World Hemoglobin A1c Monitoring Market

World Hemoglobin A1c Monitoring Market

This report analyzes the worldwide markets for Hemoglobin A1c Monitoring in US$ Million. The specific Test Types analyzed are HbA1c Laboratory Testing, and HbA1c Point of Care Testing & Self-Monitoring. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East, Latin America, and Rest of World. Annual forecasts are provided for each region for the period of 2000 through 2015. The report profiles 39 companies including many key and niche players worldwide such as Abbott Laboratories, Axis-Shield, Bayer Healthcare Diabetes Care, Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Biosafe Laboratories, Inc., Diabetes Technologies, Inc., Flexsite Diagnostics, Inc., Primus Diagnostics, Roche Diagnostics, and Tosoh Bioscience, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

HEMOGLOBIN A1c MONITORING MCP-1218
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 Definition and Scope of Study I-3
HbA1c Laboratory Testing I-3
HbA1c Point of Care Testing & Self-Monitoring I-4


II. EXECUTIVE SUMMARY

1. Market Overview II-1
Current and Future Analysis II-1
Diabetes Monitoring Market II-1
Higher Levels of Glycosylated Hemoglobin Increases the Risk
of Death II-2
Regular HbA1c Test Keeps Heart Risk at Bay II-2
Home Monitoring II-2

2. Product Overview II-4
Product Definition II-4
HbA1c Monitoring II-4
What is A1C II-4
Hemoglobin A1C (HbA1c) Test II-4
Interpreting HbA1c Test Readings II-5
Table 1: Interpreting HbA1c Test Readings II-5
Result of Hemoglobin A1c Test II-6
Advantages of A1c Assessment & Interpretation II-6
Risks Associated with HbA1c Testing II-6
Methods of Measurement for Glycohemoglobin II-6
The Diabetes Control & Complications Trial (DCCT) II-7
The Kumamoto and UK Prospective Studies II-7
Glycemia Tests Used in Monitoring Diabetes II-7
Urine Glucose Testing II-7
Glycated Protein Testing II-8
Table 2: Relation Between A1C Level and Mean Plasma
Glucose Levels II-8
HbA1c Test Types II-8
HbA1c Laboratory Testing II-9
HbA1c Laboratory Testing Product Development Over the Years II-9
HbA1c Point of Care Testing & Self-Monitoring II-12
POCT HbA1c Testing Market (2004) II-12
POCT & Self-Monitoring Product Developments: (2000-2003) II-13

3. Diabetes - A Brief Profile of the Disease II-15
What Causes Diabetes II-15
Types of Diabetes II-15
Major Types of Diabetes II-16
Likely Complications II-16
Nephropathy (Kidney Disease) II-16
Diabetic Neuropathy (Nerve Damage) II-16
Retinopathy (Damage to the Eye and Blindness) II-17
Poor Healing of Infections and Wounds II-17
Impotence in Men II-17
Periodontal Disease II-17
Cardiovascular Disease II-17
Interpreting the A1c Range II-17
Blood Glucose Level Guidelines* in the US II-18
Overview of Diabetes Care Market in the 1990s II-18
Future Outlook II-18
Table 3: World Diabetes and Population Statistics (2003 &
2025) II-18
Prevalence of Diabetes in Various Parts of the World II-19
Table 4: World Diabetes Market (2000 & 2030): Breakup by
Regions Having the Highest Number of People with Diabetes -
India, China, US, Indonesia, Japan, Pakistan, Russian
Federation, Brazil, Italy, Bangladesh, Philippines and Egypt
(in million) (includes corresponding Graph/Chart) II-19
Therapeutic Options for Diabetes II-20
Oral Medication for Type 2 Diabetes II-20
Table 5: Diabetes Treatment Options in the US: Percentage
Breakdown for Insulin or Insulin & Oral Drugs, Oral Drugs,
and Diet & Exercise (includes corresponding Graph/Chart) II-21
Side Effects of Insulin Therapy II-21
Maintaining A1c Test Result Below 7% II-21
Common Diabetes Management Practices II-21

