HEMOGLOBIN A1c MONITORING A GLOBAL STRATEGIC BUSINESS REPORT

Transcription

1 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 Definition And Scope Of Study... I-3 Hba1c Laboratory Testing... I-3 Hba1c Point Of Care Testing & Self-Monitoring... I-4 II. EXECUTIVE SUMMARY 1. Market Overview... II-1 Current and Future Analysis...II-1 Regional Analysis...II-1 Analysis by Product Segments...II-2 Diabetes Monitoring Market...II-2 Higher Levels of Glycosylated Hemoglobin Increases the Risk of Death...II-2 Regular HbA1c Test Keeps Heart Risk at Bay...II-2 Home Monitoring...II-3 2. Product Overview... II-4 Product Definition...II-4 HbA1c Monitoring...II-4 What is A1C...II-4 Hemoglobin A1C (HbA1c) Test...II-4 Interpreting HbA1c Test Readings...II-5 Table 1: Interpreting HbA1c Test Readings...II-5 Result of Hemoglobin A1c Test...II-6 Advantages of A1c Assessment & Interpretation...II-6 Risks Associated with HBA1c Testing...II-6 Methods of Measurement for Glycohemoglobin...II-6 The Diabetes Control & Complications Trial (DCCT)...II-7 The Kumamoto and UK Prospective Studies...II-7 Glycemia Tests Used in Monitoring Diabetes...II-7 Urine Glucose Testing...II-7 Glycated Protein Testing...II-8 Table 2: Relation Between A1C Level and Mean Plasma Glucose Levels...II-8 HbA1c Test Types...II-8 HbA1c Laboratory Testing...II-9 HbA1c Laboratory Testing Product Development Over the Years...II-9 HbA1c Point of Care Testing & Self-Monitoring...II-10 POCT HbA1c Testing Market (2004 E)...II-12 POCT & Self-Monitoring Product Developments: ( )...II Diabetes - A Brief Profile of the Disease... II-15 What Causes Diabetes...II-15 Types of Diabetes...II-15 Major Types of Diabetes...II-16 Likely Complications...II-16 Nephropathy (Kidney Disease)...II-16 Diabetic Neuropathy (Nerve Damage)...II-16 Retinopathy (Damage to the Eye and Blindness)...II-17 Poor Healing of Infections and Wounds...II-17 Impotence in Men...II-17 Periodontal Disease...II-17 Cardiovascular Disease...II-17 Interpreting the A1c Range...II-17 Blood Glucose Level Guidelines* in the US...II-18 Overview of Diabetes Care Market in the 1990s...II-18 Future Outlook...II-18 Table 3: World Diabetes and Population Statistics (2003 & 2025)...II-18 Prevalence of Diabetes in Various Parts of the World...II-19 Table 4: World Diabetes Market (2000 & 2030): Breakup by Regions Having the Highest Number of People with Diabetes - India, China, US, Indonesia, Japan, Pakistan, Russian Federation, Brazil, Italy, Bangladesh, Philippines and Egypt (in million) (includes corresponding Graph/Chart)...II-19 Therapeutic Options for Diabetes...II-20 Oral Medication for Type 2 Diabetes...II-20 Table 5: Diabetes Treatment Options in the US: Percentage Breakdown for Insulin or Insulin & Oral Drugs, Oral Drugs, and Diet & Exercise (includes corresponding Graph/Chart)...II-21 Side Effects of Insulin Therapy...II-21 Maintaining A1c Test Result Below 7%...II-21 Common Diabetes Management Practices...II Research and Development Highlights... II-22 G5 Diabetes Diagnostic Test by Provalis...II-22 Diabetes Risk Among Young Native Americans...II-22 Mean HbA1c Scores at National Level...II-22 Short Term Economic Benefits of Enhanced Glycemic Control...II Technological Developments... II-24 New Noninvasive Monitoring and Testing Devices...II-24 HGI as a Statistical Predictor of Nephropathy and Retinopathy...II-24 Micro-Optical Detection Method Technology - Metrika...II Regulatory Environment- What s New... II-26 Axis-Shield s Afinion System Obtains FDA CLIA Waiver...II-26 Diazyme s Enzymatic HbA1c Assay Receives NGSP Accreditation...II-26 Axis-Shield Obtains FDA Clearance for Afinion and Afinion HbA1c Test...II-26 Axis-Shield Obtains NGSP Accreditation for Afinion HbA1c Test...II-26 Abbott Laboratories and Seradyn Obtain US FDA Approval for Hemoglobin A1c Assay...II-26 Page 1

