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45 rue Sainte Geneviève, F-69006 Lyon, France
Tel: +33 472 83 01 80 - Fax: +33 472 83 01 83
Web: http://www.yole.fr
September 2010
BIOMEMS 2010
Microsystems Devices Driving
Healthcare Applications
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Content of the report
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Content of the report
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BIOMEMS 2010 Copyrights © Yole Développement SA - All rights reserved.
Content of the report
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Content of the report
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Objectives of the Report
• The report is divided in 8 main sections: – The microsystem market for Healthcare applications
– BioMEMS Market Forecast in $M
– BioMEMS Market Forecast in M units
– Microsystem and BioMEMS applications in healthcare
– Current Microsystem & BioMEMS products
• Pressure sensors
• Silicon microphones
• Accelerometers
• Gyroscopes
• Optical MEMS and Image sensors
• Microfluidic chips
• Microdispensers for drug delivery
• Flow meters
• Infrared temperature sensors
• Emerging MEMS (RFID, Strain sensors, Energy Harvesting
– BioMEMS activities in China
– Regulation Aspects for medical device development
– Conclusions
• It enables you to: – Understand the Healthcare market and define your strategy to address it
– Get an overview of the technologies and the trends for the coming years
– Understand the real added value of Microsystems and Semiconductors to the healthcare industry
– Understand the main regulatory requirements (FDA, CE…)
Pressure sensors Blood pressure
Respiratory equipment
Kidney Dialysis
Silicon Microphones Hearing Aids
Accelerometers Accelerometer for pacemaker
Gyroscopes Human motion analysis
Optical MEMS and image sensors Microspectrometers
HMDs
Endoscopes
Camera pills
X-Ray imaging
Microfluidic chips Pharmaceutical and Life Science research
Clinical & veterinary diagnostics
Human POC
Environment and industrial testing
Analytical devices (HPLC, MS, Chromatography...)
Microdispensers Inhalers
Micropumps
Microneedles
Flow meter Flow meter for medical and Diagnostics
Temperature Sensors IR-Temperature sensors for medical Diagnostics
Emerging MEMS Energy Harvesting
Strain sensors
RF ID
Devices Applications
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What has Changed Since 2008
• In 2008, Yole published the BioMEMS 2008 report. In this issue, we added
to our analysis the following devices: − Flow meters
− Infrared temperature sensors
− Optical MEMS and image sensors
− And a category we named emerging MEMS, which includes Energy harvesting, RFiD and
strain sensors.
• The following applications have been dropped from our forecasts as these
revealed to be marginal: – Accelerometers for blood pressure measurement
– Gyroscopes for wheel chair stabilization
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What has Changed Since 2008
• The microfluidic device market has been validated against reported sales
data of approximately 150 players. We estimate that these players cover
95% of the total market. This resulted in some minor adjustments of the
forecasts.
• The segmentation of microfluidic devices was found to be confusing to
some in the last report. In order to simplify the data, we classified the
microfluidic and biosensor chips into 5 applications: − Clinical and veterinary diagnostics: Laboratory equipment for clinical and veterinary diagnostics
− Point of care diagnostics: Out of the lab diagnostic equipment, for near patient testing, intensive
care, doctor office.
− Pharmaceutical and life science research: Principally microfluidic devices for drug discovery,
screening
− Analytical devices: Microfluidic cartridges for Mass spectrometry, Chromatography and HPLC
sample preparation
− Industrial and environmental testing: Microfluidic-based tests for quality and process control,
water testing (pesticides, bacteria…). Also includes military and security applications.
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What has Changed Since 2008
• Microsystem devices and BioMEMS are applied in the pharmaceutical
research, the In-vitro diagnostics and the medical device sectors.
• We noticed a clear trend towards the development of technologies for
patient monitoring outside the hospital and consumer health.
• Although the “home care” market is a subsection of the medical market, we
choose to address this segment separately in this report as it is a high
growth market.
