Diabetes Landscape: Market, Technology and Intellectual Property

• Publication date: May 2012
• Report size: 562 pages

There are as many as 183 million people unaware that they have diabetes, including at least 78% of people with diabetes in Africa. In some of the poorest regions in the world, where infectious diseases have traditionally been the focus of healthcare systems, diabetes cases are expected to increase by 90% by 2030. While most of the increase in diabetes prevalence is associated with the Type 2 form, the IDF also estimates there is a 3% incre...

There are as many as 183 million people unaware that they have diabetes, including at least 78% of people with diabetes in Africa. In some of the poorest regions in the world, where infectious diseases have traditionally been the focus of healthcare systems, diabetes cases are expected to increase by 90% by 2030.

While most of the increase in diabetes prevalence is associated with the Type 2 form, the IDF also estimates there is a 3% increase annually in Type 1 diabetes in children aged under 15. Its data show there were 490,100 children in this age group globally with the condition in 2011 and the number of cases is rising by 77,800 annually.

The human cost
According to the World Health Organisation, 50% of people with diabetes die of cardiovascular disease, primarily heart disease or stroke. After 15 years of diabetes, approximately 2% of people become blind and about 10% develop severe visual impairment. In addition, 10 to 20% die of kidney failure, while diabetic neuropathy affects up to 50% of people with diabetes.

A global challenge
Although seen as a problem mainly affecting Western countries, in fact, 80% of people with diabetes live in low and middle income countries. The IDF estimates that the Western Pacific Region had the highest number of people with diabetes aged 20 to 79 years, at 132 million, while the African Region had the smallest number, at 15 million in 2011. However, the region with the highest comparative prevalence was the Middle East and North Africa, at 11%, followed by the North America and Caribbean Region, at 10.7%. Prevalence in the Western Pacific Region was significantly lower, at 8.3%, while prevalence in the Europe region was 6.7%, representing the lowest after Africa.

Monitoring and treatment – critical components in disease management
Successful diabetes management is dependent on being able to accurately monitor blood glucose levels. That requires a range of both clinician and patient devices that are accurate, reliable and convenient. In addition, products that enable simple and convenient insulin delivery are needed by the quarter of diabetes patients that are insulin-dependent. The burgeoning diabetes burden represents a fast growing market place for companies who can supply those products.

"Who owns the rights to this technology? What trends are emerging? These and other questions are answered in this unmatched 2-volume report. Published by Espicom and UBM TechInsights, the report brings together their expertise to produce a study of insight and value."

Use this report to...

Understand the drivers of this US$12.4 billion industry
Appreciate the value of monitoring and treatment markets
Know the market share of leading companies such as J&J, Abbott, Bayer, Becton Dickinson and Medtronic
Assess new technologies and treatments which will change the diabetes market
Access detailed patent and technology analysis for the detection, treatment and monitoring of diabetes
Understand the emerging trends and commercialisation status
Compare and contrast the technology portfolio in major companies through their patent activities
Drill down into intellectual property trends in the diabetes device sector and see how they relate to market opportunities.

Who should read this report

Intellectual Property Professionals
Technology Licensing Specialists
Product Development Executives
Product and Marketing Managers
CTOs and Technical Managers
Researchers working in the diabetes space
Component Manufacturers


A high growth and resilient market
The diabetes care market has historically exhibited strong growth, leading global sales volumes to have increased from US$8.6 billion in 2005 to US$12.4 billion in 2011. This increase is generally being driven by the increasing prevalence of diabetes, the introduction of higher-priced newer technologies such as continuous glucose
monitoring, changing trends in the management of diabetes, and the development of healthcare systems of emerging markets in recent years.

Having experienced strong annual growth in the period before 2009, the market slowed considerably, rising by just 1% in that year and by 2% in 2010. Although most product areas continued to generate strong sales volumes, this lower growth was due to weakness in the self monitoring blood glucose market as a result of lower sales volumes and pricing pressure in the US due to the economic slowdown.

Since 2010, the diabetes care market has once again picked up, rising by 6% in 2011. This improvement has been due to renewed growth for self monitoring blood glucose (SMBG) products, helped by new product launches in the US but, mainly due to strong demand in emerging markets. The growth rates in the insulin delivery segment
slowed slightly during the year due to pricing pressure for pen needles and a slight slowdown in insulin pump sales as a result of the negative economic environment.