4. Research and Development Highlights II-22
G5 Diabetes Diagnostic Test by Provalis II-22
Diabetes Risk Among Young Native Americans II-22
Mean HbA1c Scores at National Level II-22

5. Technological Developments II-23
New Noninvasive Monitoring and Testing Devices II-23
HGI as a Statistical Predictor of Nephropathy and Retinopathy II-23
Micro-Optical Detection Method Technology - Metrika II-24

6. Regulatory Environment II-25
Animas Obtains FDA Approval for OneTouch Glucose Management
System II-25
ARKRAY USA Obtains FDA Approval for GLUCOCARD II-25
Bayer’s Breeze Blood Glucose Monitoring System Receives
Commendation II-25
Trinity Biotech Obtains FDA Approval for Point of Care HbA1c Test II-26
MedApps Receives FDA Clearance for OTC Use of D-PAL Remote System II-26
DexCom Receives FDA Approval for STS-7 System II-26
Diazyme’s Direct Enzymatic HbA1c Assay Kit Receives FDA Clearance II-27
Trinity Biotech Receives FDA Approval for TRIstat HbA1c Test II-27
Axis-Shield’s Afinion™ System Obtains FDA CLIA Waiver II-27
Diazyme’s Enzymatic HbA1c Assay Receives NGSP Accreditation II-27
Axis-Shield Obtains FDA Clearance for Afinion and Afinion
HbA1c Test II-27
Axis-Shield Obtains NGSP Accreditation for Afinion HbA1c Test II-28
Abbott Laboratories and Seradyn Obtain US FDA Approval for
Hemoglobin A1c Assay II-28
Medicare Reform Act Passed for Reforms in Diabetes Treatment
and Care in the US II-28
Bio-Rad Obtains FDA Approval for D-10 Hemoglobin A1c System II-28
FDA Approves OTC Diabetes Test and Clears Metrika’s A1cNow™
Diabetes Monitor for Home Use II-28
FDA Level 1 Certification for SimpleChoice A1c Test Device II-29
Metrika Obtains FDA Approval for Digital Response® HbA1c
Patient Monitor II-29

7. Product Innovations/Introductions II-30
Quantimetrix Develops GlycoHemosure II-30
Olympus Life Science Europa Unveils HbA1c assay II-30
Siemens Healthcare Introduces DCA Vantage™ Analyser II-30
Bio-Rad Introduces The in2it Analyzer II-31
Abbott Diabetes Launches FreeStyle Lite™ Blood Glucose Meter II-31
Bayer Introduces BREEZE®2 and CONTOUR® Blood Glucose Meters II-31
ARKRAY Introduces PocketChem™EZ Blood Glucose Monitoring System II-32
Abbott Rolls Out New Blood Glucose Monitoring Devices II-32
Axis-Shield UK Introduces Afinion™ II-32
Medtronic Announces Launch of Online Testing Kit for Diabetes II-32
Nova Biomedical Launches Nova Max™ Blood Glucose Monitoring
System II-33
Medtronic Announces Launch of New Continuous Glucose
Monitoring System II-33
LifeScan Offers Meter Upgrade for OneTouch® Blood Glucose
Monitoring Systems II-33
Abbot Introduces AlphaTRAK™ for Canines and Felines with Diabetes II-34
Bio-Rad Labs Introduces Variant II Turbo System and D-10 in India II-34
Deudraa Introduces Microdot II-34
Cardiocom Launches Blood Glucose Meter and Diabetes
Telemonitoring System II-34
OrSense Introduces Non-Invasive Hematocrit/ Hemoglobin Sensor II-35

