|
Sections |
| Title | Starting Page | Number of Pages |
|---|
| 1 Table of Contents | 2 | 15 |
| 1.1 List of Tables | 11 | 4 |
| 1.2 List of Figures | 15 | 2 |
| 2 Introduction | 17 | 1 |
| 2.1 What Is This Report About? | 17 | 1 |
| 3 Definitions of Markets Covered in This Report | 18 | 8 |
| 3.1 In Vitro Diagnostics | 18 | 1 |
| 3.2 Clinical Chemistry | 18 | 1 |
| 3.2.1 Clinical Chemistry Rapid Tests & POC | 18 | 1 |
| 3.2.2 Clinical Chemisty Analyzers | 18 | 1 |
| 3.2.2.1 Automated Clinical Chemistry Analyzers | 18 | 1 |
| 3.2.2.2 Semi-Automated Clinical Chemistry Analyzers | 18 | 1 |
| 3.2.3 Electrolyte Chemistry Reagents | 18 | 1 |
| 3.2.4 Enzyme Chemistry Reagents | 19 | 1 |
| 3.2.5 Metabolite Chemistry Reagents | 19 | 1 |
| 3.2.6 Urine Analysis | 19 | 1 |
| 3.2.6.1 Urine Analyzer Reagents | 19 | 1 |
| 3.2.6.2 Urine Analyzers | 19 | 1 |
| 3.3 Genetic Testing | 19 | 1 |
| 3.3.1 Acquired Gene or Chromosome Alterations | 19 | 1 |
| 3.3.2 Inborn Gene or Chromosome Alterations | 19 | 1 |
| 3.3.3 Other Genetic Tests | 19 | 1 |
| 3.4 Haematology | 19 | 1 |
| 3.4.1 Haematology Analyzers | 19 | 1 |
| 3.4.2 Haematology Cell Counters | 20 | 1 |
| 3.4.2.1 Differential Counters | 20 | 1 |
| 3.4.2.2 Hemoglobinometers | 20 | 1 |
| 3.4.3 Haematology Rapid Tests | 20 | 1 |
| 3.4.3.1 Haemostasis Rapid Tests (Home Monitoring) | 20 | 1 |
| 3.4.3.2 Rapid Haematology Tests (Point-Of-Care/Near Patient) | 20 | 1 |
| 3.4.4 Haematology Reagents | 20 | 1 |
| 3.4.4.1 Haematology Analyzer Reagents | 20 | 1 |
| 3.4.4.2 Slide Stainers | 20 | 1 |
| 3.4.5 Haemostasis | 20 | 1 |
| 3.4.5.1 Coagulation Analyzers | 20 | 1 |
| 3.4.5.2 Coagulation Factors | 20 | 1 |
| 3.4.5.3 General Coagulation Tests | 20 | 1 |
| 3.4.5.4 Platelet Factors | 21 | 1 |
| 3.4.5.5 Special Coagulation Tests | 21 | 1 |
| 3.4.6 Immunohaematology | 21 | 1 |
| 3.4.6.1 ABO Typing | 21 | 1 |
| 3.4.6.2 Antibody Detection | 21 | 1 |
| 3.4.6.3 Rhesus Typing | 21 | 1 |
| 3.5 Histology And Cytology | 21 | 1 |
| 3.5.1 Cytology | 21 | 1 |
| 3.5.1.1 Flow Cytometers | 21 | 1 |
| 3.5.2 Histology | 21 | 1 |
| 3.5.2.1 Monoclonal Antibodies | 21 | 1 |
| 3.5.2.2 Tissue Typing Reagents | 21 | 1 |
| 3.6 Immuno Chemistry | 22 | 1 |
| 3.6.1 Disease Specific Immunochemistry | 22 | 1 |
| 3.6.1.1 Auto-Immune Diseases | 22 | 1 |
| 3.6.1.2 Cardiac Markers | 22 | 1 |
| 3.6.1.3 Rheumatoid - Inflammatory Diseases Markers | 22 | 1 |
| 3.6.1.4 Tumor markers | 22 | 1 |
| 3.6.2 Drug Related Testing | 22 | 1 |
| 3.6.2.1 Drugs of Abuse / Toxicology | 22 | 1 |
| 3.6.2.2 Therapeutic Drug Monitoring | 22 | 1 |
| 3.6.3 Endocrinology Tests | 23 | 1 |
| 3.6.3.1 Fertility or Pregnancy Hormones | 23 | 1 |
| 3.6.3.2 Individual and Specified Hormones | 23 | 1 |
