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Diagnostics Bundle

TriMark Publications
May 1, 2011
3057 Pages - SKU: TRI6282648

Abstract Table of Contents Related Reports

The Diagnostics Reports Bundle includes the following TriMark Publications reports at a 15% discount off the individual reports being purchased separately:

Cancer Diagnostic Testing World Markets.
Cardiac Marker Diagnostic Testing Markets.
Companion Diagnostics in Personalized Medicine and Cancer Therapy.
High-Growth Diagnostic Testing Markets.
Key Diagnostic Testing Markets.
Molecular Diagnostics in Cancer Testing.
Molecular Diagnostics in Infectious Disease Testing.
Molecular Diagnostics Markets.
Over-the-Counter Diagnostic Products World Markets.
Point of Care Diagnostic Testing Sector Trends.
Point of Care Diagnostic Testing World Markets.
Women's Health Diagnostic Testing.

Below are summaries of each report.

Cancer is the second leading cause of death by disease in the United States, exceeded only by heart disease. Traditionally cancer has been treated with surgery, chemotherapy, hormones and radiation therapy, alone or in combination. Emerging technologies include photodynamic therapy, gene therapy, biological therapy (immunotherapy) and angiogenesis inhibitors. Pharmaceutical and biotechnology companies are investing billions of dollars to search out and develop weapons for the arsenal in the war against cancer. This TriMark Publications report provides an overview of the global market for cancer therapeutics. The examination focuses on the efforts of biotechnology companies and pharmaceutical firms to incorporate new technologies for developing anti-cancer drugs into their corporate strategies. This study examines cancer therapeutic products now on the market, as well as those currently under development that might be commercialized in the near future. Additionally, the report profiles a number of firms that are actively involved in marketing and developing of products to be used in the treatment of cancer--both large multinational corporations. The analysis also provides an overview of the disease and data on cancers by site or type. It provides incidence and mortality data for different types of the disease. In addition, the report provides a summary of each of the therapies that are being used to treat cancer.

The purpose of this TriMark Publications report is to describe the specific market segment of the in vitro diagnostics (IVD) market devoted to cardiac marker testing. This study examines clinical measurement devices and their reagents and supplies as used in hospitals, clinics and doctor's offices. This examination is arranged to provide the reader with an overview of the outstanding diagnostic test market segments of cardiac care, with evidence that these segments are poised for high future growth. An overview of the diagnostic testing cardiac marker market is presented with the latest information regarding emerging new products and industry trends. It will not only quantify but also qualify the cardiac marker market segments as an area of research, product development and investment. Forecasts of the cardiac marker market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and future possibilities within this diagnostic category.

A near-term market opportunity for cancer companion diagnostic tests exists in drug selection for cancer therapy. Co-development of molecular diagnostics and targeted therapeutics has already been proven to be a successful strategy in the development of novel anti-cancer drugs. Adoption of biomarker development in clinical research provides great opportunities to identify patient subpopulations with differential drug responses and to uncover the underlying mechanisms. These data could help to explain if clinical trials of new drugs are adequate, and offer the possibility of creating a clear prescription path based on predictive biomarkers. The purpose of this TriMark Publications report is to describe the specific segment of the diagnostics market that develops new technology platforms for evaluating the metabolism of therapeutic agents, or for evaluating which therapeutic regimes are most effective for a particular type of disease. The term companion diagnostic means that the particular diagnostic test under evaluation is specifically linked to a known therapeutic drug. This linkage could be important in the therapeutic application and clinical outcome of a drug (personalized medicine), or an important component of the drug development process. This report focuses on the former linkage, i.e., the use of companion diagnostic tests in personalized medicine.

There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.

This TriMark Publications report reviews the high-growth market segments for clinical laboratory testing equipment and supplies in the clinical hospital market, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. Further, it examines the subsections of each market segment, including the clinical laboratory and research areas. Activity and trends in the clinical diagnostic market are discussed, including the numbers of institutions using this type of testing, and the factors that influence purchasing activity. Discussion details the trends that have developed that stimulate this market, and offers detailed comments on the patterns of information processing in point of care (POC) testing instruments. The study surveys most of the important companies known to be marketing, manufacturing or developing instruments and reagents in the areas selected as high-growth diagnostic markets in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary on the company's position in its market and its strategic direction.

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

This report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics--along with the development of microarray devices to measure analytes in the blood--has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. The purpose of this report is to describe the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics. Topics covered in this study include: 1) the existing and emerging technologies in the field, 2) the U.S. and global market size for molecular diagnostic products and 3) the profiles of companies that are focusing on the molecular diagnostic sector. The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales forecasts.

The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

The purpose of this TriMark Publications analysis is to describe the specific market segments of the over-the-counter (OTC) diagnostic products and home healthcare markets. It examines the diagnostic measurement devices and their reagents and supplies that are utilized in clinics and by patients directly in their homes to diagnose and monitor disease. This study also includes a review of home healthcare kits and devices that measure health-related conditions. Focus is on market dynamics and current market drivers of the OTC and home self-testing diagnostics market. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. The analysis covers healthcare-related devices that are designed for the home market in order to allow consumers to assess their health status through self-testing. In addition, this review examines some biowarfare detection systems. The emphasis in this report is on those companies and products that are actively developing and marketing diagnostic reagents and supplies in market segments that are targeted for direct sale to the public. It is believed that this market segment has the potential for growth rates above 15% per year over the next five years in some of the less well-explored and well-developed areas.

The purpose of this TriMark Publications report is to describe the sector trends within the point of care testing (POCT) diagnostic market. It examines those measurement devices and their reagents and supplies that are utilized in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the purpose of diagnosis and monitoring of disease. This study includes all of the generally-accepted clinical analytical activities that are currently in use today. Additionally, an analysis of business and technology trends and developing areas of point of care and HPV testing is provided, along with a review of the market for point of care testing equipment and supplies in the clinical and research market segments, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. This report defines U.S. and global market dollar sales volume and analyzes factors that influence the size and growth of market segments.

The purpose of this TriMark Publications report is to describe the specific market segment of the in vitro diagnostics market called point of care testing (POCT). It examines these clinical measurement devices and their reagents and supplies as utilized in near-patient enviroments like hospitals, clinics and doctor's offices. An analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient is addressed. Moreover, the study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including the research labs, hospital labs and commercial laboratories. Additionally, rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position.

The purpose of this TriMark Publications report is to describe the specific segment of the in vitro diagnostics (IVDs) market called women's health testing. This study includes contemporary and generally accepted clinical and analytical activities. This analysis examines clinical measurement devices, as well as their reagents and supplies, as utilized in hospitals, clinics and doctor's offices. Some diagnostic tests, which are marketed primarily as over-the-counter products, are included in this report. This report also includes other important tests like mammography, (i.e., tests which are not generally associated with IVD tests, but which are an important component of the overall women's health market). This study deals with analysis related to the common chemical constituents of blood, plasma or serum of concern to patient testing in the field of women's health. Emphasis is on those companies and products that are actively developing and marketing clinical laboratory instrumentation, reagents and supplies for performing diagnostic tests related to women's health. This study concentrates on the women's health testing market segment in important worldwide markets such as the U.S., Japan and Europe.

