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Glycated Haemoglobin (HbA1c) Testing Market, 2014 - 2024

NEW YORK, Sept. 1, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Glycated Haemoglobin (HbA1c) Testing Market, 2014 - 2024

http://www.reportlinker.com/p02317667/Glycated-Haemoglobin-HbA1c-Testing-Market-2014---2024.html

INTRODUCTION

Diabetes is a chronic disease growing at an alarming rate around the globe.Over 382 million people are estimated to be currently suffering from the disease; the number, though, is likely to increase to 592 million by 2035.

With a very high prevalence, especially in some regions such as China and India, an increasing proportion of diabetic patients are expected to look for more efficient and accurate diagnostic tests in the future. HbA1c, adapted for clinical testing to monitor diabetes in 1990s, is one such test; it can monitor and give average glucose results over the past 120 days. The test offers significant advantages over usual blood glucose monitoring assays; these include no prior fasting requirement, high sample stability, low day-to-day variation and limited impact from external physical factors such as stress.

The adoption of HbA1c tests has gradually risen in the recent past. While the laboratory analyzers are likely to strengthen their existing position, a significant growth will also be driven by Point of Care (POC) devices. POC devices bring a change in overall diabetes management and the lifestyle of the individual. Compared to laboratory tests, they can be used at home with instantaneous results and accuracy. In addition, considering the lifetime costs, POC testing is comparatively cheaper than laboratory testing. Increased efforts to overcome lack of awareness, especially in emerging markets, are also expected to drive adoption levels further.

SCOPE OF THE REPORT

With a large number of devices already in market for HbA1c monitoring and more to come in the future years, HbA1c market is likely to shape up much better in the coming years. We have strong reasons to believe that the overall market outlook will stay positive in the mid-long term.

The "HbA1c Diabetes Monitoring Market, 2014-2024" report provides an exhaustive study of the growing market for HbA1c tests. Amongst other things, the report identifies HbA1c analyzers that are currently available for point of care and laboratory testing, and the high level trends which are likely to govern the evolution of this market in the US, EU5 and BRICS countries. The report also provides a competitive landscape wherein we have identified the most efficient POC devices in the market based on parameters such as user friendliness and other technical details.

One of the key objectives of this report is to understand the current and future state of the HbA1c diabetes monitoring market across various regions worldwide. This is done by analyzing the following:

- Prevalence and growth of diabetes in different countries

- Number of patients going for HbA1c tests

- Frequency of HbA1c test per patient per year

- Variable price points

- Other technical details such as sample volume required, time taken for analysis, precision etc.

We have also provided a detailed view on the key drivers behind the growth of this market, likely challenges and upcoming threats under the SWOT framework. The base year for the report is 2014. The report provides mid -long term market forecasts for the period 2014 - 2024.

EXAMPLE HIGHLIGHTS

1. We identified 41 companies which are active in the HbA1c monitoring market. Amongst the 41 companies, nine manufacture both laboratory and POC analyzers. Except for the bigger companies which account for 41% of the overall industry, the nature of the market is quite fragmented.

2. Currently, 108 HbA1c analyzers are commercially available. Of these, 71% are for laboratory use and the remaining 29% are for either home use or at physician's office.

3. Specifically, for the POC testing, turbidimetry immunoassay and boronate affinity chromatography are the most commonly deployed principles (accounting for 50% and 35% of the POC devices respectively). The POC testing market has witnessed growing interest levels; acceptance is likely to rise further as a result of increased end-user convenience. Currently

4. For laboratory analyzers, Siemens, Beckman Coulter, Roche, Bio-Rad, Abbott, ELITech are some well-known players. The global distribution network of some of these players has positioned them to actively monetize this growing market.

5. The overall market, in addition to an already well-established macro environment, will continue to benefit from continuous improvements in technology. In our base case, we expect the global HbA1c diabetes monitoring market to witness an annualized growth rate of 8.8%.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

- Annual reports

- Investor presentations

- SEC filings

- Industry databases

- News releases from company websites

- Government policy documents

- Industry analysts' views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the current scenario of HbA1c testing market and the likely mid-long term evolution.

