DIABETES LANDSCAPE Market, Technology and Intellectual Property

Transcription

1 DIABETES LANDSCAPE Market, Technology and Intellectual Property A Joint Research Report from Espicom and UBM TechInsights.

2 This report is the result of a collaborative venture between UBM TechInsights and Espicom Business Intelligence, each party bringing its own skills and knowledge to provide an unmatched analysis. UBM TechInsights UBM TechInsights is the leading provider of sophisticated information and advice to technology firms. Companies in need of technical analysis and IP management consulting rely on our deep expertise in the underlying technologies used in today s medical devices. For further information: Espicom Business Intelligence Espicom is a highly-regarded and established independent provider of business intelligence services for the global medtech industries. Based in the UK and with over 30 years of continuous research and editorial experience in the global health industry, Espicom is one of the longest established, independent business intelligence providers operating today. Espicom produces original analysis, news and forecasts using its skilled and experienced team of full-time in-house analysts, researchers and editorial experts. Over 50,000 users in more than 50 countries worldwide rely on Espicom s essential market data. For further information: Diabetes Landscape: Market, Technology and Intellectual Property Copyright 2012 Espicom Business Intelligence 2012, UBM Semiconductor Insights All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher. Every care has been taken to ensure that the information contained in this report is correct. The publisher accepts no liability for decisions made on the basis of information contained herein. ii

3 Diabetes Landscape: Table of Contents CONTENTS EXECUTIVE SUMMARY Volume I... 1 Current Technologies... 2 Geographic Trends... 2 Volume II... 2 Intellectual Property Trends... 3 Technology Trends... 3 VOLUME I - DIABETES INDUSTRY ANALYSIS 1.0 MARKET OVERVIEW BACKGROUND Diagnosis and Management of Diabetes... 8 Insulin-Dependant Diabetes Patients... 9 Current Trends in Diabetes Care THE GLOBAL DIABETES BURDEN Diabetes Prevalence Fig.1.0: Diabetes Prevalence by Geographic Region, Diabetes Prevalence for the Top 10 Countries, (million)...11 Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group Study Mortality Diabetes Complications The Cost of Diabetes THE DIABETES DEVICE MARKET Product Segments Fig.1.2: Diabetes Device Market by Major Product Category, Fig.1.3: Percentage of US Diabetes Patients by Treatment Type, Fig.1.4: Diabetes Device Market by Product Type, Current Market Trends Fig.1.5: Global Diabetes Device Market, 2011 (US$ billion)...19 Global Diabetes Market by Product Type, (US$ million)...20 Fig.1.6: Global Diabetes Market By Product Type, (US$ billion)...20 Global Diabetes Market Growth Rates by Product Type, (%)...21 Fig.1.7: Global Diabetes Device Market Growth Rates, (%) Regional Perspective Fig.1.8: Global Diabetes Device Market by Region, Fig.1.9: US Market by Product Type, Fig.1.10: European Market by Product Type, Fig.1.11: Other Regions by Product Type, COMPETITIVE ENVIRONMENT...24 Fig.1.12: Diabetes Device Market Share by Company, Key Companies Diabetes Care Sales, (US$ million)...25 Non-US Companies Diabetes Sales in Reported Currency, (million)...25 Leading Companies International Diabetes Care Sales, (US$ million)...26 Leading Companies US Diabetes Care Sales, (US$ million) New Market Entrants Market Withdrawals Rounding Out Product Portfolios...28 Key Companies: Market Presence & Position by Product Area...28 Key Companies: Current & Future Potential Market Presence by Product Area Market Consolidation GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES Regulatory and Reimbursement Environment iii

4 Table of Contents Diabetes Landscape: Connectivity and Data Integration...32 The Role of Telemonitoring in Diabetes Care...32 Safety Issues Emerging Technologies...34 New-Generation Insulin Delivery Devices Development of a Closed-Loop System...35 Rival Technologies MARKET EXPECTATIONS Fig.1.13: Global Diabetes Device Market, E (US$ billion)...38 Global Diabetes Market Forecast by Product Type, E (US$ million) Global Diabetes Market Forecast Growth Rates by Product, E (%) Fig.1.14: Global Monitoring Market Forecast, E (US$ billion) Fig.1.15: Global Insulin Delivery Market Forecast, (E) (US$ billion)...40 Fig.1.16: Diabetes Device Market by Product, 2017E DIABETES MONITORING PRODUCTS...41 Overview: Glucose Monitoring Products MARKET DYNAMICS Fig.2.1: Global Glucose Monitoring Market, (US$ billion)...44 Fig.2.2: Global Blood Monitoring Market Growth, (%)...44 Fig.2.3: Glucose Monitoring Market by Product Type, Fig.2.4: Blood Glucose Testing Market by Geographic Region, Public Companies Glucose Monitoring Sales, (US$ million) Fig.2.5: Glucose Monitoring Market Shares by Company, MANUAL SELF-MONITORING BLOOD GLUCOSE PRODUCTS Fig.2.6: Example of a Classic BGM & Test Strip: Bayer s Contour Meter Current Market Environment Fig.2.7: Global SMBG Market, (US$ million)...49 Fig.2.8: Global SMBG Market Growth Rates, (%)...49 Fig.2.9: SMBG Market by Product Type, Regional Markets and Reimbursement Fig.2.10: SMBG Market by Region, Market Developments...51 Fig.2.11: Mendor s Discreet (left) & Roche s Accu-Check Mobile with Attached Lancing Device (right) Fig.2.12: BodyTel Europe s GlucoTel BGM Fig.2.13: Medisana s GlucoDock Attached to an Apple iphone Accuracy Standards...53 Market Forecast Summary: SMBG Growth Drivers, Restraints & Opportunities Fig.2.14: Global SMBG Market, E (US$ billion) Fig.2.15: Global SMBG Market Growth Rates, E (%) Competitive Environment...56 Public Companies BGM Sales, (US$ million) Fig.2.16: SMBG Market Share by Company, Fig.2.17: United States SMBG Market Share by Company, Fig.2.18: SMBG International Market Share by Company, Market-Leading Self-Testing Blood Glucose Meters Abbott s Blood Glucose Monitors Arkray s Glucocard Products Bayer s Blood Glucose Monitoring Systems Contour USB Contour, Contour TS, Contour Link and Breeze DIDGET Meter Elite and Elite XL LifeScan OneTouch Products iv

