Global Diabetes Diagnostics Industry

NEW YORK, Nov. 23, 2016 /PRNewswire/ -- This report analyzes the worldwide markets for Diabetes Diagnostics in US$ Thousand by the following Product Segments: Continuous Glucose Monitoring (CGM) Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 58 companies including many key and niche players such as -

Abbott Diabetes Care, Inc.
Acon Laboratories, Inc.
AgaMatrix, Inc.
Alere Inc.
Animas Corporation

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3 Continuous Glucose Monitoring (CGM) Systems I-3 HbA1c Testing Devices..............I-4 Blood Glucose Monitoring Devices I-4

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW.............. II-1 Diabetes Diagnostics: Towards Easier, Economic, and Efficient Management of the Global Diabetes Epidemic II-1 Evolution of Diabetes Testing over the Years with Key Features in Each Period..............II-2 Growth Drivers in a Nutshell..............II-3 Alarming Levels of Diabetes Incidence Worldwide Drives Strong Demand for Diabetes Diagnostic Devices II-4 Table 1: Diabetes Prevalence Worldwide by Region: Number of Adults (20-79 Years) with Diabetes in 2015 and 2040 (includes corresponding Graph/Chart)..............II-5

Table 2: Global Prevalence (%) of Diabetes in Adults (20-79) by Region: 2015 & 2040 (includes corresponding Graph/Chart) II-6

Table 3: Global Prevalence of Diabetes by Gender (2015 & 2040): Number of Adults Diagnosed with Diabetes (in Million) for Men and Women (includes corresponding Graph/Chart) II-6

Table 4: Worldwide Diabetes Prevalence (%) in Adults by Age Group and Gender: 2015 (includes corresponding Graph/Chart) II-7

Table 5: Number of Adults with Diagnosed Diabetes in Urban and Rural Areas (2015 & 2040) (In Million) (includes corresponding Graph/Chart)..............II-7

Table 6: Top 10 Countries with Highest Number of Adults Diagnosed with Diabetes (in Million) for 2015 & 2040 (includes corresponding Graph/Chart) II-8 Diabetes: One of the Leading Causes of Death II-9 Table 7: Proportion of Deaths on Account of Diabetes in People Aged Less than 60 Years by Region: 2015 (includes corresponding Graph/Chart)..............II-9 Etiological Factors Causing Diabetes II-10 Diabetes Incidence and Prevalence by Region/Country II-10 North America.............. II-10 United States.............. II-10 Canada.............. II-10 Mexico.............. II-10 Europe.............. II-10 Asia-Pacific.............. II-11 Southeast Asian Region..............II-11 Western Pacific Region..............II-11 South & Central America..............II-11 Africa.............. II-12 Global Market Outlook..............II-12 Developing Countries Continue to Offer Significant Growth Opportunities.............. II-14 China: An Untapped Goldmine for Diabetes Diagnostic Devices II-14 Rising Diabetic Populace Spurs Growth in the Indian Market II-15 Table 8: Global Diabetes Diagnostics Market - Geographic Regions Ranked by CAGR (Value) for 2015-2022: China, India, Germany, UK, US, France, Italy, Russia, Spain, Canada, and Japan (includes corresponding Graph/Chart) II-16

2. COMPETITION.............. II-17 Major Pharma Players Dominate Diabetes Diagnostics Market II-17 Competition with Local Pharma Companies Intensifies in Regional Markets.............. II-17 Continuous Glucose Monitoring Systems (CGMS): Competitive Landscape.............. II-18 Table 9: Leading Products/Brands in the Global Continuous Glucose Monitoring Market (2015): Percentage Breakdown of Value Sales for Dexcom G4 Platinum, Dexcom Seven Plus, Free Style Navigator, Guardian Real Time, Minimed Paradigm Revel and Others (includes corresponding Graph/Chart) II-18 Medtronic Dominates the Global CGM Devices Market II-19 Leading Companies Continue to Focus on CGM Innovations II-19 Leading Companies and their CGM Innovations II-20 CGM Companies Outsmart Each Other with Innovative Marketing Offers.............. II-20 The Big Four in the Global Blood Glucose Monitoring (BGM) Devices Market.............. II-21 Table 10: Leading Players in the Global Blood Glucose Monitoring Devices Market (2015): Percentage Market Share Breakdown for Abbott, Bayer, LifeScan, Roche, and Others (includes corresponding Graph/Chart) II-21 Quality Products at Low Prices: Mantra for Success in the Marketplace.............. II-21 After PDAs, SMBG Makers Turn to Mobile Devices to Woo Users on the Move.............. II-22 Competition in the HbA1c Testing Devices Market II-22 Table 11: Leading Players in the Global HbA1c Reagent Market (2015E): Percentage Breakdown of Revenues for Siemens and Others (includes corresponding Graph/Chart) II-23 Select Laboratory-based HbA1c Testing Products/Analyzers II-23 Select Point of Care HbA1c Testing Products/Analyzers II-27 Major POC HbA1c Tests in the Market II-29 Select HbA1c POC Tests in the Market - A Comparison II-29 Product Innovation is the Name of the Game for HbA1c Testing Device Companies..............II-29 Manufacturers Focus on Offering Products for Developing Markets II-30

