Point-of-Need Testing: Application of Microfluidic Technologies - 2016 Report by Yole Developpement
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The report focuses on the application of microfluidic technologies for point-of-need testing, highlighting recent market data, trends, and technological advancements from 2014 onwards. It explores various segments including human, veterinary, and industrial diagnostics, providing insights into market drivers, regulatory frameworks, and reimbursement landscapes. Key players and their innovations are discussed, emphasizing the potential growth and opportunities within this sector through thorough market analysis and segmented forecasts.
Point-of-Need Testing: Application of Microfluidic Technologies - 2016 Report by Yole Developpement
- 1. From Technologies to Market Point-of-NeedTesting: Application of MicrofluidicTechnologies 2016 report Sample Sample © 2016
- 2. 2©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies Abaxis,Abbott Point of Care,Accriva Diagnostics,Achira,AgPlus Diagnostics,Akonni Biosystems,Alere (Abbott), Ativa Medical,Atlas Genetics,Atonomics, BD Diagnostics, BioCartis, Biodetection Instruments, Biofire (bioMérieux), BioSensia, Biosurfit, Carbo Analytics, Carclo Diagnostic Solutions, Cepheid, Coris BioConcept, Daktari Diagnostics, DNA electronics, Dolomite Microfluidics, Enigma Diagnostics, Etta Healthcare (OvaGene Oncology), Fast-track Diagnostics, F Cubed, FluimediX, Focus diagnostics (DiaSorin Group), Genalyte, GeneFluidics, GenePOC, Great Basin, HemoCue (Radiometer, Danaher), Ikerlan, INO, Instant Labs, Iquum (Roche), Lacrisciences, LeukoDx, Luminex, Medimate, Mesa Biotech, Micronics (Sony), Molbio Diagnostics Pvt. Ltd, Nanomix, Nanosphere, NetBio, OndaVia, OPKO Diagnostics, Oxford Nanopore, Pall Corporation, PathSensors, Patterson, Philips, POC Medical Systems, PositiveID, QuantuMDx, Radiometer (Danaher), Radisens Diagnostics, Rheonix, Roche, Samsung, Sandstone Diagnostics, Sanwa Biotech, Schlumberger, SMB (Zoetis), Sony DADC (Stratec), Spartan Bioscience, Sphere Medical, SpinChip Diagnostics AS, StableLab, STMicroelectronics,TearLab, Tecil, Ubiquitome,VistaTherapeutics,Wako Diagnostics… LIST OF COMPANIES MENTIONED IN THIS REPORT
- 3. 3©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies CONTENT OF THE REPORT The report provides: • An introduction to Point-of-Need testing, our definitions and why it is used • What can microfluidic technology bring to PoN testing? • What happened in the industry since 2014, what are the new trends? • What is the state of the art in each application?What are the characteristics for each of them and the related business models? • A revision of our PoN market segmentation with technical and economical requirements per segment, examples of products, key players and market forecasts • Market data 2015 and forecasts 2016-2021 • A focus on molecular diagnostics and assay multiplexing • A detailed chapter dealing with regulations and reimbursement for several applications (human diagnostics, veterinary diagnostics, agro-food).