5 Diabetes Landscape: Table of Contents Nipro Diagnostics TRUE Products Roche Diabetes Care s Products Other Market Participants...68 Competing Self-Testing Blood Glucose Monitoring Products...68 Product Highlights Products in Development...77 Intuity Medical s POGO Blood Glucose Monitoring System Pepex Biomedical s Trio Products CONTINUOUS GLUCOSE MONITORING Fig.2.19: Example of a CGM: Medtronic s Guardian REAL-Time System The Benefits of CGM Barriers to Adoption...79 The Cost of CGM Clinical Trial Results - Highlighting Benefits and Drawbacks The TD1 Exchange: User Experiences of CGM CGM Market Trends and Opportunities...82 Fig.2.20: Global CGM Market, (US$ million) Fig.2.21: Percentage of CGM Sales Volumes by Hardware & Consumables, Regional Adoption Rates, Regulatory and Reimbursement Environment Fig.2.22: CGM Market by Region, Future Prospects Fig.2.23: Global CGM Market Forecast, E (US$ million) Fig.2.24: Global CGM Market Forecast Growth Rates, E (%)...86 Summary: CGM Benefits, Challenges & Opportunities Competitive Environment...87 Leading Companies Reported CGM Sales, (US$ million) Fig.2.25: Global CGM Market Shares by Company, Fig.2.26: US CGM Market Shares by Company, Fig.2.27: International CGM Market Shares by Company, Currently-Available Products...89 Medtronic s Guardian REAL-Time CGM System DexCom s CGMs Abbott s FreeStyle Navigator...91 A Menarini Diagnostics GlucoDay S Products in Development...92 Abbott s Navigator II...92 DexCom s Research and Development...92 New-Generation Implantable CGM Sensors...93 Minimally-Invasive CGM in Development NON-INVASIVE GLUCOSE MONITORING Competitive Environment AIMEDICS HypoMon Biosign Technologies UFIT TEN-20 Non-Invasive Blood Pressure and Glucose Meter Biovotion s Multisensor Glucose Monitoring System Integrity Applications GlucoTrack Clinical Study Results Optical Technologies C8 MediSensors Optical Glucose Monitor EyeSense s Optical Sensor Freedom Meditech s I-SugarX Glucose Monitoring System Grove Instruments Grove Glucometer Lein Applied Diagnostics LighTouch Medical s Non-Invasive Glucose Monitor Massachusetts Institute of Technology s Raman Spectroscopy System Medtronic s PreciSense Technology v

6 Table of Contents Diabetes Landscape: OrSense s NBM-200G Non-Invasive Blood Glucose Meter St Louis Medical Devices Near-Infrared Light-Based System Smart Tattoos Tear Fluid Glucose Sensors Mayo Clinic, Arizona State University and BioAccel University of Washington and Microsoft Research The University of Western Ontario s Glucose Monitoring Contact Lenses Breath-Based Glucose Monitoring PositiveID s EasyChek Xhale s Breath-Based Glucose Monitor Brown University and Saliva-Based Glucose Testing INSULIN DELIVERY PRODUCTS ADDRESSABLE PATIENT POPULATION Fig.3.1: Percentage of US Diabetes Patients by Treatment Type, MARKET TRENDS Insulin Delivery Market by Product Type (US$ million) Fig.3.2: Global Insulin Delivery Market, (US$ billion) Fig.3.3: Global Insulin Delivery Market Growth Rates, (%) Fig.3.4: Percentage of Insulin Delivery Market by Product Type, Fig.3.5: Insulin Delivery Market by Geographic Region, Competitive Environment Key Companies Insulin Delivery Sales, (US$ million) Fig.3.6: Insulin Delivery Market Share by Company, FUTURE MARKET PROSPECTS Summary: Insulin Delivery Market Growth Drivers, Restraints & Opportunities Insulin Delivery Market Forecast by Product Type E (US$ million) Fig.3.7: Global Insulin Delivery Market Forecast, (US$ billion) Fig.3.8: Global Insulin Delivery Market Estimated Growth Rates, (%) Fig.3.9: Estimated Insulin Delivery Market by Product Type, MANUAL INSULIN INJECTION PRODUCTS Fig.3.10: Manual Insulin Delivery Method by Product Type, Fig.3.11: Percentage of Novo Nordisk Insulin Sold in Pens by Region, Fig.3.12: Manual Insulin Delivery Market by Geographic Region, Insulin Pens Fig.3.13: Example Insulin Pen: Novo Nordisk s NovoPen Fig.3.14: Global Insulin Pen Market: Disposable vs Reusable Pens, Competitive Environment Fig.3.15: Insulin Pen Use by Manufacturer, Currently-Available Products Needles and Syringes Fig.3.16: Insulin Needles & Syringes Market by Manufacturer, Pen Needles INSULIN PUMPS Fig.3.17: Example Insulin Pump: Medtronic s MiniMed Paradigm REAL-Time Revel Fig.3.18: Example Insulin Pump: Roche s Accu-Check Spirit Insulin Pump Market: Growth Drivers, Restraints & Opportunities The TD1 Exchange: User Experiences of CGM Current Market Trends Fig.3.19: Global Insulin Pump Market, (US$ million) Fig.3.20: Global Insulin Pump Market Growth Rates, (%) Fig.3.21: Insulin Pump Market by Product, Regional Perspective Fig.3.22: Insulin Pump Market by Region, Fig.3.23: Insulin Pump Adoption Rates for Type 1 Diabetes Patients by Key Country, 2010 (%) vi

