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  HEMOGLOBIN A1C MONITORING
A Global Strategic Business Report

This report analyzes the worldwide markets for Hemoglobin A1c Monitoring in US$ Million. The report provides separate comprehensive analytics for US, Europe, and Rest of World. The US market is further analyzed by the following Test Types: HbA1c Laboratory Testing, and HbA1c Point of Care Testing & Self-Monitoring. Annual estimates and forecasts are provided for each region for the period 2006 through 2015. The report profiles 36 companies including many key and niche players such as Abbott Laboratories, Axis-Shield Plc, Bayer Healthcare Diabetes Care, Beckman Coulter, Inc., Bio-Rad Laboratories Inc., Biosafe Laboratories Inc., Diabetes Technologies Inc., Flexsite Diagnostics Inc., Roche Diagnostics, Seradyn, Inc., Tosoh Bioscience, Inc., Trinity Biotech plc, and Primus 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.

CODE:    MCP-1218  PAGES:    430
PRICE:    $3950  DATE:       April 2010
COMPANIES:  36  MARKET DATA TABLES:   111
Due to the proprietary nature, our previews are offered only to manufacturers, top-tier management consultants, investment banks, and investment research groups.

 TABLE OF CONTENTS  
  HEMOGLOBIN A1C MONITORING (Complete Report) Pages : 430   | $3950
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS3$100
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2  
   Data Interpretation & Reporting Level.....I-3
Quantitative Techniques & Analytics.....I-3
Product Definition and Scope of Study.....I-3
  
II. EXECUTIVE SUMMARY58$2250
  1. MARKET OVERVIEW.....II-14 $400  
   Introduction.....II-1
Current and Future Analysis.....II-1
1$100
   Diabetes Monitoring Market.....II-2
Higher Levels of Glycosylated Hemoglobin Increases the Risk of Death.....II-2
Non-Invasive Glucose Meters Threatens HbA1c Market.....II-2
1$100
   Regular HbA1c Test Keeps Heart Risk at Bay.....II-3
Home Monitoring.....II-3
1$100
   Technology Developments Revolutionize Diagnostics in Diabetes Care.....II-4
1$100
  2. PRODUCT OVERVIEW.....II-515 $1100  
   Product Definition.....II-5
Hemoglobin – A Brief.....II-5
Hemoglobin A1C- Description.....II-5
HbA1c Monitoring.....II-5
What is A1C.....II-5
1$100
   HbA1c Laboratory Testing.....II-6
HbA1c Point of Care Testing & Self-Monitoring.....II-6
Hemoglobin A1C (HbA1c) Test.....II-6
1$100
   Interpreting HbA1c Test Readings.....II-7
Interpreting HbA1c Test Readings.....II-7
Result of Hemoglobin A1c Test.....II-7
1$100
   Clinical Use of A1c Testing.....II-8
Advantages of A1c Assessment & Interpretation.....II-8
Risks Associated with HbA1c Testing.....II-8
Methods of Measurement for Glycohemoglobin.....II-8
1$100
   Why Opt for HbA1c Testing?.....II-9
The Diabetes Control & Complications Trial (DCCT).....II-9
1$100
   The Kumamoto and UK Prospective Studies.....II-10
Glycemia Tests Used in Monitoring Diabetes.....II-10
Urine Glucose Testing.....II-10
Glycated Protein Testing.....II-10
1$100
   Table 1: Relation Between A1C Level and Mean Plasma Glucose Levels.....II-11
HbA1c Test Types.....II-11
HbA1c Laboratory Testing.....II-11
1$300
   HbA1c Laboratory Testing Product Development Over the Years.....II-123$300
   HbA1c Point of Care Testing & Self-Monitoring.....II-151$100
   Advantages of POC Testing Over Lab Testing.....II-16
Disadvantages of POC Testing.....II-16
Technological Advancements in POCT.....II-16
1$100
   POCT HbA1c Testing Market (2004 and later).....II-171$100
   POCT & Self-Monitoring Product Developments: (2000-2003).....II-18
2$200
  3. DIABETES - A BRIEF PROFILE OF THE DISEASE.....II-2010 $1600  
   What Causes Diabetes.....II-20
Types of Diabetes.....II-20
1$100
   Major Types of Diabetes.....II-21
Likely Complications.....II-21
Nephropathy (Kidney Disease).....II-21
1$100
   Diabetic Neuropathy (Nerve Damage).....II-22
Retinopathy (Damage to the Eye and Blindness).....II-22
Poor Healing of Infections and Wounds.....II-22
Impotence in Men.....II-22
Periodontal Disease.....II-22
Cardiovascular Disease.....II-22
1$100
   Interpreting the A1c Range.....II-23
Blood Glucose Level Guidelines* in the US.....II-23
Overview of Diabetes Care Market in the 1990s.....II-23
1$100
   Key Global Statistics.....II-24
Table 2: World Diabetes and Population Statistics (2010 & 2030).....II-24

