There's a fair amount of data available on respiratory syncytial virus
(RSV) that permits an estimate of market size. I'll summarize key
data at the top of this response, then proceed to an analysis:
1. The oft-quoted Centers for Disease Control (CDC) numbers note that
there are 90,000 hospitalizations and 4,500 deaths each year due to
RSV.
2. The CDC estimates are that 0.5% to 2 percent of children under age
1 require hospitalization from respiratory infections of all kinds.
The American Lung Association estimates that 75% of the respiratory
infections are in fact RSV.
3. CDC monitoring over a nearly 20-year period has had 70-90 hospital
laboratories involved or about 2.3% of the larger (110+ bed) hospitals
in the U.S. Annually about 124,000 tests for RSV are run, with about
19,000 positives. Positive responses vary between the 10-15% range in
the summer months to the 30-40% range from December through April.
Some labs don't run RSV tests during the summer -- only during the
winter.
4. Studies have shown that 95% of children under age 2 show exposure
to RSV. There are about 7.7 million children under age 2, according
to the 2000 U.S. Census.
5. RSV is highly infectious, leading to outbreaks within communities
-- and within child care or other facilities where children are
present. There are more than 50,000 child care facilities in the U.S.
Kids Health notes that "when RSV infects a day-care center, it is not
usual to see 100% of the children come down with an RSV infection.
RSV commonly spreads through hospitals, too, infecting both patients
and staff."
6. According to the Associated and Regional University Pathologists,
the cause of lower respiratory infections in children -- largely from
RSV -- is $700 million. Excluded is the cost of upper respiratory
infections.
7. Early detection of RSV reduces hospital stays, halves and use of
antimicrobials and reduces the cost of health care by 26%, according
to a study by Woo, Chiu, Seto and Peiris published in the Journal of
Clinical Microbiology, "Cost-effectiveness of rapid diagnosis of viral
respiratory tract infections in pediatric patients," in 1997.
8. While this analysis only covers the potential market for RSV
diagnostic test for humans, RSV is also a leading cause of death for
calves. There may be a potential market for the test among
veterinarians, especially as Pfizer has a vaccine in the market for
bovine RSV.
9. Active participants in the diagnostic test market are:
Abbott Laboratories, Testpak RSV
Becton Dickinson, Directigen RSV
Kallestad Diagnostics, Pathfinder
Biodesign International, Gull RSV-Mab
Bartels (outside U.S.) under a variety of names, including Primatin
Biotrin
Quadratech, Check 4RSV
Using CDC reporting labs, it can be estimated that the large (100+
bed) hospitals could be expected to run 5.4 million RSV tests. If the
2,400 smaller hospitals ran RSV tests at half that rate, it would add
another 1.9 million tests.
Is this reasonable with a U.S. population with this profile:
* under age 1: 3.8M
* under age 2: 7.7M
* under age 5: 19.2M
Yes, it's entirely reasonable, given that depending on season, RSV is
testing positive at a 10-40% rate. With 90,000 hospitalizations, the
infection rate is in the 8M per year range -- and doctor's offices are
probably receiving at least 2 million visits for young children with
respiratory problems that need screening.
Because of the infectiousness of the disease, which is spread by
coughing, sneezing and hand-to-hand contact, other potential users for
a diagnostic test would include the tens of thousands of doctors
offices and more than 50,000 child care providers.
Day care facilities would potentially be interested in early detection
of RSV and not have the skills to differ its symptoms from cold or
flu. During the winter months, tests might be run more than once each
week with children at risk, adding another 1 million tests per year.
Doctor's offices -- at least those with pediatric practices -- might
find the test faster and more accurate than blood tests or exams.
According to AMA Statistics reported in the "American Almanac:
Statistical Abstract of the United States," about 14 percent of the
doctors in the U.S. are in family practice or are pediatricians. The
30,800 pediatricians alone report seeing 127 patients per week -- or
about 3.9 million visits per week. (Note that there are almost twice
as many family practice offices as pediatricians.)
In conclusion: what's a safe range for the market potential for a
diagnostic RSV test in the U.S.? Easily in excess of 5 million tests;
perhaps 8 million to 12 million with development of all hospital,
daycare and family/pediatric practice markets.
Additional markets would include veterinary markets; plus similar
channels in all of the developed countries, which have similar
incidences of RSV.
Google search strategy:
syncytial + RSV
syncytial + RSV + test
CDC + MMWR + RSV
And here are some of the best resources for background information on
RSV and testing:
Center for Disease Control (CDC)
"RSV, US, 1999-2000 Season"
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4903a2.htm
CDC NREVSS (National Respiratory and Enteric Virus Surveillance
System) reporting labs list of 90 in 48 states:
http://www.cdc.gov/ncidod/dvrd/revb/nrevss/labc.htm
CDC Surveillance Summaries, dating back to 1984:
http://www.cdc.gov/ncidod/dvrd/revb/nrevss/summ.htm
CDC
"Respiratory Syncytial Virus"
http://www.cdc.gov/ncidod/dvrd/revb/respiratory/rsvfeat.htm
Webscape's WedMD
"Rapid Diagnostic Testing for URIs in Children: Impact on Physician
Decision Making and Costs" (2002) -- cached version available on
Google
Kathleen M. Williams, MD, Mary Anne Jackson, MD, Marilyn Hamilton, MD
www.medscape.com/viewarticle/431124_print
Kids Health
"Respiratory Syncytial Virus"
May 2001
http://kidshealth.org/parent/infections/bacterial_viral/rsv.html
RSV Information Center
"Diagnosing RSV", Undated
http://www.rsvinfo.com/diagnosing/diagnosing.html#sub2
Associated and Regional University pathologists (ARUP)
"Respiratory Viruses" (undated) cached version on Google
http://www.aruplab.com/guides/clt/tests/clt_165b.htm
Best regards,
Omnivorous-GA |
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