Global Hemoglobin A1c Monitoring Industry

NEW YORK, Dec. 4, 2012 /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#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

This report analyzes the worldwide markets for Hemoglobin A1c Monitoring in US$ Million. The report analyzes the Hemoglobin A1c Monitoring in Europe and Rest of World as a single consolidated segment, the US market is analyzed by the following Test Types: HbA1c Laboratory Testing, and HbA1c Point of Care Testing & Self-Monitoring. The report provides separate comprehensive analytics for US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. The report profiles 25 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., Diabetes Technologies Inc., Geonostics, Inc., HEMOCUE® AB, Menarini Diagnostics, Roche Diagnostics, Seradyn, Inc., Siemens Healthcare Diagnostics, Tosoh Bioscience, Inc., and Trinity Biotech plc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

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-2

Product Definition and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW II-1

HbA1c Testing on a Growth Spree II-1

Current and Future Analysis II-2

Home Monitoring - Laced with Accuracy Concerns II-2

Technology Developments Revolutionize Diagnostics in Diabetes

Care II-2

Higher Levels of Glycosylated Hemoglobin Increases the Risk of

Death II-3

Market Dynamics & Trends II-4

Regular HbA1c Test Keeps Heart Risk at Bay II-4

New Application to Boost Adoption II-4

Is HbA1c Test Right in Being Recommended for Diagnostic

Purposes? II-4

Near Patient Testing Gaining Ground II-5

POC Testing Versus Lab-Based Testing II-5

Glycated Albumin - A Potential Threat to HbA1c? II-5

HbA1c Level Customization for Patients - A Part of the New

Guidelines II-6

Complex Competitive Environment Prevails in POC Diagnostics

Market II-6

Major Benefits of POC HbA1c Tests II-6

Enhanced Patient Care II-6

Quality Results at par with Laboratory Tests II-7

Compact Size II-7

Ease-of-Use II-7

Convenience to Patients II-7

Major Testing Methods in POC HbA1c Tests II-7

Immunoassays II-8

Boronate Affinity Chromatography II-8

Micro-Optical Detection Methods II-8

Leading HbA1c Tests in the Market - A Comparison II-9

Non-Invasive Glucose Meters Threatens HbA1c Market II-10

2. PRODUCT OVERVIEW II-11

Product Definition II-11

Hemoglobin - A Brief II-11

Hemoglobin A1c- Description II-11

HbA1c Monitoring II-11

What is A1c II-11

1. HbA1c Laboratory Testing II-12

2. HbA1c Point of Care Testing & Self-Monitoring II-12

Hemoglobin A1c (HbA1c) Test II-12

Interpreting HbA1c Test Readings II-13

Interpreting HbA1c Test Readings II-13

Result of Hemoglobin A1c Test II-13

Clinical Use of A1c Testing II-13

Advantages of A1c Assessment & Interpretation II-14

Risks Associated with HbA1c Testing II-14

Methods of Measurement for Glycohemoglobin II-14

Why Opt for HbA1c Testing? II-15

The Diabetes Control & Complications Trial (DCCT) II-15

The Kumamoto and UK Prospective Studies II-15

Glycemia Tests Used In Monitoring Diabetes II-15

Urine Glucose Testing II-15

Glycated Protein Testing II-16

Table 1: Relation Between A1c Level and Mean Plasma

Glucose Levels II-16

HbA1c Test Types II-17

HbA1c Laboratory Testing II-17

HbA1c Laboratory Testing Product Development Over the Years II-17

HbA1c Point of Care Testing & Self-Monitoring II-20

3. DIABETES - A BRIEF PROFILE OF THE DISEASE II-22

What Causes Diabetes II-22

Types of Diabetes II-22

Major Types of Diabetes II-23

Likely Complications II-23

Nephropathy (Kidney Disease) II-23

Diabetic Neuropathy (Nerve Damage) II-23

Retinopathy (Damage to the Eye and Blindness) II-24

Poor Healing of Infections and Wounds II-24