8. Product Introductions in Recent Past II-36
Axis-Shield Introduces NycoCard HbA1c Control II-36
Primus Corp Rolls Out Ultra2™ A1c, an HPLC system II-36
Axis-Shield Introduces AFINION, New POCT System II-36
Bristol-Myers Squibb Unveils Choice DM ™ A1C Home Test II-36
Beckton Launches FDA Approved Products for Diabetes Management II-37
International Technidyne Rolls Out Hgb Pro Professional
Hemoglobin Testing System™ II-37
Bayer Unveils HbA1c Assay for the ADVIA® 1650 Chemistry System II-37
Catachem Launches Glycated Hemoglobin In-Vitro Diagnostic Kit II-37
Beijing Blue Cross Biotech Launches Colibri System II-37
Cholestech Obtains Clearance to Market Cholestech GDX™ System
in Canada II-38
SpectRx Announces Launch of SimpleChoice® Products II-38
DCA 2000+ Analyzer Minimizes Risk and Helps to Monitor HbA1c
Levels II-38
BioSafe Laboratory Introduces BioSafe HbA1c Test Kit II-38
FlexSite Diagnostics, Inc. Launches A1c At Home™ Test Kit II-38
Integrated Technologies Launched ABAKA to Measure Glib II-39
Provalis Develops Glycosal II-39

9. Recent Industry Activity II-40
Roche Inks Marketing Agreement with Mankind Pharma II-40
Nicholas Piramal Forms Joint Venture with Arkray II-40
Quotient Diagnostics to Commence Production of Quo-Test System II-40
Pelikan and Eli Lilly Sign Co-Promotion Agreement II-40
Sysmex America and Bio-Rad Sign Long-term Distribution Agreement II-41
Medtronic Enters in to Alliance with Bayer HealthCare II-41
Inverness Snaps Up Cholestech II-41
IQ Micro to Complete Lifecare Acquisition II-41
HemoCue and Cardinal Health Sign Distribution Agreement II-42
HemoCue Signs Product Supply Agreement with the American Red
Cross II-42
Abbott to Establish a New Production Facility in Donegal Town II-43
Bayer Diabetes Care Takes Over Metrika II-43
Cardiocom Establishes GlucoCom Division II-43
Bio-Rad Acquires Provalis Medical Diagnostics Business II-43
Bio-Rad Laboratories Inks Multi-year Contract with Premier II-44
Bayer Divests Diagnostic Division of Bayer Healthcare to Siemens II-44

10. Strategic Corporate Developments in Recent Past II-45
Trinity Biotech Acquires Primus Corp II-45
Abbott Laboratories and Seradyn Receive FDA Clearance for
Multigent™ Hemoglobin A1c Test II-45
Shanghai Upper Biotech Signs Agreement with Chinese Ministry
of Health II-45
Roche Acquires Insulin Pump Unit of Disetronic II-45
Becton Dickinson Diversifies into Blood-Glucose Meter Products II-46
Sysmex Corp Pens Distribution Agreement with Bio-Rad II-46
Tosoh Medics Adopts New Corporate Identity II-46
G5 to Enter Trials in the US II-46
Cholestech Signs Global Distribution Agreement with Provalis II-47
BioSafe Announces Distribution of Free and Low- Cost HbA1c Tests II-47
Tosoh and Sysmex Sign Sales Agreement II-47
Bayer Diagnostics Pens Co-Marketing Agreement with Cholestech
Corporation II-47
Provalis Obtains US Patent for Glycosal II-47
Axis-Shield Plc Acquires Nycomed Diagnostics II-48
Quest Selects COBAS Integra Hemoglobin A1c Assay from Roche II-48

11. Focus on Select Global Players II-49
Abbott Laboratories (USA) II-49
Axis-Shield (UK) II-49
Bayer Healthcare Diabetes Care (USA) II-49
Beckman Coulter, Inc. (US) II-50
Bio-Rad Laboratories Inc (USA) II-51
Biosafe Laboratories Inc (USA) II-51
Diabetes Technologies Inc (USA) II-51
Flexsite Diagnostics Inc (USA) II-51
Primus Diagnostics (USA) II-52
Roche Diagnostics (Switzerland) II-52
Tosoh Bioscience, Inc (USA) II-52