7 Diabetes Landscape: Table of Contents Regulatory Environment - FDA Infusion Pump Improvement Initiative Negative Publicity and the Potential for Cyber Attacks Market Outlook Fig.3.24: Global Insulin Pump Market Forecast, (US$ million) Fig.3.25: Global Insulin Pump Market Estimated Growth Rates, (%) Competitive Environment Key Companies Insulin Pump Sales, (US$ million) Fig.3.26: Insulin Pump Market Shares, Currently-Available Insulin Pumps Animas Insulin Pumps Asante Solutions Pearl Insulin Pump D Medical Industries Spring Pumps and Infusion Sets Medtronic s MiniMed Paradigm Revel Insulin Pump and Infusion Sets Sooil Development s Diabecare Insulin Pumps Roche Insulin Pumps Tandem Diabetes Care s t:slim Insulin Delivery System Insulin Delivery Patch Pumps Products in Development Becton Dickinson-JDRF Micro-Needle Technology CeQur s Insulin Patch Infuser D Medical Industries Spring Hybrid Patch Pump Debiotech s JewelPUMP Insulet s Second-Generation OmniPod Insuline Medical s InsuPatch and InsuPad Roche s SOLO Micropump ALTERNATIVE INSULIN DELIVERY DEVICES Generex Biotechnology s Oral-lyn Insulin Inhalers Development Considerations Fig.3.27: MannKind s Dreamboat (Gen2) Insulin Inhaler COMBINED CGM-INSULIN PUMP SYSTEMS CURRENTLY-AVAILABLE PRODUCTS Medtronic s Paradigm Integrated Diabetes Management Products Paradigm REAL-Time Revel Fig.4.1: MiniMed Paradigm REAL-Time System Enlite CGM Sensor Clinical Trials ONSET Study REAL Trend Study Animas Vibe PRODUCTS IN DEVELOPMENT D Medical Industries Combined CGM-Pump System ARTIFICIAL PANCREAS TECHNOLOGY SEMI-CLOSED LOOP SYSTEMS Medtronic s Paradigm Veo System with Low Glucose Suspend Fig.5.1: Medtronic s Paradigm Veo System with Low Glucose Suspend ASPIRE Study RESEARCH & DEVELOPEMNT FDA Artificial Pancreas Development Guidelines Key Closed-Loop Development Projects The Juvenile Diabetes Research Foundation s Artificial Pancreas Project Mayo Clinic UC Santa Barbara, Sansum Diabetes Research Institute, Mayo Clinic, Universities of Virginia & Padova 172 AP@home Project vii

8 Table of Contents Diabetes Landscape: MD-Logic Artificial Pancreas System Medtronic s Closed-Loop System Rensselaer Polytechnic Institute POC MANUFACTURERS POC COMPANY DIRECTORY LEADING COMPANY PROFILES Abbott Laboratories Recent Key Events Blood Glucose Monitors In Development - Navigator II CGM System Alliance with Insulet Litigation Financial Performance Abbott Diabetes Care Sales by Region, (US$ million) Fig.6.1: Percentage of Abbott Diabetes Care Revenue by Region, Arkray Recent Key Events Blood Glucose Self-Testing Current Alliances and Contracts Bayer Recent Key Events Blood Glucose Monitoring Systems Current Alliances Litigation Financial Performance Bayer Diabetes Care Revenue, (EUR million) Becton, Dickinson and Company Recent Key Events BD Diabetes Care Products Collaboration with the JDRF Litigation with Insulet Financial Performance BD Diabetes Care Sales by Region, (US$ million) Fig.6.2: Percentage of BD Diabetes Care s Revenue by Region, DexCom Recent Key Events SEVEN PLUS CGM System GlucoClear Research and Development SweetSpot Diabetes Care Acquisition Current Alliances Litigation with Abbott Financial Performance DexCom - Operating Results, (US$ thousands) Insulet Recent Key Events OmniPod Insulin Management System Current Alliances Acquisition of Neighborhood Diabetes Litigation with Becton, Dickinson and Company Financial Performance Insulet - Operating Results, (US$ thousands) Johnson & Johnson Recent Key Events viii

