based testing, particularly for symptomatic patients, surgical candidates, and those undergoing routine health evaluations. Annual reports from healthcare systems have highlighted investments in laboratory automation and integration of HCV testing into broader infectious disease panels, further supporting hospital dominance.
Additionally, hospitals serve as key hubs for government-funded screening campaigns and specialist referrals, reinforcing their role in HCV detection and management. As healthcare infrastructure strengthens in emerging markets and hospital laboratories continue adopting advanced diagnostic technologies, the hospitals segment is expected to maintain its leadership in end-user adoption of HCV testing.
The rising prevalence of hepatitis C virus infection is the primary driver of the global hepatitis C virus testing market. Inadequate blood donation strategies are the leading cause of hepatitis C virus infection.
Also, hepatitis C screening is required before organ donation, and growing organ donation projects around the world are expected to drive future growth.
The introduction of point-of-care testing products for HCV testing raises the potential for HCV testing kits. The FDA approved the OraQuick HCV Rapid Antibody Test in 2010, and it is now widely used as an alternative to enzyme immunoassay testing for HCV. Also, the use of new electrochemical immuno-sensor and nano-sensor technologies in HPV testing is expected to change current practices.
Factors that are limiting the adoption of hepatitis C virus testing include:
| Country/ Region | Market Share (2025) |
|---|---|
| North America | 33.4% |
| The United States | 29.5% |
An estimated 12.5-40% of detained people in North America have HCV-antibody positivity, supporting the recommendation to screen this population for HCV infection and increasing market demand.
Infection with the Hepatitis C virus (HCV) is a leading cause of morbidity and mortality in the United States. HCV is primarily transmitted via parenteral exposure to infectious blood or body fluids containing blood, most commonly through injection drug use.
With 8-12 weeks of all-oral medication regimens, direct-acting antiviral treatment can result in a virologic cure in most people. This factor is increasing market demand in North America.
HCV infection rates nearly doubled among women with live births in North America between 2009 and 2014, as new HCV infections increased among reproductive-aged adults.
As a result, this factor is expected to drive market growth in this region. As per Future Market Insights, North America is likely to account for more than 33.4% of the global Hepatitis C virus testing market in 2025.
-testing-market-cagr-analysis-by-country.webp "Hepatitis C Virus (hcv) Testing Market Cagr Analysis By Country")
| Attribute | Details |
|---|---|
| Europe’s Market Share (2025) | 30.7% |
| Germany’s Market Share (2025) | 10% |
| The United Kingdom’s Forecast CAGR (2025 to 2035) | 5.7% |
In 2025, Europe is forecasted to account for more than 30.7% share in the hepatitis C virus testing market, and is projected to maintain this growth throughout the forecast period, states Future Market Insights.
-testing-market-europe-country-market-share-analysis,-2025-&-2035.webp "Hepatitis C Virus (hcv) Testing Market Europe Country Market Share Analysis, 2025 & 2035")
According to a research paper published in the medical journal BMJ Open in August 2024, HCV diagnosis rates in Germany are projected to exceed 70% by 2035 under the current approach. Such encouraging trends in HCV testing in the country are expected to significantly aid market growth during the forecast period.
In Europe, Hepatitis C is one of the most common infectious diseases. Several initiatives in the region have been inaugurated to better understand disease trends, such as prevalence and the most widely known genotypes. It is a liver disease caused by the hepatitis C virus (HCV), and it can contribute to the development of liver cancer if left untreated.
Germany has historically had a low prevalence of hepatitis C than developing countries. However, the country's demographics have changed in recent years. Also, the increasing influx of migrants and rising drug abuse through injections among the general population are projected to augment the country's hepatitis C prevalence.
-testing-market-analysis-by-company.webp "Hepatitis C Virus (hcv) Testing Market Analysis By Company")
The swelling dispersion of start-ups in the hepatitis C virus testing market has improved product quality and elevated global sales. Besides, to gain a competitive edge, new start-ups are working on novel developments and launching new products. Moreover, some notable players offering hepatitis C virus testing kits are as follows:
| Start-up’s Name | Product in Detail |
|---|---|
| NATSpert | NATSpert, established in 2020 in Pune, India, is a developer of blood detection kits for viral diseases. Its product- NATSpert ID TripleH is a qualitative, real-time PCR test for the simultaneous detection of HIV, HBV, and HCV respectively. The kit comes in a single tube format and allows for screening of HIV type 1 group M-RNA, HIV-1 group-O RNA, HIV-2 RNA, Hepatitis C Virus RNA, and Hepatitis B Virus DNA in human blood plasma. |
| HepC | Founded in 2005, HepC is a developer of antiviral biologic products. The company deploys IBDV, a non-pathogenic double-stranded RNA virus. This virus acts as a master activator of antiviral gene responses as its primary vector system. Its product development includes HC001 for treating advanced chronic viral hepatitis caused by HBV and HCV infections. |
Some of the manufacturers identified in the global hepatitis C virus testing market include OraSure Technologies, Inc., Abbott Laboratories Inc., Siemens Healthcare GmbH, Bio Rad Laboratories Inc., Ortho Clinical Diagnostic Inc. (Johnson & Johnson), Bayer AG, QIAGEN N.V., Thermo Fisher Scientific Inc., BioGenex, AccuQuick, Roche Diagnostics (H. Hoffman-La Roche Ltd.), STD Rapid Test Kits, etc. among others.
