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TRANSCRIPT
© 2019
From Technologies to Markets
Microfluidic technologies are
taking point-of-care testing to the next
level
Yole Développement
Sébastien Clerc
Molecular Medicine Tri-Conference
Monday, March 11, 2019
2| www.yole.fr | ©2019
AGENDA
Yole Group presentation
Introduction about microfluidics and definitions
An increasing on-chip complexity for always more integration and automation
Commercialization of microfluidic technologies for POC testing: dream or reality?
Q&A
30 minutes
Molecular Medicine Tri-Conference | Monday, March 11, 2019
© 2019
Yole Développement
From Technologies to Market
Source: Wikimedia Commons
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Molecular Medicine Tri-Conference | Monday, March 11, 2019
Microfluidic technologies are taking point-of-care testing to the next level
10
INTRODUCTION
Definition - our vision of microfluidics
What do we consider as
microfluidics?
Microfluidics is the science and technology that deals with the manipulation of fluids, usually in the range of microliters(10-6) to picoliters (10-12) and/or in networks of micrometer-size channels
Our definition of microfluidics encompasses:
Methods controlling very
small fluid volumes
Micro-fabricated devices with
channels below ~500µm in size
and/or
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
11
INTRODUCTION
Microfluidics - advantages and drawbacks
Reduced sample and reagent volumesShorter times for liquid displacement,
thermal transfers, and analysis
Automation and integration of complex
operations Precise liquid control
Diffusion-based mixing (due to
highly-viscous forces) takes timeActuation is required for improving mixing steps
Better control of chemical reactions Improved safety for chemical reactions
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
12
INTRODUCTION
Our vision of the microfluidics market
Example: Binx Health
analyzer
Microfluidic device: chip
(raw hardware)
Microfluidic product: cartridge with
reagents and packaging
Example: Binx Health
cartridge
Microfluidic analyzer
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
13
INTRODUCTION
There is no “one single microfluidic technology”
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
14
DIFFERENT APPLICATIONS CAN BE TARGETED
Point-of-Need
Testing
Veterinary
testing
Industrial
testing
Agro-food
testing
Environmental
testing
Forensics
Human testing
Point-of-care
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
PON = Decentralized testing = Out of reference laboratories
15
2000
2015
2020
ROADMAP FOR MICROFLUIDIC-BASED POC TESTING
2010Blood gases
Blood chemistry
Glucose
coagulationMolecular diagnostics
Molecular diagnostics
Cardiac markers
HIV/AIDS
CBC
Immunoassays
Possibilities: DNA
sequencing in a doctor’s
office, etc.
“Empty” period without
major breakthroughs (in
terms of new products)
First PoC wave:
decentralization and
automation of “simple” tests
(exception: Cepheid)
Second PoC wave:
decentralization and
automation of
complex tests
New platforms entered the
market. The trend is now to
expand assay menus and multiplex
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
16
POINT-OF-NEED TESTING
Why are microfluidic solutions used?
The added-value is not equal in all applications
Cost
advantages
Operational
Benefits
Enabler for
new
functions
High added-value!
Microfluidic is an enabling technology and will be used
ONLY if the perceived associated added-value is high.
If advantages are provided only on one axis, it’s often not enough!©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
17
POINT-OF-NEED TESTING
A compromise is needed
These three factors cannot all
be improved simultaneously. So what matters the
most for your application?
Sensitivity
Detect more things,
earlier
Throughput
Treat more samples,
faster
Simplicity
Miniaturize,
automate,
enable use by
untrained users
Home patient monitoring
Doctor’s office screening
Defense
Hospital testing
Water monitoring
Industrial testing
Food safety
Forensics
Emergency testing
Veterinary testing
Epidemics in remote areas©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
18
MARKET QUANTIFICATION
Number of tests (products) - in million units
In 2017, the volume of
microfluidic-based PoN tests was 213M units, of which only
27M units were not for human
diagnostics.
