The consumer-driven healthcare trend is pushing for more home diagnostics, way beyond the pregnancy tests and glucose monitors that currently comprise this $7 billion market. While this market is active now in the U.S., it is poised to grow even faster in Europe.

That is the conclusion of 32 pharmaceutical and diagnostics experts in the U.S. and Europe, gathered for two workshops recently hosted by Cambridge Consultants (Cambridge, England/Cambridge, Massachusetts), in an effort to diagnose the future of home testing.

As new technologies decrease costs and improve the ease-of-use and reliability of home tests, the horizon is replete with a wave of diagnostics for diseases such as asthma and allergies, as well as genetic pre-dispositions to future conditions and diseases.

Simon Burnell, head of diagnostics for Cambridge Consultants, authored two reports that summed up the consensus findings of the workshops, which included participants from companies such as Quest Diagnostics and Proctor & Gamble.

Burnell said that the market for these products will expand only if the companies producing them provide outcomes that guide action by the user.

“Diagnostic companies need to consider that the tests are only one element of the product,” Burnell told Medical Device Daily. “They have to consider the consumer. They need an actionable outcome. Simply giving the consumer a cardiac marker level or a metabolic rate is useless because the number is meaningless. What would be far better, if you have metabolic syndrome for example, is you need to take these action steps and then follow-up to find out if you’ve improved. These companies just produce the tests. They are not really considering the education and support needed after the test.”

Burnell said strategic partnerships are key for small firms.

For example, a small company developing a diagnostic test is unlikely to get it into a wide marketing channel unless it works with a larger consumer-oriented company they have routes into the market. “If they partner with a pharmaceutical company, they can make use of the test and give consumers actionable outcomes.”

“The diagnostics industry can do much to increase the acceptance of consumer testing,” according to the report, titled “The future of diagnostics: a consumer driven world? The U.S. perspective.”

Burnell said that in Europe, “some governments are increasing the power given to pharmacists to conduct diagnostic testing and screening in an effort to lower the burden on their socialized healthcare systems. In the U.S., physicians have limited time for patient consultations, and one could envisage that the large U.S. pharmacy chains may take advantage of this to include on-site diagnostic testing facilities as a means to entice customers into their stores.”

Given the regulatory hurdles in the U.S., companies are looking for softer markets in an effort to gain early acceptance for new test kits, Burnell said.

“There’s a real question of where this new generation of tests will actually have their start. India is one example of a country with very little regulation from an IDE perspective but it has a growing wealthy middle upper class.

“While the U.S. has a logical drive because of the infrastructure and repay structure that goes along with insurance model, you could see there’s an attraction to get products into a market quicker.”

The group considers Europe as the prime incubator for more home test kits, rather than the U.S., because Europe’s healthcare systems are state-owned.

“Italy and the U.K. are the more fertile ground as there is a pharmacy network which is supported by highly trained and underutilized pharmacy staff,” according to the report. “This is expected to be further accelerated by the review of the U.K.’s independent dispensing legislation, the results of which are about to come into effect and give pharmacies more control and power. The roll-out of over-the-counter testing in pharmacies is likely to increase consumers’ acceptance.”

Another potential market driver is sample collection and processing, which is not only key to test accuracy, but also related to user compliance. “All consumers exhibit a clear preference for non-invasive sampling [e.g. imaging, oximetry, blood pressure, temperature, weight, body fat, transcutaneous measurement] followed by minimally invasive sampling [e.g. tears, sweat, urine, stool, hair, skin, saliva, breath] in place of invasive sampling [e.g. blood, tissue],” according to the U.S. version of the report. “Considering alternative methods to obtain the sample can dramatically increase compliance and therefore the utility of the test.”

Regardless of the location of market expansion, the test types most likely to emerge are targeted to four main areas: screening, disease identification, disease monitoring and prognostics.

The latter is the most interesting and perhaps the most controversial, Burnell said.

“One of the things indicative of both European and U.S. healthcare markets is reactive medicine,” Burnell said. “When you’re ill, you go to the doctor. When you’re not you don’t go. Prognostics present the idea of doing predisposition tests to determine what sort of conditions you might be prone to have in 20 years time so that you can do something about that in advance.”

“The technology exists to allow consumers to identify future likelihood of disease and severity but in the short term it is not clear who is willing to pay,” according to the European version of the report.

“Will patients demand these technologies and will they be prepared to pay for them? Will they integrate them into their lives? In order for success the industry must demonstrate a clear economic benefit.”

Burnell said there are no prognostic tests on the market yet, although he knows of at least one British company, undisclosed, analyzing a breast cancer predisposition test.

“But they’re having a problem selling to labs because nobody wanted it.”

In the more immediate future, Burnell said the next big test to hit the market will likely be a home monitoring kit for congestive heart failure.

“It’s like diabetes — you’ve already been diagnosed, you’re on a therapy. It’s about monitoring that therapy and improving people’s quality of life.”

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