Global Hemoglobin A1c Monitoring Industry

NEW YORK, June 16 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Hemoglobin A1c Monitoring industry

http://www.reportlinker.com/p0197150/Global-Hemoglobin-A1c-Monitoring-industry.html

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.

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-3

Quantitative Techniques & Analytics I-3

Product Definition and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW II-1

Introduction II-1

Current and Future Analysis II-1

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

Regular HbA1c Test Keeps Heart Risk at Bay II-3

Home Monitoring II-3

Technology Developments Revolutionize Diagnostics in Diabetes

Care II-4

2. PRODUCT OVERVIEW II-5

Product Definition II-5

Hemoglobin - A Brief II-5

Hemoglobin A1C- Description II-5

HbA1c Monitoring II-5

What is A1C II-5

HbA1c Laboratory Testing II-6

HbA1c Point of Care Testing & Self-Monitoring II-6

Hemoglobin A1C (HbA1c) Test II-6

Interpreting HbA1c Test Readings II-7

Interpreting HbA1c Test Readings II-7

Result of Hemoglobin A1c Test II-7

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

Why Opt for HbA1c Testing? II-9

The Diabetes Control & Complications Trial (DCCT) II-9

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

Table 1: Relation Between A1C Level and Mean Plasma

Glucose Levels II-11

HbA1c Test Types II-11

HbA1c Laboratory Testing II-11

HbA1c Laboratory Testing Product Development Over the Years II-12

HbA1c Point of Care Testing & Self-Monitoring II-15

Advantages of POC Testing Over Lab Testing II-16

Disadvantages of POC Testing II-16

Technological Advancements in POCT II-16

POCT HbA1c Testing Market (2004 and later) II-17

POCT & Self-Monitoring Product Developments: (2000-2003) II-18

3. DIABETES - A BRIEF PROFILE OF THE DISEASE II-20

What Causes Diabetes II-20

Types of Diabetes II-20

Major Types of Diabetes II-21

Likely Complications II-21

Nephropathy (Kidney Disease) II-21

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

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

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

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-25

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-26

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

Therapeutic Options for Diabetes II-28

Oral Medication for Type 2 Diabetes II-28

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

4. RESEARCH AND DEVELOPMENT HIGHLIGHTS II-30

G5 Diabetes Diagnostic Test by Provalis II-30

Diabetes Risk Among Young Native Americans II-30

Mean HbA1c Scores at National Level II-30

5. TECHNOLOGICAL DEVELOPMENTS II-31

New Noninvasive Monitoring and Testing Devices II-31

HGI as a Statistical Predictor of Nephropathy and Retinopathy II-31

Micro-Optical Detection Method Technology - Metrika II-32

6. REGULATORY ENVIRONMENT II-33

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

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

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

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

7. PRODUCT INNOVATIONS/INTRODUCTIONS II-37

Randox Introduces HbA1c Test II-37

Quantimetrix Develops GlycoHemosure II-37

Olympus Life Science Europa Unveils HbA1c assay II-37

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

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

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

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

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

8. RECENT INDUSTRY ACTIVITY II-43

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

Quest Diagnostics Receives Accreditation from NABL and CAP II-44

PPD Inks an Agreement with PUL to Expand Lab Services into China II-44

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

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

IQ Micro to Complete Lifecare Acquisition II-47

HemoCue and Cardinal Health Sign Distribution Agreement II-47

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

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

Trinity Biotech Acquires Primus Corp II-50

9. FOCUS ON SELECT GLOBAL PLAYERS II-51

Abbott Laboratories (USA) II-51

Axis-Shield plc (UK) II-51

Bayer Healthcare Diabetes Care (USA) II-52

Beckman Coulter, Inc. (USA) II-52

Bio-Rad Laboratories Inc (USA) II-53

Biosafe Laboratories Inc (USA) II-53

Diabetes Technologies Inc (USA) II-54

Flexsite Diagnostics Inc (USA) II-54

Roche Diagnostics (Switzerland) II-54

Seradyn, Inc. (USA) II-55

Tosoh Bioscience, Inc (USA) II-55

Trinity Biotech plc (Ireland) II-55

Primus Diagnostics (USA) II-56

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-57

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-58

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 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

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

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

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

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

Reimbursements from Managed Care Organizations III-7

The Diabetes A1c Initiative™ III-7

A1c Kits Available in the US III-7

The US Clinical Laboratory Services Testing Market - A

Historical Perspective III-8

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

Strategic Corporate Developments III-19

Key Players III-22

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

Table 17: US Historical Perspective 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

2. EUROPE III-29

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

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

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-31

Product Innovations/Introductions III-32

Strategic Corporate Developments III-34

Key Players III-37

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

3. REST OF WORLD III-39

A.Market Analysis III-39

Outlook III-39

Overview of Select Regional Markets III-39

Africa III-39

Canada III-39

India III-40

United Kingdom III-40

Diabetes Statistics in Latin America III-41

Table 22: Central and South American Diabetes and

Population Statistics (2010 & 2030) III-41

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-42

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

Table 25: African Diabetes Prevalence and Population

Statistics (2010 Estimates) - Top Regions with High

Prevalence of Diabetes By Gender (includes corresponding

Graph/Chart) III-44

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

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

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

Product Innovations/Introductions III-48

Strategic Corporate Developments III-49

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

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 36 (including Divisions/Subsidiaries - 46)

------------------------------------------

Region/Country Players

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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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