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市場調査レポート

血糖検査・糖尿病管理の世界市場

Blood Glucose Testing and Diabetes Management

発行 TriMark Publications 商品コード 301307
出版日 ページ情報 英文 311 Pages
納期: 即日から翌営業日
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血糖検査・糖尿病管理の世界市場 Blood Glucose Testing and Diabetes Management
出版日: 2015年09月01日 ページ情報: 英文 311 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、医療分野の市場分析に定評のある調査会社です。血糖検査シリーズが充実しており、アメリカ市場の分析を得意としています。本レポートでもアメリカの主要な企業の情報が網羅されております。TriMark Publicationsが発行するレポートは、比較的短いスパンで情報が更新される商品が多く、最新データが網羅されているとして継続的に購入されるお客様の多い人気のシリーズです。
概要

世界中で糖尿病の罹患率が劇的に上昇しており、拡大する肥満問題が状況を深刻化させています。その結果、世界の血糖検査製品市場は糖尿病治療のための新たな分析技術開発によって大きく変化を遂げています。体外診断 (IVD) 業界の血糖検査セグメントは成熟していますが、糖尿病管理のための在宅検査装置などのセグメントは大きく成長するとみられています。非侵襲性の検査がIVD検査の新たな応用分野として注目されています。

当レポートでは、血糖検査市場について調査し、現在用いられている一般に認められた臨床分析方法のすべてを検証しながら、臨床測定装置や試薬の概要、および参入企業のプロファイルをまとめております。

第1章 概要

第2章 糖尿病

  • 糖尿病の人口統計
    • 世界の罹患率
    • 米国の糖尿病
  • 糖尿病に関連する代謝性疾患の理解
    • 糖尿病予備軍
    • メタボリックシンドローム
    • 糖尿病の進行
    • 糖尿病と炎症
    • リスクファクターと糖尿病
    • 糖尿病の合併症と併存疾患
  • 糖尿病の経済学
    • 世界の糖尿病コスト
    • 米国の糖尿病コスト

第3章 市場分析:規模、成長、シェア、競合企業

  • 世界の血糖検査市場
    • 世界の血糖自己検査市場
    • 世界の専用血糖検査市場
    • 継続的血糖モニタリング市場
  • 米国市場
    • OTC自己検査市場
    • 専門検査市場
  • 欧州市場
  • アジア市場
    • 日本
    • 中国
    • インド
    • 韓国
    • 東南アジア
    • その他
  • 競合動向
    • 主要企業
    • 市場、競合および製品ミックスの分析
    • 専門血糖モニタリング市場の分析
  • 市場促進因子と阻害因子
    • 市場促進因子
    • 市場阻害因子
  • 市場および製品動向
    • 市場動向
    • 技術動向
  • 戦略的提言
  • 競合戦略
  • 専門血糖メーター市場における新たな機会
  • 周辺市場

第4章 血糖診断およびモニタリングに関する提言

  • 糖尿病の診断
  • 糖尿病の治療における厳しい血糖管理
  • 糖尿病患者における血糖管理の提言
  • 低血糖および治療

第5章 血糖検査技術プラットフォームと消耗品

  • 血糖測定技術の種類
  • 血糖濃度測定に用いられる酵素反応
  • 血糖モニターの開発:歴史的な評価
  • 血糖メーターの正確性・精密性
  • 血糖検査装置の主な課題
  • 既存血糖検査の限界
  • 血糖メーター性能における潜在的な改善領域
  • 血糖試薬検査ストリップ
  • ハンドヘルド血糖メーターと臨床試験血糖測定との比較
  • 持続的血糖モニタリング技術
  • 非侵襲性血糖モニタリング技術のサマリー
  • A1cモニタリング技術
  • フルクトサミン検査
  • 関連試薬と設備

第6章 上市されている血糖検査装置

  • 自己検査用ハンドヘルド血糖メーターおよびストリップ
  • 専門家用ポイントオブケア血糖メーター
  • 臨床血液化学分析装置
  • 継続的患者血糖モニタリングシステム
  • 非侵襲性患者血糖モニタリングシステム
  • A1c検査
  • 新製品の上市
  • 開発中の血糖メーター、CGM、データ管理ソフトウェア
  • 近年の業界活動
  • M&A活動

第7章 血糖検査のビジネス動向

  • 臨床血糖検査の促進因子
  • POC血糖検査をめぐる競争
  • 医療費管理
  • 患者マネジメントの変化
  • 試験所ケアの地域化
  • サテライト施設
  • ポイントオブケア検査
  • OTC医療製品流通に影響を及ぼす要因
  • 糖尿病ケア分類に重要なドラッグストア
  • OTC・自己検査市場の促進因子
  • 血糖自己検査のコスト要因
  • 欧州における事業実施コスト
  • 欧州におけるコスト抑制
  • 血糖自己検査保険のカバー範囲および医療費償還
  • 米国におけるラボ検査医療費償還の動向
  • 医療費償還の課題
  • マネージドケア
  • 医療機器の政府規制、ほか