Table 3: World Diabetes and Population Statistics (in Million) By Region for 2010 and 2030 - For Africa, Europe, Middle East and North Africa, North America and Caribbean Region, South and Central America South East Asia, and Western Pacific Region (includes corresponding Graph/Chart).....II-24
1$300
   Table 4: Global Prevalence of Diabetes Mellitus (in Million) By Gender (Male and Female) in the year 2010 - For Africa, Europe, Middle East and North Africa, North America and Caribbean Region, South and Central America, South East Asia, and Western Pacific Region (includes corresponding Graph/Chart).....II-251$300
   Table 5: Global Prevalence of Diabetes Mellitus (in Million) By Age Group (20-39, 40-59, and 60-79) in the year 2010 - For Africa, Europe, Middle East and North Africa, North America and Caribbean Region, South and Central America, South East Asia, and Western Pacific Region (includes corresponding Graph/Chart).....II-261$300
   Prevalence of Diabetes in Various Parts of the World.....II-27
Table 6: World Diabetes Market (2010 & 2030): Top 10 Regions With the Highest Number of People Diagnosed with Diabetes (in Million) in the Age Group 20-79 years (includes corresponding Graph/Chart).....II-27
1$300
   Therapeutic Options for Diabetes.....II-28
Oral Medication for Type 2 Diabetes.....II-28
1$100
   Table 7: Various Treatment Options Adopted by US Adults Diagnosed with Diabetes During the Period 2004 to 2006 - Percentage Share for Insulin Only, Insulin with Oral Medication, Oral Medication Only, and No Medication (includes corresponding Graph/Chart).....II-29
Side Effects of Insulin Therapy.....II-29
Maintaining A1c Test Result Below 7%.....II-29
Common Diabetes Management Practices.....II-29
1$300
  4. RESEARCH AND DEVELOPMENT HIGHLIGHTS.....II-301 $100  
   G5 Diabetes Diagnostic Test by Provalis.....II-30
Diabetes Risk Among Young Native Americans.....II-30
Mean HbA1c Scores at National Level.....II-30
1$100
  5. TECHNOLOGICAL DEVELOPMENTS.....II-312 $200  
   New Noninvasive Monitoring and Testing Devices.....II-31
HGI as a Statistical Predictor of Nephropathy and Retinopathy.....II-31
1$100
   Micro-Optical Detection Method Technology - Metrika.....II-32
1$100
  6. REGULATORY ENVIRONMENT.....II-334 $400  
   Animas Obtains FDA Approval for OneTouch Glucose Management System.....II-33
ARKRAY USA Obtains FDA Approval for GLUCOCARD.....II-33
Bayer’s Breeze Blood Glucose Monitoring System Receives Commendation.....II-33
1$100
   Trinity Biotech Obtains FDA Approval for Point of Care HbA1c Test.....II-34
MedApps Receives FDA Clearance for OTC Use of D-PAL Remote System.....II-34
1$100
   DexCom Receives FDA Approval for STS-7 System.....II-35
Diazyme’s Direct Enzymatic HbA1c Assay Kit Receives FDA Clearance.....II-35
Trinity Biotech Receives FDA Approval for TRIstat HbA1c Test.....II-35
Axis-Shield’s Afinion™ System Obtains FDA CLIA Waiver.....II-35
1$100
   Diazyme’s Enzymatic HbA1c Assay Receives NGSP Accreditation.....II-36
Axis-Shield Obtains FDA Clearance for Afinion and Afinion HbA1c Test.....II-36
Axis-Shield Obtains NGSP Accreditation for Afinion HbA1c Test.....II-36
1$100
  7. PRODUCT INNOVATIONS/INTRODUCTIONS.....II-376 $450  
   Randox Introduces HbA1c Test.....II-37
Quantimetrix Develops GlycoHemosure.....II-37
Olympus Life Science Europa Unveils HbA1c assay.....II-37
1$100
   Siemens Healthcare Introduces DCA Vantage™ Analyser.....II-38
Bio-Rad Introduces The in2it Analyzer.....II-38
Abbott Diabetes Launches FreeStyle Lite™ Blood Glucose Meter.....II-38
1$100
   Bayer Introduces BREEZE®2 and CONTOUR® Blood Glucose Meters.....II-39
ARKRAY Introduces PocketChem™EZ Blood Glucose Monitoring System.....II-39
Abbott Rolls Out New Blood Glucose Monitoring Devices.....II-39
1$100
   Axis-Shield UK Introduces Afinion™.....II-40
Medtronic Plans Launch of Online Testing Kit for Diabetes.....II-40
Nova Biomedical Launches Nova Max™ Blood Glucose Monitoring System.....II-40
1$100
   Medtronic Announces Launch of New Continuous Glucose Monitoring System.....II-41
LifeScan Offers Meter Upgrade for OneTouch® Blood Glucose Monitoring Systems.....II-41
Abbot Introduces AlphaTRAK™ for Canines and Felines with Diabetes.....II-41
1$100
   Bio-Rad Labs Introduces Variant II Turbo System and D-10 in India.....II-42
Deudraa Introduces Microdot.....II-42
Cardiocom Launches Blood Glucose Meter and Diabetes Telemonitoring System.....II-42
OrSense Introduces Non-Invasive Hematocrit/ Hemoglobin Sensor.....II-42
1$100
  8. RECENT INDUSTRY ACTIVITY.....II-438 $600  
   ADA Recommends HbA1c Lab Test for Identification of Pre-Diabetes.....II-43
Trinity Biotech Submits TRIstat™ CLIA Application to FDA.....II-43
Arkray Partners with Elitech to Supply In-vitro Diagnostic Systems.....II-43
1$100
   Quest Diagnostics Receives Accreditation from NABL and CAP.....II-44
PPD Inks an Agreement with PUL to Expand Lab Services into China.....II-44
1$100
   Roche Inks Marketing Agreement with Mankind Pharma.....II-45
Nicholas Piramal Forms Joint Venture with Arkray.....II-45
Quotient Diagnostics to Commence Production of Quo-Test System.....II-45
Pelikan and Eli Lilly Sign Co-Promotion Agreement.....II-45
1$100
   Sysmex America and Bio-Rad Sign Long-term Distribution Agreement.....II-46
Medtronic Enters in to Alliance with Bayer HealthCare.....II-46
Inverness Snaps Up Cholestech.....II-46
1$100
   IQ Micro to Complete Lifecare Acquisition.....II-47
HemoCue and Cardinal Health Sign Distribution Agreement.....II-47
1$100
   HemoCue Signs Product Supply Agreement with the American Red Cross.....II-48
Abbott to Establish a New Production Facility in Donegal Town.....II-48
Bayer Diabetes Care Takes Over Metrika.....II-48
1$100
   Cardiocom Establishes GlucoCom Division.....II-49
Bio-Rad Acquires Provalis Medical Diagnostics Business.....II-49
Bio-Rad Laboratories Inks Multi-year Contract with Premier.....II-49
Bayer Divests Diagnostic Division of Bayer Healthcare to Siemens.....II-49
1$100
   Trinity Biotech Acquires Primus Corp.....II-50
1$100
  9. FOCUS ON SELECT GLOBAL PLAYERS.....II-516 $400  
   Abbott Laboratories (USA).....II-51
Axis-Shield plc (UK).....II-51
1$100
   Bayer Healthcare Diabetes Care (USA).....II-52
Beckman Coulter, Inc. (USA).....II-52
1$100
   Bio-Rad Laboratories Inc (USA).....II-53
Biosafe Laboratories Inc (USA).....II-53
1$100
   Diabetes Technologies Inc (USA).....II-54
Flexsite Diagnostics Inc (USA).....II-54
Roche Diagnostics (Switzerland).....II-54
1$100
   Seradyn, Inc. (USA).....II-55
Tosoh Bioscience, Inc (USA).....II-55
Trinity Biotech plc (Ireland).....II-55
1$100
   Primus Diagnostics (USA).....II-56
1$100
  10. GLOBAL MARKET PERSPECTIVE.....II-57   
   Table 8: World Recent Past, Current and Future Analysis for HbA1c Monitoring by Geographic Region - US, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart).....II-571$300
   Table 9: World 10-Year Perspective for HbA1c Monitoring by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for the Years 2006, 2009 & 2015 (includes corresponding Graph/Chart).....II-581$300
III. MARKET50$1950
  1. THE UNITED STATES.....III-128 $1675  
   A. Market Overview.....III-1
An Insight.....III-1
Current and Future Analysis.....III-1
Market Highlights.....III-1
1$75
   Challenges in the HbA1c Monitoring Market in the US.....III-2
Key Players.....III-2
Table 10: 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-2
1$150
   Diabetes: The Statistics.....III-3
Age Factor.....III-3
Table 11: US Market for Diabetes (2006): Percentage Breakdown of Prevalence by Age Group – Under 20 years, 21-60 years, and 60 years+ (includes corresponding Graph/Chart).....III-3
Prevalence by Race/Ethnicity.....III-3
1$150
   Table 12: US Market for Diabetes (2004 to 2006): Percentage Breakdown of Prevalence by Race/Ethnicity- Non-Hispanic Blacks, Hispanics, Asian Americans, and Non-Hispanic Whites (includes corresponding Graph/Chart).....III-4

