BIOMEMS 2010 - · PDF file45 rue Sainte Geneviève, F-69006 Lyon, France Tel: +33 472...

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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BIOMEMS 2010 Copyrights © Yole Développement SA - All rights reserved.

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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• 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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• 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


World Share 40%

Growth 4%

Japan


World Share 9%

Growth 4%

China


World Share 4%

Growth 14%

Russia


World Share 2%

Growth 8%

Canada


World Share 2%

Growth 8%

Brazil


World Share 1%

Growth 7%

India


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%



Drug discovery and

sales

$825B 2009

CAGR 06 : 7% Source IMS Health, VFA


$200 M

Medical Home Care

Prescribed Medical

devices and services

for home care

~$50B 2009

CAGR : 9%



Wide range of products.

Excludes consumer health

and sport products

http://shop-in-morocco.com/store/images/categories/Medical.jpg

http://grandseminairejp2.tg/jp2/alia/pub/prince_pharma_comprimees.jpg

http://westburydiagnostics.com/wp-content/uploads/2008/10/test4.jpg

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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%

http://artfiles.art.com/5/p/LRG/8/881/HSYJ000Z/money.jpg

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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

http://www.discountmobilityusa.com/logo/invacare_xpo.jpg

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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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