Prospects for new market entrants

Although the diabetes devices market comprises close to 100 companies, it is dominated by just six major manufacturers: Roche, Johnson & Johnson (J&J), Bayer, Medtronic, Abbott and Becton Dickinson. Given the importance of SMBG in the overall diabetes device market, it follows that most of these companies owe their strong market position to offerings in this area, where brand recognition and a strong sales and marketing presence are vital. Although the significant market positions of the top six companies imply there is little room for smaller companies, there do remain good
opportunities for companies with unique products or devices that compete in yet-to-be established markets.

For example, Insulet has grown its sales from just US$4 million in 2006 to nearly US$120 million in 2011 as a result of offering a unique insulin pump with significant benefits over those offered by the established market leaders. Its OmniPod was the world’s first tubing-free insulin pump, meaning it is smaller than many other devices; can be worn more discreetly; eliminates interruptions in insulin delivery due to
tubing kinks, leaks or disconnections; and, enables patients to move, dress, sleep and exercise more easily.
A forensic investigation of 5,900 patents in the diabetes device area has been distilled to provide a detailed assessment of who holds key technology patents worldwide.

This volume provides an in-depth analysis of the technologies and IP associated with diabetes devices, including:

Diabetes Monitoring
Blood glucose meters and test strips
Continuous glucose monitoring
Non-invasive and emerging technologies

Diabetes Treatment
Insulin delivery (including pens and insulin pumps)
Open loop continuous glucose monitoring/pumps
Closed loop artificial pancreas technology
Software & Algorithms

There are a significant number (over 500) of patent assignees. This report provides detailed analysis of:

Overall diabetes patent portfolio (including Priority Year, Patent Totals by Technology, Top Twenty Assignees, IPC and USP Classifications)
Diabetes patents by technology subcategory (including Priority Date, Top Twenty Assignees, and Analysis of Sample Patents)
Diabetes patents by key company (including Priority Date, Patent Distribution by Technology, and Patent Source Jurisdiction)

Analysis and commentary include discussion of the patent and product portfolio coverage of key companies. There are significant research and product development areas where leading companies lack coverage.

Investigation of assignee by technology group and forward citations of key patents provides insight into the large number of players and identifies potential targets for acquisition.

The patent holding and status of the following companies is covered in great detail:

Abbott
Arkray
Bayer
Becton Dickinson
DexCom
Insulet
J&J
Medtronic
Nipro
Novo Nordisk
Roche
Sanofi-aventis



This unprecedented combination of market, technology, and intellectual property information will provide a detailed look at the market and devices in this space as well as provide a perspective of the challenges and opportunities associated with diabetes.