12. Global Market Perspective II-53
Table 6: World Recent Past, Current and Future Analysis for
HbA1c Monitoring by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), the Middle East, 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-53

Table 7: World Long-Term Projections for HbA1c Monitoring by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), the Middle East, 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-54

Table 8: World 10-Year Perspective for HbA1c Monitoring by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the
Middle East and Latin America and Rest of World Markets for
Years 2003, 2008, 2012 (includes corresponding Graph/Chart) II-55
By Test Types II-56
Table 9: World Recent Past, Current and Future Analysis for
HbA1c Laboratory Testing by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), the Middle East
and 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-56

Table 10: World Long-Term Projections for HbA1c Laboratory
Testing by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), the Middle East, 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-57

Table 11: World 10-Year Perspective for HbA1c Laboratory
Testing by Geographic Region - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), the Middle East and Latin America and Rest of World
Markets for Years 2003, 2008, 2012 (includes corresponding
Graph/Chart) II-58

Table 12: World Recent Past, Current and Future Analysis for
HbA1c Point of Care and Self-Monitoring by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the
Middle East and 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-59

Table 13: World Long-Term Projections for HbA1c Point of Care
and Self-Monitoring by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), the Middle East, 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-60

Table 14: World 10-Year Perspective for HbA1c Point of Care
and Self-Monitoring by Geographic Region - Percentage
Breakdown of Dollar Sales for US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), the Middle East and Latin
America and Rest of World Markets for Years 2003, 2008, 2012
(includes corresponding Graph/Chart) II-61


III. MARKET

1. The United States III-1
A.Market Overview III-1
An Insight III-1
Current and Future Analysis III-1
Market Highlights III-1
Challenges in the HbA1c Monitoring Market in the US III-2
Key Players III-2
Table 15: US HbA1c Point of Care Testing Market (2005):
Percentage Breakdown of Revenues for Major Players-
Metrika, Bayer Diagnostics, Bio-Rad, Cholestech and
Provalis (includes corresponding Graph/Chart) III-2

Table 16: US HbA1c Laboratory Testing Market (2006 &
2007): Percentage Breakdown of Revenues for Major Players
- Bio-Rad, Roche Diagnostics, Tosoh and Others (includes
corresponding Graph/Chart) III-3
Diabetes: The Statistics III-3
Age Factor III-3
Table 17: US Market for Diabetes (2005): Percentage
Breakdown of Prevalence by Age Group - 20-44 years, 45-64
years, 65-74 years and 75 years+ (includes corresponding
Graph/Chart) III-3
Prevalence by Race/Ethnicity III-4
Table 18: US Market for Diabetes (2004): Percentage
Breakdown of Prevalence by Race/Ethnicity- American
Indians/Alaska Natives, Non-Hispanic Blacks,
Hispanic/Latin Americans and Non-Hispanic Whites (includes
corresponding Graph/Chart) III-4

Table 19: Prevalence of Diabetes in Americans 20 Years or
Over by Race/Ethnicity and Gender (includes corresponding
Graph/Chart) III-4
Diabetes Statistics in the Recent Past - A Review III-5
Table 20: Prevalence Estimates of Diabetes Mellitus in the
US: 2000 - 01 III-5

Table 21: Prevalence Estimates of Type 1 Diabetes Mellitus
in the US: 2000 - 01 III-5

Table 22: Diabetic Cases in the US in 2000 by State III-5
Market Trends & Issues III-6
Impact of Pricing and Innovation III-6
HbA1c Monitoring Vs Blood Glucose Monitoring III-6
Impact of Diabetes Education Campaigns on HbA1c Monitors Usage III-7
Impact of Sedentary Lifestyle III-7
Reimbursements from Managed Care Organizations III-7
The Diabetes A1c Initiative™ III-7
A1c Kits Available in the US III-8
The US Clinical Laboratory Services Testing Market - A
Historical Perspective III-9
Clinical Testing Service Sites in the US III-9
Growth of Clinical Laboratory Market Over the Years III-9
Regulatory Guidelines & Approvals III-10
Product Innovations/Introductions III-15
Recent Industry Activity III-20
Key US Players III-23
B.Market Analytics III-27
Table 23: US Recent Past, Current and Future Analysis for
HbA1c Monitoring by Test Type - HbA1c Laboratory Testing and
HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-27

