Summary
This completely updated edition of this comprehensive and indispensable report covers the breadth of traditional IVD testing. The report contains complete market statistics and analysis for all areas of IVD, including: - Point-of-Care
- Clinical Chemistry
- Immunoassays
- Molecular Assays
- Hematology
- Coagulation
- Microbiology and Virology
- Blood Banking
- Histology and Cytology
Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Projections are made through 2010. This new 1,000-page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on: - the movement toward POC and decentralization in lab medicine
- miniaturization and molecularization of devices
- geo-economic and demographic influences on markets
- non-invasive sampling
- greatly expanded market data on PGx and SNP testing
- revamped segmentation for clinical chemistry to include workstations and immunoanalyzers
- more information about more immunoassays
- the renewed interest in microbiology/virology based on resistance and the re-emergence of serious hospital- and community-based organisms
- world blood banking developments
- expanded sections on histology/cytology developments including emerging areas such as tissue microarrays, circulating tumor cells, and genomics-fueled innovation.
In addition, there are now profiles of more than established and emerging players in IVD with profiles of more than 421 companies, from the top tier to emerging and niche competitors to watch.
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Content
Chapter One: Executive Summary Blood Collection
Blood Typing and Testing for Diseases
o Blood Typing
o Blood Testing
Blood Storage And Processing
Blood Transfusions
Blood Management And Safety Issues
Synthetic Blood Products
Scope And Methodology
Blood Products Market
Blood Testing And Typing Products Market
Plasma and Blood Collection Equipment Market
Synthetic Blood Products Market
Chapter Two: Introduction and Overview The Global Blood Industry
History of the Blood Industry
o United States
o Europe
o Asia
Blood and its Components
o Red Blood Cells (Erythrocytes)
o White Blood Cells (Leukocytes)
o Platelets
o Plasma
Immunoglobulin Products
Blood Transfusions
o Diseases Contracted from Blood Transfusions and Related Identification Testing
o Transfusion-Associated Risks
Efforts to Create a Virus-Free Blood Supply
o Plasma Treatment
o Platelet Treatments
Synthetic Blood Products
o Blood Volume Expanders
o Hemoglobin Based Oxygen Carriers
o Immunologic Properties
o Vasoactive Properties
o Performance
o Perflurocarbon (PFC) Based Blood Products
o Developmental Status
o Commercialization Challenges
o Factor Products for Hemophilia A
o Synthetic Platelets
Chapter Three: The Blood Management System: Collection, Processing, and Use
Blood Collection
Organizations Collecting Blood
o Not-For-Profit Blood Collection
o Red Cross
o Community Blood Banks
o Hospitals
o Other Blood Collection Sites
o For-Profit Blood Collection
o National Donor Deferral Registry
Donor Donation Demographics
Donor Recruitment
Blood Screening and Evaluation
Methods for Collecting Blood from Donors
o Manual Blood Collection
o Automated Blood Collection
o Plasmapheresis
o Plateletpheresis
o Leukopheresis
o Red Blood Cell Apheresis
Cord Blood Collection
Plasma Collection
o Plasma Fractionators
o Distributors/Brokers
Blood Typing and Testing for Diseases
o Blood Typing
o Methods of Blood Typing
o Manual Blood Typing Methods
o Automated Blood Typing and Screening Methods
Blood Testing
o Nucleic Acid Amplification Testing (NAT)
o CBER Licensed NAT Screening Tests