Global Pathology Industry

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 7
1.1 BACKGROUND 7
1.1.1 Diagnosis and Management of Diabetes .8
Insulin-Dependant Diabetes Patients .9
Current Trends in Diabetes Care ..9
1.2 THE GLOBAL DIABETES BURDEN .10
1.2.1 Diabetes Prevalence 10
Fig.1.0: Diabetes Prevalence by Geographic Region, 2011-2030 .11
Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million) 11
Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group Study .12
1.2.2 Mortality .12
1.2.3 Diabetes Complications 13
1.2.4 The Cost of Diabetes 14
1.3 THE DIABETES DEVICE MARKET ..15
1.3.1 Product Segments .16
Fig.1.2: Diabetes Device Market by Major Product Category, 2011 .16
Fig.1.3: Percentage of US Diabetes Patients by Treatment Type, 2007-2009 .17
Fig.1.4: Diabetes Device Market by Product Type, 2011 18
1.3.2 Current Market Trends 19
Fig.1.5: Global Diabetes Device Market, 2011 (US$ billion) .19
Global Diabetes Market by Product Type, 2005-2011 (US$ million) ..20
Fig.1.6: Global Diabetes Market By Product Type, 2005-2011 (US$ billion) 20
Global Diabetes Market Growth Rates by Product Type, 2006-2011 (%) .21
Fig.1.7: Global Diabetes Device Market Growth Rates, 2006-2011 (%) ..21
1.3.3 Regional Perspective 21
Fig.1.8: Global Diabetes Device Market by Region, 2011 .22
Fig.1.9: US Market by Product Type, 2011 ..22
Fig.1.10: European Market by Product Type, 2011 23
Fig.1.11: Other Regions by Product Type, 2011 .23
1.4 COMPETITIVE ENVIRONMENT 24
Fig.1.12: Diabetes Device Market Share by Company, 2011 .25
Key Companies’ Diabetes Care Sales, 2005-2011 (US$ million) ..25
Non-US Companies’ Diabetes Sales in Reported Currency, 2005-2011 (million) 25
Leading Companies’ International Diabetes Care Sales, 2005-2011 (US$ million) ..26
Leading Companies’ US Diabetes Care Sales, 2005-2011 (US$ million) ..26
1.4.1 New Market Entrants .26
1.4.2 Market Withdrawals 27
1.4.3 Rounding Out Product Portfolios 28
Key Companies: Market Presence & Position by Product Area .28
Key Companies: Current & Future Potential Market Presence by Product Area ..29
1.4.4 Market Consolidation ..29
1.5 GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES ..30
1.5.1 Regulatory and Reimbursement Environment 31
1.5.2 Connectivity and Data Integration 32
The Role of Telemonitoring in Diabetes Care .32
Safety Issues 33
1.5.3 Emerging Technologies .34
New-Generation Insulin Delivery Devices .34
Development of a Closed-Loop System .35
Rival Technologies .35
1.6 MARKET EXPECTATIONS ..38
Fig.1.13: Global Diabetes Device Market, 2011-2017E (US$ billion) 38
Global Diabetes Market Forecast by Product Type, 2011-2017E (US$ million) 39
Global Diabetes Market Forecast Growth Rates by Product, 2011-2017E (%) 39
Fig.1.14: Global Monitoring Market Forecast, 2011-2017E (US$ billion) .39
Fig.1.15: Global Insulin Delivery Market Forecast, 2011-2017(E) (US$ billion) 40
Fig.1.16: Diabetes Device Market by Product, 2017E .40
2.0 DIABETES MONITORING PRODUCTS .41
Overview: Glucose Monitoring Products ..42
2.1 MARKET DYNAMICS .44
Fig.2.1: Global Glucose Monitoring Market, 2005-2011 (US$ billion) 44
Fig.2.2: Global Blood Monitoring Market Growth, 2005-2011 (%) ..44
Fig.2.3: Glucose Monitoring Market by Product Type, 2011 ..45
Fig.2.4: Blood Glucose Testing Market by Geographic Region, 2011 .45
Public Companies’ Glucose Monitoring Sales, 2005-2011 (US$ million) 45
Fig.2.5: Glucose Monitoring Market Shares by Company, 2011 .46
2.2 MANUAL SELF-MONITORING BLOOD GLUCOSE PRODUCTS 47
Fig.2.6: Example of a Classic BGM & Test Strip: Bayer’s Contour Meter .48
2.2.1 Current Market Environment . 48
Fig.2.7: Global SMBG Market, 2005-2011 (US$ million) .49
Fig.2.8: Global SMBG Market Growth Rates, 2005-2011 (%) .49
Fig.2.9: SMBG Market by Product Type, 2011 ..49
Regional Markets and Reimbursement 50
Fig.2.10: SMBG Market by Region, 2011 50
Market Developments 51
