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ヘモグロビンA1c検査市場

Hemoglobin A1c Testing Markets

発行 TriMark Publications 商品コード 264567
出版日 ページ情報 英文 138 Pages
納期: 即日から翌営業日
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ヘモグロビンA1c検査市場 Hemoglobin A1c Testing Markets
出版日: 2015年09月01日 ページ情報: 英文 138 Pages
担当者のコメント
米国ニューヨークに本社を置くTriMark Publicationsは、医療分野の中でも糖尿病検査分野のリサーチに力を入れている市場調査会社です。独自のデータベースを有し、情報のアップデートにともない更新版が発行されることから、継続的に購入されるお客様の多い人気のレポートです。
概要

ヘモグロビンA1c(HbA1c)検査は、糖尿病検査市場に取り入れられた最新の主要技術です。世界における糖尿病の有病率は急増を続け、世界の患者数は3億6,600万人以上となっており、HbA1c検査は現在、糖尿病検査レパートリーの必要不可欠なアッセイとなっています。

当レポートでは、糖尿病診断およびモニタリング向け検査を含めたヘモグロビンA1c検査市場について調査し、現在、HbA1cレベルの測定に用いられている一般的な臨床分析手法のレビュー、病院、診療所、医局、および在宅ケアで用いられている臨床測定装置および試薬の分析を提供しており、主要企業のプロファイル、売上予測・市場シェアデータなどをまとめてお届けいたします。

第1章 概要

第2章 糖尿病

  • 糖尿病の人口統計
  • 糖尿病に内在・関連する代謝条件の理解
  • 糖尿病のエコノミクス

第3章 市場分析:規模・成長・シェア・競合企業

  • 世界のHbA1c検査市場
  • HbA1cセルフテスト市場
  • 競合状況
  • 市場促進因子・阻害因子
  • 市場・製品動向
  • 周辺市場

第4章 HbA1c検査の概要

  • HbA1c測定に用いられる技術プラットフォーム
  • HbA1c検査の開発:歴史的評価
  • HbA1c検査および認証基準の標準化
  • HbA1c評価のメリット・デメリット
  • HbA1c検査の提案
  • HbA1c検査における正確さ・精度
  • HbA1c検査に影響する潜在的干渉変数
  • HbA1c検査性能向上の潜在領域
  • ポイントオブケア(POC)HbA1c検査の最適化
  • HbA1c検査の主な課題
  • HbA1c検査および血糖検査:補助的ツール

第5章 市販のHbA1c検査デバイス

  • HbA1cセルフテストデバイス
  • 専門HbA1c検査デバイス
  • 新製品革新・投入
  • 近年の産業活動&企業発展

第6章 HbA1c検査の事業動向

  • 臨床HbA1c検査の促進因子・動向
  • 医療費の管理
  • 医療機器の消費税に影響を与える手ごろな医療費
  • 患者管理の変化
  • ラボケアの地域化
  • サテライト施設
  • ポイントオブケア検査
  • OTC医薬品流通の影響因子
  • OTCおよびセルフテストHbA1c市場の促進因子・阻害因子

第7章 規制環境・医療費償還

  • 米国政府の医療機器規制
  • EUの医療装置規制
  • FDAラベリング要件
  • Clinical Laboratory Improvement Act (CLIA)
  • HbA1c検査の保険適用範囲・医療費償還
  • マネージドケア

第8章 企業プロファイル

図表インデックス

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目次
Product Code: TMRHBA1C15-0901

Hemoglobin A1c (HbA1c) testing is the most recent major technology to have entered the diabetes testing market. As the global prevalence of diabetes mellitus continues to increase rapidly, with more than 366 million diabetics worldwide, hemoglobin A1c testing is now an essential assay in the diabetes testing repertoire. Its clinical utility and improvements in its accuracy and implementation of standardized protocols have translated into continued market growth. This TriMark Publications report describes the specific market segment that encompasses hemoglobin A1c testing for diagnosing and monitoring diabetes. The study reviews all of the generally accepted clinical analytical methods that are currently in use today for measuring HbA1c levels. Moreover, it examines clinical measurement devices and reagents as utilized in hospitals, clinics, doctorÂ's offices and at-home care locations. The report also analyzes almost all of the companies known to be marketing, manufacturing or developing hemoglobin A1c testing. Detailed tables and charts with sales forecasts and marketshare data are also included.

