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Sci-fi to Sci-fact - Market Opportunities for Point of Care DNA Testing Devices
HBS Consulting, Feb 2002, Pages: 123
As the Human Genome project and myriad other research endeavours 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? This report analyses both the impressive driving forces, and the market restraints, to the development and commercialisation 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 fuelling 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. The report 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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