Table 13: Prevalence of Diabetes in Americans 20Years or Over by Race/Ethnicity and Gender (includes corresponding Graph/Chart).....III-4
1$150
   North American Diabetic Prevalence Data.....III-5
Table 14: North American and Caribbean Regional Population and Diabetes Prevalence Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes for Various Age Groups (20-39, 40-59, and 60-79) and Gender (Male and Female) (includes corresponding Graph/Chart).....III-5
1$150
   Table 15: North American and Caribbean Diabetes and Population Statistics (2010 & 2030).....III-6
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-6
Impact of Sedentary Lifestyle.....III-6
1$150
   Reimbursements from Managed Care Organizations.....III-7
The Diabetes A1c Initiative™.....III-7
A1c Kits Available in the US.....III-7
1$75
   The US Clinical Laboratory Services Testing Market - A Historical
  Perspective.....III-8
1$75
   Clinical Testing Service Sites in the US.....III-9
Growth of Clinical Laboratory Market Over the Years.....III-9
1$75
   Regulatory Guidelines & Approvals.....III-105$375
   Product Innovations/Introductions.....III-154$300
   Strategic Corporate Developments.....III-193$225
   Key Players.....III-225$375
   B. Market Analytics.....III-27
Table 16: US Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Type - Laboratory Testing and Point of Care Markets Independently Analyzed with Annual Sales Figures in US$ Million or Years 2007 through 2015 (includes corresponding Graph/Chart).....III-27
1$150
   Table 17: US Historic Review for HbA1c Monitoring by Test Type - Laboratory Testing and Point of Care Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2006 (includes corresponding Graph/Chart).....III-28