- 4. 4©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies OBJECTIVES OF THE REPORT • This report provides a complete update of the market data and drivers, key technical, economic requirements and prospects of microfluidic technologies for Point of Need diagnostics • It provides an analysis of relation between the potential PON applications, the emerging technologies and the assets of microfluidics Applications •Market requirements •Market drivers •Health system drivers and constrains Technologies, Systems •System requirements •Sample injection, preparation •Volume of sample •Systems requirements (economic, technical) Microfluidics •Microfluidic Device •Detection technology •Fluid handling, mixing •Manufacturing and materials
- 5. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 5 WHO SHOULD BE INTERESTED IN THIS REPORT? o Diagnostics companies: • To have a broad overview of all Point-of-Need testing applications and markets • To identify new markets and the associated requirements • To monitor and benchmark potential competitors • To understand behavior evolution o Industrial & Services companies: • To understand what is the state of the art and which solutions could bring operational benefits o Financial & Strategic investors: • To understand the potential for Point-of-Need testing • To know the latest moves within the industry • To get a list of PoN players and their activities • To understand which are the sweet spots and the promising applications o R&D players: • To understand new challenges in PoN testing and microfluidics • To address the right market with the right technology o Microfluidic foundries and device makers: • To understand technical requirements depending on the applications • To identify business opportunities and prospects o Healthcare & Governmental organizations: • To evaluate benefits of using PoN testing • To identify relevant companies o Electronics, MEMS and optics companies: • To understand the challenges and requirements in microfluidics, biology and healthcare
- 6. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 6 TABLE OF CONTENTS 1/2 • Introduction • What happened since 2014? – Mergers and acquisition analysis – Collaborations – Fundraising – New products launched on the market – Statistical analysis (application covered, type of sample used…) • Market data and forecasts – Our definitions and Market segmentation – Point of need tests market data and forecast in volume – Point of need tests market data and forecast in value – Related Microfluidic device market for point of need testing in volume and value – Microfluidics contribution in the final selling price of a test – Microfluidic based PoN tests market growth per segments • Market segmentation – Methodology – Segments descriptions o S1: Emergency testing o S2:Third-world infections: remote areas testing o S3: Home tests, Doctor’s office screening, Decentralized hospital tests o S4: Genetic testing, companion diagnostics, forensics o S5:Veterinary testing o S6: Environmental and Industrial testing o S7:Agro-food testing • Focus on molecular diagnostics – Sample preparation challenges – Who’s the next PoC giant?
- 7. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 7 TABLE OF CONTENTS 2/2 • Assay menus and multiplexing – Which company is providing which assay menu? – Focus on cardiac biomarkers – High-plex vs. Low-plex • Regulatory & market access for Point-of-Care testing – Regulatory requirement per countries (USA, Europe, China) – Focus on the new IVD Directive arriving in Europe • Reimbursement landscape for Point-of-Care testing – Reimbursement landscape in USA – Reimbursement landscape in France, Germany, UK • Regulations for veterinary diagnostics • Regulations for agro-food industry • Supply Chain • Conclusions
- 8. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 8 REPORT METHODOLOGY Market forecast methodology Yole’s analysis
- 9. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 9 REPORT METHODOLOGY Technology analysis methodology Information collection
- 10. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 10 DEFINITION • This year, we decided to change the title of our report from « Point-of-Care » to « Point-of-Need ». Indeed, Point-of-Care refers to human testing whereas we discuss a much larger scope: • Human testing • Veterinary testing • Industrial testing (oil & gas, chemicals…) • Agro-food testing (dairy, food, beverage, crops…) • Environmental testing (water quality monitoring and bacteria detection…) • Forensics • … • What is Point-of-Need testing? Several criteria can be discussed: portability, out-of-the-lab, ease of use… • We define as Point-of-Need testing any diagnostic test performed out of reference laboratories: at home, at the patient’s bed, in ICUs (Intensive Care Units), at the physician’s office, near a production line, etc.
- 11. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 11 SCOPE OF THE REPORT • This report will focus on tests to be performed at the point of need (= decentralized testing), already commercialized or in development, based on microfluidic technology. • Microfluidic technology can be used both in the cartridge/chip and in the system reader. • Simple tests such as lateral flow analysis and tests done on strips (dedicated for Drugs of abuse tests, Fertility tests, Respiratory disease tests...) are not included in the scope of this report.
- 12. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 12 UPDATED MARKET SEGMENTATION We updated our market segmentation, accordingly with the market evolution, and explain which market segments are likely to appear in the next few years. For each segment, a detailed description is given along with the technical and economic requiremends, examples of products, market data and forecasts, examples of players…
- 13. 13 MARKET DATA AND FORECASTS ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies Market data and forecasts are provided and explained per segment and sub-segments, along with an analysis of the value chain (microfluidic device/reagents/margin…)
- 14. 14 MARKET SHARES PER PLAYER AND PER SEGMENT ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies Market share estimations are provided per segment
- 15. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 15 MARKET ANALYSIS Which are the recent strategic moves? How much money has been raised? What are the advantages and limits of the business models adopted by Point-of-Need players?
- 16. ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 16 TECHNOLOGY ANALYSIS What are the recent technology improvements?What are technology developers now focusing on? Are there major trends on the technical side?
