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Predicting Swift Growth in Molecular Diagnostics
Molecular diagnostics is growing fast, fueled by the steady
introduction of new tests and new instruments to perform and automate
analysis. Ongoing identification and
validation of novel genes and biomarkers guarantees that more new tests are on
the horizon. That is why the field of molecular
diagnostics is both rapidly growing and rapidly changing.
In 2007, the global market for in vitro molecular diagnostics grew from $2.5 billion to $2.8
billion. In the United States,
the molecular diagnostics market increased from $1.3 billion to $1.5 billion in
the U.S. The first and largest segment of the market
is infectious diseases, currently dominated by tests for sexually transmitted
diseases and hepatitis. Infectious
disease testing is about 70% of the molecular diagnostics market, representing
sales of about $2.2 billion in 2007.
Other market segments include traditional genetics,
personalized medicine, and cancer. These segments make up 13%, 9%, and 8%,
respectively, of the labs services market in the U.S. These categories are expected to grow much
faster than infectious diseases, now considered a relatively mature
segment. Jorge Leon, Ph.D., president of
Leomics Associates,
predicts that the cancer segment is growing about 20% a year and traditional
genetics about 15% a year. This is
compared to a 5-10% growth rate for infectious diseases.
Some individual tests are experiencing huge growth. The Digene HPV test saw a 38% increase in sales from fiscal 2005 to 2006, from $97.4 million to
$134.4 million. This same test enjoyed a
42% growth rate in the first nine months of fiscal 2007, compared with the same
period in 2006.
In a recent Web survey by Sannes & Associates, over 250
participants ranked the molecular diagnostic market segments poised for growth
over the next two years. "Near term,
respondents predicted significant growth in oncology at 33% and infectious
disease at 30.1% with less growth seen for genetic testing at 14.5%, and
pharmacogenomics at 12.5%," wrote survey report author Lucy J. Sannes, Ph.D., President
of Sannes & Associates.
These predictions of steady, double-digit growth rates in
molecular diagnostics have a consequence for clinical laboratories. It means
they should have a strategy to incorporate molecular diagnostics into their
clinical service menu. Further, steady
advances in molecular technology mean that laboratory directors and
pathologists will need to plan to acquire and deploy these new technologies to
maintain state-of-the-art testing services for their referring clinicians.
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