2 Medicare Reform Act Passed for Reforms in Diabetes Treatment and Care in the US...II-27 Bio-Rad Obtains FDA Approval for D-10 Hemoglobin A1c System...II-27 FDA Approves OTC Diabetes Test and Clears Metrika s A1cNow Diabetes Monitor for Home Use...II-27 FDA Level 1 Certification for SimpleChoice A1c Test Device...II-27 Metrika Obtains FDA Approval for Digital Response HbA1c Patient Monitor...II Product Innovations/Introductions... II-29 OrSense Introduces Non-Invasive Hematocrit/ Hemoglobin Sensor...II-29 Bayer to Divest Diagnostic Division of Bayer Healthcare to Siemens...II-29 Primus Corp Rolls Out Ultra2 A1c, an HPLC system...ii-29 Axis-Shield Introduces AFINION, New POCT System...II-29 Bristol-Myers Squibb Unveils Choice DM A1C Home Test...II-30 Beckton Launches FDA Approved Products for Diabetes Management...II-30 International Technidyne Rolls Out Hgb Pro Professional Hemoglobin Testing System...II-30 Bayer Unveils HbA1C Assay for the ADVIA 1650 Chemistry System...II-30 Catachem Launches Glycated Hemoglobin In-Vitro Diagnostic Kit...II-31 Beijing Blue Cross Biotech Launches Colibri System...II-31 Cholestech Obtains Clearance to Market Cholestech GDX System in Canada...II-31 SpectRx Announces Launch of SimpleChoice Products...II-31 DCA Analyzer Minimizes Risk and Helps to Monitor HbA1c Levels...II-31 BioSafe Laboratory Introduces BioSafe HbA1c Test Kit...II-31 FlexSite Diagnostics, Inc. Launches A1c At Home Test Kit...II-32 Integrated Technologies Launched ABAKA to Measure Glib...II-32 Provalis Develops Glycosal...II Recent Industry Activity... II-33 Bio-Rad Laboratories Inks Multi-year Contract with Premier...II-33 Trinity Biotech Acquires Primus Corp...II-33 Axis-Shield Obtains Approval for AFINION...II-33 Abbott Laboratories and Seradyn Receive FDA Clearance for Multigent Hemoglobin A1c Test...II-33 Shanghai Upper Biotech Signs Agreement with Chinese Ministry of Health...II-34 Roche Acquires Insulin Pump Unit of Disetronic...II-34 Becton Dickinson Diversifies into Blood-Glucose Meter Products...II-34 Sysmex Corp Pens Distribution Agreement with Bio-Rad...II-34 Tosoh Medics Adopts New Corporate Identity...II-35 G5 to Enter Trials in the US...II-35 Cholestech Signs Global Distribution Agreement with Provalis...II-35 BioSafe Announces Distribution of Free and Low- Cost HbA1c Tests...II-35 Tosoh and Sysmex Sign Sales Agreement...II-35 Bayer Diagnostics Pens Co-Marketing Agreement with Cholestech Corporation...II-36 Provalis Obtains US Patent for Glycosal...II-36 Axis-Shield Plc Acquires Nycomed Diagnostics...II-36 Quest Selects COBAS Integra Hemoglobin A1c Assay from Roche...II Focus on Select Global Players... II-37 Abbott Laboratories (USA)...II-37 Axis-Shield (UK)...II-37 Bayer (Germany)...II-37 Beckman Coulter, Inc. (US)...II-38 Bio-Rad Laboratories Inc (USA)...II-39 Biosafe Laboratories Inc (USA)...II-39 Diabetes Technologies Inc (USA)...II-39 Flexsite Diagnostics Inc (USA)...II-40 Metrika Inc (USA)...II-40 Primus Corporation (USA)...II-40 Provalis Plc (UK)...II-41 Roche Diagnostics (Switzerland)...II-41 SpectRx Inc. (USA)...II-41 Tosoh Bioscience, Inc (USA)...II Global Market Perspective... II-42 Table 6: World Recent Past, Current and Future Analysis for HbA1c Monitoring by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East, Latin America and Rest of World Figures (includes corresponding Graph/Chart)...II-42 Table 7: World 11-Year Perspective for HbA1c Monitoring by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East and Latin America and Rest of World Markets for Years 2000, 2005, 2010 (includes corresponding Graph/Chart)...II-43 Table 8: World Recent Past, Current and Future Analysis for HbA1c Laboratory Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East and Latin America and Rest of World Figures (includes corresponding Graph/Chart)...II-44 Table 9: World 11-Year Perspective for HbA1c Laboratory Testing by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East and Latin America and Rest of World Markets for Years 2000, 2005, 2010 (includes corresponding Graph/Chart)...II-45 Page 2