Additional Information

Continuation of Table of Contents
Over-the-Counter Diagnostic Products World Markets
1 Overview: 1.1 Statement of Report; 1.2 About This Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology; 1.6 Executive Summary
2 Sector Overview: 2.1 Global Diagnostic Products Industry; 2.2 Global OTC Diagnostic Products Industry; 2.3 Description of the U.S. OTC Diagnostics Industry Segment; 2.4 Market Drivers in the OTC Diagnostics Sector; 2.5 Key Players in the OTC Diagnostics Segment; 2.6 Sector Analysis
3 Market Analysis: Size, Growth, Share and Competitors: 3.1 Glucose Monitoring; 3.2 Pregnancy Testing; 3.3 Hepatitis Testing; 3.4 Drugs of Abuse Screening Testing; 3.5 Infectious Disease Testing; 3.6 Cholesterol Testing; 3.7 Coagulation Testing; 3.8 Urine Dipstick Testing; 3.9 Fertility Testing; 3.10 At-Home DNA Analysis; 3.11 Biowarfare Detection; 3.12 Home Patient Monitoring Devices; 3.13 Home Patient Alert Systems; 3.14 Home Genetic Testing Kits; 3.15 Home Paternity Testing; 3.16 Health Hazards Detection; 3.17 Thyroid Disease; 3.18 Carpal Tunnel; 3.19 Allergies; 3.20 Nutrition and Wellness; 3.21 Colorectal Cancer (Occult Blood) Testing; 3.22 Alzheimer’s Disease Home Screening Test; 3.23 Tobacco Testing
4. Business Trends In The Industry: 4.1 Wholesale Distribution Overview; 4.2 Factors Affecting OTC Medical Product Distribution; 4.3 Government Regulation of Medical Devices; 4.4 Clinical Laboratory Improvement Act (CLIA); 4.5 Legal, M&A and Corporate Partnerships; 4.6 New Product Launches
5. Patient Management Trends: 5.1 Trends in OTC Testing and Reimbursement; 5.3 Cost Elements of OTC Testing; 5.4 Important Elements of OTC Testing; 5.5 Growth of Home Care Testing; 5.6 Non-Traditional Methods for Sample Collecting
6. Technology Trends: 6.1 Sensor Systems for Diagnostic Applications; 6.2 Glucose Measurements; 6.3 Cholesterol Testing; 6.4 Immunoassay Technology; 6.5 Biosensor Technology; 6.6 Fructosamine Test; 6.7 Home Telemedicine Devices
7. OTC Testing: Critical Issues: 7.1 Moderators of Growth for OTC Testing; 7.2 Attitudes of Critical Care Nurses and Physicians; 7.3 Personnel Impact for OTC Testing; 7.4 Data Management Issues; 7.5 POC Decentralization Issues; 7.6 POC Testing and Clinical Outcomes; 7.7 Focused Testing; 7.8 Satellite Facilities; 7.9 POC Testing Comparison and Cost Analysis
8. Competitive Assessments of the High-Growth Markets: 8.1 Glucose Monitoring; 8.2 Coagulation Testing; 8.3 Cholesterol Testing; 8.4 Infectious Disease Testing; 8.5 Drugs of Abuse; 8.6 Home Pregnancy Testing
9. Current Issues for OTC and Home Diagnostic Testing: 9.1 New Markets for OTC and Home Diagnostic Testing; 9.2 Utility of OTC and Home Self-Testing; 9.3 Corporate Screening; 9.4 Generational Drivers of Home Testing; 9.5 Move Away from Central Laboratories; 9.6 Healthcare Cost Controls; 9.7 Mergers of Diagnostic Companies; 9.8 Home Healthcare Trends; 9.9 Home Healthcare Providers versus Mass Market Retailers; 9.10 Demographic Merchandising; 9.11 Marketing Strategies; 9.12 Third-Party Pharmacy Networks; 9.13 Which Customer Segments Are Purchasing Home Healthcare, and What Products Fit Their Needs?; 9.14 Future of Patient Self-Testing
10. Corporate Profiles: 10.1 Abbott Diagnostics (MediSense); 10.2 AmeriSourceBergen; 10.3 Avitar Technologies, Inc.; 10.4 Bayer Diagnostics; 10.5 Beacon Diagnostics; 10.6 Becton Dickinson; 10.7 Bindley Western Industries, Inc.; 10.8 Biosite, Inc.; 10.9 Cardinal Health, Inc.; 10.10 Cholestech; 10.11 HemoCue; 10.12 Home Access Health Corp.; 10.13 Inverness Medical Innovations, Inc.; 10.14 Johnson & Johnson; 10.15 LifeScan; 10.16 Princeton BioMeditech; 10.17 Quidel Corp.; 10.18 Roche Diagnostics; 10.19 Saliva Diagnostics; 10.20 Technical Chemicals & Products, Inc.; 10.21 Worldwide Medical Corporation
11. Corporate Directory: Appendix 1: Over-the-Counter In Vitro Diagnostic Devices; Appendix 2: OTC Waived Tests for Drugs of Abuse; Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing; Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare; Appendix 5: Tests Waived by the FDA from January 2000 to June 30, 2005; Appendix 6: Frequently-Asked Questions About Drug Screening Kits
Point of Care Diagnostic Testing Sector Trends
1. Overview: 1.1 Statement of Report; 1.2 Scope of the Report; 1.3 Objectives; 1.4 Methodology; 1.5 Executive Summary
2. Overview of Diagnostic Point of Care Testing: 2.1 Key Issues in the Point of Care Diagnostic Testing Sector; 2.2 Global Point of Care Marketplace; 2.3 Shifts from Central Lab Testing to POCT; 2.4 Geographical Distribution; 2.5 Emerging New Technologies; 2.6 Challenges of POCT; 2.7 Key Issues for POCT; 2.8 The Future of POCT
3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors: 3.1 Global POCT Market; 3.2 U.S. Point of Care Markets; 3.3 European POCT Market; 3.4 Japanese POCT Market
4. The Place of POCT in Critical Care: 4.1 Technological Diversity in POCT; 4.2 Point of Care Addresses Critical Requirements; 4.3 POCT versus Central Laboratory Testing
5. POCT Sector Trends and Forecasts
6. Business Trends in the Point of Care Sector: 6.1 Sector Consolidation; 6.2 Acquisition, License Agreements, Internal Development and Partnerships; 6.3 Product Breadth in POCT; 6.4 Companies Exiting From POCT; 6.5 Increased Market Penetration; 6.6 Costs of Doing Business in Europe; 6.7 Drivers of European Diagnostics Testing; 6.8 European Reimbursement Practices; 6.9 Cost Containment in Europe; 6.10 Significant Factors That Provide Competitive Advantage; 6.11 Sales and Marketing Strategies for POCT
