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Table of Contents vi © Espicom Business Intelligence © 2012 UBM Semiconductor Insights Diabetes Landscape: OrSense’s NBM-200G Non-Invasive Blood Glucose Meter ........................................................................................................... 108 St Louis Medical Devices Near-Infrared Light-Based System ....................................................................................................... 109 Smart Tattoos ........................................................................................................................................................................................ 109 2.3.7 Tear Fluid Glucose Sensors .......................................................................................................................................110 Mayo Clinic, Arizona State University and BioAccel ........................................................................................................................110 University of Washington and Microsoft Research ........................................................................................................................111 The University of Western Ontario’s Glucose Monitoring Contact Lenses .................................................................................111 2.3.8 Breath-Based Glucose Monitoring .........................................................................................................................112 PositiveID’s EasyChek ...........................................................................................................................................................................112 Xhale’s Breath-Based Glucose Monitor .............................................................................................................................................112 Brown University and Saliva-Based Glucose Testing .....................................................................................................................112 3.0 INSULIN DELIVERY PRODUCTS ...............................................................................................................114 3.1 ADDRESSABLE PATIENT POPULATION ...............................................................................................................................116 Fig.3.1: Percentage of US Diabetes Patients by Treatment Type, 2007-2009 ............................................................................................................................................. 116 3.2 MARKET TRENDS ...................................................................................................................................................................117 Insulin Delivery Market by Product Type 2005-2011 (US$ million) .............................................................................................................................................................117 Fig.3.2: Global Insulin Delivery Market, 2005-2011 (US$ billion) ...............................................................................................................................................................117 Fig.3.3: Global Insulin Delivery Market Growth Rates, 2006-2011 (%) ..................................................................................................................................................... 118 Fig.3.4: Percentage of Insulin Delivery Market by Product Type, 2011 ....................................................................................................................................................... 118 Fig.3.5: Insulin Delivery Market by Geographic Region, 2011 .................................................................................................................................................................... 119 3.2.1 Competitive Environment ........................................................................................................................................120 Key Companies’ Insulin Delivery Sales, 2006-2011 (US$ million) .............................................................................................................................................................. 120 Fig.3.6: Insulin Delivery Market Share by Company, 2011 ......................................................................................................................................................................... 120 3.3 FUTURE MARKET PROSPECTS ............................................................................................................................................ 121 Summary: Insulin Delivery Market Growth Drivers, Restraints & Opportunities ...................................................................................................................................... 121 Insulin Delivery Market Forecast by Product Type 2011-2017E (US$ million) ............................................................................................................................................. 122 Fig.3.7: Global Insulin Delivery Market Forecast, 2011-2017 (US$ billion) ................................................................................................................................................. 122 Fig.3.8: Global Insulin Delivery Market Estimated Growth Rates, 2012-2017 (%) .................................................................................................................................... 122 Fig.3.9: Estimated Insulin Delivery Market by Product Type, 2017 ............................................................................................................................................................. 123 3.4 MANUAL INSULIN INJECTION PRODUCTS ........................................................................................................................ 124 Fig.3.10: Manual Insulin Delivery Method by Product Type, 2011 ............................................................................................................................................................. 124 Fig.3.11: Percentage of Novo Nordisk Insulin Sold in Pens by Region, 2011 ............................................................................................................................................... 125 Fig.3.12: Manual Insulin Delivery Market by Geographic Region, 2011 ..................................................................................................................................................... 125 3.4.1 Insulin Pens ................................................................................................................................................................126 Fig.3.13: Example Insulin Pen: Novo Nordisk’s NovoPen 4 ......................................................................................................................................................................... 126 Fig.3.14: Global Insulin Pen Market: Disposable vs Reusable Pens, 2011 ................................................................................................................................................... 126 Competitive Environment ..................................................................................................................................................................127 Fig.3.15: Insulin Pen Use by Manufacturer, 2011 ........................................................................................................................................................................................ 127 Currently-Available Products ............................................................................................................................................................. 128 3.4.2 Needles and Syringes ................................................................................................................................................130 Fig.3.16: Insulin Needles & Syringes Market by Manufacturer, 2011 ......................................................................................................................................................... 131 Pen Needles ............................................................................................................................................................................................131 3.5 INSULIN PUMPS .................................................................................................................................................................... 133 Fig.3.17: Example Insulin Pump: Medtronic’s MiniMed Paradigm REAL-Time Revel ................................................................................................................................ 133 Fig.3.18: Example Insulin Pump: Roche’s Accu-Check Spirit ...................................................................................................................................................................... 133 Insulin Pump Market: Growth Drivers, Restraints & Opportunities ........................................................................................................................................................... 134 3.5.1 The TD1 Exchange: User Experiences of CGM .........................................................................................................135 3.5.2 Current Market Trends .............................................................................................................................................136 Fig.3.19: Global Insulin Pump Market, 2005-2011 (US$ million) .............................................................................................................................................................. 136 Fig.3.20: Global Insulin Pump Market Growth Rates, 2006-2011 (%) ...................................................................................................................................................... 136 Fig.3.21: Insulin Pump Market by Product, 2011 ........................................................................................................................................................................................ 137 Regional Perspective ............................................................................................................................................................................137 Fig.3.22: Insulin Pump Market by Region, 2011 ......................................................................................................................................................................................... 137 Fig.3.23: Insulin Pump Adoption Rates for Type 1 Diabetes Patients by Key Country, 2010 (%) ............................................................................................................... 138 May 2012