3 Table 10: World Recent Past, Current and Future Analysis for HbA1c Point of Care and Self-Monitoring by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East and Latin America and Rest of World Figures (includes corresponding Graph/Chart)...II-46 Table 11: World 11-Year Perspective for HbA1c Point of Care and Self-Monitoring by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), the Middle East and Latin America and Rest of World Markets for Years 2000, 2005, 2010 (includes corresponding Graph/Chart)...II-47 III. MARKET 1. The United States... III-1 A. Market Overview...III-1 An Insight...III-1 Current and Future Analysis...III-1 Market Highlights...III-1 Challenges in the HbA1c Monitoring Market in the US...III-2 Key Players...III-2 Table 12: HbA1c Point of Care and Self-Monitoring Market in the US ( ): Market Shares by Sales for Metrika, BioSafe, Flexsite Diagnostics, Diabetes Tech, SpectRx, and Others (includes corresponding Graph/Chart)...III-2 Table 13: HbA1c Laboratory Testing Market in the US ( ): Market Shares by Sales for Bio-Rad, Roche, Tosoh, Bayer, and Others (includes corresponding Graph/Chart)...III-3 Diabetes: The Statistics...III-3 Age Factor...III-3 Table 14: US Market for Diabetes (2005 E): Percentage Breakdown of Prevalence by Age Group years, years, years and 75 years + (includes corresponding Graph/Chart)...III-4 Prevalence by Race/Ethnicity...III-4 Table 15: US Market for Diabetes (2004 E): Percentage Breakdown of Prevalence by Race/Ethnicity- American Indians/Alaska Natives, Non-Hispanic Blacks, Hispanic/Latin Americans and Non-Hispanic Whites (includes corresponding Graph/Chart)...III-4 Table 16: Prevalence of Diabetes in Americans 20 Years or Over by Race/Ethnicity and Gender (includes corresponding Graph/Chart)...III-5 Diabetes Statistics in the Recent Past - A Review...III-5 Table 17: Prevalence Estimates of Diabetes Mellitus in the US: III-5 Table 18: Prevalence Estimates of Type 1 Diabetes Mellitus in the US: III-5 Table 19: Diabetic Cases in the US in 2000 by State... III-5 Market Trends & Issues... III-6 Impact of Pricing and Innovation... III-7 HbA1c Monitoring Vs Blood Glucose Monitoring... III-7 Impact of Diabetes Education Campaigns on HbA1c Monitors Usage... III-7 Impact of Sedentary Lifestyle... III-7 Reimbursements from Managed Care Organizations... III-7 The Diabetes A1c Initiative... III-8 A1c Kits Available in the US... III-8 The US Clinical Laboratory Services Testing Market - A Historical Perspective... III-9 Clinical Testing Service Sites in the US... III-9 Growth of Clinical Laboratory Market Over the Years... III-10 Regulatory Guidelines & Approvals... III-10 Product Innovations/Introductions... III-12 Recent Industry Activity... III-14 Key US Players... III-16 B. Market Analytics... III-20 Table 20: US Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Types - HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)... III-20 Table 21: US 11-Year Perspective for HbA1c of for 2000, 2005, III Canada... III-21 A. Market Overview... III-21 Current and Future Analysis... III-21 Key Diabetes Statistics... III-21 Table 22: Prevalence Estimates of Diabetes Mellitus in Canada: III-21 Table 23: Prevalence Estimates of Type 1 Diabetes Mellitus in Canada: III-21 Industry Activity in the Recent Past... III-22 B. Market Analytics... III-22 Table 24: Canadian Market for HbA1c Monitoring - A Current & Future Analysis. Annual Sales for the Years 2000 through 2010 in US$ Million. HbA1c Test Types Independently Analyzed - HbA1c Laboratory Testing and HbA1c Point of Care Testing & Self-Monitoring (includes corresponding Graph/Chart)... III-22 Page 3

