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Hemoglobin A1c Monitoring

Published by: Global Industry Analysts

Published: Oct. 1, 2008 - 239 Pages


Table of Contents


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations

Disclaimers

Data Interpretation & Reporting Level

Quantitative Techniques & Analytics

Product Definition and Scope of Study

HbA1c Laboratory Testing

HbA1c Point of Care Testing & Self-Monitoring

II. EXECUTIVE SUMMARY

1. Market Overview

Current and Future Analysis

Diabetes Monitoring Market

Higher Levels of Glycosylated Hemoglobin Increases the Risk of Death

Regular HbA1c Test Keeps Heart Risk at Bay

Home Monitoring

2. Product Overview

Product Definition

HbA1c Monitoring

What is A1C

Hemoglobin A1C (HbA1c) Test

Interpreting HbA1c Test Readings

Table 1: Interpreting HbA1c Test Readings

Result of Hemoglobin A1c Test

Advantages of A1c Assessment & Interpretation

Risks Associated with HbA1c Testing

Methods of Measurement for Glycohemoglobin

The Diabetes Control & Complications Trial (DCCT)

The Kumamoto and UK Prospective Studies

Glycemia Tests Used in Monitoring Diabetes

Urine Glucose Testing

Glycated Protein Testing

Table 2: Relation Between A1C Level and Mean Plasma Glucose Levels

HbA1c Test Types

HbA1c Laboratory Testing

HbA1c Laboratory Testing Product Development Over the Years

HbA1c Point of Care Testing & Self-Monitoring

POCT HbA1c Testing Market (2004)

POCT & Self-Monitoring Product Developments: (2000-2003)

3. Diabetes - A Brief Profile of the Disease

What Causes Diabetes

Types of Diabetes

Major Types of Diabetes

Likely Complications

Nephropathy (Kidney Disease)

Diabetic Neuropathy (Nerve Damage)

Retinopathy (Damage to the Eye and Blindness)

Poor Healing of Infections and Wounds

Impotence in Men

Periodontal Disease

Cardiovascular Disease

Interpreting the A1c Range

Blood Glucose Level Guidelines* in the US

Overview of Diabetes Care Market in the 1990s

Future Outlook

Table 3: World Diabetes and Population Statistics (2003 & 2025)

Prevalence of Diabetes in Various Parts of the World

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)

Therapeutic Options for Diabetes

Oral Medication for Type 2 Diabetes

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)

Side Effects of Insulin Therapy

Maintaining A1c Test Result Below 7%

Common Diabetes Management Practices

4. Research and Development Highlights

G5 Diabetes Diagnostic Test by Provalis

Diabetes Risk Among Young Native Americans

Mean HbA1c Scores at National Level

5. Technological Developments

New Noninvasive Monitoring and Testing Devices

HGI as a Statistical Predictor of Nephropathy and Retinopathy

Micro-Optical Detection Method Technology - Metrika

6. Regulatory Environment

Animas Obtains FDA Approval for OneTouch Glucose Management System

ARKRAY USA Obtains FDA Approval for GLUCOCARD

Bayer’s Breeze Blood Glucose Monitoring System Receives Commendation

Trinity Biotech Obtains FDA Approval for Point of Care HbA1c Test

MedApps Receives FDA Clearance for OTC Use of D-PAL Remote System

DexCom Receives FDA Approval for STS-7 System

Diazyme’s Direct Enzymatic HbA1c Assay Kit Receives FDA Clearance

Trinity Biotech Receives FDA Approval for TRIstat HbA1c Test

Axis-Shield’s Afinion™ System Obtains FDA CLIA Waiver

Diazyme’s Enzymatic HbA1c Assay Receives NGSP Accreditation

Axis-Shield Obtains FDA Clearance for Afinion and Afinion HbA1c Test

Axis-Shield Obtains NGSP Accreditation for Afinion HbA1c Test

Abbott Laboratories and Seradyn Obtain US FDA Approval for Hemoglobin A1c

Assay

Medicare Reform Act Passed for Reforms in Diabetes Treatment and Care in the

US

Bio-Rad Obtains FDA Approval for D-10 Hemoglobin A1c System

FDA Approves OTC Diabetes Test and Clears Metrika’s A1cNow™ Diabetes Monitor for Home

