Decentralization and Demand for Genetic Testing to Shape the Reference Code: GBIME0067MR Publication Date: March 2012 In Vitro Diagnostics Market Forecast to Increase at a CAGR of XX% during 2011 2018 The global In Vitro Diagnostics (IVD) market is forecast to grow at a Compounded Annual Growth Rate (CAGR) of XX% during 2011-2018 to reach a value of $XX billion by 2018 In Vitro Diagnostics Market, Global, Revenue ($bn), 2011 2018 CAGR XX% Revenue ($bn) 2011 2018 Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases The global In Vitro Diagnostics (IVD) market is forecast to grow at a Compounded Annual Growth Rate (CAGR) of XX% during 2011-2018 to reach a value of $XX billion by 2018. The IVD market will be driven by the shift to preventive healthcare from curative healthcare, the increase in the incidence of infectious diseases, the increase in the percentage of elderly people and technological advances. Technological advances such as automation, biosensor technology, miniaturization, integration of workstations, and Information Technology (IT) optimizing laboratory workflow will lead to an increased demand for innovative technologies and drive the growth of the overall IVD market. Emerging countries have huge potential for IVD and demand will be high in these countries. Factors such as an increase in income levels, growing awareness among patients, an increase in the patient pool and the increased adoption of Point of Care (POC) testing will drive the market growth in these countries. The advantages of POC testing include reduced Turnaround Time (TAT), minimal infrastructure requirements and accessibility. These advantages will be major factors contributing to the increased demand for POC tests and will drive the growth of the overall IVD market. Page 1
1 Table of Contents 1 Table of Contents...5 1.1 List of Tables...9 1.2 List of Figures...11 2 Introduction...13 2.1 GBI Research Guidance...13 3 Global In Vitro Diagnostics Market: Market Characterization...14 3.1 Global in Vitro Diagnostics Market, Revenue ($bn), 2004 2011...14 3.2 Global In Vitro Diagnostics Market, Revenue ($bn), 2011 2018...16 3.3 Global In Vitro Diagnostics Market, Key Company Shares (%), 2010...18 3.4 Global In Vitro Diagnostics Market: Key Market Trends...19 3.4.1 Growing Trend towards Preventive Healthcare is Driving the Growth of In Vitro Diagnostics...19 3.4.2 Increased Use of Information Technology in IVD for Effective Workflow Management...20 3.4.3 Laboratory Consolidation is a Major Trend in the IVD Industry...21 3.4.4 Demand for Decentralized Laboratory Testing is increasing Significantly Across the World...23 3.4.5 Consolidation Activity has Increased Significantly in the IVD Industry in Recent Years...23 3.4.6 Automation is the Key Technology Trend in IVD Market...24 3.5 Global In Vitro Diagnostics Market: Market Dynamics...26 3.5.1 Market Drivers...26 3.5.2 Market Restraints...27 4 Global In Vitro Diagnostics Market: Market Category Analysis and Forecasts...28 4.1 In Vitro Diagnostics Market: Cross-Category Analysis...28 4.2 Immunochemistry...30 4.2.1 Immunochemistry Market, Global, Revenue ($m), 2004 2011...30 4.2.2 Immunochemistry Market, Global, Revenue ($m), 2011 2018...31 4.2.3 Immunochemistry Market, Global, Company Share, (%), 2010...32 4.3 Immunochemistry Market: Market Dynamics...33 4.3.1 Market Drivers...33 4.3.2 Market Restraints...35 4.4 Clinical Chemistry...36 4.4.1 Clinical Chemistry Market, Global, Revenue ($m), 2004 2011...36 4.4.2 Clinical Chemistry Market, Global, Revenue ($m), 2011 2018...37 4.4.3 Clinical Chemistry Market, Global, Key Company Shares, (%), 2010...38 4.5 Clinical Chemistry Market: Market Dynamics...39 4.5.1 Market Drivers...39 4.5.2 Market Restraints...41 4.6 Infectious Immunology...42 4.6.1 Infectious Immunology Market, Global, Revenue ($m), 2004 2011...42 4.6.2 Infectious Immunology Market, Global, Revenue ($m), 2011 2018...43 4.6.3 Infectious Immunology Market, Global, Key Company Shares, (%), 2010...44 4.7 Infectious Immunology Market: Market Dynamics...45 4.7.1 Market Drivers...45 4.7.2 Market Restraints...46 4.8 Hematology...47 4.8.1 Hematology Market, Global, Revenue ($m), 2004 2011...47 4.8.2 Hematology Market, Global, Revenue ($m), 2011 2018...48 4.8.3 Hematology Market, Global, Key Company Shares, (%), 2010...49 4.9 Hematology Market: Market Dynamics...50 4.9.1 Market Drivers...50 4.9.2 Market Restraints...50 4.10 Microbiology Culture...51 Page 5
4.10.1 Microbiology Culture Market, Global, Revenue ($m), 2004 2011...51 4.10.2 Microbiology Culture Market, Global, Revenue ($m), 2011 2018...52 4.10.3 Microbiology Culture Market, Global, Company Shares, (%), 2010...53 4.11 Microbiology Culture Market: Market Dynamics...54 4.11.1 Market Drivers...54 4.11.2 Market Restraints...54 4.12 Histology and Cytology...55 4.12.1 Histology and Cytology Market, Global, Revenue ($m), 2004 2011...55 4.12.2 Histology and Cytology Market, Global, Revenue ($m), 2011 2018...56 4.12.3 Histology and Cytology Market, Global, Company Share, (%), 2010...57 4.13 Histology and Cytology Market: Market Dynamics...58 4.13.1 Market Drivers...58 4.13.2 Market Restraints...58 4.14 Genetic Testing...59 4.14.1 Genetic Testing Market, Global, Revenue ($m), 2004 2011...59 4.14.2 Genetic Testing Market, Global, Revenue ($m), 2011 2018...60 4.14.3 Genetic Testing Market, Global, Company Share, (%), 2010...61 4.15 Genetic Testing Market: Market Dynamics...62 4.15.1 Market Drivers...62 4.15.2 Market Restraints...63 5 Global In Vitro Diagnostics Market: Country Analysis and Forecasts...64 5.1 In Vitro Diagnostics Market: Cross-Country Analysis...64 5.2 Historic and Forecast Revenue, By Country...66 5.2.1 In Vitro Diagnostics Market, The US, Revenue ($m), 2004 2011...66 5.2.2 In Vitro Diagnostics Market, the US, Revenue ($m), 2011 2018...67 5.2.3 In Vitro Diagnostics Market, Canada, Revenue ($m), 2004 2011...68 5.2.4 In Vitro Diagnostics Market, Canada, Revenue ($m), 2011 2018...69 5.2.5 In Vitro Diagnostics Market, the UK, Revenue ($m), 2004 2011...70 5.2.6 In Vitro Diagnostics Market, the UK, Revenue ($m), 2011 2018...71 5.2.7 In Vitro Diagnostics Market, Germany, Revenue ($m), 2004 2011...72 5.2.8 In Vitro Diagnostics Market, Germany, Revenue ($m), 2011 2018...73 5.2.9 In Vitro Diagnostics Market, France, Revenue ($m), 2004 2011...74 5.2.10 In Vitro Diagnostics Market, France, Revenue ($m), 2011 2018...75 5.2.11 In Vitro Diagnostics Market, Italy, Revenue ($m), 2004 2011...76 5.2.12 In Vitro Diagnostics Market, Italy, Revenue ($m), 2011 2018...77 5.2.13 In Vitro Diagnostics Market, Spain, Revenue ($m), 2004 2011...78 5.2.14 In Vitro Diagnostics Market, Spain, Revenue ($m), 2011 2018...79 5.2.15 In Vitro Diagnostics Market, Japan, Revenue ($m), 2004 2011...80 5.2.16 In Vitro Diagnostics Market, Japan, Revenue ($m), 2011 2018...81 5.2.17 In Vitro Diagnostics Market, China, Revenue ($m), 2004 2011...82 5.2.18 In Vitro Diagnostics Market, China, Revenue ($m), 2011 2018...83 5.2.19 In Vitro Diagnostics Market, India, Revenue ($m), 2004 2011...84 5.2.20 In Vitro Diagnostics Market, India, Revenue ($m), 2011 2018...85 5.2.21 In Vitro Diagnostics Market, Australia, Revenue ($m), 2004 2011...86 5.2.22 In Vitro Diagnostics Market, Australia, Revenue ($m), 2011 2018...87 5.2.23 In Vitro Diagnostics Market, Brazil, Revenue ($m), 2004 2011...88 5.2.24 In Vitro Diagnostics Market, Brazil, Revenue ($m), 2011 2018...89 6 Global In Vitro Diagnostics Market: Competitive Assessment...90 6.1 Key Market Participants...91 6.1.1 F. Hoffmann La Roche Ltd...91 6.1.2 Siemens Healthcare (Subsidiary of Siemens AG)...92 6.1.3 Abbott Laboratories...93 6.1.4 Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)...94 6.1.5 Ortho Clinical Diagnostics Inc. (Subsidiary of Johnson & Johnson)...95 6.1.6 biomerieux S.A. (Subsidiary of Merieux Alliance group)...95 Page 6
6.1.7 Sysmex Corporation (Sysmex)...96 6.1.8 Becton, Dickinson and Company...97 6.1.9 Bio Rad Laboratories, Inc. (Bio Rad)...98 6.1.10 Alere Inc. (formerly Inverness Medical Innovations, Inc.)...99 7 Global In Vitro Diagnostics Market: Product Pipeline Analysis...100 7.1 In Vitro Diagnostics Market: Pipeline Products Summary...100 7.1.1 Pipeline Products Analysis: Immunochemistry Market...102 7.1.2 Pipeline Products Analysis: Infectious Immunology...103 7.1.3 Pipeline Products Analysis: Genetic Testing...104 7.1.4 Pipeline Products Analysis: Clinical Chemistry...105 7.1.5 Pipeline Products Analysis: Hematology...106 7.1.6 Pipeline Products Analysis: Microbiology Culture...107 7.1.7 Pipeline Products Analysis: Histology and Cytology...108 7.2 In Vitro Diagnostics Market: Profiles of Key Pipeline Products...109 7.2.1 ImmProCon Technology...109 7.2.2 RAPIDPoint 500 System Lactate Assay...109 7.2.3 Sali Chek Reader...109 7.2.4 Point-of-Care Diagnostic Device...110 7.2.5 ACE Alera Clinical Chemistry System Direct A1c Assay...110 7.2.6 Advia 120 Hematology System IRF Test...110 7.2.7 Advia 2120 Hematology System MPC Test...111 7.2.8 AIA 600 II D dimer Test...111 8 Global In Vitro Diagnostics Market: Consolidation Landscape...112 8.1 Deals by Number, 2008 2011...112 8.2 In Vitro Diagnostics Market: Key Deals, 2008 2011...120 8.2.1 Roche Completes Acquisition of mtm laboratories...120 8.2.2 biomerieux Acquires Argene...120 8.2.3 Thermo Fisher Completes Acquisition of Phadia...120 8.2.4 Quest Diagnostics Completes Acquisition of Athena Diagnostics...121 8.2.5 Danaher Completes Acquisition of Beckman Coulter...121 8.2.6 Laboratory Corporation of America Completes Acquisition of Genzyme Genetics From Genzyme...122 8.2.7 Merck Completes Acquisition of Millipore...122 8.2.8 Thermo Fisher Scientific Completes Acquisition of Ahura Scientific...122 8.2.9 Inverness Medical Innovations Acquires 78.13% Stake in Standard Diagnostics..123 8.2.10 Quidel Completes Acquisition of Diagnostic HYBRIDS...123 8.2.11 Danaher Completes Acquisition of Genetix Group...123 8.2.12 QIAGEN Completes Acquisition of DxS...123 8.2.13 Thermo Fisher Scientific Completes Acquisition of B.R.A.H.M.S....124 8.2.14 Laboratory Corporation of America Holdings Completes Acquisition of Monogram Biosciences...124 8.2.15 Inverness Medical Innovations Completes Acquisition of Concateno From Marwyn 125 8.2.16 Gen Probe Acquires Tepnel Life Sciences...125 8.2.17 Hologic Acquires Third Wave Technologies...125 8.2.18 Immucor Acquires BioArray Solutions...125 8.2.19 Werfen Life Acquires INOVA Diagnostics...126 8.2.20 Abbott Laboratories Acquires Ibis Biosciences from Isis Pharmaceuticals...126 8.2.21 biomerieux Acquires AviaraDx...126 8.2.22 Bio Rad Laboratories Acquires Diamed...127 9 Appendix...128 9.1 Definitions...128 9.1.1 Clinical Chemistry...128 9.1.2 Immunochemistry Test Reagents...129 9.1.3 Hematology...130 Page 7
9.1.4 Histology And Cytology...131 9.1.5 Microbiology Culture...132 9.1.6 Infectious Immunology...132 9.1.7 Genetic Testing...133 9.2 Sources...133 9.3 Acronyms...133 9.4 Research Methodology...134 9.4.1 Secondary Research...134 9.4.2 Primary Research...135 9.4.3 Models...135 9.4.4 Forecasts...135 9.4.5 Expert Panels...135 9.5 Contact Us...136 9.6 Disclaimer...136 Page 8