• This document only addresses the market of “Medical Home Care”, that we
define as “prescribed home care medical devices”. Consumer, over the
counter products, and sport/fitness equipment does not fall under the
scope of this analysis.
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Microsystems and BioMEMS in this report
• Medical Devices produced re-using
semiconductor manufacturing processes
• Microeletromechanical systems, or
MEMS, are integrated microdevices or
systems combining electrical and
mechanical components, fabricated
using integrated circuit compatible
batch –processing techniques, and
varying in size from micrometers to
millimeters. These systems merge
computation with sensing and
actuation.
MCNC 1996
• Bio-Medical Microstructured products
made out of Glass, silicon, polymer,
ceramic or metal
There are many definitions of Microsystems and BioMEMS
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Geographic distribution of the medical
device market (including IVD) - 2009
EU
Market s ize B$ 80,04
World Share 33%
Growth 5%
USA
Market s ize B$ 96,29
World Share 40%
Growth 4%
Japan
Market s ize B$ 20,66
World Share 9%
Growth 4%
China
Market s ize B$ 10,47
World Share 4%
Growth 14%
Russia
Market s ize B$ 5,19
World Share 2%
Growth 8%
Canada
Market s ize B$ 5,04
World Share 2%
Growth 8%
Brazil
Market s ize B$ 3,06
World Share 1%
Growth 7%
India
Market s ize B$ 3,02
World Share 1%
Growth 12%
China
India
Brazil
Canada
Europe
USA
Japan
Russia
Sources: EDM services, ESPICOM, OSEC, Medical device Network, Eucomed, Yole Développement
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Life sciences
The main markets considered
Pharmaceutical
R&D spending ~17 %
of annual turnover source PhRma
Medical Devices In Vitro Diagnostics
Environment
control
• water
monitoring,
• homeland
security,…
Agrofood
control
. process
control,
traceability,
…
Medical equipment
development and sales
$240B 2009
CAGR : 6%
BioMEMS contribution:
$360 M Source Yole estimation
R&D spending between
3 and 6 % of sales source Eucomed
Biological tests
development and sales
$53.5B 2009
CAGR 06 : ~9%
BioMEMS contribution:
$630 M Source Yole estimation
Drug discovery and
sales
$825B 2009
CAGR 06 : 7% Source IMS Health, VFA
BioMEMS contribution:
$200 M
Medical Home Care
Prescribed Medical
devices and services
for home care
~$50B 2009
CAGR : 9%
BioMEMS contribution:
$40 M Source Yole estimation
Wide range of products.
Excludes consumer health
and sport products
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Market Growth 2009-2015, by application domain, in $M
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
2009 2015
Mic
rosy
ste
m d
evi
ces
for
he
alth
care
ap
plic
atio
ns
ma
rke
t 2
00
9-2
01
5 in
$M
2009-2015 CAGR
Pharmaceutical and biological Research In Vitro Diagnostics Home Care Medical devices
32,5%
24,5%
18,6%
14,7%
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Wired125 Munits
45%
Wireless10 Munits
4%
Autonomous wireless139 Munits
51%
2009 Wired478 Munits
45%
Wireless17 Munits
2%
Autonomous wireless
567 Munits53%
2015
Evolution towards autonomous wireless
systems, in Munits
Total Market 274 Munits
Total Market 1062 Munits
Wireless systems represent more than 50% of the
MEMS and microsystem market in units. The
total market will increase by almost a factor four
from 2009 to 2015.