Impotence in Men II-24

Periodontal Disease II-24

Cardiovascular Disease II-24

Interpreting the A1c Range II-24

Blood Glucose Level Guidelines* in the US II-25

Overview of Diabetes Care Market in the 1990s II-25

Key Global Statistics II-26

Table 2: World Diabetes and Population Statistics (2010 &

2030) (includes corresponding Graph/Chart) II-26

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-27

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-28

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-29

Prevalence of Diabetes in Various Parts of the World II-30

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-30

Therapeutic Options for Diabetes II-31

Oral Medication for Type 2 Diabetes II-31

Side Effects of Insulin Therapy II-32

Side Effects II-32

Maintaining A1c Test Result Below 7% II-32

Common Diabetes Management Practices II-32

4. PRODUCT APPROVALS/INTRODUCTIONS II-33

EKF Obtains CE Mark for Quo-Lab POC HbA1c Analyser II-33

Streck Launches A1c-Cellular Linearity Verification Material II-33

Abbott Obtains CE Marking for ARCHITECT HbA1c (IA) Fully

Automated Assay II-34

Trinity Obtains FDA Approval for Premier Hb9210 HbA1c Device II-34

Siemens Launches Fortified Version of DCA Vantage Analyzer II-35

Tosoh Launches New Assay on its AIA-600II and AIA-360 Analyzers II-35

Siemens Unveils ADVIA® Chemistry HbA1c Assay II-36

Bayer Healthcare Introduces A1CNow® SELFCHECK II-36

Randox Introduces HbA1c Test II-36

Animas Obtains FDA Approval for OneTouch Glucose Management

System II-36

ARKRAY USA Obtains FDA Approval for GLUCOCARD II-37

Bayer's Breeze Blood Glucose Monitoring System Receives

Commendation II-37

Quantimetrix Develops GlycoHemosure II-37

Olympus Life Science Europa Unveils HbA1c assay II-38

Siemens Healthcare Introduces DCA Vantage™ Analyser II-38

5. RECENT INDUSTRY ACTIVITY II-39

Trinity Inks Distribution Agreement with Menarini for Premier

Hb9210 II-39

Danaher Acquires Beckman Coulter II-39

Geonostics Takes Over Consumer Diabetes Tests of FlexSite II-39

EKF Diagnostics Takes Over Quotient Diagnostics II-39

ADA Recommends HbA1c Lab Test for Identification of Pre-Diabetes II-40

HemoCue and MEC Dynamics Inks Distribution Agreement for Avie

A1c POC Test II-40

Trinity Biotech Submits TRIstat™ CLIA Application to FDA II-40

Arkray Partners with Elitech to Supply In-vitro Diagnostic

Systems II-41

Quest Diagnostics Receives Accreditation from NABL and CAP II-41

Quest Diagnostics Achieves Accreditation for its Laboratory in

India II-41

PPD Inks an Agreement with PUL to Expand Lab Services into China II-42

Roche Inks Marketing Agreement with Mankind Pharma II-42

Nicholas Piramal Forms Joint Venture with Arkray II-42

Quotient Diagnostics to Commence Production of Quo-Test System II-42

Pelikan and Eli Lilly Sign Co-Promotion Agreement II-43

6. FOCUS ON SELECT GLOBAL PLAYERS II-44

Abbott Laboratories (USA) II-44

Axis-Shield plc (UK) II-44

Bayer Healthcare Diabetes Care (USA) II-45

Beckman Coulter, Inc. (USA) II-45

Bio-Rad Laboratories Inc (USA) II-45

Diabetes Technologies Inc (USA) II-46

Geonostics, Inc. (USA) II-46

HEMOCUE® AB (Sweden) II-47

Menarini Diagnostics (UK) II-47

Roche Diagnostics (Switzerland) II-47

Siemens Healthcare Diagnostics (Germany) II-47

Tosoh Bioscience, Inc (USA) II-48

Trinity Biotech plc (Ireland) II-48

7. GLOBAL MARKET PERSPECTIVE II-49

Table 7: 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 2010 through 2018 (includes

corresponding Graph/Chart) II-49

Table 8: World Historic Review for HbA1c Monitoring by

Geographic Region - US, Europe, and Rest of World Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2004 through 2009 (includes corresponding