9 Diabetes Landscape: Table of Contents Animas Operations LifeScan Operations Financial Performance J&J Diabetes Care Revenue, (US$ million) Fig.6.3: J&J Diabetes Care Sales by Region, Fig.6.4: J&J Diabetes Care Sales, (US$ million) Medtronic Recent Key Events Integrated Diabetes Management Products Guardian REAL-Time CGM System ipro Professional Use CGM Products Enlite CGM Sensor MiniMed Paradigm Revel Insulin Pump and Infusion Sets CareLink Software Blood Glucose Meters Clinical Trials Research and Development Alliance with Bayer Financial Performance Fig.6.5: Medtronic Diabetes Revenue, (US$ million) Medtronic - Diabetes Sales by Region, (US$ million) Fig.6.6: Medtronic Diabetes Revenue by Region, Fig.6.7: Medtronic Diabetes Revenue by Product Type, 2010* Nipro Diagnostics Recent Key Events Blood Glucose Monitoring Products Blood Glucose Monitors Roche Diabetes Care Recent Key Events Diabetes Care Products Accu-Chek Combo BGM and Pump System Insulin Pumps Data Management Tools In Development - SOLO Micropump Current Alliances and Contracts Litigation Financial Performance Roche Diabetes Care Sales by Product, (SFr million) Roche Diabetes Care Sales by Region, (SFr million) Fig.6.8: Roche Diabetes Care - Revenue by Product Line, Fig.6.9: Roche Diabetes Care - Revenue by Region, Ypsomed Recent Key Events mylife Diabetes Care Products Ypsomed Delivery Systems Acquisition of ICU Medical s Orbit Infusion Set Business Current Alliances Financial Performance Ypsomed - Operating Results, Y/E 31st March (SFr millions) Ypsomed - Results by Business Segment, Y/E 31st March (SFr millions) Ypsomed - Revenue by Geographic Region, Y/E 31st March (SFr millions) Fig.6.10: Ypsomed - Revenue by Business Segment, Fiscal Fig.6.11: Ypsomed - Revenue by Geographic Location, Fiscal APPENDICES ix

10 Table of Contents Diabetes Landscape: 7.1 LIST OF ABBREVIATIONS REPORT METHODOLOGY Sources Market forecasts VOLUME II - DIABETES TECHNOLOGY AND INTELLECTUAL PROPERTY ANALYSIS 1.0 SUMMARY Figure 1.1 Diabetes Landscape by Technology Figure 1.2 High Level Overview of Diabetes Patent Activity Figure 1.3 Bar Chart of Totals for each Technology Group Figure 1.4 Top 20 Assignees Patents from this Study Figure Blood Extraction by Priority Date by Assignee Figure 1.6 Number of Patents versus Revenue for Highlighted Companies Figure 1.7 Litigation Analysis Table 1.1 Table of Highlighted Companies and Technologies INTRODUCTION TECHNOLOGY Figure 3.1 Diabetes Landscape by Technology Figure 3.2 Self Monitoring of Blood Glucose Figure 3.3 Blood Glucose Test Strip Operation Figure 3.4 Continuous Glucose Monitoring (CGM) Figure 3.5 Artificial Pancreas Representative Diagram OVERVIEW OF PATENT ACTIVITIES Figure 4.1 High Level Overview of Diabetes Patent Activity Analysis of Patents Sorted by this Study Figure 4.2 Bar Chart of Totals for each Technology Group Figure 4.3 Top 20 Assignees Patents from This Study Figure 4.4 Patents by Priority Date Figure 4.5 Priority Date by Top 5 Companies Figure 4.6 Patents by Published Date Figure 4.7 Patents by Source Jurisdiction Figure 4.8 Top 10 IPC Codes from the Patents Analyzed Figure 4.9 Total U.S. Patents by Assignee Figure 4.10 USP Classification Analysis within the U.S. Dataset PATENT ANALYSIS BY TECHNOLOGY SUBCATEGORY Detection and Monitoring Periodic Invasive Blood Extraction Figure 5.1 Blood Extraction Top Assignees Priority Date by Year and Source: Figure Blood Extraction by Priority Date Priority Date by Year by Top 5 Assignees within the Subcategory: Figure Blood Extraction by Priority Date by Assignee Published Date by Year and Source: Figure Blood Extraction by Published Date IPC Analysis Top 10 Codes: Figure Blood Extraction by IPC Code USPC Analysis Top 10 Codes: Figure Blood Extraction by USPC Code Figure 5.7 Blood Extraction - Text Clustering Analysis Source Jurisdiction: Figure Blood Extraction by Source Jurisdiction Top Patents Table Top Patents Identified in the Blood Extraction Group x

11 Diabetes Landscape: Table of Contents US B1: Abbott Laboratories Figure 5.9 Representative Image in US Figure 5.10 Top 20 Companies Citing US US A: Bayer AG Figure 5.11 Representative Images of US Figure 5.12 Top 20 Companies Citing US Detection and Monitoring Periodic Invasive Test Strips Figure 5.13 Test Strips Top Assignees Priority Date by Year and Source: Figure Test Strips by Priority Date Priority Date by Year by Assignee: Figure Test Strips by Priority Date by Assignee Published Date by Year: Figure Test Strips by Published Date IPC Analysis Top 10 Codes: Figure Test Strips by IPC Code USPC Analysis Top 10 Codes: Figure Test Strips by USPC Code Text Clustering Analysis: Figure 5.19 Test Strips - Text Clustering Analysis Source Jurisdiction: Figure Test Strips by Source Jurisdiction Top Patents Table Top Patents Identified in the Test Strips Group US A: Arkray, Inc Figure 5.21 Representative Image in US Figure 5.22 Top 20 Companies Citing US US : Johnson & Johnson Figure 5.23 Representative Image in US Figure 5.24 Top 20 Companies Citing US Detection and Monitoring Periodic Invasive Devices Figure 5.25 Devices Top Assignees Priority Date by Year: Figure Devices by Priority Date Priority Date by Year by Assignee: Figure Devices by Priority Date by Assignee Published Date by Year and Source: Figure Devices by Published Date IPC Analysis Top 10 Codes: Figure Devices by IPC Code USPC Analysis Top 10 Codes: Figure Devices by USPC Code Text Clustering Analysis: Figure 5.31 Devices - Text Clustering Analysis Source Jurisdiction: Figure Devices by Source Jurisdiction Top Patents Table Top Patents Identified in the Devices Group US : Johnson & Johnson Figure 5.33 Representative Image in US Figure 5.34 Top 20 Companies Citing US Detection and Monitoring Periodic Minimally Invasive Interstitial Fluid Figure 5.35 Interstitial Fluid Top Assignees Priority Date by Year: Figure Interstitial Fluid by Priority Date xi

