By application, Frédéric Breussin, Project Manager at Yole Développement describes the different requirements such as target price, sample volume, sensitivity. In this study, over 40 new technologies and technologies in development are reviewed, considering the commercial status, the targeted applications and the addressable segments, the sample volume, the sensitivity level and the target price.
Source: Yole DéveloppementMarket overview
Point‐of‐care diagnostics is a field just beginning to hit its stride, according to many in the industry. Advances in microfluidics, lab‐on‐a‐chip methodologies, miniaturization of testing methods and improvements in detection technologies are leading the way.
From bedside to battlefield, point of‐care diagnostics also represent one solution to helping solve a major healthcare challenge: how to do more with less.
Today, Point of care diagnostics represents 15 percent of the In‐Vitro‐Diagnostics market and has shown tremendous growth over the last three years. This market share is expected to exceed 30 percent by 2014. Key driver for growth will be bringing fast, low cost testing to high volumes of users at the point of care—but only if developers of the technology focus on the right application with real benefit to specific purchasers, and bring together disparate technologies into integrated systems for simple, accurate and low cost tests.
Point‐of‐care diagnostics has yet to develop into the big market many expected. Testing for infectious diseases and applications in agriculture and environmental screening now look like the most promising markets, as companies develop more sophisticated integrated systems that go beyond simple immunoassays to complex sample preparation and molecular diagnostics at reasonable cost. A focus on wellness testing also is expected to enhance the field. But don’t expect point of care to surge overnight.
Report highlights
“The first issue is finding the real markets, where a point of care solution really matters enough to some purchaser to drive demand”, explains Frédéric Breussin. “Obvious as this sounds it has actually proved quite difficult to find the right mix of need, volume and cost to break into the complex established medical infrastructure.”
The compelling advantage of true point‐of‐care diagnostics is of course fast results, right where they’re needed, where getting test results in minutes in an emergency can enable immediate critical treatment. There are, however, only a handful of these critical applications, and most turn out not to be huge markets, typically generating demand of under 500,000 units year.
Other applications haven’t gotten much traction, however, as it is not so clear just how much speed is worth, and just who most benefits. The medical benefit to the patient of a getting a diagnosis in minutes instead of days may be marginal. The operational benefits to the system of increased efficiency and reduced costs may be huge but they are likely to be too diffuse to have a clear champion.
Finally, the report addresses the challenges related to the cost and supply chain. Semiconductor and MEMS companies are expert at integrating sophisticated systems on silicon for high volume manufacture at low cost, but the diagnostics market demand simpler systems in volumes notably far below usual silicon MEMS production volumes. Silicon has to compete with low cost glass and polymer at common microfluidics feature sizes.
In this study, Yole Développement also explains why disposable microfluidic devices will need production costs under $5, for volumes ranging from 100,000‐ 1 million units per year, in order to sell commercial tests for $50‐$100 including reagents, marketing and distribution. This value chain analysis is illustrated as well by a cost simulation of commercially available microfluidic device.
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