Global Immunoassay Systems Industry

  • May 2012
  • -
  • Global Industry Analysts
  • -
  • 780 pages

This report analyzes the worldwide markets for Immunoassay Systems in US$ Million by the following Product Segments (includes Immunoassay Analyzers and Reagents): Enzyme Immunoassay Systems, Fluorescence Immunoassay Systems, Chemiluminescence Immunoassay Systems, Radio Immunoassay Systems, and Nephelometric Immunoassay Systems. The report provides separate comprehensive analytics for the US, Canada, Japan Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. A six-year historic analysis is also provided for these markets. The report profiles 65 companies including many key and niche players such as Abbott Laboratories, Beckman Coulter Inc., bioMérieux, Bio-Rad Laboratories Inc., Ortho-Clinical Diagnostics Inc., Roche Diagnostics, and Siemens Healthcare Diagnostics. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Table Of Contents




I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3
Enzyme Immunoassay I-4
Fluorescence Immunoassay I-4
Chemiluminescence Immunoassay I-4
Radioimmunoassay I-5
Nephelometric Immunoassay I-5


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
In-Vitro Diagnostics - A Rudimentary Overview II-1
Technologies Used in IVD II-1
Market Structure II-2
Factors Influencing IVD Industry: On a Scale of 1-5 II-3
Key Statistical Findings: II-3
Table 1: World In-Vitro Diagnostic Products Market by
End-Use Segment (2011) - Percentage Breakdown by Value
Sales for Hospital Labs, Commercial Labs, Self-Testing and
POC (includes corresponding Graph/Chart) II-3

Table 2: Global IVD Market (2011): Percentage Share
Breakdown of Value Sales by Country/Region (includes
corresponding Graph/Chart) II-3
Competition in the IVD Market II-4
Table 3: Global IVD Market (2011): Percentage Market Share
Breakdown of Leading Players (includes corresponding
Graph/Chart) II-4
Immunoassays - A Key Component in the IVD Market II-4
Waxing Importance of Immunoassays in the Overall Diagnostic
Test Market II-5
Innovation - Name of the Game II-5
Novel Biomarkers and Advanced Technologies to Boost Market II-6
Expanding Immunoassay Applications Boost Demand for
Immunoassay Systems II-7
Table 4: Global Laboratory Based Immunoassay Market (2011):
Percentage Share Breakdown of Value Sales by Analyte Type
(includes corresponding Graph/Chart) II-8

Table 5: World Immunoassay Market by End-Use Industry
(2011): Percentage Breakdown by Value Sales for Clinical,
Food and Environment Industries (includes corresponding
Graph/Chart) II-8
Increasing Use of Immunoassays in Food Sciences and Quality
Control II-8
Immunoassay Techniques for Testing Environmental Samples
Makes a Mark II-9
Application of Immunoassays for Trace Methodology II-9
Outlook II-9
Developing Markets to Turbo Charge Growth in the Market II-9
Table 6: Worldwide Immunoassay Systems Market (2011) -
Percentage Share Breakdown of Value Sales by Leading
Players (includes corresponding Graph/Chart) II-10

2. INDUSTRY TRENDS and ISSUES II-11
Impact of the 2007-2009 Recession in Retrospect II-11
The Future of Immunoassays in a Rationing Healthcare System
in Europe II-11
Market for Adjunctive Therapies to Grow Fast II-12
Hospital and Laboratory Consolidations Drive the Market for
Immunoassay Products II-13
Advancement in Genetic Research Drives the Growth II-13
Emerging Assays to Make the Cut II-13
Shift Towards Point-of-Care Test Systems II-13
Introduction of Portable Immunoassay Systems Energizes the
Market II-14
Increasing Demand for Random Access Immunoanalyzers..... II-14
Task-Targeted Automated Chemiluminescent Assays to Penetrate II-14
Changing Scene for Immunodiagnostic Testing... II-15
Laboratory Automation on Rise II-15
Implications for Immunoassay Market II-15
Challenges Stifle Bio-Marker Research II-16
Radioimmunoassay Systems Lose Sheen Despite Being a Reliable
IVD Diagnostic Platform II-16
Instrument Rental - A Boon or a Bane? II-17
Immunochemistry Analyzers: Gaining Traction II-17