Fig.2.11: Mendor’s Discreet (left) & Roche’s Accu-Check Mobile with Attached Lancing Device (right) .51
Fig.2.12: BodyTel Europe’s GlucoTel BGM ..51
Fig.2.13: Medisana’s GlucoDock Attached to an Apple iPhone .52
Accuracy Standards ..53
Market Forecast 54
Summary: SMBG Growth Drivers, Restraints & Opportunities ..55
Fig.2.14: Global SMBG Market, 2011-2017E (US$ billion) .55
Fig.2.15: Global SMBG Market Growth Rates, 2012-2017E (%) ..56
2.2.2 Competitive Environment 56
Public Companies’ BGM Sales, 2005-2011 (US$ million) .57
Fig.2.16: SMBG Market Share by Company, 2011 .57
Fig.2.17: United States SMBG Market Share by Company, 2011 .58
Fig.2.18: SMBG International Market Share by Company, 2011 58
2.2.3 Market-Leading Self-Testing Blood Glucose Meters 59
1. Abbott’s Blood Glucose Monitors 59
2. Arkray’s Glucocard Products .60
3. Bayer’s Blood Glucose Monitoring Systems 61
4. ContourUSB 62
5. Contour, Contour TS, Contour Link and Breeze 2 62
6. DIDGET Meter ..63
7. Elite and Elite XL .63
LifeScan OneTouch Products 63
Nipro Diagnostics’ TRUE Products 66
Roche Diabetes Care’s Products 67
2.2.4 Other Market Participants 68
Competing Self-Testing Blood Glucose Monitoring Products 68
Product Highlights .71
2.2.5 Products in Development .77
Intuity Medical’s POGO Blood Glucose Monitoring System 77
Pepex Biomedical’s Trio Products .77
2.3 CONTINUOUS GLUCOSE MONITORING 78
Fig.2.19: Example of a CGM: Medtronic’s Guardian REAL-Time System .78
2.3.1 The Benefits of CGM 78
2.3.2 Barriers to Adoption .79
The Cost of CGM 79
2.3.3 Clinical Trial Results - Highlighting Benefits and Drawbacks .79
2.3.4 The TD1 Exchange: User Experiences of CGM 81
2.3.5 CGM Market Trends and Opportunities 82
Fig.2.20: Global CGM Market, 2006-2011 (US$ million) 82
Fig.2.21: Percentage of CGM Sales Volumes by Hardware & Consumables, 2011 82
Regional Adoption Rates, Regulatory and Reimbursement Environment .83
Fig.2.22: CGM Market by Region, 2011 83
Future Prospects ..84
Fig.2.23: Global CGM Market Forecast, 2011-2017E (US$ million) 85
Fig.2.24: Global CGM Market Forecast Growth Rates, 2011-2017E (%) .86
Summary: CGM Benefits, Challenges & Opportunities ..86
2.3.6 Competitive Environment 87
Leading Companies’ Reported CGM Sales, 2006-2011 (US$ million) 87
Fig.2.25: Global CGM Market Shares by Company, 2011 88
Fig.2.26: US CGM Market Shares by Company, 2011 .88
Fig.2.27: International CGM Market Shares by Company, 2011 .89
2.3.7 Currently-Available Products 89
Medtronic’s Guardian REAL-Time CGM System .89
DexCom’s CGMs 90
Abbott’s FreeStyle Navigator .91
A Menarini Diagnostics’ GlucoDay S 92
2.3.8 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 .95
2.4 NON-INVASIVE GLUCOSE MONITORING ..100
2.4.1 Competitive Environment .. 100
2.4.2 AIMEDICS’ HypoMon .101
2.4.3 Biosign Technologies’ UFIT TEN-20 Non-Invasive Blood Pressure and Glucose Meter 101
2.3.4 Biovotion’s Multisensor Glucose Monitoring System 102
2.3.5 Integrity Applications’ GlucoTrack .103
Clinical Study Results .103
2.3.6 Optical Technologies ..105
C8 MediSensors Optical Glucose Monitor ..105
EyeSense’s Optical Sensor 105
Freedom Meditech’s I-SugarX Glucose Monitoring System .106
Grove Instruments’ Grove Glucometer ..106
Lein Applied Diagnostics ..107
LighTouch Medical’s Non-Invasive Glucose Monitor .107
Massachusetts Institute of Technology’s Raman Spectroscopy System .108
Medtronic’s PreciSense Technology ..108
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
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
MD-Logic Artificial Pancreas System .173
Medtronic’s Closed-Loop System .174
Rensselaer Polytechnic Institute .175
6.0 POC MANUFACTURERS ..176
6.1 POC COMPANY DIRECTORY ..176
6.2 LEADING COMPANY PROFILES .184
6.2.1 Abbott Laboratories ..184
Recent Key Events .184
Blood Glucose Monitors 185
In Development - Navigator II CGM System .186
Alliance with Insulet .187
Litigation ..187
Financial Performance .188
Abbott Diabetes Care Sales by Region, 2006-2011 (US$ million) 188
