Point-of-Need 2020 – Including PCR-Based Testing

From Technologies to Markets
© 2020
Point-of-Need
2020
Including PCR-
Based Testing
Market and Technology
Report 2020 - Sample

22
• Glossary and definitions 2
• Table of contents 4
• Report scope 6
• Report methodology 9
• About the authors 10
• Companies cited in this report 11
• What we got right, What we got wrong 12
• Who should be interested by this report 13
• Yole Developpement related reports 14
• Executive summary 16
• Context 65
o Definitions – our vision of microfluidics
o Microfluidics – advantages and drawbacks
o Our vision of the microfluidic market
o Benefits of point-of-need and point-of-care testing
o Drivers fostering adoption of point-of-care
o Main requirements for point-of-need testing technologies
o When is NOT a device appropriate for use at the PON?
o Compromises are needed to better address every situation
• Market forecasts 76
o Markets definition
o Introduction to our market segmentation
o Market forecasts in units and dollars, for devices and for tests, per segment
and per type of test
o Dynamics per segment
o Test and device ASP evolution, per segment and per type of test
o What has changed? (comparison with the 2018 report) Point-of-Need 2020 - Including PCR-Based Testing | Sample | www.yole.fr | ©2020
TABLE OF CONTENTS
Part 1/2
• Market trends 104
o An increasing on-chip complexity for ever more integration and automation
o The problem of non-optimized cost structures
o There is no “one single microfluidic technology”
o Point-of-care testing roadmap
o Towards testing “anywhere, by anyone”
o Razor and razor-blade business model
o Charts: Installed base of instruments, instruments placed per year, tests per instrument
per year, test ASP per type of test, consumable pullthrough per instrument
o In-house vs. Outsourced production
o The lure of high-volume microfluidic device production
o Reaching commercial success is not an easy path
o Addressing other markets before human diagnostics, a wrong good idea?
o Distribution networks are key for success
o Examples of distribution agreements
o Why are non-human testing applications struggling to take off?
o Rapid, high-multiplex molecular testing
o Examples of success stories (past, current, future), companies to watch in the coming
years, recent failures, other companies examples and stories
o Chart: time from company inception to product launch, in function of funds raised
o Point-of-Need instrument type roadmap
o Importance of multiplexing and wide assay menu
o FLEX pricing to counterbalance the lack of reimbursement
o The advent of multi-modal testing platforms?
o The development of « open platform » business models
o The dynamics are much different than in classic semiconductor markets
o Impact of the Covid-19 outbreak & companies active to develop SARS-CoV-2 tests

33Point-of-Need 2020 - Including PCR-Based Testing | Sample | www.yole.fr | ©2020
TABLE OF CONTENTS
Part 2/2
• Market segments description 167
o For each segment: description, technical requirements, economic
requirements, market insights, type of tests, value of microfluidics, key
players and products
• Market shares and supply chain 227
o Market shares for the whole microfluidic-based point-of-need testing market
o Market shares for each market segment
o Microfluidic fabs: list of fabs per material type, geographical map, and analysis:
why do companies choose to internalize or outsource production, where
are the opportunities for fabs, what are the difficulties, why don’t large
companies work (much) with the fabs, how do fabs climb into the supply
chain?
o Other levels of the supply chain: design houses, surface modification
companies, etc.
o Who’s working with whom?
• Technology trends 270
o Materials
o Hybrid integration
o Manufacturing process comparison
o Reshaping processes overview
o Detection methods overview
o Matrix: type of test vs. type of detection (number of players, examples of
players)
o Focus on acoustic detection methods
o Roadmap: towards instrument-free consumables
o Achieving very rapid PCR diagnostics
o Cost of reagents
o The advent of silicon-based platforms
o Integration and automation of complex sample preparation
o Toward standardized cartridge footprints
o Multiplexing: high-plex vs. low-plex
o Smartphone-based products
• Outlooks 292