3. MARKET TRENDS, ISSUES & DRIVERS II-31 Growing Prominence of Real-Time Glucose Sensing and Monitoring Drive Robust Demand for Minimally-Invasive CGM Devices II-31 CGM Market Gradually Breaks through Barriers to Adoption II-32 Table 12: Penetration Rate (%) of CGM Devices in Type 1 and Type 2 Diabetes Market in the United States: 2013 through 2020 (includes corresponding Graph/Chart) II-33 Intensive Care Units: A Highly Promising Market for CGMs II-33 Proven Efficacy for Development of Intervention Strategies Drives Demand for HbA1c Testing Devices II-33 Rising Popularity of Near Patient Testing Benefits Prospects for HbA1c Devices.............. II-35 Myriad Benefits of POC HbA1c Tests over Lab Tests Drives Widespread Adoption..............II-35 Home HbA1c Testing: Lack of Reimbursement Coverage & Accuracy Concerns Affect Adoption..............II-37 Glycated Albumin: A Potential Threat to HbA1c? II-38 Approval for HbA1c Testing for Diabetes Diagnosis: An Opportunity to Tap..............II-39 Is HbA1c Test Right in Being Recommended for Diagnostic Purposes?.............. II-40 HbA1c Tests for Diabetes Diagnosis Need to Address Issues Related to Hemoglobin Variants II-40 ESC and ADA Release Revised Guidelines for HbA1c Testing II-41 Despite Competition from CGM Systems and HbA1c Testing Devices, BGM Devices Continues to Dominate Sales II-42 Cost: The Ultimate Factor Favoring Growth in Demand for Blood Glucose Monitoring Systems..............II-43 Self-Monitoring/Household Blood Glucose: Sustaining Growth in Demand.............. II-44 Key Trends in the Glucose Meter/Monitoring Systems II-44 Smartphone Penetration Favors SMBG Market II-45 Table 13: Smartphone Penetration Rate (%) for Select Countries Worldwide as a Percentage of Population Owning a Phone: 2016 (includes corresponding Graph/Chart) II-46 Demand for BGM Products to Witness Varying Patterns in Developed and Developing Markets II-47 Barriers to Adoption of New Technology in BGM Products II-47 Accuracy Issues Plague Blood Glucose Meters Market II-48 Advancements in Glucose Monitoring Devices Offers a New Ray of Hope.............. II-49 Undiagnosed Diabetes: A Major Healthcare Challenge Offering Huge Untapped Potential..............II-50 Table 14: Number of Undiagnosed Individuals (20-79 Years in Million) Living with Diabetes and Proportion (%) Worldwide by Region: 2015 (includes corresponding Graph/Chart) II-51 Undiagnosed Diabetics: More Prone to Cardiovascular Diseases II-51 Increased Vulnerability of Diabetics to Various Health Complications Boosts Demand for Diagnostic Devices II-52 Heart Disease.............. II-52 Stroke.............. II-53 High Blood Pressure..............II-53 Blindness.............. II-53 Kidney Disease.............. II-53 Nerve Disease.............. II-53 Amputations.............. II-53 Dental Disease.............. II-53 Pregnancy.............. II-53 Microvascular Complications (Small Blood Vessel Damage) II-53 Retinopathy.............. II-53 Diabetic Neuropathy..............II-54 Nephropathy.............. II-54 Macrovascular Complications (Large Blood Vessel Damage) II-54 Cardiac Problems..............II-54 Hypertension (High Blood Pressure) II-54 Infections.............. II-54 Impotence.............. II-54 Pregnancy Complications..............II-55 Other Complications Resulting from Diabetes II-55 Obesity.............. II-55 Obsessive Compulsive Disorder..............II-55 Foot Ulcers.............. II-55 Dementia.............. II-56 Hypoglycemia.............. II-56 Diabetic Ketoacidosis..............II-57 Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Lead to Cardiovascular Complications..............II-57 High Risk of Diabetes in the Fast Expanding Aging Population Benefit Market Expansion..............II-58 Demographic Statistics of the Global Aging Populace: Unfurling the Market Potential..............II-59 Table 15: Global Aging Population (in Thousands) by Age Group: 1975-2050 (includes corresponding Graph/Chart) II-59

Table 16: Global Population by Age-Group: Percentage Change Over the Period 2010-2050 (includes corresponding Graph/Chart).............. II-59

