SPI Infoamtion

Table of Contents

1. Executive Summary
1.1 The Scope of this Report
1.2 Chapter Outlines
1.3 Research and Analysis Methods

2. Introduction to In Vitro Diagnostics
2.1 What are In Vitro Diagnostic Tests?
2.2 Classifying IVD: EDMA Classification
2.2.1 Clinical Chemistry
2.2.2 Immunochemistry
2.2.3 Haematology
2.2.4 Microbiology
2.2.5 Genetic Testing
2.3 Classifying IVD: Disease Areas
2.4 Regulatory Issues
2.4.1 FDA Classifications
2.4.2 Regulation of IVD Tests
2.5 Types of IVD Tests
2.6 Personalised Medicine: Pharmacogenomics, Pharmacogenetics, Theranostics, and Proteomics
2.6.1 Pharmacogenomics
2.6.2 Proteomics
2.7 Sensitivity and Specificity

3. In Vitro Diagnostics Market: Global Outlook 2010-2025
3.1 The Global IVD Market in 2009
3.2 Global IVD Market: Forecast 2010-2025
3.3 Global IVD Market: Forecasts by EDMA Category 2010-2025
3.3.1 Clinical Chemistry: Forecast 2010-2025
3.3.2 Immunochemistry: Forecast 2010-2025
3.3.3 Haematology: Forecast 2010-2025
3.3.4 Microbiology (Culture): Forecast 2010-2025
3.3.5 Immunotechnology for Infectious Diseases: Forecast 2010-2025
3.3.6 Genetic Testing: Forecast 2010-2025
3.4 Point-of-Care Testing: Forecast 2010-2025
3.5 Laboratory Testing: Forecast 2010-2025

4. In Vitro Diagnostics: Leading National Markets
4.1 Leading IVD Markets in 2009
4.2 Forecasts by Country 2010-2025
4.3 US IVD Market: Forecast and Outlook 2010-2025
4.4 Japanese IVD Market: Forecast and Outlook 2010-2025
4.5 Leading European IVD Markets: Forecasts and Outlook 2010-2025
4.6 Chinese IVD Market: Forecast and Outlook 2010-2025
4.7 Indian IVD Market: Forecast and Outlook 2010-2025
4.8 How National Market Shares will Change During the Forecast Period
4.9 Global IVD Market by Region

5. Some Leading Companies in the IVD Sector
5.1 IVD Manufacturers
5.1.1 Roche
5.1.2 Siemens AG
5.1.3 Abbott Laboratories
5.1.4 Beckman Coulter
5.1.5 Becton Dickinson
5.2 Laboratory Services
5.2.1 Quest Diagnostics
5.2.2 Laboratory Corporation of America
5.3 Direct-to-Consumer Genomic Testing Companies

6. Important Therapy Areas for IVD Tests
6.1 Diabetes
6.2 Oncology
6.3 Infectious Disease
6.3.1 Hospital-Acquired Infections
6.3.2 HIV
6.3.3 Tuberculosis
6.3.3.1 Skin Tests
6.3.3.2 Smear Microscopy
6.3.3.3 Microbiological Culture
6.3.3.4 Nucleic Acid-Based Testing
6.3.3.5 Immunoassays
6.3.3.6 Phage Assay
6.3.4 Influenza
6.4 Reproductive Tests
6.5 Drugs of Abuse
6.5.1 Drugs Commonly Tested For
6.5.2 Types of Sample
6.6 Cardiovascular Disease
6.6.1 Cardiac Markers
6.6.2 Cholesterol Screening

7. Personalised Medicine and Theranostics
7.1 What is Personalised Medicine?
7.2 Maximising Benefits to Healthcare Stakeholders
7.3 Minimising Harm
7.4 Increasing Patient Compliance
7.5 Streamlining Clinical Trials
7.6 Reviving Failed or Withdrawn Drugs
7.7 Reducing the Costs of Healthcare
7.8 Shifting From Reaction to Prevention
7.9 What is Required for Personalised Medicine to Become Widespread?
7.9.1 The Cost of Genomic Sequencing Must Fall Further
7.9.2 Large-Scale Studies and Databases
7.9.3 A Healthcare IT Infrastructure that Integrates Clinical Data and Other Research
7.9.4 Medical Education
7.9.5 Guaranteed Reimbursements?
7.10 Theranostics Forecast

