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Point of Care Testing 2014: Applications for Microfluidic Technologies
Jun.2014

yole pointofcare microfluidic device may 2014
5 990 €

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Description

Yole PointOfCare May 2014 iconeflyerWhat strategies could new players use to enter the Point of Care market?

MICROFLUIDIC-BASED POINT OF CARE IS NOW A MUST-HAVE FOR DIAGNOSTIC COMPANIES. IS THE MERGERS & ACQUISITIONS SEASON OVER?

The Point of Care (POC) market’s contribution to in vitro diagnostic is poised to increase from 13% to 17% over the next five years, leading to a market of around $30B in 2019.

Different types of Point of Care tests are available on the market. Whereas simple lateral flow tests work perfectly without fluid management technology, microfluidics is necessary when test complexity increases. Indeed, microfluidics is an enabling technology allowing miniaturization and integration of laboratory protocols into portable devices.

POC testing based on microfluidic technology is expected to grow sharply, from $1.6B in 2013 to $5.6B in 2019, at a CAGR 2014 - 2019 of 23%. Major diagnostics companies (Alere, Abbott Point of Care, BD Diagnostics, Cepheid, Abaxis, etc.) have realized the potential of rapid molecular diagnostic testing. Indeed, several successful Point of Care products based on microfluidic technology have been launched in the past few years. Access to microfluidic technologies for diagnostic companies often passes through acquisitions, as this reduces the technology development risk and increases reactivity. The most recent acquisition was that of IQuum by Roche for $275M in April 2014.

This new Yole Développement report describes how mergers and acquisitions will decrease in volume but increase in value.

Based on a complete analysis of the last three years’ developments, we have been able to draw effective conclusions. Despite slower than expected growth in 2012, we explain why strong future growth is still likely.

Yole PointOfCare Microfluidic device May 2014

THE MARKET IS HIGHLY SEGMENTED AND NO PRODUCTS FIT EVERY APPLICATION

POC 2014 report describes the following applications:

  • Emergency testing
  • Home tests
  • Doctor’s office screening
  • Decentralized hospital tests
  • Environmental testing
  • Forensic and military
  • Third-world infections
  • Agro-food
Each of these are explained using market data, trends and drivers, key players and technologies used.

Also, growth perspectives and a value chain analysis are detailed for each application, and examples of innovative products are provided.


Moreover, this new report provides an overview of nearly 65 new technologies (commercialized or close to market), with information regarding commercial status, targeted application, technology description, sample volume, sensitivity level and target price.

Yole PointOfCare Market segmentation May 2014
WILL WE SEE A STANDARDIZATION OF MICROFLUIDIC DEVICE DESIGN?

Today’s microfluidic device market for Point of Care applications will increase three-fold over the next five years, reaching close to $600M by 2019. Of course, an increase in the adoption of microfluidic devices leads to the burning question of device design standardization.

Standardization is currently happening at the material level, i.e. the wide acceptance of polymer mainly due to cost pressure. But what’s the next step? In this report, Yole Développement provides theoretical scenarios for the potential design standardization of microfluidic chips, and also considers who could benefit from such standardization.

FROM MICROFLUIDIC COMPANY TO MAJOR DIAGNOSTIC COMPANY: HOW TO BRIDGE THE GAP?

Yole Développement report provides a detailed analysis of two tremendous success stories: Cepheid and Abaxis. How have these two companies, both specialized in microfluidic Point of Care technologies, been able to make hundreds of millions in revenue?
We also gives a list of pitfalls and challenges, and some advice to overcome them:

Technical and regulatory challenges
POC testing faces several technical requirements. Some of them are universal; for instance, specificity and sensibility must be higher than the reference method. Others, however, are highly dependent on the application.

Economic challenges
Yole Développement value chain analysis provides an understanding of costs related to the different manufacturing steps (included packaging and quality control) in relation to the cost of the final test, which includes reagent, commercialization and distribution costs.

Supply & value chain challenges
We delve into the microfluidic supply chain, from R&D to commercialization and distribution. Also, we illustrate the main players for each material type, and their role in the supply chain.

Yole PointOfCare Crossing the gap May 2014

Table of contents

Executive summary 4
Introduction 28
The market for Point of Care diagnostics 34
> POC positioning in the IVD market
> Top 10 Point of Care players
> POC testing based on microfluidic
> Microfluidic device market for Point of Care application

What’s happened since 2011? 47

> Latest news
> New products arrive on the market
> Product portfolio repartition

Market segmentation 57

> Methodology
> Segments description
- Emergency tests
- Home tests
- Doctor office screening
- Decentralized hospital tests
- Environment testing
- Forensic and military
- Third world infections
- Agro-food
> Microfluidic device market forecasts per segment in volume and value
> 2013 Microfluidic device market vs. CAGR2014-2018
> Microfluidic devices for Point of Care testing: sweet spots applications
> Microfluidic row chip contribution in Point of Care test per segment

Point of Care technologies 84

> Technology chart
> Microfluidic assets
> Chemical analysis and immunoassay-based technologies
> Cytometry
> DNA/RNA-based analysis
> Multiple detection methods in a single reader
> Products / Market segments matrix

 Success stories analysis 126
> Split between disposable/system sales
> Crossing the gap - become a major diagnostic company

POC challenges 133

> Technical challenges (requirements by of POC application vs today achievements)
> Economic challenges (diagnostics cost breakdown, Microfluidic POC tests price ranges)
> Regulatory challenges (which standards apply to POC, CLIA waived and non-waived tests)

Supply and value chain 165

> Supply chain and collaborations
> Materials mix per microfluidic application
> Value chain analysis
> Microfluidic device standardization

Outlook 180

> Industrial testing (Tests classification)
> Medical testing (Third world testing, > Microfluidic paper-based analytical devices)

Summary and conclusions 193

 

Companies cited

3M - Focus Diagnostic
Abaxis
Abbott Point of Care
Accumetrics
Achira
Akonni Biosystems
Alere
Ativa
Bio-Rad
BioCartis
Biodetection Instruments
bioMérieux
Cepheid
Curetis
Daktari
DNA Electronics
Enigma Diagnostics

F-Cubed
Genefluidics
GenePOC
Great Basin
Handylab (BD)
IBM
Ikerlan
INO
Iquum
Johnson & Johnson (Amic)
LeukoDX
Lumora
Medimate
MIT Lincoln Laboratory
Molbio Diagnostics
Molecular Vision (Abingdon Health)
Nanosphere

NetBio
Norchip
OcuSense
On-Chip Biotechnologies
OPKO Diagnostics
Pall Corporation
Philips
Rheonix
Roche
Siemens
Smiths Detection
Sony (Micronics)
SpinChip Diagnostics AS
STMicroelectronics
ThermoFisher
Vista Therapeutics
Wako Diagnostics
Zyomyx Inc

 

KEY FEATURES OF THE REPORT

All applications of GaAs wafer and market metrics, detailing:

  • Top 10 POC players’ market share, turnover, reference products
  • Consolidation of 2012-2014 market data and 2014-2019 microfluidic POC device forecasts with a unique market segmentation for the different applications
  • Detailed supply and value chain analysis providing evidence for the value of material and structuring in the complete value chain
  • Analysis of market evolution and key events over the last three years