- 17. 17 SUPPLY CHAIN ANALYSIS ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies Supply chain analysis is provided, along with examples of collaborations per segment
- 18. 18 REGULATORY, REIMBURSEMENT AND MARKET ACCESS LANDSCAPE ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies Deep investigation has been carried out concerning the regulations, market access and reimbursement landscape for several markets (medical, veterinary, agro-food) and geographic areas (Europe, USA, China)
- 19. 19 Biography & contact THE AUTHORS Sébastien Clerc Market &Technology Analyst MedicalTechnologies He is a Medical Technologies Analyst at Yole Développement, the “More than Moore” market research and strategy consulting company. After graduating from Grenoble INP with a Biomedical Technologies Master degree, he completed his training with a Master degree in Innovation and Technology Management, during which he oversaw strategy and marketing.. Contact: clerc@yole.fr Benjamin Roussel, PharmD Activity Leader MedicalTechnologies He is leading the MedTech activity (microfluidic and medical technologies) at Yole Développement, the “More than Moore” market research and strategy consulting company. He holds a pharmacy diploma from the University Claude Bernard Lyon, complemented by a master degree in Technology and Innovation Management from EM Lyon Business School. Contact: benjamin.roussel@yole.fr ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
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- 22. 21 EVERYYEAR,YOLE DÉVELOPPEMENT ATTENDS MAIN EVENTS. MEET WITH US AT*: • NEPCON Japan January 13-15, 2016 – Tokyo, Japan • CS International March 1-2, 2016 – Brussels, Belgium • Image Sensors March 15-17, 2016 – London, UK • International Conference and Exhibition on Device Packaging March 15-17, 2016 – Fountain Hills, USA • Lab-on-a-Chip European Congress March 15-16, 2016 – Madrid, Spain • APEC March 20-24, 2016 – Long Beach, USA • PCIM Europe May 10-12, 2016 – Nuremberg, Germany • ECTC May 31-June 3, 2016 – LasVegas, USA • Sensors Expo Conf June 21-23, 2016 – San José, USA • SEMICON West July 12-15, 2016 – San Francisco, USA • LED Professional Symposium – LpS September 20-23, 2016 – Bregenz,Austria • SEMICON Europa October 25-27, 2016 – Grenoble, France • SEMICON Japan December 14-16, 2016 – Tokyo, Japan *Non exhaustive list ©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
- 23. © 2016 Yole Développement FromTechnologies to Market
- 24. 23 MEMS Sensors LED Compound Semi. Imaging Photonics MedTech Manufacturing Advanced Packaging Batteries / Energy Management Power Electronics FIELDS OF EXPERTISE Yole Développement’s 30 analysts operate in the following areas
- 25. 24 4 BUSINESS MODELS o Consulting and Analysis • Market data research, marketing analysis • Technology analysis • Strategy consulting • Reverse engineering costing • Patent analysis www.yole.fr o Reports • Market Technology reports • Patent Investigation and patent infringement risk analysis • Teardowns Reverse Costing Analysis • Cost SimulationTool www.i-Micronews.com/reports o Financial services • MA (buying and selling) • Due diligence • Fundraising • Maturation of companies • IP portfolio management optimization www.yolefinance.com www.bmorpho.com o Media • i-Micronews.com website • @Micronews e-newsletter • Communication webcast services • Events www.i-Micronews.com
- 26. 25 A GROUP OF COMPANIES Market, technology and strategy consulting www.yole.fr MA operations Due diligences www.yolefinance.com Innovation and business maker www.bmorpho.com Manufacturing costs analysis Teardown and reverse engineering Cost simulation tools www.systemplus.fr IP analysis Patent assessment www.knowmade.fr
- 28. 27 RESEARCH PRODUCTS - CONTENT COMPARISON Custom analysis scope is defined with you to meet your information and budget needs Breadth of the analysis Depthoftheanalysis Custom Analysis Workshops Standard Reports
- 29. 28 SERVING THE ENTIRE SUPPLY CHAIN Our analysts provide market analysis, technology evaluation, and business plan along the entire supply chain Integrators and end-users Device makers Suppliers: material, equipment, OSAT, foundries… Financial investors, RD centers
- 30. 29 SERVING MULTIPLE INDUSTRIAL FIELDS We are working accross multiples industries to understand the impact of More-than- Moore technologies from device to system From A to Z… Transportation makers Mobile phone and consumer electronics Automotive Medical systems Industrial and defense Energy