Fig.6.1: Percentage of Abbott Diabetes Care Revenue by Region, 2011 .188
6.2.2 Arkray ..189
Recent Key Events .189
Blood Glucose Self-Testing .189
Current Alliances and Contracts 191
6.2.3 Bayer .192
Recent Key Events .192
Blood Glucose Monitoring Systems 192
Current Alliances .194
Litigation 195
Financial Performance .195
Bayer Diabetes Care Revenue, 2005-2011 (EUR million) 195
6.2.4 Becton, Dickinson and Company .196
Recent Key Events .196
BD Diabetes Care Products .196
Collaboration with the JDRF 197
Litigation with Insulet ..197
Financial Performance .197
BD Diabetes Care Sales by Region, 2006-2011 (US$ million) 198
Fig.6.2: Percentage of BD Diabetes Care’s Revenue by Region, 2011 198
6.2.5 DexCom .199
Recent Key Events .199
SEVEN PLUS CGM System ..200
GlucoClear 201
Research and Development .201
SweetSpot Diabetes Care Acquisition 201
Current Alliances .202
Litigation with Abbott .203
Financial Performance .204
DexCom - Operating Results, 2007-2011 (US$ thousands) .205
6.2.6 Insulet .206
Recent Key Events .207
OmniPod Insulin Management System .207
Current Alliances .208
Acquisition of Neighborhood Diabetes .209
Litigation with Becton, Dickinson and Company .209
Financial Performance .209
Insulet - Operating Results, 2007-2011 (US$ thousands) .210
6.2.7 Johnson & Johnson .211
Recent Key Events .211
Animas Operations .212
LifeScan Operations 214
Financial Performance ..217
J&J Diabetes Care Revenue, 2006-2011 (US$ million) .218
Fig.6.3: J&J Diabetes Care Sales by Region, 2011 .218
Fig.6.4: J&J Diabetes Care Sales, 2004-2011 (US$ million) .218
6.2.8 Medtronic .219
Recent Key Events .219
Integrated Diabetes Management Products ..220
Guardian REAL-Time CGM System 221
iPro Professional Use CGM Products ..222
Enlite CGM Sensor ..222
MiniMed Paradigm Revel Insulin Pump and Infusion Sets ..222
CareLink Software ..223
Blood Glucose Meters ..223
Clinical Trials ..224
Research and Development .225
Alliance with Bayer 225
Financial Performance .226
Fig.6.5: Medtronic Diabetes Revenue, 2005-2011 (US$ million) 226
Medtronic - Diabetes Sales by Region, 2008-2011 (US$ million) .227
Fig.6.6: Medtronic Diabetes Revenue by Region, 2011 227
Fig.6.7: Medtronic Diabetes Revenue by Product Type, 2010* .227
6.2.9 Nipro Diagnostics 229
Recent Key Events .229
Blood Glucose Monitoring Products .230
Blood Glucose Monitors .230
6.2.10 Roche Diabetes Care 232
Recent Key Events .232
Diabetes Care Products 233
Accu-Chek Combo BGM and Pump System .234
Insulin Pumps 234
Data Management Tools 235
In Development - SOLO Micropump ..235
Current Alliances and Contracts ..236
Litigation 236
Financial Performance .237
Roche Diabetes Care Sales by Product, 2010-2011 (SFr million) 237
Roche Diabetes Care Sales by Region, 2006-2011 (SFr million) .237
Fig.6.8: Roche Diabetes Care - Revenue by Product Line, 2011 238
Fig.6.9: Roche Diabetes Care - Revenue by Region, 2011 .238
6.2.11 Ypsomed 239
Recent Key Events .239
mylife Diabetes Care Products .240
Ypsomed Delivery Systems 240
Acquisition of ICU Medical’s Orbit Infusion Set Business .241
Current Alliances .241
Financial Performance .242
Ypsomed - Operating Results, Y/E 31st March 2007-2011 (SFr millions) 243
Ypsomed - Results by Business Segment, Y/E 31st March 2009-2011 (SFr millions) ..243
Ypsomed - Revenue by Geographic Region, Y/E 31st March 2009-2011 (SFr millions) 244
Fig.6.10: Ypsomed - Revenue by Business Segment, Fiscal 2010 .244
Fig.6.11: Ypsomed - Revenue by Geographic Location, Fiscal 2010 245
7.0 APPENDICES 246
7.1 LIST OF ABBREVIATIONS 246
7.2 - REPORT METHODOLOGY 247
Sources ..247
Market forecasts 248
VOLUME II - DIABETES TECHNOLOGY AND INTELLECTUAL PROPERTY ANALYSIS
1.0 SUMMARY 251
Figure 1.1 – Diabetes Landscape by Technology 252
Figure 1.2 – High Level Overview of Diabetes Patent Activity .254
Figure 1.3 – Bar Chart of Totals for each Technology Group .255
Figure 1.4 – Top 20 Assignees Patents from this Study 256