Table 18: US 13-Year Perspective for HbA1c Monitoring by Test Type - Percentage Breakdown of Dollar Sales for Laboratory and Point of Care Markets for years 2003, 2009 and 2015.....III-28
1$150
  2. EUROPE.....III-2910 $750  
   A. Market Analysis.....III-29
Outlook.....III-29
Overview.....III-29
Characteristics of European HbA1c Market.....III-29
Factors Restricting Growth of Diabetes Diagnostics market.....III-29
1$75
   European POCT Market.....III-30
Factors Driving the Market.....III-30
Diabetes Statistics in Europe.....III-30
Table 19: European Diabetes and Population Statistics (2010 & 2030).....III-30
1$150
   Table 20: European Population and Diabetes Prevalence Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes for Various Age Groups (20-39, 40-59, and 60-79) and Gender (includes corresponding Graph/Chart).....III-311$150
   Product Innovations/Introductions.....III-322$150
   Strategic Corporate Developments.....III-343$225
   Key Players.....III-371$75
   B. Market Analytics.....III-38
Table 21: European Recent Past, Current and Future Analysis for HbA1c Monitoring Market - Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart).....III-38
1$150
  3. REST OF WORLD.....III-3912 $1000  
   A. Market Analysis.....III-39
Outlook.....III-39
Overview of Select Regional Markets.....III-39
Africa.....III-39
Canada.....III-39
1$75
   India.....III-40
United Kingdom.....III-40
1$75
   Diabetes Statistics in Latin America.....III-41
Table 22: Central and South American Diabetes and Population Statistics (2010 & 2030).....III-41
1$150
   Table 23: Central and South American Population (in Thousands) and Diabetes Prevalence Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes by Gender (includes corresponding Graph/Chart).....III-421$150
   Diabetes Prevalence Rates in the Asia-Pacific Region.....III-43
Diabetes Prevalence Data Across Select Regions.....III-43
Table 24: African Diabetes and Population Statistics (2010 & 2030).....III-43
1$150
   Table 25: African Diabetes Prevalence and Population Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes By Gender (includes corresponding Graph/Chart).....III-441$150
   Table 26: Middle East and North African Diabetes and Population Statistics (2010 & 2030).....III-45