| 3.6.3.3 Thyroid Function Hormones | 23 | 1 |
| 3.6.4 Immunochemistry Analyzers | 23 | 1 |
| 3.6.4.1 Chemiluminescence Analyzers | 23 | 1 |
| 3.6.4.2 ELISA Instruments | 23 | 1 |
| 3.6.4.3 Immunofluorescence Analyzers | 23 | 1 |
| 3.6.4.4 Radioimmunoassay Analyzers | 23 | 1 |
| 3.6.5 Immunochemistry Rapid Tests | 23 | 1 |
| 3.6.6 Organ Function Assays | 23 | 1 |
| 3.6.7 Specific Proteins | 24 | 1 |
| 3.7 Infectious Immunology | 24 | 1 |
| 3.7.1 Bacteriology | 24 | 1 |
| 3.7.2 Hepatitis Viruses | 24 | 1 |
| 3.7.3 Other Virology | 24 | 1 |
| 3.7.4 Retroviruses | 24 | 1 |
| 3.8 Microbiology Culture | 24 | 1 |
| 3.8.1 Bacterial Identification & Susceptibility Testing | 24 | 1 |
| 3.8.2 Blood Culture | 24 | 1 |
| 3.8.3 Immunological Culture Identification | 24 | 1 |
| 3.8.4 Microbiology Analyzers | 24 | 1 |
| 3.8.4.1 Automated Microbiology Analyzers | 24 | 1 |
| 3.8.4.2 Semi-Automated Microbiology Analyzers | 25 | 1 |
| 3.8.5 Mycobacteria Culture | 25 | 1 |
| 3.8.6 Mycology Culture | 25 | 1 |
| 3.8.7 Parasitology Culture | 25 | 1 |
| 4 Healthcare Sector Review | 26 | 10 |
| 4.1 Healthcare Expenditure | 26 | 4 |
| 4.2 Healthcare Infrastructure | 30 | 4 |
| 4.3 Healthcare Policy | 34 | 2 |
| 5 Regulation System | 36 | 19 |
| 5.1 Medical Equipment Approval Process | 36 | 1 |
| 5.1.1 Classification | 36 | 7 |
| 5.1.2 Registration and Conformity Assessment | 43 | 2 |
| 5.2 Advertising | 45 | 1 |
| 5.3 Labeling and Packaging | 46 | 1 |
| 5.4 Post-market Surveillance | 47 | 1 |
| 5.5 Registration Fee | 47 | 8 |
| 6 Pricing and Reimbursement | 55 | 1 |
| 7 Distribution Structure | 56 | 1 |
| 8 In Vitro Diagnostics In Australia | 57 | 7 |
| 8.1 In Vitro Diagnostics, Australia, Overall Revenue ($ mn), 2000-2015 | 57 | 6 |
| 8.2 In Vitro Diagnostics, Australia, Company Share (2007-2008) | 63 | 1 |
| 9 Clinical Chemistry In Australia | 64 | 10 |
| 9.1 Clinical Chemistry Overall Revenue (2000-2015) | 64 | 4 |
| 9.1.1 Clinical Chemistry Analyzers Revenue (2000-2015) | 68 | 2 |
| 9.1.2 Urine Analysis Revenue (2000-2015) | 70 | 2 |
| 9.2 Clinical Chemistry Distribution Share (2007-2008) | 72 | 1 |
| 9.3 Clinical Chemistry, Australia, Company Share (2007-2008) | 73 | 1 |
| 10 Genetic Testing In Australia | 74 | 4 |
| 10.1 Genetic Testing Overall Revenue (2000-2015) | 74 | 2 |
| 10.2 Genetic Testing Distribution Share (2007-2008) | 76 | 1 |
| 10.3 Genetic Testing, Australia, Company Share (2007-2008) | 77 | 1 |
| 11 Haematology In Australia | 78 | 18 |
| 11.1 Haematology Overall Revenue (2000-2015) | 78 | 4 |
| 11.1.1 Haematology Reagents Revenue (2000-2015) | 82 | 2 |
| 11.1.2 Immunohaematology Revenue (2000-2015) | 84 | 2 |
