Cover Image
市場調查報告書

全球血糖值自我檢測市場

World Glucose Self-Testing Markets

出版商 TriMark Publications 商品編碼 231765
出版日期 內容資訊 英文 276 Pages
商品交期: 最快1-2個工作天內
價格
Back to Top
全球血糖值自我檢測市場 World Glucose Self-Testing Markets
出版日期: 2015年09月01日 內容資訊: 英文 276 Pages
簡介

全球糖尿病發病率正在大幅上升,推計到2030年將有4億3,900萬人發病。全球血糖自我檢驗產品市場由於新的分析技術興起及為求糖尿病監測而推廌嚴格的血糖管理,而正處於重大的轉移過程。此外由於新興國家,特別是中國及印度上中產階級的增加,罹患第二型糖尿病的患者急增,更進一步增加了疾病管理用資金確保方法。

本報告提供全球血糖值自我檢測市場現況與展望相關調查,提供您全球糖尿病的患病情形,血糖值自我測量儀的市場規模實際成果與預測,彙整市場影響因素分析,市場及產品趨勢,各種技術平台/產品種類與概要,優點與課題,新技術的開發趨勢,主要企業簡介等等詳細內容。

第1章 概要

第2章 糖尿病

  • 糖尿病的人口統計
  • 糖尿病相關代謝性症狀的理解
  • 糖尿病的經濟學

第3章 市場分析:市場規模·成長率·市場佔有率

  • 全球血糖值檢驗市場
  • 全球市場
  • 美國市場
  • 歐洲市場
  • 亞洲市場
  • 競爭情形
  • 市場促進因素·阻礙要素
  • 市場·產品趨勢
  • 策略性建議
  • 競爭策略
  • 鄰近市場

第4章 血糖值的診斷及監測相關建議

  • 糖尿病的診斷
  • 治療糖尿病的嚴格血糖控制
  • 對糖尿病患者血糖控制的建議
  • 低血糖和治療

第5章 血糖值自我檢測技術平台與消耗品

  • 血糖值自我檢測技術的各種類型
  • 血糖值自我測量儀所使用的酵素反應
    • 葡萄糖氧化酵素
    • 葡萄糖脫氫酶
    • 葡萄糖己糖激酶
  • 血糖值螢幕的開發:歷史評價
    • 第1代血糖值生物感應器
    • 第2代血糖值生物感應器
    • 第3代血糖值生物感應器
  • 血糖值計的準確度
  • 血糖值自我測量儀主要課題
  • 現有的血糖值自我檢測產品的限制
  • 干涉的因素·情形
  • 血糖監測系統的性能之潛在改良領域
  • 連續血糖監測系統(CGM)技術
    • 連續測量的優點
    • FDA的認證
    • 應該檢討的功能
    • 新技術
  • 非侵入性血糖監測系統的技術:摘要
  • A1c監測技術
  • 果糖胺測試
  • 相關試劑·設備
    • 採血針
    • 對照溶液·校準器
    • 銳利器材等
  • 血糖值自我檢測系統的新開發
    • 語音操作
    • 藍芽支援
    • 電腦連接
    • 資料管理
    • 遠隔患者監視
    • 整合型檢驗:血糖值檢測·試驗帶·採血針
    • 長期感應生物植入
    • 支援輸液泵無線通訊的測量儀

第6章 市場上市的血糖值自我測量儀:測量儀概要

  • 測量儀及測試條
  • 連續·非侵入性血糖監測系統
  • 開發中的非侵入性血糖監測系統
  • A1c自我檢驗
  • 新產品的投入
  • 開發中的血統測量儀·CGM·資料管理軟體
  • 最近的產業的配合措施
  • M&A

第7章 產業的商務趨勢

  • 批發銷售概要
  • OTC產品銷售的因素
  • 糖尿病護理類別中重要的藥局
  • OTC·自我檢驗市場成長推進因素
  • 血糖值自我檢驗的成本要素
  • OTC檢驗的重要要素
  • 居家護理·自我檢驗的成長
  • 保險與給付
  • 政府醫療設備相關的法律規章
  • Clinical Laboratory Improvement Act (CLIA)
  • FDA的標籤檢視要件等

第8章 技術趨勢

  • OTC血糖儀的改善
  • 生物感應器技術
  • 人工胰臟
  • 果糖胺測試
  • 遠端照護
  • 樣品收集的非傳統手法
  • 資料管理

第9章 OTC檢驗:重要課題

第10章 OTC·診斷用自我檢驗的目前課題

第11章 SWOT分析

  • Roche
  • LifeScan

第12章 企業簡介

圖表

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
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
Back to Top