Table 27: Middle East and Northern African Diabetes Prevalence and Population Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes By Gender (includes corresponding Graph/Chart).....III-45
1$150
   Table 28: Western Pacific Diabetes and Population Statistics (2010 & 2030).....III-46

Table 29: Western Pacific Regional Population and Diabetes Prevalence Statistics (2010 Estimates) - Top Regions with High Prevalence of Diabetes By Gender (includes corresponding Graph/Chart).....III-46
1$150
   Table 30: South East Asian Diabetes and Population Statistics (2010 & 2030).....III-47

Table 31: South East Asian Population and Diabetes Prevalence Statistics (in Thousands) (2010 Estimates) - Top Regions with High Prevalence of Diabetes By Gender (includes corresponding Graph/Chart).....III-47
1$150
   Product Innovations/Introductions.....III-481$75
   Strategic Corporate Developments.....III-491$75
   B. Market Analytics.....III-50
Table 32: Rest of World Recent Past, Current and Future Analysis for HbA1c Monitoring - Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart).....III-50
1$150
IV. COMPETITIVE LANDSCAPE 310$995
  
Total Companies Profiled: 36 (including Divisions/Subsidiaries - 46)

Region/Country                 Players


The United States                 31   
Japan                              4
Europe                            10
     Germany                       2
     The United Kingdom            4
     Italy                         1
     Rest of Europe                3
Asia-Pacific (Excluding Japan)     1
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Due to the proprietary nature, our previews are offered only to manufacturers, top-tier management consultants, investment banks, and investment research groups.

© Copyrights 2010, Global Industry Analysts, Inc., USA.