Table 17: Global Aging Population in Select Regions/ Countries: Population of 60+ Individuals in '000s and as a Percentage of Total Population for 2015 & 2050 (includes corresponding Graph/Chart)..............II-60 Glycosylated Hemoglobin Tests Pave the Way for Early-Stage Diabetes Diagnosis.............. II-61 Increasing Healthcare Expenditure Aids Diabetes Diagnostics & Testing Market.............. II-61 Table 18: Global Per Capita Healthcare Spending (in US$) by Geographic Region for the Year 2014 (includes corresponding Graph/Chart).............. II-62

Table 19: Healthcare Spending as % of GDP by Geographic Region (2016E) (includes corresponding Graph/Chart) II-63

Table 20: Top Countries with the Highest Per Capita Healthcare Spending (2014) (includes corresponding Graph/Chart).............. II-63 Rising Expenditure on Diabetes Management Drives the Need for Timely Diagnosis and Diagnostic Devices II-64 Table 21: Global Prevalence of Diabetes and Expenditure on its Management by Region (2015 & 2040P): Number of People Diagnosed with Diabetes in the Age Group 20-79 Years (Billions) and Expenditure on Management of Diabetes and its Complications (in US$ Billions) (includes corresponding Graph/Chart).............. II-64

Table 22: Leading Countries by Health Expenditure on Diabetes (2015 & 2040) (in US$ Billion) (includes corresponding Graph/Chart)..............II-65

Table 23: Expenditure on Diabetes in Adult (20-79) as % of Total Healthcare Spending by Region (2015) (includes corresponding Graph/Chart)..............II-66

Table 24: Health Expenditure on Diabetes by Region: Average Diabetes-Related Spending per Person with Diabetes in US$ for 2015 (includes corresponding Graph/Chart) II-67

Table 25: Health Expenditure on Diabetes (2015): Average Diabetes-Related Spending per Person with Diabetes (US$) in Select Countries (includes corresponding Graph/Chart) II-68 Increasing Obesity Levels Underpins Market Growth II-69 Table 26: Global Obesity Epidemic: Percentage of Overweight, Obese, and Severely Obese Adults for 2014 & 2025 (includes corresponding Graph/Chart)..............II-69

Table 27: Severely Obese Population (in Thousands) Worldwide by Country: 2014 & 2025 (includes corresponding Graph/Chart) II-70

4. DIABETES DIAGNOSTICS INNOVATIONS & ADVANCEMENTS II-71 mHealth Solutions for Diabetes Diagnosis II-71 Non-invasive Wearable Glucose Testing Devices II-71 Apple and Google to Develop Wearable Continuous Glucose Monitors II-72 GlySens Focus on Developing Implantable Continuous Glucose Monitor.............. II-73 Researchers Develop Prototype of Wearable Closed-Loop System II-73 Glucovation SugarSenz: Cloud Enabled CGM Device II-74 EyeSense to Develop Affordable CGM Device II-75 Insulin Pump with CGM Sensor..............II-75 Glucose Monitoring through Smartphone Apps: The Latest Breakthrough.............. II-75 Table 28: No. of Diabetic Patients Worldwide and No. of App-Using Patients (in Million): 2014 & 2018P (includes corresponding Graph/Chart)..............II-76 Bar-Illan University of Israel's Research for Non-invasive, Wearable Glucose Testing Device II-76 Nanotechnology-based Breathalyzer for Non-Invasive Glucose Monitoring.............. II-77 EMG 1000: Needle-free Device for Glucose Monitoring II-77 Glucase: Smartphone Case with Glucose Testing Kit II-78 Painless Diabetes Monitoring Using NFC Technology II-78 GlucoSense: Laser Device for Non-invasive Monitoring of Glucose Levels.............. II-79 ClearPath DS-120: Enabling Early Detection of Diabetes & Prediabetes.............. II-79 Sugar.IQ App: Powerful Features for Diabetics II-80 NoStrip™ Technology: Eliminating Need for Individual Test Strips II-80 Artificial Pancreas System (APS): The Future of Diabetes Care II-80

5. PRODUCT OVERVIEW.............. II-81 A Prelude.............. II-81 Continuous Glucose Monitoring (CGM) Systems II-81 Hemoglobin A1c (HbA1c) Test..............II-82 HbA1c Test Types..............II-82 HbA1c Laboratory Testing..............II-82 Analytical Techniques Used for Quantifying HbA1c in Labs II-83 Standardization of HbA1c Results II-83 Table 29: CAP Accuracy Grading for HbA1c Measurements ( 2007-2013).............. II-84 HbA1c Point of Care Testing & Self-Monitoring II-84 Blood Glucose Testing Devices II-85 Blood Glucose Monitor/Meter..............II-85 Diabetes Testing Supplies..............II-85 Blood Glucose Test Strips..............II-85 Lancet.............. II-85 Lancet Device.............. II-85 Reagent Strips.............. II-85 Reagent Tablet.............. II-85 Diabetes: A Chronic Body Disorder II-86 Diabetes Symptoms..............II-86 Types of Diabetes..............II-86 Type I Diabetes: Insulin-Dependent Diabetes Mellitus (IDDM) II-86 Type II Diabetes: Non Insulin-Dependent Diabetes Mellitus ( NIDDM).............. II-87