3. CONCEPTUAL OVERVIEW II-18
Immunoassays - Definition and Description.... II-18
Down the Timeline II-18
Immunoassay Analyzers II-18
Immunoassay Reagents II-19
Radioimmunoassay II-19
Non-Isotopic Immunoassays II-19
Customized Immunoassays II-20
Demerits of Immunoassays II-20
Labels - Necessary for Detection II-20
Select End-Use Applications of Immunoassays II-21
Infectious Disease II-21
Endocrine Testing Procedures II-21
Blood Processing Market II-21
Cancer Testing Markets II-22
Drugs of Abuse Testing Market II-22
Therapeutic Drug Monitoring II-22
Immune Disease II-23
Blood Grouping and Typing II-23
Components of Immunoassays II-23
Signal Response II-23
Labeled Tracer II-24
Binder II-24
Buffer Matrix II-24
Incubation Conditions II-24
Separation Process II-24
Standard Specimens II-24
Control Specimens II-25
Unknown Specimens II-25
Chemiluminescent Substrates - Growing Appeal II-25
Radioimmunoassay Analyzers, Gamma Counters II-25
Fundamentals of Operation II-26
Problems Involved II-27
Enzyme Immunoassay Analyzers, Fluorescence Immunoassay
Analyzers and Chemiluminescence’s Immunoassay Analyzers II-28
Enzyme Immunoassays II-28
Automation Enabled II-29
Customization of Assays II-29
ELISA - A Flexible Enzyme Immunoassay Test..... II-30
Constituents of ELISA II-30
Working II-30
Binding the Antigen and Antibody II-30
Conjugate Binding II-30
Evidence of Binding II-31
Fluorescence Immunoassay - Operating Principle II-31
Light Sources II-31
Sample Cell II-31
Filters II-31
Detector II-32
Time-Resolved Fluoroimmunoassay II-32
Chemiluminescence Immunoassay II-32
Types of Immunoassay Techniques II-32
Fluorescence Polarization Immunoassay II-33
Radiative Energy Attenuation (REA) II-33
Substrate-Labeled Fluorescence II-34
Enzyme Immunoassay with Fluorescence Detection II-34
Solid-Phase Microsphere Immunoassay II-34
Microparticle Enzyme Immunoassay (MEIA) II-35
Enzyme-Linked Fluorescence Immunoassay II-35
ELISA With Photometric Detection II-35
Dry-Phase Techniques II-36
Sandwich Technique II-36
Competitive Binding II-36
Reversible Complex Formation II-36
The Phase of Development II-36
Problems and Limitations.... II-37
Purchase Considerations..... II-38
Cost Considerations.... II-38
Nephelometric Immunoassay II-38
Nephelometry II-39
Types of Scatter...... II-39
Rayleigh Scatter II-39
Mie Scatter II-39
Rayleigh-Debye Scatter II-39
Key Components of Nephelometric Immunoassay Analyzers.... II-39
Light Sources II-39
Detectors II-40
Automated Nephelometers.... II-40
Modes of Operation.... II-41
Nephelometric Immunoassay Procedures.... II-41
Associated Problems...... II-41
Purchase Considerations.... II-42
Test Menu II-43
Analytical Range II-43
Linearity II-43
Specificity II-43
Precision II-43
Stability II-43
Carryover II-43
Downtime II-43
Upgrading / Interfacing II-43
Reagents II-44
Additional Features..... II-44
Competing Technologies II-44
Mature Technologies..... II-44
Cell Counting II-44
Clinical Chemistry II-44
Microbiology II-45
Emerging Technologies...... II-45
DNA Probes II-45
Miniaturization and Microchip Fabrication II-45
Blood Glucose Testing II-45
Immunohistochemistry (IHC) II-46
Non-Invasive Technology II-46
Image Analysis and Pattern Recognition II-46
Rapidly Growing Molecular Diagnostics II-46
New Technologies II-47
High-Definition Cell Assay Technologies: II-47
(1) Rapid, High-Definition Assays for Cellular Efficacy (
RHACE) II-47
(2) Single-Cell Analysis of Physiological Effects (SAPhE) II-47
(3) Matrix Analysis of Genomically-Indexed Cells (MAGIC) II-47