4 Table 25: Canadian Market for HbA1c Monitoring - An 11-Year Perspective. A comparative presentation of the recent past, present and future perspective by staging dollar sales estimates for years 2000, 2004 and A Tabular depiction of growth/decline trends across the HbA1c test type - HbA1c Laboratory Testing, and HbA1c Point of Care Testing & Self-Monitoring...III Japan... III-23 A. Market Overview...III-23 Current and Future Analysis...III-23 Industry Activity in the Recent Past...III-23 Key Japanese Player...III-24 B. Market Analytics...III-24 Table 26: Japanese Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Types - HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)...III-24 Table 27: Japanese 11-Year Perspective for HbA1c for 2000, 2005, III Europe... III-25 A. Market Overview...III-25 Current and Future Analysis...III-25 Regional Analysis...III-25 Analysis by Product Segments...III-25 The European POCT Market...III-25 Factors Driving the Market:...III-25 Diabetes Statistics in Europe...III-26 Table 28: Prevalence Estimates of Diabetes Mellitus in Europe: III-26 Table 29: Prevalence Estimates of Type 1 Diabetes Mellitus in Europe: III-27 B. Market Analytics...III-28 Table 30: European Recent Past, Current and Future Analysis for HbA1c Monitoring by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Sales Figures (includes corresponding Graph/Chart)...III-28 Table 31: European 11-Year Perspective for HbA1c Monitoring by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2000, 2005, 2010 (includes corresponding Graph/Chart)...III-28 Table 32: European Recent Past, Current and Future 2010 (includes corresponding Graph/Chart)... III-29 Table 33: European 11-Year Perspective for HbA1c of Dollar Sales for HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-29 4a. France... III-30 A. Market Overview... III-30 Current and Future Analysis... III-30 B. Market Analytics... III-30 Table 34: French Recent Past, Current and Future Analysis Figures (includes corresponding Graph/Chart)... III-30 Table 35: French 11-Year Perspective for HbA1c of for 2000, 2005, III-30 4b. Germany... III-31 A. Market Overview... III-31 Current and Future Analysis... III-31 B. Market Analytics... III-31 Table 36: German Recent Past, Current and Future Analysis Figures (includes corresponding Graph/Chart)... III-31 Table 37: German 11-Year Perspective for HbA1c HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-31 4c. Italy... III-32 A. Market Overview... III-32 Current and Future Analysis... III-32 B. Market Analytics... III-32 Table 38: Italian Recent Past, Current and Future Analysis Figures (includes corresponding Graph/Chart)... III-32 Page 4

5 Table 39: Italian 11-Year Perspective for HbA1c Monitoring by Test Types- Percentage Breakdown of Dollar Sales for HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-32 4d. The United Kingdom... III-33 A. Market Overview...III-33 Current and Future Analysis...III-33 Key Statistics...III-33 Product Innovations/Introductions...III-33 Recent Industry Activity...III-34 Key Players in the UK...III-35 B. Market Analytics...III-37 Table 40: UK Recent Past, Current and Future Analysis for HbA1c Monitoring Test Types - HbA1c Laboratory by Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)...III-37 Table 41: UK 11-Year Perspective for HbA1c Monitoring by Test Types- Percentage Breakdown of Dollar Sales for HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-37 4e. Spain... III-38 A. Market Overview...III-38 Current and Future Analysis...III-38 B. Market Analytics...III-38 Table 42: Spanish Recent Past, Current and Future Analysis Figures (includes corresponding Graph/Chart)...III-38 Table 43: Spanish 11-Year Perspective for HbA1c HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-38 4f. Russia... III-39 A. Market Overview...III-39 Current and Future Analysis...III-39 B. Market Analytics...III-39 Table 44: Russian Recent Past, Current and Future 2010 (includes corresponding Graph/Chart)...III-39 Table 45: Russian 11-Year Perspective for HbA1c Monitoring by Test