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市場調査レポート

世界の血糖値自己測定市場

World Glucose Self-Testing Markets

発行 TriMark Publications 商品コード 231765
出版日 ページ情報 英文 276 Pages
納期: 即日から翌営業日
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世界の血糖値自己測定市場 World Glucose Self-Testing Markets
出版日: 2015年09月01日 ページ情報: 英文 276 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。世界市場の中でもアメリカ市場の分析を得意とし、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血糖値測定シリーズです。
概要

世界の糖尿病発症率は大幅に上昇しており、2030年には4億3,900万人が発症すると推計されています。 世界の血糖自己検査製品の市場は、新しい解析技術の台頭や糖尿病のモニタリングのための厳しい血糖管理の推奨から、大きな移行の過程にあります。また、新興国、特に中国やインドにおける中流階級の増加から、2型糖尿病の罹患者が急増しており、さらに疾病管理のための資金確保手段も増加しています。

当レポートでは、世界の血糖値自己測定市場の現状と見通しについて調査し、世界の糖尿病の罹患状況、血糖値自己測定器の市場規模実績・予測、市場影響因子の分析、市場および製品の動向、各種技術プラットフォーム/製品の種類と概要、メリットと課題、新技術の開発動向、主要企業のプロファイルなどを詳細にわたってまとめています。

第1章 概要

第2章 糖尿病

  • 糖尿病の人口統計
  • 糖尿病に関連する代謝性症状への理解
  • 糖尿病のエコノミクス

第3章 市場分析:市場規模・成長率・市場シェア

  • 世界の血糖値検査市場
  • 世界市場
  • 米国市場
  • 欧州市場
  • アジア市場
  • 競合状況
  • 市場成長推進因子・阻害因子
  • 市場・製品動向
  • 戦略的提言
  • 競合戦略
  • 隣接市場

第4章 血糖値の診断およびモニタリングに関する提言

  • 糖尿病の診断
  • 糖尿病治療における厳格な血糖コントロール
  • 糖尿病患者の血糖コントロールにおける提言
  • 低血糖と治療

第5章 血糖値自己測定技術プラットフォームと消耗品

  • 血糖値自己測定技術の各種タイプ
  • 血糖値自己測定器に利用される酵素反応
    • グルコースオキシダーゼ
    • グルコースデヒドロゲナーゼ
    • グルコースヘキソキナーゼ
  • 血糖値モニターの開発:歴史的評価
    • 第1世代血糖値バイオセンサー
    • 第2世代血糖値バイオセンサー
    • 第3世代血糖値バイオセンサー
  • 血糖値計の精度
  • 血糖値自己測定器の主な課題
  • 既存の血糖値自己測定製品の制約
  • 干渉する要素・状況
  • 血糖モニタリングの性能における潜在的改良領域
  • 連続血糖モニタリング(CGM)技術
    • 連続計測のメリット
    • FDAの認証
    • 検討すべき機能
    • 新技術
  • 非侵襲性血糖モニタリングのための技術: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・機器
    • ランセット
    • 対照溶液・キャリブレーター
    • 鋭利器材、など
  • 血糖値自己測定システムの新たな開発
    • 音声操作
    • Bluetooth対応
    • コンピューター接続
    • データ管理
    • 遠隔患者監視
    • 統合型検査:血糖値測定・テストストリップ・ランセット
    • 長期センシングバイオインプラント
    • 注入ポンプとの無線通信に対応した測定器

第6章 市場に出回っている血糖値自己測定器:測定器の概要

  • 測定器およびストリップ
  • 連続・非侵襲性血糖モニタリングシステム
  • 開発中の非侵襲性血糖モニタリングシステム
  • A1c自己検査
  • 新製品の投入
  • 開発中の血統測定器・CGM・データ管理ソフトウェア
  • 最近の業界における取り組み
  • M&A

第7章 業界のビジネストレンド

  • 卸売販売の概要
  • OTC製品販売への影響因子
  • 糖尿病ケアカテゴリーで重要なドラッグストア
  • OTC・自己検査市場の成長推進因子
  • 血糖値自己検査のコストエレメント
  • OTC検査の重要エレメント
  • ホームケア・自己検査の成長
  • 保険と償還
  • 政府による医療機器関連の法規制
  • Clinical Laboratory Improvement Act (CLIA)
  • FDAのラベル表示要件、など

