Emerging Markets for Microfluidic Applications in Life Sciences and In-Vitro Diagnostics

Micromachine Summit 29 April 2010

© 2010

Content
– Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions
STmicroelectronics In-Check lab-on-chip

Fluidigm (US) - TOPAZ™ Screening Chips

TOPAZ™ Screening Chips .Content – Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions STmicroelectronics In-Check lab-on-chip Fluidigm (US) .

• Our fields of competence include: • MEMS • Microfluidics • Compound Semiconductor (SiC. SoC.500 interviews annually • We have a global customer base and a global view. AlN. TSV. • 20 full time analysts with technical and marketing degrees • Primary research includes over 2. GaN. France. . ZnO) LED & HB LED.Yole Développement • Yole Développement is a market research and strategy consulting company. WLP) Nanomaterials • Our market research is performed by in-house personnel conducting open-ended discussion based interviews. founded in 1998 with headquarters in Lyon. RF devices • • • • Power electronics Photovoltaic Advanced Packaging (3D IC.

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TOPAZ™ Screening Chips .Content – Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions STmicroelectronics In-Check lab-on-chip Fluidigm (US) .

… R&D spending between 3 and 8 % of sales source Eucomed .5 Billion USD 2008 CAGR 06-08: ~14% Microfluidic contribution: $563 M Source Yole estimation Medical devices Medical equipment development and sales 336 Billion USD 2008 CAGR: 6% Source MX: Business Strategies for Medical Technology Executives Microfluidic contribution: $160 M Microfluidic contribution: $120 M Source Yole estimation R&D spending around (17 %) of annual turnover source PhRma Agrofood control . process control. traceability.… Environment control . water monitoring. VFA In vitro diagnostic (IVD) Biological tests development and sales 45. homeland security.8% Source IMS Health.Markets Considered Life sciences Pharmaceutical & Biotech industry Drug discovery and sales 773 Billion USD 2008 CAGR 08: 4.

Geographic Market Distribution Geographic distribution of the medical and diagnostic market in 2009 – source Eucomed Canada 2% Europe 33% China 2% Japan 11% US 45% Bresil 1% India 1% Australia 1% .

7% 17.16 US 2.792 net sales 2006 7.93 1.8% 13. medical devices and pharmaceuticals is dominated by the US and European industry.72 US 4.Market Distribution The market of in-vitro diagnostics.32 D 4.697 change % 13.564 US 0.84 1.7% 12. The top 10 diagnostic companies share approximately 80% of the diagnostic market. rank 1 2 3 4 5 6 7 8 9 10 company Roche S iemens Medical * Johnson & Johnson Abbott Beckman Coulter BD BioMerieux BioRad S ysmex corp Unknown top 10 IVD companies by sales in $ billion country net sales 2007 CH 8.1 US 3.8% 7.0% • • All data related to exchange rate at the end of exercise date *E stimation Y Developpement ole .1% 10.48 3.1% 10.163 US 1.17 0.755 1. The diagnostic market is very concentrated.6849 0.8% 89.562 2.365 0.905 France 1.9% 12.832 Japan 0.

microneedles) Industrial and environmental MicrofluidicDevicesmarket in M$ 2500. micropumps.00 2000.00 CAGR 16% 2005 – 2011 CAGR 16% Drug delivery (inhalers.00 clinical & veterinary diagnostics 500.Microfluidic Component Market Value and forecast Market in $M MicrofluidicDevices market in M$ 3500.00 Analytical devices 1500.00 3000.00 Pharmaceutical and life science research Point of Care diagnostics 1000.00 0.00 2006 2007 2008 2009 2010 2011 2012 2013 2014 The microfluidic device market will exceed $3 Billion in 2014 .

.Compound Annual Growth Rates 2006-2008 and 2009-2014 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% clinical & veterinary diagnostics 13% 19% Point of Care diagnostics 35% 39% Pharmaceutical and life science research 26% 33% Analytical devices 17% 14% Industrial and environmental 27% 27% Drug delivery 38% 22% Total microfluidic market 22% 26% CAGR2006-2008 CAGR2009-2014 The largest growth is expected in the Point of Care diagnostics field. This is particularly true for the technologies enabling multiplexing. Pharmaceutical research applications will see significant growth as well.