第8章 技術動向

  • 現在のOTC血糖メーターの改良
  • バイオセンサー技術
  • 人工膵臓
  • 遠隔医療
  • 試料収集のための非従来的方法
  • データ管理

第9章 企業プロファイル

図表リスト

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目次
Product Code: TMRGLUC15-0901

There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes, particularly Type 2 diabetes, among adults across the world. As such, the global market for blood glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market, such as home testing devices for diabetes management, will exhibit strong growth. Whats more, non-invasive testing now represents a major new area for the application of IVD testing. Additionally, direct access testing--or over-the-counter testing, which allows consumers to order tests themselves without visiting a doctor--has emerged as a strong force in the blood glucose testing segment. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctors offices and at-home care locations. The report has made a survey of selected companies marketing, manufacturing or developing various blood glucose testing and diabetes management supplies throughout the world. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the companys market position. Detailed tables and charts with sales forecasts and market share 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.
  • 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 Glucose Testing Market
    • 3.1.1. Global Blood Glucose Self-Testing Market
    • 3.1.2. Worldwide Professional Blood Glucose Testing Market
    • 3.1.3. Continuous Glucose Monitoring Markets
  • 3.2. U.S. Market
    • 3.2.1. U.S. Over-the-Counter (OTC) Self-Testing Glucose Market
    • 3.2.2. U.S. Professional Glucose Testing Market
  • 3.3. European Market
  • 3.4. Asian Market
    • 3.4.1. Japanese Market
    • 3.4.2. Chinese Market
    • 3.4.3. Indian Market
    • 3.4.4. Korean Market
    • 3.4.5. Southeast Asian Market
    • 3.4.6. ROW Markets
  • 3.5. Competitive Situation
    • 3.5.1. Key Players in the Self-testing Market
    • 3.5.2. Analyses of the Self-testing Market Conditions, Competition and Product Mix
    • 3.5.3. Analyses of the Professional Blood Glucose Monitoring Market
  • 3.6. Market Drivers and Restraints
    • 3.6.1. Market Drivers
    • 3.6.2. Market Restraints
  • 3.7. Market and Product Trends
    • 3.7.1. Market Trends
    • 3.7.2. Technology Trends
  • 3.8. Strategic Recommendations
  • 3.9. Competitive Strategies
  • 3.10. New Opportunities in the Professional Blood Glucose Meter Market
  • 3.11. Adjacent Markets

4. Glucose Diagnostic and Monitoring Recommendations

  • 4.1. Diagnosis of Diabetes Mellitus
  • 4.2. Tight Glucose Control in Treating Diabetes
    • 4.2.1. Tight Glucose Control Lowers Cardiovascular Complications
  • 4.3. Recommendations for Glucose Control in Diabetic Patients
    • 4.3.1. New Plasma Blood Sugar and HbA1c Target Recommendation for Children with Type 1 Diabetes
    • 4.3.2. Recommended Frequency of Blood Glucose Testing
    • 4.3.3. Using Blood Glucose Data to Monitor and Modify Patient Therapy
    • 4.3.4. Testing in Individuals with Type 2 Diabetes
    • 4.3.5. Continuous Glucose Monitoring (CGM)
    • 4.3.6. A1c Testing Recommendations
    • 4.3.7. Blood Glucose Testing for All Hospitalized Patients According to Guidelines by The Endocrine Society
  • 4.4. Hypoglycemia and Treatment