Diabetes Landscape: May 2012 © Espicom Business Intelligence © 2012 UBM Semiconductor Insights Table of Contents Regulatory Environment - FDA Infusion Pump Improvement Initiative ................................................................................... 139 Negative Publicity and the Potential for Cyber Attacks ................................................................................................................ 140 Market Outlook ......................................................................................................................................................................................141 Fig.3.24: Global Insulin Pump Market Forecast, 2011-2017 (US$ million) ................................................................................................................................................. 141 Fig.3.25: Global Insulin Pump Market Estimated Growth Rates, 2012-2017 (%) ..................................................................................................................................... 141 3.5.3 Competitive Environment ........................................................................................................................................142 Key Companies’ Insulin Pump Sales, 2005-2011 (US$ million) .................................................................................................................................................................. 142 Fig.3.26: Insulin Pump Market Shares, 2011 .............................................................................................................................................................................................. 143 3.5.4 Currently-Available Insulin Pumps .........................................................................................................................143 Animas Insulin Pumps ......................................................................................................................................................................... 143 Asante Solutions’ Pearl Insulin Pump ............................................................................................................................................... 144 D Medical Industries’ Spring Pumps and Infusion Sets ................................................................................................................. 144 Medtronic’s MiniMed Paradigm Revel Insulin Pump and Infusion Sets .................................................................................... 145 Sooil Development’s Diabecare Insulin Pumps .............................................................................................................................. 146 Roche Insulin Pumps ........................................................................................................................................................................... 146 Tandem Diabetes Care’s t:slim Insulin Delivery System .................................................................................................................147 Insulin Delivery Patch Pumps .............................................................................................................................................................147 3.5.5 Products in Development .........................................................................................................................................150 Becton Dickinson-JDRF Micro-Needle Technology ...................................................................................................................... 150 CeQur’s Insulin Patch Infuser ............................................................................................................................................................. 150 D Medical Industries’ Spring Hybrid Patch Pump .......................................................................................................................... 150 Debiotech’s JewelPUMP .......................................................................................................................................................................151 Insulet’s Second-Generation OmniPod ............................................................................................................................................151 Insuline Medical’s InsuPatch and InsuPad ........................................................................................................................................151 Roche’s SOLO Micropump .................................................................................................................................................................. 152 3.6 ALTERNATIVE INSULIN DELIVERY DEVICES....................................................................................................................... 153 3.6.1 Generex Biotechnology’s Oral-lyn ...........................................................................................................................153 3.6.2 Insulin Inhalers ..........................................................................................................................................................154 Development Considerations ............................................................................................................................................................ 154 Fig.3.27: MannKind’s Dreamboat (Gen2) Insulin Inhaler .......................................................................................................................................................................... 155 4.0 COMBINED CGM-INSULIN PUMP SYSTEMS ...........................................................................................157 4.1 CURRENTLY-AVAILABLE PRODUCTS ................................................................................................................................. 158 4.1.1 Medtronic’s Paradigm Integrated Diabetes Management Products ....................................................................158 Paradigm REAL-Time Revel ................................................................................................................................................................ 158 Fig.4.1: MiniMed Paradigm REAL-Time System .......................................................................................................................................................................................... 158 Enlite CGM Sensor ................................................................................................................................................................................ 159 Clinical Trials .......................................................................................................................................................................................... 159 ONSET Study ......................................................................................................................................................................................... 160 REAL Trend Study ................................................................................................................................................................................. 160 4.1.2 Animas Vibe ...............................................................................................................................................................161 4.2 PRODUCTS IN DEVELOPMENT ............................................................................................................................................ 162 4.2.1 D Medical Industries’ Combined CGM-Pump System ............................................................................................162 5.0 ARTIFICIAL PANCREAS TECHNOLOGY .................................................................................................. 163 5.1 SEMI-CLOSED LOOP SYSTEMS ............................................................................................................................................ 165 5.1.2 Medtronic’s Paradigm Veo System with Low Glucose Suspend ............................................................................165 Fig.5.1: Medtronic’s Paradigm Veo System with Low Glucose Suspend ..................................................................................................................................................... 165 ASPIRE Study ........................................................................................................................................................................................ 166 5.2 RESEARCH & DEVELOPEMNT ............................................................................................................................................. 167 5.2.1 FDA Artificial Pancreas Development Guidelines ..................................................................................................167 5.2.2 Key Closed-Loop Development Projects .................................................................................................................168 The Juvenile Diabetes Research Foundation’s Artificial Pancreas Project ............................................................................... 168 Mayo Clinic ............................................................................................................................................................................................ 172 UC Santa Barbara, Sansum Diabetes Research Institute, Mayo Clinic, Universities of Virginia & Padova 172 AP@home Project ................................................................................................................................................................................. 172 vii
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