Discover Recent Occurrences Shaping the Market
| Organization’s Name | Roche |
|---|---|
| Nature of Development | Roche releases Novel Hepatitis C Virus Diagnostic test. |
| Key Particulars About the Event | Roche has introduced a new dual antibody and antigen diagnostic testing called Elecys HCV Duo immunoassay to treat the hepatitis C virus. The test is launched in countries that permit the CE Mark. |
| Organization’s Name | WHO and the University of BRISTOL |
|---|---|
| Nature of Development | WHO Collaborated with the University of BRISTOL to lead the research related to HCV. |
| Key Particulars About the Event | A new study exhibits the advantages of a quick clinic-based diagnostic test for HCV infection over a general laboratory-based test. The discoveries from the study have resulted in the WHO recommending the adoption of the point-of-care (POC) HCV test. These rapid tests make HCV diagnosis close and accessible to the community. |
| Organization’s Name | Mylab |
|---|---|
| Nature of Development | Pune’s Mylab Introduces Rapid Test Kits to rapidly Detect HCV, HIV, and Syphilis. |
| Key Particulars About the Event | Mylab Discovery Solutions, a Pune-based company, announced in February 2025, that it is releasing three new rapid tests to quickly detect STIs. STIs pose a grave hurdle as WHO predicts that the caseload of STIs is going to reach 1 million/day, globally. |
| Organization’s Name | J MITRA |
|---|---|
| Nature of Development | J MITRA releases 4th Gen Elisa-based HCV Test. |
| Key Particulars About the Event | In September 2025, J Mitra, which is an IVD Company, introduced the HCV Gen 4 Ag & Ab Microlisa, which is a 4th generation Elisa-based HCV Test. The kit aims to screen blood donations to detect and discard infection units of blood. The kit is also used as a clinical diagnostic test for Hepatitis C. |
| Organization’s Name | Access Bio Inc. and Atomo Diagnostics |
|---|---|
| Nature of Development | Access Bio Inc. and Atomo Diagnostics revealed the development of RDT. |
| Key Particulars About the Event | Access Bio Inc. and Atomo Diagnostics announced the development of a rapid diagnostic test (RDT) for screening for the hepatitis C virus in April 2020. (HCV). The tests were commercially available by the end of this year 2020. |
| Organization’s Name | Gilead Sciences Inc. |
|---|---|
| Nature of Development | Gilead Sciences Inc. reported the HepConnect Initiative. |
| Key Particulars About the Event | Gilead Sciences Inc. announced the HepConnect initiative to reduce hepatitis C infections in Great Appalachia in March 2020. |
| Report Attributes | Details |
|---|---|
| Growth Rate | CAGR of 5.1% from 2025 to 2035 |
| Market Value in 2025 | USD 0.9 billion |
| Market Value in 2035 | USD 1.4 billion |
| Base Year for Estimation | 2025 |
| Historical Period | 2020 to 2025 |
| Forecast Period | 2025 to 2035 |
| Quantitative Units | Revenue in USD million and CAGR from 2025 to 2035 |
| Report Coverage | Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis |
| Segments Covered | Technique, End User, Test Type, Region |
| Regions Covered | North America; Latin America; Europe; Asia Pacific; The Middle East and Africa |
| Key Countries Profiled | The United States, Canada, Brazil, Mexico, Germany, The United Kingdom, France, Spain, Italy, China, Japan, South Korea, Malaysia, Singapore, Australia, New Zealand, GCC Countries, South Africa, Israel |
| Key Companies Profiled | OraSure Technologies, Inc.; Abbott Laboratories Inc.; Siemens Healthcare GmbH; Bio Rad Laboratories Inc.; Ortho Clinical Diagnostic Inc. (Johnson & Johnson); Bayer AG; QIAGEN N.V.; Thermo Fisher Scientific Inc.; BioGenex; AccuQuick,; Roche Diagnostics (F. Hoffman-La Roche Ltd.); STD Rapid Test Kits |
| Customization | Available Upon Request |
The global hepatitis c virus (HCV) testing market is estimated to be valued at USD 0.9 billion in 2025.
The market size for the hepatitis c virus (HCV) testing market is projected to reach USD 1.4 billion by 2035.
The hepatitis c virus (HCV) testing market is expected to grow at a 5.1% CAGR between 2025 and 2035.
The key product types in hepatitis c virus (HCV) testing market are immunoassays-based hepatitis c virus testing, polymerase chain reaction-based (pcr) hepatitis c virus testing and other hepatitis c virus testing techniques.
In terms of test type, hcv antibody testing segment to command 52.1% share in the hepatitis c virus (HCV) testing market in 2025.
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Hepatitis C Virus (HCV) Testing Market
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