5. Glucose Testing Technology Platforms and Consumable Products

  • 5.1. Types of Glucose Determination Technologies
  • 5.2. Enzymatic Reactions Used to Determine Glucose Concentrations
    • 5.2.1. Glucose Oxidase (GOX)
    • 5.2.2. Glucose Dehydrogenase (GDH)
      • 5.2.2.1. GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide)
      • 5.2.2.2. GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide)
      • 5.2.2.3. GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone)
    • 5.2.3. Glucose Hexokinase
  • 5.3. Development of Blood Glucose Monitors: A Historical Evaluation
    • 5.3.1. First Generation Blood Glucose Biosensors
    • 5.3.2. Second Generation Blood Glucose Biosensors
    • 5.3.3. Third Generation Blood Glucose Biosensor
  • 5.4. Accuracy and Precision in Glucose Meters
    • 5.4.1. Clinical and Laboratory Standards Institute (CLSI) POCT12-A3
    • 5.4.2. International Organization for Standardization (ISO) 15197:2013
    • 5.4.3. FDA Guidelines for Blood Glucose Testing Systems
    • 5.4.4. Determining Clinical Accuracy Using the Error Grid Analysis (EGA)
    • 5.4.5. Quality Control Criteria
    • 5.4.6. Potential Variables Affecting Glucose Concentrations
  • 5.5. Key Issues for Glucose Testing Devices
    • 5.5.1. Important Elements for Glucose Testing
    • 5.5.2. Key Features to Aid Specific Patient Populations
  • 5.6. Limitations of Existing Glucose Testing
    • 5.6.1. Common User Errors in Glucose Self-Testing
    • 5.6.2. Interfering Substances and Conditions
      • 5.6.2.1. Environmental
      • 5.6.2.2. Physiologic
      • 5.6.2.3. Operational
      • 5.6.2.4. Manufacturing Variations
      • 5.6.2.5. Drugs/Medications
      • 5.6.2.6. Patient Factors
    • 5.6.3. Errors Associated with GDH-PQQ Technology
    • 5.6.4. Optimizing of Point-of-Care (POC) Blood Glucose Testing
  • 5.7. Potential Areas of Improvement in Blood Glucose Meter Performance
    • 5.7.1. Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems
  • 5.8. Blood Glucose Reagent Test Strips
  • 5.9. Comparison of Hand-Held Blood Glucose Meters with Clinical Laboratory Glucose Measurements
  • 5.10. Continuous Glucose Monitoring Technology
    • 5.10.1. Advantages of Continuous Readings
    • 5.10.2. FDA Approval of CGM
    • 5.10.3. CGM Functions to Consider
    • 5.10.4. New Technologies for CGM
  • 5.11. Summary of Technologies Being Explored for Non-invasive Glucose Monitoring
    • 5.11.1. GlucoTrack
    • 5.11.2. Non-invasive Glucose Monitoring Technologies in Development
    • 5.11.3. Goals of Non-Invasive Testing
    • 5.11.4. Non-Invasive Diabetes Screening Test
  • 5.12. A1c Monitoring Technology
    • 5.12.1. PTS Diagnostics' (Chek Diagnostics') A1c Home Test
  • 5.13. Fructosamine Test
  • 5.14. Related Reagents and Equipment
    • 5.14.1. Lancets
      • 5.14.1.1. Types of Lancing Devices
      • 5.14.1.2. Market Size
    • 5.14.2. Control Solutions and Calibrators
    • 5.14.3. Sharps Devices
    • 5.14.4. Needle Destruction Devices
    • 5.14.5. Urine Strips
    • 5.14.6. Ketone Testing
    • 5.14.7. Long-term Glucose Sensing Bio-implants