12 Table of Contents Diabetes Landscape: Priority Date by Year by Assignee: Figure Interstitial Fluid by Priority Date Published Date by Year: Figure Interstitial Fluid by Published Date IPC Analysis - Top 10 Codes: Figure Interstitial Fluid by IPC Code USPC Analysis Top 10 Codes: Figure Interstitial Fluid by USPC Code Text Clustering Analysis: Figure 5.41 Interstitial Fluid - Text Clustering Analysis Source Jurisdiction: Figure Interstitial Fluid by Source Jurisdiction Top Patents Table Top Patents Identified in the Interstitial Fluid Group US : Alere Incorporated Figure 5.43 Representative Image in US Figure 5.44 Top 20 Companies Citing US Detection and Monitoring Periodic Minimally Invasive Skin Diffusion Figure 5.45 Skin Diffusion Top Assignees Priority Date by Year: Figure Skin Diffusion by Priority Date Priority Date by Year by Assignee: Figure Skin Diffusion by Priority Date by Assignee Published Date by Year: Figure Skin Diffusion by Published Date IPC Analysis Top 10 Codes: Figure Skin Diffusion by IPC Code USPC Analysis Top 10 Codes: Figure Skin Diffusion by USPC Code Text Clustering Analysis: Figure 5.51 Skin Diffusion - Text Clustering Analysis Source Jurisdiction: Figure Skin Diffusion by Source Jurisdiction Top Patents Table Top Patents Identified in the Skin Diffusion Group US : Johnson & Johnson Figure 5.53 Representative Image in US Figure 5.54 Top 20 Companies Citing US Detection and Monitoring Periodic Non Invasive Optical Figure 5.55 Non Invasive - Optical Top Assignees Priority Date by Year: Figure Non Invasive - Optical by Priority Date Priority Date by Year by Assignee: Figure Non Invasive - Optical by Priority Date Published Date by Year: Figure Non Invasive - Optical by Published Date IPC Analysis Top 10 Codes: Figure Non Invasive - Optical by IPC Code USPC Analysis Top 10 Codes: Figure Non Invasive - Optical by USP Class Code Text Clustering Analysis: Figure 5.61 Non Invasive - Optical - Text Clustering Analysis Source Jurisdiction: Figure Non Invasive - Optical by Source Jurisdiction Top Patents xii

13 Diabetes Landscape: Table of Contents Table 5.6- Top Patents Identified in the Non Invasive Optical Group US : Masimo Corporation Figure 5.63 Representative Image in US Figure 5.64 Top 20 Companies Citing US US : Sensys Medical Inc Figure 5.65 Patent Diagram of US Figure 5.66 Top 20 Companies Citing US Detection and Monitoring Periodic Non Invasive Other Figure 5.67 Non-Invasive Other Top Assignees Priority Date by Year: Figure 5.68 Non-Invasive Other by Priority Date Priority Date by Year by Assignee: Figure Non-Invasive Other by Priority Date by Assignee Published Date by Year: Figure Non-Invasive Other by Published Date IPC Analysis Top 10 Codes: Figure Non Invasive Other by IPC Code USPC Analysis Top 10 Codes: Figure Non Invasive Other by USPC Code Text Clustering Analysis: Figure 5.73 Non Invasive Other - Text Clustering Analysis Source Jurisdiction: Figure 5.74 Non-Invasive - Other by Source Jurisdiction Top Patents Table Top Patents Identified in the Non Invasive Other Group US : Medtronic Inc Figure 5.75 Representative Image in US Figure 5.76 Top 20 Companies Citing US Detection and Monitoring Continuous Non-Implanted Figure 5.77 Continuous Non-Implanted Top Assignees Priority Date by Year: Figure Continuous Non-Implanted by Priority Date Priority Date by Year by Assignee: Figure Continuous Non-Implanted by Priority Date by Assignee Published Date by Year: Figure Continuous Non-Implanted by Published Date IPC Analysis Top 10 Codes: Figure Continuous Non-Implanted by IPC Code USPC Analysis Top 10 Codes: Figure Continuous Non-Implanted by USPC Code Figure 5.83 Continuous Non-Implanted -Text Clustering Analysis Source Jurisdiction: Figure Continuous Non-Implanted by Source Jurisdiction Top Patents Table Top Patents Identified in the Continuous Non-Implanted Group US : Dexcom, Inc Figure 5.85 Representative Image in US Figure 5.86 Top 20 Companies Citing US Detection and Monitoring Continuous Implanted Figure 5.87 Continuous Implanted Top Assignees Priority Date by Year: Figure Continuous Implanted by Priority Date Priority Date by Year by Assignee: Figure Continuous Implanted by Priority Date by Assignee Published Date by Year: xiii