o Polymerase Chain Reaction (PCR) Amplification
o CBER Licensed PCR Screening Tests
o Immunoassays
o Enzyme-Linked Immunosorbent Assays
o Basic ELISA
o Alternate ELISA Methods
o Sandwich Method
o Reverse Sandwich Method
o Reverse Sandwich Inhibition Method
o Costs and Other Barriers
o Blood Storage
Blood Processing
o Cohn Fractionation
o Classical Fractionation Methods
o Advanced Fractionation Methods
o Cascade Plasma Fractionation
Blood Transfusions
o Testing Before Transfusion
o Coombs Test
o Manual Cross-Match Techniques
o Major Cross-Match
o Minor Cross-Match
o Antibody Screen
Types of Transfusions
o Packed Red Blood Cells
o Platelets
o Leukocytes
o Fresh Frozen Plasma (FFP)
o Cryoprecipitate
o Immune Serum Globulin/IMIG/IGIV
o FactorVIII
o Factor IX and Factor IX Complex
o Factor VIIa
o Fibrin/Thrombin
o Therapeutic Apheresis
Blood Management Issues
o Availability
o Increasing Repeat Donation Rates
o Increasing Voluntary Donation
o Safety Issues
o Reducing Blood Typing Errors
o Improving Donor Screening
o Improving Viral Screening
o Enhancing Viral Inactivation Processes
o Preventing Bacterial Infections
o Prion Reduction
o Other Safety Precautions
Chapter Four: The Human Blood and Blood Products Market o Variables Influencing the Demand for Blood Transfusions
o Market Size
Changing Patterns of Transfusion Procedures
o Leukocyte Reduction
o Impact of Autologous Donations
o Types of Autologous Donations
Pricing of Blood
o National Blood Exchange
o RBCs and Leukoreduced RBCs
o Washed Red Blood Cells
o Deglycerolized Red Blood Cells
o Single-Donor Platelets and Random-Donor Platelets
o Fresh Frozen Plasma and Platelet-Rich Plasma
o Cryoprecipitate
o Granulocytes
o Gamma-Irradiated Blood
Average Cost of Transfusion
Plasma and Plasma Derived Products
o Plasma Market Size
o Market Dynamics
o Immunoglobulins
o Immunoglobulin Market Dynamics
o Immunoglobulin Market Size
o RSV Immunoglobulin
o CMV Immunoglobulin
o Hepatitis B Immunoglobulin
o RhoD Immunoglobulin
o Tetanus Immunoglobulin
o Rabies Immunoglobulin
o Varicella Immunoglobulin
o Vaccinia Immunoglobulin
o Albumin
o Albumin Market Dynamics
o Albumin Market Size
o Prothrombin Complex Concentrates
o Alpha-1 Proteinase Inhibitors
o Fibrin Sealants
o Clotting Factors and Factor VIIa
Chapter Five: The Blood Testing and Typing Markets Blood Testing Products for Donor Screening
o Market Size
o Immunoassays
o Nucleic Acid Testing
o Market Participants
o Immunoassays
o Nucleic Acid Testing
Blood Typing Products
Plasma and Blood Collection Equipment
o Market Participants
Chapter six: Synthetic Blood Products Market Driving Forces of the Synthetic Blood Products Industry
Recombinant Factor Market
Market Size
o Oxygen Carrier Market
o Synthetic Blood Products in Clinical Development
-Hemolink (Hemosol)
-Hemopure (Biopure)
-PolyHeme (Northfield Laboratories)
-Oxygent (Alliance Pharmaceutical)
-Albrec (Mitsubishi Pharma)
-PHP (Curacyte)
-Advate (Baxter)
o Recombinant Factors
-Synthocytes
- Gene Therapy
o Other Research Initiatives
- Jerome H. Holland Laboratory
- Center for Blood Research
- National Blood Foundation
Chapter seven: Company Profiles Abbott Laboratories
Alliance Pharmaceuticals
American Association of Blood Banks (AABB)
America's Blood Centers
American Red Cross
Baxter International
Biopure Corp.
Bio-Rad Laboratories
BioTime Inc.
Chiron (Acquired by Novartis)
Gen-Probe Inc.
Grifols Biologicals, Inc.
Haemonetics, Inc.
Hemosol Corp.
JP Laboratories Inc.
Massachusetts Public Health Biologic Labs
Medimmune Corp.
Northfield Laboratories
Novo Nordisk A/S
Ortho Clinical Diagnostics
Perftoran
Sanguine Corp.