7. Biotechnology Industry Trends: 7.1 Pharmaceutical Industry Trends
8. Government Regulation: 8.1 Regulatory Overview; 8.2 Post Filing Regulations For Point of Care Devices; 8.3 Exporting Unapproved POCTs; 8.4 Analyte Specific Reagents (Home Brew Tests); 8.5 Medical Device Registration; 8.6 Product Labeling; 8.7 Punitive FDA Actions; 8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws; 8.9 Impact of Regulations on the Industry; 8.10 Minimizing Regulatory Barriers; 8.11 Waived Testing
9. Limited Reimbursements by Third-Party Payers Obstruct Sales: 9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales; 9.2 Reimbursement Codes Classification; 9.3 Point of Care Product Line Reimbursement Picture
10. Barriers to Business: 10.1 Concentration of Customers; 10.2 Intense Competition From Other Companies; 10.3 Protection of Intellectual Property Rights; 10.4 Physician Acceptance; 10.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth; 10.6 Additional Applications of Technology Platform; 10.7 Management of Growth; 10.8 Difficulty of Establishing a Marketing Infrastructure
11. Acquisition Activity: 11.1 The Ideal Acquisition Profile; 11.2 Markets of Interest For Acquisition of POCT; 11.3 Key M&A Steps
12. Company Profiles: 12.1 Abaxis, Inc.; 12.2 Abbott Diagnostics; 12.3 Accumetrics, Inc.; 12.4 Accurex Biomedical Pvt., Ltd.; 12.5 Akers Bioscience (ABI); 12.6 Alfa Scientific Design, Inc.; 12.7 Ambri, Ltd.; 12.8 American Bio Medica Corp.; 12.9 Ani Biotech; 12.10 Apogent Technologies; 12.11 Ark Therapeutics; 12.12 ARKRAY; 12.13 Atlas Genetics; 12.14 Atonomics; 12.15 Avox Systems; 12.16 Axis-Shield; 12.17 Bayer Corp.; 12.18 Beacon Diagnostics; 12.19 Beckman Coulter; 12.20 Binax Corporation; 12.21 Biomerica; 12.22 BioMérieux Vitek, Inc.; 12.23 BioScan Screening Systems, Inc.; 12.24 Biosite Diagnostics; 12.25 BioStar; 12.26 British Biocell Holdings; 12.27 Caliper Life Sciences; 12.28 Calypte Biomedical; 12.29 Cardiovascular Diagnostics; 12.30 Chembio Diagnostics; 12.31 Cholestech; 12.32 CompuCyte Corporation; 12.33 Cozart Bioscience; 12.34 Cygnus Therapeutic Systems; 12.35 Cytogen; 12.36 Dade Behring; 12.37 Daiichi Sankyo Group; 12.38 Denka Seiken Co., Ltd.; 12.39 Diagnostic Chemicals, Ltd.; 12.40 EY Laboratories, Inc.; 12.41 Enterix, Inc.; 12.42 Focus Diagnostic, Inc.; 12.43 GDS Technology; 12.44 GenBio; 12.45 Genzyme Diagnostics; 12.46 Grant Life Sciences, Inc.; 12.47 Gryphus Diagnostics, LLC; 12.48 Guided Therapeutics, Inc; 12.49 Helena Laboratories; 12.50 Hema Diagnostic Systems; 12.51 HemoCue, Inc.; 12.52 Home Access Health Corp.; 12.53 i-STAT Corporation; 12.54 ImmunoScience, Inc.; 12.55 Instrumentation Laboratory; 12.56 International Medical Innovations; 12.57 Inverness Medical Innovations; 12.58 Johnson & Johnson; 12.59 LifeAssays; 12.60 LifePoint, Inc.; 12.61 Lifestream Technologies; 12.62 LXN Corp. (Inverness Medical Technologies); 12.63 Matritech; 12.64 Medical Services International, Inc.; 12.65 MediSense; 12.66 Medisys; 12.67 Medix Biochemica; 12.68 MedMira Laboratories; 12.69 Meretek Diagnostics Group; 12.70 Meridian Bioscience; 12.71 MiniMed; 12.72 Mitsubishi Chemical USA, Inc.; 12.73 Mitsubishi Kagaku Iatron; 12.74 Nanogen; 12.75 New Horizons Diagnostics; 12.76 Nova Biomedical; 12.77 OraSure; 12.78 Orgenics; 12.79 Orion Diagnostica; 12.80 PanBio, Ltd.; 12.81 Phamatech Corporation; 12.82 PharmaNetics, Inc.; 12.83 Phillips Medical Systems; 12.84 Polymedco; 12.85 Polymer Technology Systems; 12.86 Princeton BioMeditech Corporation; 12.87 Quest Diagnostics; 12.88 Quidel; 12.89 Radiometer; 12.90 Response Biomedical Corp.; 12.91 Roche Diagnostics; 12.92 Royal Philips Electronics; 12.93 StatSure Diagnostic Systems (Saliva Diagnostics); 12.94 Savyon Diagnostics; 12.95 Selfcare, Inc.; 12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech); 12.97 Shionogi & Co., Ltd.; 12.98 Siemens Corporation; 12.99 Guided Therapeutics (SpectRx, Inc.); 12.100 Spectral Diagnostics; 12.101 StatSure Diagnostics; 12.102 Strategic Diagnostics; 12.103 Sun Biomedical Laboratories; 12.104 Thoratec/International Technidyne Corp.; 12.105 Trinity Biotech, PLC; 12.106 Väsamed, Inc.; 12.107 Venkateshwara Hatcheries Pvt., Ltd.; 13. FDA Currently Waived Tests
Point of Care Diagnostic Testing World Markets
1. Overview: 1.1 About this Report; 1.2 Scope of the Report; 1.3 Objectives; 1.4 Methodology; 1.5 Executive Summary
2. Overview of Diagnostic Testing Point of Care: 2.1 Point of Care Testing Sites; 2.2 Point of Care Market Structure; 2.3 New Directions in Clinical IVD Testing
3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth,Share and Competitors: 3.1 Global POCT Market; 3.2 U.S. POCT Market; 3.3 European POCT Market; 3.4 Asian POCT Markets; 3.5 Rest of the World POCT Market; 3.6 Overview of Asian Healthcare Market
4. POCT Individual Markets: 4.1 Glucose Testing; 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors; 4.3 Blood Gas and Electrolytes; 4.4 Rapid Coagulation Tests; 4.5 Rapid Cardiac Markers; 4.6 Drugs of Abuse Screening Testing; 4.7 Urine Strips; 4.8 Pregnancy Tests; 4.9 Fecal Occult Blood; 4.10 Hemoglobin Testing; 4.11 Miscellaneous Rapid Tests; 4.12 Human Immunodeficiency Virus (HIV); 4.13 Cholesterol; 4.14 Infectious Disease; 4.15 Infant Jaundice; 4.16 Anthrax; 4.17 Rupture of Fetal Membranes (ROM); 4.18 Food Pathogens; 4.19 Typhoid
