Cholesterol Testing/Monitoring Drug and Alcohol Screening Glucose Testing and Monitoring Infectious Disease Testing...

Transcription

1 CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 SCOPE OF REPORT... 1 DEFINING POC... 2 METHODOLOGY... 2 ANALYST CREDENTIALS... 3 RELATED REPORTS... 3 BCC ON-LINE SERVICES... 4 DISCLAIMER... 4 CHAPTER TWO SUMMARY... 5 OVERVIEW... 5 MAJOR FINDINGS... 5 MAJOR FINDINGS (CONTINUED)... 6 SUMMARY TABLE FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, THROUGH 2016 ($ MILLIONS)... 7 SUMMARY FIGURE FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, ($ MILLIONS)... 7 CHAPTER THREE: INDUSTRY OVERVIEW... 8 WHAT IS POC TESTING?... 8 OVERVIEW OF POC MARKET... 8 POC AS PART OF CLINICAL DIAGNOSTICS INDUSTRY STRUCTURE... 9 MEDICAL BENEFITS DERIVED FROM IMMEDIATE DIAGNOSTIC TESTING... 9 POC TESTING SITES TABLE 1 SELECTED KEY STATISTICS FOR POC TESTING SITES HOME USE/SELF-CARE EMERGENCY ROOMS (ER) CRITICAL-CARE UNITS (CCU) BEDSIDE TESTING TABLE 2 NUMBER OF HOSPITALS FOR SELECTED COUNTRIES, OPERATING ROOMS (OR)/PROCEDURE ROOMS (PR) PHYSICIANS OFFICES/CLINICS/TREATMENT CENTERS/OTHER NONCRITICAL-CARE SITES TABLE 3 NUMBER OF U.S. HEALTHCARE FACILITIES BY TYPE, 2009* POC PRODUCT SEGMENTS POC CLINICAL ASSAY CATEGORIES Blood Chemistry and Electrolytes Cardiac Marker... 14

2 Cholesterol Testing/Monitoring Drug and Alcohol Screening Glucose Testing and Monitoring Infectious Disease Testing Pregnancy and Fertility Testing Hemoglobin and Hemostasis Tumor Marker Urinalysis/Urine Chemistry COMMONLY PERFORMED POC TESTS TABLE 4 SELECTED POC TESTS CLIA WAIVED SIGNIFICANCE OF CLIA IN THE UNITED STATES OTHER REGULATORY AGENCIES FDA Good Manufacturing Practice (GMP) TABLE 5 PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING IN VITRO DIAGNOSTICS INITIATIVE FOR HIV/AIDS TESTING DRIVING FORCES OF THE POC MARKET COST CONTAINMENT Rising Healthcare Costs TABLE 6 HEALTH EXPENDITURES AS PERCENTAGE OF GDP BY COUNTRY: FIGURE 1 HEALTH EXPENDITURES AS PERCENT OF GDP BY COUNTRY, Average Length of Stay TABLE 7 HOSPITAL USAGE STATISTICS, AVERAGE, (DAYS) FIGURE 2 HOSPITAL USAGE STATISTICS (DAYS) PUBLIC HEALTHCARE SYSTEMS AROUND THE WORLD TABLE 8 WORLD HEALTH ORGANIZATION RANKING OF HEALTHCARE SYSTEMS, TOP 50, TABLE 8 (CONTINUED) GLOBAL SHORTAGE OF HEALTHCARE WORKERS TECHNOLOGICAL ADVANCEMENT Availability Ease of Use Devices New Technologies CHANGES IN INCIDENCE OF DISEASE TABLE 9 STATISTICS OF SELECTED DISEASES IN THE GLOBAL POPULATION, ESTIMATES Asthma Cardiovascular Disease Cancer Diabetes Diarrheal Disease... 31