Table 24: US Long-Term Projections for HbA1c Monitoring by
Test Type - HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-27

Table 25: US 10-Year Perspective for HbA1c Monitoring by
Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-28

2. Canada III-29
A.Market Overview III-29
Current and Future Analysis III-29
Key Diabetes Statistics III-29
Table 26: Prevalence Estimates of Diabetes Mellitus in
Canada: 2000 - 01 (Historic Data) III-29

Table 27: Prevalence Estimates of Type 1 Diabetes Mellitus
in Canada: 2000 - 01 (Historic Data) III-29
Strategic Developments III-30
B.Market Analytics III-31
Table 28: Canadian Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-31

Table 29: Canadian Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-32

Table 30: Canadian 10-Year Perspective for HbA1c Monitoring
by Test Type - Percentage Breakdown of Dollar Sales for
HbA1c Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for years 2003, 2008 and 2012 III-32

3. Japan III-33
A.Market Overview III-33
Current and Future Analysis III-33
Industry Activity in the Recent Past III-33
Key Player III-34
B.Market Analytics III-34
Table 31: Japanese Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-34

Table 32: Japanese Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-35

Table 33: Japanese 10-Year Perspective for HbA1c Monitoring
by Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-35

4. Europe III-36
A.Market Overview III-36
Current and Future Analysis III-36
The European POCT Market III-36
Factors Driving the Market: III-36
Diabetes Statistics in Europe III-36
Table 34: Prevalence Estimates of Diabetes Mellitus in
Europe: 2000 - 01 (Historic Data) III-37

Table 35: Prevalence Estimates of Type 1 Diabetes Mellitus
in Europe: 2000 - 01 III-38
B.Market Analytics III-39
Table 36: European Recent Past, Current and Future Analysis
for HbA1c Monitoring by Geographic Region - France, Germany,
Italy, UK, Spain, Russia and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-39

Table 37: European Long-Term Projections for HbA1c
Monitoring by Geographic Region - France, Germany, Italy,
UK, Spain, Russia and Rest of Europe Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-40

Table 38: European 10-Year Perspective for HbA1c Monitoring
by Geographic Region - Percentage Breakdown of Dollar Sales
for France, Germany, Italy, UK, Spain, Russia and Rest of
Europe Markets for Years 2003, 2008, 2012 (includes
corresponding Graph/Chart) III-41

Table 39: European Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-42

Table 40: European Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-43

Table 41: European 10-Year Perspective for HbA1c Monitoring
by Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-43

4a. France III-44
Market Overview III-44
Table 42: French Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-44

Table 43: French Long-Term Projections for HbA1c Monitoring
by Test Type - HbA1c Laboratory Testing and HbA1c Point of
Care and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-45

Table 44: French 10-Year Perspective for HbA1c Monitoring by
Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-45

4b. Germany III-46
A.Market Overview III-46
Current and Future Analysis III-46
Product Launches III-46
Strategic Corporate Developments III-47
B.Market Analytics III-48
Table 45: German Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-48

Table 46: German Long-Term Projections for HbA1c Monitoring
by Test Type - HbA1c Laboratory Testing and HbA1c Point of
Care and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-49

Table 47: German 10-Year Perspective for HbA1c Monitoring by
Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-49

4c. Italy III-50
Market Overview III-50
Table 48: Italian Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-50

Table 49: Italian Long-Term Projections for HbA1c Monitoring
by Test Type - HbA1c Laboratory Testing and HbA1c Point of
Care and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-51

Table 50: Italian 10-Year Perspective for HbA1c Monitoring
by Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-51

