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Molecular Diagnostics - Revolution or Hype
HBS Consulting, Jan 2003
Molecular diagnostic technologies offer the potential for moving from diagnostics to prognostics.
But what is “molecular diagnostics?
By definition, it includes all tests and methods to identify a disease or the predisposition for a disease analyzing Dna- or RNA of an organism.
Still, the market for molecular diagnostics is difficult to estimate as it overlaps with the in vitro diagnostic market and is less well defined than the pharmaceutical or device markets.
But in the post era of accomplishing the “Human Genome Project”, molecular diagnostics is ready to get its due as the legitimate future business trend in healthcare.
The genomic discovery will fuel the diagnostic marketplace because every gene-based therapeutic might need an accompanying (molecular) diagnostic test.
At approximately 30,000 genes for the human genome and with an estimated diagnostic significance of about 5%, the commercialization of 1,500 gene-based tests can be expected.
The way is paved by infectious disease testing and blood banking applications, but pharmacogenetic, predisposition diagnostics and molecular cancer diagnostics applications will follow soon and post strong numbers in the years to come.
Cancer for instance, represents a set of diseases with vast unmet clinical need for improved diagnostics and therapeutics. Cancer in the developed western countries with a prevalence between 1.0 and 1.5% depicts a large market with a high potential for R& D and fields like therapy specific diagnostics (theranostics).
Those segments with significant revenue potential will benefit from the advantages the molecular technologies present: sensitivity, specificity and speed.
In addition, non-invasive or minimal-invasive procedures to obtain the material for those tests will facilitate the implementation. Cross-benefits like almost instant diagnostic results, more targeted therapies and shorter hospitalization times constitute higher costs for molecular test in comparison to traditional analyses like microbiology today. But molecular diagnostics will help to abate cost for diagnosis, therapy and healthcare altogether in the middle-term.
If the expiration of the basic Pcr-licence in 2005 will affect prizes for molecular diagnostic tests remains to be seen, but prizes will drop clearly with the gradually automation of the tests.
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