44
This new Yole Développement report provides a complete analysis of microfluidic device/product,
markets, and technologies for Point-of-Need testing applications:
o An overview of what microfluidic technology offers to PoN testing
o New major trends and evolutions at the market level and at the technology level
o Examples of success stories and failures, companies to watch in the coming years, and key considerations
for commercial success
o Updated market data and forecast up to 2025, in value and units for microfluidic devices and tests, per
segment and per type of test
o Supply chain description and analysis
o Market segmentation with technical and economical requirements per segment, product examples, key
players, market share, and market + technology trends
Point-of-Need 2020 - Including PCR-Based Testing | Sample | www.yole.fr | ©2020
REPORT OBJECTIVES

REPORT SCOPE (1/3)
Point-of-Need
Testing
Veterinary
testing
Industrial
testing
Agro-food
testing
Environmental
testing
Forensics
Human testing
Point-of-care
PON = Decentralized testing = Out of reference laboratories
In this report, we define as Point-of-Need testing any diagnostic test performed out of reference laboratories,
at the “point-of-need”: at home, at the patient’s bed, in ICUs (Intensive Care Units), at the physician’s office,
near a production line, etc.
Point-of-need is
NOT limited to
point-of-care

66
Our definition of Point-of-Need includes equipment in laboratories on-site, for example on the floor a
food manufacturing facility or a room next to it. Just walking the sample from one room to the next to
perform the test, as you might do in a hospital, does not exclude the products from our definition. It is
still point of need if you aren't running the instrument in the patient's room but just next to it.
Important criteria however are:
- Ease of use and automation (use by minimally-trained people)
- Low or no manual steps
- Rapid results (minutes or few hours, depending on the type of test)
REPORT SCOPE (2/3)

77
This report focuses on tests based on microfluidic 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.
Microfluidic technology can be used in the cartridge/chip and/or in the instrument (reader).
Simple tests, i.e. lateral flow tests and tests done on strips are not part of this report’s scope.
REPORT SCOPE (3/3)
Yours needs are
out of the report’
scope?
Contact us for a custom:

REPORT METHODOLOGY
Market
Volume (in Munits)
ASP (in $)
Revenue (in $M)
Yole’s market forecast model is based on the matching of several sources:
Information
Aggregation
Preexisting
information

99
Sébastien Clerc
Sébastien Clerc is a Technology & Market Analyst in Microfluidics, Sensing & Actuating at Yole Développement
(Yole).
As part of the Photonics & Sensing team, Sébastien has authored a collection of market and technology reports
dedicated to microfluidics and other micro-devices for both market segments: medical (including diagnostics,
pharmaceutical, biotechnology, drug delivery, medical devices) and industrial (including environment, agro-food).
At the same time, he is involved in custom projects such as strategic marketing, technology scouting and
technology evaluation to help academic and industrial players in their innovation processes.Thanks to his
technology & market expertise, Sébastien has spoken in more than 20 industry conferences worldwide over the
last 5 years.
Sébastien Clerc graduated from Grenoble Institute of Technology (Grenoble INP - Grenoble, France) with a
Master’s degree in Biomedical Technologies. He then completed his academic studies with a Master’s degree in
Innovation and Technology Management in the same institute.
Email: sebastien.clerc@yole.fr
Biography & Contact
ABOUT THE AUTHORS