6. Glucose Testing Devices on the Market

  • 6.1. Hand-Held Blood Glucose Meters and Strips for Self-testing
    • 6.1.1. LifeScan
    • 6.1.2. Roche Diagnostics Corporation
    • 6.1.3. Bayer
    • 6.1.4. Abbott (MediSense)
    • 6.1.5. AgaMatrix, Inc.
    • 6.1.6. ARKRAY, Inc.
    • 6.1.7. Bionime Corporation
    • 6.1.8. BioSense Medical Devices
    • 6.1.9. CVS/pharmacy
    • 6.1.10. Diabetic Supply of Suncoast
    • 6.1.11. Entra Health Systems
    • 6.1.12. Fifty50 Pharmacy
    • 6.1.13. Fora Care
    • 6.1.14. Genesis Health Technologies
    • 6.1.15. GlucoCom
    • 6.1.16. iHealth
    • 6.1.17. Infopia
    • 6.1.18. Livongo Health
    • 6.1.19. Nipro Diagnostics, Inc.
    • 6.1.20. Nova Biomedical
    • 6.1.21. Oak Tree International Holdings, Inc.
    • 6.1.22. Omnis Health
    • 6.1.23. Phylosis
    • 6.1.24. Prodigy Diabetes Care, LLC (an affiliate of Diagnostic Devices, Inc.)
    • 6.1.25. Sanofi
    • 6.1.26. Target
    • 6.1.27. Telcare
    • 6.1.28. Tyson Biomedical
    • 6.1.29. US Diagnostics
    • 6.1.30. Walgreens
    • 6.1.31. Walmart
    • 6.1.32. 77 Elektronika Kft.
    • 6.1.33. A. Menarini Diagnostics
    • 6.1.34. All Medicus
    • 6.1.35. i-SENS
    • 6.1.36. Apex Biotechnology Corp.
    • 6.1.37. Glucoplus, Inc.
    • 6.1.38. Polymer Technology Systems
    • 6.1.39. Smiths Medical MD, Inc.
    • 6.1.40. TaiDoc Technology Corp.
    • 6.1.41. IN4 Technology Corporation
    • 6.1.42. ACON Laboratories
    • 6.1.43. Pepex Biomedical
    • 6.1.44. HMD BioMedical
    • 6.1.45. BTNX
    • 6.1.46. Decision Diagnostics Corporation and Pharma Tech Solutions
  • 6.2. Point of Care Blood Glucose Meters for Professional Use
    • 6.2.1. Abbott
      • 6.2.1.1. Precision Xceed ProÒ Blood Glucose and Beta-Ketone Monitoring System
      • 6.2.1.2. i-STATÒ System
    • 6.2.2. Alere
      • 6.2.2.1. epoc® Blood Analysis System
      • 6.2.2.2. Alere Cholestech LDX System
    • 6.2.3. Apex Biotechnology
    • 6.2.4. ARKRAY
      • 6.2.4.1. AssureÒ Platinum and Assure Prism Multi
    • 6.2.5. EKF Diagnostics
      • 6.2.5.1. Biosen Series of Glucose and Lactate Analyzers
    • 6.2.6. Fora Care
      • 6.2.6.1. VSM100 Pro Vital Sign Monitor
    • 6.2.7. HemoCue (part of Radiometer)
      • 6.2.7.1. HemoCueÒ Glucose 201+, Glucose 201 RT, Glucose 201 DM, and Glucose DM RT Systems
    • 6.2.8. HMD BioMedical
      • 6.2.8.1. NS101
    • 6.2.9. Infopia
      • 6.2.9.1. Lipid Pro
    • 6.2.10. Jant Pharmacal
      • 6.2.10.1. LipidPlus® Lipid Profile and Glucose Measuring System
    • 6.2.11. Medtronic
      • 6.2.11.1. iPro™ Continuous Glucose Monitor
    • 6.2.12. Nova Biomedical
      • 6.2.12.1. StatStripÒ Hospital Glucose Monitoring System
    • 6.2.13. Polymer Technology Systems
      • 6.2.13.1. CardioChek® PA Point-of-Care Device
    • 6.2.14. Roche
      • 6.2.14.1. Accu-ChekÒ Inform II System
      • 6.2.14.2. AccutrendÒ Plus System
    • 6.2.15. Techno Medica Co., Ltd
      • 6.2.15.1. GASTAT-mini
    • 6.2.16. LifeScan
  • 6.3. Clinical Blood Chemistry Analyzers
    • 6.3.1. Abaxis, Inc.
      • 6.3.1.1. Piccolo® Xpress Blood Chemistry Analyzers
    • 6.3.2. Abbott
      • 6.3.2.1. ARCHITECT
    • 6.3.3. Alere
      • 6.3.3.1. Cholestech LDX® System
    • 6.3.4. AMS
      • 6.3.4.1. SAT 600
      • 6.3.4.2. SAT 450
      • 6.3.4.3. LIASYS
      • 6.3.4.4. ELLIPSE
      • 6.3.4.5. NEPHYS
      • 6.3.4.6. VEGASYS
    • 6.3.5. ARKRAY, Inc.
      • 6.3.5.1. SPOTCHEM™ EZ
      • 6.3.5.2. SPOTCHEM D-02 (SD-4810) & SPOTCHEM D-03 (SD-4820)
    • 6.3.6. Beckman Coulter
      • 6.3.6.1. AU chemistry systems
      • 6.3.6.2. UniCel® DxC chemistry systems
    • 6.3.7. DiaSys
      • 6.3.7.1. InnovaStar®
      • 6.3.7.2. SensoStar GL30 touch and SensoStar GLHsix
      • 6.3.7.3. respons® 910 and 920
      • 6.3.7.4. BioMajesty® JCA-BM6010/C
    • 6.3.8. Diatron
      • 6.3.8.1. Pictus 500
      • 6.3.8.2. Pictus 700
      • 6.3.8.3. Pictus 400
      • 6.3.8.4. Pictus 200
      • 6.3.8.5. Pictus B
    • 6.3.9. Instrumentation Laboratory
      • 6.3.9.1. IL GEM Premier 4000, 3500 and 3000
    • 6.3.10. LifeHealth (formerly International Techidyne Corporation)
      • 6.3.10.1. IRMA TruPoint®
    • 6.3.11. Nova Biomedical
      • 6.3.11.1. Nova Electrolyte/Chemistry Analyzers
      • 6.3.11.2. Stat Profile® Critical Care Xpress
      • 6.3.11.3. Stat Profile® pHOx® Plus
      • 6.3.11.5. Stat Profile® pHOx® Ultra
    • 6.3.12. Radiometer™
      • 6.3.12.1. ABL™80 FLEX
      • 6.3.12.2. ABL™90 FLEX
      • 6.3.12.3. ABL™800 FLEX
    • 6.3.13. Randox Laboratories
      • 6.3.13.1. RX Series of clinical chemistry analyzers
    • 6.3.14. Roche
      • 6.3.14.1. cobas® 4000, cobas® 6000, and cobas® 8000 modular Analyzer Series
      • 6.3.14.2. cobas® c 111 Analyzer
      • 6.3.14.3. cobas® b 221 System
      • 6.3.14.4. Reflotron® Systems
    • 6.3.15. Siemens Healthcare Diagnostics
      • 6.3.15.1. Point-of-care Blood Gas Analyzers
      • 6.3.15.2. Central (Core) Laboratory Clinical Chemistry Systems
    • 6.3.16. Span Diagnostics
      • 6.3.16.1. Autochem Xact
      • 6.3.16.2. BT 1500
    • 6.3.17. Stanbio Laboratory
      • 6.3.17.1. Excel Semi-Automated Clinical Chemistry Analyzer
