New Therapies, Risk Factors Drive Hepatitis C Diagnostics

New Therapies, Risk Factors Drive Hepatitis C Diagnostics

This blog post discusses findings from Kalorama Information’s just-published market research report,The World Market for Molecular Diagnostics, 7th Edition (Infectious Disease, Cancer, NAT Blood Screening, Transplantation, Histology/Cytology, Inherited Diseases).

Clinical molecular diagnostics does not lack in targets. Decentralized diagnostic platforms are focused on infections treated near-patient in hospital wards, clinics and in the developing world such as respiratory infections, hospital-acquired infections (HAIs), and tuberculosis (TB). In cancer research, the unraveling of disease pathways has introduced a wide range of genetic biomarkers. These dynamic expansion markets have headlined assay development efforts in recent years, but they are not the only major opportunities in molecular diagnostics. More than 50% of global molecular infectious disease diagnostics market is represented by established segments: molecular virology including HIV and hepatitis as well as common sexually transmitted infections (STIs) like Chlamydia and gonorrhea (CT/NG).

With molecular virology, the market for molecular hepatitis C virus (HCV) diagnostics has grown robustly in recent years and at a rate uncharacteristic of well-established market segments. The market opportunity for molecular HCV diagnostics is best characterized in terms of recent IVD product development and drivers of healthcare demand.

HCV Assay Development Activities

Decentralized diagnostic platforms have prioritized assays for respiratory and sexually transmitted infections (STIs) encountered in primary care, critical infections combated in inpatient care and high-burden diseases treated in low-resource labs of the developing world. For many of these platforms, the next round of assays returns to focus to virology. The Alere q instrument for molecular HIV testing of early infants has a planned HCV assay for development. Hospital molecular analyzer specialist Biocartis also has the long-term development goal of an HCV assay. Cepheid, a company that significantly expanded molecular testing within hospital labs, plans to target larger clinical lab clients with an HCV viral load assay for its GeneXpert platform.

Molecular diagnostics competitors in high-volume labs have also targeted HCV diagnostics recently. Hologic has a leading position in molecular STI and HPV testing, and plans to supplement its PANTHER instrument menu with virology assays. Hologic’s Aptima HIV viral load assay was approved by the U.S. FDA in January 2017; the CE-IVD marked HCV viral load assay is likely to follow. Beckman Coulter’s first major foray into molecular diagnostics with its DxN Veris is led by a virology assay menu including HIV, HCV, hepatitis B virus (HBV), and cytomegalovirus (CMV).

Rising Demand for Hepatitis C Therapies

Hepatitis C is a robustly growing market for both IVD and pharmaceutical players in the developed world. Hepatitis C pharmaceutical growth is hedged by pricing pressures as new players seek to undercut the market leader Gilead Sciences. Newer antivirals introduced first by Gilead in 2014 can cure even acute hepatitis C infections in many cases. The leading market barrier has been the price of therapy, but price cutting is expected eventually in order to maximize market penetration and as a result of competitive pressures. Antiviral treatment regimens are continued or concluded based on repeated testing of patient HCV levels or viral load.

The introduction of new, more effective therapies has coincided with rising hepatitis C patient volumes in U.S. healthcare. Hepatitis C is more prevalent among older U.S. individuals, particularly those of the “baby boomer” generation (born 1945-1965), than younger generations. According to one estimate from the National Health and Nutrition Examination Survey (NHANES), HCV can be found in between 3% and 5% of all U.S. individuals born in the 1950s. For comparison, HCV prevalence for individuals born in the 1940s and 1960s averaged roughly 2%. The higher rate of hepatitis C infection among baby boomers is believed to be a result of blood transfusion-transmitted infections (TTIs) and past intravenous drug use. Hepatitis screening of older patients has been implemented in much of U.S. healthcare to catch asymptomatic and mildly symptomatic cases.

The combination of Medicare eligibility for hepatitis C patients, higher screening activity and effective therapies has grown HCV viral load test volumes in the United States. The volume of viral load tests for hepatitis C accepted for payment under Medicare Part B rose from approximately 65,000 procedures in 2010 to nearly 190,000 procedures in 2015. Kalorama Information projects the number of HCV-infected U.S. individuals newly eligible for Medicare (aged 65 during the year) will increase from over 90,000 in 2015 to more than 170,000 in 2020. Medicare coverage of hepatitis C therapies has improved in the past several years, and some private insurers are also likely to follow suit for older patients more at risk of complications from disease progression.

Hepatitis C is not just a concern with older U.S. generations; disease incidence in recent years has risen dramatically among individuals between 20-39 years of age. Rising intravenous drug use and needle sharing is the culprit in the United States. With the disease likely to scourge millions of U.S. individuals for decades to come, the foundation of U.S. demand for hepatitis C treatment is so strong that some in healthcare have advocated the acquisition of Gilead Sciences by the U.S. government. Government production of Gilead hepatitis C antivirals, so the argument goes, would save billions of dollars over reimbursements that government payers will be responsible for in the coming decades.


Success in the future molecular diagnostics market depends upon IVD platforms’ sustained relevance in light of evolving demand in clinical testing. Companies that broke through in more specialized markets such as hospital lab molecular testing, CLIA-waived molecular testing or molecular STI testing need platforms available to all of their clients’ testing needs. Market share and client retention will depend in part upon the competitiveness of hepatitis C viral load assays. While the U.S. market is deservedly at the forefront of the molecular HCV diagnostics market, the disease burden abroad cannot be understated. When less costly HCV therapies become available to overseas markets, sizeable markets for molecular HCV diagnostics will follow in undeveloped markets of Asia and Latin America.