Synthetic Blood International
Talecris Biotherapeutics
ZLB Behring
List of Exhibits
Chapter One: Executive Summary
Exhibit 1: Market Summary: Global Blood Products Market by Component 2005
Exhibit 2: Global Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Estimates by Analyte 2005-2012
Exhibit 3: Global Market for Blood Collection Equipment Total Revenue vs Automated Equipment Revenue 2000-2012
Exhibit 4: Recombinant Factor and High Blood Loss Market 2005-2012
Chapter Two: Introduction and Overview
Exhibit 5: Timeline of Global Blood Industry Development 2006-2011
Exhibit 6: Composition of Blood Plasma
Exhibit 7: Viral Inactivation Methods for Viruses Found in Platelets
Exhibit 8: Viral Inactivation Methods for Viruses Found in Red Blood Cells
Chapter Three: The Blood Management System: Collection, Processing, and Use
Exhibit 9: Worldwide Annual Blood Collection by Component
Exhibit 10: Basic Blood Types
Exhibit 11: Blood Transfusion Compatibility
Exhibit 12: PCR-Based Screening Tests Licensed by CBER
Exhibit 13: Comparison of Direct and Indirect ELISA
Exhibit 14: Results of Cohn Fractionation Method
Exhibit 15: Plasma Proteins of Therapeutic Interest
Exhibit 16: Risk of Contamination by Organism/Contaminant
Exhibit 17: Viral Inactivation by Procedures and Targets
Chapter Four: The Human Blood and Blood Products Market
Exhibit 18: Geographical Distribution of RBC Demand by Region (United States, Europe, Japan, ROW) 2005
Exhibit 19: Projected World Demand for RBCs 2005-2012
Exhibit 20: Worldwide Demand for RBCs for Acute and Chronic Conditions, 2005
Exhibit 21: Number of High Blood Loss Surgical Procedures, Units of RBC per Procedure, Total Units Transfused, and Total Market Value by Procedure Type (Gastrointestinal, Cardiovascular, Orthopedic, Urologic, Thoracic, Other) 2005
Exhibit 22: Average Blood and Component Requirements by Condition
Exhibit 23: Global Blood Products Market by Type of Product, Number of Units, Average Price, and Total Value, 2005
Exhibit 24: Global Blood Collection and Transfusion Estimates (Millions of Units) 2005-2012
Exhibit 25: Global Plasma Collection and Transfusion Estimates 2005-2012
Exhibit 26: Countries Conducting Routine Leukocyte Reduction, 2006
Exhibit 27: Surgical Procedures Amenable to Autologous Blood Donation
Exhibit 28: CMS Platelet Reimbursement Rates by CPT/HCPCS Code 2005
Exhibit 29: CMS Platelet Reimbursement Rates, 2005
Exhibit 30: Selected Plasma Derived Product Approvals (Year, Product, Manufacturer, Indication, Benefit) 2002-2006
Exhibit 31: The Global Market for Plasma and Plasma Derived Products 2000-2012
Exhibit 32: Selected Plasma Industry Shifts, 2003-2006
Exhibit 33: Sales and Market Shares of Leading Suppliers of Plasma and Plasma Derived Products 2005
Exhibit 34: Global Market for Immunoglobulins by Leading Manufacturer 2005-2012
Exhibit 35: Global Market for Human Albumin Products by Brand 2005-2012
Exhibit 36: Prevalence of Conditions Requiring Prothrombin Complex Concentrates by Factor
Exhibit 37: Leading Factor IX Products, 2006
Chapter five: The Blood Testing and Typing Markets
Exhibit 38: Global Blood Banking and Plasmapheresis Testing Volume by Molecular Diagnostics by Analyte (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2005-2012
Exhibit 39: U.S. Blood Banking and Plasmapheresis Testing Volume by Molecular Diagnostics by Analyte (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2005-2012
Exhibit 40: Global Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential (Number of Tests, Cost per Test, Market Size) by Analyte (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2005-2012
Exhibit 41: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the United States: 2005-2012
Exhibit 42: Commercially Available Molecular (Nucleic Acid) Tests for Blood, Plasma and Organ Donor Screening in the United States (Tradename, Format, Sample, Use, Manufacturer, Approval Date)
Exhibit 43: Global Market for Blood Collection Equipment 2005-2012
Exhibit 44: Global Market for Automated Blood Collection Equipment: 2005-2012
Chapter six: Synthetic Blood Products Market
Exhibit 45: World Recombinant Factor Market by Brand 2005-2012
Exhibit 46: High Blood Loss Market HBOC and PFC Agent Revenues 2007-2012
Exhibit 47: Recombinant Factor Products in Clinical Trials
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