IMMUNOASSAYS: TECHNOLOGIES AND GLOBAL MARKETS -- FOCUS ON INFECTIOUS DISEASE IMMUNOASSAYS. BIO125A April Carlet Auguste Project Analyst

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1 IMMUNOASSAYS: TECHNOLOGIES AND GLOBAL MARKETS -- FOCUS ON INFECTIOUS DISEASE IMMUNOASSAYS BIO125A April 2013 Carlet Auguste Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 CONTRIBUTIONS TO THE STUDY AND FOR WHOM 2 SCOPE AND FORMAT 3 METHODOLOGY 3 INFORMATION SOURCES 3 RELATED REPORTS 3 BCC ONLINE SERVICES 3 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 SUMMARY TABLE GLOBAL DEMAND FOR IMMUNOASSAYS BY REGION, THROUGH 2017 ($ MILLIONS) SUMMARY FIGURE GLOBAL DEMAND FOR IMMUNOASSAYS BY REGION, ($ MILLIONS) 7 7 CHAPTER 3 OVERVIEW 9 IMMUNOASSAYS 9 ENZYME IMMUNOASSAYS 10 TABLE 1 ADVANTAGES OF ENZYME IMMUNOASSAY 10 TABLE 2 LIMITATIONS OF ENZYME IMMUNOASSAY 11 FLUORESCENT IMMUNOASSAYS 11 TABLE 3 ADVANTAGES OF FLUORESCENT IMMUNOASSAY 11 TABLE 4 LIMITATIONS OF FLUORESCENT IMMUNOASSAY 12 IMMUNOASSAY TECHNOLOGIES 12 DISPOSABLE MATRIX DEVICES 13 Handheld Immunochromatographic Assays (HHAs) 13 BTA Test Strips 13 Sensitive Membrane Antigen Rapid Test (SMART) 13 REAGENT TAG BIOSENSOR APPROACHES 14 NO-TAG REAGENT BIOSENSOR METHODS 14 RADIOISOTOPES 15 TABLE 5 ADVANTAGES OF RADIOISOTOPES 15 TABLE 6 LIMITATIONS OF RADIOISOTOPES 15 CHAPTER 4 GLOBAL TRENDS IMPACTING DEMAND FOR IMMUNOASSAY TESTING 18 MEDICAL AND RESEARCH LABORATORY SUPPLIES INDUSTRY TRENDS 18 DEMOGRAPHIC CHANGE 18 THE MAJOR U.S. COMPETITORS 19 GLOBAL DEMAND TRENDS 19 TABLE 7 GLOBAL MEDICAL PRODUCTS MARKET, ($ BILLIONS) 19 INDUSTRY TRADE OBSTACLES AND OPPORTUNITIES 20 DRUG TESTING TRENDS 20 CHAPTER 5 THE GLOBAL MARKET 22

3 WORLD DEMAND FOR IMMUNOASSAYS 22 EUROPEAN DEMAND FOR IMMUNOASSAYS 22 TABLE 8 WESTERN EUROPEAN DEMAND FOR IMMUNOASSAYS BY COUNTRY TABLE 9 EASTERN EUROPEAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, ASIAN DEMAND FOR IMMUNOASSAYS 26 TABLE 10 ASIAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 11 OCEANIA DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 12 SOUTHEAST ASIAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THE AMERICAS' DEMAND FOR IMMUNOASSAYS 29 TABLE 13 NORTH AMERICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 14 CENTRAL AND SOUTH AMERICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, AFRICAN DEMAND FOR IMMUNOASSAYS 31 TABLE 15 NORTH AFRICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) SUB-SAHARAN AFRICAN DEMAND FOR IMMUNOASSAYS 32 TABLE 16 SUB-SAHARAN AFRICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, MIDDLE EASTERN DEMAND FOR IMMUNOASSAYS 33 TABLE 17 MIDDLE EASTERN DEMAND FOR IMMUNOASSAYS BY COUNTRY, CHAPTER 6 INFECTIOUS DISEASE IMMUNOASSAYS 37 TABLE 18 GLOBAL DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY REGION, EUROPEAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS 38 TABLE 19 WESTERN EUROPEAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 20 EASTERN EUROPEAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, ASIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS 40 TABLE 21 ASIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 22 OCEANIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 23 SOUTHEAST ASIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, THE AMERICAS' DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS 42 TABLE 24 NORTH AMERICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 25 CENTRAL AND SOUTH AMERICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, AFRICA DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS 43 TABLE 26 NORTH AFRICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY,