| 11.1.3 Haemostasis revenue (2000-2015) | 86 | 4 |
| 11.1.4 Haematology Rapid Tests Revenue (2000-2015) | 90 | 2 |
| 11.1.5 Haematology Cell Counters Revenue (2000-2015) | 92 | 2 |
| 11.2 Haematology Distribution Share (2007-2008) | 94 | 1 |
| 11.3 Haematology, Australia, Company Share (2007-2008) | 95 | 1 |
| 12 Histology And Cytology In Australia | 96 | 6 |
| 12.1 Histology And Cytology Overall Revenue (2000-2015) | 96 | 2 |
| 12.1.1 Histology Revenue (2000-2015) | 98 | 2 |
| 12.2 Histology And Cytology Distribution Share (2007-2008) | 100 | 1 |
| 12.3 Histology And Cytology, Australia, Company Share (2007-2008) | 101 | 1 |
| 13 Immuno Chemistry In Australia | 102 | 17 |
| 13.1 Immuno Chemistry Overall Revenue (2000-2015) | 102 | 4 |
| 13.1.1 Disease Specific Immunochemistry Revenue (2000-2015) | 106 | 2 |
| 13.1.2 Drug Related Testing Revenue (2000-2015) | 108 | 2 |
| 13.1.3 Endocrinology Tests Revenue (2000-2015) | 110 | 2 |
| 13.1.4 Immunochemistry Analyzers Revenue (2000-2015) | 112 | 4 |
| 13.2 Immuno Chemistry Distribution Share (2007-2008) | 116 | 1 |
| 13.3 Immuno Chemistry, Australia, Company Share (2007-2008) | 117 | 2 |
| 14 Infectious Immunology In Australia | 119 | 7 |
| 14.1 Infectious Immunology Overall Revenue (2000-2015) | 119 | 4 |
| 14.2 Infectious Immunology Distribution Share (2007-2008) | 123 | 1 |
| 14.3 Infectious Immunology, Australia, Company Share (2007-2008) | 124 | 2 |
| 15 Microbiology Culture In Australia | 126 | 8 |
| 15.1 Microbiology Culture Overall Revenue (2000-2015) | 126 | 4 |
| 15.1.1 Microbiology Analyzers Revenue (2000-2015) | 130 | 2 |
| 15.2 Microbiology Culture Distribution Share (2007-2008) | 132 | 1 |
| 15.3 Microbiology Culture, Australia, Company Share (2007-2008) | 133 | 1 |
| 16 Overview of Key Companies in India In Vitro Diagnostics Market | 134 | 29 |
| 16.1 F. Hoffmann-La Roche Ltd. | 134 | 1 |
| 16.1.1 Company Overview | 134 | 1 |
| 16.2 Siemens Healthcare | 134 | 1 |
| 16.2.1 Company Overview | 134 | 1 |
| 16.3 Sysmex Corporation | 135 | 1 |
| 16.3.1 Company Overview | 135 | 1 |
| 16.3.2 Sysmex Corporation Pipeline Products | 135 | 1 |
| 16.3.2.1 Sysmex Corporation Pipeline Products By Equipment Type | 135 | 1 |
| 16.3.2.2 Sysmex Corporation Pipeline Products By Development Stage | 135 | 1 |
| 16.3.2.3 Sysmex Corporation Pipeline Products By Therapy Area | 135 | 1 |
| 16.3.2.4 Sysmex Corporation Pipeline Products By News Summary | 136 | 1 |
| 16.4 Abbott Laboratories | 137 | 1 |
| 16.4.1 Company Overview | 137 | 1 |
| 16.4.2 Abbott Laboratories Pipeline Products | 137 | 1 |
| 16.4.2.1 Abbott Laboratories Pipeline Products By Equipment Type | 137 | 1 |
| 16.4.2.2 Abbott Laboratories Pipeline Products By Development Stage | 137 | 1 |
