World Diabetes Diagnostics Market

World Diabetes Diagnostics Market

This report analyzes the worldwide markets for Diabetes Diagnostics in Millions of US$. The major product segments analyzed are Blood Glucose Testing Devices (Blood Glucose Test Ki, Blood Glucose Meter/Monitor, Diabetes Kit, & Diabetes Tracking System), and Diabetes Testing Supplies (Blood Glucose Test Strips, Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta Glucose, & Others (Include Blood Glucose Sensors, Control Solution, Glutose, Reagent Strip, & Blood Glucose Insta Glucose), and Others (Include Blood Glucose Sensors, Control Solution, Glutose, and Reagent Tablets). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World. Annual forecasts are provided for each region for the period of 2000 through 2015. The report profiles 61 companies including many key and niche players worldwide such as Abbott Diabetes Care, Bayer HealthCare, Bayer Diabetes Care, Metrika, Inc., Bio-Rad Laboratories, Home Diagnostics, Inc., Inverness Medical Innovations, Inc., LifeScan, Inc., Medtronic MiniMed, Inc, Roche Diagnostics, Sanwa Kagaku Kenkyusho Co. Ltd., and Siemens Healthcare Diagnostics. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

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A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Blood Glucose Testing Devices I-4
Blood Glucose Monitor I-4
Diabetes Kit I-4
Diabetes Tracking System I-4
Blood Glucose Sensor I-4
Diabetes Testing Supplies I-4
Blood Glucose Test Strips I-4
Lancet I-4
Lancet Device I-5
Reagent Strips I-5


II. EXECUTIVE SUMMARY

1. Market Overview II-1
Current & Future Analysis II-1
Analysis by Geographic Region II-1
Table 1: Global Market for Diabetes Diagnostics (2000-2010):
Geographic Regions (US, Canada, Japan, Europe, Asia-Pacific
and Latin America) Ranked by CAGR (includes corresponding
Graph/Chart) II-1
Analysis by Product Group II-1
Table 2: Global Market for Diabetes Diagnostics (2000-2010):
Product Groups (Blood Glucose Testing Devices, Diabetes
Testing Supplies, and Others) Ranked by CAGR (includes
corresponding Graph/Chart) II-2
Major Pharma Players - Focusing on Diabetes Diagnostics II-2
Increasing Number of Diabetic Cases Drives Demand for Diagnostics II-2
Prevalence of Diabetes II-3
Diabetes- Take the Toll in Developing Countries II-3
Table 3: A Peek into Aging Population Statistics in BRIC
Countries by Age Group - 15 to 64 Years and More than 65
Years for the Years 2005 & 2006 (In %) (includes
corresponding Graph/Chart) II-3

Table 4: Worldwide Diabetics Market (2000 & 2025):
Percentage Breakdown of Diabetes Incidence by Region -
India, China, Brazil, Russia and Others (includes
corresponding Graph/Chart) II-4

2. Market Trends II-5
Focus on Established Procedures Driving Growth II-5
Insulin Delivery Systems - A Potential High Growth Segment II-5
Significant Increase in Number of Diabetics II-5
Footwear Manufacturers Gaining from Diabetes II-5
Portable Glucose Meters Fast Replacing Conventional Testing
Methods II-5
Point-of-Care Testing - A Profitable Venture II-6
It Pays to be Customer Focused in a Mature Market II-6
Competitive Scenario in the Recent Past II-6
Table 5: Leading Players in the Global Blood Glucose
Monitoring Systems Market in the Recent Past (2003 & 2004):
Percentage Breakdown of Sales Revenues for Roche Diagnostics,
LifeScan (Johnson & Johnson), Bayer, Abbott Diabetes Care,
Home Diagnostics and Others (includes corresponding
Graph/Chart) II-6

Table 6: Leading Players in the US Blood Glucose Meters
Market in the Recent Past (2003 & 2004): Percentage Breakdown
of Sales Revenues for LifeScan (Johnson & Johnson), Roche,
Bayer, Abbott Diabetes Care and Others (includes
corresponding Graph/Chart) II-7