14 Table of Contents Diabetes Landscape: Figure Continuous Implanted by Published Date IPC Analysis Top 10 Codes: Figure Continuous Implanted by IPC Code USPC Analysis Top 10 Codes: Figure Continuous Implanted by USPC Code Text Clustering Analysis: Figure 5.93 Continuous Implanted - Text Clustering Analysis Source Jurisdiction: Figure Continuous Implanted by Source Jurisdiction Top Patents Table Top Patents Identified in the Continuous Implanted Group Figure 5.95 Representative Image in US Figure 5.96 Top 20 Companies Citing US Treatment Manual Syringe Figure 5.97 Syringe Top Assignees Priority Date by Year: Figure Syringe by Priority Date Priority Date by Year by Assignee: Figure Syringe by Priority Date by Assignee Published Date by Year: Figure Syringe by Published Date IPC Analysis Top 10 Codes: Figure Syringe by IPC Code USPC Analysis Top 10 Codes: Figure Syringe by USPC Code Text Clustering Analysis: Figure Syringe - Text Clustering Analysis Source Jurisdiction: Figure Syringe by Source Jurisdiction Top Patents Table Top Patents Identified in the Syringe Group US : Medtronic, Inc Figure Representative Image in US Figure Top 20 Companies Citing US Treatment Manual Pen Figure Pen Top Assignees Priority Date by Year: Figure Pen by Priority Date Priority Date by Year by Assignee: Figure Pen by Priority Date by Assignee Published Date by Year: Figure Pen by Published Date IPC Analysis Top 10 Codes: Figure Pen by IPC Code USPC Analysis Top 10 Codes: Figure Pen by USPC Code Text Clustering Analysis: Figure Pen - Text Clustering Analysis Source Jurisdiction: Figure Pen by Source Jurisdiction Top Patents Table Top Patents Identified in the Pen Group US : Becton, Dickinson and Company Figure Representative Image in US Figure Top 20 Companies Citing US xiv

15 Diabetes Landscape: Table of Contents US : Roche Holding Ltd Figure Representative Image in US Figure Top 20 Companies Citing US Treatment Manual - Patch Figure Patch Top Assignees Priority Date by Year: Figure Patch by Priority Date Priority Date by Year by Assignee: Figure Patch by Priority Date by Assignee Published Date by Year: Figure Patch by Published Date IPC Analysis Top 10 Codes: Figure Patch by IPC Code USPC Analysis Top 10 Codes: Figure Patch by USPC Code Text Clustering Analysis: Figure Patch - Text Clustering Analysis Source Jurisdiction: Figure Patch by Source Jurisdiction Top Patents Table Top Patents Identified in the Patch Group US : Purdue Pharma LP Figure Representative Image in US Figure Top 20 Companies Citing US Treatment Manual Other Figure Treatment - Other Top Assignees Priority Date by Year: Figure Treatment Other by Priority Date Priority Date by Year by Assignee: Figure Treatment Other by Priority Date by Assignee Published Date by Year: Figure Treatment Other by Published Date IPC Analysis Top 10 Codes: Figure Treatment Other by IPC Code USPC Analysis Top 10 Codes: Figure Treatment - Other by USPC Code Text Clustering Analysis: Figure Treatment Other - Text Clustering Analysis Source Jurisdiction: Figure Treatment - Other by Source Jurisdiction Top Patents Table Top Patents Identified in the Treatment Other Group US : Novartis AG Figure Top 20 Companies Citing US Treatment Automatic External Pump Figure External Pump Top Assignees Priority Date by Year: Figure External Pump by Priority Date Priority Date by Year by Assignee: Figure External Pump by Priority Date by Assignee Published Date by Year: Figure External Pump by Published Date IPC Analysis Top 10 Codes: Figure External Pump by IPC Code USPC Analysis Top 10 Codes: xv

16 Table of Contents Diabetes Landscape: Figure External Pump by USPC Code Text Clustering Analysis: Figure External Pump - Text Clustering Analysis Source Jurisdiction: Figure External Pump by Source Jurisdiction Top Patents Table Top Patents Identified in the External Pump Group US : Insulet Corporation Devices Figure Representative Image in US Figure Top 20 Companies Citing US Treatment Automatic Implanted Pump Figure Implanted Pump Top Assignees Priority Date by Year: Figure Implanted Pump by Priority Date Priority Date by Year by Assignee: Figure Implanted Pump by Priority Date by Assignee Published Date by Year: Figure Implanted Pump by Published Date IPC Analysis Top 10 Codes: Figure Implanted Pump by IPC Code USPC Analysis Top 10 Codes: Figure Implanted Pump by USPC Code Text Clustering Analysis: Figure Implanted Pump - Text Clustering Analysis Source Jurisdiction: Figure Implanted Pump by Source Jurisdiction Top Patents Table Top Patents Identified in the Implanted Pump Group US : Medtronic, Inc Figure Representative Image in US Figure Top 20 Companies Citing US Treatment Automatic SW and Algorithms Figure SW/Algorithm Top Assignees Priority Date by Year: Figure SW/Algorithm by Priority Date Priority Date by Year by Assignee: Figure SW/Algorithm by Priority Date by Assignee Published Date by Year: Figure SW/Algorithm by Published Date IPC Analysis Top 10 Codes: Figure SW/Algorithm by IPC Code USPC Analysis Top 10 Codes: Figure SW/Algorithm by USPC Code Text Clustering Analysis: Figure SW/Algorithm - Text Clustering Analysis Source Jurisdiction: Figure SW/Algorithm by Source Jurisdiction Top Patents Table Top Patents Identified in the SW/Algorithms Group US : Robert Bosch GmbH Figure Front Page Diagram of US Figure Top 20 Companies Citing US US : Medtronic, Inc Figure Representative Image in US Figure Top 20 Companies Citing US xvi