1.1 List of Tables Table 1: In Vitro Diagnostics Market, Global, Revenue ($bn), 2004 2011...14 Table 2: In Vitro Diagnostics Market, Global, Revenue ($bn), 2011 2018...16 Table 3: Global In Vitro Diagnostics Market, Key Company, Revenue ($m) 2010...18 Table 4: In Vitro Diagnostics Market, Global, Diagnostics Laboratories, Key M&A Deals, 2007..21 Table 5: In Vitro Diagnostics Market, Global, Diagnostics Laboratories, Key M&A Deals, 2008 2009...22 Table 6: Key M&A, IVD Market, Global, 2010 2011...24 Table 7: In Vitro Diagnostics Market, Global, Cross Category Analysis,CAGR (%), 2004 2018 28 Table 8: Immunochemistry Market, Global, Revenue ($m), 2004 2011...30 Table 9: Immunochemistry Market, Global, Revenue ($m), 2011 2018...31 Table 10: Global Immunochemistry Market, Key Company, Revenue ($m) 2010...32 Table 11: Global Immunochemistry Market, Tumor Markers...34 Table 12: Clinical Chemistry Market, Global, Revenue ($m), 2004 2011...36 Table 13: Clinical Chemistry Market, Global, Revenue ($m), 2011 2018...37 Table 14: Clinical Chemistry Market, Global, Key Company Revenue ($m), 2010...38 Table 15: Infectious Immunology Market, Global, Revenue ($m), 2004 2011...42 Table 16: Infectious Immunology Market, Global, Revenue ($m), 2011 2018...43 Table 17: Infectious Immunology Market, Global, Key Company, Revenue ($m) 2010...44 Table 18: Hematology Market, Global, Revenue ($m), 2004 2011...47 Table 19: Hematology Market, Global, Revenue ($m), 2011 2018...48 Table 20: Hematology Market, Global, Key Company Revenue ($m), 2010...49 Table 21: Microbiology Culture Market, Global, Revenue ($m), 2004 2011...51 Table 22: Microbiology Culture Market, Global, Revenue ($m), 2011 2018...53 Table 23: Microbiology Culture Market, Global, Key Company Revenue ($m), 2010...54 Table 24: Histology and Cytology Market, Global, Revenue ($m), 2004 2011...55 Table 25: Histology and Cytology Market, Global, Revenue ($m), 2011 2018...56 Table 26: Histology and Cytology Market, Global, Key Company, Revenue ($m) 2010...57 Table 27: Genetic Testing Market, Global, Revenue ($m), 2004 2011...59 Table 28: Genetic Testing Market, Global, Revenue ($m), 2011 2018...60 Table 29: Genetic Testing Market, Global, Key Company Revenue ($m), 2010...61 Table 30: In Vitro Diagnostics Market, Global, Genetic Testing, Home Genetic Test Kits, Examples...62 Table 31: IVD Market, Global, Cross-Country Analysis, CAGR (%), 2004 2018...64 Table 32: In Vitro Diagnostics Market, The US, Revenue ($m), 2004 2011...66 Table 33: In Vitro Diagnostics Market, The US, Revenue ($m), 2011 2018...67 Table 34: In Vitro Diagnostics Market, Canada, Revenue ($m), 2004 2011...68 Table 35: In Vitro Diagnostics Market, Canada, Revenue ($m), 2011 2018...69 Table 36: In Vitro Diagnostics Market, The UK, Revenue ($m), 2004 2011...70 Table 37: In Vitro Diagnostics Market, The UK, Revenue ($m), 2011 2018...71 Table 38: In Vitro Diagnostics Market, Germany, Revenue ($m), 2004 2011...72 Table 39: In Vitro Diagnostics Market, the Germany, Revenue ($m), 2011 2018...73 Table 40: In Vitro Diagnostics Market, France, Revenue ($m), 2004 2011...74 Table 41: In Vitro Diagnostics Market, France, Revenue ($m), 2011 2018...75 Table 42: In Vitro Diagnostics Market, Italy, Revenue ($m), 2004 2011...76 Table 43: In Vitro Diagnostics Market, Italy, Revenue ($m), 2011 2018...77 Table 44: In Vitro Diagnostics Market, Spain, Revenue ($m), 2004 2011...78 Table 45: In Vitro Diagnostics Market, Spain, Revenue ($m), 2011 2018...79 Table 46: In Vitro Diagnostics Market, Japan, Revenue ($m), 2004 2011...80 Table 47: In Vitro Diagnostics Market, Japan, Revenue ($m), 2011 2018...81 Table 48: In Vitro Diagnostics Market, China, Revenue ($m), 2004 2011...82 Table 49: In Vitro Diagnostics Market, China, Revenue ($m), 2011 2018...83 Table 50: In Vitro Diagnostics Market, India, Revenue ($m), 2004 2011...84 Table 51: In Vitro Diagnostics Market, India, Revenue ($m), 2011 2018...85 Table 52: In Vitro Diagnostics Market, Australia, Revenue ($m), 2004 2011...86 Table 53: In Vitro Diagnostics Market, Australia, Revenue ($m), 2011 2018...87 Table 54: In Vitro Diagnostics Market, Brazil, Revenue ($m), 2004 2011...88 Table 55: In Vitro Diagnostics Market, Brazil, Revenue ($m), 2011 2018...89 Table 56: In Vitro Diagnostics (IVD) Market, Global, Pipeline Products by Category, 2011...100 Table 57: In Vitro Diagnostics Market, Pipeline Assessment, by Development Stage...101 Table 58: Immunochemistry Market, Global, Pipeline Products Analysis, 2011...102 Table 59: Infectious Immunology Market, Global, Pipeline Products Analysis, 2011...103 Page 9
Table 60: Genetic Testing Market, Global, Pipeline Products Analysis, 2011...104 Table 61: Clinical Chemistry Market, Global, Pipeline Products Analysis, 2011...105 Table 62: Hematology Market, Global, Pipeline Products Analysis, 2011...106 Table 63: Microbiology Culture Market, Global, Pipeline Products Analysis, 2011...107 Table 64: Histology and Cytology Market, Global, Pipeline Products Analysis, 2011...108 Table 65: ImmProCon Technology, Product Status, 2011...109 Table 66: RAPIDPoint 500 System, Product Status, 2011...109 Table 67: Sali Chek Reader, Product Status, 2011...109 Table 68: Point-of-Care Diagnostic Device, Product Status, 2011...110 Table 69: ACE Alera Clinical Chemistry System Direct A1c Assay, Product Status, 2011...110 Table 70: Advia 120 Hematology System IRF (Immature Reticulocyte Fraction) Test, Product Status, 2011...110 Table 71: Advia 2120 Hematology System MPC (Mean Platelet Component) Test, Product Status, 2011...111 Table 72: AIA (Automated Immunoassay Analyzer) 600 II D dimer Test, Product Status, 2011...111 Table 73: IVD Market, Mergers and Acquisitions, Number of Deals, Global, 2008 2011...112 Table 74: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2008...113 Table 75: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2009 Table 1...114 Table 76: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2009 Table 2...115 Table 77: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2010 Table 1...116 Table 78: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2010 Table 2...117 Table 79: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2011 Table 1...118 Table 80: In Vitro Diagnostics Market, Global, Mergers and Acquisitions, 2011 Table 2...119 Page 10