4. PRODUCT LAUNCHES II-48
Bio-Rad Laboratories Unveils Bio-Plex Proâ„¢ Immunoassays II-48
Bio-Rad Laboratories Launches Bio-Plex Data Proâ„¢ Software II-48
Bio-Rad Laboratories Unveils Bio-Plex Proâ„¢ Magnetic Bead-
based Multiplex Immunoassays II-48
Roche Diagnostics Unveils Full Range of STAT Immunoassays II-49
Siemens Healthcare Diagnostics Unveils VersaCellâ„¢ Solution to
Streamline Workflow II-49
Siemens Healthcare Diagnostics Introduces HIV Combo Assay
ADVIA Systems II-49
Roche Introduces Roche Cardiac 200 II-50
Bio-Rad Introduces Bio-Plex Proâ„¢ II-50
IDS Introduces IDS-iSYS hGH II-50
IDS Introduces IDS-iSYS PINP II-50
IDS Introduces IDS-iSYS and IDS-iSYS Vitamin D Assay II-50
Abbott Introduces ARCHITECT c4000 Clinical Chemistry Analyzer II-51
Siemens Introduces Clinical Laboratory Automation Solutions II-52
Ortho-Clinical Diagnostics Introduces New Laboratory System II-52
Cell Biosciences Launches Kit for Analysis of Oncoproteins II-53
Roche Diagnostics Introduces Pre-Eclampsia In-Vitro Tests
across Europe II-53
Abbott To Launch New ARCHITECT® ci4100™ Integrated
Immunoassay and Clinical Chemistry System II-54
Abbott Introduces ARCHITECT® i1000SR® Immunochemistry Analyzer II-54
Ortho Clinical Diagnostics Unveils Vitros® 3600
Immunodiagnostic System and Vitros® 5600 Integrated System II-54
PerkinElmer Releases New AplhaLISAâ„¢ Immunoassay Diagnostic Kits II-55
Assay Designs Introduces ImmunoSetâ„¢ ELISA Development Kit II-56
Trinity Biotech Introduces New Lyme Enzyme Diagnostic
Products for European Markets (Europe) II-56
bioMerieux Introduces VIDAS® NT-proBNP II-57
Beckman Coulter Introduces UniCel DxC 880i Synchron® Access® II-57
Beckman Coulter Introduces UniCel® DxI 600 II-57
bioMerieux Introduces VIDAS® B•R•A•H•M•S PCT® Assay II-57
Siemens Rolls Out ADVIA Centaur® Cyclosporine (CsA) Assay II-57
Ortho-Clinical Diagnostics Launches VITROS Troponin I ES Assay II-58
Ortho-Clinical Diagnostics Introduces VITROS® Rubella IgG Assay II-58