| 16.4.2.3 Abbott Laboratories Pipeline Products By Therapy Area | 137 | 1 |
| 16.5 Beckman Coulter, Inc. | 138 | 1 |
| 16.5.1 Company Overview | 138 | 1 |
| 16.5.2 Beckman Coulter, Inc. Pipeline Products | 138 | 1 |
| 16.5.2.1 Beckman Coulter, Inc. Pipeline Products By Equipment Type | 138 | 1 |
| 16.5.2.2 Beckman Coulter, Inc. Pipeline Products By Development Stage | 139 | 1 |
| 16.5.2.3 Beckman Coulter, Inc. Pipeline Products By Therapy Area | 140 | 1 |
| 16.5.2.4 Beckman Coulter, Inc. Pipeline Products By News Summary | 140 | 1 |
| 16.6 Ortho-Clinical Diagnostics Inc. | 141 | 1 |
| 16.6.1 Company Overview | 141 | 1 |
| 16.6.2 Ortho-Clinical Diagnostics Inc. Pipeline Products | 141 | 1 |
| 16.6.2.1 Ortho-Clinical Diagnostics Inc. Pipeline Products By Equipment Type | 141 | 1 |
| 16.6.2.2 Ortho-Clinical Diagnostics Inc. Pipeline Products By Development Stage | 142 | 1 |
| 16.6.2.3 Ortho-Clinical Diagnostics Inc. Pipeline Products By Therapy Area | 142 | 1 |
| 16.7 OLYMPUS CORPORATION | 143 | 1 |
| 16.7.1 Company Overview | 143 | 1 |
| 16.8 Qiagen N.V. | 143 | 1 |
| 16.8.1 Company Overview | 143 | 1 |
| 16.9 bioMerieux S.A. | 144 | 1 |
| 16.9.1 Company Overview | 144 | 1 |
| 16.10 Bio-Rad Laboratories, Inc. | 144 | 1 |
| 16.10.1 Company Overview | 144 | 1 |
| 16.11 Phadia AB | 145 | 1 |
| 16.11.1 Company Overview | 145 | 1 |
| 16.11.2 Phadia AB Pipeline Products | 145 | 1 |
| 16.11.2.1 Phadia AB Pipeline Products By Equipment Type | 145 | 1 |
| 16.11.2.2 Phadia AB Pipeline Products By Development Stage | 145 | 1 |
| 16.11.2.3 Phadia AB Pipeline Products By Therapy Area | 146 | 1 |
| 16.11.2.4 Phadia AB Pipeline Products By News Summary | 146 | 1 |
| 16.12 DiaSorin S.p.A | 147 | 1 |
| 16.12.1 Company Overview | 147 | 1 |
| 16.12.2 DiaSorin S.p.A Pipeline Products | 147 | 1 |
| 16.12.2.1 DiaSorin S.p.A Pipeline Products By Equipment Type | 147 | 1 |
| 16.12.2.2 DiaSorin S.p.A Pipeline Products By Development Stage | 147 | 1 |
| 16.12.2.3 DiaSorin S.p.A Pipeline Products By Therapy Area | 147 | 1 |
| 16.13 Becton, Dickinson and Company | 148 | 1 |
| 16.13.1 Company Overview | 148 | 1 |
| 16.14 Gen-Probe Incorporated | 149 | 1 |
| 16.14.1 Company Overview | 149 | 1 |
| 16.14.2 Gen-Probe Incorporated Pipeline Products | 149 | 1 |
| 16.14.2.1 Gen-Probe Incorporated Pipeline Products By Equipment Type | 149 | 1 |
| 16.14.2.2 Gen-Probe Incorporated Pipeline Products By Development Stage | 150 | 1 |
| 16.14.2.3 Gen-Probe Incorporated Pipeline Products By Therapy Area | 150 | 1 |
| 16.14.2.4 Gen-Probe Incorporated Pipeline Products By Clinical Trials | 150 | 1 |
| 16.14.2.5 Gen-Probe Incorporated Pipeline Products By News Summary | 151 | 1 |