      • 6.3.17.2. Sirrus® Clinical Chemistry Analyzer
    • 6.3.18. Techno Medica Co., Ltd
    • 6.3.19. Thermo Fisher Scientific
      • 6.3.19.1. Indiko™ Clinical and Specialty Chemistry System
      • 6.3.19.2. Indiko™ Plus Clinical and Specialty Chemistry System
      • 6.3.19.3. Konelab™ 20XT Clinical Chemistry Analyzer
      • 6.3.19.4. Konelab™ PRIME 60 Clinical Chemistry Analyzer
      • 6.3.19.5. MGC 240 Benchtop Analyzer
    • 6.3.20. Tokyo Boeki Medisys
      • 6.3.20.1. BiOLis family of analyzers
    • 6.3.21. YSI Life Sciences
      • 6.3.21.1. YSI 2300 STAT Plus™ Glucose & Lactate Analyzer
  • 6.4. Continuous Glucose Patient Monitoring Systems
    • 6.4.1. Medtronic's Continuous Glucose Monitoring Systems (CGMS)
      • 6.4.1.1. MiniMed Paradigm REAL-Time Revel System
      • 6.4.1.2. Guardian REAL-Time
      • 6.4.1.3. MiniMed 530G with Enlite
      • 6.4.1.4. iPro®2 Professional CGM
    • 6.4.2. Dexcom, Inc.'s Continuous Glucose Monitoring System
      • 6.4.2.1. G4 Platinum Continuous Glucose Monitoring System
      • 6.4.2.2. Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
      • 6.4.2.3. Dexcom G5 Mobile Continuous Glucose Monitoring System
    • 6.4.3. Animas Vibe System
    • 6.4.4. Abbott's Continuous Glucose Monitor System
      • 6.4.4.1. FreeStyle Libre
      • 6.4.4.2. FreeStyle Navigator (discontinued)
    • 6.4.5. GlucoDay® S Continuous Glucose Monitor
    • 6.4.6. Minimally-Invasive Continuous Glucose Monitors in Development
      • 6.4.6.1. GlySens Inc.
      • 6.4.6.2. Senseonics (formerly Sensors for Medicine and Science)
      • 6.4.6.3. Ultradian
  • 6.5. Non-Invasive Glucose Patient Monitoring Systems
    • 6.5.1. Cygnus GlucoWatch Biographer
    • 6.5.2. AiMedics
    • 6.5.3. Echo Therapeutics
    • 6.5.4. EyeSense GmbH
    • 6.5.5. Freedom Meditech
    • 6.5.6. Google and Novartis
    • 6.5.7. Integrity Applications Ltd.
    • 6.5.8. Lein Applied Diagnostics
    • 6.5.9. LighTouch Medical
    • 6.3.10. Miraculins, Inc.
    • 6.5.11. Xhale Inc.
  • 6.6. A1c Testing
  • 6.7. New Product Launches
    • 6.7.1. OneTouch® Verio®Sync Blood Glucose Monitoring System
    • 6.7.2. Medtronic's MiniMed 530G with Enlite Sensor Technology
    • 6.7.3. Contour Next Link Meter Approved for Use with Medtronic's New MiniMed 530G with Enlite Insulin Pump System
    • 6.7.4. Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System
    • 6.7.5. Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System
    • 6.7.6. LabStyle Innovations' Dario Diabetes Management System
    • 6.7.7. BlueStar by WellDoc
    • 6.7.8. FDA Approves Bayer's Contour Next EZ
    • 6.7.9. Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App
    • 6.7.10. Sanofi-Aventis's iBGStar
    • 6.7.11. iHealth Glucose Meter Device
    • 6.7.12. MyGlucoHealth® Diabetes
    • 6.7.13. Enlite™ Sensor
    • 6.7.14. Medtronic Gains Approval of First Artificial Pancreas Device System, the MiniMed® 530G with Enlite®
    • 6.7.15. Nipro Diagnostics TrueMetrix Air
    • 6.7.16. Animas Vibe System
    • 6.7.17. Abbott's FreeStyle Libre and FreeStyle Libre Pro
    • 6.7.18. Abbott's FreeStyle Precision Neo Blood Glucose Monitoring System
    • 6.7.19. Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
    • 6.7.20. Medtronic's MiniMed Connect
    • 6.7.21. Dexcom G5 Mobile CGM System
  • 6.8. Blood Glucose Meters, CGMs, and Data Management Software in Development
    • 6.8.1. Abbott's Flash Glucose Monitoring System
    • 6.8.2. Google Announces Plan to Create Contact Lens Glucose Sensors
    • 6.8.3. Socrates Health Solutions' Companion Blood Glucose Monitor
    • 6.8.4. Boston University's Bionic Pancreas Project
    • 6.8.5. IGI Stat's Test to Identify Type 1 Diabetes
    • 6.8.6. Medtronic's Next-generation Combination Pump and CGM
    • 6.8.7. Medtronic and IBM's Watson Health to Develop Data Management Solutions
  • 6.9. Recent Industry Activity
    • 6.9.1. Roche Diagnostics Corp. Cutting Jobs in Diabetes Division
    • 6.9.2. AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership
    • 6.9.3. LifeScan Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed
    • 6.9.4. Medtronic and Bayer Healthcare Expand International Alliance
    • 6.9.5. PositiveID Corporation Licenses iglucose Technology to Smart Glucose Meter Corp
    • 6.9.6. BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump
    • 6.9.7. Court Sides with Decision Diagnostics in Patent Infringment Case
    • 6.9.8. Senseonics Partners with Rubin Medical to Commercialize New CGM
    • 6.9.9. Abbott re-entering Continuous Glucose Monitoring Market in Europe with FreeStyle Libre
    • 6.9.10. Medtronic and IBM's Watson Health Partnering to Develop Personalized Diabetes Management Solutions
  • 6.10. M&A Activity
    • 6.10.1. Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to Become Nipro Diagnostics, Inc.
    • 6.10.2. Medtronic, Inc. Acquires New Diabetes Technology from PreciSense AS
    • 6.10.3. Geonostics Acquires FlexSite's Consumer Diabetes Tests
    • 6.10.4. Radiometer Medical Acquires Hemocue
    • 6.10.5. Additional M&A
    • 6.10.6. Important Deals in BGM market