5. RECENT INDUSTRY ACTIVITY II-59
Beckman Coulter Obtains FDA 510(k) Clearance for AU5800
Chemistry Systems II-59
bioMerieux Takes Over ARGENE to Expand Molecular Diagnostic
Offerings II-59
Roche Files 510 (k) Clearance for Elecsys Analyzers and Cobas
Immunoassay II-59
Siemens Obtains FDA Clearance for Immulite 2000 XPi II-59
Roche Bags Premarket Approval from FDA for Anti-HBc IgM Assay II-60
Beckman Coulter Signs Strategic Agreement with Trillium
Diagnostics to Market Flow Cytometry Offerings II-60
bioMerieux Inks Agreement with Biocartis to Develop Assays II-60
bioMerieux Acquvires Meikang Biotech II-61
Bio-Rad Purchases Biotest AG’s Diagnostics Businesses II-61
Immunodiagnostic Systems Receives FDA Approval for IDS-iSYS
Immunoassay Analyzer II-61
Roche Diagnostics Receives Immunoassay Contract from Premier
Purchasing Partner II-61
Ortho Clinical Gets US FDA Approval for Usage of VITROS®
Hepatitis B Surface Antigen (HBsAG) on VITROS® 5600
Integrated and VITROS® 3600 II-62
Neogen Takes Over International Diagnostic Systems II-62
eBioscience Acquires Bender MedSystems II-62
Inverness to Acquire ACON’s Lateral Flow Immunoassay
Diagnostics Business II-63
Beckman Coulter to Purchase Olympus Corp’s Diagnostics Division II-63
Instrumentation Laboratory Secures FDA Approval for ACL
AcuStarTM Hemostasis Testing System II-63
Abbott Receives FDA Premarket Approval for ARCHITECT CORE II-64
Ivax Diagnostics Inks Distribution Deal with Lin-Zhi
International II-64
Axis-Shield Inks Distribution Deals for Marketing Afinion II-64
bioMerieux and Shanghai Kehua Set Up JV II-64
bioMerieux and Quidel to Form Global Alliance for Rapid
Diagnostics II-65
Johnson and Johnson Nordic AB Takes Over Amic II-65
Roche Acquires Ventana Medical Systems, Inc. II-66
Abbott Terminates Sale Agreement with GE II-66
Abbott Inks Agreement with Premier, Inc. II-66
Beckman Coulter Renews Agreement with MedAssets II-66
Beckman Coulter Extends Agreement Amerinet II-66
Beckman Coulter Extends Partnership with Bio-Rad II-67
Siemens Acquires Dade Behring II-67
Roche Acquires BioVeris II-67
Siemens Healthcare Diagnostics Inks Agreement with Amerinet II-67
Siemens Healthcare Diagnostics Signs Agreement with Bio-Rad II-67
Siemens Medical Solutions USA Sets Up Siemens Healthcare
Diagnostics II-68

6. FOCUS ON SELECT MARKET PARTICIPANTS II-69
Abbott Laboratories (US) II-69
Beckman Coulter Inc. (US) II-69
bioMerieux (France) II-70
Bio-Rad Laboratories Inc. (US) II-70
Ortho-Clinical Diagnostics Inc (US) II-71
Roche Diagnostics (US) II-71
Siemens Healthcare Diagnostics (US) II-72

7. GLOBAL MARKET PERSPECTIVE II-73
Table 7: World Recent Past, Current and Future Analysis for
Immunoassay Systems by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific and Latin American Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) II-73

Table 8: World Historic Review for Immunoassay Systems by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) II-74

Table 9: World 15-Year Perspective for Immunoassay Systems by
Geographic Region - Percentage Breakdown of Value Sales for
US, Canada, Japan, Europe, Asia-Pacific and Latin American
Markets for Years 2004, 2011 and 2018 (includes corresponding
Graph/Chart) II-75
Immunoassay Systems Market by Product Segment II-76
Table 10: World Recent Past, Current and Future Analysis for
Enzyme Immunoassay Systems by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) II-76

Table 11: World Historic Review for Enzyme Immunoassay Systems
by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) II-77

Table 12: World 15-Year Perspective for Enzyme Immunoassay
Systems by Geographic Region - Percentage Breakdown of Value
Sales for US, Canada, Japan, Europe, Asia-Pacific and Latin
American Markets for Years 2004, 2011 and 2018 (includes
corresponding Graph/Chart) II-78

Table 13: World Recent Past, Current and Future Analysis for
Fluorescence Immunoassay Systems by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) II-79

Table 14: World Historic Review for Fluorescence Immunoassay
Systems by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific and Latin American Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) II-80

Table 15: World 15-Year Perspective for Fluorescence
Immunoassay Systems by Geographic Region - Percentage
Breakdown of Value Sales for US, Canada, Japan, Europe,
Asia-Pacific and Latin American Markets for Years 2004, 2011
and 2018 (includes corresponding Graph/Chart) II-81

Table 16: World Recent Past, Current and Future Analysis for
Chemiluminescence Immunoassay Systems by Geographic Region -
US, Canada, Japan, Europe,Asia-Pacific and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-82

Table 17: World Historic Review for Chemiluminescence
Immunoassay Systems by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific and Latin American Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) II-83