Use

FDA Level 1 Certification for SimpleChoice A1c Test Device

Metrika Obtains FDA Approval for Digital Response® HbA1c Patient Monitor

7. Product Innovations/Introductions

Quantimetrix Develops GlycoHemosure

Olympus Life Science Europa Unveils HbA1c assay

Siemens Healthcare Introduces DCA Vantage™ Analyser

Bio-Rad Introduces The in2it Analyzer

Abbott Diabetes Launches FreeStyle Lite™ Blood Glucose Meter

Bayer Introduces BREEZE®2 and CONTOUR® Blood Glucose Meters

ARKRAY Introduces PocketChem™EZ Blood Glucose Monitoring System

Abbott Rolls Out New Blood Glucose Monitoring Devices

Axis-Shield UK Introduces Afinion™

Medtronic Announces Launch of Online Testing Kit for Diabetes

Nova Biomedical Launches Nova Max™ Blood Glucose Monitoring System

Medtronic Announces Launch of New Continuous Glucose Monitoring System

LifeScan Offers Meter Upgrade for OneTouch® Blood Glucose Monitoring Systems

Abbot Introduces AlphaTRAK™ for Canines and Felines with Diabetes

Bio-Rad Labs Introduces Variant II Turbo System and D-10 in India

Deudraa Introduces Microdot

Cardiocom Launches Blood Glucose Meter and Diabetes Telemonitoring System

OrSense Introduces Non-Invasive Hematocrit/ Hemoglobin Sensor

8. Product Introductions in Recent Past

Axis-Shield Introduces NycoCard HbA1c Control

Primus Corp Rolls Out Ultra2™ A1c, an HPLC system

Axis-Shield Introduces AFINION, New POCT System

Bristol-Myers Squibb Unveils Choice DM ™ A1C Home Test

Beckton Launches FDA Approved Products for Diabetes Management

International Technidyne Rolls Out Hgb Pro Professional Hemoglobin Testing

System™

Bayer Unveils HbA1c Assay for the ADVIA® 1650 Chemistry System

Catachem Launches Glycated Hemoglobin In-Vitro Diagnostic Kit

Beijing Blue Cross Biotech Launches Colibri System

Cholestech Obtains Clearance to Market Cholestech GDX™ System in Canada

SpectRx Announces Launch of SimpleChoice® Products

DCA 2000+ Analyzer Minimizes Risk and Helps to Monitor HbA1c Levels

BioSafe Laboratory Introduces BioSafe HbA1c Test Kit

FlexSite Diagnostics, Inc. Launches A1c At Home™ Test Kit

Integrated Technologies Launched ABAKA to Measure Glib

Provalis Develops Glycosal

9. Recent Industry Activity

Roche Inks Marketing Agreement with Mankind Pharma

Nicholas Piramal Forms Joint Venture with Arkray

Quotient Diagnostics to Commence Production of Quo-Test System

Pelikan and Eli Lilly Sign Co-Promotion Agreement

Sysmex America and Bio-Rad Sign Long-term Distribution Agreement

Medtronic Enters in to Alliance with Bayer HealthCare

Inverness Snaps Up Cholestech

IQ Micro to Complete Lifecare Acquisition

HemoCue and Cardinal Health Sign Distribution Agreement

HemoCue Signs Product Supply Agreement with the American Red Cross

Abbott to Establish a New Production Facility in Donegal Town

Bayer Diabetes Care Takes Over Metrika

Cardiocom Establishes GlucoCom Division

Bio-Rad Acquires Provalis Medical Diagnostics Business

Bio-Rad Laboratories Inks Multi-year Contract with Premier

Bayer Divests Diagnostic Division of Bayer Healthcare to Siemens

10. Strategic Corporate Developments in Recent Past

Trinity Biotech Acquires Primus Corp

Abbott Laboratories and Seradyn Receive FDA Clearance for Multigent™ Hemoglobin A1c

Test

Shanghai Upper Biotech Signs Agreement with Chinese Ministry of Health

Roche Acquires Insulin Pump Unit of Disetronic

Becton Dickinson Diversifies into Blood-Glucose Meter Products

Sysmex Corp Pens Distribution Agreement with Bio-Rad

Tosoh Medics Adopts New Corporate Identity

G5 to Enter Trials in the US

Cholestech Signs Global Distribution Agreement with Provalis

BioSafe Announces Distribution of Free and Low- Cost HbA1c Tests

Tosoh and Sysmex Sign Sales Agreement

Bayer Diagnostics Pens Co-Marketing Agreement with Cholestech Corporation

Provalis Obtains US Patent for Glycosal

Axis-Shield Plc Acquires Nycomed Diagnostics

Quest Selects COBAS Integra Hemoglobin A1c Assay from Roche

11. Focus on Select Global Players

Abbott Laboratories (USA)

Axis-Shield (UK)

Bayer Healthcare Diabetes Care (USA)

Beckman Coulter, Inc. (US)

Bio-Rad Laboratories Inc (USA)

Biosafe Laboratories Inc (USA)

Diabetes Technologies Inc (USA)

Flexsite Diagnostics Inc (USA)

Primus Diagnostics (USA)

Roche Diagnostics (Switzerland)

Tosoh Bioscience, Inc (USA)

12. Global Market Perspective

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)

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)

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)

By Test Types

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)

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)

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)

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)

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)

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)

III. MARKET

1. The United States

A. Market Overview

An Insight

Current and Future Analysis

Market Highlights

Challenges in the HbA1c Monitoring Market in the US

Key Players

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)

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)

Diabetes: The Statistics

Age Factor

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)