4d. The United Kingdom III-52
A.Market Overview III-52
Current and Future Analysis III-52
Key Statistics III-52
Product Innovations/Introductions III-52
Recent Industry Activity III-53
Key Players III-55
B.Market Analytics III-56
Table 51: UK Recent Past, Current and Future Analysis for
HbA1c Monitoring Test Type - HbA1c Laboratory by Testing and
HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-56

Table 52: UK Long-Term Projections for HbA1c Monitoring by
Test Type - HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-57

Table 53: UK 10-Year Perspective for HbA1c Monitoring by
Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-57

4e. Spain III-58
Market Overview III-58
Table 54: Spanish Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-58

Table 55: Spanish Long-Term Projections for HbA1c Monitoring
by Test Type - HbA1c Laboratory Testing and HbA1c Point of
Care and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-59

Table 56: Spanish 10-Year Perspective for HbA1c Monitoring
by Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-59

4f. Russia III-60
Market Overview III-60
Table 57: Russian Recent Past, Current and Future Analysis
for HbA1c Monitoring by Test Type - HbA1c Laboratory Testing
and HbA1c Point of Care and Self-Monitoring Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-60

Table 58: Russian Long-Term Projections for HbA1c Monitoring
by Test Type - HbA1c Laboratory Testing and HbA1c Point of
Care and Self-Monitoring Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-61

Table 59: Russian 10-Year Perspective for HbA1c Monitoring
by Test Type- Percentage Breakdown of Dollar Sales for HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets for 2003, 2008, 2012 III-61

4g. Rest of Europe III-62
A.Market Overview III-62
Current and Future Analysis III-62
Strategic Development III-62
Industry Activity in the Recent Past III-63
Key Player III-63
B.Market Analytics III-64
Table 60: Rest of Europe Recent Past, Current and Future
Analysis for HbA1c Monitoring by Test Type - HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-64

Table 61: Rest of Europe Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-65

Table 62: Rest of Europe 10-Year Perspective for HbA1c
Monitoring by Test Type- Percentage Breakdown of Dollar
Sales for HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets for 2003, 2008, 2012 III-65

5. Asia-Pacific III-66
A.Market Overview III-66
Current and Future Analysis III-66
Self Monitoring Blood Glucose Device Market to Grow III-66
Diabetes Prevalence Rates in the Asia-Pacific Region III-66
Table 63: Prevalence Estimates of Diabetes Mellitus in
South-East Asia: 2000 - 01 (Historic Data) III- 67

Table 64: Prevalence Estimates of Type 1 Diabetes Mellitus
in Southeast Asia: 2000 - 01 (Historic Data) III-67

Table 65: Prevalence Estimates of Diabetes Mellitus in
Western Pacific: 2000 - 01 (Historic Data) III-68
Product Launches III-68
Recent Industry Activity III-69
B.Market Analytics III-70
Table 66: Asia Pacific Recent Past, Current and Future
Analysis for HbA1c Monitoring by Test Type - HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-70

Table 67: Asia-Pacific Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-71

Table 68: Asia Pacific 10-Year Perspective for HbA1c
Monitoring by Test Type- Percentage Breakdown of Dollar
Sales for HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets for 2003, 2008, 2012 III-71

6. The Middle East III-72
A.Market Overview III-72
Current and Future Analysis III-72
Table 69: Prevalence Estimates of Diabetes Mellitus in the
Middle East in 2000 - 01 (Historic Data) III-72

Table 70: Prevalence Estimates of Type 1 Diabetes Mellitus
in the Middle East in 2000 - 01 (Historic Data) III-73
Product Introduction III-73
B.Market Analytics III-74
Table 71: Middle East Recent Past, Current and Future
Analysis for HbA1c Monitoring by Test Types - HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-74

Table 72: Middle East Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-75

Table 73: Middle East 10-Year Perspective for HbA1c
Monitoring by Test Type- Percentage Breakdown of Dollar
Sales for HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets for 2003, 2008, 2012 III-75

7. Latin America III-76
A.Market Overview III-76
Current and Future Analysis III-76
Diabetes Statistics in Latin America III-76
Table 74: Prevalence of Diabetes Complications in South and
Central American Region: 2004 III-76