Content – Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions STmicroelectronics In-Check lab-on-chip Fluidigm (US) .TOPAZ™ Screening Chips .

Philips Magnotec • Philips Handheld Immunoassays focuses on developing innovative solutions for point-of-care testing. • . Philips has established the Handheld Immunoassays business venture to develop novel handheld diagnostic testing solutions based on the Magnotech technology.

PCR amplification and detection. The chip costs approximately $160. thermal. Temperature Control System – – – Compact Optical Reader . An independent Temperature Control System (TCS) that manages up to five different In-Check chip tests and protocols simultaneously.STMicroelectronics In-Check platform • • Commercialized product through Veredus and Mobidiag An integrated system to perform sample preparation. This easy-to-use automatic instrument is particularly suited for non trained personnel and point-of-care applications. An independent compact optical reader to detect and analyze the microarray in a few seconds. a miniaturized PCR reactor and a custom microarray. comprising: – In-Check lab-on-chip consumables = silicon chips that integrate all the functions needed to identify given oligonucleotide sequences in a sample. electrical and fluidic connections. The chip is mounted on a 1” x 3” plastic slide that provides the necessary mechanical. and can include 10 targets. including microfluidic handling.

Integration of sample preparation. separation and optical detection at the micro scale using mass production semiconductor MEMS. . DNA amplification. .DALSA Semiconducteur BioMEMS A highly miniaturized DNA identification equipment for inexpensive point-of-care diagnostics. DALSA has developed an integrated Point-of-care device that fits on a USB stick. • To demonstrate its capabilities. HV. CMOS and IMAGING technologies is the key to drive the costs down by several orders of magnitude. and provide accessible healthcare applications.

Chemicals are then used to break the cell-walls and copy and label the DNA. of a pathogen. .Siemens Medical Solutions Quicklab Siemens Medical Solutions (development taken over from Infineon .May 2005) Quicklab® silicon lab-on-chip is a molecular diagnostic system to perform quick tests in clinical routine diagnostics. was in the blood. and enzymes ensure that an electric signal is triggered. The aim is that this purely electrical identification process will be performed so economically that it will only come to a fraction of the cost of an analysis in a laboratory. Bio-molecules capture the target sequences of DNA. •When a drop of blood is placed on the card. capillary forces draw a microliter of it into a channel and various chambers. This signal is the indicator that the gene of interest. e.g. The entire analysis system is integrated on a smart card and provides the basis for comprehensive as well as cost-effective analysis method.

•It is therefore crucial for technology providers to set-up partnership with the key players in the development phase. .Semicon Industry Needs Partnership •Many Players from the Semicon industry try to enter the diagnostic and Point-of-Care market •However. access to the market has to be done through diagnostic companies.

Content – Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions STmicroelectronics In-Check lab-on-chip Fluidigm (US) .TOPAZ™ Screening Chips .

Microfluidic Prototyping and Production .

In general.9 59.9 44.8 97.6 8.4 4.4 20.5 9. polymer is preferred for disposable devices due to its low cost.5 0.0 autres S i Glass Polymer • • The choice of material depends on the application.1 3.3 19.2 8.1 Analytical devices (MS GC.Materials by Application Microfluidicdevices market.5 107.0 26. in M$ Material breakdown 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Market share Clinical and veterinary diagnostics 3.3 Pharmaceutical research 2.4 8.7 219. which are manufactured in Silicon .2 156. HPLC) .6 208.0 Point of care devices 0.2 41.6 Drug Delivery 1.8 Total microfluidic device market 8. 0.7 364.3 98.3 Industrial & environment applications 0. The drug delivery market is dominated by the Inhaler from Boehringer Ingelheim and the insuline micropumps.6 78.