Table of Contents

1. Overview

  • 1.1 Statement of Report
  • 1.2 About this Report
  • 1.3 Scope of the Report
  • 1.4 Methodology
  • 1.5 Executive Summary

2. Diabetes

  • 2.1 Demographics of Diabetes
    • 2.1.1 Worldwide Diabetes Incidence
    • 2.1.2 Diabetes in the U.S. 1
  • 2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes
    • 2.2.1 Pre-Diabetes Syndrome
    • 2.2.2 Metabolic Syndrome
    • 2.2.3 Progression of Diabetes
    • 2.2.4 Diabetes and Inflammation
    • 2.2.5 Risk Factors and Diabetes
      • 2.2.5.1 Obesity
      • 2.2.5.2 Stress-Induced Hyperglycemia
    • 2.2.6 Complications and Co-Morbidities in Diabetes
      • 2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes
      • 2.2.6.2 Cardiovascular Disease Facts
  • 2.3 Economics of Diabetes
    • 2.3.1 Worldwide Costs of Diabetes
    • 2.3.2 Costs of Diabetes in the U.S.

3. Market Analysis: Size, Growth, Share and Competitors

  • 3.1 Worldwide HbA1c Testing Market
    • 3.1.1 U.S. HbA1c Testing Market
  • 3.2 HbA1c Self-Testing Market
  • 3.3 Competitive Situation
    • 3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix
    • 3.3.2 Competitive Strategies and Strategic Recommendations
    • 3.3.3 Future Competing Technologies-Glycated Albumin
  • 3.4 Market Drivers and Restraints
    • 3.4.1 Market Drivers
    • 3.4.2 Market Restraints
  • 3.5 Market and Product Trends
    • 3.5.1 Increase in POC HbA1c Testing
    • 3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays
  • 3.6 Adjacent Markets

4. Overview of HbA1c Testing

  • 4.1 Technology Platforms Used to Measure HbA1c
    • 4.1.1 High-Performance Liquid Chromatography (HPLC)
    • 4.1.2 Immunoassays
    • 4.1.3 Boronate Affinity Chromatography
    • 4.1.4 Enzymatic Assay
    • 4.1.5 Micro-Optical Detection Methods
  • 4.2 Development of HbA1c Testing: A Historical Evaluation
    • 4.2.1 The Diabetes Control and Complications Trial (DCCT)
  • 4.3 Standardization of HbA1c Testing and Certification Criteria
    • 4.3.1 National Glycohemoglobin Standardization Program (NGSP)
    • 4.3.2 International Federation of Clinical Chemistry (IFCC)
    • 4.3.3 New NGSP Certification Criteria
    • 4.3.4 ADAG (A1c Derived Average Glucose)
    • 4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c
    • 4.3.6 College of American Pathologists (CAP) Proficiency Program
    • 4.3.7 Certifications and Selecting HbA1c Assays
  • 4.4 Advantages and Disadvantages of HbA1c Assessment
  • 4.5 HbA1c Testing Recommendations
    • 4.5.1 Frequency of HbA1c Testing
    • 4.5.2 Diagnostic HbA1c Testing
    • 4.5.3 Screening for Pre-diabetes
    • 4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals
    • 4.5.5 New HbA1c Target Recommendation for Children with Type 1 Diabetes
  • 4.6 Accuracy and Precision in HbA1c Testing
    • 4.6.1 Biological Variation
    • 4.6.2 Pre-Analytical Variation
    • 4.6.3 Analytical Variation
  • 4.7 Potential Interfering Variables Affecting HbA1c Testing
  • 4.8 Potential Areas of Improvement in HbA1c Testing Performance
  • 4.9 Optimizing of Point of Care (POC) HbA1c Testing
  • 4.10 Key Issues for HbA1c Testing
  • 4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools

