IVD To Grow Nearly 7% Annually
US demand for in vitro diagnostic (IVD) reagents and instrumentation is expected
to reach $12.2 billion in 2005. Spurred by novel technologies, an aging population
and market penetration of personal monitoring devices, the industry is poised
for annual gains approaching seven percent going forward. P>Cost-containment
pressures in the healthcare industry will continue to be a source of concern;
however, a plethora of new tests result-ing from the widespread availability
of genomic information and the ongoing trend toward home-based products will
more than offset managed care constraints. The insurance industry -- recognizing
that accurate diagnosis can often minimize hospitalizations and more expensive
treatment alterna-tives -- will continue to be a valuable ally of IVD manu-facturers.
Home Testing Kits Becoming Simpler, Faster
Laboratory-based clinical chemistry and immunoassays will remain the major
revenue sources in IVD; however, many of these tests -- blood glucose monitoring
and cholesterol monitoring, among others -- will continue to move out of the
laboratory and into the home as new devices and simpler, more rapid test kits
reach the marketplace.
Blood glucose monitoring among diabetics, for ex-ample, has been limited by
cumbersome devices requir-ing frequent finger sticks in order to measure glucose
in blood. The advent of portable, continuous, noninvasive monitors -- as demonstrated
by FDA approval of the first such device in March 2001 -- is expected to lead
to stellar growth in this segment.
Nucleic acid diagnostics will continue to experience the fastest growth in
the IVD market. The development -- and more important, regula-tory approval
-- of commer-cial DNA microarrays capable of analyzing thou-sands of genes and/or
thousands of patients for genetic changes simulta-neously is expected to revolutionize
diagnostics for diseases with strong genetic components, including cancer, heart
disease and infectious diseases.
Human Genome Project To Open New Opportunities
The completion of the sequencing of the human genome in 2000 is antici-pated
to lead to the identifica-tion of hundreds of additional mutations directly
or indi-rectly culpable in disease.
Pharmacogenomic profiling -- the assessment of which therapeutic drugs are
best suited patients based on their genetic makeup -- will also come to the
fore in the next few years, as millions of single-nucleotide polymor-phisms
are now available.
Industry Composition
The US IVD market remains highly concentrated, with the vast majority of products
supplied by seven large, diversified firms -- Abbott Labs, Bayer, Beckman Coulter,
Becton Dickinson, Dade Behring, Johnson & Johnson and Roche -- each of which
is active in multiple technologies. Over the last few years, the trend toward
consolidation has slowed somewhat, as the market leaders have sought to shore
up existing markets and technology platforms.
Study Coverage
Details on these and other key findings are available in In Vitro Diagnostics,
a new Freedonia study. Historical data plus forecasts to 2005 and 2010 are given
in current dollars for in vitro diagnostic reagents and instrumentation demand
by type, condition and point-of- care. In addition to disease diagnostics, the
markets for drug testing and pregnancy and ovulation testing are covered as
well. This study also evaluates market share and profiles key competitors.
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