4 TABLE 27 SUBSARAHAN AFRICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, MIDDLE EASTERN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS 46 TABLE 28 MIDDLE EASTERN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, CHAPTER 7 COMPANY PROFILES 49 TABLE 29 RANKING OF LEADING IMMUNOASSAY TECHNOLOGY MANUFACTURERS 49 ABBOTT DIAGNOSTICS 49 ACON LABORATORIES INC. 50 AMAR IMMUNODIAGNOSTICS 50 BAYER AG 51 BECKMAN COULTER INC. 51 HISTORY OF BECKMAN COULTER MANUAL IMMUNOASSAYS 51 IMMUNOTECH 52 DIAGNOSTIC SYSTEMS LABORATORIES (DSL) 52 BECKMAN COULTER MANUAL IMMUNOASSAYS TODAY 52 BECTON DICKENSON 53 BEIJING WANGER BIOTECHNOLOGY CO. LTD. 53 BHAT BIO-TECH INDIA PRIVATE LTD. 54 BIOO SCIENTIFIC CORP. 54 BIOVENDOR, LLC 54 RESEARCH & DIAGNOSTIC PRODUCTS DIVISION 55 LABORATORY MEDICINE DIVISION 55 CLINICAL PRODUCTS DIVISION 55 PROFESSIONAL CONSULTATION SERVICES 56 BIOMERIEUX SA 56 CANDOR BIOSCIENCE GMBH 56 CAYMAN CHEMICAL CO. 57 DIAMOND DIAGNOSTICS INC. 58 DIASOURCE IMMUNOASSAYS S.A. 58 IBL INTERNATIONAL GMBH 59 IMMUNOCHEMISTRY TECHNOLOGIES LLC 60 HISTORY 60 PRODUCTS, SERVICES, AND RESEARCH 60 IMMUNOSHOP INDIA PVT LTD. 61 INSTITUTE OF ISOTOPES CO. LTD 61 INSTRUMENTATION LABORATORY CO. 62 NOVARTIS VACCINES & DIAGNOSTICS INC. 62 JEI DANIEL BIOTECH CORP. 63 LABOR DIAGNOSTIKA NORD GMBH & CO. KG 63 MICROPOINT BIOSCIENCE INC. 64 ORTHO CLINICAL DIAGNOSTICS 65 PANTEX 65 PROMEGA CORP. 65 QQLAB LLC 66 QUIDEL CORP. 66 RADIOMETER GMBH 68

5 ROCHE DIAGNOSTICS CORP. 69 SIEMENS HEALTHCARE 69 SYSMEX 69 THERMO FISHER LIFE SCIENCES 70 COMPANY OVERVIEW 70 PRODUCTS AND SERVICES 70 TRINITY BIOTECH PLC 71 WEIFANG 3V BIOENGINEERING GROUP CO. LTD. 72 WEIFANG KANGHUA BIOTECH CO. LTD. 73 XIAMEN BOSON BIOTECH CO. LTD. 73 ZHEJIANG ZHUJI BETAI BIOTECHNOLOGY CO. LTD. 74 CHAPTER 8 PATENT ANALYSIS 76 INTRODUCTION 76 GLOBAL PATENT TRENDS 76 TABLE 30 GLOBAL PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 31 GLOBAL PATENT SHARES BY ASSIGNEE 77 U.S. PATENT TRENDS 81 TABLE 32 U.S. PATENT GENERATION TRENDS BY YEARS, (NO. OF TABLE 33 U.S. PATENT SHARES BY TECHNOLOGY, U.S. PATENT SHARES BY ASSIGNEE 82 TABLE 34 U.S. PATENT SHARES BY ASSIGNEE SAMPLE ABSTRACTS OF U.S. PATENT ABSTRACTS 83 AUTOANTIBODY-ENHANCED IMMUNOASSAYS AND KITS 83 FLUORESCENCE POLARIZATION ASSAYS FOR DETERMINING CLOSTRIDIAL TOXIN ACTIVITY CHEMILUMINESCENT COMPOSITIONS FOR USE IN DETECTION OF MULTIPLE ANALYTES U.S. REGISTERED PATENTS 84 TABLE 35 SAMPLE OF U.S. IMMUNOASSAY PATENTS, EUROPEAN PATENT TRENDS 85 TABLE 36 EUROPEAN PATENT GENERATION TRENDS BY YEARS, (NO. OF TABLE 37 EUROPEAN PATENT SHARES BY TECHNOLOGY, EUROPEAN PATENT SHARES BY PATENT HOLDER 86 TABLE 38 EUROPEAN PATENT SHARES BY APPLICATION, SAMPLE ABSTRACTS OF EUROPEAN PATENT ABSTRACTS 88 IMMUNOASSAY PRODUCT AND PROCESS 88 ENZYME IMMUNOASSAY MEMBRANE STRIP WITH CRITICAL VALUE LINE AND INTERPRETATION METHOD THEREOF FLUORESCENCE IMMUNOASSAY METHOD OF USING ZINC OXIDE QUANTUM DOTS TO MARK ANTIBODY EUROPEAN REGISTERED PATENTS 89 TABLE 39 SAMPLE OF EUROPEAN IMMUNOASSAY PATENTS, JAPANESE PATENT TRENDS 90 TABLE 40 JAPANESE PATENT GENERATION TRENDS BY YEAR, (NO. OF