6. PRODUCT LAUNCHES.............. II-88 Roche Launches Accu-Chek Guide BGM System II-88 Cellnovo Introduces Manual Input Feature to CGM Users II-88 ACON to Offer New Glucose Meter System with On Call® Products II-88 Senseonics Receives CE Mark Approval for Eversense® CGM System II-88 Ascensia Receives CE Mark Approval for CONTOUR Glucose Monitoring Systems.............. II-88 Intuity Medical Receives FDA Clearance for its POGO® System II-88 Medtronic plc Reports Favorable Study Data on its MiniMed® Insulin Pump.............. II-88 Nemaura Medical Receives CE Approval for sugarBEAT® CGM System II-89 ACON Laboratories Launches OptiLance™ Push-Button Safety Lancets II-89 LabStyle Innovations Launches Smartphone-powered Glucometer Dario II-89 J&J's LifeScan Introduces OneTouch Verio System With Easy-to- read Results.............. II-89 Abbott Receives Approval from TGA for FreeStyle® Libre System II-89 Dnurse Technology Announces CE Approval for Dnurse Glucose Meter and App.............. II-89 FDA Approves Animas® Vibe® Insulin Pump and CGM System for Use in Children.............. II-89 Owen Mumford Launches Touch-Activated Lancet Unistik® Touch II-90 Dexcom's G5® Mobile CGM System Receives CE Mark II-90 Dexcom Receives FDA Approval for its G5® Mobile CGM System II-90 Abbott Receives FDA Approval for OTC Glucose Monitor II-90 ARKRAY Unveils New Instruments for HbA1c Measurement II-90 Roche Introduces New Cobas C513 Analyser II-90 ARKRAY Launches B-analyst HbA1c Control for HbA1c Tests II-90 ARKRAY Unveils CinQ HbA1c Range of Reagent Kit II-91 Transasia Bio-Medicals Introduces HbA1c & HbA2/F-Fully Automated Analyzer.............. II-91 ARKRAY Releases PocketChem A1c HbA1c Analyzer II-91 Bio-Rad Bags FDA Approval for D-100™ System for A1c Testing II-91 Bio-Rad's VARIANT™ II TURBO HbA1c Kit - 2.0 Receives FDA Approval for Use in Diabetes Diagnosis II-91 Abnova Concludes Clinical Trial for Personal A1c Diabetes Rapid Test.............. II-91 Ortho-Clinical Diagnostics Obtains FDA Approval for VITROS® Chemistry Products HbA1c Reagent Kit II-92 FDA Approves Animas® Vibe™ insulin pump and CGM for Adults II-92 CVS/pharmacy Launches its Brand of FDA-Approved Advanced Glucose Meter.............. II-92 Dexcom Receives FDA Approval for Remote Blood Sugar Monitoring Tool.............. II-92 Abbott's FreeStyle Libre System Receives EU Approval II-92 iHealth Lab Launches iHealth Align II-92 Dexcom Receives FDA Approval for Real-time Professional CGM II-92 Nipro Diagnostics Receives FDA Clearance for TRUE METRIX™ & TRUE METRIX™ PRO.............. II-93 LifeScan Launches OneTouch Verio Glucose Monitoring Device II-93 Omnis Health Launches EmbraceEVO™ Blood Glucose Meter II-93 GE Healthcare Announces Validation of GE200 Blood Glucose Meter II-93 Sanofi Launches Blood Glucose Monitor that Offers HbA1c Estimates II-93 Beckman Coulter Introduces Next-Generation Hemoglobin A1c II-93 ARKRAY Unveils ADAMS A1c mini Glycated- Hemoglobin Analyzer II-93 Axis-Shield Introduces HbA1c Turbidimetric Immunoassay II-94 ARKRAY Unveils ADAMS Hybrid AH-8290 Dual HbA1c and Glucose Analyzer.............. II-94 Sebia Unveils Capillarys HbA1c Assay II-94 Abbott Gains FDA Approval for ARCHITECT Clinical Chemistry HbA1c Test.............. II-94