Chapter 3 provides a general introduction to the HbA1c testing for diabetes diagnosis and monitoring. We have discussed key concepts behind the test, principles involved, applications, test recommendations, advantages and limitations of the test.

Chapter 4 provides an overview of the competition in the HbA1c market. The chapter provides an extensive list of point of care and laboratory analyzers for HbA1c testing. It also discusses the evolution and adoption of HbA1c tests in the US, EU5 and BRICS countries.

Chapter 5 focuses on the point of care HbA1c analyzers. It covers the general considerations for POC devices, the market analysis for home and physician HbA1c analyzers, product profiles of specific devices and key company profiles.

Chapter 6 includes the company profiles of five key companies manufacturing laboratory analyzers for HbA1c monitoring. The profiles cover overview of the company, financial information, manufacturing facilities, recent partnerships and the future outlook of these companies.

Chapter 7 presents a scenario based approach to identify the future evolution of the industry. Given the uncertainty surrounding the adoption rates, we have done a multivariate sensitivity analysis to present different tracks of industry's evolution.

Chapter 8 provides our analysis of the strengths, weaknesses, opportunities and threats in the HbA1c diabetes monitoring market, capturing the key elements likely to influence future growth. Chapter 9 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapters 10 and 11 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report.

TABLE OF CONTENTS

1. PREFACE

1.1 Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. HbA1c TESTING: AN INTRODUCTION