Table 7: Leading Players in the US Blood Glucose Strips
Market in the recent Past (2003 & 2004): Percentage Breakdown
of Sales Revenues for LifeScan (Johnson & Johnson), Roche,
Bayer, Abbott Diabetes Care and Others (includes
corresponding Graph/Chart) II-7

3. Trends in Diabetes Management II-8
Rising Population of Diabetics II-8
Advancements in Glucose Monitoring Devices - A New Ray of Hope II-8
Innovations in Insulin Delivery II-8
Pain-Free and Alternate-Site Glucose Monitoring II-9
Continuous Glucose Monitoring II-9
Up-to-the-Minute Monitoring II-9
Advances in Insulin Delivery II-10
Pulmonary Insulin Delivery II-10
Jet Injection II-10
Ultrasonic Transdermal-Patch Technology II-10
Insulin Delivery via Mouth Spray II-10
Artificial Pancreas Technology II-11
Increased Incidence of Diabetes Among HIV+ II-12
Recent Advancements in Diabetes Management II-12
New Developments II-12
Recent Advancements in Diabetes Therapy II-13
Aldose Reductase Inhibitors (ARI) II-13
Advanced Glycation End-Product Inhibitors (AGEI) II-13

4. Technological Trends II-14
Innovative Product Design Developments Enhancing Diabetic’s
Quality of Life II-14
Reducing Costs for Managed Care Service Providers - Emerging
Trend II-14
Finding Solutions Through Innovations II-14

5. Bloodless Testing II-16
High Price - The Only Hurdle II-16
The World’s First Non-Invasive Glucose Sensor II-16
Medicare Coverage - A Strong Positive II-16

6. OTC/Physicians’ Office Diabetes Tests Market II-17
In-home Tests: Making Health Control Easier II-17
Common OTC Tests II-17
Glucose Monitor II-17
Cholesterol II-17
Major Market Segments in OTC/Physicians’ Office Diabetes Tests II-17
Urine Strips II-17
Blood Glucose Strips: A Well Established Market II-18
Blood Glucose Meters II-18
PBGM Devices: Based on Photometric or Biosensor Technology II-19

7. Laboratory Diabetes Tests Market II-21
Various Types of Laboratory Diabetes Tests II-21
Blood Glucose & Related Tests II-21
Fructosamine Tests: To Diagnose Gestational Diabetes II-21
Glycosylated Hemoglobin Tests: A Promising Approach in
Diagnosing Diabetes Mellitus II-21
Glycosylated Haemoglobin Tests - Paving Way for Early Stage
Diabetes Diagnosis II-21
Immunoassays (Anti-Insulin and Anti-Islet Antibodies) II-22
It Pays to Introduce Advanced Instruments II-22
Urine Ketones and Microalbuminuria: To Test Type I Diabetes II-22
Diabetic Renal Disease with Reference to Microalbuminuria II-23
All Other Diabetes Tests II-23
Diabetes Tests II-23
Fasting Plasma Glucose Test II-23
Casual Glucose Test II-23

8. Diabetes Diagnostics - An Overview II-24
Classification II-24
Blood Glucose Testing Devices II-24
Blood Glucose Monitor/Meter II-24
Select Blood Glucose Meters Based on Test Strips II-25
Select Blood Glucose Monitors Based on Sampling Method II-25
Diabetes Kit II-25
Diabetes Tracking System II-25
Blood Glucose Sensor II-25
Diabetes Testing Supplies II-26
Blood Glucose Test Strips II-26
Lancet II-26
Lancet Device II-26
Reagent Strips II-26
Reagent Tablet II-26

9. Diabetes: A Chronic Body Disorder II-27
Diabetes Symptoms II-27
Diabetes: One of the Leading Causes of Death in Developed
Countries II-27
Types of Diabetes II-28
Type I Diabetes: Insulin-Dependent Diabetes Mellitus (IDDM) II-28
Type II Diabetes: Non Insulin-Dependent Diabetes Mellitus (
NIDDM) II-28
NIDDM Might Lead to Cardiovascular Complications II-29
Increasing Occurrence of Type II Diabetes Worldwide II-29
Factors Influencing Type 2 diabetes II-30
Agents Used For Type2 Diabetes Treatment II-30
Diabetes: A Major Healthcare Challenge II-30
Etiological Factors Causing Diabetes II-30
Insulin Types II-31