1.2 List of Figures Figure 1: In Vitro Diagnostics Market, Global, Revenue ($bn), 2004 2011...14 Figure 2: In Vitro Diagnostics Market, Global, Revenue ($bn), 2011 2018...16 Figure 3: Global In Vitro Diagnostics Market, Key Company Shares (%), 2010...18 Figure 4: In Vitro Diagnostics Market, Global, Cross-Category Analysis, CAGR (%), 2004 201828 Figure 5: Immunochemistry Market, Global, Revenue ($m), 2004 2011...30 Figure 6: Immunochemistry Market, Global, Revenue ($m), 2011 2018...31 Figure 7: Immunochemistry Market, Global, Company Share, (%), 2010...32 Figure 8: Clinical Chemistry Rapid Tests & POC Market, Global, Revenue ($m), 2004 2011...36 Figure 9: Clinical Chemistry Market, Global, Revenue ($m), 2011 2018...37 Figure 10: Clinical Chemistry Market, Global, Key Company, Revenues ($m) 2010...38 Figure 11: Infectious Immunology Market, Global, Revenue ($m), 2004 2011...42 Figure 12: Infectious Immunology Market, Global, Revenue ($m), 2011 2018...43 Figure 13: Infectious Immunology Market, Global, Key Company Shares, (%), 2010...44 Figure 14: Hematology Market, Global, Revenue ($m), 2004 2011...47 Figure 15: Hematology Market, Global, Revenue ($m), 2011 2018...48 Figure 16: Hematology Market, Global, Key Company Shares, (%), 2010...49 Figure 17: Microbiology Culture Market, Global, Revenue ($m), 2004 2011...51 Figure 18: Microbiology Culture Market, Global, Revenue ($m), 2011 2018...52 Figure 19: Microbiology Culture Market, Global, Company Shares, (%), 2010...53 Figure 20: Histology and Cytology Market, Global, Revenue ($m), 2004 2011...55 Figure 21: Histology and Cytology Market, Global, Revenue ($m), 2011 2018...56 Figure 22: Histology and Cytology Market, Global, Company Share, (%), 2010...57 Figure 23: Genetic Testing Market, Global, Revenue ($m), 2004 2011...59 Figure 24: Genetic Testing Market, Global, Revenue ($m), 2011 2018...60 Figure 25: Genetic Testing Market, Global, Company Share, (%), 2010...61 Figure 26: In Vitro Diagnostics Market, Global, Cross-Country Analysis, CAGR (%), 2004 2018..64 Figure 27: In Vitro Diagnostics Market, The US, Revenue ($m), 2004 2011...66 Figure 28: In Vitro Diagnostics Market, the US, Revenue ($m), 2011 2018...67 Figure 29: In Vitro Diagnostics Market, Canada, Revenue ($m), 2004 2011...68 Figure 30: In Vitro Diagnostics Market, Canada, Revenue ($m), 2011 2018...69 Figure 31: In Vitro Diagnostics Market, The UK, Revenue ($m), 2004 2011...70 Figure 32: In Vitro Diagnostics Market, The UK, Revenue ($m), 2011 2018...71 Figure 33: In Vitro Diagnostics Market, Germany, Revenue ($m), 2004 2011...72 Figure 34: In Vitro Diagnostics Market, the Germany, Revenue ($m), 2011 2018...73 Figure 35: In Vitro Diagnostics Market, France, Revenue ($m), 2004 2011...74 Figure 36: In Vitro Diagnostics Market, France, Revenue ($m), 2011 2018...75 Figure 37: In Vitro Diagnostics Market, Italy, Revenue ($m), 2004 2011...76 Figure 38: In Vitro Diagnostics Market, Italy, Revenue ($m), 2011 2018...77 Figure 39: In Vitro Diagnostics Market, Spain, Revenue ($m), 2004 2011...78 Figure 40: In Vitro Diagnostics Market, Spain, Revenue ($m), 2011 2018...79 Figure 41: In Vitro Diagnostics Market, Japan, Revenue ($m), 2004 2011...80 Figure 42: In Vitro Diagnostics Market, Japan, Revenue ($m), 2011 2018...81 Figure 43: In Vitro Diagnostics Market, China, Revenue ($m), 2004 2011...82 Figure 44: In Vitro Diagnostics Market, China, Revenue ($m), 2011 2018...83 Figure 45: In Vitro Diagnostics Market, India, Revenue ($m), 2004 2011...84 Figure 46: In Vitro Diagnostics Market, India, Revenue ($m), 2011 2018...85 Figure 47: In Vitro Diagnostics Market, Australia, Revenue ($m), 2004 2011...86 Figure 48: In Vitro Diagnostics Market, Australia, Revenue ($m), 2011 2018...87 Figure 49: In Vitro Diagnostics Market, Brazil, Revenue ($m), 2004 2011...88 Figure 50: In Vitro Diagnostics Market, Brazil, Revenue ($m), 2011 2018...89 Figure 51: In Vitro Diagnostics Market, Global, Competitive Assessment...90 Figure 52: In Vitro Diagnostics Market, Global, Pipeline Product Summary (%), 2010...100 Figure 53: In Vitro Diagnostics Market, Pipeline Assessment, by Development Stage...101 Figure 54: Immunochemistry Market, Global, Pipeline Products Analysis, 2011...102 Figure 55: Infectious Immunology Market, Global, Pipeline Products Analysis, 2011...103 Figure 56: Genetic Testing Market, Global, Pipeline Products Analysis, 2011...104 Figure 57: Clinical Chemistry Market, Global, Pipeline Products Analysis, 2011...105 Figure 58: Hematology Market, Global, Pipeline Products Analysis, 2011...106 Figure 59: Microbiology Culture Market, Global, Pipeline Products Analysis, 2011...107 Figure 60: Histology and Cytology Market, Global, Pipeline Products Analysis, 2011...108 Page 11
Figure 61: Cardiovascular Devices Market, Mergers and Acquisitions, Number of Deals, Global, 2008 2011...112 Page 12