5. POCT: Reagents and Equipment: 5.1 Blood Glucose Monitoring; 5.2 Blood Gas and Electrolytes; 5.3 Rapid Coagulation Tests; 5.4 Rapid Cardiac Markers; 5.5 Rapid Drugs of Abuse; 5.6 Rapid Pregnancy and Fertility Tests; 5.7 Fecal Occult Blood; 5.9 Miscellaneous Rapid Tests; 5.10 HIV; 5.11 Cholesterol; 5.12 Infectious Disease; 5.14 Anthrax; 5.15 Homeland Defense (Plague and Tularemia); 5.16 BSE (Mad Cow Disease); 5.17 Tuberculosis; 5.18 Typhoid; 5.19 Avian Flu; 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter); 5.21 Ruptured Fetal Membranes (ROM)
6. POCT: Growth Regulators: 6.1 Moderators of Growth; 6.2 Personnel Acceptance; 6.3 Key People for POCT; 6.4 Information Management Issues; 6.5 Key Elements for POCT; 6.6 POCT and Reimbursement; 6.7 Effectiveness of Clinical Outcomes; 6.8 Rapid Near-Patient Testing in Hospitals; 6.9 Satellite Facilities; 6.10 Regionalization of Laboratory Care; 6.11 Requirements for POCT; 6.12 Locations of Point of Care for Patient Care; 6.13 Benefits of POCT; 6.14 Cost Elements of POCT; 6.15 Necessary Functions in POCT; 6.16 TAT for POCT; 6.17 Clinical Laboratory Improvement Amendments (CLIA); 6.18 Sexually-transmitted Diseases in Underdeveloped Countries
7. Business Trends in the Point of Care Sector: 7.1 Sector Consolidation; 7.2 Diagnostic Testing Growth Trends; 7.3 Acquisition, License Agreements, Internal Development and Partnerships; 7.4 Product Testing Depth in POCT; 7.5 Government Regulation; 7.6 Increased Market Penetration; 7.7 Costs of doing Business in Europe; 7.8 Drivers of European Diagnostics Testing; 7.9 European Reimbursement Practices; 7.10 Cost Containment in Europe
8. Technology Platform Innovations in POCT: 8.1 Sensor Systems for Diagnostic Applications; 8.2 Glucose Measurements; 8.3 Glucose Test Methods; 8.4 Cholesterol Testing; 8.5 The New Paradigm; 8.6 Consolidated Workstations and Modularity; 8.7 Automation and Robotics in the Clinical Laboratory; 8.8 Laboratory Information Systems (LIS); 8.9 Biosensor Technology; 8.10 Nanogen Third Generation Point of Care Analyzer; 8.11 Quidel MChip
9. Data Management and Connectivity: 9.1 Wireless LANs; 9.2 Connectivity Platforms; 9.3 Advantages of POCT Connectivity
10. Corporate Profiles: 10.1 Abaxis, Inc.; 10.2 Abbott Laboratories; 10.3 Accumetrics, Inc.; 10.4 AccuTech, LLC; 10.5 ACON Laboratories; 10.6 Acrongenomics; 10.7 Aerscher Diagnostics; 10.8 Akers Biosciences, Inc.; 10.9 Alere; 10.10 Alfa Scientific Designs, Inc.; 10.11 American Bio Medica Corporation; 10.12 Amic AB; 10.13 Ani Biotech Oy Ltd.; 10.14 Arkray, Inc.; 10.15 Atonomics A/S; 10.16 Audit Diagnostics; 10.17 Augurix Diagnostics Ltd.; 10.18 Axis-Shield; 10.19 Bayer; 10.20 Beckman Coulter; 10.21 BioLytical Laboratories; 10.22 Biomerica, Inc.; 10.23 BiOracle; 10.24 Bio-Rad Laboratories, Inc.; 10.25 BioScan Screening Systems, Inc.; 10.26 BioSite; 10.27 Calmark Sweden AB; 10.28 Calypte Biomedical Corporation; 10.29 Chembio Diagnostic Systems; 10.30 Chempaq A/S; 10.31 Cholestech; 10.32 Claros Diagnostics; 10.33 Concateno Plc; 10.34 Dexcom; 10.35 Enigma Diagnostics Ltd.; 10.36 Epinex Diagnostics; 10.37 Eurotrol; 10.38 Exalenz Bioscience; 10.39 GenBio; 10.40 Genzyme; 10.41 Helena Laboratories; 10.42 HemoCue AB; 10.43 HemoSense; 10.44 Home Diagnostics (Nipro Diagnostics); 10.45 IND Diagnostic; 10.46 Instrumentation Laboratory Company; 10.47 Jant Pharmacal Corporation; 10.48 Johnson & Johnson; 10.49 Lein Applied Diagnostics; 10.50 LifeAssays AB; 10.51 LifeSign; 10.52 Mediwatch; 10.53 Medix Biochemica; 10.54 MedMira; 10.55 MELA Sciences (formerly Electro-Optical Sciences); 10.56 Meretek Diagnostics Group; 10.57 Meridian Bioscience; 10.58 Micronics; 10.59 3M; 10.60 New Horizons Diagnostics; 10.61 OraSure Technologies; 10.62 Orion Diagnostica; 10.63 Polymer Technology Systems; 10.64 Prima Biomedical Company; 10.65 QBC Diagnostics; 10.66 Qualigen; 10.67 Quidel; 10.68 Radiometer Medical; 10.69 Response Biomedical; 10.70 SA Scientific; 10.71 Siemens AG; 10.72 Stanbio Laboratory
11. POCT Sector Trends and Forecasts: 11.1 Home Care Analysis as Part of Near-Patient Testing; 11.2 Non-Traditional Collection for POCT; 11.3 New Systems for Critical Care and Near-Patient Testing; 11.4 Utility of Near-Patient Testing in Critical Care Settings; 11.5 Physician's Office Market; 11.6 Information Management Advances; 11.7 Test-Ordering Patterns and Demand for POCT; 11.8 Demand for Emergency Department Services; 11.9 Move Away from Central Laboratory; 11.10 Healthcare Cost Controls; 11.11 M&A in POCT; 11.12 Competition for Services; 11.13 Drivers of POCT; 11.14 Confluence of New Technology; 11.15 Difficulties of Design for Point of Care Products; 11.16 European Hospital Structure; 11.17 The Biggest New Opportunities in POCT; 12. Corporate Directory
Women’s Health Diagnostic Testing
1.0 Overview: 1.1 Statement of Report; 1.2 Scope of this Report; 1.3 Methodology; 1.4 Executive Summary
2.0 Introduction - Sector Overview: 2.1 Global Diagnostic Products Industry
3.0 Women’s Health Testing Market Analysis in Size, Growth and Share: 3.1 Global Women’s Health Testing Markets; 3.2 U.S. Women’s Health Testing Market; 3.3 European Women’s Health Diagnostic Test Market; 3.4 Japanese Women’s Care Testing Market; 3.5 Chinese Women’s Care Market; 3.6 Rest of the World Women’s Care Testing Market
4.0 Women’s Health Testing Individual Markets: 4.1 Pregnancy Testing; 4.2 Osteoporosis Testing; 4.3 Prenatal Screening Testing; 4.4 Fertility Testing; 4.5 Breast Cancer; 4.6 Ovarian Cancer; 4.7 Cervical Cancer; 4.8 Miscellaneous Testing; 4.9 Human Immunodeficiency Virus (HIV); 4.10 Infectious Disease Testing; 4.11 Infant Jaundice
5.0 World Mammography Market: 5.1 Mammography Overview; 5.2 Market Overview; 5.3 Market Opportunities; 5.4 Market Analysis; 5.5 Strategic Outlook; 5.6 Film-Based Mammography Market; 5.7 Digital X-Ray Mammography Market