10. Diabetes-Related Complications II-32
Possible Complications of Diabetes II-32
Microvascular Complications (Small Blood Vessel Damage) II-32
Macrovascular Complications (Large Blood Vessel Damage) II-32
Other Complications II-33
Microvascular Complications (Small Blood Vessel Damage) II-33
Retinopathy II-33
Diabetic Neuropathy II-33
Nephropathy II-33
Macrovascular Complications (Large Blood Vessel Damage) II-33
Cardiac Problems II-33
Hypertension (High Blood Pressure) II-33
Other Major Complications II-34
Infections II-34
Impotence II-34
Pregnancy Complications II-34
Other Complications Resulting from Diabetes II-34
Obesity II-34
Obsessive Compulsive Disorder II-34
Foot Ulcers II-34
Dementia and its Association with Diabetes II-35
Hypoglycemia II-35
Diabetic Ketoacidosis II-36
Undiagnosed Diabetics: More Prone to Cardiovascular Diseases II-36

11. Diabetes Incidence II-37
Diabetics Cases Worldwide - A Demographic Analysis by
Geographic Region II-37
North America II-37
United States II-37
Canada II-37
Mexico II-37
Table 8: Prevalence Estimates of Diabetes Mellitus in North
America: 2000-2001 II-38

Table 9: Prevalence Estimates of Type 1 Diabetes Mellitus
in North America: 2000-2001 II-38
Europe II-38
Table 10: Prevalence Estimates of Diabetes Mellitus in
Europe: 2000-2001 II-39

Table 11: Prevalence Estimates of Type 1 Diabetes Mellitus
in Europe: 2000-2001 II-40
Asia-Pacific II-41
Southeast Asian Region II-41
Western Pacific Region II-41
Table 12: Prevalence Estimates of Diabetes Mellitus in
South-East Asia: 2000-2001 II-41

Table 13: Prevalence Estimates of Type 1 Diabetes Mellitus
in Southeast Asia: 2000-2001 II-42

Table 14: Prevalence Estimates of Diabetes Mellitus in
Western Pacific: 2000-2001 II-42
South & Central America II-42
Type-1 Diabetes II-42
Type-2 Diabetes II-43
Prevalence of Complications II-43
Table 15: Prevalence of Diabetes Complications in South
and Central American Region: 2000 II-43

Table 16: Prevalence Estimates of Diabetes Mellitus in
South & Central America: 2000-2001 II-44

Table 17: Prevalence Estimates of Type 1 Diabetes Mellitus
in South & Central America: 2000-2001 II-45
Rest of World II-46
Table 18: Prevalence Estimates of Diabetes Mellitus in
Africa: 2000-2001 II-46

Table 19: Prevalence Estimates of Type 1 Diabetes Mellitus
in Africa: 2000-2001 II-47

12. Product Launches/Introductions II-48
Medtronic, Bayer to Launch Blood Glucose Meter II-48
Bio-Rad Launches Liquichek™ Diabetic Control II-48
Home Diagnostics Introduces TRUEread II-48
Medtronic’s CGMS® iPro™ Receives FDA Approval II-48
Siemens Introduces the DCA Vantage™ Analyzer II-49
Arkray Introduces Analyzers for Diabetes Testing II-49
Bayer Releases Brio® and Breeze® Diabetes Management Systems
in South Korea and China II-49
GenExel-Sein Introduces DUO-CARE™ Home-Use Diabetes Products II-49
HemoCue Unveils New Testing System for Point of Care Use II-50
LifeScan Launches Easy-to-Use Glucose Meter II-50
Roche Rolls Out ACCU-CHEK® Spirit Insulin Pump System II-50
Novo Nordisk Introduces Simple-to-Use GlucaGen ® HypoKit™ II-50
Biomerica Launches New Diabetes Diagnostic Test II-50
Hypoguard Introduces New Glucose Meter II-51
Bio-Rad Launches VARIANT™ II TURBO Monitoring System II-51
Roche Launches Accu-Chek Go for Blood Glucose Monitoring II-51
Roche Diagnostics Launches Accu-Chek Lancing System II-51
LifeScan Introduces Glucose Meter in India II-51
Abbott Laboratories Introduces Two New Glucose Meters in Europe II-51
HDI Launches KetoCare™ Ketone Test Strips II-52
Roche Diagnostics Unveils Accu-Chek D-TRON Plus II-52
Abbott Introduces Precision Xtra™ Advanced Diabetes Management
System II-52
Abbott Diabetes Care Launches Precision Xtra™ Blood Glucose
Test Strip II-52
LifeScan Introduces Onetouch Horizon II-52
Bayer Diagnostics Unveils Ascensia® CONTOUR™ Blood Glucose
Monitoring System II-52