5. HbA1c Testing Devices on the Market

  • 5.1 HbA1c Self-Testing Devices
    • 5.1.1 A1CNow SELFCHECK
    • 5.1.2 DTI Laboratories, Inc.
  • 5.2 Professional HbA1c Testing Devices
    • 5.2.1 Point of Care HbA1c Testing
      • 5.2.1.1 A. Menarini Diagnostics
      • 5.2.1.2 Alere
      • 5.2.1.3 Apex Biotechnology
      • 5.2.1.4 Convergent Technologies GmbH & Co.
      • 5.2.1.5 DiaSys Diagnostic Systems
      • 5.2.1.6 Diazyme Laboratories
      • 5.2.1.7 EKF Diagnostics
      • 5.2.1.8 Eurolyser
      • 5.2.1.9 Green Cross Medis (formerly Ceragem Medisys)
      • 5.2.1.10 HemoCue (a division of Radiometer)
      • 5.2.1.11 Infopia
      • 5.2.1.12 Roche
      • 5.2.1.13 SD Biosensor
      • 5.2.1.14 Siemens Healthcare Diagnostics
    • 5.2.2 HbA1c Laboratory Testing
      • 5.2.2.1 Abbott
      • 5.2.2.2 Alere
      • 5.2.2.3 AMS
      • 5.2.2.4 Arkray
      • 5.2.2.5 Beckman Coulter
      • 5.2.2.5 Bio-Rad
      • 5.2.2.7 DiaSys Diagnostic Systems
      • 5.2.2.8 Diazyme Laboratories
      • 5.2.2.9 Diatron
      • 5.2.2.10 EKF Diagnostics
      • 5.2.2.11 ELITechGroup
      • 5.2.2.12 Green Cross Medis (formerly Ceragem Medisys)
      • 5.2.2.13 Kyowa Medex, Co., Ltd.
      • 5.2.2.14 Ortho Clinical Diagnostics (part of Johnson & Johnson)
      • 5.2.2.15 Pointe Scientific, Inc. (part of MedTest Holdings)
      • 5.2.2.16 Randox Laboratories
      • 5.2.2.17 Roche
      • 5.2.2.18 Sebia
      • 5.2.2.19 Siemens Healthcare Diagnostics
      • 5.2.2.20 Tosoh
      • 5.2.2.21 Trinity Biotech
  • 5.3 New Product Innovations and Introductions
    • 5.3.1 Roche's Cobas Integra 800 Tina-quant HbA1cDx Assay Is First FDA-approved Test for Diagnosing Diabetes
    • 5.3.2 Abbott Announces FDA Clearance for a its ARCHITECT Clinical Chemistry Hemoglobin A1c Test for the Diagnosis and Monitoring of Diabetes
    • 5.3.3 Sebia Announces a New HbA1c Test
    • 5.3.4 Sebia's CAPILLARYS 2 FLEX Piercing System
    • 5.3.5 Sebia's MINICAP Flex Piercing
    • 5.3.6 Shelf-life of EKF Diagnostics' Quo-Lab HbA1c Test Extended
    • 5.3.7 Convergent Technologies Launches Convergys® HbA1c
    • 5.3.8 Beckman Coulter Receives FDA Clearance on Next Generation Hemoglobin A1c Test
    • 5.3.9 Trinity Biotech Launches the Premier Hb9210
    • 5.3.10 Trivitron to Enter HbA1c Market
    • 5.3.11 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer
    • 5.3.12 EKF Diagnostics to Launch the Quo-Lab HbA1c
    • 5.3.13 Tosoh Introduces the ST AIA-PACK HbA1c Assay
    • 5.3.14 Tosoh Introduces a Comprehensive HbA1c Product Line
    • 5.3.15 Abnova's Personal A1c Diabetes Rapid Test
    • 5.3.16 FDA Clears Ortho-Clinical Diagnostics' Enhanced HbA1c Reagent Kit
  • 5.4 Recent Industry Activity & Corporate Developments
    • 5.4.1 PTS, Inc. (now Chek Diagnostics) Acquires A1CNow from Bayer Diabetes Care
    • 5.4.2 Polymer Technology Systems, Inc. (PTS, Inc.) Changes Name to Chek Diagnostics
    • 5.4.3 EKF Diagnostics Quo-Test and Quo-Lab HbA1c POCT Analyzers Comparable to Laboratory HPLC
    • 5.4.4 Radiometer Medical ApS Acquires HemoCue AB
    • 5.4.5 Axis-Shield Acquired by Alere
    • 5.4.6 EKF Diagnostics Opens New Manufacturing Facility at its Quotient Diagnostics Base
    • 5.4.7 EKF Diagnostics Acquires Quotient Diagnostics
    • 5.4.8 EKF Diagnostics Acquires Stanbio Laboratories
    • 5.4.9 Geonostics Acquires FlexSite's Diagnostics
    • 5.4.10 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini Diagnostics
    • 5.4.11 Pointe Scientific Acquired by MedTest Holdings