17 Diabetes Landscape: Table of Contents 5.17 Artificial Pancreas Figure Artificial Pancreas Top Assignees Priority Date by Year: Figure Artificial Pancreas by Priority Date Priority Date by Year by Assignee: Figure Artificial Pancreas by Priority Date by Assignee Published Date by Year: Figure Artificial Pancreas by Published Date IPC Analysis Top 10 Codes: Figure Artificial Pancreas by IPC Code USPC Analysis Top 10 Codes: Figure Artificial Pancreas by USPC Code Text Clustering Analysis: Figure Artificial Pancreas - Text Clustering Analysis Source Jurisdiction: Figure Artificial Pancreas by Source Jurisdiction Top Patents Table Top Patents Identified in the Artificial Pancreas Group US : Abbott Laboratories Figure Representative Image in US Figure Top 20 Companies Citing US US : Johnson & Johnson Figure Representative Image in US Figure Top 20 Companies Citing US PATENT ANALYSIS BY KEY COMPANIES Figure 6.1 Number of Patents versus Revenue for Highlighted Companies Litigation Figure 6.2 Litigation Analysis Johnson & Johnson Johnson & Johnson Overall Patent Portfolio Priority Date by Year: Figure 6.3 Johnson & Johnson Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.4 Johnson & Johnson Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.5 Johnson & Johnson Overall Patent Portfolio Source Jurisdiction Johnson & Johnson Patents Specific to This Study Figure 6.6 Johnson & Johnson Diabetes Patents by Technology Group Priority Date by Year: Figure Johnson & Johnson Diabetes Patents by Priority Year Publication Date by Year: Figure 6.8 Johnson & Johnson Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.9 Johnson & Johnson Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure 6.10 Johnson & Johnson Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.11 Johnson & Johnson Diabetes Patents by Source Jurisdiction Abbott Laboratories Abbott Overall Patent Portfolio Priority Date by Year: Figure Abbott Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.13 Abbott Overall Patent Portfolio by Published Year xvii

18 Table of Contents Diabetes Landscape: Source Jurisdiction: Figure 6.14 Abbott Overall Patent Portfolio by Source Jurisdiction Abbott Patents Specific to This Study Figure 6.15 Abbott Diabetes Patents by Technology Group Priority Date by Year: Figure Abbott Diabetes Patents by Priority Year Publication Date by Year: Figure 6.17 Abbott Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.18 Abbott Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure 6.19 Abbott Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.20 Abbott Diabetes Patents by Source Jurisdiction Roche Holding Ltd Roche Overall Patent Portfolio Priority Date by Year: Figure 6.21 Roche Overall Patent Portfolio by Priority Year Published Date by Year: Figure Roche Overall Patent Portfolio by Published Year Source Jurisdiction: Figure Roche Overall Patent Portfolio by Source Jurisdiction Roche Patents Specific to This Study Figure 6.24 Roche Diabetes Patents by Technology Group Priority Date by Year: Figure Roche Diabetes Patents by Priority Year Publication Date by Year: Figure Roche Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure Roche Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure Roche Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.29 Roche Diabetes Patents by Source Jurisdiction Medtronic Inc Medtronic Overall Patent Portfolio Priority Date by Year: Figure Medtronic Overall Patent Portfolio by Priority Year Published Date by Year: Figure Medtronic Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.32 Medtronic Overall Patent Portfolio by Source Jurisdiction Medtronic Patents Specific to This Study Figure 6.33 Medtronic Diabetes Patents by Technology Group Priority Date by Year: Figure Medtronic Diabetes Patents by Priority Year Publication Date by Year: Figure Medtronic Diabetes Patents by Published Year IPC Analysis - Top 10 Codes: Figure Medtronic Diabetes Patents by IPC Code USPC Analysis- Top 10 Codes: Figure Medtronic Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.38 Medtronic Diabetes Patents by Source Jurisdiction Becton, Dickinson and Co xviii