2 Introduction In Vitro Diagnostics (IVD) includes all diagnostic tests that are performed in laboratories or other health professional settings using body fluids such as urine, blood and tissues derived from the human body. The tests are done to diagnose disease, provide disease screening, to monitor therapy and to ensure safety during blood transfusions. The IVD tests are also used for monitoring disease progression and to target patients for specific drugs. Major IVD market categories include: clinical chemistry, immunochemistry, microbiology culture, hematology, cytology and histology, genetic testing and infectious immunology. IVD companies supply instruments and reagents for these categories. The global IVD market is highly fragmented with a large number of companies operating in the market. Increased Merger and Acquisition (M&A) activities in the past few years have resulted in companies expanding their product portfolios through inorganic means. Increased demand for advanced tests such as genetic tests, combined with the growing demand for IVD in emerging countries, have increased the focus of IVD companies in these areas. Companies are expanding their test menu as well as their geographic presence in emerging countries. The IVD market is expected to grow at a moderate rate of XX% to 2018. 2.1 GBI Research Guidance This report begins with an executive summary which captures the key categories and factors driving and restraining the growth of the global IVD market. This chapter also outlines the major categories and companies operating in the IVD market. Chapter two provides an introduction to IVD and an overview of the market. Chapter three provides information on the historic size of the market during 2004 2011 and the expected market size during the forecast period 2011 2018. It also includes information related to market trends and dynamics. In the market dynamics section, comprehensive information is provided on market drivers and restraints, as well as the competitive landscape for the overall IVD market. Chapter four includes category level details of the IVD market. Market size information for the historic (2004 2011) and forecast (2011 2018) periods are discussed for each category, in addition to market dynamics and competition. Chapter five provides historic (2004 2011) and forecast (2011 2018) information on the IVD market for the US, Canada, The UK, France, Germany, Italy, Spain, Japan, China, India, Australia and Brazil. Chapter six provides a competitive assessment of the market, and profiles of the leading IVD companies and their product portfolios. Chapter seven focuses on the pipeline products for the various market categories. Key pipeline products are listed and discussed in detail. Product approval and expected launch dates are also provided for a number of products. Chapter eight discusses the consolidation landscape in the IVD industry. This chapter looks at the total number of deals that took place during 2004 2011. Page 13
3.3 Global In Vitro Diagnostics Market, Key Company Shares (%), 2010 In 2010, F. Hoffmann-La Roche Ltd was the market leader in the IVD market and was closely followed by Siemens Healthcare, each with a market share of XX% Figure 3: Global In Vitro Diagnostics Market, Key Company Shares (%), 2010 F. Hoffmann-La Roche Ltd. Siemens Healthcare Others Abbott Laboratories Alere Inc. Beckman Coulter, Inc. Ortho-Clinical Diagnostics Inc. biomerieux S.A. Sysmex Corporation Becton, Dickinson and Company Bio-Rad Laboratories, Inc. Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases Table 3: Global In Vitro Diagnostics Market, Key Company, Revenue ($m) 2010 Company Name F. Hoffmann-La Roche Ltd. Siemens Healthcare Abbott Laboratories Beckman Coulter, Inc. Ortho-Clinical Diagnostics Inc. biomerieux S.A. Sysmex Corporation Becton, Dickinson and Company Bio-Rad Laboratories, Inc. Alere Inc. Others Total Revenue ($m) Source: GBI Research, Company Annual Reports, Interviews with Industry Expert and Key Opinion Leaders, Investor Presentations, News and Press Releases Page 18
4.12.2 Histology and Cytology Market, Global, Revenue ($m), 2011 2018 Figure 21: Histology and Cytology Market, Global, Revenue ($m), 2011 2018 Revenue ($m) 2011 2012 2013 2014 2015 2016 2017 2018 Flow Cytometers Tissue Typing Reagents Monoclonal Antibodies Source: GBI Research, Company Annual Reports and Interviews with Industry Experts and Key Opinion Leaders Table 25: Histology and Cytology Market, Global, Revenue ($m), 2011 2018 Flow Cytometers Tissue Typing Reagents Monoclonal Antibodies Total 2011 2012 2013 2014 2015 2016 2017 2018 Source: GBI Research, Company Annual Reports and Interviews with Industry Experts and Key Opinion Leaders CAGR 2011 2018 The histology and cytology market is expected to grow at a CAGR of XX% during 2011 2018 to reach a value of $XXm by 2018. The increase in the number of cancer cases and technological advances, such as automation and use of advanced digital imaging techniques, are expected to drive the market growth. Page 56
9 Appendix 9.1 Definitions In Vitro Diagnostics (IVD) include analyzers and reagents which are used in the diagnosis of disease or other health conditions, and also tests to determine the state of health, in order to treat or prevent disease. Such reagents, instruments and systems are used in the processes such as sample collection, sample preparation, and examination of samples taken from the human body. 9.1.1 Clinical Chemistry Clinical chemistry includes reagents, test kits and devices that determine the concentration and/or protein activity, carbohydrates, lipids, electrolytes, enzymes or small bio molecules in human body fluids such as blood, plasma, serum, or urine. Immuno chemical reagents are not included under this category and are tracked separately under Immunochemistry. This category comprises of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for all enzyme, metabolite and electrolyte analysis and instruments used for clinical chemistry diagnosis are also covered in this category. 9.1.1.1 Enzyme Chemistry Reagents Reagents and test kits used for quantification and detection of enzymes that act as a marker for identification and determination of disease states and bodily functions. Examples of enzymes tracked include acid phosphatase, alkaline phosphatase, creatine kinase, and lactate dehydrogenase. 