1010
Abaxis (Zoetis), Abbott, Abionic, Accelix (LeukoDx), Accriva Diagnostics (Instrumentation Laboratory, Werfen), Achira Labs, Agilent Technologies, AgPlus
Diagnostics, Akonni Biosystems, Alere (Abbott, Quidel, Siemens), ALine, ANDE, Aprimeo Diagnostics (R-Biopharm), Applied Microarrays, Ativa Medical,
Atonomics, Avalun, Axxicon, Balda AG (Stevanato Group), Bayer, BD (Becton Dickinson), Biko, binx health (formerly Atlas Genetics), Biocartis, Biodetection
Instruments, BioFire Diagnostics (bioMérieux), BioMensio, bioMérieux, Bionuclear, Bio-Rad, BioSensia, Biosurfit, Blusense Diagnostics, Boehringer Ingelheim
Mobinostics, Bosch Healthcare, Boule Diagnostics, Caliper Life Sciences (PerkinElmer), Carbo Analytics, Cepheid (Danaher), Charles River Laboratories, Click
Diagnostics, Coris Bioconcept, Covance (LabCorp), Cubed Laboratories (formerly FCubed), Cue Health, Curetis, Curiosity Diagnostics (Scope Fluidics),
Daktari Diagnostics, Denz BIO-Medical, DiaSorin Molecular, DNAe (DNA Electronics), DxNA, Enigma Diagnostics, ENPLAS, Etta Healthcare (Ovagene
Oncology), ExcitePCR (PositiveID Corporation), Flow Alliance, Fluid-Screen, FluimediX, Fluxergy, Focus Diagnostics (DiaSorin Molecular), Future Horizon
Scientific, Genalyte, GeneFluidics, GenePOC (Meridian Bioscience), GenMark Diagnostics, GenSpeed Biotech, Great Basin Scientific (Vela Diagnostics), Gulf
Bio Analytical, GSK, Hahn-Schickard, Helvoet, HemoCue (Radiometer, Danaher), IDEX Health&Science, IQuum (Roche), iLine Microsystems, imec,
Inflammatix, InSilixa, Instant Labs (Luminultra), IntegenX (Thermo Fisher Scientific), Klearia, LacriScience, LeukoDx, LexaGene, Luminex Corporation,
LumiraDx, Maccura, MBio Diagnostics, Medimate (CE-Mate), MeMed, Menarini, Meridian Bioscience, Mesa Biotech, Microfluidic ChipShop, MicroLiquid,
Micronics (Sony), Micronit, Minicare (Siemens), MiniFAB (Schott), Mobidiag, MolBio Diagnostics, NanoEntek, Nanomix, Nanosphere (Luminex), Nichirei
Biosciences, Nypro (Jabil), Ondavia, Ontera (formerly Two Pore Guys), OPKO Diagnostics, Optolane Technologies, Osler Diagnostics, Oxford Nanopore
Technologies, Pall Corporation (Danaher), PathSensors, Phase Three Product Development, Philips, POC Medical Systems, Qiagen, Qorvo Biotechnologies,
Quanterix, QuantuMDx, Quidel, Quimica Valaner, Qvella, RAB-Microfluidics, Radisens Diagnostics, Randox Biosciences, Rapid Diagnostics, R-Biopharm,
RedBud Labs, Rheonix, Righton, Roche, rqmicro, Samsung, Sandstone Diagnostics, Sanwa Biotech, Sekisui Diagnostics, SensoDx, Siemens Healthineers, Sight
Diagnostics, SMB (Zoetis), SpinChip Diagnostics, Spindiag, Stat-Dx (Qiagen), STMicroelectronics, Stratec Consumables, Surfix, Symbient Product Development,
TearLab, Technicolor Precision Biodevices, Theranos, thinXXS (IDEX), Truvian Sciences, T2 Biosystems, Vela Diagnostics, Veredus Laboratories, Wako
Diagnostics,Wi inc,Wondfo,Yield Engineering Systems (YES), Zenosense, z-microsystems, Zoetis, Zomedica Pharmaceuticals, and more.
COMPANIES CITED IN THIS REPORT
290+ slides of market and technology analysis
Information gathered through direct discussions with players all along the supply chain