19 Diabetes Landscape: Table of Contents Becton, Dickinson and Co Overall Patent Portfolio Priority Date by Year: Figure 6.39 Becton, Dickinson and Co Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.40 Becton, Dickinson and Co Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.41 Becton, Dickinson and Co Overall Patent Portfolio by Source Jurisdiction Becton, Dickinson and Co Patents Specific to This Study Figure 6.42 Becton, Dickinson and Co Diabetes Patents by Technology Group Priority Date by Year: Figure 6.43 Becton, Dickinson and Co Diabetes Patents by Priority Year Publication Date by Year: Figure 6.44 Becton, Dickinson and Co Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.45 Becton, Dickinson and Co Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure 6.46 Becton, Dickinson and Co Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.47 Becton, Dickinson and Co Diabetes Patents by Source Jurisdiction Dexcom INC Dexcom Overall Patent Portfolio Priority Date by Year: Figure Dexcom Overall Patent Portfolio by Priority Year Published Date by Year: Figure Dexcom Overall Patent Portfolio by Published Year Source Jurisdiction: Figure Dexcom Overall Patent Portfolio by Source Jurisdiction Dexcom Patents Specific to This Study Figure 6.51 Dexcom Diabetes Patents by Technology Group Priority Date by Year: Figure Dexcom Diabetes Patents by Priority Year Publication Date by Year: Figure 6.53 Dexcom Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.54 Dexcom Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure 6.55 Dexcom Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.56 Dexcom Diabetes Patents by Source Jurisdiction Novo Nordisk A/S Novo Nordisk Overall Patent Portfolio Priority Date by Year: Figure Novo Nordisk Overall Patent Portfolio by Priority Year Published Date by Year: Figure Novo Nordisk Overall Patent Portfolio by Published Year Source Jurisdiction: Figure Novo Nordisk Overall Patent Portfolio by Source Jurisdiction Novo Nordisk Patents Specific to This Study Figure 6.60 Novo Nordisk Diabetes Patents by Technology Group Priority Date by Year: Figure Novo Nordisk Diabetes Patents by Priority Year Publication Date by Year: Figure Novo Nordisk Diabetes Patents by Published Year IPC Analysis Top 10: Codes Figure Novo Nordisk Diabetes Patents by IPC Code xix

20 Table of Contents Diabetes Landscape: USPC Analysis Top 10 Codes: Figure Novo Nordisk Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.65 Novo Nordisk Diabetes Patents by Source Jurisdiction Bayer AG Bayer Overall Patent Portfolio Priority Date by Year: Figure Bayer Overall Patent Portfolio by Priority Year Published Date by Year: Figure Bayer Overall Patent Portfolio by Published Year Source Jurisdiction: Figure Bayer Overall Patent Portfolio by Source Jurisdiction Bayer Patents Specific to This Study Figure 6.69 Bayer Diabetes Patents by Technology Group Priority Date by Year: Figure Bayer Diabetes Patents by Priority Year Publication Date by Year: Figure Bayer Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure Bayer Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure Bayer Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.74 Bayer Diabetes Patents by Source Jurisdiction Insulet Corporation Insulet Overall Patent Portfolio Priority Date by Year: Figure Insulet Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.76 Insulet Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.77 Insulet Overall Patent Portfolio by Source Jurisdiction Insulet Patents Specific to This Study Figure 6.78 Insulet Diabetes Patents by Technology Group Priority Date by Year: Figure Insulet Diabetes Patents by Priority Year Publication Date by Year: Figure 6.80 Insulet Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.81 Insulet Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure 6.82 Insulet Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.83 Insulet Diabetes Patents by Source Jurisdiction Nipro Diagnostic Nipro Overall Patent Portfolio Priority Date by Year: Figure 6.84 Nipro Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.85 Nipro Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.86 Nipro Overall Patent Portfolio by Source Jurisdiction Nipro Patents Specific to This Study Figure 6.87 Nipro Diabetes Patents by Technology Group Priority Date by Year: xx

21 Diabetes Landscape: Table of Contents Figure Nipro Diabetes Patents by Priority Year Publication Date by Year: Figure 6.89 Nipro Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.90 Nipro Diabetes Patents by IPC Code USPC Codes Top 10 Codes: Figure 6.91 Nipro Diabetes Patents by USPC Code Source Jurisdiction: Figure 6.92 Nipro Diabetes Patents by Source Jurisdiction Arkray Inc Arkray Overall Patent Portfolio Priority Date by Year: Figure 6.93 Arkray Overall Patent Portfolio by Priority Year Published Date by Year: Figure 6.94 Arkray Overall Patent Portfolio by Published Year Source Jurisdiction: Figure 6.95 Arkray Overall Patent Portfolio by Source Jurisdiction Arkray Patents Specific to This Study Figure 6.96 Arkray Diabetes Patents by Technology Group Priority Date by Year: Figure Arkray Diabetes Patents by Priority Year Publication Date by Year: Figure 6.98 Arkray Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure 6.99 Arkray Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure Arkray Diabetes Patents by USPC Code Source Jurisdiction: Figure Arkray Diabetes Patents by Source Jurisdiction Sanofi Aventis SA Sanofi-Aventis Overall Patent Portfolio Priority Date by Year: Figure Sanofi-Aventis Overall Patent Portfolio by Priority Year Published Date by Year: Figure Sanofi-Aventis Overall Patent Portfolio by Published Year Source Jurisdiction: Figure Sanofi-Aventis Overall Patent Portfolio by Source Jurisdiction Sanofi-Aventis Patents Specific to Diabetes Project Figure Sanofi-Aventis Diabetes Patents by Technology Group Priority Date by Year: Figure Sanofi-Aventis Diabetes Patents by Priority Year Published Date by Year: Figure Sanofi-Aventis Diabetes Patents by Published Year IPC Analysis Top 10 Codes: Figure Sanofi-Aventis Diabetes Patents by IPC Code USPC Analysis Top 10 Codes: Figure Sanofi-Aventis Diabetes Patents by USPC Code Source Jurisdiction: Figure Sanofi-Aventis Diabetes Patents by Source Jurisdiction SUMMARY OF PATENT AND PRODUCT POSITIONS OF TOP DIABETES DEVICE COMPANIES Table 7.1 Table of Highlighted Companies and Technologies APPENDIX A - ASSUMPTIONS Patent Current Assignee vs. Ultimate Parent xxi