第8章 技術動向

  • OTC血糖測定器の改善
  • バイオセンサー技術
  • 人工膵臓
  • フルクトサミン検査
  • テレメディシン
  • サンプル収集の非従来型手法
  • データ管理

第9章 OTC検査:重要課題

第10章 OTC・診断用自己検査の現在の課題

第11章 SWOT分析

  • Roche
  • LifeScan

第12章 企業プロファイル

図表

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目次
Product Code: TMRWGST15-0901

The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this TriMark Publications report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market. The term "self-testing" is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor's offices, the so-called "professional" component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. 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 Objectives
  • 1.5 Methodology
  • 1.6 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
  • 2.3 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
  • 3.2 Global Glucose Self-Testing Market
    • 3.2.1 Continuous Glucose Monitoring Markets
  • 3.3 U.S. Market
  • 3.4 European Market
  • 3.5 Asian Market
    • 3.5.1 Japanese Market
    • 3.5.2 Chinese Market
    • 3.5.3 Indian Market
    • 3.5.4 Korean Market
    • 3.5.5 Southeast Asian Market
    • 3.5.6 ROW Markets
  • 3.6 Competitive Situation
    • 3.6.1 Key Players
    • 3.6.2 Analyses of the Current Market Conditions, Competition and Product Mix
    • 3.6.2 Abbott re-entering Continuous Glucose Monitoring Market in Europe
    • 3.6.3 A Range of Products
  • 3.7 Market Drivers and Restraints
    • 3.7.1 Market Drivers
    • 3.7.2 Market Restraints
  • 3.8 Market and Product Trends
    • 3.8.1 Market Trends
    • 3.8.2 Technology Trends
  • 3.9 Strategic Recommendations
  • 3.10 Competitive Strategies
  • 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
    • 4.3.1 Recommended Frequency of Blood Glucose Testing
    • 4.3.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy
    • 4.3.3 Testing in Individuals with Type 2 Diabetes
    • 4.3.4 Continuous Glucose Monitoring (CGM)
    • 4.3.5 A1c Testing Recommendations
  • 4.4 Hypoglycemia and Treatment