The figures presented have not been validated by Caliper. dicing 6% Yield Losses 4% Labor Cost 24% • Cost Breakdown for 500 000 units/ year Depreciation Cost 3% Packaging and QC 17% Manufacturing Cost 10% • Raw Wafer Cost 36% • Chip unit price as a function of the production volume $10 000.10 10 100 1000 10000 100000 1000000 10000000 .00 $1 000. exact data may differ from reality. material choice and production location.Case Study Cost analysis Caliper Labchip The production costs have been estimated using our reverse costing model.00 Polymer $1. This model simulates the different process steps and the associated costs. Therefore.00 $100. as we do not possess all the necessary information. yield… However. such as depreciation of the equipment.00 $0.00 Glass $10. it is a very powerful tool to analyze trends such as the effect of production volume. The model provides an order of magnitude of the manufacturing costs.

10 to $10 Diagnostic company add value related to biology (application knowledge. The added value of design and manufacturing of a microfluidic based device brings the price of a device to the order of $0.00 $150. the cost paid by the patient can reach up to $300 for molecular biology tests.Cost Breakdown Patient test Laboratory costs.00 $200. reagents) and take care of marketing and distribution. marketing.00 $100. distribution.00 Market value • • • • Material costs are a very small fraction of the final cost of an IVD test. manpower. .00 $300. principally due to manpower of highly qualified laboratory staff. margin… Diagnostic device Biology. margin Maretials $- $50.00 $350. The price per test becomes in the order of $30 to $100 At the end. margin Microfluidic Device Design.00 $250. IP. Manufacturing.

Content – Presentation Yole Development – Market of microfluidic devices – Examples – Value chain – Conclusions STmicroelectronics In-Check lab-on-chip Fluidigm (US) .TOPAZ™ Screening Chips .

The Point of care market did not really take-off yet. However. these technologies have been acquired by major players.Conclusions Many things happened over the last 3 years: A large number of companies have been created and/or raised funds. Some technologies entered the market successfully. Although some technologies have been already acquired by major players. Research applications show high growth rates. In many cases. it is expected to grow considerably in the coming years • • • • • . One particular aspect is the need for technologies allowing multiplexing and simplifying High Throughput Screening (HTS). However. and a large number of microfluidic based technologies have been developed. this domain is very segmented in terms of requirements and technologies. it will still require some time for microfluidic technologies to become common diagnostic products.

In fact. the complex reality of marketing to medical infrastructure probably means any diagnostics technology supplier will have to partner with one of the top ten medical diagnostics players. figuring it’s well worth paying a higher price for 100% assurance of success. • • • • • . so close and effective partnerships between very different companies are required. Now they prefer acquire technology supplying companies. Preferably these partnerships will have to be formed before development proceeds too far.Conclusions Point of care diagnostics suppliers need both microfluidics technology and medical expertise. however. but it’s a problematic model for big semiconductor companies developing these technologies. those key medical companies do not want to take any risks on new technology. Unfortunately. so development work focuses on users’ practical needs early on. It provides an efficient exit strategy for biotechnology startups.

Conclusions • They may have a hard time interesting these risk-adverse giant medical companies in partnerships. and will have then to propose extremely innovative solutions precisely fitting with the market needs. but the understanding the biology remains the main success factor • The launching of a device in the LS field and especially the medical or diagnostic field is time consuming. . • Be aware of the big market risk – the diagnostic field is represented by many different segments with their own requirements and expectations from an economic and technological point of view. • The high technology level is important.

F-69006 Lyon.fr 45 rue Sainte Geneviève.i-micronews. Or get one of our market reports ! EMMA 2009 Emerging Markets for Microfluidic Applications in Life Sciences and In-Vitro Diagnostics POC 2010 Point of Care Testing : Applications of Microfluidic Technologies Overview of the technical & economic requirements for POC applications July 2009 March 2010 45 rue Sainte Geneviève.yole.Fax : +33 472 83 01 83 Web: http://www.fr Subscribe to our newsletters online. France Tel : +33 472 83 01 80 .yole.For More Information … Visit our websites www. France Tel: +33 472 83 01 80 .Fax: +33 472 83 01 83 Web: http://www.fr . F-69006 Lyon.com www.yole.

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