Point of Care Testing 2014:
Applications for Microfluidic Technologies
What 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.
THE MARKET IS HIGHLY SEGMENTED AND NO PRODUCTS FIT EVERY APPLICATION
POC 2014 report describes the following applications:
Doctor’s office screening
Decentralized hospital tests
Forensic and military
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.
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.
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.
OBJECTIVES OF THE REPORT
This report’s objectives are as follows:
Provide an in-depth analysis of microfluidic devices dedicated to Point of Care
List nearly 60 new technologies (commercialized or close to market), with information regarding commercial status, targeted application, technology description, sample volume, sensitivity level and target price
Propose a structured market vision through an innovative market segmentation and associated market forecasts
Strategic analysis of the latest acquisitions
Global recalculation of the microfluidic POC market
10+ new products analysed
Overview of the incredible success of Cepheid and Abaxis, two microfluidic diagnostic companies
Supply chain analysis and collaboration examples
Question of the microfluidic device standardization
KEY FEATURES OF THE REPORT
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
COMPANIES CITED IN THE REPORT (non exhaustive list)
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. and many others.
Executive summary 4
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
New products arrive on the market
Product portfolio repartition
Market segmentation 57
Doctor office screening
Decentralized hospital tests
Forensic and military
Third world infections
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
Chemical analysis and immunoassay-based technologies
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)