As the Human Genome project and myriad other research endeavors contribute to our understanding of pathological pathways, new diagnostic tests
continue to emerge. Some are used in drug discovery; others will eventually carve a niche in routine patient testing. But how many of these new or
revised tests will find a use in near patient or point of care testing?
In a strategic report available in September 2001, HBS Consulting analyses both the impressive driving forces, and the market restraints, to the
development and commercialization of genetic POC testing devices. Genetic tests are used for both diagnostic and predictive purposes. Near patient
predictive testing is unnecessary, as by the definition of predictive testing, there is no need to have rapid results. That leaves diagnostics.
Some seven of the top ten causes of death in the developed world have a genetic disease component, and therefore are targets of diagnostic and/or
predictive testing. In the US, the world's largest diagnostics market, currently 469 laboratories and 895 genetics clinics are performing tests for
753 genetic diseases, according to an Internet-based directory. In Europe, hundreds of thousands of genetics tests are run each year, and the number
is increasing.
Worldwide, the diagnostics industry is at a crucial turning point, for several reasons. The major developments in the field of genomics are
reverberating throughout the diagnostics industry, while the impact of consumerism and public dissatisfaction with healthcare systems in some
countries are driving consumer demand for testing. As well, increased government scrutiny of healthcare, in response to public concern about errors,
is fueling the drive for faster, more accurate testing. And, although the overall market for diagnostics equipment and reagents has been sluggish for
the last few years, diagnostics companies now see the areas of nucleic acid probes, DNA chips and genomics as offering astonishing revenue growth
during the next 5-10 years.
One of the most exciting developments is the leveraging of company skill sets into other revenue generating areas. The interplay between
diagnostics companies and drug discovery (pharmaceutical and biotechnology) companies is triggering mergers, acquisitions and strategic partnerships
as firms realize that offshoots of their research will produce profitable applications elsewhere.
The majority of new tests are being developed by laboratories for their own use. These 'home brew' tests are often exempt from national regulatory
laws. Yet, while this sounds like an area ripe for exploitation, some countries decline to purchase these 'home-brew' tests, preferring to develop
their own tests for the particular disease variants prevalent in their country.
A number of countries either restrict or prohibit the sale of genetic testing devices to the public, at this time. These restrictions are in place
for several reasons, such as ongoing concerns regarding the ethical, legal or social issues, or the quality control of the tests, or the desire to
restrict such testing to the physician or hospital laboratory. Despite such restraints, the potential revenues are so attractive that diagnostics and
biotech companies continue to develop genetic tests that come closer to the grail of near-patient testing.
However, the restraints should not be dismissed lightly. In Germany, the GKV's draft reform of a new testing fee schedule is predicted to collapse
the market for diagnostics in that country. This will diminish the role of Germany as a location for biotech diagnostics research, which will in turn
drive further mergers and acquisitions in this market. Diagnostics companies will be driven to relocate elsewhere, continuing a trend seen during the
last few years.
HBS Consulting offers a brief overview of the technology, followed by market analyses by region and application. The report explores the potential
market size and the opportunities arising in the area of genetic point of care testing. It reviews the regulatory environment for genetic testing in
the US, the UK, France, Germany, Italy and Japan, outlines opportunities and strategies for market penetration, and wraps up with highlights of the
major companies active in genetics, diagnostics and point of care testing. Weaving together the market forces with the strengths and shortcomings of
the companies, the report provides functional insight into the opportunities for revenue generation in this field, insight that will assist companies
striving to achieve the highest return on their diagnostics investments.
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