8. Commercial Drivers and Restraints in the IVD Sector 2010-2025
8.1 SWOT Analysis of the IVD Market Area
8.2 Factors Driving Growth of the IVD Market
8.3 Factors Restraining Growth of the IVD Market

9. Interviews with Industry Experts
9.1 Interview 1: Director of a Diagnostics Company
9.1.1 Most-Promising Therapeutic Areas for IVD
9.1.2 Unmet Medical Needs in IVD
9.1.3 Greatest Obstacles to Market Growth
9.1.4 Prospects for IVD Market Growth in Developing Countries
9.1.5 Prospects for Theranostics
9.2 Interview 2: CEO of a Diagnostics Company
9.2.1 Most-Promising Therapeutic Areas for IVD
9.2.2 Unmet Medical Needs in IVD
9.2.3 Greatest Obstacles to Market Growth
9.2.4 Prospects for IVD Market Growth in Developing Countries
9.2.5 Prospects for Theranostics
9.3 Interview 3: Director of a Diagnostics Company
9.3.1 Most-Promising Therapeutic Areas for IVD
9.3.2 Unmet Medical Needs in IVD
9.3.3 Greatest Obstacles to Market Growth
9.3.4 Prospects for IVD Market Growth in Developing Countries
9.3.5 Prospects for Theranostics
9.4 Interview 4: Business Development Director of a Diagnostics Company
9.4.1 Most-Promising Therapeutic Areas for IVD
9.4.2 Unmet Medical Needs in IVD
9.4.3 Greatest Obstacles to Market Growth
9.4.4 Prospects for IVD Market Growth in Developing Countries
9.4.5 Prospects for Theranostics

10. Conclusions
10.1 In Vitro Diagnostics are Vital to Clinical Decision Making
10.2 Significant Growth of In Vitro Diagnostics Market from 2010 to 2025
10.3 The Top Five Manufacturers Command the Majority of the IVD Market
10.4 Expansion of the World Market Boosted by Rising Sales in the Developing Healthcare Markets
10.5 IVD Solutions are the Cornerstone of Personalised Medicine
10.6 Expansion into Developing National Markets and Lifestyle Diseases Will Drive Market