13. Recent Industry Activity II-53
OPG Acquires Hahn & Hahn II-53
Nanobac Agrees to Acquire DNAPrint Genomics II-53
Novo Nordisk’s R&D Plans in India II-53
NationsHealth Acquires Diabetes Care & Education II-53
Inverness Acquires Cholestech II-53
WaveSense Launches European Subsidiary II-54
XMDC, Diabetes Detection Sign on Distribution Agreement II-54
IQMC Agrees on Acquisition of Lifecare AS II-54
Bayer’s Contour TS Test Strip Market Recall II-54
BBI Acquires CDx and Audiometrics II-54
Bayer Receives Ease-Of-Use Commendation for Ascensia® BREEZE®
Blood Glucose Monitoring System II-54
BYETTA® (exenatide) Receives Marketing Authorization from
European Commission II-55
Bayer Diabetes Care Acquires Metrika II-55
BD Walks Out of BGM Market II-55
Bio-Rad Acquires Provalis’ Medical Diagnostics Division II-55
Bio-Rad Inks Multi-Year Agreement with Premier II-55
Cholestech and Life Line Collaborate Over Diagnostic Testing II-55
FDA Approves Medtronic’s MiniMed Paradigm® RT CGM System II-56
FDA Clears Abbott’s FreeStyle® Freedom™ Blood Glucose Meter II-56
FDA Approves Hypoguard’s Blood Glucose Monitor II-56
FDA Approves DexCom’s Continuous Glucose Monitoring System II-56
Johnson & Johnson Acquires Animas Corporation II-56
LifeScan and NIR Agree on Extension of First Option Agreement II-57
Pfizer Obtains Global Rights to Inhalable Human Insulin -
Exubera® II-57
Roche Receives FDA Clearance for Acu-Check Insulin Pump II-57
Sphere Medical and Analogic Team up for Monitoring Solutions II-57
NeuroMetrix Wins Exclusive Marketing License of DigiScope II-57
FDA Recommends Exubera® for Diabetic Patients II-57
Bio-Rad and Sysmex Ink Co-Marketing Agreement II-58
Diabetes Gold Forms Joint Venture with BioTex Labs II-58
FDA Grants 510(k) Clearance for Abbott’s Freestyle Connect™
Blood Glucose Meter II-58
FDA Clears Hypoguard’s Advance Micro-draw™ Blood Glucose System II-58
FDA Approves Home Diagnostics’ Blood Glucose Testing System II-58
Insulet Corporation and Solectron Collaborate to Develop OmniPod™ II-58
PolyMedica Acquires National Diabetic Pharmacies II-59
Cygnus, Inc. Divests its Glucose-Monitoring Assets II-59
Home Diagnostics’ Blood Glucose Monitor Features in Best Rx
Value Drug List of Ohio II-59
Roche Diagnostics Receives US FDA Approval for its Latest
Blood Glucose Meter II-59
Provalis Ships in2it A1C to US II-59
Hitachi Develops Unique Non-Invasive Device for Diabetes
Monitoring II-60
Bayer Diagnostics Business Splits into Two Units II-60
Abbott Laboratories Acquires TheraSense Inc. II-60
Roche Acquires Infusion Systems Division of Disetronic II-60
Bristol-Myers Squibb Enters into Alliance with Merck II-60
Provalis Receives FDA Approval II-60
Gunze Enters into an Agreement with Sanko Junyaku Strike II-61
Health Hero Network Receives US FDA Approval II-61
Roche Diagnostics Corporation Receives Contract from Premier Inc II-61
Vitro Introduces Stem Cell Therapy for Diabetes II-61
Home Diagnostics’ Blood Glucose Monitor Features in RxAmerica
National Formulary II-61
Home Diagnostics’ Blood Glucose Monitor Features in Procare Rx
National Formulary II-61
Medtronic Receives FDA Approval for its New Continuous
Glucose Monitoring System II-61
Roche Diagnostics Awarded Blood Glucose and Lancet Contracts II-62
HDI’s TrueTrack Smart System Wins FDA Approval for AST II-62
Seradyn Bags US FDA Clearance for HbA1c Assay II-62
Bristol-Myers Squibb Receives Exclusive Rights to AlcNow
Diabetes Monitor II-62
Bio-Rad Laboratories Awarded 510(k) Clearance for VARIANT™ II
TURBO II-62