6 TABLE 41 JAPANESE PATENT SHARES BY TECHNOLOGY, (NO. OF JAPANESE PATENT SHARES BY ASSIGNEE 91 TABLE 42 JAPANESE PATENT SHARES BY ASSIGNEE, (NO. OF SAMPLE ABSTRACTS OF JAPANESE PATENT ABSTRACTS 92 ENZYME IMMUNOASSAY USING ENZYME LABELED ANTIBODY 92 FLUORESCENCE IMMUNOASSAY 93 FLUORESCENT POLYMER MICROPARTICLE, ITS PRODUCTION, AND REAGENT AND METHOD FOR FLUORO IMMUNOASSAY UTILIZING THE SAME JAPANESE PATENT REGISTERED PATENTS 94 TABLE 43 SAMPLE OF JAPANESE IMMUNOASSAY PATENTS, CHINESE PATENT TRENDS 94 TABLE 44 CHINESE PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 45 CHINESE PATENT SHARES BY TECHNOLOGY, (NO. OF CHINESE PATENT SHARES BY HOLDER 96 TABLE 46 CHINESE PATENT SHARES BY PATENT HOLDER, (NO. OF SAMPLE ABSTRACTS OF CHINESE PATENT ABSTRACTS 97 IMMUNOASSAY AND DIAGNOSTIC REAGENT FOR MALARIA 97 ENZYME IMMUNOASSAY KIT FOR COXSACKIE VIRUS B ANTIGEN AND ITS PREPARING PROCESS VISUAL FLUORESCENCE IMMUNOASSAY METHOD FOR DETERMINING BIOLOGICAL ACTIVE SUBSTANCE CHINESE PATENTS 98 TABLE 47 SAMPLE OF CHINESE IMMUNOASSAY PATENTS, TAIWANESE PATENT TRENDS 99 TABLE 48 TAIWANESE PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 49 TAIWANESE PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 50 TAIWANESE PATENT SHARES BY ASSIGNEE, (NO. OF SAMPLE ABSTRACTS OF TAIWAN PATENTS 101 IMMUNOASSAY METHOD FOR DETERMINING GLYCOSYLATED PROTEIN AND TEST LIQUID THEREOF CARRIER-ENZYME-PROTEIN COMPLEX AND IMMUNOASSAY KIT COMPRISING THE SAME TAIWANESE REGISTERED PATENTS 102 TABLE 51 SAMPLE OF TAIWANESE IMMUNOASSAY PATENTS, SOUTH KOREA PATENT TRENDS 102 TABLE 52 SOUTH KOREAN PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 53 SOUTH KOREAN PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 54 SOUTH KOREAN PATENT SHARES BY ASSIGNEE, (NO. OF SAMPLE ABSTRACTS OF SOUTH KOREAN PATENTS

7 IMMUNOASSAY METHOD USING MEASUREMENT VALUE LOWERING INHIBITOR FOR IMMUNOASSAY METHOD METHOD OF IMMUNOASSAY FOR THE DETECTION OF TEICOPLANIN 105 IMMUNOASSAY DEVICE FOR ASSAYING WHOLE BLOOD AND IMMUNOASSAY METHOD USING THE SAME SOUTH KOREAN REGISTERED PATENTS 106 TABLE 55 SAMPLE OF SOUTH KOREAN IMMUNOASSAY PATENTS,