6.0 Women’s Health Testing: Growth Regulators

6.1 Moderators of Growth

6.2 Personnel Acceptance

6.3 Key People for Women’s Health Testing

6.4 Key Elements for Women’s Health Testing

6.5 Women’s Health Testing and Reimbursement

6.6 Rapid Near-Patient Testing in Hospitals

6.7 Satellite Facilities

6.8 Regionalization of Laboratory Care

6.9 Requirements for Women’s Health Testing

6.10 Clinical Laboratory Improvement Act of 1988 (CLIA)

7.0 Business Trends in the Industry

7.1 Sector Consolidation

7.2 Diagnostic Testing Growth Trends

7.3 Acquisition, License Agreements, Internal Development and Partnerships

7.4 Product Testing Depth in Women’s Health Testing

7.5 Government Regulation

7.5.1 U.S. Regulation

7.5.1.1 Importing Medical Devices into the U.S.

7.5.1.2 Exporting Medical Devices from the U.S.

7.5.2 U.K. Regulation

7.5.3 E.U. Regulation

7.5.4 Japanese Regulation

7.6 Increased Market Penetration

7.7 Legal Issues

8.0 Important Technology Trends

9.0 Company Profiles

9.1 Abbott Diagnostics

9.2 Accurex Biomedical, Pvt., Ltd

9.3 Adeza Biomedical Corporation (Acquired by Hologic)

9.4 Agfa-Gevaert Corporation

9.5 Ambri Ltd.

9.6 American Biomedica Corp. (ABMC)

9.7 Analogic Corporation

9.8 Axis-Shield Plc.

9.9 Becton Dickinson (BD)

9.10 Biomerica, Inc.

9.11 Capintec, Inc.

9.12 Carestream Health, Inc.

9.13 CMT Medical Technologies Ltd.

9.14 Concateno Plc.

9.15 Dalsa Corp.

9.16 Denka Seiken Co., Ltd.

9.17 DiaDexus, Inc.

9.18 Dilon Diagnostics

9.19 FujiFilm Medical Systems USA

9.20 General Electric Healthcare

9.21 Genzyme Corp.

9.22 Hologic Inc.

9.23 iCAD, Inc.