7. RECENT INDUSTRY ACTIVITY..............II-95 Ypsomed Collaborates with Novo Nordisk for Insulin Pumps II-95 Senseonics Holdings Signs Exclusive Distribution Agreement with Roche.............. II-95 Siemens Healthcare Rebrands as Siemens Healthineers II-95 Cellnovo and Roche Sign Agreement on Blood Glucose Monitors II-95 Bayer to Sell Diabetes Care Business to Panasonic Healthcare II-95 Sinocare to Acquire PTS Diagnostics II-95 Abbott Inks Definitive Agreement to Take over Alere II-96 Decision Diagnostics Enters into R&D Agreement with Korean Manufacturer.............. II-96 Medtronic Collaborates with Qualcomm for Disposable CGM II-96 Integrity Applications Enters into Distribution Agreements with LifeCaring Technologies and Guangzhou Guang Yuan Biological.............. II-96 Insulet Corporation Extends Agreement with Abbott II-96 Decision Diagnostics Acquires Genstrip from Shasta Technologies II-96

8. FOCUS ON SELECT GLOBAL PLAYERS..............II-97 Abbott Diabetes Care, Inc. (US)..............II-97 Acon Laboratories, Inc. (US)..............II-97 AgaMatrix, Inc. (US)..............II-97 Alere Inc. (US).............. II-98 Animas Corporation (US)..............II-98 Apex Biotechnology Corporation (Taiwan) II-99 ARKRAY, Inc. (Japan)..............II-99 Ascensia Diabetes Care Holdings AG (Switzerland) II-100 A.Menarini Diagnostics Ltd. (UK) II-100 B. Braun Melsungen AG (Germany)..............II-100 Becton, Dickinson and Company (US) II-101 Bayer Healthcare Diabetes Care (US) II-102 Beckman Coulter, Inc. (US)..............II-102 Bio-Rad Laboratories (US)..............II-103 BIONIME Corporation (Taiwan)..............II-103 Diazyme Laboratories Inc. (US) II-104 Dexcom, Inc. (US).............. II-104 EKF Diagnostics Holdings Plc (UK) II-104 HemoCue® AB (Sweden)..............II-105 Infopia Co., Ltd. (South Korea)..............II-105 LifeScan, Inc. (US).............. II-106 Medtronic MiniMed, Inc. (US)..............II-106 Nova Biomedical Corporation (US) II-106 PTS Diagnostics (US)..............II-107 Roche Diagnostics (Switzerland)..............II-107 Sanofi S.A. (France)..............II-108 Sanwa Kagaku Kenkyusho Co, Ltd. (Japan) II-109 Siemens Healthineers (Germany) II-109 Taidoc Technology Corporation (Taiwan) II-110 Tandem Diabetes Care, Inc. (US)..............II-110 Terumo Corporation (Japan)..............II-110 Tosoh Bioscience, Inc. (US)..............II-111 Trinity Biotech plc (Ireland)..............II-111 Trividia Health, Inc. (US)..............II-111 Ypsomed AG (Switzerland)..............II-112

9. GLOBAL MARKET PERSPECTIVE..............II-113 Table 30: World Recent Past, Current & Future Analysis for Diabetes Diagnostics by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) II-113

Table 31: World Historic Review for Diabetes Diagnostics by Geographic Region/ Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)..............II-114

Table 32: World 14-Year Perspective for Diabetes Diagnostics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-115

By Product Segment:..............II-116

Table 33: World Recent Past, Current & Future Analysis for CGM Systems by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............II-116

Table 34: World Historic Review for CGM Systems by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).............. II-117

Table 35: World 14-Year Perspective for CGM Systems by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-118

Table 36: World Recent Past, Current & Future Analysis for HbA1c Testing Devices by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) II-119

Table 37: World Historic Review for HbA1c Testing Devices by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)..............II-120

Table 38: World 14-Year Perspective for HbA1c Testing Devices by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-121

Table 39: World Recent Past, Current & Future Analysis for Blood Glucose Monitoring Devices by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) II-122

Table 40: World Historic Review for Blood Glucose Monitoring Devices by Geographic Region/Country - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)..............II-123

Table 41: World 14-Year Perspective for Blood Glucose Monitoring Devices by Geographic Region/Country - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)..............II-124

III. MARKET

1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 The US: The Largest Diabetes Diagnostics Market Worldwide III-1 Diabetes: A Leading Cause of Death in the US III-1 Table 42: Diabetes and Population Statistics in North America and Caribbean Region (2015 & 2040) (includes corresponding Graph/Chart)..............III-2

Table 43: Diabetes Statistics in the US (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) III-2 Aging Population: A Key Growth Factor III-2 Table 44: Diabetes Prevalence in the US (2015E): Percentage Share of Number of Diabetics by Gender (includes corresponding Graph/Chart)..............III-3

Table 45: Diabetes Prevalence in the US (2015E): Percentage Share of Number of Diabetics by Age Group (includes corresponding Graph/Chart)..............III-3

