Abstract
MARKET 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% 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.
REPORTS HIGHLIGHTS
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 MEM S 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, BioMerieux, 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...
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
- Chemical detection and immunoassays tables
- Products / market segment
- Cytometry
- Cytometry table
- Products / market segments matrix
- Technology descriptions
- DNA/RNA based analysis
- DNA/RNA based analysis tables
- Products / market segments matrix
- Technology descriptions
POC Challenges
- Issues
- POC Management is complex
- Which standards apply to POC
- Waived and non-waived tests
- Technical Challenges
- Technical requirements
- POC analysis steps
- Sample preparation
- Miniaturization, a main challenge
- Sample volume
- Product mapping
- Detection required sensitivity
- Sensitivity levels
- Achieved sensitivity levels
- Economic Challenges
- Economic requirements
- Diagnostics cost breakdown
- Microfluidic POC tests price ranges
- The cost of POC versus laboratory tests
- 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