3.1. Context and Background

3.2. Diabetes Monitoring

3.3. HbA1c Testing

3.3.1. Test Definition

3.3.2. Historical Background

3.3.3. Test Principles

3.3.4. HbA1c Test Results Interpretation

3.3.5. HbA1c Test Recommendations

3.3.6. Advantages of HbA1c Testing

3.3.7. Limitations of HbA1c Testing

4. MARKET OVERVIEW

4.1. Chapter Overview

4.2. HbA1c Chemical Analyzers: Manufacturer's Landscape

4.3. Competitive Analysis: Point of Care and Laboratory Analyzers

4.4. Other Companies: Controls, Kits, Reagents Providers

4.5. HbA1c: Mapping the Opportunity Size

4.6. Diabetes and HbA1c: Regional Analysis

4.6.1. BRICS Countries

4.6.2. UK & Other EU5 Countries

4.6.3. US

5. HbA1c POINT OF CARE ANALYZERS MARKET

5.1. Introduction

5.2. Manufacturing Considerations for POC Analyzers

5.3. Distribution of Analyzers by Number of Companies

5.4. Distribution of Analyzers by Sample Volume

5.5. Distribution of Analyzers by Time Taken For Analysis

5.6. Product Profiles: Key Characteristics

5.6.1. Afinion HbA1c Analyzer

5.6.2. DCA Vantage Analyzer

5.6.3. HemoCue Analyzer

5.6.4. A1c NOW+ Analyzer

5.6.5. in2it(II) Analyzer

5.7. POC Market Analysis

5.7.1. Category I POC Devices

5.7.2. Category 2 POC Devices

5.8. Key Company Profiles

5.8.1. ROHM

5.8.2. Alere

5.8.3. Trinity Biotech

5.8.4. Eurolyser

5.9. Other Companies

5.9.1. Chek Diagnostics

5.9.2. Radiometer

5.9.3. SD Biosensor

5.9.4. Ceragem Medisys

6. HbA1c LABORATORY ANALYZERS MARKET

6.1. Chapter Overview

6.2. Siemens

6.2.1. Company Overview

6.2.2. Financial Information

6.2.3. Product Pipeline

6.2.4. Manufacturing Facilities

6.2.5. Future Outlook

6.3. Roche Laboratories

6.3.1. Company Overview

6.3.2. Financial Performance

6.3.3. Business Segments

6.3.4. Product Portfolio

6.3.5. Partnerships

6.3.6. Manufacturing Facilities

6.3.7. Future Outlook

6.4. Abbott Laboratories

6.4.1. Financial Performance

6.4.2. Product Portfolio

6.4.3. Partnerships

6.4.4. Manufacturing Facilities

6.4.5. Future Outlook

6.5. Bio-Rad Laboratories

6.5.1. Financial Performance

6.5.2. Product Portfolio

6.5.3. Partnerships

6.5.4. Manufacturing Facilities

6.5.5. Future Outlook

6.6. ELITech Group

6.6.1. Company Overview

6.6.2. Product Portfolio

6.6.3. Partnerships

6.6.4. Future Outlook

6.7. Other Companies

6.7.1. Beckman Coulter

6.7.2. Tosoh Bioscience

6.7.3. Sebia

6.7.4. Ortho Clinical Diagnostics

7. MARKET SIZE AND FORECAST

7.1. Chapter Overview

7.2. Forecast Methodology

7.3. HbA1c Diabetes Testing Market: Global and Regional Analysis, 2014 – 2024

7.4. HbA1c Diabetes Testing Market, 2014- 2024: Distribution by POC and Laboratory Analyzers

8. SWOT ANALYSIS

8.1. Chapter Overview

8.1. Strengths

8.2. Weaknesses

8.3. Opportunities

8.4. Threats

9. CONCLUSION

9.1. HbA1c: Significant Advantages

9.2. Point of Care Devices Likely to Play a Key Role

9.3. Emergence of New Delivery Models

9.4. Active Participation of Diagnostics Companies

9.4. Overall Opportunity is Big; We Project a 8.8% Growth in 'Base Scenario'

10. APPENDIX 1: TABULATED DATA

11. APPENDIX2: LIST OF COMPANIES

LIST OF FIGURES

Figure 3.1 Diabetes Population: EU5, US, BRICS (Million)

Figure 3.2 Historic Timeline: Organizations Formed for Standardizing HbA1c Test Results

Figure 4.1 HbA1c Analyzers: Distribution by Number of Companies

Figure 4.2 HbA1c Analyzer Manufacturers:Distribution by Number of Analyzers

Figure 4.3 HbA1c Testing: Market Landscape

Figure 4.4 HbA1c Analyzers:Distribution by Place of Operation

Figure 4.5 Number of People Suffering From Diabetes in EU5, US, BRICS (Million)

Figure 4.6 Number of Deaths Due to Diabetes in EU5, US, BRICS, 2013 (Million)

Figure 4.7 Frequency of HbA1c Testing by Type of Insurance (Brazil)

Figure 4.8 Frequency of HbA1c Testing by Levels of HbA1c (Brazil)

Figure 4.9 HbA1c Values for Russians: By Age Group

Figure 4.10 The UK: HbA1c Adoption Trends, 2009-2012 (Diabetes Type 1)

Figure 4.11 The UK: HbA1c Adoption Trends, 2009-2012(Diabetes Type 2)

Figure 5.1 POC Analyzers: Distribution by Companies

Figure 5.2 POC Analyzers: Distribution by Place of Analysis

Figure 5.3 POC Analyzers: Distribution by Principle Used for Analysis

Figure 5.4 POC Analyzers: Distribution by Sample Volume Used for Analysis

Figure 5.5 POC Analyzers: Distribution by Time Taken for Analysis

Figure 5.6 POC Market Analysis: Category 1 Devices, Set 1

Figure 5.7 POC Market Analysis: Category 1 Devices, Set 2

Figure 5.8 POC Market Analysis: Category 2 Devices, Set 1

Figure 5.9 POC Market Analysis: Category 2 Devices, Set 2

Figure 5.10 ROHM Annual Sales, 2009-2014 (JPY Million)

Figure 5.11 ROHM Annual Sales: Distribution by Industrial Applications

Figure 5.12 Alere Annual Sales, 2009-2014 (USD Million)

