BIOMEMS Microsystems Devices Driving Healthcare Applications. September 2010

Transcription

1 BIOMEMS 2010 Microsystems Devices Driving Healthcare Applications September rue Sainte Geneviève, F Lyon, France Tel: Fax: Web:

2 Content of the report

3 Content of the report

4 Content of the report

5 Content of the report

6 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 Silicon Microphones Accelerometers Gyroscopes Optical MEMS and image sensors Microfluidic chips Microdispensers Devices Flow meter Temperature Sensors Emerging MEMS Applications Blood pressure Respiratory equipment Kidney Dialysis Hearing Aids Accelerometer for pacemaker Human motion analysis Microspectrometers HMDs Endoscopes Camera pills X-Ray imaging Pharmaceutical and Life Science research Clinical & veterinary diagnostics Human POC Environment and industrial testing Analytical devices (HPLC, MS, Chromatography...) Inhalers Micropumps Microneedles Flow meter for medical and Diagnostics IR-Temperature sensors for medical Diagnostics Energy Harvesting Strain sensors RF ID

7 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

8 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

9 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

10 Microsystems and BioMEMS in this report There are many definitions of Microsystems and BioMEMS 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

11 Geographic distribution of the medical device market (including IVD) EU Russia Canada Market size B$ 5,04 World Share 2% Growth 8% Market size B$ 80,04 World Share 33% Growth 5% Market size B$ 5,19 World Share 2% Growth 8% Russia Japan Market size B$ 20,66 World Share 9% Growth 4% Canada Europe Japan USA USA Market size B$ 96,29 World Share 40% Growth 4% Brazil Market size B$ 3,06 World Share 1% Growth 7% India China India Brazil Market size B$ 3,02 World Share 1% Growth 12% China Market size B$ 10,47 World Share 4% Growth 14% Sources: EDM services, ESPICOM, OSEC, Medical device Network, Eucomed, Yole Développement

12 The main markets considered Pharmaceutical In Vitro Diagnostics Life sciences Medical Devices Medical Home Care Drug discovery and sales Biological tests development and sales Medical equipment development and sales Prescribed Medical devices and services for home care $825B 2009 CAGR 06 : 7% Source IMS Health, VFA BioMEMS contribution: $200 M $53.5B 2009 CAGR 06 : ~9% BioMEMS contribution: $630 M Source Yole estimation $240B 2009 CAGR : 6% BioMEMS contribution: $360 M Source Yole estimation ~$50B 2009 CAGR : 9% BioMEMS contribution: $40 M Source Yole estimation R&D spending ~17 % of annual turnover source PhRma Agrofood control. process control, traceability, Environment control water monitoring, homeland security, R&D spending between 3 and 6 % of sales source Eucomed Wide range of products. Excludes consumer health and sport products

13 Microsystem devices for healthcare applications market in $M Market Growth , by application domain, in $M CAGR ,6% ,7% 24,5% ,5% Pharmaceutical and biological Research In Vitro Diagnostics Home Care Medical devices

14 Evolution towards autonomous wireless systems, in Munits 2015 Total Market 1062 Munits 2009 Total Market 274 Munits Wired 125 Munits 45% Autonomous wireless 567 Munits 53% Wired 478 Munits 45% Wireless 17 Munits 2% Autonomous wireless 139 Munits 51% Wireless 10 Munits 4% 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

15 Market trends Blood-sugar level sensor Catheter Insulin Pump ex: MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System Dispensing Pharmaceutical research Industrial and environmental testing Analytical devices IVD Diagnostic 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 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 Infusion devices Surgery, imaging, Camera pills Kidney Dialysis Medical Respiratory Monitoring Oxygen concentrators Capnographs Ventilator and anesthesia Point of care Blood Monitoring Cardiac Monitoring Hearing aids Safety Comfort Patient monitoring Home Care Activity 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 postoperation monitoring towards home care Improvements of sensors and bio-sensors will lead to improved patient monitoring and prevention

16 Miniaturization and integration level Miniaturization roadmap Anywhere Care Ease of use Near Patient Hospital and Lab Care Home Care Point of care Benchtop Mobility Portable Quality of Life IVD Point of care Infusion and drug delivery Respiratory monitoring... Medical requirements Only for chronic diseases and for medical safety reasons Wearable Glucose monitoring Kidney dialysis Theranostics Activity monitoring Patient monitoring Smart pills... Implantable Pacemakers Neurostimulators ECG Coclear implants... Anesthesia ventilators medical monitoring... Time

17 Overview of BioMEMS Players in China Research Biochips Medical devices Company Product Size Remark SIMIT DICP Shanghai BioChip CapitalBio Shanghai HealthDigital United Gene Shanghai YuLong BioTech Shanghai BaiO Shanxi ChaoYing Biotechnology Shanxi LifeGen Microfluidics and Biochips Microfluidics and Biochips Biochips and microfluidic analysis services Biochips and microfluidic production and analysis services Microarrays and lab-on-chip systems Gene Chips, microarrays Protein chips, Gene chips and Liquichip for different disease detection Development and production of different gene chips and their analyzer/platforms. Production of tissue microarray Biochip microarray systems for clinical use and life science research Large -640 employees in SIMIT, including 345 R&D staff,2 CAS members and 126 researchers Large staffs including 76 professors Large. Over 300 employees. Provide Services/Analysis based on 44% market share in imported biochips biochip service Large; over 500 employees; own products & distributor Affymetrix, turnover more than Phadia, Biomérieux, Alpha innotech 14$million in % of sales in EU and US Large - 50 to 100 employees Medium - 20 to 50 employees Medium - 20 to 50 Expertise in R&D, production and sales employees Medium - 20 to 50 employees Medium - 20 to 50 employees Large; 70 employees today 85% of Chinese market share of tissue microarray Over 80 Chinese and international Tianjin BioChip Corp Genome Arrays Large; over 300 employees patents Gene chips, Protein chips, Potomac Biochip Medium - 20 to 50 Research, development, production, Potomac Biotechnology Scanner System employees sale and technical support Large - 50 to 100 QINMING Medical Pacemakers employees blood pressure monitor Large, about 100 Golden Elephant of XinXiang Stethoscope employees Large - 50 to 100 medical equipment R&D YUYUE Medical Equipment Large panel of medical equipments employees manufacturing and marketing ZA Medical Devices Needle-free injector Small - 1 to 20 employees