Table 46: Aging Population in the US (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-3

Table 47: North American Aging Population by Age Group: 1975-2050 (includes corresponding Graph/Chart) III-4 Economic Burden of Diabetes..............III-4 Table 48: Health Expenditure (in US$ Billion) on Diabetes in the US: 2015 & 2040 (includes corresponding Graph/Chart) III-5 Healthcare Reform Legislation: Impact on Diabetes Diagnostics III-5 HbA1c Testing for Diabetes Detection Gains Support III-6 ADA Recommends HbA1c Test for Diabetes Diagnosis III-6 ADA Recommends New Guidelines for HbA1c Testing for Certain Patients.............. III-6 HbA1c - Increasingly Moving into Physician's Office III-7 Study Finds Dentist Visits to be an Opportunity for HbA1c- based Diabetes Screening & Management III-7 Growing Inclination towards CLIA-Waived Tests III-8 Wearable and Non-Invasive Glucose Monitoring Devices Favored III-8 FDA Guidance for Blood Glucose Meters III-8 Emerging "Grey Market" for Testing Strips III-9 Competitive Landscape..............III-10 US Near Patient HbA1c Testing: A Highly Consolidated Market III-10 Table 49: Leading Players in the US Near Patient HbA1c Testing Market (2015E): Percentage Share Breakdown of Revenues for Alere, Siemens and Others (includes corresponding Graph/Chart) III-10 CGM Devices: Highly Consolidated Marketplace III-10 Table 50: Leading Companies in the US CGM Market (2014 & 2020P): Percentage Share Breakdown of Revenue for Abbott, DexCom, and Medtronic (includes corresponding Graph/Chart) III-10 Companies Focus on Research for Better Diabetes Diagnostics III-11 Drugstores Benefit from the Diabetic Care Category III-11 Integrated Products: An Upcoming Trend III-11 Product Launches..............III-12 Strategic Corporate Developments III-15 Select Key Players..............III-16 B.Market Analytics..............III-24 Table 51: US Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-24

Table 52: US Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-25

Table 53: US 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-26

2. CANADA.............. III-27 A.Market Analysis.............. III-27 Current & Future Analysis..............III-27 Diabetes Statistics in Canada: Opportunity Indicator for Diabetes Diagnostics..............III-27 Table 54: Diabetes Statistics in Canada (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) III-27

Table 55: Adult Diabetes in Canada (2015E): Percentage Share Breakdown of Diabetic Population by Gender (includes corresponding Graph/Chart)..............III-28

Table 56: Adult Diabetes in Canada (2015E): Percentage Share Breakdown of Diabetic Population by Age Group (includes corresponding Graph/Chart) III-28 Aging Population: Key Opportunity Indicator III-28 Table 57: Aging Population in Canada (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-28 B.Market Analytics..............III-29 Table 58: Canadian Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-29

Table 59: Canadian Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-30

Table 60: Canadian 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-31

3. JAPAN.............. III-32 A.Market Analysis.............. III-32 Growing Aging Population Drives Diabetes Diagnostics Market III-32 Table 61: Aging Population in Japan (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-32 Trends Influencing Diabetes Diagnostics Market III-33 Table 62: Diabetes Statistics in Japan (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-33 Product Launches..............III-33 Select Key Players..............III-34 B.Market Analytics..............III-36 Table 63: Japanese Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-36

Table 64: Japanese Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-37

Table 65: Japanese 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-38

4. EUROPE.............. III-39 A.Market Analysis.............. III-39 Diabetes Diagnostics Market in Europe - A Promising Outlook III-39 Proven Efficacy and Benefits of POCT HbA1C Tests Spur Adoption III-40 Diabetes Statistics in Europe..............III-40 Table 66: Diabetes and Population Statistics in Europe (2015 & 2040) (includes corresponding Graph/Chart) III-41

Table 67: Diabetes Statistics in Europe (2015) - Number of Adults with Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart) III-42 Reimbursement Scenario..............III-43 Product Launch.............. III-43 B.Market Analytics..............III-44 Table 68: European Recent Past, Current & Future Analysis for Diabetes Diagnostics by Geographic Region/Country - France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-44

Table 69: European Historic Review for Diabetes Diagnostics by Geographic Region/ Country - France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-45

Table 70: European 14-Year Perspective for Diabetes Diagnostics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, Russia, and Rest of Europe Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-46

Table 71: European Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-47

Table 72: European Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-48

Table 73: European 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-49

4a. FRANCE.............. III-50 A.Market Analysis.............. III-50 France: Diabetes & Aging Statistics III-50 Table 74: Diabetes Statistics in France (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-50

Table 75: Aging Population in France (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-50 Product Launches..............III-51 Strategic Corporate Development III-51 Sanofi S.A.: A Major France-Based Company III-51 B.Market Analytics..............III-52 Table 76: French Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-52