8 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL DEMAND FOR IMMUNOASSAYS BY REGION, THROUGH 2017 ($ MILLIONS) TABLE 1 ADVANTAGES OF ENZYME IMMUNOASSAY 10 TABLE 2 LIMITATIONS OF ENZYME IMMUNOASSAY 11 TABLE 3 ADVANTAGES OF FLUORESCENT IMMUNOASSAY 11 TABLE 4 LIMITATIONS OF FLUORESCENT IMMUNOASSAY 12 TABLE 5 ADVANTAGES OF RADIOISOTOPES 15 TABLE 6 LIMITATIONS OF RADIOISOTOPES 15 TABLE 7 GLOBAL MEDICAL PRODUCTS MARKET, ($ BILLIONS) 19 TABLE 8 WESTERN EUROPEAN DEMAND FOR IMMUNOASSAYS BY COUNTRY TABLE 9 EASTERN EUROPEAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 10 ASIAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 11 OCEANIA DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 12 SOUTHEAST ASIAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 13 NORTH AMERICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 14 CENTRAL AND SOUTH AMERICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 15 NORTH AFRICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 16 SUB-SAHARAN AFRICAN DEMAND FOR IMMUNOASSAYS BY COUNTRY, TABLE 17 MIDDLE EASTERN DEMAND FOR IMMUNOASSAYS BY COUNTRY, THROUGH 2017 ($ MILLIONS) TABLE 18 GLOBAL DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY REGION, TABLE 19 WESTERN EUROPEAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 20 EASTERN EUROPEAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 21 ASIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 22 OCEANIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 23 SOUTHEAST ASIAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 24 NORTH AMERICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 25 CENTRAL AND SOUTH AMERICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 26 NORTH AFRICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 27 SUBSARAHAN AFRICAN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY, TABLE 28 MIDDLE EASTERN DEMAND FOR INFECTIOUS DISEASE IMMUNOASSAYS BY COUNTRY,

9 TABLE HEADING TABLE 29 RANKING OF LEADING IMMUNOASSAY TECHNOLOGY MANUFACTURERS 49 TABLE 30 GLOBAL PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 31 GLOBAL PATENT SHARES BY ASSIGNEE 77 TABLE 32 U.S. PATENT GENERATION TRENDS BY YEARS, (NO. OF TABLE 33 U.S. PATENT SHARES BY TECHNOLOGY, TABLE 34 U.S. PATENT SHARES BY ASSIGNEE TABLE 35 SAMPLE OF U.S. IMMUNOASSAY PATENTS, TABLE 36 EUROPEAN PATENT GENERATION TRENDS BY YEARS, (NO. OF TABLE 37 EUROPEAN PATENT SHARES BY TECHNOLOGY, TABLE 38 EUROPEAN PATENT SHARES BY APPLICATION, TABLE 39 SAMPLE OF EUROPEAN IMMUNOASSAY PATENTS, TABLE 40 JAPANESE PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 41 JAPANESE PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 42 JAPANESE PATENT SHARES BY ASSIGNEE, (NO. OF 91 TABLE 43 SAMPLE OF JAPANESE IMMUNOASSAY PATENTS, TABLE 44 CHINESE PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 45 CHINESE PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 46 CHINESE PATENT SHARES BY PATENT HOLDER, (NO. OF TABLE 47 SAMPLE OF CHINESE IMMUNOASSAY PATENTS, TABLE 48 TAIWANESE PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 49 TAIWANESE PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 50 TAIWANESE PATENT SHARES BY ASSIGNEE, (NO. OF TABLE 51 SAMPLE OF TAIWANESE IMMUNOASSAY PATENTS, TABLE 52 SOUTH KOREAN PATENT GENERATION TRENDS BY YEAR, (NO. OF TABLE 53 SOUTH KOREAN PATENT SHARES BY TECHNOLOGY, (NO. OF TABLE 54 SOUTH KOREAN PATENT SHARES BY ASSIGNEE, (NO. OF TABLE 55 SAMPLE OF SOUTH KOREAN IMMUNOASSAY PATENTS,

10 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL DEMAND FOR IMMUNOASSAYS BY REGION, ($ MILLIONS) 7