- 31. 30 REPORTS COLLECTION o Yole Développement publishes a comprehensive collection of market technology reports and patent analysis in: • MEMS Sensors • Imaging • Medical technologies (MedTech) • Photonics • Advanced packaging • Manufacturing • Power electronics • Batteries and Energy management • Compound semiconductors • LED o Our reports are unmatched in quality and technology depth and typically include: • Technology trends and evolution: costs, barriers, roadmaps, etc. • Supply value chain analysis: business models, relationships, value flows, etc. • In-depth analysis of applications and market drivers: challenges, inflection points, etc. • Market data ($, units, wafer starts, etc.) • Patent investigation • Component and module reverse engineering and costing analysis o Every year, Yole Développement, System Plus Consulting and Knowmade publish +70 reports. o Take the full benefit from our Bundle and Annual Subscription offers. www.i-Micronews.com
- 32. 31 OUR 2016 REPORTS PLANNING (1/2) MARKET ANDTECHNOLOGY REPORTS byYole Développement o MEMS SENSORS − Gas Sensor Technology and Market 2016 − Status of the MEMS Industry 2016* − Sensors for Cellphones and Tablets 2016 − Market and Technology Trends of Inkjet Printheads: Towards New Printing Opportunities 2016… − Sensors for Biometry and Recognition 2016 − Finger Print Sensors Market and Technologies 2016 − 3D Imaging Sensing 2016** − Silicon Photonics 2016 − Emerging Non Volatile Memories 2016* o IMAGING OPTOELECTRONICS − Sensors for Drones and Robots: Market Opportunities and Technology Revolution 2016 − Status of the CMOS Image Sensor Industry 2016* − Uncooled Infrared Imaging Technology Market Trends 2016* − Imaging Technologies for Automotive 2016 − 3D Imaging Sensing 2016** − Silicon Photonics 2016 o MEDTECH − BioMEMS: Microsystems for Healthcare Applications 2016 − Point of Need Testing 2016: Application of Microfluidic Technologies o ADVANCED PACKAGING − FanOut WLP: Technology Trends and Business Update 2016* − Embedded Die Packaging: Technology and Markets Trends 2016* − 2.5D 3D IC Business Update 2016 − Status of the Advanced Packaging Industry 2016* − Advanced Packaging in Emerging Markets: China 2016 o MANUFACTURING − Inspection and Metrology Technology and Applications Trends in Advanced Packaging 2016** − Equipment and Materials for Fan Out Technology (Wafer vs Panel) − Equipment and Materials for Advanced Substrates − Equipment and Materials for 3D T(X)V Technology − Thinning Dicing Equipment for Advanced Packaging, MEMS, Photovoltaics, LED, CMOS 2016 **To be confirmed
- 33. 32 OUR 2016 REPORTS PLANNING (2/2) o COMPOUND SEMICONDUCTORS − GaN RF Devices Market: Applications, Players, Technology, and Substrates 2016 – 2022 − SiC Modules, Devices and Substrates for Power Electronics 2016* − GaN Modules, Devices and Substrates for Power Electronics 2016* − Sapphire Applications Market 2016: from LED to Consumer Electronics* o LED − Automotive Lighting: Technology, Industry, and Market Trends 2016 − OLED for Lighting - Technology, Industry and Market Trends 2016 − Sapphire Applications and Market 2016: From LED to Consumer Electronics* − LED Packaging 2016 − Microdisplays and MicroLEDs − UV LED Technology, Manufacturing and Applications Trends 2016* o POWER ELECTRONICS − Power Electronics for EV/HEV 2016: Market, Innovations and Trends − GaN RF Devices Market: Applications, Players, Technology, and Substrates 2016 – 2022 − Opportunities for Power Electronics in Renewable Electricity Generation 2016 − Status of Power Electronics Industry 2016* − Passive Components Technologies and Market Trends for Power Electronics 2016 − SiC Modules, Devices and Substrates for Power Electronics 2016* − GaN Modules, Devices and Substrates for Power Electronics 2016* − Inverter Technologies Trends Market Expectations 2016 − Thermal Management for LED and Power 2016 o BATTERY − Market Trends and Technologies in Battery Pack and Assembly 2016 − Innovative and Emerging Technologies in Energy Storage Market 2016 **To be confirmed PATENT ANALYSIS by Knowmade o Patent Infringement (crossed analysis based on Knowmade and System Plus Analysis expertise) o Patent Investigation (crossed analysis based on Knowmade Yole Développement expertise) o Patent Landscape TEARDOWN REVERSE COSTING by System Plus Consulting More than 30 teardowns and reverse costing analysis and cost simulation tools to be published in 2016.