7. Business Trends in Glucose Testing

  • 7.1. Drivers of Clinical Glucose Testing
  • 7.2. Competition for Professional POC Glucose Testing
  • 7.3. Healthcare Cost Controls
  • 7.4. Changes in Patient Management
  • 7.5. Regionalization of Laboratory Care
  • 7.6. Satellite Facilities
  • 7.7. Professional Point-of-Care Testing
  • 7.8. Factors Affecting OTC Medical Product Distribution
  • 7.9. Drug Stores Critical to the Diabetic Care Category
  • 7.10. Drivers of OTC and Self-Testing Markets
  • 7.10.1. Brand Loyalty
  • 7.11. Cost Elements of Glucose Self-Testing
  • 7.12. Costs of Doing Business in Europe
  • 7.13. Drivers of European Diagnostics Testing
  • 7.14. Cost Containment in Europe
  • 7.15. Blood Glucose Self-Testing Insurance Coverage and Reimbursement
    • 7.15.1. American OTC Testing and Self-Testing Reimbursement
    • 7.15.2. European Reimbursement
  • 7.16. Reimbursement Challenges
    • 7.16.1. New Medicare Part B
  • 7.17. Managed Care
  • 7.18. Government Regulation of Medical Devices
    • 7.18.1. U.S. Regulations
    • 7.18.2. E.U. Regulations
    • 7.18.3. U.K. Regulations
  • 7.19. Clinical Laboratory Improvement Act (CLIA)
    • 7.19.1. Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems
  • 7.20. FDA Labeling Requirements
  • 7.21. Legal Liability for Glucose Meters
  • 7.22. FDA's Artificial Pancreas Guidance Document

8. Technology Trends

  • 8.1. Improving Today's Over-The-Counter (OTC) Blood Glucose Meters
  • 8.2. Biosensor Technology
  • 8.3. Artificial Pancreas
  • 8.4. Telemedicine
    • 8.4.1. Remote Patient Monitoring
      • 8.4.1.1. Infopia Eocene System
      • 8.4.1.2. Health Buddy Systems Monitoring Technologies
      • 8.4.1.3. GlucoCom Glucose Monitoring System
      • 8.4.1.4. Alere's DayLink® Monitor
      • 8.4.1.5. Alere HomeLink Receives FDA Approval for Over-the-Counter Use
      • 8.4.1.6. iGlucose System
  • 8.5. Non-Traditional Methods for Sample Collection
  • 8.6. Data Management
    • 8.6.1. Medical Device Radiocommunications Service (MedRadio)
    • 8.6.2. Connectivity
    • 8.6.3. Advantages of Connectivity
    • 8.6.4. Connectivity Platforms
    • 8.6.5. DataLink Data Management System
    • 8.6.6. RALS-Plus
    • 8.6.7. FDA Required Software Verification
    • 8.6.8. Information Management Advances
    • 8.6.9. POL Laboratory Data Management
      • 8.6.9.1. Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software
      • 8.6.9.2. Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System
      • 8.6.9.3. Technical Problems of Connectivity
      • 8.6.9.4. Web-Based Data Interface
    • 8.6.10. HIT Competition