Figure 1.5 - Blood Extraction by Priority Date by Assignee .257
Figure 1.6 – Number of Patents versus Revenue for Highlighted Companies .258
Figure 1.7 – Litigation Analysis ..259
Table 1.1 – Table of Highlighted Companies and Technologies .260
2.0 INTRODUCTION .262
3.0 TECHNOLOGY .264
Figure 3.1 – Diabetes Landscape by Technology .265
Figure 3.2 – Self Monitoring of Blood Glucose 266
Figure 3.3 – Blood Glucose Test Strip Operation 267
Figure 3.4 – Continuous Glucose Monitoring (CGM) .267
Figure 3.5 – Artificial Pancreas Representative Diagram 269
4.0 OVERVIEW OF PATENT ACTIVITIES .270
Figure 4.1 – High Level Overview of Diabetes Patent Activity .271
4.1 Analysis of Patents Sorted by this Study .273
Figure 4.2 – Bar Chart of Totals for each Technology Group .273
Figure 4.3 – Top 20 Assignees Patents from This Study .274
Figure 4.4 – Patents by Priority Date 275
Figure 4.5 – Priority Date by Top 5 Companies ..276
Figure 4.6 – Patents by Published Date .277
Figure 4.7 – Patents by Source Jurisdiction ..278
Figure 4.8 – Top 10 IPC Codes from the Patents Analyzed ..279
Figure 4.9 – Total U.S. Patents by Assignee ..280
Figure 4.10 – USP Classification Analysis within the U.S. Dataset ..281
5.0 PATENT ANALYSIS BY TECHNOLOGY SUBCATEGORY 282
5.1 Detection and Monitoring – Periodic – Invasive – Blood Extraction .283
Figure 5.1 – Blood Extraction – Top Assignees ..283
Priority Date by Year and Source: 284
Figure 5.2 - Blood Extraction by Priority Date .284
Priority Date by Year by Top 5 Assignees within the Subcategory: 285
Figure 5.3 - Blood Extraction by Priority Date by Assignee .285
Published Date by Year and Source: ..286
Figure 5.4 - Blood Extraction by Published Date 286
IPC Analysis – Top 10 Codes: .287
Figure 5.5 - Blood Extraction by IPC Code 287
USPC Analysis – Top 10 Codes: 288
Figure 5.6 - Blood Extraction by USPC Code ..288
Figure 5.7 – Blood Extraction - Text Clustering Analysis .289
Source Jurisdiction: 290
Figure 5.8 - Blood Extraction by Source Jurisdiction .290
Top Patents .291
Table 5.1 - Top Patents Identified in the Blood Extraction Group .291
US6461496B1: Abbott Laboratories 292
Figure 5.9 – Representative Image in US6461496 ..292
Figure 5.10 – Top 20 Companies Citing US6461496 .293
US5916230A: Bayer AG 294
Figure 5.11 – Representative Images of US5916230 .294
Figure 5.12 – Top 20 Companies Citing US5916230 295
5.2 Detection and Monitoring – Periodic – Invasive – Test Strips .296
Figure 5.13 – Test Strips – Top Assignees .296
Priority Date by Year and Source: 297
Figure 5.14 - Test Strips by Priority Date .297
Priority Date by Year by Assignee: 297
Figure 5.15 - Test Strips by Priority Date by Assignee 297
Published Date by Year: .298
Figure 5.16 - Test Strips by Published Date .298
IPC Analysis – Top 10 Codes: .299
Figure 5.17 - Test Strips by IPC Code 299
USPC Analysis – Top 10 Codes: 300
Figure 5.18 - Test Strips by USPC Code .300
Text Clustering Analysis: 301
Figure 5.19 – Test Strips - Text Clustering Analysis ..301
Source Jurisdiction: 302
Figure 5.20 - Test Strips by Source Jurisdiction 302
Top Patents .303
Table 5.2 - Top Patents Identified in the Test Strips Group ..303
US5496453A: Arkray, Inc. .304
Figure 5.21 – Representative Image in US5496453 304
Figure 5.22 – Top 20 Companies Citing US5496453 .305
US5563042: Johnson & Johnson .306
Figure 5.23 – Representative Image in US5563042 306
Figure 5.24 – Top 20 Companies Citing US5563042 .307
5.3 Detection and Monitoring – Periodic – Invasive – Devices 308
Figure 5.25 – Devices – Top Assignees ..308
Priority Date by Year: .309
Figure 5.26 - Devices by Priority Date 309
Priority Date by Year by Assignee: 309
Figure 5.27 - Devices by Priority Date by Assignee ..309
Published Date by Year and Source: 310
Figure 5.28 - Devices by Published Date .310
IPC Analysis – Top 10 Codes: 311
Figure 5.29 - Devices by IPC Code 311
USPC Analysis – Top 10 Codes: .312