5. Glucose Self-Testing Technology Platforms and Consumable Products

  • 5.1 Types of Glucose Self-Testing Devices
  • 5.2 Enzymatic Reactions Used in Glucose Self-Testing Devices
    • 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 International Organization for Standardization (ISO) 15197:2013
    • 5.4.2 FDA Guidelines for Blood Glucose Testing Systems
    • 5.4.3 Determining Clinical Accuracy Using the Error Grid Analysis (EGA)
    • 5.4.4 Quality Control Criteria
    • 5.4.5 Potential Variables Affecting Glucose Concentrations
    • 5.4.6 Calibration Methods
    • 5.4.7 Common User Errors
  • 5.5 Key Issues for Glucose Self-Testing Devices
    • 5.5.1 Important Elements for Glucose Self-Testing
    • 5.5.2 Key Features to Aid Specific Patient Populations
  • 5.6 Limitations of Existing Glucose Self-Testing Products
  • 5.7 Interfering Substances and Conditions
    • 5.7.1 Environmental
    • 5.7.2 Physiologic
    • 5.7.3 Operational
    • 5.7.4 Manufacturing Variations
    • 5.7.5 Drugs
    • 5.7.6 Patient Factors
      • 5.7.6.1 Errors Associated with GDH-PQQ Technology
  • 5.8 Potential Areas of Improvement in Blood Glucose Monitor Performance
    • 5.8.1 Blood Glucose Reagent Test Strips
  • 5.9 Continuous Glucose Monitoring Technology
    • 5.9.1 Advantages of Continuous Readings
    • 5.9.2 FDA Approval of CGM
    • 5.9.3 CGM Functions to Consider
    • 5.9.4 New Technologies for CGM
  • 5.10 Summary of Technologies being Explored for Non-Invasive Glucose Monitoring
    • 5.10.1 GlucoTrack
    • 5.10.2 Non-Invasive Glucose Monitoring Technologies in Development
    • 5.10.3 Goals of Non-Invasive Testing
    • 5.10.4 Non-Invasive Diabetes Screening Test
  • 5.11 A1c Monitoring Technology
    • 5.11.1 PTS Diagnostics' (Chek Diagnostics') A1c Home Test
  • 5.12 Fructosamine Test
  • 5.13 Related Reagents and Equipment
    • 5.13.1 Lancets
      • 5.13.1.1 Types of Lancing Devices
      • 5.13.1.2 Market Size
    • 5.13.2 Control Solutions and Calibrators
    • 5.13.3 Sharps Devices
    • 5.13.4 Needle Destruction Devices
    • 5.13.5 Ketone Testing
  • 5.14 New Developments in Glucose Self-Testing Systems
    • 5.14.1 Voice Operated Glucose Self-Testing Meters
    • 5.14.2 Bluetooth-Enabled Glucose Self-Testing Meters
      • 5.14.2.1 MyGlucoHealth Wireless Meter
      • 5.14.2.2 Fora D40, Fora Test N'Go, and Fora Test N'Go Voice Meters
      • 5.14.2.3 OneTouch VerioSync Blood Glucose Monitoring System
      • 5.14.2.4 Genesis Health Technologies (GHT) Meter
      • 5.14.2.5 iHealth Wireless Smart Gluco-Monitoring System
      • 5.14.2.6 Accu-chek Aviva Connect
    • 5.14.3 Cellular-enabled Glucose Self-Testing Meters
      • 5.14.3.1 Telcare BGM
      • 5.14.3.2 Solus Mobile
      • 5.14.3.3 Livongo Health's In Touch
      • 5.14.3.4 iGlucose meter
    • 5.14.4 Glucose Self-Testing Meters with Computer Connectivity
    • 5.14.5 Data Management
      • 5.14.5.1 Log Sheets/Spreadsheets
      • 5.14.5.2 Glucose Self-Testing Software
      • 5.14.5.3 External Servers and Cloud-based Data Collection Systems
      • 5.14.5.4 Smart Phone and iPad/iPod Touch Applications
    • 5.14.6 Remote Patient Monitoring
      • 5.14.6.1 Infopia Eocene System
      • 5.14.6.2 Health Buddy Systems Monitoring Technologies
      • 5.14.6.3 GlucoCom Glucose Monitoring System
      • 5.14.6.4 Alere's DayLink Monitor
      • 5.14.6.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use
      • 5.14.6.6 iGlucose System
    • 5.14.7 Integrated Testing: Glucose Meter, Test Strips and Lancet
    • 5.14.8 Long-Term Glucose Sensing Bio-Implants
    • 5.14.9 Glucose Self-Testing Meters that Wirelessly Communicate with Insulin Pumps
      • 5.14.9.1 Medtronic's MiniMed Paradigm Revel
      • 5.14.9.2 MiniMed 530G with Enlite
      • 5.14.9.3 Nova Max Link
      • 5.14.9.4 Contour Next Link
      • 5.14.9.5 One Touch Ping
      • 5.14.9.6 Accu-Chek Combo System