Table 75: Prevalence Estimates of Diabetes Mellitus in
South & Central America: 2000 - 01 (Historic Data) III-77

Table 76: Prevalence Estimates of Type 1 Diabetes Mellitus
in South & Central America: 2000 - 01 (Historic Data) III-78
Mexico III-78
Table 77: Prevalence Estimates of Diabetes Mellitus in
Mexico: 2000 - 01 (Historic Data) III-78

Table 78: Prevalence Estimates of Type 1 Diabetes Mellitus
in Mexico: 2000 - 01 (Historic Data) III-78
B.Market Analytics III-79
Table 79: Latin American Recent Past, Current and Future
Analysis for HbA1c Monitoring by Test Type - HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-79

Table 80: Latin American Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-80

Table 81: Latin American 10-Year Perspective for HbA1c
Monitoring by Test Type- Percentage Breakdown of Dollar
Sales for HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets for 2003, 2008, 2012 III-80

8. Rest of World III-81
A.Market Overview III-81
Current and Future Analysis III-81
Key Diabetes Statistics in Africa III-81
Diabetes Prevalence Rates in Africa III-82
Table 82: Prevalence Estimates of Diabetes Mellitus in
Africa: 2000 - 01 (Historic Data) III-82
Table 83: Prevalence Estimates of Type 1 Diabetes Mellitus
in Africa: 2000 - 01 (Historic Data) III-83
B.Market Analytics III-84
Table 84: Rest of World Recent Past, Current and Future
Analysis for HbA1c Monitoring by Test Type - HbA1c
Laboratory Testing and HbA1c Point of Care and
Self-Monitoring Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-84

Table 85: Rest of World Long-Term Projections for HbA1c
Monitoring by Test Type - HbA1c Laboratory Testing and HbA1c
Point of Care and Self-Monitoring Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-85

Table 86: Rest of World 10-Year Perspective for HbA1c
Monitoring by Test Type- Percentage Breakdown of Dollar
Sales for HbA1c Laboratory Testing and HbA1c Point of Care
and Self-Monitoring Markets for 2003, 2008, 2012. III-85


IV. COMPETITIVE LANDSCAPE


-A Menarini Diagnostics (Italy)
-Abbott Laboratories (USA)
-Abbott Diagnostics (USA)
-Abbott GmbH & Co, KG (Germany)
-Accutech LLC (USA)
-Arkray, Inc (Japan)
-Axis-Shield Plc (UK)
-Axis-Shield PoC As (Norway)
-Bayer Healthcare-Diagnostics GmbH (Germany)
-Bayer Healthcare Diagnostics Division (USA)
-Beckman Coulter, Inc (USA)
-Becton Dickinson and Company (USA)
-BD Medical Systems Div (USA)
-Bio-Rad Laboratories, Inc (USA)
-Biosafe Laboratories, Inc (USA)
-Bristol-Myers Squibb Company (USA)
-Cholestech Corporation (USA)
-Dade Behring, Inc (USA)
-Diabetes Technologies, Inc (USA)
-Diazyme Laboratories (USA)
-Drew Scientific Group Plc (UK)
-Flexsite Diagnostics, Inc (USA)
-Jokoh Co, Ltd (Japan)
-Lifescan, Inc (USA)
-OrSense (Israel)
-Pacific Biometrics, Inc (USA)
-Pointe Scientific, Inc (USA)
-PolyMedica- Liberty Medical Supply (USA)
-Premier, Inc (USA)
-Provalis Plc (UK)
-Provalis Diagnostics Ltd (UK)
-Roche Diagnostics (Schweiz)
AG (Switzerland)
-Roche Diagnostics Corporation (USA)
-Roche Diagnostics (Deutschland)
GmbH (Germany)
-Spectrx, Inc (USA)
-Sysmex Corporation (Japan)
-Tosoh Bioscience, Inc (USA)
-Trinity Biotech Plc (Ireland)