Analyst Comment -Tackling HCV: A Combination Of Therapy & Monitoring
02-Aug-2002
Over the years hepatitis C (HCV) has taken a back-seat role, receiving far less
attention than it has deserved, mainly due to the fact that HIV-AIDS remains
one of the principal causes of death world-wide. However, recent efforts by
politicians and hospital researchers have raised the profile of this
potentially life-threatening malady. Alex Wong, Research Analyst from Frost &
Sullivan (http://biotech.frost.com), tracks how the improved efficacy of
combination drug therapy for the treatment of HCV has led to a surge in demand
for HCV diagnosis.
Rampant HCV knows no boundaries
With HIV-AIDS traditionally making all the headlines, many people do not
realise that HCV is in fact a more widespread disease. Recent data suggest that
there are approximately 200 million people infected with HCV globally, with
about 5 million people in Europe. It is thought that for every person infected
with HIV, there are at least four more infected with HCV. Symptoms of HCV
include chronic hepatitis, cirrhosis and hepatocellular carcinoma.
In the past, treatment of HCV was based solely on interferon. More recently,
encouraging results have been obtained through the employment of a combination
of drugs, such as pegylated interferon alfa-2a and ribavirin, for HCV
management.
Early diagnosis and treatment of HCV is particularly important so as to avoid
progression to severe liver disease, which remains a leading cause of death in
hepatitis C sufferers. In order to optimise management of HCV, viral load
monitoring is essential. Although these monitor kits are more expensive
compared to conventional qualitative detection methods, monitor assays allow
quantitation of the amount of virus in the blood.
The HCV market: money-making monitoring
There are currently more HCV cases compared to HIV-AIDS cases across Europe,
with the prevalence of HCV particularly high in southern Europe. The market for
HCV monitor tests, still in its youth, is expected to experience tremendous
growth over the next decade, illustrated by the large populations who have yet
to be tested. For example, there are approximately 700,000 HCV sufferers in
France, yet only one in three people are treated.
At present, only three companies, with different proprietary technologies, are
present n the HCV monitor market: Roche Diagnostics (polymerase chain
reaction-based kit), Bayer Diagnostics (branched DNA-based kit) and BioMérieux
(nucleic acid sequence-based amplification kit).
In 2002, the European market for qualitative and quantitative NATs used for the
diagnosis of HCV was valued at approximately $49 million, marginally less than
the $53 million estimated for the HIV market. However, the market for HCV
tests, only established in some European countries at the turn of the century,
is expected to grow considerably due to the growing adoption of quantitative
tests throughout Europe to monitor HCV therapy. In fact, the HCV market is
highly likely to overtake the revenues generated through sales of HIV NAT kits
by 2006.
Surveillance of HCV
Underlying the whole HCV market is the availability of efficacious drugs.
Healthcare services across Europe in general are coming under increasing
pressure to reduce their expenditure. Although the combination of drugs used in
HCV therapy continue to be sold at high prices, too costly for most patients in
developing countries, the demand for integrated therapeutic and diagnostic
systems is expected to boom.
Over the next decade and beyond, patients who are currently asymptomatic or who
are displaying relatively mild disease are anticipated to develop severe
end-stage liver disease. This will represent a huge burden on health care
systems which are already struggling to function efficiently due to budget
restraints.
According to many experts, integrated management is necessary to combat HCV.
Essentially, the objective of such management is to tailor therapy to those
patients who are most likely to benefit, thus improving both clinical efficacy
and cost efficiency. Monitor kits, based on a variety of nucleic acid-based
amplification tests (NAT), are being employed more and more to track the
progress of patients who have been prescribed a course of drugs over a period
of 12, 24 or 48 weeks. Therefore, depending on the response, clinicians are
able to modify the antiviral therapy. For example, patients not responding to
treatment are taken off it, whereas those with undetectable viral load continue
therapy.
The importance of hepatitis C infections should not be underestimated, a view
which is now shared by governments and health care departments alike. Over the
next decade, the market for monitor kits, which are proving to be a valuable
tool in the fight against HCV, is expected to prosper, particularly with viral
load monitoring now being employed.
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