9. Company Profiles

  • 9.1. A. Menarini Diagnostics
  • 9.2. Abaxis, Inc.
  • 9.3. Abbott Laboratories
  • 9.4. ACON Laboratories
  • 9.5. AgaMatrix
  • 9.6. Alere
  • 9.7. All Medicus
  • 9.8. AMS Alliance
  • 9.9. Apex Biotechnology Corporation
  • 9.10. ARKRAY USA
  • 9.11. Bayer
  • 9.12. B. Braun Melsungen
  • 9.13. Beckman Coulter
  • 9.14. Bionime
  • 9.15. Bio-Rad Laboratories, Inc.
  • 9.16. Cambridge Sensors
  • 9.17. Cardiocom
  • 9.18. DexCom
  • 9.19. Diagnostic Devices/Prodigy Diabetes Care
  • 9.20. DiaSys
  • 9.21. Diatron
  • 9.22. Echo Therapeutics
  • 9.23. Entra Health Systems
  • 9.24. Fora Care
  • 9.25. FIFTY50 Medical, Inc.
  • 9.26. Genesis Health Technologies
  • 9.27. GenExel-Sein
  • 9.28. GlucoPlus
  • 9.29. GlySens
  • 9.30. Hainice Medical
  • 9.31. HemoCue (a Quest Diagnostics company)
  • 9.32. Home Diagnostics
  • 9.33. Infopia
  • 9.34. IN4 Technology
  • 9.35. Integrity Applications
  • 9.36. International Techidyne Corporation (ITC)
  • 9.37. Instrumentation Laboratory Company
  • 9.38. i-Sens
  • 9.39. Jant Pharmacal
  • 9.40. Johnson & Johnson
  • 9.41. LabStyle Innovations Corporation
  • 9.42. LifeHealth, LLC
  • 9.43. Medtronic
  • 9.44. Miraculins
  • 9.45. Nipro Diagnostics
  • 9.46. Nova Biomedical
  • 9.47. Polymer Technology Systems
  • 9.48. Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.)
  • 9.49. Radiometer Medical
  • 9.50. Roche Diagnostics
  • 9.51. Senseonics
  • 9.52. 77 Elektronika Kft.
  • 9.53. Siemens AG
  • 9.54. Smiths Group
  • 9.55. TaiDoc Technology
  • 9.56. Techno Medica Co., Ltd.
  • 9.57. Telcare
  • 9.58. Tokyo Boeki Medisys
  • 9.59. US Diagnostics
  • 9.60. Ypsomed Holding
  • 9.61. YSI Life Sciences

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: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S.
  • Figure 2.11: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, United States
  • Figure 2.12: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, United States
  • Figure 2.13: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD)
  • Figure 2.14: How Diabetes Dollars are Spent in the U.S.
  • Figure 2.15: Percent of Medical Condition-specific Expenditures Associated with Diabetes
  • Figure 3.1: Global Unit Sales of Glucose Testing Reagent Strips
  • Figure 3.2: Geographic Segments of the Worldwide Glucose Self-testing Market, 2013 and 2019
  • Figure 3.3: Worldwide Glucose Self-Testing Market by Region
  • Figure 4.1: Approach to Management of Hypoglycemia
  • Figure 4.2: Glycemic Status-Ranges and Health Implications
  • Figure 5.1: EGA Zones of Clinical Accuracy
  • Figure 5.2: Single-Day Continuous Blood Glucose Data
  • Figure 5.3: Factors that May Adversely Affect Glucose Testing
  • Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region
  • Figure 6.1: Medtronic's Threshold Suspend Feature