Figure 5.13 Alere Annual Sales, 2012-2013: Distribution by Business Segment (USD Million)

Figure 5.14 Alere Annual Professional Diagnostic Sales, 2012-2013: Distribution by Industry (USD Million)

Figure 5.15 Alere Professional Diagnostic Sales, 2013: Distribution by Industry (USD Million, %)

Figure 5.16 Trinity Biotech Annual Sales, 2009-2013 (USD Million)

Figure 5.17 Trinity Biotech Annual Sales, 2012-2013: Distribution by Operating Segments (USD Million)

Figure 5.18 Trinity Biotech Clinical Laboratory Sales: Distribution by Operating Segments (USD Million)

Figure 5.19 Units of Premier Hb9210 Sold (2012-2013)

Figure 6.1 Siemens Annual Sales, 2009-2013 (EUR Million)

Figure 6.2 Siemens Annual Sales, 2012-2013: Distribution by Business Segment (EUR Million)

Figure 6.3 Siemens Annual Sales (2013): Distribution by Business Segment (EUR Million, %)

Figure 6.4 Siemens: Number of Analyzers byType of Diabetes Test

Figure 6.5 Siemens: Number of Manufacturing Sites

Figure 6.6 Roche Annual Sales, 2009-2013 (CHF Million)

Figure 6.7 Roche Annual Sales: Distribution by Business Segment (CHF Million, %)

Figure 6.8 Roche Diagnostics Annual Sales: Distribution by Segment

Figure 6.9 Professional Diagnostics Market: Distribution by Share of Major Pharma Industries

Figure 6.10 In-Vitro Diagnostics Market: Distribution by Share of Major Pharma Industries

Figure 6.11 Diabetes Market: Distribution by Share of Major Pharma Industries

Figure 6.12 Roche: Distribution by Number of Manufacturing Facilities

Figure 6.13 Abbott Laboratories Annual Sales, 2011-2013 (USD Million)

Figure 6.14 Abbott Laboratories Sales, 2013: Distribution by Business Segments (USD million, %)

Figure 6.15 Abbott Diagnostic Sales, 2013 (USD Million, %)

Figure 6.16 Bio-Rad Annual Sales, 2009-2013 (USD Million)

Figure 6.17 Bio-Rad Annual Sales: Distribution by Business Segment (USD Million)

Figure 6.18 Bio-Rad Annual Sales: Distribution by Business Segment (USD Million, %)

Figure 7.1 HbA1c GlobalDiabetes Monitoring Market Forecast, 2014 - 2024: Base Scenario (USD Million)

Figure 7.2 HbA1c Regional Diabetes Monitoring Market Forecast, 2014 - 2024: Base Scenario (USD Million)

Figure 7.3 HbA1c Global Laboratory TestingMarket Forecast, 2014 - 2024: Base Scenario (USD Million)

Figure 7.4 HbA1c LaboratoryTestingMarket Forecast, 2014 – 2024 (Distribution by Geography): Base Scenario (USD Million)

Figure 7.5 HbA1c POC TestingMarket Forecast, 2014 - 2024: Base Scenario (USD Million)

Figure 7.6 HbA1c POCTestingMarket Forecast, 2014 – 2024 (Distribution by Geography): Base Scenario (USD Million)

Figure 9.1 HbA1c Testing Market: Concluding Remarks

Figure 9.2 HbA1c Diabetes Monitoring Market, 2014, 2019, 2024 (USD Million)

 