9.24 Imaging Diagnostic Systems, Inc.

9.25 Inverness Medical Innovations, Inc. (Alere)

9.26 Invivo Corp.

9.27 Johnson & Johnson, Inc.

9.28 Kyowa Medex Co., Ltd.

9.29 Lantheus Medical Imaging, Inc.

9.30 LifeScan Corporation

9.31 Matritech (Acquired by Inverness Medical Innovations)

9.32 Medix Biochemica

9.33 Mitsubishi Kagaku Iatron

9.34 Myraid Genetics, Inc.

9.35 OraSure Technologies, Inc.

9.36 Polymedco, Inc.

9.37 Procrea Cliniques

9.38 QIAGEN in USA

9.39 Quest Diagnostics, Inc.

9.40 Quidel Corp.

9.41 Rad-Icon Imaging Corp

9.42 Roche Ltd.

9.43 Scanis Inc.

9.44 Sectra Imtec AB

9.45 Shanghai Kehua Bioengineering Co., Ltd.

9.46 Siemens Medical Solutions USA, Inc.

9.47 Vidar Systems Corp.

10.0 Appendices

10.1 Digital Database for Screening Mammography (DDSM)

10.2 Sources of National Cancer Institute Information

10.3 Screening Mammograms: Questions and Answers

10.4 FDA Rule: State Certification of Mammography Facilities

Cancer Diagnostic Testing World Markets
1. Overview: 1.1 Statement of Report; 1.2 About this Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology; 1.6 Executive Summary
2. Introduction to Cancer Biology and the Diagnostic Industry: 2.1 Cancer; 2.2 The Drivers of the Biotech and Diagnostics Industry; 2.3 Outlook for Tumor Markers
3. Tumor Markers Market Segment Analysis: Size, Growth and Share: 3.1 Market Description; 3.2 Clinical Diagnostic Serum-Based Cancer Markers; 3.3 PSA Testing Market Size; 3.4 DNA Markers; 3.5 Serum Proteins; 3.6 Enzymes; 3.7 Occult Blood; 3.8 Histology and In Situ Hybridization (ISH); 3.9 Cervical Cytology; 3.10 IHC; 3.11 In Vivo Detection Cancer Products; 3.12 Radionuclides and X-Ray Detection Products; 3.13 HPV Testing; 3.14 Bladder Cancer Testing; 3.15 Tumor Assays for Adjuvant Chemotherapy
4. Diagnostic Methods for Cancer Detection: 4.1 Organ-Specific Tumor Markers; 4.2 Clinical Laboratory Methods for Measuring Tumor Markers; 4.3 New Technologies for Cancer Diagnostics; 4.4 Clinical Methods for Diagnosis of Cancer
5. Implications of Molecular Biology for New Diagnostic Cancer Tests
6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms: 6.1 Abbott Diagnostics; 6.2 Affymetrix, Inc.; 6.3 Agendia BV; 6.4 Ambrilia Biopharma, Inc.; 6.5 AMDL, Inc.; 6.6 Asuragen, Inc.; 6.7 Aureon Laboratories, Inc.; 6.8 Bard Diagnostics, Inc.; 6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath; 6.10 Beckman Coulter, Inc.; 6.11 Biocode S.A.; 6.12 BioCurex; 6.13 Biomedical Diagnostics; 6.14 Biomerica; 6.15 bioMerieux; 6.16 BioModa, Inc.; 6.17 Bruker Daltonics; 6.18 Byk Gulden; 6.19 Cepheid; 6.20 Clarient, Inc.; 6.21 Correlogic Systems, Inc.; 6.22 CytoCore (formerly Molecular Diagnostics, Inc.); 6.23 Cytogen Corporation (now EUSA Pharma); 6.24 diaDexus, Inc.; 6.25 DiagnoCure, Inc.; 6.26 Diagnostic Automation / Cortez Diagnostics, Inc.; 6.27 DRG International, Inc.; 6.28 Eisai Co., Ltd.; 6.29 Enigma Diagnostics Ltd.; 6.30 Epigenomics AG; 6.31 Exact Sciences Corporation; 6.32 Exagen Diagnostics, Inc.; 6.33 Fujirebio Diagnostics, Inc.; 6.34 Gene Logic, Inc.; 6.35 Gen-Probe, Inc.; 6.36 Genomic Health; 6.37 Geron Corporation; 6.38 Hologic, Inc. (formerly Cytyc Corporation); 6.39 Immunicon Corporation (now Veridex, LLC); 6.40 Immunomedics, Inc.; 6.41 Incyte Pharmaceuticals, Inc.; 6.42 Ipsogen; 6.43 LabCorp; 6.44 Matritech; 6.45 Mitsubishi Kagaku Medical; 6.46 Molecular Devices (formerly Arcturus Bioscience, Inc.); 6.47 Myriad Genetics, Inc.; 6.48 Nexell Therapeutics, Inc.; 6.49 Northwest Biotherapeutics, Inc.; 6.50 Nuvelo, Inc.; 6.51 Oncotech, Inc.; 6.52 Oncothyreon, Inc. (formerly Biomira); 6.53 Panacea Pharmaceuticals, Inc.; 6.54 Poniard Pharmaceuticals, Inc.; 6.55 Polymedco, Inc.; 6.56 Princeton BioMeditech Corporation; 6.57 Qiagen; 6.58 Roche (F. Hoffman-La Roche, Ltd.); 6.59 Sanko Junyaku Co., Ltd.; 6.60 Siemens Heathcare Diagnostics; 6.61 Tosoh Corporation (Bioscience division); 6.62 Ventana Medical Systems, Inc.; 6.63 Veridex, LLC; 6.64 Vermillion, Inc.; 6.65 Worldwide Medical Corporation; 6.66 Xenomics, Inc. (TrovaGene, Inc.)
7. Business Trends in the Industry: 7.1 Industry Consolidation; 7.2 Breadth of Product Offering and Pricing; 7.3 Government Regulation of Medical Devices; 7.4 Commercial Opportunities in Cancer Markers; 7.5 Moderators of Growth; 7.6 Biotechnology Industry Trends; 7.7 Pharmaceutical Industry Trends; 7.8 Sales and Marketing Strategies for Tumor Marker Tests
8. Tumor Marker Testing: Important Issues: 8.1 Trends in Patient Care and Reimbursement; 8.2 Trends in Reimbursement Practice; 8.3 Clinical Laboratory Improvement Act (CLIA); 8.4 Unmet Needs in Tumor Markers
9. Important New Technology Areas: 9.1 Proteins; 9.2 DNA Sequencing; 9.3 The Human Genome Project (HGP); 9.4 Liquid Phase Chromatography; 9.5 Polymerase Chain Reaction (PCR); 9.6 Capillary Electrophoresis; 9.7 Proteomics; 9.8 Use of MS in Sequencing; 9.9 High-Throughput Organic Synthesis
10. New Cancer Markers in Basic Research: 10.1 Genetics of Cancer; 10.2 DNA Mismatch Repair Genes (MMRs); 10.3 Telomeres; 10.4 Diseases; 10.5 Tumor Markers; 10.6 Technology; 10.7 Disease-specific Technology
11. Market Trends and Forecasts: 11.1 Ultrasensitive Cancer Tests; 11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies; 11.3 Reverse transcriptase-polymerase chain reaction (RT-PCR); 11.4 Genetic Tests of Hereditary Cancer Risk; 11.5 DNA Measurements; 11.6 Technical and Practical Issues for Potential New Markers; 11.7 Genetic Profiling; 11.8 Ploidy; 11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer; 11.10 Pharmacogenetic Tests for Cancer; 11.11 Worldwide Healthcare Spending
Appendix 1: Web Links
Appendix 2: Cancer Information Resources
Appendix 3: Colon Cancer Staging
Appendix 4: Reimbursement for Tumor Marker Testing
Appendix 5: The Pathology of Prostate Cancer
Appendix 6: Government Regulation of Tumor Marker Tests
Appendix 7: The Clinical Laboratory Improvement Act (CLIA)
Appendix 8: Marketers of Occult Blood Diagnostic Test Kits
Cardiac Marker Diagnostic Testing Markets
1. Overview: 1.1 Statement of Report; 1.2 Objectives of This Report; 1.3 Scope of This Report; 1.4 Methodology; 1.5 Executive Summary
2. Introduction: 2.1 Global Diagnostic Products Industry; 2.2 Barriers to Entry; 2.3 Company Evaluation Overview; 2.4 Market Outlook; 2.5 Technologies and Products that are the Most Successful in the New IVD; Environment
