Top Infectious Diseases in the IVD Market - Hepatitis

Top Infectious Diseases in the IVD Market - Hepatitis

The following analysis is derived from Kalorama Information’s recently released global market research report:The Worldwide Market for Infectious Disease Diagnostic Tests.

This is the third in a series of five posts outlining the leading infectious diseases or infectious disease groups in terms of IVD market sales. Previous posts were for HIV/AIDS and respiratory tract infection tests.

Tests for viral hepatitis infections, primarily hepatitis C virus (HCV) and hepatitis B virus (HBV), are among the most common infectious disease tests run in clinical laboratories. Untreated, hepatitis infections can cause tremendous health problems after years or decades of latency. Similar to human immunodeficiency virus (HIV) infections, chronic hepatitis infections are treated with antiviral drugs. The efficacy of antiviral treatment is monitored using quantitative viral load assays. Additional applications for hepatitis diagnostics include the characterization and typing of hepatitis infections to optimize clinical treatment and the screening of donated blood for transfusion medicine. Hepatitis diagnostics represents a vast and diverse market; total IVD revenue is estimated well above $2 billion with demand across geographies and test settings from high-complexity clinical labs through points of care.

Hepatitis infection is a significant challenge for the medical community. According to the CDC, around 2.7 million people in the United States have a chronic HCV infection or nearly 1% of the population. Prevalence estimates for HCV infection in Europe ranges from between 1% and 5% of the total population. An estimated 700,000-1.4 million people in the United States have a chronic HBV infection. For comparison, there are an estimated 1.2 million people in the United States with a HIV infection.

In the United States, HCV screening has been encouraged for baby boomers; individuals born between 1945 and 1965 are five times more likely to have a HCV infection than any other adult age group. Expanded insurance coverage in the United States is expected to help grow hepatitis screening volumes. Outside of the United States, screening rates for HBV and HCV are expected to improve and grow the hepatitis laboratory immunoassay market.

Chronic and acute hepatitis infections also contribute significantly to hepatitis diagnostics demand through reflex and confirmatory tests (Ag immunoassays and molecular assays); quantitative tests to assess the stage of infection (core antigen immunoassays and qPCR assays); genotyping and drug resistance characterization tests for confirmed chronic and acute infections (PCR and sequencing); and viral load tests to monitor patients during therapy (core antigen and qPCR). The rate of new HBV infection in the United States has declined more than 80% since the implementation of a national HBV elimination strategy in 1991. However, the number of reported chronic HCV infections remains on the rise in the United States likely as a result of asymptomatic infection and underreporting.

Transmission rates for HBV and HCV are presumably higher outside of the United States and developed countries where screening is not as consistently performed among at-risk populations. Chronically infected carriers continue to spread the disease and transmission is also facilitated by poor sanitation. Worldwide, chronic HBV infection is believed to affect 240 million people and be associated with 800,000 liver disease-related deaths each year. The World Health Organization (WHO) estimates that 130-150 million people are chronically infected with HCV. Liver disease caused by HCV is estimated by the WHO to be responsible for approximately 500,000 deaths around the world each year. Hepatitis disease prevention and control efforts throughout the world will be an important source of growth for molecular hepatitis diagnostics, especially programs with therapy components.

Immunoassays are most often used for hepatitis screening and diagnosis, but are superseded by molecular assays in clinical hepatitis treatment. Quantitative results from real-time PCR assays are used to determine the progression of the disease and monitor viral loads during antiviral therapy. The sensitivity of molecular assays made them an invaluable tool in modern hepatitis therapeutics as a replacement for liver biopsies; even a minute change in bloodstream viral RNA can serve as an effective indicator of viral load and infection state. Multiplex PCR and sequencing assays are also used to determine virus genotype and detect drug resistance traits, which can be determinative of individualized infection treatment.

Roughly half of the overall hepatitis diagnostics market is still represented by laboratory immunoassays. Screening for HCV and HBV infections commonly uses immunoassays that detect anti-hepatitis virus antibodies, viral surface antigens, or viral core antigens. Viral core antigens represent the latest significant market contribution to hepatitis serology; the viral marker can detect ongoing or active viral infections and provides quantitative results used to assess the state of infection. Although highly sensitive molecular assays for HCV RNA measurement are preferred in viral load testing, quantitative immunoassays for core antigen can serve as viable, lower cost alternatives or complements for infection monitoring during antiviral therapy. Rapid hepatitis antibody tests used for screening also represent one of the largest markets worldwide for rapid immunoassays.

Hepatitis testing holds a similarly well-established role in blood screening due to the infections’ prevalence worldwide and the severity of resultant disease. Hepatitis (HBV and HCV) screening is uniform across every blood screening program, alongside HIV. Nucleic acid testing (NAT) is used for confirmatory reflex testing, if not primary screening, of donated blood in the developed world (North America, Europe, Japan). Nucleic acid testing is displacing high-throughput immunodiagnostic screening such as chemiluminescent immunoassays where cost considerations allow. Antibody screening can be unreliable for ensuring a high standard of blood safety as samples of recently infected donors can be non-reactive in the first several weeks. Direct testing of hepatitis viral nucleic acids or antigens will provide earlier positive results. Chemiluminescent immunoassay testing for hepatitis antigen is now available as a more broadly accurate diagnostic, though NAT is unrivaled in terms of sensitivity and provides the best accuracy for early infections. Responding to the emergence of hepatitis E virus (HEV) as a blood safety threat, major vendors in blood screening have introduced HEV assays in the past five year. For now, HEV screening remains far from uniform among blood programs.