1111
• Diagnostic, pharmaceutical, biotechnology,
industrial, and other companies:
o Have a broad overview of all PoN testing
applications and markets along with requirements
o Understand what is “state of the art” in
microfluidic technologies, and which solutions
could bring operational benefits
o Identify the different players across the supply
chain
o Comprehend behavior evolution
o Highlight, monitor and benchmark competitors
and targets for collaborations or M&A
• Financial & strategic investors:
o Realize potential of microfluidic technologies
o See the latest moves within the industry
o Learn the sweet spots and growing applications,
and understand end-users’ objectives
• R&D players:
o Understand new challenges linked to microfluidic
technologies
o Address the right market with the right technology
• Microfluidic foundries and device makers:
o Grasp technical requirements
o Recognize business opportunities and prospects
o Understand the evolution of the supply chain
• Healthcare & governmental organizations:
o Evaluate the benefits of using PoN testing
o Pinpoint relevant companies
• Electronics, MEMS, and optics companies:
o Understand the microfluidic market and technologies
o Interpret the requirements for market entry
o Become familiar with the challenges and requirements
in microfluidics, biology, and healthcare
WHO SHOULD BE INTERESTED BY THIS REPORT?

13
Other methods controlling
very small fluid volumes
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 even below) and/or in networks of
micrometer-size channels.
Our definition of microfluidics encompasses:
Micro-fabricated devices with
channels below ~500µm in size
and/or

INTRODUCTION
Microfluidics - advantages and drawbacks
Reduced sample and reagent volumes
Shorter 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 time
Actuation is required for improving mixing steps
Better control of chemical reactions Improved safety for chemical reactions

INTRODUCTION
Our vision of the microfluidic market
Example: Binx Health
analyzer
Microfluidic device: chip
(raw hardware)
Microfluidic product: cartridge with
reagents and packaging
Example: Binx Health
cartridge
Microfluidic instrument
Also included: flow control
instruments, etc.
NOT QUANTIFIED

INTRODUCTION
Main requirements for point-of-need testing technologies
PoNT
Low sample
consumption
Simple or
automated
system
Rapid
turnaround
times
Accurate and
quantitative
results
Low-cost,
portable
readout
devices
Prolonged
reagent
storage and
shelf life
• Operation requires
minimal user intervention
• In clinical diagnostics: non-invasive
samples: urine, saliva, sweat, swabs,
etc, or blood from a fingerprick
• Within 10 minutes to 2 hours –
allowing for actionable results for
physicians or production
managers to take decisions
• Results in accordance with clinical and central laboratory findings
• Adhering to international quality standards (ISO norms)
• Cost must be lower than
central lab testing, unless the
value given by the speed of
results is very high
• Avoid inherent instability or
compromised stability due, for
example, to inappropriate storage
of in-vitro diagnostic reagents

SARS-COV-2 POINT-OF-CARE MOLECULAR DIAGNOSTIC TESTS
Emergency Use Authorization
(EUA) and/or CE mark
Number of samples
in parallel
Speed of analysis
(time to results)
For Research Use Only
(RUO)
5 hours
In development
60 min 30 min 10 min
8 samples
24 samples
96 samples
2 hours
4 samples
45 min
1 sample
2 samples
The report features our analysis
of the impact of the COVID-19
pandemic on the microfluidics
supply chain and market
forecasts. Which opportunities
for which players?
Situation as of March 31, 2020
Number of samples that can
be processed in a single run

1818
The first commercially-available lab-on-a-chip devices are now more than 20 years old. The complexity
of microfluidic devices has increased ever since, leading to extremely complex cartridges performing
very complex sample preparation steps in an automated way.
MARKET TRENDS
An increasing on-chip complexity for ever more integration and automation
One of the first commercially available lab-on-
a-chip devices: Agilent’s LabChip for the 2100
Bioanalyzer
Manufactured by Caliper Life Sciences (simple
capillary channels in a glass substrate)
Recent microfluidic cartridges for diagnostic devices, with many
functions integrated on-board, such as reagent blisters, etc.
Manufactured by Microfluidic ChipShop
~20 years of
technology
improvement
~2000 2020

MARKET TRENDS
Rapid, high-multiplex molecular testing
Degree of
multiplexing
Speed of analysis
Not commercially available yet – company claims only
30 min
6 pathogens 10 min5 hours
50+ pathogens
1 pathogen
Market-empty zone: upcoming
players will try to fill it
(2020)
(2020)
(already available for veterinary – target
human diagnostics market in 3-4 years)