3 HIV Infertility Influenza Malaria Pregnancy TABLE 10 BIRTH RATES AND BIRTHS BY COUNTRY, 2010 ESTIMATES (THOUSANDS) FIGURE 3 BIRTH RATES AND BIRTHS BY COUNTRY, 2010 ESTIMATES (THOUSANDS) Pulmonary Disease Tuberculosis NEW ATTENTION TO DRUGS OF ABUSE AGING POPULATION TABLE 11 GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, THROUGH 2030 (MILLIONS) FIGURE 4 GLOBAL POPULATION BY SELECTED AGE GROUP AND SELECTED YEARS, (MILLIONS) TABLE 12 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 (MILLIONS) FIGURE 5 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND PROJECTED 2015 (MILLIONS) CHAPTER FOUR: THE POC MARKET MARKET OVERVIEW TABLE 13 GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 6 GLOBAL FORECAST FOR THE POC MARKET, ($ MILLIONS) FIGURE 7 DISTRIBUTION OF SALES FOR THE GLOBAL POC MARKET BY TEST TYPE, 2011 (%) FIGURE 7 (CONTINUED) COMPETITOR MARKET SHARE TABLE 14 MARKET SHARE OF MAJOR POC MARKET PARTICIPANTS, 2011 (%/$ MILLIONS) FIGURE 8 MARKET SHARE MAJOR POC MARKET PARTICIPANTS, 2011 (%) MARKET STRUCTURE DISTRIBUTION FIGURE 9 DISTRIBUTION CHANNELS: POC DIAGNOSTIC DEVICES PROMOTION STRATEGIC ALLIANCES AND MERGERS MARKET COMPONENTS BLOOD CHEMISTRY AND ELECTROLYTE TESTING Blood Chemistry Parameters... 44

4 Electrolytes CLIA Quality Control (QC) Requirements for Blood Gas Analysis Market Size TABLE 15 FORECAST OF THE GLOBAL POC BLOOD GAS/ELECTROLYTE TESTING MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 10 FORECAST OF THE GLOBAL POC BLOOD GAS/ELECTROLYTE TESTING MARKET, ($ MILLIONS) Market Participants and Market Shares TABLE 16 RELATIVE MARKET SHARE OF POC BLOOD CHEMISTRY ANALYZER MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 11 RELATIVE MARKET SHARE BLOOD GAS ANALYZER MANUFACTURERS, 2011 (%) Abbott Diagnostics i-stat Abaxis Piccolo Classic and Piccolo Xpress Alere Epoc Blood Analysis System International Technidyne Corp. (ITC) IRMA TRUpoint Blood Analysis System AVOXimeter Whole Blood CO- Oximeter/Oximeter System Nova Biomedical Stat Profile phox Product Line TABLE 17 NOVA BIOCHEMICAL POC STAT PROFILE PHOX SERIES BY AVAILABLE TESTS Stat Profile CCX Product Line TABLE 18 NOVA BIOCHEMICAL POC STAT PROFILE CCX SERIES BY AVAILABLE TESTS Radiometer America, Inc ABL80 and ABL90 FLEX Roche Diagnostics Cobas b 121 System Cobas b 221 Blood Gas System Siemens Healthcare Rapidpoint 400/ RAPIDComm Data Management System CARDIAC MARKER TESTING Market Size TABLE 19 FORECAST OF THE GLOBAL POC CARDIAC MARKER TESTING MARKET, THROUGH 2016 ($ MILLIONS)... 55

5 FIGURE 12 FORECAST OF THE GLOBAL POC CARDIAC MARKER TESTING MARKET, ($ MILLIONS) Market Participants and Market Shares TABLE 20 RELATIVE MARKET SHARE OF POC CARDIAC MARKER MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 13 RELATIVE MARKET SHARE OF POC CARDIAC MARKER MANUFACTURERS, 2011 (%) Alere Triage System Heart Check System Roche Cardiac Reader System Abbott istat Response Biomedical RAMP System CHOLESTEROL TESTING Market Size TABLE 21 FORECAST OF THE GLOBAL CHOLESTEROL POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 14 FORECAST OF THE GLOBAL CHOLESTEROL POC RAPID TEST MARKET, ($ MILLIONS) Market Participants and Market Shares TABLE 22 RELATIVE MARKET SHARE OF CHOLESTEROL POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 15 RELATIVE MARKET SHARE OF CHOLESTEROL POC RAPID TEST MANUFACTURERS, 2011 (%) TABLE 23 RECENT ( ) CLIA-WAIVED APPROVED CHOLESTEROL TESTS Alere Roche Diagnostics Abaxis DRUG AND ALCOHOL ABUSE TESTING Market Size TABLE 24 FORECAST OF THE GLOBAL DRUG AND ALCOHOL POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 16 FORECAST OF THE GLOBAL DRUG AND ALCOHOL POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) Market Participants and Market Shares TABLE 25 RELATIVE MARKET SHARE OF DRUG AND ALCOHOL POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 17 RELATIVE MARKET SHARE OF DRUG AND ALCOHOL POC RAPID TEST MANUFACTURERS, 2011 (%)... 67