9.1.1.2 Metabolite Chemistry Reagents Reagents used for the quantification of metabolites for assessment of bodily functions and disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin and bilirubin. 9.1.1.3 Electrolyte Chemistry Reagents Reagents used to quantify or detect electrolytes such as sodium, potassium, chloride, bicarbonate, magnesium, and calcium from the extra cellular fluids of the body. 9.1.1.4 Clinical Chemistry Rapid Tests & POC Clinical chemistry rapid tests provide the test results immediately. These tests are used in low resource settings with the help of test strips, tablets, and solutions. Urine testing, feces testing, blood gas electrodes are tracked in this segment. Blood glucose tests strips are not tracked in this segment. 9.1.1.5 Clinical Chemistry Analyzers Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry, metabolite chemistry, electrolyte chemistry. Clinical chemistry analyzers can be fully automated or semi automated. Automated Clinical Chemistry Analyzers A fully automated clinical chemistry analyzer has software that enables the operator to feed in most test parameters. The tasks associated with performing the test such as dispensing the reagents and incubation are automated and require minimum manual work. Semi Automated Clinical Chemistry Analyzers A semi automated clinical chemistry analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually. 9.1.1.6 Urine Analysis Urine analysis is the analysis of urine for the diagnosis of disease or for detecting the presence of a specific substance. Urine Analyzers Urine analyzers are analytical laboratory equipment used in qualitative and semi quantitative tests done using urine sample. Page 128
Urine Analyzer Reagents Urine analyzer reagents are the reagents used in urine analyzers. 9.1.2 Immunochemistry Test Reagents The immunochemistry category includes reagents, instruments and test kits used for the analysis of antigen antibody interactions in any of the bodily fluids. The category includes both test kits and reagents for quantification and detection of specific proteins, hormones, drug moieties and non infectious diseases. 9.1.2.1 Specific Proteins Reagents and test kits used to quantify and detect protein molecules from bodily fluids. 9.1.2.2 Endocrinology Tests Reagents used for quantification and detection of endocrine hormones secreted in the human body. Thyroid Function Hormones Reagents used for quantification and detection of hormones secreted by the thyroid gland. Reagents used to test TSH, T3 and T4 are included in this segment. Fertility or Pregnancy Hormones Pregnancy test system is intended for the early detection of pregnancy by measurement of Human Chronic Gonadotropin (HCG), a placental hormone, in plasma or urine. Individual and Specified Hormones Reagents are used for a quantitative measurement of specific hormones from human specimens such as blood, plasma and urine. All human hormones tested for any other purpose other than pregnancy and thyroidal hormones are included here. They include reagents for testing of hormones such as Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, and Aldosterone. 9.1.2.3 Drug Related Testing Reagents used to determine the presence or quantity of drug compounds in a patient's blood sample. Therapeutic Drug Monitoring Reagents and test kits intended to measure different types of therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for measurement of both proteins based and chemical based therapeutic drugs. This include tests for antibiotics, anti analgesics, anti inflammatory, antipyretic and menstrual drugs. Drugs of Abuse/Toxicology Test kits for measurement of drugs of abuse from blood, serum or urine. They are systems used for testing of depressants, narcotics, stimulants and hallucinogens. 9.1.2.4 Disease Specific Immunochemistry Auto Immune Diseases Tests used in the diagnosis of immune system disorders and other disease states to detect auto antibodies, which are antibodies produced against the body's own tissues. Tumor markers Tests that detect specific antibody/antigen produced by the tumor itself or by the body in response to the tumor. The tests can assay markers from samples of blood, urine, or body tissue. Cardiac markers Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and other acute coronary syndromes. The tests include assays for proteins and chemicals such as Creatine Kinase MB (CK MB), myoglobin, homocysteine, C Reactive Protein (CRP), troponin T (ctnt), and troponin I (ctni), associated with heart diseases. Rheumatoid Inflammatory Diseases Markers Page 129
Rheumatoid Inflammatory diseases markers are antigen/antibodies that detect specific antigen/antibody produced by the bone, cartilage or inflammatory disease activity. 9.1.2.5 Organ Function Assays Test systems for evaluating the wellness of a specific organ through an assay of the organ metabolites. These include liver function tests and kidney function tests. 9.1.2.6 Immunochemistry Rapid Tests Spot test kits intended generally for rapid diagnosis, with immediate results, through immunoassays. 9.1.2.7 Immunochemistry Analyzers Analytical laboratory equipment used to perform both routine and special immunochemistry tests. Chemiluminescence Analyzers Chemiluminescence analyzers analyze NO, NOX, NO2 and NH3 concentrations within a gaseous sample. Radioimmunoassay Analyzers Radioimmunoassay analyzers are used to measure concentrations of antigens (for example, hormone levels in the blood) without the need to use a bioassay. Immunofluorescence Analyzers Immunofluorescence analyzers are used to label the antibodies or antigens by visualizing the sub cellular distribution of biomolecules of interest. ELISA Instruments ELISA Instruments are used in enzyme linked immuno sorbent assay. These Instruments include Micro plate readers and ELISA washers. 