14. Focus on Select Players II-63
Abbott Diabetes Care (US) II-63
Bayer HealthCare (US) II-63
Bayer Diabetes Care (US) II-63
Metrika, Inc. (US) II-63
Bio-Rad Laboratories (US) II-64
Home Diagnostics, Inc. (US) II-64
Inverness Medical Innovations, Inc (US) II-64
LifeScan, Inc. (US) II-64
Medtronic MiniMed, Inc. (US) II-65
Roche Diagnostics (Switzerland) II-65
Sanwa Kagaku Kenkyusho Co, Ltd. (Japan) II-65
Siemens Healthcare Diagnostics (US) II-66

15. Global Market Perspective II-67
Table 20: World Recent Past, Current & Future Analysis for
Diabetes Diagnostics by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-67

Table 21: World Long-term Projections for Diabetes Diagnostics
by Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-68

Table 22: World 10-Year Perspective for Diabetes Diagnostics
by Geographic Region/Country - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (Excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-69

Table 23: World Recent Past, Current & Future Analysis for
Blood Glucose Testing Devices by Geographic Region/Country -
US, Canada, Japan, Europe, Asia-Pacific (Excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) II-70

Table 24: World Long-term Projections for Blood Glucose
Testing Devices by Geographic Region/Country - US, Canada,
Japan, Europe, Asia-Pacific (Excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-71

Table 25: World 10-Year Perspective for Blood Glucose Testing
Devices by Geographic Region/Country - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-72

Table 26: World Recent Past, Current & Future Analysis for
Blood Glucose Testing Devices by Product Segment - Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) II-73

Table 27: World Long-term Projections for Blood Glucose
Testing Devices by Product Segment - Blood Glucose Test Kit,
Blood Glucose Meter/Monitor, Diabetes Kit, and Diabetes
Tracking System Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-73

Table 28: World 10-Year Perspective for Blood Glucose Testing
Devices by Product Segment - Percentage Breakdown of Dollar
Sales for Blood Glucose Test Kit, Blood Glucose Meter/Monitor,
Diabetes Kit, and Diabetes Tracking System Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-74

Table 29: World Recent Past, Current & Future Analysis for
Blood Glucose Test Kits by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-75

Table 30: World Long-term Projections for Blood Glucose Test
Kits by Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-76

Table 31: World 10-Year Perspective for Blood Glucose Test
Kits by Geographic Region/Country - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-77

Table 32: World Recent Past, Current & Future Analysis for
Blood Glucose Meters/Monitors by Geographic Region/Country -
US, Canada, Japan, Europe, Asia-Pacific (Excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) II-78

Table 33: World Long-term Projections for Blood Glucose
Meters/ Monitors by Geographic Region/Country - US, Canada,
Japan, Europe, Asia-Pacific (Excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-79

Table 34: World 10-Year Perspective for Blood Glucose
Meters/Monitors by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets for Years 2003, 2008 & 2012 (includes
corresponding Graph/Chart) II-80

Table 35: World Recent Past, Current & Future Analysis for
Diabetes Kits by Geographic Region/Country - US, Canada,
Japan, Europe, Asia-Pacific (Excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-81