6 TABLE 26 RECENT ( ) CLIA-WAIVED APPROVED POC DRUG AND ALCOHOL SCREENING TESTS TABLE 26 (CONTINUED) TABLE 26 (CONTINUED) TABLE 26 (CONTINUED) TABLE 26 (CONTINUED) TABLE 26 (CONTINUED) Alere Phamatech Orasure Technologies GLUCOSE TESTING Market Size TABLE 27 FORECAST OF THE GLOBAL POC GLUCOSE METER MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 18 FORECAST OF THE GLOBAL POC GLUCOSE METER MARKET, ($ MILLIONS) TABLE 28 MARKET SHARE FOR THE GLOBAL POC GLUCOSE METER MARKET BY COMPONENT, 2011 (%/$ MILLIONS) FIGURE 19 MARKET SHARE FOR THE GLOBAL POC GLUCOSE METER MARKET BY COMPONENT, 2011 (%) Market Participants and Market Shares TABLE 29 RELATIVE MARKET SHARE FOR GLUCOSE METERS AND SUPPLIES MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 20 RELATIVE MARKET SHARE FOR GLUCOSE METERS AND SUPPLIES MANUFACTURERS, 2011 (%) TABLE 30 RECENT ( ) CLIA-WAIVED APPROVED BLOOD GLUCOSE METERS TABLE 30 (CONTINUED) TABLE 30 (CONTINUED) TABLE 30 (CONTINUED) Roche Diagnostics Accu-Chek Aviva Meter System Accu-Chek Compact Plus Meter System Accu-Chek Active System Accu-Chek Inform System Accu-Chek Inform II Accu-Chek Voicemate System Johnson and Johnson LifeScan OneTouch Ultra 2 Meter LifeScan OneTouch UltraSmart Meter LifeScan OneTouch UltraMini LifeScan OneTouch Ultra Meter LifeScan OneTouch InDuo System LifeScan OneTouch Basic Meter... 87

7 LifeScan OneTouch SureStep Meter LifeScan OneTouch UltraLink Meter LifeScan OneTouch Diabetes Management Software Abbott Diabetes Care FreeStyle Blood Glucose Monitoring System Precision Xtra Blood Glucose and Ketone Monitoring System i-stat Nipro Diagnostics Sidekick Testing System TrueTrack Smart System TABLE 31 SELECTED LISTING OF RETAILERS SELLING HOME DIAGNOSTIC S METERS Data Management Systems TABLE 32 SELECT LISTING OF BLOOD GLUCOSE MONITORS CAPABLE OF INTERACTING WITH COMPUTER SOFTWARE INFECTIOUS DISEASE TESTING Strep A TABLE 33 RECENT ( ) CLIA-WAIVED APPROVED STREP A TESTS Alere, Inc Beckman Coulter BTNX, Inc Quidel Influenza TABLE 34 RECENT ( ) CLIA-WAIVED APPROVED INFLUENZA TESTS Alere, Inc OraSure Technologies Quidel SA Scientific Chlamydia/Trichomoniasis Quidel Sekisui Diagnostics RSV TABLE 35 RECENT ( ) CLIA-WAIVED APPROVED RSV TESTS BTNX, Inc Quidel HIV Testing TABLE 36 RECENT ( ) CLIA-WAIVED APPROVED HIV TESTS Alere, Inc