Types- Percentage Breakdown of Dollar Sales for HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III-39 4g. Rest of Europe... III-40 A. Market Overview... III-40 Current and Future Analysis... III-40 Key Player... III-40 Industry Activity in the Recent Past... III-40 B. Market Analytics... III-41 Table 46: Rest of Europe Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Types - HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)... III-41 Table 47: Rest of Europe 11-Year Perspective for HbA1c Monitoring by Test Types- Percentage Breakdown of Dollar Sales for HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets for 2000, 2005, III Asia-Pacific... III-42 A. Market Overview... III-42 Current and Future Analysis... III-42 Diabetes Prevalence Rates in the Asia-Pacific Region... III-42 Table 48: Prevalence Estimates of Diabetes Mellitus in South-East Asia: III-43 Table 49: Prevalence Estimates of Type 1 Diabetes Mellitus in Southeast Asia: III-43 Table 50: Prevalence Estimates of Diabetes Mellitus in Western Pacific: III-44 Recent Industry Activity... III-44 B. Market Analytics... III-45 Table 51: Asia Pacific Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Types - HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)... III-45 Table 52: Asia Pacific 11-Year Perspective for HbA1c for 2000, 2005, III The Middle East... III-46 A. Market Overview... III-46 Current and Future Analysis... III-46 Table 53: Prevalence Estimates of Diabetes Mellitus in the Middle East in III-46 Page 5

6 Table 54: Prevalence Estimates of Type 1 Diabetes Mellitus in the Middle East in III-47 Product Innovation/Introduction...III-47 B. Market Analytics...III-48 Table 55: Middle East Recent Past, Current and Future Analysis for HbA1c Monitoring by Test Types - HbA1c Laboratory Testing and HbA1c Point of Care and Self-Monitoring Markets Independently Analyzed with Annual Sales Figures (includes corresponding Graph/Chart)...III-48 Table 56: Middle East 11-Year Perspective for HbA1c for 2000, 2005, III Latin America... III-49 A. Market Overview...III-49 Current and Future Analysis...III-49 Diabetes Statistics in Latin America...III-49 Table 57: Prevalence of Diabetes Complications in South and Central American Region: 2004 E...III-49 Table 58: Prevalence Estimates of Diabetes Mellitus in South & Central America: III-50 Table 59: Prevalence Estimates of Type 1 Diabetes Mellitus in South & Central America: III-51 Mexico...III-51 Table 60: Prevalence Estimates of Diabetes Mellitus in Mexico: III-51 Table 61: Prevalence Estimates of Type 1 Diabetes Mellitus in Mexico: III-51 B. Market Analytics... III-52 Table 62: Latin American Recent Past, Current and Future 2010 (includes corresponding Graph/Chart)... III-52 Table 63: Latin American 11-Year Perspective for HbA1c of for 2000, 2005, III Rest of the World... III-53 A. Market Overview... III-53 Current and Future Analysis... III-53 Key Diabetes Statistics in Africa... III-53 Diabetes Prevalence Rates in Africa... III-53 Table 64: Prevalence Estimates of Diabetes Mellitus in Africa: III-54 Table 65: Prevalence Estimates of Type 1 Diabetes Mellitus in Africa: III-55 B. Market Analytics... III-56 Table 66: Rest of World Recent Past, Current and Future 2010 (includes corresponding Graph/Chart)... III-56 Table 67: Rest of World 11-Year Perspective for HbA1c for 2000, 2005, III-56 IV. COMPETITION 1. A. Menarini Diagnostics (Italy)... IV-1 2. Abbott Laboratories (USA)... IV-3 Table 68: First Quarter Sales Analysis: (In US$ Billion)... IV-5 Table 69: Annual Sales Analysis: (In US$ Billion)... IV-5 Table 70: Annual Sales Analysis By Quarter: (In US$ Billion)... IV-5 Table 71: Annual Sales Analysis By Segment: (In US$ Billion)... IV-6 Table 72: Annual Sales Analysis By Geographic Region: (In US$ Billion)... IV-6 Abbott Diagnostics (USA)... IV-12 Abbott GmbH & Co., KG (Germany)... IV Accutech LLC (USA)... IV Arkray, Inc. (Japan)... IV Axis-Shield Plc (UK)... IV-25 Table 73: Annual Sales Analysis: (In Million)... IV-25 Table 74: Annual Sales Analysis By Segment: (In Million)... IV-26 Axis-Shield PoC As (Norway)... IV Bayer Healthcare - Diagnostics GmbH (Germany)... IV-28 Bayer Healthcare Diagnostics Division (USA)... IV Beckman Coulter, Inc. (USA)... IV-32 Table 75: First Quarter Sales Analysis: (In US$ Million)... IV-36 Table 76: Annual Sales Analysis: (In US$ Million)... IV-36 Table 77: Annual Sales Analysis By Segment: (In US$ Million)... IV-36 Page 6