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Market trends
IVD Diagnostic
Home Care Medical
Respiratory Monitoring
Oxygen concentrators
Capnographs
Ventilator and anesthesia
Infusion devices
Surgery , imaging,
Camera pills
Cardiac Monitoring
Blood Monitoring
Kidney Dialysis
Hearing aids
Dispensing
Point of care
Pharmaceutical research
Industrial and environmental testing
Analytical devices
Activity Monitoring
Safety
Comfort
Patient monitoring
Trends in medical:
•Development of BioMEMS
lead to a technology shift
towards “home Care”
through miniaturization and
integration, from portable
to implantable
•Combination of diagnostic
via Bio Sensors and
treatment such as drug
delivery systems will lead
to improved patient
monitoring
Trends in Home Care:
•Home care consists today
mainly in monitoring of
some basic parameters,
such as temperature, blood
pressure, glucose, comfort
and activity.
•Development towards
portable technology will
lead to a transfer of post-
operation monitoring
towards home care
•Improvements of sensors
and bio-sensors will lead to
improved patient
monitoring and prevention
Trends in IVD:
•Major trend towards point
of care testing through
integration of disposable
biosensors in portable
devices
•Combination of
biosensors and dispensing
devices for theranostics
•Increase sensor density to
enable multiplexing and
screening
Blood-sugar level sensor
Insulin Pump
Catheter
ex: MiniMed Paradigm® REAL-Time Insulin
Pump and Continuous Glucose Monitoring
System
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Benchtop •Anesthesia
• ventilators
•medical monitoring
•...
Portable •IVD
•Point of care
•Infusion and drug delivery
•Respiratory monitoring
•...
Wearable •Glucose monitoring
•Kidney dialysis
•Theranostics
•Activity monitoring
•Patient monitoring
•Smart pills
•...
Implantable •Pacemakers
•Neurostimulators
•ECG
•Coclear implants
•...
Miniaturization roadmap M
inia
turi
za
tio
n a
nd
in
teg
rati
on
le
ve
l
Time
Mobility
Medical requirements Only for chronic diseases
and for medical safety reasons
Ease of use
Near Patient
Hospital and
Lab Care
Home Care
Point of care
Anywhere Care
Quality
of Life
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Overview of BioMEMS Players in China
Company Product Size Remark
SIMIT Microfluidics and Biochips
Large -640 employees in
SIMIT, including 345 R&D
staff,2 CAS members and
126 researchers
DICP Microfluidics and BiochipsLarge - 590 staffs including
76 professors
Shanghai BioChip Biochips and microfluidic analysis servicesLarge. Over 300 employees.
44% market share in
biochip service
Provide Services/Analysis based on
imported biochips
CapitalBioBiochips and microfluidic production and
analysis services
Large; over 500 employees;
turnover more than
14$million in 2009
own products & distributor Affymetrix,
Phadia, Biomérieux, Alpha innotech
15% of sales in EU and US
Shanghai HealthDigital Microarrays and lab-on-chip systemsLarge - 50 to 100
employees
United Gene Gene Chips, microarraysMedium - 20 to 50
employees
Shanghai YuLong BioTechProtein chips, Gene chips and Liquichip for
different disease detection
Medium - 20 to 50
employees
Expertise in R&D, production and sales
Shanghai BaiODevelopment and production of different
gene chips and their analyzer/platforms.
Medium - 20 to 50
employees
Shanxi ChaoYing Biotechnology Production of tissue microarrayMedium - 20 to 50
employees
85% of Chinese market share of tissue
microarray
Shanxi LifeGenBiochip microarray systems for clinical use
and life science researchLarge; 70 employees today
Tianjin BioChip Corp Genome Arrays Large; over 300 employeesOver 80 Chinese and international
patents
Potomac BiotechnologyGene chips, Protein chips, Potomac Biochip
Scanner System
Medium - 20 to 50
employees
Research, development, production,
sale and technical support
QINMING Medical PacemakersLarge - 50 to 100
employees
Golden Elephant of XinXiangblood pressure monitor
Stethoscope
Large, about 100
employees
YUYUE Medical Equipment Large panel of medical equipmentsLarge - 50 to 100
employees
medical equipment R&D
manufacturing and marketing
ZA Medical Devices Needle-free injector Small - 1 to 20 employees
Research
Biochips
Medical
devices
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