8 OraSure Technologies Trinity Biotech plc Infectious Mononucleosis TABLE 37 RECENT ( ) CLIA-WAIVED APPROVED INFECTIOUS MONONUCLEOSIS TESTS Beckman Coulter H. pylori TABLE 38 RECENT ( ) CLIA-WAIVED APPROVED H. PYLORI TESTS Quidel Market Size TABLE 39 FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 21 FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) TABLE 40 MARKET SHARE FOR THE GLOBAL POC INFECTIOUS DISEASE MARKET BY TEST TYPE, 2011 (%/$ MILLIONS) FIGURE 22 MARKET SHARE FOR THE GLOBAL POC INFECTIOUS DISEASE MARKET BY TEST TYPE, 2011 (%) Market Participants and Market Shares TABLE 41 RELATIVE MARKET SHARE OF INFECTIOUS DISEASE POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 23 RELATIVE MARKET SHARE OF INFECTIOUS DISEASE POC RAPID TEST MANUFACTURERS, 2011 (%) Strep A Influenza Chlamydia PREGNANCY AND FERTILITY TESTING Market Size TABLE 42 FORECAST OF THE GLOBAL PREGNANCY/FERTILITY POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 24 FORECAST OF THE GLOBAL INFECTIOUS DISEASE POC RAPID TEST MARKET, ($ MILLIONS) TABLE 43 MARKET SHARE FOR THE GLOBAL POC PREGNANCY/FERTILITY MARKET BY TEST TYPE, 2011 (%/$ MILLIONS) FIGURE 25 MARKET SHARE FOR THE GLOBAL POC PREGNANCY/FERTILITY MARKET BY TEST TYPE, 2011 (%) Market Participants and Market Shares TABLE 44 RELATIVE MARKET SHARE OF PREGNANCY/FERTILITY POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 26 RELATIVE MARKET SHARE OF PREGNANCY/FERTILITY POC RAPID TEST MANUFACTURERS, 2011 (%)

9 TABLE 45 RECENT ( ) CLIA-WAIVED APPROVED PREGNANCY TESTS TABLE 45 (CONTINUED) HEMOGLOBIN/HEMOSTASIS Hematology and Hemostasis Hemostasis (Coagulation) Market Size TABLE 46 FORECAST OF THE GLOBAL HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 27 FORECAST OF THE GLOBAL HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) Market Participants and Market Shares TABLE 47 RELATIVE MARKET SHARE OF HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 28 RELATIVE MARKET SHARE OF HEMOGLOBIN/HEMOSTASIS POC RAPID TEST MANUFACTURERS, 2011 (%) TABLE 48 RECENT ( ) CLIA-WAIVED APPROVED HEMATOLOGY TESTS TUMOR MARKER TESTING Fecal and Gastric Occult Blood Bladder Tumor Antigen Test Market Size TABLE 49 FORECAST OF THE GLOBAL TUMOR MARKER POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 29 FORECAST OF THE GLOBAL TUMOR MARKER POC RAPID TEST MARKET, THROUGH 2016 ($ MILLIONS) Market Participants and Market Shares TABLE 50 RELATIVE MARKET SHARE OF TUMOR MARKER POC RAPID TEST MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 30 RELATIVE MARKET SHARE OF TUMOR MARKER POC RAPID TEST MANUFACTURERS, 2011 (%) TABLE 51 RECENT ( ) CLIA-WAIVED APPROVED FECAL OCCULT BLOOD TESTS TABLE 52 RECENT ( ) CLIA-WAIVED APPROVED BLADDER TESTS URINE CHEMISTRY TESTING Market Size TABLE 53 FORECAST OF THE GLOBAL POC URINE CHEMISTRY ANALYZER MARKET, THROUGH 2016 ($ MILLIONS)