6. Business Trends in HbA1c Testing

  • 6.1 Drivers and Trends of Clinical HbA1c Testing
  • 6.2 Healthcare Cost Controls
  • 6.3 Affordable Care Act Excise Tax on Medical Devices
  • 6.4 Changes in Patient Management
  • 6.5 Regionalization of Laboratory Care
  • 6.6 Satellite Facilities
  • 6.7 Professional Point of Care Testing
    • 6.7.1 Key Issues in the POC Diagnostic Testing Sector
    • 6.7.2 Current Market Trends and Drivers
    • 6.7.3 POC HbA1c
    • 6.7.4 Effectiveness of POCT
    • 6.7.5 Key Customer Segments
      • 6.7.5.1 DELTA Dentists of New Jersey to Offer In-Office A1c Diabetes Testing
  • 6.8 Factors Affecting OTC Medical Product Distribution
  • 6.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets

7. Regulatory Environment and Insurance Reimbursements

  • 7.1 U.S. Government Regulation of Medical Devices
  • 7.2 E.U. Regulation of Medical Devices
  • 7.3 FDA Labeling Requirements
  • 7.4 Clinical Laboratory Improvement Act (CLIA)
  • 7.5 HbA1c Testing Insurance Coverage and Reimbursement
  • 7.6 Managed Care

8. Company Profiles

  • 8.1 Abbott Laboratories
  • 8.2 Alere, Inc.
  • 8.3 A. Menarini Diagnostics
  • 8.4 AMS Alliance
  • 8.5 Apex Biotechnology Corporation
  • 8.6 ARKRAY USA, Inc.
  • 8.7 Axis-Shield Plc
  • 8.8 Bayer Healthcare Diagnostics
  • 8.9 Beckman Coulter, Inc
  • 8.10 Bio-Rad Laboratories, Inc.
  • 8.11 Convergent Technologies GmbH
  • 8.12 DiaSys Diagnostics
  • 8.13 Diazyme Laboratories (a Division of General Atomics)
  • 8.14 Diatron
  • 8.15 DTI Laboratories, Inc.
  • 8.16 EKF Diagnostics
  • 8.17 ELITechGroup
  • 8.18 Eurolyser
  • 8.19 Green Cross Medis (formerly Ceragem Medisys)
  • 8.20 HemoCue AB (now part of Radiometer Medical)
  • 8.21 Infopia Co., Ltd.
  • 8.22 Kyowa Medex
  • 8.23 Ortho Clinical Diagnostics (part of Johnson & Johnson)
  • 8.24 Pointe Diagnostics
  • 8.25 PTS Diagnostics
  • 8.26 Randox Laboratories
  • 8.27 Roche Diagnostics
  • 8.28 SD Biosensor
  • 8.29 Sebia
  • 8.30 Siemens AG
  • 8.31 Tosoh Bioscience, Inc.
  • 8.32 Trinity Biotech Plc