LIST OF TABLES

Table 3.1 Characteristics of Type 1 and Type 2 Diabetes

Table 3.2 HbA1c Final Results: Influencing Factors

Table 3.3 Enzymatic Methods to Identify Hb Variants

Table 3.4 Different Principles to Measure Glycated Haemoglobin

Table 3.5 Conversion Values of HbA1c from One Unit to Another

Table 3.6 Interpretation of HbA1c Values

Table 4.1POC HbA1c Analyzers: Test Details and Technical Parameters

Table 4.2 Laboratory Analyzers with HbA1c on Test Menu

Table 4.3 HbA1c Tests: Accessory Manufacturers

Table 4.4Recommended Frequency of HbA1c Testing in EU5 Countries

Table 4.5 EU5: Proportion of People Getting Their HbA1c Tests Done Annually

Table 5.1 Afinion HbA1c Analyzer: Key Characteristics

Table 5.2 DCA Vantage Analyzer: Key Characteristics

Table 5.3 HemoCue: Key Characteristics

Table 5.4A1c Now +: Key Characteristics

Table 5.5 in2it (II) HbA1c Analyzer: Key Characteristics

Table 5.6 POC Category 1Devices: Competitive Landscape

Table 5.7POC Category 2 Devices: Competitive Landscape

Table 5.8 B-Analyst Measurement Chip Technical Details

Table 5.9Technical Details of the B-Analyst Analyzer (Manufactured by Ushio Group)

Table 5.10 Approval of Afinion Technology for HbA1c Tests

Table 5.11Afinion AS100 Chemical Analyzer: Technical Details

Table 5.12 Afinion AS100 Analyzer: HbA1c Test Details

Table 5.13 NycoCard: Technical Details

Table 5.14 NycoCard: Diabetes Test Parameters

Table 5.15 Trinity Biotech: Product Portfolio

Table 5.16 Trinity Biotech: Manufacturing SitesTable 5.17 Eurolyser: Analyzers for HbA1c Monitoring

Table 6.1 Siemens: Diabetes Product Portfolio

Table 6.2 DCA Vantage: Tests Parameters

Table 6.3 Roche Diagnostics: Diabetes Product Portfolio

Table 6.4 Cobas b 101Analyzer: Test Parameters

Table 6.5 Abbott Molecular: Diabetes Product Portfolio

Table 6.6 Bio-Rad: HbA1c Product Portfolio

Table 6.7 ELITech Group: Analyzers for HbA1c Monitoring

Table 6.8 ELITech Group: Diabetes Product Portfolio

Table 6.9 Beckman Coulter: Analyzers for HbA1c Monitoring

Table 6.10 Tosoh Bioscience: Analyzers for HbA1c Monitoring

Table 6.11 Tosoh Bioscience: Marketed Systems by Geographies

Table 6.12 Ortho Clinical Diagnostics: Details of Analyzers

Table 8.1 HbA1c Testing: SWOT Analysis

Table 8.2 HbA1c Analyzers: Effect of Interference

Table 8.3 Blood Glucose Monitors

Table 10.1 Diabetes Population: EU5, US, BRICS (Million)

Table 10.2 Number of HbA1c Analyzers Manufactured by a Company

Table 10.3 HbA1c Market: Number of Analyzers by Companies

Table 10.4 Distribution of HbA1c Analyzers by Place of Operation

Table 10.5 Number of Deaths Due to Diabetes in EU5, US and BRICS (Million)

Table 10.6 Frequency of HbA1c Tests in Brazil

Table 10.7 HbA1c Values for Russians: By Age Group

Table 10.8 The UK HbA1c Adoption Rates, 2009-2012 (Diabetes Type 1)

Table 10.9 The UK HbA1c Adoption Rates, 2009-2012 (Diabetes Type 2)

Table 10.10 POC Analyzers: Distribution by Manufacturers

Table 10.11 POC Analyzers: Distribution by Place of Analysis

Table 10.12 POC Analyzers Distribution by Principle Used

Table 10.13 POC Analyzers: Distribution by Sample Volume Required

Table 10.14 POC Analyzers: Distribution by Time Taken for Analysis

Table 10.15 ROHM Annual Sales, 2009-2014 (JPY Million)

Table 10.16 Alere Annual Sales, 2009-2013 (USD Million)

