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In seven best-selling editions, Shara Rosen has provided a total view of every aspect of the market for in vitro diagnostic (IVD) testing in one complete volume. The report, The Worldwide Market for In Vitro Diagnostic Tests, stands as a testament to the Kalorama methodology. Real industry knowledge combined with an exhaustive review of the medical, business, and company literature. A discovery of the trends that are impacting the industry now, and a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry. The idea behind Kalorama’s unique report is that the entire market can be captured in one volume and business planners can use it as a key reference.
Published every two years, this volume includes all of the major segments of clinical lab testing, including:
- Point of Care (POC), (Professional and Self-Testing)
- Core Lab (General Chemistries, Workstations, Analyzers)
- Immunoassays (Blood Gases, Urinalysis, Critical Care)
- Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
- Hematology
- Coagulation (Lab-Based, POC, Genetic Markers)
- Microbiology and Virology
- Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
- Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)
For each of these sections, Shara Rosen reviews the key products dominating the market segment, the innovations that are occurring, trends that are impacting the segment. Market size, and forecast and market share are provided; and a geographic share of the segment is provided where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market is provided for 2009; projections are made through 2014.
Kalorama Information’s Report – ‘The Bible of the IVD Industry’
Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. These are the numbers that it is very likely competitive companies will be using in their planning.
This 800+ page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on:
- The Impact of US Health Care Reform
- The Spread of Wireless Diagnostics
- New Screening Guidelines and Market Impact
- Chronic vs. Infectious Disease
- Strange Bedfellows? An Update on the IVD Industry Consolidation
- The Continued Molecularization of Devices
- The Current Economic Situation: Recession: Post-Recession?
- Non-Invasive Sampling
- PGx and SNP Testing
- The Dynamic Core Lab
- IVD and the Promise of Personalized Medicine
- Update on Regulation of Novel Devices
- Focus on the Continued Fight against Nosocomial Infections
- Where Molecular Diagnostics Stands Today
- Innovations in Blood Banking
- Companies on the Move, and Those in Decline
- Histology/Cytology innovations; the role of FISH testing.
- In addition, there are now profiles of established and emerging players in IVD, more than 200 companies, from the top tier to the dominant middle, to the companies to watch.
Table Of contents
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction -Doing More with Less
Scope and Methodology
Size and Growth of the Market
Regional Breakout – Major Countries
Regional Breakout- Emerging Countries
IVD Market Growth Indicators
Lean Industry
Group Purchasing
Healthcare Reform
Aging Population
Emerging Markets
Predicted Changes in the IVD Market
Top Companies
Market Trends
Human Genome Project
Remote Monitoring
Development of IVD Product Choices
Educated Consumers
Reimbursement
Need to Document Home Care Benefits
CHAPTER TWO: INTRODUCTION
New Report Design
Note on Acquired Companies
Lab Medicine Disciplines and Applications
Definitions
Market Analysis of IVD Market Segments
The Big Get Bigger
Licenses and Collaboration agreements
Test Services
Top Suppliers and Niche Players
Laggards
Point of View
A Note on 6th Edition and 7th Edition Variances
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Background
Population and Disease Demographics, Worldwide
Regional Segments of the World IVD Market and IVD Market Evolution
Latin American IVD Sales, 2009 and 2014 ($ million) Special Topics
Special Topics
Initiatives to Support Healthcare Delivery, Worldwide
China and India – Contrast and Compare
India
World Demand for IVD Tests and Services
Insurance Costs, Worldwide
An Overview of Medical Tourism
Specific Country Information
The United States
US Healthcare Reform
Japan
Europe
Denmark
Poland
China
India
CHAPTER FOUR: TRENDS AND INNOVATION
The Economics of Healthcare in Economic Stress
IVD in Recessionary Time
Hospital Market Outlook
Health Care Reform
EMR Update
Patients Seek Test Results