3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and: Share; 3.1 Global Cardiac Marker Diagnostic Testing Markets; 3.2 U.S. Cardiac Marker Testing Market; 3.3 European Cardiac Marker Diagnostic Test Market; 3.4 Japanese Diagnostic Testing Market; 3.5 Chinese Diagnostic Testing Market; 3.6 Canadian Diagnostic Market; 3.7 Cardiac Marker Testing Individual Markets
4. Cardiovascular Disease Markers: 4.1 Cholesterol, HDL and LDL; 4.2 Homocysteine; 4.3 Fibrinogen; 4.4 C-Reactive Protein; 4.5 Lipoprotein Fractions; 4.6 Pulmonary Embolism (D-Dimer Test); 4.7 Oxidized LDL and HDL; 4.8 Stroke
5. Cardiac Marker Testing Development Issues: 5.1 Genetic Testing and Personalized Medicine; 5.2 Preventive Medicine; 5.3 Patient Safety and Quality Measures; 5.4 Reimbursement; 5.5 Cardiovascular; 5.6 Screening for Diabetes; 5.7 Other Reimbursement Concerns; 5.8 CPT Test Codes and Payment Amounts; 5.9 Rapid Near-Patient Testing in Hospitals; 5.10 Satellite Facilities; 5.11 Regionalization of Laboratory Care; 5.12 Requirements for POCT; 5.13 Clinical Laboratory Improvement Amendments (CLIA); 5.14 Quality Assurance Issues; 5.15 Political Control; 5.16 Regulatory Requirements; 5.17 Recordkeeping and Data Management
6. Business Trends in the Industry: 6.1 Sector Consolidation; 6.2 Diagnostic Testing Growth Trends; 6.3 Acquisition, License Agreements, Internal Development and Partnerships; 6.4 Product Testing Depth in Cardiac Marker Testing; 6.5 Government Regulation; 6.6 Barriers to Growth; 6.7 Drivers of Growth; 6.8 Product Launches and Developments
7. Important Technology Trends: 7.1 Trends in Cardiac Marker Diagnostic Testing; 7.2 Cardiac Biomarker Research; 7.3 Potential Stroke Markers; 7.4 Future Developments for Cardiovascular Markers; 7.5 Research Questions; 7.6 Lp-PLA2; 7.7 Urotensin
8. Company Profiles: 8.1 Abbott Laboratories; 8.2 Ani Biotech; 8.3 Axis-Shield; 8.4 Bayer Corporation; 8.5 Beckman Coulter; 8.6 Biosite, Inc. (now a brand of Inverness Medical Innovations); 8.7 Inverness Medical Innovations; 8.8 Johnson & Johnson; 8.9 LifeSign; 8.10 PreMD, Inc.; 8.11 Randox Laboratories; 8.12 Response Biomedical; 8.13 Roche Diagnostics; 8.14 Sierra Resources International; 8.15 Spectral Diagnostics, Inc.
Companion Diagnostics in Personalized Medicine and Cancer Therapy
1 Overview: 1.1 Statement of Report; 1.2 About This Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology; 1.6 Executive Summary
2 Companion Diagnostics and Personalized Medicine: 2.1 Scope of this Section; 2.2 Introduction to Companion Diagnostics and Personalized Medicine; 2.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine; 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests; 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline; 2.6 The Personalized Medicine Coalition (PMC); 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space; 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care; 2.9 Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed; 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness
3 Companion Diagnostics: Qualitative and Quantitative Market Analysis: 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics; 3.2 Costs of Companion Diagnostics in Healthcare Expenditures; 3.3 Molecular Diagnostic Market; 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine; 3.5 Snapshot of Companion Diagnostics Industry Structure; 3.6 The Case for Theranostics; 3.7 Companion Diagnostics Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
4 Trends and Overview: 4.1 Companion Diagnostics: Industry SWOT Analysis; 4.2 Macro Trends in Companion Diagnostics; 4.3 Challenges for Companion Diagnostics Development; 4.4 Timeline for Impact of Various Segments in Companion Diagnostics; 4.5 Use of Proteomics to Develop Individualized Tests; 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine
5 Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics: 5.1 Sector Overview; 5.2 Companion Diagnostics on the Market; 5.3 Epidermal Growth Factor Receptor Companions; 5.4 Myriad’s TheraGuide 5-FU; 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib; 5.6 Irinotecan and UGT1A1; 5.7 Gleevec (Imatinib) Companions; 5.8 Companion Diagnostics Involving Metabolizing Enzymes; 5.9 Drivers and Barriers to Companion Diagnostics; 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets; 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer; 5.12 Companion Diagnostics Used by Clinical Service Laboratories; 5.13 New Technologies and Products under Development; 5.14 Blood-Based Technologies; 5.15 Monogram Biosciences HIV Personalized Platform; 5.16 Wako LBA\AFP Test for Liver Cancer; 5.17 Future Developments for Companion Diagnostics
6 Business and Regulatory Trends in the Companion Biomarker Testing Sector: 6.1 Industry Consolidation; 6.2 Breath of Product Offering and Pricing; 6.3 Government Regulation of Medical Devices; 6.4 Strategic Business and Marketing Considerations; 6.5 Commercial Opportunities in Companion Markers; 6.6 Moderators of Growth; 6.7 Biotechnology Industry Trends; 6.8 Pharmaceutical Industry Trends; 6.9 Acquisition, License Agreement, Partnerships; 6.10 Legal Developments; 6.11 Sales and Marketing Strategies for Tumor Marker Tests; 6.12 Product Commercialization; 6.13 Reimbursement; 6.14 Self-Referral Rules; 6.15 Health Insurance Portability and Accountability Act; 6.16 Clinical Laboratory Improvement Amendments (CLIA); 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations; 6.18 FDA’s Quality System Regulation (QSR); 6.19 FDA’S OIVD on IVDMIAs; 6.20 FDA’s Qualification of Cancer Biomarkers; 6.21 Genetic Tests and Medical Records; 6.22 Medicare Reimbursement; 6.23 Global Drivers of Clinical Laboratory Testing; 6.24 Global Outlook; 6.25 Oncology Biomarker Qualification Initiative; 6.26 FDA Critical Path; 6.27 Biomarkers and FDA’s Voluntary Genomic Data Submission; 6.28 From Personalized to Predictive Medicine; 6.29 Analysis of Cost-Effectiveness at the Individual Level; 6.30 The Patient and Advocate Perspective: An Evolution of Influence; 6.31 Real-World Experiences Translating the Vision of Personalized Medicine into Practice
7 Companies Entering the Companion Diagnostics Market: 7.1 Industry Overview; 7.2 Representative Companion Diagnostic Development Companies
Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission (March 2005)