2020
Detailed analysis of players’ manufacturing strategies, who’s working with whom and why,
which materials are the most used in point-of-need testing applications, what is the
opportunity for silicon and CMOS, estimation of the fab market and in-house production
market (in volume and in value), and insights about how fabs can find new opportunities
SUPPLY CHAIN
Deep dive into the microfluidic supply chain for point-of-need testing
340,7
113,1
0 50 100 150 200 250 300 350 400
In-house microfluidic device production
Outsourced microfluidic device
production (fab market)
Million dollars
In-house vs. Outsourced microfluidic
device market in 2018 (in value)

2121
53 500
26 300
23 000
18 000
16 700
10 400
6 400 6 000
4 600
1 310 980 620 600 527 470 400 250 220 175 131 114
-
10 000
20 000
30 000
40 000
50 000
60 000
Numberofinstruments
Instrument installed base, as of Dec. 31, 2019
Detailed data for 50+ players, presented through charts: Installed base of instruments, instruments placed
per year, tests per instrument per year, test ASP per type of test, consumable pullthrough per instrument
MARKET TRENDS
Detailed data per player/product

2222
MARKET FORECASTS
Molecular-
based point-
of-need
testing is now
making it to
the next level.
Molecular tests are much more expensive than the others and hold the largest market share. It is
also the fastest-growing category.
Market data and forecasts 2018-2025, in volume and value, per segment and per type of test (for the first time
in this report!), at two levels of the supply chain (for microfluidic devices and for microfluidic-based tests)
Device Test

MARKET TRENDS
Point-of-Need instrument type roadmap
Level of
portability
Time2000 2010 2020 2030
Handheld
Benchtop
Large benchtop
Light benchtop
Handheld
Instrument-free
consumable
Test complexity
Increasingly complex tests
required increasingly
complex instrumentation
Now companies miniaturize
this instrumentation

MARKET TRENDS
The advent of multi-modal testing platforms
Examples:
• Immunoassay + clinical chemistry
• Immunoassay + DNA/RNA detection
Immuno-
assay
platform
Clinical
chemistry /
electrolytes
platform
Hematology
platform
Cytometry
platform
DNA/RNA
detection
platform
Multi-modal
platform

25
TECHNOLOGY TRENDS
Different detection methods are possible
The detection of
analytes is mainly
done optically and
electrochemically.
Microfluidics test
Optical detection
(microscopy,
fluorescence, etc.)
Electrochemical
detection
Acoustic detection
Combination of
detection methods
Existing detection methods
Emerging detection methods
In the report, a focus is made on these emerging detection methods, especially acoustic detection

TECHNOLOGY TRENDS
Type of test vs. type of detection: number of technologies identified
Electrochemical
detection
Optical
detection
Acoustic
detection
Combination of
several detection
methods
Total
Blood chemistry,
blood gases,
electrolytes
13 14 0 1 28
Immunoassays
(proteins
detection)
5 20 2 2 29
Molecular
Diagnostics
(DNA/RNA
detection)
10 45 3 0 58
Hematology/
Cytometry
3 8 0 1 12
Total 31 87 5 4 127
In the report, dozens of examples of companies are shown in the boxes of this table