10 FIGURE 31 FORECAST OF THE GLOBAL POC URINE CHEMISTRY ANALYZER MARKET, ($ MILLIONS) Market Participants and Market Shares TABLE 54 RELATIVE MARKET SHARE OF POC URINE CHEMISTRY ANALYZER MANUFACTURERS, 2011 (%/$ MILLIONS) FIGURE 32 RELATIVE MARKET SHARE OF POC URINE CHEMISTRY ANALYZER MANUFACTURERS, 2011 (%) TABLE 55 RECENT ( ) CLIA-WAIVED APPROVED URINE CHEMISTRY ANALYZERS TABLE 55 (CONTINUED) TABLE 55 (CONTINUED) MISC. TESTING Vaginal ph Tests TABLE 56 RECENT ( ) CLIA-WAIVED APPROVED VAGINAL PH TESTS Thyroid Stimulating Hormone (TSH) Tests TABLE 57 RECENT ( ) CLIA-WAIVED APPROVED TSH TESTS Male Reproductive Tests TABLE 58 RECENT ( ) CLIA-WAIVED APPROVED MALE REPRODUCTIVE TESTS CHAPTER FIVE: TECHNOLOGY APPLICATIONS BIOSENSORS WHAT ARE BIOSENSORS? Catalytic Sensors Affinity Sensors ELECTRODES WHAT ARE ELECTRODES? CONTINUOUS TESTING ORSENSE, LTD. (OCCLUSION SPECTROSCOPY) RAPID HIV TESTS CHEMBIO DIAGNOSTIC SYSTEMS, INC DRUG TESTING PSYCHEMEDICS CORPORATION PATENT ANALYSIS NUMBER OF RECENTLY ISSUED PATENTS TABLE 59 RESULTS OF U.S. PATENT SEARCH FOR POC CATEGORIES, JANUARY 2009 TO NOVEMBER 2011 (NUMBER) FIGURE 33 U.S. PATENTS BY POC CATEGORIES, JANUARY 2009 TO NOVEMBER 2011 (NUMBER) ANALYSIS OF PATENT BY SUBJECT TABLE 60 U.S. PATENTS BY SUBJECT AREA, JANUARY 2009 TO NOVEMBER 2011 (NUMBER)

11 FIGURE 34 U.S. PATENTS BY SUBJECT AREA, JANUARY 2009 TO NOVEMBER 2011 (NUMBER) PATENT ASSIGNEES TABLE 61 PATENT ASSIGNEES BY COUNTRY, JANUARY 2009 TO NOVEMBER TABLE 61 (CONTINUED) Abbott Point of Care, Inc Chembio Diagnostic Systems, Inc Fujifilm Corporation LifeScan, Inc Panasonic Corporation Purdue Research Foundation Quidel Corporation Roche Diagnostics Operations, Inc Saladax Biomedical Tanita Corporation CHAPTER SIX: WORLDWIDE POC MARKET MARKET SIZE TABLE 62 GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016 ($ MILLIONS) TABLE 62 (CONTINUED) FIGURE 35 GLOBAL FORECAST FOR THE POC MARKET, THROUGH 2016 ($ MILLIONS) FIGURE 35 (CONTINUED) GLOBAL MARKET SHARES TABLE 63 POC GLOBAL MARKET SHARE BY REGION, 2011 ($ MILLIONS) FIGURE 36 POC GLOBAL MARKET SHARE BY REGION, 2011 (%) FIGURE 37 NORTH AMERICAN POC MARKET SHARE BY COUNTRY, 2011 (%) FIGURE 37 (CONTINUED) FIGURE 38 EUROPEAN POC MARKET SHARE BY COUNTRY, 2011 (%) FIGURE 39 ASIAN POC MARKET SHARE BY COUNTRY, 2011 (%) PRESENCE OF MANUFACTURERS IN THE WORLDWIDE MARKET PRESENCE OF MANUFACTURERS (CONTINUED) TABLE 64 MARKET SHARE OF MAJOR POC MARKET PARTICIPANTS, 2011 (%/$ MILLIONS) FIGURE 40 MARKET SHARE MAJOR POC MARKET PARTICIPANTS, 2011 (%) CHAPTER SEVEN: PROFILES OF MAJOR MARKET PARTICIPANTS OVERVIEW OF MARKET PARTICIPANTS