Appendix 2: Histochemical Markers for Cancer
High-Growth Diagnostic Testing Markets
1. Overview: 1.1 Statement of Report; 1.2 Scope of this Report; 1.3 Methodology; 1.4 Executive Summary
2. Sector Overview: 2.1 Global Diagnostic Products Industry
3. High-Growth Testing Markets: Market Segment Analysis: Size, Growth and Share: 3.1 Global High-Growth Diagnostic Testing Markets; 3.2 U.S. High-Growth Testing Market; 3.3 European High-Growth Diagnostic Test Market; 3.4 Japanese Diagnostic Testing Market; 3.5 Chinese Diagnostic Testing Market
4. High-Growth Testing Individual Markets: 4.1 Hepatitis Serologic Markers and Nucleic Acid Testing
5. Cardiac Markers: 5.1 Market Overview; 5.2 Acute Myocardial Infarction; 5.3 Heart Failure (BNP); 5.4 CRP; 5.5 Pulmonary Embolism (D-dimer Test); 5.6 Key Players
6. Cytogenetic Testing: 6.1 Cancer Testing; 6.2 Prenatal Testing and Cytogenetics; 6.3 Key Players in Segment
7. Fertility Testing
8. Clinical Laboratory Genomics: 8.1 Introduction; 8.2 Clinical Laboratory Genomics Testing; 8.3 Developments in Clinical Laboratory Genomics
9. Glucose Monitoring: 9.1 Overview of Market Segment; 9.2 Competitive Strategies; 9.3 Analyses of the Current Market Conditions, Competition and Product Mix
10. Cancer Biomarker Testing: 10.1 Segment Overview; 10.2 The Cancer Testing Market; 10.3 Competition; 10.4 Individual Markets; 10.5 Pharmacogenomic Cancer Testing
11. HPV Testing: 11.1 Overview; 11.2 U.S. Market; 11.3 European Market; 11.4 Other Markets; 11.5 The Association of HPV and Cervical Cancer; 11.6 Assays for HPV
12. Biochips for Clinical Applications: 12.1 Roche AmpliChip; 12.2 Amersham CodeLink; 12.3 Breast Cancer DNA Chips; 12.4 Osmetech eSensor; 12.5 Affymetrix GeneChip System 3000Dx v.2; 12.6 Caliper and Cepheid; 12.7 Agilent Technologies 2100 Lab-on-a-Chip
13. HIV: 13.1 U.S. Testing Market; 13.2 World Testing Market; 13.3 Major Players
14. Cellular Imaging Cytopathology and Histopathology: 14.1 Segment Overview; 14.2 The Market; 14.3 Market Drivers; 14.4 Market Restraints; 14.5 Cytology and Histology Technology Platforms; 14.6 Third-Party Reimbursement; 14.7 Competition
15. Infectious Disease Testing: 15.1 Streptococcus Testing; 15.2 Chlamydia Testing; 15.3 Mononucleosis; 15.4 Gonorrhea; 15.5 Influenza; 15.6 Malaria; 15.7 Tuberculosis; 15.8 Methicillin-Resistant Staphylococcus aureus (MRSA)
16. High-Growth Testing Diagnostic Trends: 16.1 Genetic Testing; 16.2 Quality Measures; 16.3 Moderators of Growth; 16.4 Workforce Issues; 16.5 Reimbursement; 16.6 Rapid Near-Patient Testing in Hospitals; 16.7 Satellite Facilities; 16.8 Regionalization of Laboratory Care; 16.9 Requirements for High-Growth Testing; 16.10 Clinical Laboratory Improvement Act (CLIA)
17. Business Trends in the Industry: 17.1 Sector Consolidation; 17.2 Diagnostic Testing Growth Trends; 17.3 Acquisition, License Agreements, Internal Development, Partnerships; 17.4 Product Testing Depth in High-Growth Testing; 17.5 Government Regulation; 17.6 Increased Market Penetration in High-Growth Testing
18. Important Technology Trends
19. Company Profiles: 19.1 Accurex Biomedical, Pvt., Ltd.; 19.2 Adeza Biomedical Corporation (Hologic); 19.3 Agilent Technologies, Inc.; 19.4 Ambri, Ltd.; 19.5 American Bio Medica Corp.; 19.6 Ani Biotech; 19.7 Applied Spectral Imaging; 19.8 Avitar, Inc.; 19.9 Axis-Shield; 19.10 Bayer Corporation; 19.11 Beckman Coulter; 19.12 Becton Dickinson; 19.13 Biomerica; 19.14 Bio-Rad, Inc.; 19.15 Cozart Bioscience; 19.16 Denka Seiken Co., Ltd.; 19.17 diaDexus LLC; 19.18 Enterix, Inc. (Subsidiary of Quest Diagnostics); 19.19 Genetix; 19.20 Genzyme Diagnostics; 19.21 Hologic, Inc.; 19.22 Iatron; 19.23 Inverness Medical Innovations; 19.24 Jiangnan Biotech; 19.25 Johnson & Johnson; 19.26 Kyowa Medex Co., Ltd.; 19.27 LifePoint, Inc.; 19.28 LifeScan; 19.29 Matritech; 19.30 Medix Biochemica; 19.31 Myriad Genetics; 19.32 OraSure; 19.33 Pheromone Sciences; 19.34 Polymedco; 19.35 Procrea; 19.36 QIAGEN; 19.37 Quidel; 19.38 Roche Diagnostics; 19.39 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech); 19.40 Shionogi & Co.; 19.41 Siemens; 19.42 Spectral Diagnostics, Inc.; 19.43 Third Wave Technologies
20. Appendix 1: Opportunities in the Chinese Biotech Market
21. Appendix 2: Opportunities in the Indian Diagnostics Market
Key Diagnostic Testing Markets
1. Overview: 1.1 Objectives; 1.2 Content and Scope; 1.3 Methodology; 1.4 Executive Summary
2. Introduction: 2.1 Basic Structure and Perspectives; 2.2 Global Diagnostic Products Industry Status and Prognosis; 2.3 Size, Structure and Growth of the Industry; 2.4 Trends and Forces Driving the Industry; 2.5 Alternate Site Diagnostic Testing
3. Market Analysis: 3.1 Glucose Monitoring; 3.2 Rapid Coagulation Tests; 3.3 Rapid Cardiac Markers; 3.4 Drugs of Abuse Screening; 3.5 Infectious Disease Testing; 3.6 Cholesterol Testing; 3.7 Tumor Markers
4. Business Trends: 4.1 Industry Consolidation; 4.2 Breadth of Product Offering; 4.3 Government Regulation of Medical Devices; 4.4 Clinical Laboratory Improvement Act (CLIA)
5. Patient Management Trends: 5.1 Trends in Patient Care and Reimbursement; 5.2 Alternate Site Testing; 5.3 Moderators of Growth; 5.4 Personnel for POC Testing; 5.5 Locations of POC for Patient Care; 5.6 Focused Testing; 5.7 Satellite Facilities; 5.8 POC Testing; 5.9 Hospital Labs; 5.10 Doctor’s Office Testing; 5.11 Home Care; 5.12 Non-traditional Collection for Sample Testing
6. Technology Trends: 6.1 Sensor Systems for Diagnostic Applications; 6.2 Glucose Measurements; 6.3 Cholesterol Testing; 6.4 The New Paradigm; 6.5 Consolidated Workstations and Modularity; 6.6 Automation and Robotics; 6.7 Laboratory Information Systems (LIS); 6.8 Biosensor Technology; 6.9 Protein Sequencing; 6.10 DNA Sequencing; 6.11 The Human Genome Project; 6.12 Liquid Phase Chromatography; 6.13 Polymerase Chain Reaction; 6.14 Capillary Electrophoresis; 6.15 Proteomics
7. Data Management Issues: 7.1 Wireless Local Area Networks; 7.2 Wireless Technology; 7.3 Wireless Devices; 7.4 Considerations; 7.5 Hospital Costs of Information Management; 7.6 Other Information Processing Capabilities
8. Competitive Assessment of High-Growth Markets: 8.1 Glucose Monitoring; 8.2 Tumor Markers; 8.3 Cardiac Care; 8.4 Infectious Disease

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