Table 77: French Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-53

Table 78: French 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-54

4b. GERMANY.............. III-55 A.Market Analysis.............. III-55 Germany: Diabetes & Aging Statistics III-55 Table 79: Diabetes Statistics in Germany (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-55

Table 80: Aging Population in Germany (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-55 Strategic Corporate Developments III-56 Select Key Players..............III-56 B.Market Analytics..............III-58 Table 81: German Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-58

Table 82: German Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-59

Table 83: German 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-60

4c. ITALY.............. III-61 A.Market Analysis.............. III-61 Italy: Diabetes & Aging Statistics III-61 Table 84: Diabetes Statistics in Italy (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-61

Table 85: Aging Population in Italy (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-61 B.Market Analytics..............III-62 Table 86: Italian Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-62

Table 87: Italian Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-63

Table 88: Italian 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-64

4d. THE UNITED KINGDOM..............III-65 A.Market Analysis.............. III-65 NHS England Launches Action for Diabetes Plan III-65 NHS Guidelines for Lancets, Testing Strips, and Meters for Blood Glucose Testing..............III-65 Self-Monitoring Blood Glucose Meters Gain Popularity III-66 NICE Recommendations for Self-Monitoring Blood Glucose (SMBG) III-66 Diabetes Statistics & Management - An Insight III-67 Table 89: Diabetes Statistics in United Kingdom (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-67

Table 90: Aging Population in the United Kingdom (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart).............. III-68 Rising Obesity Cases - Increased Risk of Diabetes III-68 Type 1 Diabetes in Children III-69 Table 91: Number of Children with Type 1 Diabetes in Select Countries (2015) (includes corresponding Graph/Chart).............. III-69 Product Launches..............III-69 Select Key Players..............III-70 B.Market Analytics..............III-72 Table 92: UK Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-72

Table 93: UK Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-73

Table 94: UK 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-74

4e. SPAIN.............. III-75 A.Market Analysis.............. III-75 Spain: Diabetes & Aging Statistics III-75 Table 95: Diabetes Statistics in Spain (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-75

Table 96: Aging Population in Spain (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-75 B.Market Analytics..............III-76 Table 97: Spanish Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-76

Table 98: Spanish Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-77

Table 99: Spanish 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-78

4f. RUSSIA.............. III-79 A.Market Analysis.............. III-79 Russia: Diabetes & Aging Statistics III-79 Table 100: Diabetes Statistics in Russia (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-79

Table 101: Aging Population in Russia (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-80 B.Market Analytics..............III-81 Table 102: Russian Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-81

Table 103: Russian Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-82

Table 104: Russian 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-83

4g. REST OF EUROPE.............. III-84 A.Market Analysis.............. III-84 Product Launches..............III-84 Strategic Corporate Developments III-84 Select Key Players..............III-85 B.Market Analytics..............III-88 Table 105: Rest of European Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-88

Table 106: Rest of European Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart).............. III-89

Table 107: Rest of European 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-90

5. ASIA-PACIFIC.............. III-91 A.Market Analysis.............. III-91 Technological Integration: An Emerging Trend in the Asia- Pacific Medical Devices Market III-91 Public and Private Sector Diabetes Care III-91 Public Sector.............. III-91 Private Sector.............. III-92 BGM Devices: Competitive Landscape III-92 Rising Diabetes Incidence in Asia-Pacific Offers Significant Growth Opportunities..............III-92 Table 108: Diabetes and Population Statistics in Western Pacific (2015 & 2040) (includes corresponding Graph/Chart) III-93

Table 109: Diabetes Statistics in Western Pacific (2015) - Number of Adults with Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart).............. III-94

Table 110: Diabetes and Population Statistics in South East Asia (2015 & 2040) (includes corresponding Graph/Chart) III-95

Table 111: Diabetes Statistics in South East Asia (2015) - Number of Adults with Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart).............. III-96 Role of Healthcare Societies and Associations III-96 India.............. III-96 Bangladesh.............. III-97 Western Pacific Declaration on Diabetes III-97 China.............. III-97 China: Lower Penetration Offers High Growth Potential III-97 Table 112: Leading Companies in the Chinese Glucose Meter Market (2015): Percentage Share Breakdown of Revenue for Abbott, Bayer, J&J, Omron, Roche, Sinocare & Yuyue (includes corresponding Graph/Chart) III-98 Reimbursement of Diabetes Diagnostics in China (2015): Glucose Meters and Test Strips' Reimbursement Status and Percentage.............. III-98 Increasing Diabetes Incidence Remains Growth Driver III-98 Table 113: Diabetes Statistics in China (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-99 Key Opportunity Indicator: Aging Population III-100 Table 114: Aging Population in China (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-100 India.............. III-100 Market Overview..............III-100 Growth Stimulants & Challenges in a Nutshell III-101 HbA1c Testing on Growth Spree III-101 Most Glucose Meters in Indian Market Feature Imported Technology.............. III-101 ICMR Develops New Indigenous, Low-Cost Diabetes Detection Technology.............. III-102 Market Restraints..............III-103 Rising Diabetes Cases - Opportunities for Diabetes Diagnostics III-103 Table 115: Diabetes Statistics in India (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s) III-104 Key Opportunity Indicator: Aging Population III-104 Table 116: Aging Population in India (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-104 Australia.............. III-105 Australia: An Insight into Diabetes Statistics III-105 Table 117: Diabetes Population in Australia (2015): Percentage Share Breakdown of Number of Diabetics by Age Group (includes corresponding Graph/Chart) III-105