INDEX OF TABLES

  • Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions
  • Table 2.2: Countries with the Largest Numbers of Diabetics
  • Table 2.3: Countries with the Largest Estimated Numbers of Diabetics
  • 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: U.S. Population of Diagnosed Diabetics Aged 20 - 79 Years
  • Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State
  • Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
  • Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
  • Table 2.10: Prevalence of Complications Among Patients with Diabetes
  • Table 2.11: Major Causes of End-stage Renal Disease
  • Table 2.12: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
  • Table 2.13: Clinical Recommendations for Adults with Diabetes
  • Table 2.14: Laboratory Assessment of Diabetic Vascular Disease
  • Table 2.15: Average Years Gained Free of Diabetes-related Disease with Intensive Management
  • Table 2.16: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.
  • Table 2.17: Cost of Diagnosed Diabetes in the U.S.
  • Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes
  • Table 2.19: Healthcare Utilization by Diabetic Patients
  • Table 3.1: Worldwide Comprehensive Glucose Testing Market (includes reagents and supplies in both the Self-testing and Professional Markets in $ Billions), 2013-2019
  • Table 3.2: Total Global Unit Demand for Glucose Testing Reagent Strips
  • Table 3.3: Global Dollar Sales of Glucose Testing Reagent Strips
  • Table 3.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets)
  • Table 3.5: World Market Share of Glucose Self-testing Marketers
  • Table 3.6: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC & POL)
  • Table 3.7: Global Revenues for Professional Point-of-Care Blood Glucose Monitoring Systems (within Hospitals and Physician's Offices)
  • Table 3.8: Global Revenues for Continuous Glucose Monitoring Systems
  • Table 3.9: Comprehensive Glucose Testing Market in the U.S. (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.10: U.S. Blood Glucose Reagent Strip Market (includes both Self-testing and Professional Markets)
  • Table 3.11: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips, and Lancets)
  • Table 3.12: Market Share of U.S. Blood Glucose Self-Testing
  • Table 3.13: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages
  • Table 3.14: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
  • Table 3.15: Demographic Characteristics Glucose Self-Testing Kit Buyers
  • Table 3.16: Top Brand Preferences for Glucose Self-Testing Kits
  • Table 3.17: Instances when Patients Prefer Professional's Glucose Testing
  • Table 3.18: Advantages of a Glucose Self-Testing Kit
  • Table 3.19: Disadvantages of Using a Glucose Self-Testing Kit
  • Table 3.20: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits
  • Table 3.21: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2014
  • Table 3.22: Market for Total Professional Glucose Testing (Central Laboratory and Hospital POC & POL) in the U.S., 2013-2019
  • Table 3.23: U.S. Revenues for Professional POC Blood Glucose Monitoring (Hospital & POL)
  • Table 3.24: European Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.25: European Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.26: Asian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.27: Asian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.28: Japanese Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.29: Japanese Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.30: Chinese Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.31: Chinese Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.32: Indian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.33: Indian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.34: Southeast Asian Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets
  • Table 3.35: Southeast Asian Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Table 3.36: Southeast Asian Comprehensive Glucose Testing Market by Country
  • Table 3.37: Southeast Asian Market for Glucose Self-Testing by Country (includes Meters, Strips, and Lancets)
  • Table 3.38: ROW Comprehensive Glucose Testing Market (includes reagents and supplies in the Self-testing and Professional Markets)
  • Table 3.39: ROW Market for Glucose Self-Testing (includes Meters, Strips, and Lancets)
  • Professional POC
  • Table 3.40: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point-of-Care Market
  • Table 3.41: Key Market Drivers for Glucose Testing
  • Table 3.42: Market Drivers for Continuous Glucose Monitoring
  • Table 3.43: Point-of-Care Glucose Testing Market: Market Drivers Ranked in Order of Impact
  • Table 3.44: Key Market Restraints for Glucose Testing
  • Table 3.45: Market Restraints for Continuous Glucose Monitoring
  • Table 3.46: Point-of-Care Glucose Testing Market: Market Restraints Ranked in Order of Impact
  • Table 4.1: Criteria for the Diagnosis of Diabetes
  • Table 4.2: Categories of Increased Risk for Diabetes (Pre-Diabetes)
  • Table 4.3: Normal Glucose Values-Fasting State
  • Table 4.4: Criteria for Testing for Diabetes in Asymptomatic Adults
  • Table 4.5: Criteria for Type 2 Diabetes in Asymptomatic Children
  • Table 4.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM)
  • Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
  • Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes
  • Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes
  • Table 4.10: Plasma Blood Glucose and A1c Goals for Type 1 Diabetes by Age-group
  • Table 4.11: Glucose Monitoring Recommendations
  • Table 4.12: Key Issues for SMBG in Insulin-independent Type 2 Diabetics
  • Table 4.13: A1c Testing Recommendations
  • Table 4.14: Correlation of A1c with Mean Blood Glucose
  • Table 5.1: Analytic Performance Criteria for Glucose Meters
  • Table 5.2: Potential Variables Affecting Glucose Concentrations
  • Table 5.3: Key Features Considered for Glucose Testing Devices
  • Table 5.4: Common User Errors Made While Self-Testing for Blood Glucose
  • Table 5.5: Compatibility of Various Blood Glucose Meters with Icodextrin Peritoneal Dialysis (PD) Solution
  • Table 5.6: Ten Factors Needed to Improve the Performance of Blood Glucose Meters
  • Table 5.7: Features Required For Safe and Effective Meters for Hospital Settings
  • Table 5.8: Key Features Considered for Reagent Test Strips
  • Table 5.9: Differences between Laboratory Instruments for Glucose Analysis and Hand-Held Blood Glucose Meters
  • Table 5.10: Relationship of A1c to Average Whole Blood and Plasma Glucose Levels
  • Table 5.10: Unit Sales of Homecare Lancets in the U.S.
  • Table 5.11: Unit Sales of Homecare Lancets in the E.U.
  • Table 5.12: Dollar Sales of Homecare Lancets in the U.S.
  • Table 5.13: Dollar Sales of Homecare Lancets in the E.U.
  • Table 5.14: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S.
  • Table 5.15: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U.
  • Table 5.17: Competition in the Lancet Market Segment
  • Table 5.18: Limitations of Urine Glucose Monitoring
  • Table 5.19: Advantages of Urine Glucose Monitoring
  • Table 5.20: Blood Ketone Reading Indications
  • Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features
  • Table 6.2: Point of Care Blood Glucose or Blood Gas Meters Marketed for Professional Use
  • Table 6.3: Clinical Blood Chemistry Analyzers with Glucose Assays
  • Table 6.2: Detailed Features of Selected CGM Systems Currently Available
  • Table 6.5: Non-Invasive Glucose Monitoring Systems in Development
  • Table 7.1: POC Procedural Advantages for Hospital Testing
  • Table 7.2: Financial Comparison for Moderate and Waived CLIA Labs
  • Table 8.1: Data Entry and Data Management Features to Include in Future Meters
  • Table 8.2: Leading Companies for Patient Monitoring Products
  • Table 8.3: Customized Reports Must Support CAP and JCAHO Requirements 275
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