| 16.15 Inverness Medical Innovations, Inc. | 152 | 1 |
| 16.15.1 Company Overview | 152 | 1 |
| 16.15.2 Inverness Medical Innovations, Inc. Pipeline Products | 152 | 1 |
| 16.15.2.1 Inverness Medical Innovations, Inc. Pipeline Products By Equipment Type | 152 | 1 |
| 16.15.2.2 Inverness Medical Innovations, Inc. Pipeline Products By Development Stage | 153 | 1 |
| 16.15.2.3 Inverness Medical Innovations, Inc. Pipeline Products By Therapy Area | 153 | 1 |
| 16.15.2.4 Inverness Medical Innovations, Inc. Pipeline Products By Clinical Trials | 153 | 1 |
| 16.15.2.5 Inverness Medical Innovations, Inc. Pipeline Products By News Summary | 154 | 1 |
| 16.16 Dade Behring Holdings, Inc. | 155 | 1 |
| 16.16.1 Company Overview | 155 | 1 |
| 16.17 Ventana Medical Systems, Inc. | 155 | 1 |
| 16.17.1 Company Overview | 155 | 1 |
| 16.18 Vision BioSystems Ltd | 155 | 1 |
| 16.18.1 Company Overview | 155 | 1 |
| 16.19 Cellestis Limited | 156 | 1 |
| 16.19.1 Company Overview | 156 | 1 |
| 16.20 GeneWorks Pty. Ltd. | 156 | 1 |
| 16.20.1 Company Overview | 156 | 1 |
| 16.21 Astral Scientific Pty Ltd | 156 | 1 |
| 16.21.1 Company Overview | 156 | 1 |
| 16.22 Enterix Australia Pty Ltd | 157 | 1 |
| 16.22.1 Company Overview | 157 | 1 |
| 16.23 Cellabs Pty Ltd | 157 | 1 |
| 16.23.1 Company Overview | 157 | 1 |
| 16.24 Diagnostic Technology | 158 | 1 |
| 16.24.1 Company Overview | 158 | 1 |
| 16.24.2 Diagnostic Technology Pipeline Products | 158 | 1 |
| 16.24.2.1 Diagnostic Technology Pipeline Products By Equipment Type | 158 | 1 |
| 16.24.2.2 Diagnostic Technology Pipeline Products By Development Stage | 158 | 1 |
| 16.24.2.3 Diagnostic Technology Pipeline Products By Therapy Area | 158 | 1 |
| 16.24.2.4 Diagnostic Technology Pipeline Products By Clinical Trials | 158 | 1 |
| 16.25 Universal Biosensors, Inc. | 159 | 1 |
| 16.25.1 Company Overview | 159 | 1 |
| 16.25.2 Universal Biosensors, Inc. Pipeline Products | 159 | 1 |
| 16.25.2.1 Universal Biosensors, Inc. Pipeline Products By Equipment Type | 159 | 1 |
| 16.25.2.2 Universal Biosensors, Inc. Pipeline Products By Development Stage | 159 | 1 |
| 16.25.2.3 Universal Biosensors, Inc. Pipeline Products By Therapy Area | 160 | 1 |
| 16.26 Panbio Limited | 161 | 1 |
| 16.26.1 Company Overview | 161 | 1 |
| 16.26.2 Panbio Limited Pipeline Products | 161 | 1 |
| 16.26.2.1 Panbio Limited Pipeline Products By Equipment Type | 161 | 1 |
| 16.26.2.2 Panbio Limited Pipeline Products By Development Stage | 161 | 1 |
| 16.26.2.3 Panbio Limited Pipeline Products By Therapy Area | 162 | 1 |
| 16.26.2.4 Panbio Limited Pipeline Products By News Summary | 162 | 1 |
| 17 Financial Deals Landscape | 163 | 5 |