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
0
100
200
300
400
500
600
700
800
2016 2017 2018 2019 2020 2021 2022 2023
Millio
ns
of
test
s sh
ipp
ed
Microfluidic-based PoN testing market (volume)
S1 - Emergency testing (total)
S2 - Third world infections: remote areas testing
S3 - Home tests
S4 - Doctor office screening
S5 - Decentralized Hospital tests
S6 - Genetic testing, companion diagnostics, forensics
S7 - Veterinary testing
S8 - Environmental & Industrial testing
S9- Agro-food testing
19
POINT-OF-NEED REVENUE STREAM
Why so many tests? Razor/razor-blade business model
The majority of revenue comes from consumables
Contribution of consumables in 2017 revenue:
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
20
FOCUS ON PON MOLECULAR DIAGNOSTICS
A myriad of active players (non-exhaustive list)
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
21
PON MOLECULAR DIAGNOSTICS
An increasing on-chip complexity for always more integration and automation
Example: Alere q HIV cartridge
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
22
PON MOLECULAR DIAGNOSTICS
An increasing on-chip complexity for always more integration and automation
Example: GenMark Diagnostics ePlex cartridge
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
23
PON MOLECULAR DIAGNOSTICS
An increasing on-chip complexity for always more integration and automation
Example: Qiagen DiagCORE cartridge (Stat-Dx)
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
24
PON MOLECULAR DIAGNOSTICS
An increasing on-chip complexity for always more integration and automation
Example: bioMérieux FilmArray pouch (BioFire)
Lysis chamber (bead-beating)
Purification and elution chambers
First PCR chamber
Second PCR chamber
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
25| www.yole.fr | ©2019
SUCCESS OF MICROFLUIDIC TECHNOLOGIES - DREAM OR REALITY? (1/2)
Company ProductsTechnology / Application
Assay menu Status
Abaxis
VetScan /
Piccolo Xpress
Immunoassays /
Blood
chemistry
Blood Chemistry
Microbiome
Canine
Bovine
Equine
8M veterinary reagent discs were sold in
2017, generating an amount of $101M
For human testing, Abaxis sold 2.3M units in
2017 for $29.3M
Abbott
i-STAT
Immunoassays /
Blood gases
Blood Chemistry
Hematology
Blood gases
Coagulation
Endocrinology
Cardiac markers
In 2017, Abbott sold 52M i-Stat cartridges,
generating $513M in revenue
Roche
cobas LIAT
Real-time PCR
Infectious diseases
Flu A/B
Flu A/B + RSV
Strep A
C.Diff
MRSA/SA
Installed base 2500 as of Dec. 2017
~3M tubes sold in 2017, generating $120M in
revenue
High double-digit growth
Molecular Medicine Tri-Conference | Monday, March 11, 2019
26| www.yole.fr | ©2019
SUCCESS OF MICROFLUIDIC TECHNOLOGIES - DREAM OR REALITY? (2/2)
Company ProductTechnology / Application
Assay menu Status
Cepheid
GeneXpert
Real-time PCR
Infectious diseases
/ oncology
Flu
Flu/RSV
Strep A
MTB/RIF
MRSA
C.Diff
etc.
Consumables revenue for 2017 was $580M,
through the sale of an estimated 19M units of
GeneXpert tests at a $30 ASP
Installed base is 17,000 systems (+6000 since
Danaher acquisition)
GenePOC
Revogene
Real-time PCR
Infectious diseases
Strep B
C.diff
GBS
2018’s objective was to achieve the
commercialization of 1M units/year
BioMérieux
(BioFire) FilmArray
Real-time PCR
High-multiplex
panels for
infectious diseases
Respiratory panel
Gastrointestinal
panel
Sepsis/blood culture
identification panel
Meningitis/encephalit
is panel
$388M in 2017, generated by 3M units of
FilmArray tests
Installed base 6100 instruments at end 2017,
now more than 8200
High double-digit growth
27
…BUT IT’S NOT THAT EASY!
Time-to-market depends on platform and test complexity… And on money spent!
Time from conception to market
Tota
l fu
ndra
isin
g si
nce
ince
ption
2020+
$10M
$30M
$100M
Unknown
Clinic
Agro food & water
Veterinary
2016 2020+
2011 2019+
in development
In development
2004
2007 2017
1989 1995 Platform development: Piccolo® Xpress
2013 2017
2007 2014
2005 2015
2005 2016
2011 2019
2013
2019+2013
2007 2017
2016
20122019
2019
Time from inception to market
2000 2010
In development
Platform development
takes many years
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
28
CONCLUSION
• Microfluidics enable complex sample prep steps, miniaturization and automation on-chip
• Increasingly complex assays are transferred to microfluidic chips, and can be performed out of reference laboratories
• However it is never easy to meet commercial success
• We believe it is only the beginning
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
29
THANKS FOR YOUR ATTENTION!
Please take a look at our website www.i-micronews.com for industry news and for more information about our reports
Point-of-Need Testing: Application of Microfluidic Technologies 2018Released in March. 2018
210+ slides report
Some slides for this presentation have been taken from the following reports:
Status of the Microfluidics Industry 2017Released in May. 2017
240+ slides report
Sébastien CLERC
Technology and Market Analyst, Microfluidics & Medical Technologies
©2019 | www.yole.fr | Molecular Medicine Tri-Conference | Monday, March 11, 2019
We have a booth! #908
We will be happy to discuss