Table 10.17 Alere Annual Sales, 2012-2013: Distribution by Business Segment (USD Million)

Table 10.18 Alere Professional Diagnostic Sales, 2012-2013: Distribution by Industry (USD Million)

Table 10.19 Trinity Annual Sales, 2009-2013 (USD Million)

Table 10.20 Trinity Annual Sales, 2012-2013: Distribution by Operating Segment (USD Million)

Table 10.21 Trinity Annual Sales, 2012-2013: Distribution by Clinical Laboratory Segment (USD Million)

Table 10.22 Units of Premier Hb9210 Analyzer Sold, 2012-2013

Table 10.23 Siemens Annual Sales, 2009-2013 (EUR Million)

Table 10.24 Siemens Annual Sales, 2012-2013: Distribution by Business Segment (EUR Million)

Table 10.25 Siemens Healthcare: Number of Analyzers by Type of Diabetes Test

Table 10.26 Siemens: Number of Manufacturing Sites

Table 10.27 Roche Annual Sales, 2009-2013(CHF Million)

Table 10.28 Roche Annual Sales, 2013: Distribution by Business Segment (CHF Million)

Table 10.29 Roche: Number of Manufacturing Sites

Table 10.30 Abbott Laboratories Annual Sales, 2011-2013(USD Million)

Table 10.31 Bio-Rad Annual Sales, 2009-2013(USD Million)

Table 10.32 Bio-Rad Annual Sales, 2012-2013: Distribution by Business Segment (USD Million)

Table 10.33 HbA1c Global Diabetes Monitoring Market Forecast, 2014 - 2024: Base Scenario (USD Million)

Table 10.34 HbA1c Regional Diabetes Monitoring Market Forecast, 2014 - 2024: Base Scenario (USD Million)

Table 10.35 HbA1c Laboratory Testing Market Forecast, 2014 – 2024: Base Scenario (USD Million)

Table 10.36 HbA1c Laboratory Testing Market Forecast, 2014 – 2024 (Distribution by Geography): Base Scenario (USD Million)

Table 10.37 HbA1c POC Testing Market Forecast, 2014 – 2024: Base Scenario (USD Million)

Table 10.38 HbA1c POC Testing Market Forecast, 2014 – 2024 (Distribution by Geography): Base Scenario (USD Million)

Table 10.39 HbA1c Global Diabetes Monitoring Market Forecast, 2014 - 2024: Conservative Scenario (USD Million)

Table 10.40 HbA1c Regional Diabetes Monitoring Market Forecast,2014 - 2024: Conservative Scenario (USD Million)

Table 10.41 HbA1c LaboratoryTesting Market Forecast, 2014 – 2024: Conservative Scenario (USD Million)

Table 10.42 HbA1c LaboratoryTesting Market Forecast, 2014 – 2024 (Distribution by Geography): Conservative Scenario (USD Million)

Table 10.43 HbA1c POC Testing Market Forecast, 2014 – 2024: Conservative Scenario (USD Million)

Table 10.44 HbA1c POC Testing Market Forecast, 2014 – 2024 (Distribution by Geography): Conservative Scenario (USD Million)

Table 10.45 HbA1c Global Diabetes Monitoring Market Forecast, 2014 - 2024: Optimistic Scenario (USD Million)

Table 10.46 HbA1c Regional Diabetes Monitoring Market Forecast, 2014 - 2024: Optimistic Scenario (USD Million)

Table 10.47 HbA1c LaboratoryTesting Market Forecast, 2014 – 2024: Optimistic Scenario (USD Million)

Table 10.48 HbA1c Laboratory Testing Market Forecast, 2014 – 2024 (Distribution by Geography): Optimistic Scenario (USD Million)

Table 10.49 HbA1c POC Testing Market Forecast, 2014 – 2024: Optimistic Scenario (USD Million)

Table 10.50 HbA1c POC Testing Market Forecast, 2014 – 2024 (Distribution by Geography): Optimistic Scenario (USD Million).

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