MARKET SEGMENTS DESCRIPTION
For each segment, one-slide summary + additional slides detailing main trends and players
VeterinaryTesting - segment description:
Animal testing directly at home, in veterinary offices, at farms and breeder facilities for emergency testing (sick or wounded animal)
as well as routine disease detection and animal health monitoring. Also wildlife and zoo animals testing, and race horses
monitoring.
Technical requirements:
• Fast turnaround time, high throughput for breeding
• Portable analyzers for breeding, unless the farmer owns its own instrument, and
sometimes for wildlife/zoo animals testing; benchtop in the other use cases
• Comprehensive test panels with multiplexing for animal health monitoring: an
animal can less easily communicate about his feelings to identify the disease
• Ease of use for direct use by farmers or pet owners
Economic requirements:
• For livestock, cost pressure is very high but the associated volumes are high as
well
• For pets and race horses, the sky is the limit: their owners are ready to pay very
high amounts for their animal’s health
Key players and products
Zoetis (Abaxis) VetScan (VS2, VSPro) and iSTAT v (in partnership with Abbott),
FluimediX NanoCycler, Fluxergy, Sanwa Biotech ALiA.
Several newcomers soon, including Zomedica (in partnership with Qorvo
Biotechnologies) and Boehringer Ingelheim Mobinostics.
Test types:
• Liver, renal, hepatic diseases, blood chemistry, somatic cells count, antibiotic
testing, infectious diseases
Market insights:
• Good potential for veterinary point-of-care: humans can easily and inexpensively
travel to a hospital to provide a sample that does not travel well, however taking
large animals such as cattle or race horses to a central lab is pricey and not easy.
• Regulatory requirements are lower than in human testing
Microfluidic value:
Automation of complex tests, speed of analysis, ease of use through automation,
miniaturization for portability
Microfluidic market data:
Veterinary 2019 2025 CAGR 2019-2025
$M
Microfluidic-based tests
Microfluidic devices
$171.0
$6.7
$439.6
$19.9
17.0%
20.0%
M units 10.7 24.6 14.8%
ASP
($)
Microfluidic-based tests
Microfluidic devices
$15.9
$0.6
$17.9
$0.8
1.9%
4.5%

2828
21%
18%
15%
11%
6%4%3%2%2%1%
1%
1%
1%
1%
1%
1%
0%
0%
0%
0%
10%
Overall 2019 revenue and market shares
Microfluidic-based point-of-need testing
MARKET SHARES
Detailed market shares, for the overall market and for each market segment
Others
Market value
$4,8B
in 2019

2929
Over the past few years we have also observed some failures. Though the reasons are sometimes unclear, it is
possible for some of them to assess what happened.
MARKET TRENDS
A chapter dedicated to in-depth analysis of success stories and failures, and companies to
watch in coming years
• Philips Minicare (Philips
Handheld Diagnostics) was
commercially launched in
2016. Less than two years
later, the division was
dropped (no official
communication, but
rumors state of lack of
performance and
reproducibility).
• The team relaunched as a
startup, Minicare B.V.
• Siemens acquired the
assets in 2019
• It is strange that Philips has
not tried to sell the
business, even for a few
million dollars.
• The Samsung LABGEO
product lines, launched a
few years ago, have been
discontinued at the end
2019. No official reason
was given
• We can imagine that
Samsung struggled to
penetrate a crowded
market and gain market
share, perhaps because of
lack of experience in the
IVD market.
• It is not clear what the
technology will become,
and what will be offered to
existing customers
• Had a great technology for
molecular diagnostic of
infectious diseases (several
FDA-approved panels) but
was burning too much
cash with too little
revenue (certainly due to
high COGS and insufficient
sales force).
• After several massive
dilutions of the stock, the
company filed for
bankruptcy.Its assets were
purchased byVela
Diagnostics, which
relaunched the platform
shortly thereafter.
• Micronics, part of Sony
Corporation, was
developing a molecular
diagnostics platform since
many years.
• It finally got its instrument
and a panel FDA-approved
in June 2018, but filed for
bankruptcy few months
later.
• Certainly it had run out of
cash and Sony was not
eager to put money in the
project anymore, after
years of development and
several competitors
already that entered the
market first.

30
Contact our
SalesTeam
for more
information
30
Contact our
SalesTeam
for more
information
Next Generation Sequencing & DNA
Synthesis:Technology, Consumables
Manufacturing and MarketTrends 2019
Organs-on-Chips Market &
Technology Landscape 2019
Status of the Microfluidics
Industry 2019
Cameras for Microscopy and
Next-Generation Sequencing
2019
YOLE GROUP RELATED REPORTS
Yole Développement

31About Yole Développement | www.yole.fr | ©2020
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