Figure 5.30 - Devices by USPC Code 312
Text Clustering Analysis: .313
Figure 5.31 – Devices - Text Clustering Analysis .313
Source Jurisdiction: .314
Figure 5.32 - Devices by Source Jurisdiction ..314
Top Patents 315
Table 5.3 - Top Patents Identified in the Devices Group .315
US6233471: Johnson & Johnson .316
Figure 5.33 – Representative Image in US6233471 316
Figure 5.34 – Top 20 Companies Citing US6233471 .317
5.4 Detection and Monitoring – Periodic – Minimally Invasive – Interstitial Fluid .318
Figure 5.35 – Interstitial Fluid – Top Assignees .318
Priority Date by Year: 319
Figure 5.36 - Interstitial Fluid by Priority Date 319
Priority Date by Year by Assignee: .319
Figure 5.37 - Interstitial Fluid by Priority Date 319
Published Date by Year: .320
Figure 5.38 - Interstitial Fluid by Published Date .320
IPC Analysis - Top 10 Codes: 321
Figure 5.39 - Interstitial Fluid by IPC Code 321
USPC Analysis – Top 10 Codes: 322
Figure 5.40 - Interstitial Fluid by USPC Code ..322
Text Clustering Analysis: 323
Figure 5.41 – Interstitial Fluid - Text Clustering Analysis .323
Source Jurisdiction: 324
Figure 5.42 - Interstitial Fluid by Source Jurisdiction .324
Top Patents .325
Table 5.4 - Top Patents Identified in the Interstitial Fluid Group 325
US5582184: Alere Incorporated .326
Figure 5.43 – Representative Image in US5582184 326
Figure 5.44 – Top 20 Companies Citing US5582184 .327
5.5 Detection and Monitoring – Periodic – Minimally Invasive – Skin Diffusion ..328
Figure 5.45 – Skin Diffusion – Top Assignees .328
Priority Date by Year: .329
Figure 5.46 - Skin Diffusion by Priority Date .329
Priority Date by Year by Assignee: 329
Figure 5.47 - Skin Diffusion by Priority Date by Assignee .329
Published Date by Year: .330
Figure 5.48 - Skin Diffusion by Published Date ..330
IPC Analysis – Top 10 Codes: .331
Figure 5.49 - Skin Diffusion by IPC Code .331
USPC Analysis – Top 10 Codes: 332
Figure 5.50 - Skin Diffusion by USPC Code 332
Text Clustering Analysis: 333
Figure 5.51 – Skin Diffusion - Text Clustering Analysis 333
Source Jurisdiction: 334
Figure 5.52 - Skin Diffusion by Source Jurisdiction ..334
Top Patents .334
Table 5.5 - Top Patents Identified in the Skin Diffusion Group .334
US6454710: Johnson & Johnson .335
Figure 5.53 – Representative Image in US6454710 335
Figure 5.54 – Top 20 Companies Citing US6454710 .336
5.6 Detection and Monitoring – Periodic – Non Invasive – Optical .337
Figure 5.55 – Non Invasive - Optical – Top Assignees .337
Priority Date by Year: .338
Figure 5.56 - Non Invasive - Optical by Priority Date .338
Priority Date by Year by Assignee: 338
Figure 5.57 - Non Invasive - Optical by Priority Date .338
Published Date by Year: .339
Figure 5.58 - Non Invasive - Optical by Published Date 339
IPC Analysis – Top 10 Codes: .340
Figure 5.59 - Non Invasive - Optical by IPC Code 340
USPC Analysis – Top 10 Codes: 341
Figure 5.60 - Non Invasive - Optical by USP Class Code 341
Text Clustering Analysis: 342
Figure 5.61 – Non Invasive - Optical - Text Clustering Analysis .342
Source Jurisdiction: 343
Figure 5.62 - Non Invasive - Optical by Source Jurisdiction .343
Top Patents .344
Table 5.6- Top Patents Identified in the Non Invasive Optical Group 344
US5743262: Masimo Corporation 345
Figure 5.63 – Representative Image in US5743263 345
Figure 5.64 – Top 20 Companies Citing US5743263 346
US6040578: Sensys Medical Inc 347
Figure 5.65 – Patent Diagram of US6040578 .347
Figure 5.66 – Top 20 Companies Citing US6040578 .348
5.7 Detection and Monitoring – Periodic – Non Invasive – Other 349
Figure 5.67 – Non-Invasive Other – Top Assignees 349
Priority Date by Year: .350
Figure 5.68 – Non-Invasive Other by Priority Date .350
Priority Date by Year by Assignee: 350
Figure 5.69 - Non-Invasive Other by Priority Date by Assignee 350
Published Date by Year: .351
Figure 5.70 - Non-Invasive Other by Published Date 351
IPC Analysis – Top 10 Codes: .352