- 34. 33 OUR 2015 PUBLISHED REPORTS LIST o MEMS SENSORS − Sensors and Data Management for Autonomous Vehicles − Sensors for Wearable Electronics And Mobile Healthcare − Status of the MEMS Industry − Uncooled Infrared Imaging Technology Market Trends − Infrared Detector Technology Market Trends − High-End Gyroscopes, Accelerometers and IMUs for Defense, Aerospace Industrial − Emerging Non Volatile Memory (NVM) Technology Market Trends o IMAGING OPTOELECTRONICS − Camera Module Industry − Uncooled Infrared Imaging Technology Market Trends − Status of the CMOS Image Sensors − Infrared Detector Technology Market Trends o MEDTECH − Sample Preparation Automation Through Emerging Microfluidic Technologies − 2015 Microfluidic Applications in the Pharmaceutical, Life Sciences, In-Vitro Diagnostic, and Medical Device Markets − Sensors for Wearable Electronics And Mobile Healthcare o COMPOUND SEMICONDUCTORS − Sapphire Applications Market 2015: from LED to Consumer Electronics − SiC, GaN, and other Wide Band Gap (WBG) materials for power electronics applications − GaN and SiC Devices for Power Electronics Applications o LED − LED Lighting Module Technology, Industry and Market Trends 2015 − UV LED - Technology, Manufacturing and Application Trends − Phosphors Quantum Dots 2015: LED Downconverters for Lighting Displays − Sapphire Applications Market 2015: from LED to Consumer Electronics o POWER ELECTRONICS − Power Packaging Technology Trends and Market Expectations − Energy Management for Smart Grid, Cities and Buildings: Opportunities for Battery Electricity Storage Solutions − Status of Chinese Power Electronics Industry − New Technologies and Architectures for Efficient Data Center − IGBT Market and Technology Trends − Status of Power Electronics Industry − SiC, GaN, and other Wide Band Gap (WBG) materials for power electronics applications − GaN and SiC Devices for Power Electronics Applications o ADVANCED PACKAGING − Status of the Advanced Packaging Industry − Supply Chain Readiness for Panel Manufacturing in Packaging − Fan-in Wafer Level Packaging: Market and Technology Trends − Flip Chip: Technologies and Markets Trends − Fan-Out and Embedded Die: Technologies Market Trends o MANUFACTURING − Photolithography Equipment and Materials for Advanced Packaging, MEMS and LED Applications − Emerging Non Volatile Memory (NVM) Technology Market Trends
- 35. 34 MICRONEWS MEDIA o About Micronews Media Micronews Media, powered by Yole Développement, ensures you the best visibility in the disruptive semiconductor community. With our services, we help you to reach your customers worldwide with the media products they prefer, including our website, e-newsletter, webcasts, and magazines. Invest in a high added- value editorial program and get access to Yole Développement’s network (48 000+ contacts). o Four supports and channels for your visibility • A webcast to highlight your expertise and develop your business identifying commercial leads • Articles, advertisements logo and banners dedicated to your company, its products and expertise in @Micronews e- newsletter and on i-Micronews.com Focused community Identified contacts Large community Mass contacts
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- 37. 36 CONTACT INFORMATION Follow us on • Consulting and Specific Analysis • North America: Steve LaFerriere, Director of Northern America Business Development Email: laferriere@yole.fr • Japan Asia:Takashi Onozawa, Representative Director,Yole KK Email: onozawa@yole.fr • RoW: Jean-Christophe Eloy, CEO President,Yole Développement Email eloy@yole.fr • Report business • North America: Steve LaFerriere, Director of Northern America Business Development Email: laferriere@yole.fr • Europe: Lizzie Levenez, EMEA Business Development Manager Email: levenez@yole.fr • Japan Asia:Takashi Onozawa, Representative Director,Yole KK. Email: onozawa@yole.fr • Greater China: Mavis Wang, Business Development Director Email: wang@yole.fr • Financial services • Jean-Christophe Eloy, CEO President Email: eloy@yole.fr • General • Email: info@yole.fr