7 Table 78: Annual Sales Analysis By Geographic Region: (In US$ Million)... IV Becton Dickinson and Company (USA)... IV-39 Table 79: Half Yearly Sales Analysis: (H1) (In US$ Million)... IV-41 Table 80: Half Yearly Sales Analysis By Quarter: (H1) (In US$ Million)... IV-41 Table 81: Half Yearly Sales Analysis By Segment: (H1) (In US$ Million)... IV-41 Table 82: Annual Sales Analysis: (In US$ Million)... IV-41 BD Medical Systems Div. (USA)... IV Bio-Rad Laboratories, Inc. (USA)... IV-44 Table 83: First Quarter Sales Analysis: (In US$ Million)... IV-45 Table 84: First Quarter Sales Analysis By Segment: (In US$ Million)... IV-45 Table 85: Annual Sales Analysis: (In US$ Million)... IV-46 Table 86: Annual Sales Analysis By Quarter: (In US$ Million)... IV-46 Table 87: Annual Sales Analysis By Segment: (In US$ Million)... IV-46 Table 88: Annual Sales Analysis By Geographic Region: (In US$ Million)... IV Biosafe Laboratories, Inc. (USA)... IV Bristol-Myers Squibb Company (USA)... IV-57 Table 89: First Quarter Sales Analysis: (In US$ Million)... IV-58 Table 90: Annual Sales Analysis: (In US$ Million)... IV Cholestech Corporation (USA)... IV-62 Table 91: First Quarter Sales Analysis: (In US$ Million)... IV-62 Table 92: Annual Sales Analysis: (In US$ Million)... IV Dade Behring, Inc. (USA)... IV-64 Table 93: Half Year Sales Analysis: (H1) (In US$ Million)... IV-65 Table 94: Half Year Sales Analysis By Segment: (H1) (In US$ Million)... IV-66 Table 95: Half Year Sales Analysis By Geographical Region: (H1) (In US$ Million)... IV-66 Table 96: Annual Sales Analysis: (In US$ Million)... IV-66 Table 97: Annual Sales Analysis By Quarter: (In US$ Million)... IV-66 Table 98: Annual Sales Analysis By Segment: (In US$ Million)... IV-67 Table 99: Annual Sales Analysis By Geographical Region: (In US$ Million)... IV Diabetes Technologies, Inc. (USA)... IV Diazyme Laboratories (USA)... IV Drew Scientific Group Plc (UK)... IV Flexsite Diagnostics, Inc. (USA)... IV Jokoh Co., Ltd. (Japan)... IV Lifescan, Inc. (USA)... IV OrSense (Israel)... IV Pacific Biometrics, Inc. (USA)... IV-95 Table 100: Nine Months Sales Analysis: (Nine Months Ended, March) (In US$ Million)... IV-95 Table 101: Annual Sales Analysis: (In US$ Million)... IV-96 Table 102: Annual Sales Analysis By Quarter: (In US$ Million)... IV Pointe Scientific, Inc. (USA)... IV PolyMedica- Liberty Medical Supply (USA)... IV Premier, Inc. (USA)... IV Provalis Plc (UK)... IV-101 Table 103: Annual Sales Analysis: (In Million)... IV-102 Table 104: Annual Sales Analysis By Segment: (In Million)... IV-102 Table 105: Annual Sales Analysis By Geographic Region: (In Million)... IV-102 Provalis Diagnostics Ltd. (UK)... IV Roche Diagnostics (Schweiz) AG (Switzerland)... IV-105 Roche Diagnostics Corporation (USA)... IV-107 Roche Diagnostics (Deutschland) GmbH (Germany)... IV Spectrx, Inc. (USA)... IV-109 Table 106: Annual Sales Analysis: (In US$ Thousands)... IV-109 Table 107: Annual Sales Analysis By Geographic Region: (In US$ Thousands)... IV Sysmex Corporation (Japan)... IV Tosoh Bioscience, Inc. (USA)... IV Trinity Biotech Plc (Ireland)... IV-118 Table 108: Annual Sales Analysis: (In US$ Million)... IV-118 Table 109: Annual Sales Analysis By Product: (In US$ Million)... IV-119 Table 110: Annual Sales Analysis By Geographic Region: (In US$ Million)... IV-119 Primus Corporation (USA)... IV-120 Page 7