Table 18: World 15-Year Perspective for Chemiluminescence
Immunoassay Systems by Geographic Region - Percentage
Breakdown of Value Sales for US, Canada, Japan, Europe,
Asia-Pacific and Latin American Markets for Years 2004, 2011
and 2018 (includes corresponding Graph/Chart) II-84

Table 19: World Recent Past, Current and Future Analysis for
Radio Immunoassay Systems and Reagents by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) II-85

Table 20: World Historic Review for Radio Immunoassay Systems
by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Latin American Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) II-86

Table 21: World 15-Year Perspective for Radio Immunoassay
Systems by Geographic Region - Percentage Breakdown of Value
Sales for US, Canada, Japan, Europe, Asia-Pacific and Latin
American Markets for Years 2004, 2011 and 2018 (includes
corresponding Graph/Chart) II-87

Table 22: World Recent Past, Current and Future Analysis for
Nephelometric Immunoassay Systems by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific and Latin American Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) II-88

Table 23: World Historic Review for Nephelometric Immunoassay
Systems by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific and Latin American Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) II-89

Table 24: World 15-Year Perspective for Nephelometric
Immunoassay Systems by Geographic Region - Percentage
Breakdown of Value Sales for US, Canada, Japan, Europe,
Asia-Pacific and Latin American Markets for Years 2004, 2011
and 2018 (includes corresponding Graph/Chart) II-90


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
US In-Vitro Diagnostics Market - A Special Review III-1
Evolving Trends to Benefit IVD Market III-1
Key Statistics III-2
Table 25: US In-Vitro Diagnostics (IVD) Market (2011):
Percentage Share Breakdown of Revenue by Leading Players
(includes corresponding Graph/Chart) III-2
US Market for Clinical Laboratory Instruments III-2
Laboratory Consolidation and Automation on a Rise III-3
Product Launches III-3
Strategic Corporate Developments III-9
Focus on Select Players III-14
Abbott Laboratories III-14
Beckman Coulter III-15
Bio-Rad Laboratories Inc. III-16
Ortho-Clinical Diagnostics Inc III-16
Roche Diagnostics III-17
Siemens Healthcare Diagnostics III-17
B.Market Analytics III-18
Table 26: US Recent Past, Current and Future Analysis for
Immunoassay Systems by Product Segment - Enzyme Immunoassay
Systems, Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-18

Table 27: US Historic Review for Immunoassay Systems by
Product Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-19

Table 28: US 15-Year Perspective for Immunoassay Systems by
Product Segment - Percentage Breakdown of Value Sales for
Enzyme Immunoassay Systems, Fluorescence Immunoassay
Systems, Chemiluminescence Immunoassay Systems, Radio
Immunoassay Systems, and Nephelometric Immunoassay Systems
Markets for 2004, 2011 and 2018 (includes corresponding
Graph/Chart) III-20

2. CANADA III-21
Market Analysis III-21
Table 29: Canadian Recent Past, Current and Future Analysis
for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-21

Table 30: Canadian Historic Review for Immunoassay Systems
by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-22

Table 31: Canadian 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-23

3. JAPAN III-24
A.Market Analysis III-24
Outlook III-24
Strategic Corporate Development III-24
Focus on Key Players III-24
Fujirebio Inc III-24
Tosoh Corporation III-25
B.Market Analytics III-26
Table 32: Japanese Recent Past, Current and Future Analysis
for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-26

Table 33: Japanese Historic Review for Immunoassay Systems
by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for
Years 2004 through 2009 (includes corresponding
Graph/Chart) III-27

Table 34: Japanese 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-28

4. EUROPE III-29
A. Market Analytics III-29
Current and Future Analysis III-29
Overview of Immunochemistry Analyzer Market in Europe III-29
High Switching Costs and Restricted Hospital Budgets
Inhibit Market Expansion III-29
Panorama of the European Immunoassay Market III-30
Challenges III-30
Decreasing Profitability III-30
Immunodiagnostic Products Market - A Focus III-31
Trends in Immunodiagnostic Market..... III-31
Product Launches III-32
Strategic Corporate Development III-32
B.Market Analytics III-34
Table 35: European Recent Past, Current and Future Analysis
for Immunoassay Systems by Geographic Region - France,
Germany, Italy, the UK, Spain and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-34