12 COMPANY PROFILES ABAXIS, INC TABLE 65 ABAXIS COMPANY REVENUES, * ($ MILLIONS) FIGURE 41 ABAXIS COMPANY REVENUES, * ($ MILLIONS) ABBOTT LABORATORIES Abbott Laboratories (Continued) TABLE 66 ABBOTT S COMPANY REVENUES, ($ MILLIONS) FIGURE 42 ABBOTTS COMPANY REVENUES, ($ MILLIONS) ALERE, INC Alere, Inc. (Continued) TABLE 67 ALERE S COMPANY REVENUES, ($ MILLIONS) FIGURE 43 ALERE S COMPANY REVENUES ($ MILLIONS) BECKMAN COULTER, INC TABLE 68 BECKMAN COULTER S COMPANY REVENUES, ($ MILLIONS) FIGURE 44 BECKMAN COULTER S COMPANY REVENUES, ($ MILLIONS) BECTON, DICKINSON, & CO TABLE 69 BECTON DICKINSON S COMPANY REVENUES, * ($ MILLIONS) FIGURE 45 BECTON DICKINSON S COMPANY REVENUES, * ($ MILLIONS) CHURCH & DWIGHT CO., INC TABLE 70 CHURCH & DWIGHT S COMPANY REVENUES, ($ MILLIONS) FIGURE 46 CHURCH & DWIGHT S COMPANY REVENUES, ($ MILLIONS) DANAHER CORP./RADIOMETER TABLE 71 DANAHER S COMPANY REVENUES, ($ MILLIONS) FIGURE 47 DANAHER S COMPANY REVENUES, ($ MILLIONS) HEMOCUE AB TABLE 72 QUEST S COMPANY REVENUES, ($ MILLIONS) FIGURE 48 QUEST S COMPANY REVENUES, ($ MILLIONS) INTERNATIONAL TECHNIDYNE CORP TABLE 73 ITC S COMPANY SALES, ($ MILLIONS) FIGURE 49 ITC S COMPANY SALES, ($ MILLIONS) JOHNSON & JOHNSON

13 TABLE 74 JOHNSON & JOHNSON S COMPANY REVENUES, ($ MILLIONS) FIGURE 50 JOHNSON & JOHNSON S COMPANY REVENUES, ($ MILLIONS) NIPRO DIAGNOSTICS, INC TABLE 75 NIPRO CORPORATION S COMPANY REVENUES, * ($ MILLIONS) FIGURE 51 NIPRO CORPORATION S COMPANY REVENUES, * ($ MILLIONS) NOVA BIOMEDICAL ORASURE TECHNOLOGIES TABLE 76 ORASURE S COMPANY REVENUES, ($ MILLIONS) FIGURE 52 ORASURE S COMPANY REVENUES, ($ MILLIONS) PHAMATECH, INC QUIDEL CORP TABLE 77 QUIDEL S COMPANY REVENUES, ($ MILLIONS) FIGURE 53 QUIDEL S COMPANY REVENUES, ($ MILLIONS) ROCHE TABLE 78 ROCHE GROUP S REVENUES, ($ MILLIONS) FIGURE 54 ROCHE GROUP S REVENUES, ($ MILLIONS) SA SCIENTIFIC, LTD SEKISUI DIAGNOSTICS TABLE 79 SEKISUI CHEMICAL CO S REVENUES, ($ MILLIONS) FIGURE 55 SEKISUI CHEMICAL CO S REVENUES, ($ MILLIONS) SIEMENS MEDICAL SOLUTIONS TABLE 80 SIEMENS COMPANY REVENUES, ($ MILLIONS) FIGURE 56 SIEMENS COMPANY REVENUES, ($ MILLIONS) SPECTRAL DIAGNOSTICS TABLE 81 SPECTRAL S COMPANY REVENUES, ($ MILLIONS) FIGURE 57 SPECTRAL S COMPANY REVENUES, ($ MILLIONS) TRINITY BIOTECH PLC TABLE 82 TRINITY S COMPANY REVENUES, ($ MILLIONS) FIGURE 58 TRINITY S COMPANY REVENUES, ($ MILLIONS)

14 APPENDIX KEY SOURCES OF INFORMATION KEY SOURCES OF INFORMATION (CONTINUED) KEY SOURCES OF INFORMATION (CONTINUED) KEY SOURCES OF INFORMATION (CONTINUED) KEY SOURCES OF INFORMATION (CONTINUED)