Graph/Chart) II-50

Table 9: World 15-Year Perspective for HbA1c Monitoring by

Geographic Region - Percentage Breakdown of Dollar Sales for

US, Europe and Rest of World Markets for the Years 2004, 2011

& 2018 (includes corresponding Graph/Chart) II-51

III. MARKET

1. THE UNITED STATES III-1

A.Market Analysis III-1

An Insight III-1

Current and Future Analysis III-1

Market Dynamics and Trends III-1

HbA1c - Increasingly Moving into Physician's Office III-1

HbA1c Testing for Diabetes Detection Gains Support III-1

ADA Recommends HbA1c Test for Diabetes Diagnosis III-2

Rising Inclination towards CLIA-Waived Tests III-2

Need for Further Stringency in Requirements Arises III-2

QuoTest Eyes the US Market III-3

QuoLab - A Cost Effective HbA1c Solution for Developing

Markets III-3

Competitive Landscape III-4

US Near Patient HbA1c Testing - A Highly Consolidated Market III-4

Diabetes in the US III-5

Highlights III-5

The Statistics III-6

Age Factor III-6

Table 10: US Diabetes Statistics (2010): Number of

Diabetics and % Prevalence by Age Group -20 -39 Years,

45-59 Years, and 60 - 79 Years (includes corresponding

Graph/Chart) III-6

Diabetes Risk Among Young Native Americans III-6

Mean HbA1c Scores at National Level III-7

Prevalence by Race/Ethnicity III-7

Table 11: US Market for Diabetes (2010): Percentage

Breakdown of Prevalence by Race/Ethnicity- Non-Hispanic

Blacks and Non-Hispanic Whites (includes corresponding

Graph/Chart) III-7

North American Diabetic Prevalence Data III-8

Table 12: 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-8

Table 13: North American and Caribbean Diabetes and

Population Statistics (2010 & 2030) III-9

Product Approvals/Launches III-9

Strategic Corporate Developments III-11

Select Key Players III-13

B.Market Analytics III-17

Table 14: US Recent Past, Current and Future Analysis for

HbA1c Monitoring by Test Type - Laboratory Testing and Point

of Care Testing Markets Independently Analyzed with Annual

Sales Figures in US$ Million or Years 2010 through 2018

(includes corresponding Graph/Chart) III-17

Table 15: US Historic Review for HbA1c Monitoring by Test

Type - Laboratory Testing and Point of Care Testing Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2004 through 2009 (includes corresponding

Graph/Chart) III-18

Table 16: US 15-Year Perspective for HbA1c Monitoring by

Test Type - Percentage Breakdown of Dollar Sales for

Laboratory Testing and Point of Care Testing Markets for

years 2004, 2011 and 2018 (includes corresponding

Graph/Chart) III-19

2. EUROPE III-20

A.Market Analysis III-20

Current & Future Analysis III-20

Sizeable Expansion Prospects Lie Ahead of European Diabetes

Diagnostics Market III-20

Factors Restricting Growth of Diabetes Diagnostics market III-20

Competitive Environment III-21

Siemens Dominates the European HbA1c Market III-21

Table 17: Leading Players in the European Point-of-Care

HbA1c Tests Market (2011E): Percentage Breakdown of

Revenues for Siemens Healthcare Diagnostics, Axis-Shield,

Homecue and Others (includes corresponding Graph/Chart) III-21

Significant Diversity Exists in POC Test Adoption III-21

Diabetes Statistics in Europe III-22

Table 18: European Diabetes and Population Statistics (2010

& 2030) III-22

Table 19: 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-23

Key Diabetes Statistics in the UK III-24

Product Approvals/Launches III-24

Strategic Corporate Developments III-28

Select Key Players III-29

B.Market Analytics III-32

Table 20: European Recent Past, Current and Future Analysis

for HbA1c Monitoring Market - Annual Sales Figures in US$

Million for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-32

Table 21: European Historic Review for HbA1c Monitoring

Market - Annual Sales Figures in US$ Million for Years 2004

through 2009 (includes corresponding Graph/Chart) III-33

3. REST OF WORLD III-34

A.Market Analysis III-34

Current & Future Analysis III-34

POC Testing Rises in Japan, Physician's Office Testing Lags

Behind III-34

Diabetes Statistics In Select Regions/Countries Under Rest

of World III-34

Canada III-34

Latin America III-35

Table 22: Central and South American Diabetes and

Population Statistics (2010 & 2030) III-35

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-36

Asia-Pacific III-37

Table 24: Western Pacific Diabetes and Population

Statistics (2010 & 2030) III-37

Table 25: Western Pacific Regional Population and Diabetes

Prevalence Statistics (2010 Estimates) - Top Regions with

High Prevalence of Diabetes By Gender (includes

corresponding Graph/Chart) III-38

Table 26: South East Asian Diabetes and Population

Statistics (2010 & 2030) III-39

Table 27: 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-39

Key Diabetes Statistics in India III-40

Africa and the Middle East III-40

Table 28: African Diabetes and Population Statistics (2010 &

2030) III-40

Table 29: African Diabetes Prevalence and Population

Statistics (2010 Estimates) - Top Regions with High

Prevalence of Diabetes By Gender (includes corresponding

Graph/Chart) III-41

Table 30: Middle East and North African Diabetes and

Population Statistics (2010 & 2030) III-42

Table 31: 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-43

Strategic Corporate Developments III-44

B.Market Analytics III-46

Table 32: Rest of World Recent Past, Current and Future

Analysis for HbA1c Monitoring - Annual Sales Figures in US$

Million for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-46

Table 33: Rest of World Historic Review for HbA1c Monitoring -

Annual Sales Figures in US$ Million for Years 2004 through

2009 (includes corresponding Graph/Chart) III-47

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 25 (including Divisions/Subsidiaries - 36)

The United States (19)

Canada (1)

Japan (3)

Europe (12)

- Germany (1)

- The United Kingdom (6)

- Italy (1)

- Rest of Europe (4)

Asia-Pacific (Excluding Japan) (1)

To order this report:

In_Vitro_Diagnostic Industry: Global Hemoglobin A1c Monitoring Industry

Contact Nicolas: [email protected]
US: (805)-652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker