Hepatitis C Virus (HCV) Testing Market

Hepatitis C Virus (HCV) Testing Market Outlook (2023 to 2033)

The global Hepatitis C Virus (HCV) Testing Market size is expected to accumulate USD 785.3 million in value by 2023 end. During the forecast period ranging from 2023 to 2033, a CAGR worth 5.4% has been projected for the market, with an expected closing value worth USD 1,326.7 million. From 2018 to 2022, the industry unfolded at a value CAGR worth 4.6%.

The growing burden of infectious diseases on the global healthcare system is a significant consideration, with developing countries bearing a disproportionate share of the burden. Over time, the burden of hepatitis C virus infection has accelerated. According to the Institute of Liver and Biliary Sciences India, around 3% of the world's population is infected with the hepatitis C virus.

In 80 percent of infected patients, HCV did cause chronic infection. Initial hepatitis C virus testing employs serological assays to detect antibodies against HCV in blood samples. According to the Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C screening, a cut-off ratio for anti-HPV antibodies is added, which aids in the selection of additional assays for confirmation of screening results.

The Nucleic Acid Amplification Test (NAT) is used to confirm and determine viral load. Regarding all constructive HCV antibody tests, an RNA test is performed. HCV genotyping tests are used in clinical HPV management to determine viral load and optimal treatment duration. Also, the use of non-sterile needles for tattooing and body piercing is a common cause of hepatitis C virus infection spread.

Attributes	Key Statistics
Global Market CAGR (2023 to 2033)	5.4%
Anticipated Market Value (2023)	USD 785.3 million
Global Market (2033)	USD 1,326.7 million
Global Market Attraction	The rising prevalence of hepatitis C virus infection fueled by inadequate blood donation strategies

Factors Spearheading the Global Hepatitis C Virus (HCV) Testing Market

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 Stunting the Global Hepatitis C Virus (HCV) Testing Market

Factors that are limiting the adoption of hepatitis C virus testing include:

• Insufficient insurance coverage for hepatitis C testing
• Limited access to regular healthcare

North America Emerging as an Opportunistic Hepatitis C Virus (HCV) Testing Market

Country/ Region	Market Share (2022)
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 2023.

Demand for Hepatitis C Virus (HCV) Testing Burgeoning in Europe

Attribute	Details
Europe’s Market Share (2022)	30.7%
Germany’s Market Share (2022)	10%
The United Kingdom’s Forecast CAGR (2023 to 2033)	5.7%

In 2023, 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.

According to a research paper published in the medical journal BMJ Open in August 2020, HCV diagnosis rates in Germany are projected to exceed 70% by 2030 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.

Start-ups Adding Value to the Global Market

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 2017 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.

Key Players Leading the Hepatitis C Virus Testing Marketplace

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 2023, 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 2022, 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 2019. (HCV). The tests were commercially available by the end of this year 2019.

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 2019.

Report Scope

Report Attributes	Details
Growth Rate	CAGR of 5.4% from 2023 to 2033
Market Value in 2023	USD 785.3 million
Market Value in 2033	USD 1,326.7 million
Base Year for Estimation	2022
Historical Period	2018 to 2022
Forecast Period	2023 to 2033
Quantitative Units	Revenue in USD million and CAGR from 2023 to 2033
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

Key Segments Covered in the Hepatitis C Virus (HCV) Testing Market Survey

By Technique:

• Immunoassays-based Hepatitis C Virus Testing
• Polymerase Chain Reaction-based (PCR) Hepatitis C Virus Testing
• Other Hepatitis C Virus Testing Techniques

By Test Type:

• HCV Antibody Testing
• HCV Viral Load Testing
• HCV Genotyping Testing

By End User:

• Hospitals
• Diagnostic Centers
• Blood Donation Centers

By Region:

• North America
• Latin America
• Europe
• Asia Pacific
• The Middle East & Africa

Frequently Asked Questions

How Big will the the Hepatitis C Virus (HCV) Testing Market?

This market is estimated to reach USD 1,326.7 million by 2033.

What is North America’s Market Growth Outlook?

North America expanded at a market share of 33.4% in 2022.

What Restrains the Market Growth?

Limited access to regular healthcare restrains the market growth.

Which is the Top Driver in the Market?

Infectious diseases drive sales, hitting global healthcare and developing nations.

Which Region holds Lucrative Opportunities?

North America holds a substantial share of the market.