Introduction:
Therapeutic Markets: Opportunities and Pipeline Analysis
WHO and the European Centre for Disease Prevention and
Control (ECDC) are advising countries to prepare for a more severe second wave
of A/H1N1 2009 in the winter of 2009-2010. This advisement could be warranted,
given that no infectious disease has killed more people in a short period of
time than influenza. Without preventive measures—such as vaccines—the current
A/H1N1 (“swine flu”) 2009 pandemic could claim more than 1 million lives in the
seven major markets we cover. The onus on public health agencies and the
pharmaceutical industry, therefore—both now and in the future—is to learn from
their past successes and failures to ensure that systems are in place that can
quickly identify, prevent, and treat a pandemic virus.
Questions Answered in This Report:
*
Prior to A/H1N1, SARS and H5N1 (“avian flu”) influenza were
the first major infectious disease scares of the millennium.
What lessons
did these two events provide? How are lessons learned from these infectious
outbreaks being applied to the current A/H1N1 2009 situation?
*
Without preventive measures such as vaccines, A/H1N1 2009
will affect a considerable number of people in the major markets under
study.
How many cases, hospitalizations, and deaths will result if no
preventive measures are put in place?
*
Traditional methods of vaccine production are being challenged
by new technologies.
What are the old technologies and what advantages will
the new vaccine technologies have over them? What companies are involved in
these new technologies? How are the emerging vaccines differentiating
themselves from one another?
*
Vaccines for A/H1N1 2009 were approved by the FDA beginning on
September 15, 2009.
Which companies obtained FDA approval for their
vaccines? Which patient populations are each of these companies permitted to
vaccinate? Despite these approvals, what obstacles stand in the way of vaccines
coming out in the coming months?
*
Antivirals and diagnostics are useful tools in the A/H1N1 2009
fight, but each technology has room for improvement.
What are the downsides
to antiviral treatments? How can diagnostics be improved to assist in current
or future pandemics? In which situations will certain antivirals be used, and
what factors might limit the uptake of antiviral use during this pandemic?Scope:
Primary research: interviews with three influenza
experts.
Up-to-date Decision Resources epidemiology review of A/H1N1
2009: pandemic versus seasonal influenza, genetic drift versus genetic
shift, emerging influenza threats, the current pandemic (cases,
hospitalizations, deaths) compared with seasonal flu (cases, hospitalizations,
deaths).
Case studies: history of influenza, severe acute
respiratory syndrome (SARS), H5N1 influenza (“avian flu” or “bird flu”).
Influenza vaccines: development and production
processes, current egg-based technologies, current and emerging cell-based
technologies, companies with approved or potential A/H1N1 2009 vaccines.
Antivirals: Tamiflu, Relenza, peramivir.
Diagnostics: recent FDA A/H1N1 2009 diagnostic
approvals, challenges with influenza diagnostics, opportunities and needs for
pandemic diagnostics.