INDEX OF FIGURES

  • Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035
  • Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years)
  • Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age
  • Figure 2.4: Prevalence of Diabetes by Age in the U.S.
  • Figure 2.5: Diagnosed Diabetes by Age in the U.S.
  • Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State
  • Figure 2.7: Number of Deaths from Diabetes by Age in the U.S.
  • Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S.
  • Figure 2.9: Maintenance of Normal Blood Sugar Levels
  • Figure 2.10: Prevalence of Self-Reported Obesity (BMI 330) Among U.S. Adults
  • Figure 2.11: Prevalence of Obesity (BMI ≥30) Among Adults in the U.S.
  • Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S.
  • Figure 2.13: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S.
  • Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, United States
  • Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, United States
  • Figure 2.16: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD)
  • Figure 2.17: How Diabetes Dollars are Spent in the U.S.
  • Figure 3.1: Worldwide HbA1c Testing Market
  • Figure 3.2: U.S. HbA1c Testing Market
  • Figure 3.3: Global HbA1c Self-Testing Market
  • Figure 4.1: Non-Enzymatic Glycation of Hemoglobin
  • Figure 4.2: Boronate Affinity Binding of Glycated Protein
  • Figure 4.3: Comparison of HbA1C and Blood Glucose Measurements over a Four-Day Period
  • Figure 4.4: Range of Variation in HbA1c Assay
  • Figure 4.5: Range of Variation in the FPG Assay
  • Figure 7.1: CLIA Laboratories by Certificate Types

INDEX OF TABLES

  • Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035
  • Table 2.2: Countries with the Largest Numbers of Diabetics
  • Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035
  • Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group
  • Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes
  • Table 2.6: New Cases of Diagnosed Diabetes Among U.S. Adults Aged 20 Years or Older
  • Table 2.7: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013
  • Table 2.8: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2013
  • Table 2.9: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
  • Table 2.10: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
  • Table 2.11: Prevalence of Complications Among Patients with Diabetes
  • Table 2.12: Major Causes of End-stage Renal Disease
  • Table 2.13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
  • Table 2.14: Clinical Recommendations for Adults with Diabetes
  • Table 2.15: Laboratory Assessment of Diabetic Vascular Disease
  • Table 2.16: Average Years Gained Free of Diabetes-related Disease with Intensive Management
  • Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.
  • Table 2.18: Cost of Diagnosed Diabetes in the U.S.
  • Table 2.19: Annual Cost of Care of United Healthcare Adult Members with Diabetes
  • Table 2.20: Healthcare Utilization by Diabetic Patients
  • Table 3.1: Worldwide HbA1c Testing Market, 2010-2019
  • Table 3.2: U.S. HbA1c Testing Market, 2010-2019
  • Table 3.3: Global HbA1c Self-Testing Market, 2010-2019
  • Table 3.4: Key Players in the HbA1c Clinical Laboratory Market
  • Table 3.5: Key Players in the HbA1c POC Market
  • Table 3.6: Key Players in the HbA1c Self-Testing Market
  • Table 3.7: Key Market Drivers for HbA1c Testing
  • Table 4.1: Summary of NGSP Certification Criteria
  • Table 4.2: Summary of the 2010 Consensus Statement on the Worldwide Standardization of HbA1c
  • Table 4.3: Advantages of HbA1c versus Blood Glucose Testing
  • Table 4.4: Disadvantages of HbA1c versus Blood Glucose Testing
  • Table 4.5: HbA1c Testing Recommendations
  • Table 4.6: Criteria for the Diagnosis of Diabetes
  • Table 4.7: Categories of Increased Risk for Diabetes (Pre-Diabetes)
  • Table 4.8: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
  • Table 4.9: Glycemic Recommendations for Women with Gestational Diabetes
  • Table 4.10: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes
  • Table 4.11: Conditions Known to Interfere with HbA1c Assays
  • Table 4.12: Interference from Hb Variants in Select HbA1c Testing Systems
  • Table 4.13: History of NGSP Manufacturer Certification Criteria
  • Table 4.14: Correlation of HbA1c with Mean Blood Glucose
  • Table 5.1: HbA1c Testing Devices and Assays on the Market
  • Table 5.2: Premier Hb9210 Placements Worldwide
  • Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs
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