6. Glucose Self-Testing Meters on the Market: Description of Test Meters

  • 6.1 Blood Glucose Self-Testing Meters and Strips
    • 6.1.1 LifeScan, Inc.
    • 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, Inc.
    • 6.1.46 Decision Diagnostics Corporation and Pharma Tech Solutions
  • 6.2 Continuous Glucose Patient Monitoring Systems
    • 6.2.1 Medtronic's Continuous Glucose Monitoring Systems (CGMS)
      • 6.2.1.1 MiniMed Paradigm Revel System
      • 6.2.1.2 Guardian REAL-Time
      • 6.2.1.3 MiniMed 530G with Enlite
      • 6.2.1.4 iPro®2 Professional CGM
    • 6.2.2 Dexcom, Inc.'s Continuous Glucose Monitoring Systems
      • 6.2.2.1 Dexcom G4 Platinum Continuous Glucose Monitoring System
      • 6.2.2.2 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
      • 6.2.2.3 Dexcom G5 Mobile Continuous Glucose Monitoring System
    • 6.2.3 Animas Vibe System
    • 6.2.4 Abbott's Continuous Glucose Monitor System
      • 6.2.4.1 FreeStyle Libre
      • 6.2.4.2 FreeStyle Navigator (discontinued)
    • 6.2.5 GlucoDay S Continuous Glucose Monitor
    • 6.2.6 Minimally-Invasive Continuous Glucose Monitors in Development
      • 6.2.6.1 GlySens, Inc.
      • 6.2.6.2 Senseonics (formerly Sensors for Medicine and Science)
      • 6.2.6.3 Ultradian Diagnostics
  • 6.3 Non-Invasive Glucose Patient Monitoring Systems in Development
    • 6.3.1 Cygnus GlucoWatch Biographer
    • 6.3.2 AiMedics
    • 6.3.3 Echo Therapeutics, Inc.
    • 6.3.4 EyeSense GmbH
    • 6.3.5 Freedom Meditech
    • 6.3.6 Google and Novartis
    • 6.3.7 Integrity Applications Ltd.
    • 6.3.8 Lein Applied Diagnostics
    • 6.3.9 LighTouch Medical, Inc.
    • 6.3.10 Miraculins, Inc.
    • 6.3.11 Xhale, Inc.
  • 6.4 A1c Self-Testing
    • 6.4.1 A1CNow SELFCHECK
    • 6.4.2 DTI Laboratories
    • 6.4.3 Polymer Technology Systems' A1C Tests
    • 6.4.4 Walmart's ReliOn A1c Test (Mail-in)
  • 6.5 New Product Launches
    • 6.5.1 OneTouch VerioSync Blood Glucose Monitoring System
    • 6.5.2 Medtronic's MiniMed 530G with Enlite Sensor Technology, the First Artificial Pancreas Device System
    • 6.5.3 Contour Next Link Meter Approved for Use with Medtronic's New MiniMed 530G with Enlite Insulin Pump System
    • 6.5.4 Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System
    • 6.5.5 LabStyle Innovations' Dario Diabetes Management System
    • 6.5.6 BlueStar by WellDoc
    • 6.5.7 FDA Approves Bayer's Contour Next EZ
    • 6.5.8 Glooko Received its Second 510(k) Clearance for Glucose Monitoring Logbook App
    • 6.5.9 Sanofi-Aventis's iBGStar
    • 6.5.10 iHealth Glucose Meter Device
    • 6.5.11 Nipro Diagnostics TrueMetrix Air
    • 6.5.12 Animas Vibe System
    • 6.5.13 Abbott's FreeStyle Libre and FreeStyle Libre Pro
    • 6.5.14 Abbott's FreeStyle Precision Neo Blood Glucose Monitoring System
    • 6.5.15 Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
    • 6.5.16 Medtronic's MiniMed Connect
    • 6.5.17 Dexcom G5 Mobile CGM System
  • 6.6 Blood Glucose Meters, CGMs, and Data Management Software in Development
    • 6.6.1 Abbott's Flash Glucose Monitoring System
    • 6.6.2 Google Announces Plan to Create Contact Lens Glucose Sensors
    • 6.6.3 Socrates Health Solutions' Companion Blood Glucose Monitor
    • 6.6.4 Boston University's Bionic Pancreas Project
    • 6.6.5 IGI Stat's Test to Identify Type 1 Diabetes
    • 6.6.6 Medtronic's Next-generation Combination Pump and CGM
    • 6.6.7 Medtronic and IBM's Watson Health to Develop Data Management Solutions
  • 6.7 Recent Industry Activity
    • 6.7.1 Roche Diagnostics Corp. Cutting Jobs in Diabetes Division
    • 6.7.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership
    • 6.7.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed
    • 6.7.4 Medtronic and Bayer Healthcare Expand International Alliance
    • 6.7.5 PositiveID Corporation Licenses iglucose Technology to Smart Glucose Meter Corp
    • 6.7.6 BD and JDRF Collaborating on a Device Using a Single Infusion Catheter for Both CGM and Pump
    • 6.7.7 Court Sides with Decision Diagnostics in Patent Infringement Case
    • 6.7.8 Senseonics Partners with Rubin Medical to Commercialize New CGM
    • 6.7.9 Abbott re-entering Continuous Glucose Monitoring Market in Europe with FreeStyle Libre
    • 6.7.10 Medtronic and IBM's Watson Health Partnering to Develop Personalized Diabetes Management Solutions
  • 6.8 M&A Activity
    • 6.8.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become Nipro Diagnostics, Inc.
    • 6.8.2 Medtronic, Inc. (MDT) Acquires New Diabetes Technology from PreciSense AS
    • 6.8.3 Geonostics Acquires FlexSite's Consumer Diabetes Tests
    • 6.8.4 Additional M&A
    • 6.8.5 Important Deals in BGM Market