Table 118: Diabetes Statistics in Australia (2015) - Number of Adults with Diabetes (in 000s), Adults with Undiagnosed Diabetes (in '000s), National Diabetes Prevalence (%), Number of Diabetes-Related Deaths (in '000s), and No. of Children with Type 1 diabetes (in '000s).............. III-106 Key Opportunity Indicator: Aging Population Statistics in Rest of Asia-Pacific..............III-106 Table 119: Aging Population in Rest of Asia by Country (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart).............. III-106 Product Launches..............III-107 Select Key Players..............III-107 B.Market Analytics..............III-109 Table 120: Asia-Pacific Recent Past, Current & Future Analysis for Diabetes Diagnostics by Geographic Region/Country - China, India, and Rest of Asia-Pacific Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-109

Table 121: Asia-Pacific Historic Review for Diabetes Diagnostics by Geographic Region/ Country - China, India, and Rest of Asia-Pacific Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart) III-110

Table 122: Asia-Pacific 14-Year Perspective for Diabetes Diagnostics by Geographic Region/ Country - Percentage Breakdown of Dollar Sales for China, India, and Rest of Asia-Pacific Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)..............III-111

Table 123: Asia-Pacific Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-112

Table 124: Asia-Pacific Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart).............. III-113

Table 125: Asia-Pacific 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-114

6. LATIN AMERICA.............. III-115 A.Market Analysis.............. III-115 Diabetes in Latin America - A Glance at Key Statistics III-115 Table 126: Diabetes and Population Statistics in Central and South America (2015 & 2040) (includes corresponding Graph/Chart).............. III-116

Table 127: Diabetes Statistics in South & Central America (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart).............. III-117 Key Opportunity Indicator: Aging Population III-118 Table 128: Aging Population in Latin America and the Caribbean by Region (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart) III-118

Table 129: Aging Population in Latin America by Country (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart).............. III-119 B.Market Analytics..............III-120 Table 130: Latin American Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-120

Table 131: Latin American Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart).............. III-121

Table 132: Latin American 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-122

7. REST OF WORLD.............. III-123 A.Market Analysis.............. III-123 Diabetes Statistics in Africa and the Middle East III-123 Table 133: African Diabetes and Population Statistics (2015 & 2040) (includes corresponding Graph/Chart) III-123

Table 134: Diabetes Statistics in Africa (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart) III-124

Table 135: Diabetes and Population Statistics in Middle East and North Africa (2015 & 2040) (includes corresponding Graph/Chart).............. III-125

Table 136: Diabetes Statistics in Middle East and North Africa (2015) - Number of Adults with Diabetes (in 000s), Number of Adults with Undiagnosed Diabetes (in 000s), Diabetes Prevalence (%) and Number of Diabetes-Related Deaths (in '000s) for Select Countries (includes corresponding Graph/Chart)..............III-126 Key Opportunity Indicator: Aging Population III-127 Table 137: Aging Population in the Middle East by Country (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart).............. III-127

Table 138: Aging Population in Africa by Region (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart).............. III-128 Strategic Corporate Development III-128 Clinical-Stage Company Based in Israel - Integrity Applications III-128 B.Market Analytics..............III-129 Table 139: Rest of World Recent Past, Current & Future Analysis for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart) III-129

Table 140: Rest of World Historic Review for Diabetes Diagnostics by Product Segment - CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets Independently Analyzed with Annual Sales Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart).............. III-130

Table 141: Rest of World 14-Year Perspective for Diabetes Diagnostics by Product Segment - Percentage Breakdown of Dollar Sales for CGM Systems, HbA1c Testing Devices, and Blood Glucose Monitoring Devices Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III-131

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 58 (including Divisions/Subsidiaries - 75)

The United States (35) Canada (1) Japan (4) Europe (23) - France (2) - Germany (4) - The United Kingdom (8) - Italy (1) - Rest of Europe (8) Asia-Pacific (Excluding Japan) (10) Middle-East (2)
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