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Point of Care Testing Applications of Microfluidics Technologies

Price:
USD $5,390.00
ISBN/SKU #:
YD4485
Research Group:
Yole Development
Date of Publication:
March 2010
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Summary

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% of the In-Vitro Diagnostics market and has shown tremendous growth over the last 3 years. This market share is expected to exceed 30% 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. Significant hurdles remain in the technology itself and its fusion into the healthcare system.

The first issue is finding the real markets, where a point of care solution really matters enough to some purchaser to drive demand. 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.
 
This report provides a segmentation of the Point of Care market and a deep analysis of the different applications for microfluidic technologies. By application, we describe the different requirements such as target price, sample volume, sensitivity…
 
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.
 
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 MEM S production volumes. Silicon has to compete with low cost glass and polymer at common microfluidics feature sizes.
 
We explain 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.

COMPANIES CITED IN THE REPORT

3M, Abaxis, Abbott Point of Care, Amic (Johnson & Johnson), Axis Shield POC, BD Diagnostics, BioMérieux, Biosite, Caliper, Cepheid, Chempaq, Dalsa Semiconducteur, Dxtech , Enigma Diagnostics, Epocal, Genefluidics, IBM, Ikerlan, Iquum, Lumora, Mobidiag , Molecular Vision, Nanosphere, Norchip, NXP, Ocusense, Philips, Qiagen, Siemens, STM icroelectronics, Texas Instrument, Tokyo Electron, Vista Therapeutics, Wako Diagnostics and many others.

Benefits

  • This report provides a segmentation of the Point of Care market and a deep analysis of the different applications for microfluidic technologies. By application, we describe the different requirements such as target price, sample volume, sensitivity
  • 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.


TABLE OF CONTENTS

Executive Summary
 
Introduction
• Context, Introduction, Objectives
 
 
The Market of Point of Care Diagnostics
       The market of Point of Care
       POC positioning in the IV D market
       POC part in the microfluidic component market: Value and forecast in $M
       POC part in the microfluidic component market: Value and forecast in Munits
       Compound annual growth rates - CAGR 2006-2008 and 2009-2014
       Microfluidic devices for Point-of-Care
       Market analysis
       Key events
       Life & death
 
Point of Care Applications
       Introduction to market segmentation
       Segmentation methodology
       Discriminating technical parameter: The sample
       3 Types of Point of Care applications
       Selected examples of improved outcomes resulting from POC
       Market segmentation
       Segments description
       Market window 2010
       Market size
       Market of microfluidic devices, by POC application – in M$
       Market of microfluidic devices, by POC application – in Munits
       Focus on 2009 market
 
Point of Care technologies
       Outlines
       Technology chart
       Microfluidic assets
       Chemical analysis and immunoassaybased technologies
o    Chemical detection and immunoassays tables
o    Products / market segment
       Cytometry
o    Cytometry table
o    Products / market segments matrix
o    Technology descriptions
       DNA/RNA based analysis
o    DNA/RNA based analysis tables
o    Products / market segments matrix
o    Technology descriptions
 
POC Challenges
       Issues
       POC Management is complex
       Which standards apply to POC
       Waived and non-waived tests
       Technical Challenges
o    Technical requirements
o    POC analysis steps
o    Sample preparation
o    Miniaturization, a main challenge
o    Sample volume
o    Product mapping
o    Detection required sensitivity
o    Sensitivity levels
o    Achieved sensitivity levels
       Economic Challenges
o    Economic requirements
o    Diagnostics cost breakdown
o    Microfluidic POC tests price ranges
o    The cost of POC versus laboratory tests
o    Insurance companies influence
 
Supply and Value Chains
       Introduction
       Diagnostic market distribution
       Semicon industry needs partnership
       Examples of collaboration
       Industrial supply chain
       Materials by application
       Microfluidic prototyping and production
       Cost analysis case study
 
Conclusions
Summary and conclusions

Additional Information

PDF File, Number of Pages: 148