Table 36: European Historic Review for Immunoassay Systems
by Geographic Region - France, Germany, Italy, the UK,
Spain and Rest of Europe Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-35

Table 37: European Recent Past, Current and Future Analysis
for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-36

Table 38: European Historic Review for Immunoassay Systems
by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-37

Table 39: European 15-Year Perspective for Immunoassay
Systems by Geographic Region - Percentage Breakdown of Value
Sales for France, Germany, Italy, the UK, Spain and Rest of
Europe Markets for Years 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-38

Table 40: European 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for Years (includes corresponding
Graph/Chart) III-39

4a. FRANCE III-40
A.Market Analysis III-40
Current and Future Analysis III-40
Strategic Corporate Development III-40
bioMerieux - A Key Player III-41
B.Market Analytics III-42
Table 41: French Recent Past, Current and Future Analysis for
Immunoassay Systems by Product Segment - Enzyme Immunoassay
Systems, Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-42

Table 42: French Historic Review for Immunoassay Systems by
Product Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-43

Table 43: French 15-Year Perspective for Immunoassay Systems
by Product Segment - Percentage Breakdown of Value Sales for
Enzyme Immunoassay Systems, Fluorescence Immunoassay
Systems, Chemiluminescence Immunoassay Systems, Radio
Immunoassay Systems, and Nephelometric Immunoassay Systems
Markets for 2004, 2011 and 2018 (includes corresponding
Graph/Chart) III-44

4b. GERMANY III-45
A.Market Analysis III-45
Current and Future Analysis III-45
In-Vitro Diagnostics Market - A Snapshot III-45
B.Market Analytics III-46
Table 44: German Recent Past, Current and Future Analysis for
Immunoassay Systems by Product Segment - Enzyme Immunoassay
Systems, Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-46

Table 45: German Historic Review for Immunoassay Systems by
Product Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-47

Table 46: German 15-Year Perspective for Immunoassay Systems
by Product Segment - Percentage Breakdown of Value Sales for
Enzyme Immunoassay Systems, Fluorescence Immunoassay
Systems, Chemiluminescence Immunoassay Systems, Radio
Immunoassay Systems, and Nephelometric Immunoassay Systems
Markets for 2004, 2011 and 2018 (includes corresponding
Graph/Chart) III-48

4c. ITALY III-49
Market Analysis III-49
Table 47: Italian Recent Past, Current and Future Analysis
for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-49

Table 48: Italian Historic Review for Immunoassay Systems by
Product Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-50

Table 49: Italian 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-51

4d. THE UNITED KINGDOM III-52
A.Market Analysis III-52
Current and Future Analysis III-52
IDS - A Key Player in the UK III-52
Product Launches III-52
B.Market Analytics III-53
Table 50: UK Recent Past, Current and Future Analysis for
Immunoassay Systems by Product Segment - Enzyme Immunoassay
Systems, Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-53

Table 51: UK Historic Review for Immunoassay Systems by
Product Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-54

Table 52: UK 15-Year Perspective for Immunoassay Systems by
Product Segment - Percentage Breakdown of Value Sales for
Enzyme Immunoassay Systems, Fluorescence Immunoassay
Systems, Chemiluminescence Immunoassay Systems, Radio
Immunoassay Systems, and Nephelometric Immunoassay Systems
Markets for 2004, 2011 and 2018 (includes corresponding
Graph/Chart) III-55

4e. SPAIN III-56
A.Market Analysis III-56
Current and Future Analysis III-56
B.Market Analytics III-56
Table 53: Spain Recent Past, Current and Future Analysis for
Immunoassay Systems by Product Segment - Enzyme Immunoassay
Systems, Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-56

Table 54: Spain Historic Review for Immunoassay Systems
byProduct Segment - Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-57