9.1.3 Hematology Hematology includes reagents, rapid tests and instruments used for determination and diagnosis of both physiological and pathological aspects of blood and its components. The category also includes immune relates reagents used for analysis of blood and its components. 9.1.3.1 Hematology Reagents Reagents are provided for substantially lysing red blood cells in a whole blood sample prior to hematology analysis. Hematology Analyzer Reagents Hematology analyzer reagents are exclusively used in the blood lysing techniques. Slide Stainers Slide stainers are reagents used in staining of the slides and smears. 9.1.3.2 Hematology Analyzers Analytical laboratory equipment used to perform tests related to blood and its components 9.1.3.3 Hemostasis Analyzers that conduct blood coagulation related tests. General Coagulation Tests Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or PTT), bleeding time, and plasma thrombin time. Special Coagulation Tests Special coagulation tests are used to provide quantitative determination of anticoagulant activities of heparin and thrombin formation. Coagulation Factors Page 130
Reagents used in detecting the coagulation factor Platelet Factors Tests used in the determination of cytokines belonging to the chemokine family. Coagulation Analyzers Automated laboratory equipment used in clotting assay, chromogenic assay, and hemostasis profile. 9.1.3.4 Hematology Cell Counters Blood counters for complete blood count determination in routine examinations. Hemoglobin meters Instruments used to measure the percentage of hemoglobin in a blood sample. Differential Counters Instruments used in detection of the count of white cell types. 9.1.3.5 Immuno Hematology Immuno Hematology studies antigen antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders. ABO Typing Reagents used for detecting blood types into four categories of Type A, Type B, Type AB, Type O. Rhesus Typing Test to detect Rh factor (antigen) on the surface of the red blood cells. Antibody Detection Antibody detection is done for the differential diagnosis of many different pathological conditions. Determination of specific antibodies to bacterial and viral pathogens as well as to parasites enabled the correct therapeutic measures to be taken. 9.1.3.6 Hematology Rapid Tests Spot tests that generate results immediately and can be done in low resource setting Rapid Hematology Tests (Point Of Care/Near Patient) Spot tests to be performed to get an immediate result. These tests are performed to detect the Hemoglobin, Erythrocytes, and Hematocrit. Hemostasis Rapid Tests (Home Monitoring) Spot tests to detect hemostasis. These include prothrombin time rapid test, D Dimer rapid test, and Activated Clotting Time (ACT) Rapid Test. 9.1.4 Histology And Cytology Reagents test kits and instruments used in tissue and cell typing techniques. 9.1.4.1 Histology Reagents used for the analysis of structure and chemical composition of tissues. Tissue Typing Reagents Test to determine the compatibility of tissues from a prospective donor and a recipient prior to transplantation. Monoclonal Antibodies Monoclonal antibodies for cell surface antigen are antibodies for specific target cell which identifies the tissue by the cell surface antigen. Page 131
9.1.4.2 Cytology Cytology is the examination and study of cells and its related structures. In this segment flow cytometers are tracked. Flow Cytometers Flow cytometers are electronic detection apparatus used is a technique for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid. 9.1.5 Microbiology Culture This category includes reagents used for the preparation of growth medium for microbial organisms. 9.1.5.1 Blood Culture Culture media used for the preparation of medium capable of supporting the growth of mycobacterium. They are generally in solid/liquid forms or only solid and liquid forms with constituents specific to the bacteria. 9.1.5.2 Mycobacteria Culture Culture media used for the preparation of medium capable of supporting the growth of mycobacterium. 9.1.5.3 Bacterial Identification & Susceptibility Testing Reagents used to test the sensitivity of bacteria towards an antimicrobial substance. 9.1.5.4 Immunological Culture Identification Reagents used to test Streptococci grouping, Staphylococci, and Meningitis. 9.1.5.5 Parasitology Culture Culture media used for the preparation of medium capable of supporting growth of blood parasites such as plasmodium and pneumocystis. 9.1.5.6 Mycology Culture Reagents for preparation of medium that is capable of supporting growth of fungi 9.1.5.7 Microbiology Analyzers Analytical laboratory equipment used to perform routine and special microbiology tests. Microbiology analyzers can be fully automated or semi automated. Automated Microbiology Analyzers A fully automated clinical chemistry analyzer is connected to a software program that allows the user to feed in most test parameters. The tasks associated with performing the test such as dispensing the reagents and incubation are automated and require minimum manual work. Semi Automated Microbiology Analyzers A semi automated clinical chemistry analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually. 9.1.6 Infectious Immunology Reagents, instruments and test kits used for the analysis of antigen antibody interactions for the detection or quantification of bacteria and viruses. 9.1.6.1 Bacteriology Reagents, instruments and test kits to detect the pathogenicity of the bacteria such as Chlamydia, Gonococci, Syphilis, Helicobacter Pylori, and Salmonella. 9.1.6.2 Hepatitis Viruses Diagnostic kits used to detect the hepatitis virus such as HAV, HBV, HCV, and HbsAg. Page 132