List of Tables
Table 2.1 Criticisms of the CLIA System
Table 3.1 Global IVD Market: Revenues by EDMA Category, 2009
Table 3.2 The Global IVD Market: Revenue Forecast, 2010-2025
Table 3.3 Global IVD Market: Revenue Forecast by Submarket, 2010-2015
Table 3.4 Clinical Chemistry IVD Applications, 2010
Table 3.5 Clinical Chemistry IVD Market: Revenue Forecast, 2010-2025
Table 3.6 Immunochemistry IVD Applications, 2010
Table 3.7 Immunochemistry IVD Market: Revenue Forecast, 2010-2025
Table 3.8 Haematology IVD Applications, 2010
Table 3.9 Haematology IVD Market: Revenue Forecast, 2010-2025
Table 3.10 Microbiological Culture Applications, 2010
Table 3.11 Microbiology Culture IVD Market: Revenue Forecast, 2010-2025
Table 3.12 Infectious Immunology Applications, 2010
Table 3.13 Infectious Immunology Market: Revenue Forecast, 2010-2025
Table 3.14 Genetic Testing Applications, 2010
Table 3.15 Genetic Testing Market: Revenue Forecast, 2010-2025
Table 3.16 POCT and Laboratory Testing Market Shares by Revenue, 2009
Table 3.17 The Point-of-Care IVD Market: Revenue Forecast, 2010-2025
Table 3.18 The Laboratory Testing Market: Revenue Forecast, 2010-2025
Table 3.19 The Laboratory Testing and POCT Markets: Revenue Forecasts, 2010-2025
Table 4.1 Leading IVD Markets by Revenue, 2009
Table 4.2 Nine Leading National IVD Markets: Revenue Forecasts, 2010-2025
Table 4.3 The US IVD Market: Revenue Forecast, 2010-2025
Table 4.4 The US IVD Market: Revenue Forecast, 2010-2025
Table 4.5 Healthcare Budgets and IVD Spending of Top Five European Countries, 2009
Table 4.6 The German IVD Market: Revenue Forecast, 2010-2025
Table 4.7 The French IVD Market: Revenue Forecast, 2010-2025
Table 4.8 The Italian IVD Market: Revenue Forecast, 2010-2025
Table 4.9 The Spanish IVD Market: Revenue Forecast, 2010-2025
Table 4.10 The UK IVD Market: Revenue Forecast, 2010-2025
Table 4.11 The Chinese IVD Market: Revenue Forecast, 2010-2025
Table 4.12 The Indian IVD Market: Revenue Forecast, 2010-2025
Table 4.13 Global IVD Market by Regional Revenue Shares, 2009
Table 5.1 Top Five IVD Manufacturers by Revenue, 2009
Table 5.2 Roche: Diagnostic Business Revenues, 2009
Table 5.3 Roche: Bestselling IVD Products, 2009
Table 5.4 Siemens: Revenues by Business Segment, 2009
Table 5.5 Abbott: Revenues by Business Segment, 2009
Table 5.6 Beckman Coulter: Revenues by Business Segment, 2009
Table 5.7 BD: Revenues by Business Segment, 2009
Table 5.8 Quest: Revenues by Business Segment, 2009
Table 5.9 LabCorp: Revenues by Business Segment, 2009
Table 5.10 Conditions Tested for by 23andMe, 2010
Table 6.1 Key Disease Areas: Revenues from IVDs, 2009
Table 6.2 Diabetes Market by Marker, 2009
Table 6.3 POCT by Application, 2009
Table 6.4 Cancer IVD Revenues, 2009
Table 6.5 Theranostics for Oncology, 2010
Table 6.6 Infectious Disease IVD Market by Technology, 2009
Table 6.7 Infectious Disease IVD Market: Revenues by Disease, 2009
Table 6.8 HIV IVD Market: Revenues by Application, 2009
Table 6.9 TB Diagnostics by Revenue, 2009
Table 6.10 Male and Female Fertility Markers, 2010
Table 6.11 Detection Windows for Various DoA Tests, 2010
Table 6.12 Cardiovascular IVD Market: Revenue by Application, 2009
Table 6.13 Common Cardiac Markers, 2010
Table 6.14 Cardiac Marker IVD Market: Revenues by Test Type, 2009
Table 7.1 Comparison of Traditional and Personalised Medicine, 2010
Table 7.2 Average Response Rates to Treatment for Various Diseases, 2010
Table 7.3 Drugs Metabolised by CYP450: 2C19 and 2D6, 2010
Table 7.4 The Falling Cost of Sequencing Complete Human Genome
Table 7.5 Diagnostics and Theranostics: Revenue Forecasts, 2010-2025
Table 7.6 Genetic IVDs: Theranostics and Other Tests Revenue Forecasts, 2010-2025
Table 8.1 SWOT Analysis of IVD Market, 2010-2025