Table 36: World Long-term Projections for Diabetes Kits by
Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-82

Table 37: World 10-Year Perspective for Diabetes Kits by
Geographic Region/Country - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (Excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-83

Table 38: World Recent Past, Current & Future Analysis for
Diabetes Tracking Systems by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-84

Table 39: World Long-term Projections for Diabetes Tracking
Systems by Geographic Region/Country - US, Canada, Japan,
Europe, Asia-Pacific (Excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-85

Table 40: World 10-Year Perspective for Diabetes Tracking
Systems by Geographic Region/Country - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-86

Table 41: World Recent Past, Current & Future Analysis for
Diabetes Testing Supplies by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-87

Table 42: World Long-term Projections for Diabetes Testing
Supplies by Geographic Region/Country - US, Canada, Japan,
Europe, Asia-Pacific (Excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-88

Table 43: World 10-Year Perspective for Diabetes Testing
Supplies by Geographic Region/Country - Percentage Breakdown
of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-89

Table 44: World Recent Past, Current & Future Analysis for
Diabetes Testing Supplies by Product Segment - Blood Glucose
Test Strips, Lancet, Lancet Device, Reagent Strip, and Blood
Glucose Insta Glucose Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-90

Table 45: World Long-term Projections for Diabetes Testing
Supplies by Product Segment - Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, and Blood Glucose Insta
Glucose Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-90

Table 46: World 10-Year Perspective for Diabetes Testing
Supplies by Product Segment - Percentage Breakdown of Dollar
Sales for Blood Glucose Test Strips, Lancet, Lancet Device,
Reagent Strip, and Blood Glucose Insta Glucose Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-91

Table 47: World Recent Past, Current & Future Analysis for
Blood Glucose Test Strips by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-91

Table 48: World Long-term Projections for Blood Glucose Test
Strips by Geographic Region/Country - US, Canada, Japan,
Europe, Asia-Pacific (Excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-93

Table 49: World 10-Year Perspective for Blood Glucose Test
Strips by Geographic Region/Country - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-94

Table 50: World Recent Past, Current & Future Analysis for
Lancets by Geographic Region/Country - US, Canada, Japan,
Europe, Asia-Pacific (Excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-95

Table 51: World Long-term Projections for Lancets by
Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-96

Table 52: World 10-Year Perspective for Lancets by Geographic
Region/Country - Percentage Breakdown of Dollar Sales for US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-97

Table 53: World Recent Past, Current & Future Analysis for
Lancet Devices by Geographic Region/Country - US, Canada,
Japan, Europe, Asia-Pacific (Excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-98

Table 54: World Long-term Projections for Lancet Devices by
Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-99

Table 55: World 10-Year Perspective for Lancet Devices by
Geographic Region/Country - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (Excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-100

Table 56: World Recent Past, Current & Future Analysis for
Reagent Strips by Geographic Region/Country - US, Canada,
Japan, Europe, Asia-Pacific (Excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-101

Table 57: World Long-term Projections for Reagent Strips by
Geographic Region/Country - US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-102

Table 58: World 10-Year Perspective for Reagent Strips by
Geographic Region/Country - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (Excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012(includes corresponding Graph/Chart) II-103

Table 59: World Recent Past, Current & Future Analysis for
Blood Glucose Insta Glucose by Geographic Region/Country - US,
Canada, Japan, Europe, Asia-Pacific (Excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-104

Table 60: World Long-term Projections for Blood Glucose Insta
Glucose by Geographic Region/Country - US, Canada, Japan,
Europe, Asia-Pacific (Excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-105

Table 61: World 10-Year Perspective for Blood Glucose Insta
Glucose by Geographic Region/Country - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-106

Table 62: World Recent Past, Current & Future Analysis for
Other Diabetes Diagnostic Products/Supplies by Geographic
Region/Country - US, Canada, Japan, Europe, Asia-Pacific
(Excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) II-107

Table 63: World Long-term Projections for Other Diabetes
Diagnostic Products/Supplies by Geographic Region/Country -
US, Canada, Japan, Europe, Asia-Pacific (Excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) II-108