Status of EMR Conversion
Wireless Connectivity and Healthcare Efficiencies
IVD Wireless Applications
Connectivity Imperative for POC devices
RALS
Wireless Apps Everywhere
Consumer Reaction to Wireless Devices
Lab-on-a chip
The search for non-invasive tools
Saliva
Breath
Optical Techniques
Patch Technology
Wearable Sensors/Textiles
Reimbursement Challenges and Developments
The Biomarker Revolution
The In Vivo – In Vitro Diagnostic Service
CHAPTER FIVE: POINT-OF-CARE TESTS
Overview
The Major POC Test Players
DTC – The Myth of Consumerism
Market Analysis
Diabetes Testing – Blood Glucose Monitoring (BGM)
Blood Glucose Self-Testing
Continuous Self Testing
Blood Glucose Testing by Professionals
Diabetes Testing – Glycated Hemoglobin
The Commercial Outlook for POC Tests
CHAPTER SIX: THE CORE LAB
Core Lab Overview
Workstations
Automation
Overview of Chemistry Tests
Market Analysis
Lab-based Chemistries
Critical Care Analysis
Continuous Testing
Urinalysis
The Commercial Outlook for Chemistry Tests
CHAPTER SEVEN: IMMUNOASSAYS
Overview of Immunoassays
Special Topics
The Role of Immunoassays in Disease Management
Market Analysis: Leading Suppliers and Growth Potential
Immunoassay Test Segments — Mature, Maturing and Emerging
Mature Assay Segment
Thyroid Function
Therapeutic drug tests
Anemia
Tox/DAU
Allergy
Maturing Immunoassays
Proteins
Growth Immunoassays
Tumor Markers
Cardiac Markers
Autoimmune
Sepsis
Diabetes
Miscellaneous
Point-of-care OTC and Professional Use
Patient Self-tests (OTC)
Pregnancy Testing
The Commercial Outlook for Immunoassays
CHAPTER EIGHT: MOLECULAR ASSAYS
Overview
Special Topics
The Promise of Personalized Medicine – The $1000 Genome
Molecular Testing Innovation – Sequencing and Mass Spectroscopy
Molecular Testing Innovation: Technology and Players
Market Analysis
Nucleic Acid Tests
Prenatal Chromosome Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests
CHAPTER NINE: HEMATOLOGY
Overview
Decentralized Hematology Testing
Market Analysis: Leading Suppliers
The Commercial Outlook for Hematology Tests
CHAPTER TEN: COAGULATION
Overview of Coagulation and Immunohematology Tests
The PGx Debate
Market Analysis
Lab-based Testing
Genetic Markers of Hypercoagulopathies
Decentralized Coagulation testing – Professional Use
Decentralized Coagulation testing – OTC
Platelet Testing
Leading Suppliers
The Commercial Market for Coagulation Tests
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
Overview
Special Topics
Infectious Disease Diagnostics in 2009
Global Disease Surveillance
Hospital Acquired Infections (HAIs)
Emerging Organisms and the Globalization of Infectious Diseases
Market Analysis
Supplies
Microbial Identification and Antimicrobial Sensitivity Tests
Blood Culture
Rapid Tests
Immunoassays – Lab Based
Immunoassays – Rapid
TB
HIV
Molecular Tests
Figure 8-4
The Commercial Outlook for Microbiology / Virology Tests
CHAPTER TWELVE: BLOOD BANKING SERVICES
Overview
Blood Management – are all these transfusions good medicine?
Automation to save time
Artificial Blood Products – renewed interest
Market Analysis
Blood Banking Diagnostics Market, 2009 and 2014
Blood Grouping
Immunoassays
Nucleic Acid Testing (NAT) Continues to Grow
The Commercial Outlook for Blood Banking
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
Overview
Special Topics
The Growth of Histology/Cytology Test Services
Market Analysis
Histology/Cytology
Traditional Stains
Immunohistochemistry and In situ hybridization
Pharmacodiagnostic Histology
Digital Imaging
Tissue Microarrays
Circulating Tumor Cells
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
CHAPTER FOURTEEN: COMPANY PROFILES: THE TOP TIER
Abbot Diagnostics
Recent Revenue History
Key Comment
Immunoassays
Core Lab
Hematology
Molecular Histology
Molecular Diagnostics
Infectious Diseases – Molecular
Oncology
Abbott Diabetes Care
Blood Bank
Point of Care
Microbiology
Information Technology
ARKRAY (formerly Kyoto Daiichi)
Recent Revenue History
Key Comment
Becton, Dickinson and Company (BD)
Recent Revenue History ($ million, estimated)
Key Comment
Histology
Flow Cytometry
Molecular
Microbiology
BD Vacutainer Blood Collection Products (Preanalytical Systems)
Beckman Coulter Inc
Recent Revenue History ($ million, * estimated)
Key Comment
Hematology
Core Lab
Automation
Immunoassays
Coagulation
FOB
Flow Cytometry
Image Cytometry
Molecular
Research Markets
The Olympus franchise
Blood Bank
Automation
bioMérieux Inc
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