List of Figures
Figure 3.1 Global IVD Market: Revenues by EDMA Category, 2009
Figure 3.2 The Global IVD Market: Revenue Forecast, 2010-2025
Figure 3.3 Global IVD Market: Revenue Forecast by Submarket, 2010-2015
Figure 3.4 Clinical Chemistry IVD Market: Revenue Forecast, 2010-2025
Figure 3.5 Immunochemistry IVD Market: Revenue Forecast, 2010-2025
Figure 3.6 Haematology IVD Market: Revenue Forecast, 2010-2025
Figure 3.7 Microbiology Culture IVD Market: Revenue Forecast, 2010-2025
Figure 3.8 Infectious Immunology Market: Revenue Forecast, 2010-2025
Figure 3.9 Genetic Testing Market: Revenue Forecast, 2010-2025
Figure 3.10 POCT and Laboratory Testing Market Shares, 2009
Figure 3.11 The Point-of-Care IVD Market: Revenue Forecast, 2010-2025
Figure 3.12 The Laboratory Testing Market: Revenue Forecast, 2010-2025
Figure 3.13 The Laboratory Testing and POCT Markets: Revenue Forecasts, 2010-2025
Figure 4.1 Leading National IVD Markets by Share of Worldwide Revenue, 2009
Figure 4.2 Leading National IVD Markets (Upper Tier): Revenue Forecasts, 2010-2025
Figure 4.3 Leading National IVD Markets (Lower Tier): Revenue Forecast, 2010-2025
Figure 4.4 The US IVD Market: Revenue Forecast, 2010-2025
Figure 4.5 The Japanese IVD Market: Revenue Forecast, 2010-2025
Figure 4.6 The German IVD Market: Revenue Forecast, 2010-2025
Figure 4.7 The French IVD Market: Revenue Forecast, 2010-2025
Figure 4.8 The Italian IVD Market: Revenue Forecast, 2010-2025
Figure 4.9 The Spanish IVD Market: Revenue Forecast, 2010-2025
Figure 4.10 The UK IVD Market: Revenue Forecast, 2010-2025
Figure 4.11 The Chinese IVD Market: Revenue Forecast, 2010-2025
Figure 4.12 The Indian IVD Market: Revenue Forecast, 2010-2025
Figure 4.13 Market Shares of Leading National Markets, 2010
Figure 4.14 Market Shares of Leading National Markets, 2015
Figure 4.15 Market Shares of Leading National Markets, 2020
Figure 4.16 Market Shares of Leading National Markets, 2025
Figure 4.17 Global IVD Market by Region, 2009
Figure 5.1 Market Shares of the Top Five IVD Manufacturers, 2009
Figure 5.2 Roche: Diagnostic Business by Revenue, 2009
Figure 5.3 Roche: Bestselling IVD Products, 2009
Figure 5.4 Siemens Healthcare: Revenues by Division, 2009
Figure 5.5 Siemens AG: Revenues by Business Segment, 2009
Figure 5.6 Abbott: Revenues by Business Segment, 2009
Figure 5.7 Beckman Coulter: Revenues by Business Segment, 2009
Figure 5.8 BD: Revenues by Business Segment, 2009
Figure 5.9 Quest: Revenues by Business Segment, 2009
Figure 5.10 LabCorp: Revenues by Business Segment, 2009
Figure 6.1 Key Disease Areas: Revenues from IVD Applications, 2009
Figure 6.2 Diabetes Market by Marker, 2009
Figure 6.3 POCT Market by Application, 2009
Figure 6.4 Cancer IVD Revenues, 2009
Figure 6.5 Infectious Disease IVD Market: Revenues by Technology, 2009
Figure 6.6 Infectious Disease IVD Market: Revenues by Disease, 2009
Figure 6.7 HIV IVD Market: Market Shares by Application, 2009
Figure 6.8 TB Diagnostics by Revenue, 2009
Figure 6.9 Cardiovascular IVD: Market Shares by Application, 2009
Figure 6.10 Cardiac Marker IVDs: Market Shares by Test Type, 2009
Figure 7.1 Average Response Rates to Treatment for Various Diseases, 2010
Figure 7.2 The Falling Cost of Sequencing the Whole Human Genome
Figure 7.3 Theranostic IVD Market: Revenue Forecast, 2010-2025
Figure 7.4 Global IVD Market: Theranostic and Diagnostic Market Shares, 2010-2025
Figure 7.5 Genetic IVD Applications: Revenue Forecasts for Theranostics and Other Tests, 2010-2025