7. Business Trends in the Industry

  • 7.1 Wholesale Distribution Overview
  • 7.2 Factors Affecting OTC Medical Product Distribution
  • 7.3 Drugstores Critical to the Diabetic Care Category
  • 7.4 Drivers of OTC and Self-Testing Markets
    • 7.4.1 Brand Loyalty
  • 7.5 Cost Elements of Glucose Self-Testing
  • 7.6 Important Elements of OTC Testing
  • 7.7 Growth of Home Care and Self-Testing
  • 7.8 Blood Glucose Self-Testing Insurance Coverage and Reimbursement
    • 7.8.1 American OTC Testing and Self-Testing Reimbursement
    • 7.8.2 European Reimbursement
    • 7.8.3 Reimbursement Challenges
    • 7.8.4 New Medicare Part B
  • 7.9 Government Regulation of Medical Devices
    • 7.9.1 U.S. Regulations
    • 7.9.2 E.U. Regulations
    • 7.9.3 U.K. Regulations
  • 7.10 Clinical Laboratory Improvement Act (CLIA)
    • 7.10.1 Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems
  • 7.11 FDA Labeling Requirements
  • 7.12 Legal Liability for Glucose Meters
  • 7.13 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 Fructosamine Test
  • 8.5 Telemedicine
    • 8.5.1 Remote Patient Monitoring
      • 8.5.1.1 Infopia Eocene System
      • 8.5.1.2 Health Buddy Systems Monitoring Technologies
      • 8.5.1.3 GlucoCom Glucose Monitoring System
      • 8.5.1.4 Alere's DayLink Monitor
      • 8.5.1.5 Alere HomeLink Receives FDA Approval for Over-the-Counter Use
      • 8.5.1.6 iGlucose System
  • 8.6 Non-Traditional Methods for Sample Collection
  • 8.7 Data Management
    • 8.7.1 Medical Device Radiocommunications Service (MedRadio)
    • 8.7.2 FDA Required Software Verification

9. OTC Testing: Critical Issues

  • 9.1 Moderators of Growth for OTC Testing
  • 9.2 Attitudes of Critical Care Nurses and Physicians
  • 9.3 Personnel Impact for OTC Testing
  • 9.4 Data Management Issues

10. Current Issues for OTC and Diagnostic Self-Testing

  • 10.1 New Markets for OTC and Diagnostic Self-Testing
  • 10.2 Utility of OTC and Self-Testing
  • 10.3 Generational Drivers of Home Testing
  • 10.4 Move Away from Central Laboratories
  • 10.5 Healthcare Cost Controls
  • 10.6 Mergers of Diagnostic Companies
  • 10.7 Home Healthcare Trends
  • 10.8 Home Healthcare Providers versus Mass Market Retailers
  • 10.9 Demographic Merchandising
  • 10.10 Marketing Strategies
  • 10.11 Third-Party Pharmacy Networks
  • 10.12 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs?
  • 10.13 Future of Patient Self-Testing