Table 55: Spain 15-Year Perspective for Immunoassay Systems
by Product Segment - Percentage Breakdown of Value Sales for
Enzyme Immunoassay Systems, Fluorescence Immunoassay
Systems, Chemiluminescence Immunoassay Systems, Radio
Immunoassay Systems, and Nephelometric Immunoassay Systems
Markets for 2004, 2011 and 2018 (includes corresponding
Graph/Chart) III-58

4f. REST OF EUROPE III-59
A.Market Analysis III-59
Current and Future Analysis III-59
Strategic Corporate Development III-59
B.Market Analytics III-60
Table 56: Rest of Europe Recent Past, Current and Future
Analysis for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-60

Table 57: Rest of Europe Historic Review for Immunoassay
Systems by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-61

Table 58: Rest of Europe 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-62

5. ASIA-PACIFIC III-63
A.Market Analysis III-63
Market Highlights..... III-63
Growing In-Vitro Diagnostics (IVD) Market Fuels the Demand
for Immunoassay Instruments in Asia III-63
Product Registration: A Major Roadblock III-63
Distribution: A Major Challenge III-63
Review of Select Asian Markets III-64
China III-64
Chinese Market for Diagnostic Products.... III-64
Influencing Forces III-64
Market Characteristics III-64
Competitive Analysis III-65
Strategies III-65
End-User Analysis III-65
Hospitals III-66
Laboratories III-66
General Population III-66
Difficulties Posed by the Market III-66
Distribution Channels III-66
India III-67
Overview III-67
Immunoassays - Market Drivers III-67
Emerging Trends in the Indian Immunodiagnostics Market III-67
Key Statistics III-68
Table 59: Indian Immunochemistry Instruments and Reagents
Market (2011): Percentage Share Breakdown of Revenue by
Segment (includes corresponding Graph/Chart) III-68

Table 60: Indian Immunochemistry Instruments and Reagents
Market (2011): Percentage Share Breakdown of Dollar Sales
by Segment (includes corresponding Graph/Chart) III-68

Table 61: Indian Immunoassay Reagent Market (2011):
Percentage Share Breakdown of Revenue by Reagent Type
(includes corresponding Graph/Chart) III-69
Indonesia III-69
Malaysia III-69
Health Care Services - A Review III-69
A Potential Market for Immunoassays III-70
Singapore III-70
Clinical Laboratory Equipment Market in Singapore.... III-70
Market Characteristics III-71
Imports Scene III-71
Distribution III-71
End-User Analysis III-72
Philippines III-72
Strategic Corporate Developments III-72
B.Market Analytics III-74
Table 62: Asia Pacific Recent Past, Current and Future
Analysis for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-74

Table 63: Asia Pacific Historic Review for Immunoassay
Systems by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-75

Table 64: Asia Pacific 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-76

6. LATIN AMERICA III-77
Market Analysis III-77
Table 65: Latin American Recent Past, Current and Future
Analysis for Immunoassay Systems by Product Segment - Enzyme
Immunoassay Systems, Fluorescence Immunoassay Systems,
Chemiluminescence Immunoassay Systems, Radio Immunoassay
Systems, and Nephelometric Immunoassay Systems Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) III-77

Table 66: Latin America Historic Review for Immunoassay
Systems by Product Segment - Enzyme Immunoassay Systems,
Fluorescence Immunoassay Systems, Chemiluminescence
Immunoassay Systems, Radio Immunoassay Systems, and
Nephelometric Immunoassay Systems Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2004 through 2009 (includes corresponding Graph/Chart) III-78

Table 67: Latin American 15-Year Perspective for Immunoassay
Systems by Product Segment - Percentage Breakdown of Value
Sales for Enzyme Immunoassay Systems, Fluorescence
Immunoassay Systems, Chemiluminescence Immunoassay Systems,
Radio Immunoassay Systems, and Nephelometric Immunoassay
Systems Markets for 2004, 2011 and 2018 (includes
corresponding Graph/Chart) III-79


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 65 (including Divisions/Subsidiaries - 94)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 46
Canada 5
Japan 10
Europe 29
France 4
Germany 7
The United Kingdom 3
Italy 4
Rest of Europe 11
Asia-Pacific (Excluding Japan) 3
Middle East 1
------------------------------------------

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