Table 64: World 10-Year Perspective for Other Diabetes
Diagnostic Products/Supplies by Geographic Region - Percentage
Breakdown of Dollar Sales for US, Canada, Japan, Europe,
Asia-Pacific (Excluding Japan), Latin America and Rest of
World Markets for Years 2003, 2008 & 2012 (includes
corresponding Graph/Chart) II-109


III. MARKET

1. The United States III-1
A.Market Analysis III-1
Current and Future Analysis III-1
Diabetes: A Leading Cause of Death in the US III-1
Market Trends III-2
Companies Focus on Research for Better Diabetes Diagnostics III-2
Focus on Established Procedures Driving Growth III-2
Insulin Delivery Systems - A Potential High Growth Segment III-2
Leading Players’ Market Shares in the Recent Past III-3
Table 65: Leading Players in the US Blood Glucose Meters
Market in the Recent Past (2003 & 2004): Percentage
Breakdown of Sales Revenues for LifeScan (Johnson &
Johnson), Roche, Bayer, Abbott Diabetes Care and Others
(includes corresponding Graph/Chart) III-3

Table 66: Leading Players in the US Blood Glucose Strips
Market in the recent Past (2003 & 2004): Percentage
Breakdown of Sales Revenues for LifeScan (Johnson &
Johnson), Roche, Bayer, Abbott Diabetes Care and Others
(includes corresponding Graph/Chart) III-3
Complications Associated with Diabetes III-4
Heart Disease III-4
Stroke III-4
High Blood Pressure III-4
Blindness III-4
Kidney Disease III-4
Nerve Disease III-4
Amputations III-4
Dental Disease III-4
Pregnancy III-4
Table 67: Prevalence Estimates of Diabetes Mellitus in
North America: 2000-2001 III-5

Table 68: Prevalence Estimates of Type 1 Diabetes
Mellitus in North America: 2000-2001 III-5
Product Launches/Introductions III-5
Strategic Corporate Developments III-8
Select US Players III-15
B.Market Analytics III-18
Table 69: US Recent Past, Current & Future Analysis for
Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-18

Table 70: US Long-term Projections for Diabetes Diagnostics
by Product Segment - Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/ Monitor, Diabetes
Kit, and Diabetes Tracking System) and Diabetes Testing
Supplies (Blood Glucose Test Strips, Lancet, Lancet Device,
Reagent Strip, Blood Glucose Insta Glucose) and Other
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) III-19

Table 71: US 10-Year Perspective for Diabetes Diagnostics by
Product Segment - Percentage Breakdown of Dollar Sales for
Blood Glucose Testing Devices (Blood Glucose Test Kit, Blood
Glucose Meter/Monitor, Diabetes Kit, and Diabetes Tracking
System) and Diabetes Testing Supplies (Blood Glucose Test
Strips, Lancet, Lancet Device, Reagent Strip, Blood Glucose
Insta Glucose) and Other Markets for 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-20

2. Canada III-21
A.Market Analysis III-21
Current and Future Analysis III-21
Diabetes Incidence III-21
B.Market Analytics III-22
Table 72: Canadian Recent Past, Current & Future Analysis
for Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2000 through
2010 (includes corresponding Graph/Chart) III-22

Table 73: Canadian Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2011 through
2015 (includes corresponding Graph/Chart) III-23

Table 74: Canadian 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System) and Diabetes Testing Supplies
(Blood Glucose Test Strips, Lancet, Lancet Device, Reagent
Strip, Blood Glucose Insta Glucose) and Other Markets for
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-24

3. Japan III-25
A.Market Analysis III-25
Current and Future Analysis III-25
Growing Aging Population III-25
Miscellaneous Trends Influencing Diabetes Diagnostics Market III-25
Product Launch III-26
Strategic Corporate Developments in Recent Past III-26
Sanwa Kagaku Kenkyusho Co, Ltd. - A Select Player III-26
B.Market Analytics III-27
Table 75: Japanese Recent Past, Current & Future Analysis
for Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2000 through
2010 (includes corresponding Graph/Chart) III-27

Table 76: Japanese Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose Meter/
Monitor, Diabetes Kit, and Diabetes Tracking System) and
Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2011 through
2015 (includes corresponding Graph/Chart) III-28