11. SWOT Analysis

  • 11.1 Roche
  • 11.2 LifeScan

12. Company Profiles

  • 12.1 A. Menarini Diagnostics
  • 12.2 Abbott Laboratories
  • 12.3 ACON Laboratories
  • 12.4 AgaMatrix
  • 12.5 Allmedicus Co., Ltd.
  • 12.6 Apex Biotechnology Corporation
  • 12.7 ARKRAY USA, Inc.
  • 12.8 Bayer
  • 12.9 B. Braun Melsungen
  • 12.10 Bionime
  • 12.11 Cambridge Sensors
  • 12.12 Cardiocom
  • 12.13 DexCom
  • 12.14 Diagnostic Devices/Prodigy Diabetes Care
  • 12.15 Echo Therapeutics, Inc.
  • 12.16 Entra Health Systems
  • 12.17 Fora Care
  • 12.18 FIFTY50 Medical, Inc.
  • 12.19 Genesis Health Technologies
  • 12.20 GlucoPlus
  • 12.21 GlySens, Inc.
  • 12.22 Google
  • 12.23 Hainice Medical
  • 12.24 Home Diagnostics
  • 12.25 Infopia
  • 12.26 IN4 Technology
  • 12.27 Integrity Applications
  • 12.28 i-Sens
  • 12.29 Johnson & Johnson 271
  • 12.30 LabStyle Innovations Corporation
  • 12.31 Livongo Health
  • 12.32 Medtronic
  • 12.33 Miraculins
  • 12.34 Nipro Corporation
  • 12.35 Nova Biomedical
  • 12.36 Novartis
  • 12.37 PTS Diagnostics
  • 12.38 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.)
  • 12.39 Roche
  • 12.40 77 Elektronika Kft.
  • 12.41 Senseonics
  • 12.42 Smart Meter Corporation
  • 12.43 Smiths Group
  • 12.44 TaiDoc Technology
  • 12.45 Telcare
  • 12.46 US Diagnostics

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 **sup**3**/sup**30) 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, in the U.S.
  • Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment in the U.S.
  • Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes
  • Figure 2.17: How Diabetes Dollars are Spent in the U.S.
  • Figure 3.1: Geographic Segments of the Worldwide Glucose Self-Testing Market
  • Figure 3.2: Worldwide Glucose Self-Testing Market by Region
  • Figure 3.3: Worldwide Glucose Self-Testing Market Segments
  • 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, 2014
  • 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: 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
  • Table 2.8: Percentage of U.S. Adults with Diagnosed Diabetes by State
  • 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: 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: Total Global Unit Demand for Glucose Testing Reagent Strips
  • Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips
  • Table 3.3: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and Lancets)
  • Table 3.4: World Market Share of Glucose Self-Testing Marketers
  • Table 3.5: Global Revenues for Continuous Glucose Monitoring Systems
  • Table 3.6: Market for Glucose Self-Testing in the U.S. (Includes Meters, Strips and Lancets)
  • Table 3.7: Market Share of U.S. Blood Glucose Self-Testing
  • Table 3.8: U.S. OTC Glucose Self-Testing Market Repeat Retail Replacement Sales Percentages
  • Table 3.9: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
  • Table 3.10: Demographic Characteristics Glucose Self-Testing Kit Buyers
  • Table 3.11: Top Brand Preferences for Glucose Self-Testing Kits
  • Table 3.12: Instances when Patients Prefer Professional's Glucose Testing
  • Table 3.13: Advantages of a Glucose Self-Testing Kit
  • Table 3.14: Disadvantages of Using a Glucose Self-Testing Kit
  • Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-Testing Kits
  • Table 3.16: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2014
  • Table 3.17: European Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.18: Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.19: Japanese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.20: Chinese Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.21: Southeast Asian Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.22: Southeast Asian Market for Glucose Self-Testing by Country (Includes Meters, Strips and Lancets)
  • Table 3.23: ROW Market for Glucose Self-Testing (Includes Meters, Strips and Lancets)
  • Table 3.24: Key Market Drivers for Glucose Self-Testing
  • Table 3.25: Market Drivers for Continuous Glucose Monitoring
  • Table 3.26: Key Market Restraints for Glucose Self-Testing
  • Table 3.27: Market Restraints for Continuous Glucose Monitoring
  • 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: Common User Errors Made while Self-Testing for Blood Glucose
  • Table 5.4: Key Features Considered for Glucose Self-Testing Devices
  • Table 5.5: Key Features Considered for Reagent Test Strips
  • Table 5.6: Compatibility of Various Blood Glucose Meters with Icodextrin PD Solution
  • Table 5.7: Ten Factors Needed to Improve the Performance of Blood Glucose Monitors
  • Table 5.8: Key Features Considered for Reagent Test Strips
  • Table 5.9: 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 5.16: Competition in the Lancet Market Segment
  • Table 5.17: Blood Ketone Reading Indications
  • Table 5.18: Leading Companies for Patient Monitoring Products
  • Table 6.1: Current Blood Glucose Self-Testing Meters: Sample Size, Test Time, and Other Features
  • Table 6.2: Detailed Features of Selected CGM Systems Currently Available
  • Table 6.3: Non-Invasive Glucose Monitoring Systems in Development
  • Table 7.1: 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
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