9.1.6.3 Retroviruses Diagnostic kits used to detect the antigen/antibody of HIV and HTLV. 9.1.6.4 Other Virology Diagnostic kits used to confirm the antigen/antibody of Rubella, Cytomegalovirus, Herpes Simplex Virus, and Epstein Barr Virus. 9.1.7 Genetic Testing Genetic testing reagents used for identifying the specific syndrome present and can improve the accuracy of the diagnostic tests leading to a better treatment. 9.1.7.1 Inborn Gene or Chromosome Alterations Genetic tests to detect monogenetic disorders, polygenetic disorders, chromosomal disorders, and polymorphisms Acquired Gene or Chromosome Alterations Genetic tests to detect cancer causing genes/related alterations. 9.1.7.2 Other Genetic Tests Other genetic tests include pharmaco-genomics and other tests. 9.2 Sources American Association for Clinical Chemistry American Diabetes Association Annual reports and SEC filings Center for Disease Control Company websites World Health Organization, 2011, Fact sheet N 310. Updated June 2011. URL: http://www.who.int/mediacentre/factsheets/fs310/en/index.html. BIOMERIEUX, 2011, A World Leader in In Vitro Diagnostics. A report from Biomerieux. URL: ttp://www.biomerieux.com/upload/biomerieux%20discovery%20december%202011-1.pdf [Accessed on Feb, 15, 2012] Economist Intelligence Unit (Sponsored by Roche), 2010, Broadening healthcare access in Brazil through innovation. A report from the Economist. URL:Intelligence Unit http://www.managementthinking.eiu.com/sites/default/files/roche_healthcare_web_english.p df [Accessed on Feb, 10, 2012] José Cech (2011). Living Longer and Better in Brazil: Challenges and Opportunities Faced by a Graying Society. Available from: http://journal.aarpinternational.org. [Accessed on Feb, 20, 2012] 9.3 Acronyms ACT: BGM: Activated Clotting Time Blood Glucose Monitoring CAGR: Compound Annual Growth Rate CAP: CLI: ECL: ED: College of American Pathologists Chemiluminescence Electrochemiluminescence Emergency Departments ELISA: Enzyme Linked Immunosorbent Assay Ery: Erythrocytes Page 133
FISH: Hb: HCT: ICU: IFA: IFCC ISO: Fluorescent in situ Hybridization Hemoglobin Hematocrit Intensive Care Units Immunofluorescence the International Federation of Clinical Chemistry the International Standardization Organization IUPAC: International Union of Pure and Applied: Chemistry LIS/HIS: Lab Information Systems and Hospital Information Systems MEMS: Microelectromechanical Systems NCCLS: National Committee for Clinical Laboratory Standards NHS: OR: National Health Service Operation Rooms POCT: Point Of Care Rapid Tests RIA: WHO: Radioimmunoassay the World Health Organization 9.4 Research Methodology GBI Research s dedicated Research and Analysis Teams consists of experienced professionals with a pedigree in marketing, market research, consulting background in the medical devices industry and advanced statistical expertise. GBI Research adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and the Society of Competitive Intelligence Professionals (www.scip.org). All GBI Research databases are continuously updated and revised. The following research methodology is followed for all databases and reports. 9.4.1 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC Filings. Industry trade journals, scientific journals and other technical literature. Internal and external proprietary databases. Relevant patent and regulatory databases. National government documents, statistical databases and market reports. Procedure registries. News articles, press releases and web-casts specific to the companies operating in the market. Page 134
9.4.2 Primary Research GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions: It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook etc. Helps in validating and strengthening the secondary research findings. Further develops the Analysis Team s expertise and market understanding. Primary research involves e-mail correspondence, telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to: Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers. Hospital stores, laboratories, pharmacies, distributors and para-medics. Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets. Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment. 9.4.3 Models Where no hard data is available GBI Research uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted: Available hard data is cross referenced with the following data types to produce estimates: Demographic data: population, split by segment. Macro-economic indicators: GDP, inflation rate.. Healthcare Indicators: health expenditure, physicians base, healthcare infrastructure and facilities. Selected epidemiological and procedure statistics. Data is then cross checked by the expert panel. All data and assumptions relating to modeling are stored and are available to clients on request. 9.4.4 Forecasts GBI Research uses proprietary forecast models. The following four factors are used in the forecast models: Historic growth rates. Macro indicators such as population trends and healthcare spending. Forecast epidemiological data. Qualitative trend information and assumptions. Data is then cross checked by the Expert Panel. 9.4.5 Expert Panels GBI Research uses a panel of experts to cross verify its databases and forecasts. GBI Research s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies. Page 135
Historic data and forecasts are relayed to GBI Research s Expert Panel for feedback and adjusted in accordance with this feedback. 9.6 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research. Page 136