Figure 5.71 - Non Invasive Other by IPC Code 352
USPC Analysis – Top 10 Codes: 353
Figure 5.72 - Non Invasive Other by USPC Code ..353
Text Clustering Analysis: 354
Figure 5.73 – Non Invasive Other - Text Clustering Analysis .354
Source Jurisdiction: 355
Figure 5.74 – Non-Invasive - Other by Source Jurisdiction .355
Top Patents .355
Table 5.7 - Top Patents Identified in the Non Invasive – Other Group .355
US6572542: Medtronic Inc .356
Figure 5.75 – Representative Image in US6572542 356
Figure 5.76 – Top 20 Companies Citing US6572542 .357
5.8 Detection and Monitoring – Continuous – Non-Implanted .358
Figure 5.77 – Continuous Non-Implanted – Top Assignees .358
Priority Date by Year: .359
Figure 5.78 - Continuous Non-Implanted by Priority Date .359
Priority Date by Year by Assignee: 359
Figure 5.79 - Continuous Non-Implanted by Priority Date by Assignee 359
Published Date by Year: .360
Figure 5.80 - Continuous Non-Implanted by Published Date ..360
IPC Analysis – Top 10 Codes: .361
Figure 5.81 - Continuous Non-Implanted by IPC Code .361
USPC Analysis – Top 10 Codes: 362
Figure 5.82 - Continuous Non-Implanted by USPC Code .362
Figure 5.83 – Continuous Non-Implanted -Text Clustering Analysis 363
Source Jurisdiction: 364
Figure 5.84 - Continuous Non-Implanted by Source Jurisdiction 364
Top Patents .365
Table 5.8 - Top Patents Identified in the Continuous Non-Implanted Group 365
US6931327: Dexcom, Inc. ..366
Figure 5.85 – Representative Image in US6931327 366
Figure 5.86 – Top 20 Companies Citing US6931327 367
5.9 Detection and Monitoring – Continuous – Implanted .368
Figure 5.87 – Continuous Implanted – Top Assignees 368
Priority Date by Year: .369
Figure 5.88 - Continuous Implanted by Priority Date ..369
Priority Date by Year by Assignee: 369
Figure 5.89 - Continuous Implanted by Priority Date by Assignee ..369
Published Date by Year: .370
Figure 5.90 - Continuous Implanted by Published Date .370
IPC Analysis – Top 10 Codes: .371
Figure 5.91 - Continuous Implanted by IPC Code .371
USPC Analysis – Top 10 Codes: 372
Figure 5.92 - Continuous Implanted by USPC Code .372
Text Clustering Analysis: 373
Figure 5.93 – Continuous Implanted - Text Clustering Analysis 373
Source Jurisdiction: .374
Figure 5.94 - Continuous Implanted by Source Jurisdiction 374
Top Patents .375
Table 5.9 - Top Patents Identified in the Continuous Implanted Group .375
Figure 5.95 – Representative Image in US6001067 376
Figure 5.96 – Top 20 Companies Citing US6001067 .377
5.10 Treatment – Manual – Syringe 378
Figure 5.97 – Syringe – Top Assignees 378
Priority Date by Year: .379
Figure 5.98 - Syringe by Priority Date 379
Prior

Endocrine, Nutritional And Metabolic Diseases in World

Iran Protein-energy Malnutrition, 70+ Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Iran, World

Turkey Protein-energy Malnutrition, 70+ Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : World

Mali Protein-energy Malnutrition, 70+ Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Mali, World

Oman Protein-energy Malnutrition, 70+ Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Oman, World

Peru Protein-energy Malnutrition, 70+ Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2004 To 2029
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Peru, World

Pathology in World

Palau Post-traumatic Stress Disorder, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : World

Iraq Prostate Cancer, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Iraq, World

Cote D`ivoire Post-traumatic Stress Disorder, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : World

Congo-brazzaville Peptic Ulcer Disease, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : World

Mali Post-traumatic Stress Disorder, 45-59 Yrs, Male, Dalys

• $ 250
• Industry data
• May 2013

Yearly, From 2005 To 2030
By Business Monitor International
Source: WHO, World Bank, IMF, BMI research

• Industries : Pathology
• Countries : Mali, World