Table 77: Japanese 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System) and Diabetes Testing Supplies
(Blood Glucose Test Strips, Lancet, Lancet Device, Reagent
Strip, Blood Glucose Insta Glucose) and Other Markets for
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-29

4. Europe III-30
A.Market Analysis III-30
Current and Future Analysis III-30
A Regional Perspective III-30
Analysis by Product Groups/Segments III-30
Market Trends III-30
Significant Increase in Number of Diabetics III-30
Portable Glucose Meters Fast Replacing Conventional Testing
Methods III-30
Point-of-Care Testing - A Profitable Venture III-30
It Pays to be Customer Focused in a Mature Market III-31
Diabetes Incidence in Recent Past III-31
Table 78: Prevalence Estimates of Diabetes Mellitus in
Europe: 2000-2001 III-31

Table 79: Prevalence Estimates of Type 1 Diabetes Mellitus
in Europe: 2000-2001 III-33
Product Launches//Introductions III-34
Strategic Corporate Developments III-35
Roche Diagnostics (Switzerland) - A Select Player III-37
B.Market Analytics III-38
Table 80: European Recent Past, Current & Future Analysis
for Diabetes Diagnostics by Geographic Region/Country -
France, Germany, Italy, UK and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-38

Table 81: European Long-term Projections for Diabetes
Diagnostics by Geographic Region/Country - France, Germany,
Italy, UK and Rest of Europe Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-39

Table 82: European 10-Year Perspective for Diabetes
Diagnostics by Geographic Region/Country - Percentage
Breakdown of Dollar Sales for France, Germany, Italy, UK and
Rest of Europe Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-40

Table 83: European Recent Past, Current & Future Analysis
for Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-41

Table 84: European Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-42

Table 85: European 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System) and Diabetes Testing Supplies
(Blood Glucose Test Strips, Lancet, Lancet Device, Reagent
Strip, Blood Glucose Insta Glucose) and Other Markets for
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-43

4a. France III-44
Market Analysis III-44
Current and Future Analysis III-44
Table 86: French Recent Past, Current & Future Analysis for
Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2000 through
2010 (includes corresponding Graph/Chart) III-44

Table 87: French Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2011 through
2015 (includes corresponding Graph/Chart) III-45

Table 88: French 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System) and Diabetes Testing Supplies
(Blood Glucose Test Strips, Lancet, Lancet Device, Reagent
Strip, Blood Glucose Insta Glucose) and Other Markets for
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-46

4b. Germany III-47
A.Market Analysis III-47
Current and Future Analysis III-47
Strategic Corporate Development III-47
B.Market Analytics III-48
Table 89: German Recent Past, Current & Future Analysis for
Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2000 through
2010 (includes corresponding Graph/Chart) III-48

Table 90: German Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2011 through
2015 (includes corresponding Graph/Chart) III-49

Table 91: German 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test Kit, Blood Glucose Meter/Monitor, Diabetes Kit,
and Diabetes Tracking System) and Diabetes Testing Supplies
(Blood Glucose Test Strips, Lancet, Lancet Device, Reagent
Strip, Blood Glucose Insta Glucose) and Other Markets for
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-50

4c. Italy III-51
Market Analysis III-51
Current and Future Analysis III-51
Table 92: Italian Recent Past, Current & Future Analysis for
Diabetes Diagnostics by Product Segment - Blood Glucose
Testing Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2000 through
2010 (includes corresponding Graph/Chart) III-52

Table 93: Italian Long-term Projections for Diabetes
Diagnostics by Product Segment - Blood Glucose Testing
Devices (Blood Glucose Test Kit, Blood Glucose
Meter/Monitor, Diabetes Kit, and Diabetes Tracking System)
and Diabetes Testing Supplies (Blood Glucose Test Strips,
Lancet, Lancet Device, Reagent Strip, Blood Glucose Insta
Glucose) and Other Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2011 through
2015 (includes corresponding Graph/Chart) III-53

Table 94: Italian 10-Year Perspective for Diabetes
Diagnostics by Product Segment - Percentage Breakdown of
Dollar Sales for Blood Glucose Testing Devices (Blood
Glucose Test