Prevalence by Race/Ethnicity

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)

Table 19: Prevalence of Diabetes in Americans 20 Years or Over by Race/Ethnicity and Gender (includes corresponding Graph/Chart)

Diabetes Statistics in the Recent Past - A Review

Table 20: Prevalence Estimates of Diabetes Mellitus in the US: 2000 - 01

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

Table 22: Diabetic Cases in the US in 2000 by State

Market Trends & Issues

Impact of Pricing and Innovation

HbA1c Monitoring Vs Blood Glucose Monitoring

Impact of Diabetes Education Campaigns on HbA1c Monitors Usage

Impact of Sedentary Lifestyle

Reimbursements from Managed Care Organizations

The Diabetes A1c Initiative™

A1c Kits Available in the US

The US Clinical Laboratory Services Testing Market - A Historical

Perspective

Clinical Testing Service Sites in the US

Growth of Clinical Laboratory Market Over the Years

Regulatory Guidelines & Approvals

Product Innovations/Introductions

Recent Industry Activity

Key US Players

B. Market Analytics

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)

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)

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

2. Canada

A. Market Overview

Current and Future Analysis

Key Diabetes Statistics

Table 26: Prevalence Estimates of Diabetes Mellitus in Canada: 2000 - 01 (Historic Data)

Table 27: Prevalence Estimates of Type 1 Diabetes Mellitus in Canada: 2000 - 01 (Historic Data)

Strategic Developments

B. Market Analytics

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)

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)

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

3. Japan

A. Market Overview

Current and Future Analysis

Industry Activity in the Recent Past

Key Player

B. Market Analytics

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)

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)

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

4. Europe

A. Market Overview

Current and Future Analysis

The European POCT Market

Factors Driving the Market:

Diabetes Statistics in Europe

Table 34: Prevalence Estimates of Diabetes Mellitus in Europe: 2000 - 01 (Historic Data)

Table 35: Prevalence Estimates of Type 1 Diabetes Mellitus in Europe: 2000 - 01

B. Market Analytics

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)

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)

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)

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)

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)

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

4a. France

Market Overview

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)

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)

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

4b. Germany

A. Market Overview

Current and Future Analysis

Product Launches

Strategic Corporate Developments

B. Market Analytics

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)

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)

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

4c. Italy

Market Overview

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)

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)

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

4d. The United Kingdom

A. Market Overview

Current and Future Analysis

Key Statistics

Product Innovations/Introductions

Recent Industry Activity

Key Players

B. Market Analytics

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)

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)

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

4e. Spain

Market Overview

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)

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)

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

4f. Russia

Market Overview

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)

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)

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

4g. Rest of Europe

A. Market Overview

Current and Future Analysis

Strategic Development

Industry Activity in the Recent Past

Key Player

B. Market Analytics

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)

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)

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

5. Asia-Pacific

A. Market Overview

Current and Future Analysis

Self Monitoring Blood Glucose Device Market to Grow

Diabetes Prevalence Rates in the Asia-Pacific Region

Table 63: Prevalence Estimates of Diabetes Mellitus in South-East Asia: 2000 - 01 (Historic Data)

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

Table 65: Prevalence Estimates of Diabetes Mellitus in Western Pacific: 2000 - 01 (Historic Data)

Product Launches

Recent Industry Activity

B. Market Analytics

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)

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)

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

6. The Middle East

A. Market Overview

Current and Future Analysis

Table 69: Prevalence Estimates of Diabetes Mellitus in the Middle East in 2000 - 01 (Historic Data)

Table 70: Prevalence Estimates of Type 1 Diabetes Mellitus in the Middle East in 2000 - 01 (Historic Data)

Product Introduction

B. Market Analytics

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)

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)

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

7. Latin America

A. Market Overview

Current and Future Analysis

Diabetes Statistics in Latin America

Table 74: Prevalence of Diabetes Complications in South and Central American Region: 2004

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

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

Mexico

Table 77: Prevalence Estimates of Diabetes Mellitus in Mexico: 2000 - 01 (Historic Data)

Table 78: Prevalence Estimates of Type 1 Diabetes Mellitus in Mexico: 2000 - 01 (Historic Data)

B. Market Analytics

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)

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)

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

8. Rest of World

A. Market Overview

Current and Future Analysis

Key Diabetes Statistics in Africa

Diabetes Prevalence Rates in Africa

Table 82: Prevalence Estimates of Diabetes Mellitus in Africa: 2000 - 01 (Historic Data)

Table 83: Prevalence Estimates of Type 1 Diabetes Mellitus in Africa: 2000 - 01 (Historic Data)

B. Market Analytics

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)

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)

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

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 39 (including Divisions/Subsidiaries - 48)

Region/Country Players

The United States32

Japan 3

Europe 10

Germany2

The United Kingdom 4

Italy 1

Rest of Europe 3

Asia-Pacific (Excluding Japan)2

Middle East 1


Abstract

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

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