Table of Contents
ONE: Executive Summary
The Global Blood Industry
Scope and Methodology
Overview
Blood Collection
Blood Typing and Testing for Diseases
Blood Typing
Blood Testing
Blood Storage and Processing
Blood Transfusions
Blood Management and Safety Issues
Synthetic Blood Products
Blood Products Market
Blood Testing and Typing Products Market
Plasma and Blood Collection Equipment Market
Synthetic Blood Products Market
TWO: Overview
The Global Blood Industry
History of the Blood Industry
United States
Europe
Asia
Current Blood Industry Issues
Effects of the Economy
Changes from Health Care Reform
Demographic Shifts
Blood and Its Components
Red Blood Cells (Erythrocytes)
White Blood Cells (Leukocytes)
Platelets
Plasma
Immunoglobulin Products
Blood Transfusions
Diseases Contracted from Blood Transfusions and Related Identification Testing
Donor Deferral and Special Populations of Donors
Transfusion-Associated Risks
Efforts to Create a Virus-Free Blood Supply
Plasma Treatment
Platelet Treatments
Red Blood Cell Treatments
Synthetic Blood Products
Blood Volume Expanders
Hemoglobin-Based Oxygen Carriers
Immunologic Properties
Vasoactive Properties
Performance
Perflurocarbon (PFC)-Based Blood Products
Developmental Status
Commercialization Challenges
Factor Products for Hemophilia A
Synthetic Platelets
THREE: The Blood Management System: Blood Collection, Processing and Use
Blood Collection
Organizations Collecting Blood
Not-For-Profit Blood Collection
Red Cross
Community Blood Banks
Hospitals
Other Blood Collection Sites
For-Profit Blood Collection
National Donor Deferral Registry
Donor Donation Demographics
Donor Recruitment
Blood Screening and Evaluation
Methods for Collecting Blood from Donors
Manual Blood Collection
Automated Blood Collection
Plasmapheresis
Plateletpheresis
Leukopheresis
Red Blood Cell Apheresis
Cord Blood Collection
Plasma Collection
Plasma Fractionators
Distributors/Brokers
Blood Typing and Testing for Diseases
Blood Typing
Methods of Blood Typing
Manual Blood Typing Methods
Automated Blood Typing and Screening Methods
Blood Testing
Nucleic Acid Amplification Testing (NAT)
CBER Licensed NAT Screening Tests
Polymerase Chain Reaction (PCR) Amplification
CBER Licensed PCR Screening Tests
Immunoassay
Enzyme-Linked Immunosorbent Assay
Basic ELISA
Alternate ELISA Methods
Sandwich Method
Reverse Sandwich Method
Reverse Sandwich Inhibition Method
Costs and Other Barriers
Blood Storage
Blood Processing
Cohn Fractionation
Newer Fractionation Methods
Advanced Fractionation Methods
Cascade Plasma Fractionation
Automated Fractionation
Blood Transfusions
Testing Before Transfusion
Coombs Test
Manual Cross-Match Techniques
Major Cross-Match
Minor Cross-Match
Antibody Screen
Types of Transfusions
Whole Blood
Packed Red Blood Cells
Platelets
Leukocytes
Fresh Frozen Plasma (FFP)
Cryoprecipitate
Immune Serum Globulin/IMIG/IGIV
Factor VIII
Factor IX and Factor IX Complex
Factor VIIa
C1 Inhibitor
Fibrin/Thrombin
Therapeutic Apheresis
Blood Management Issues
Availability
Safety Issues
Reducing Blood Typing Errors
Improving Donor Screening
Improving Viral Screening
Increasing Repeat Donation Rates
Enhancing Viral Inactivation Processes
Increasing Voluntary Donation
Preventing Bacterial Infections
Biovigilance
Other Safety Precautions
FOUR: The Human Blood and Blood Products Market
Driving Forces of the Human Blood Industry
Variables Influencing the Demand for Blood Transfusions
Market Size
Changing Patterns of Transfusion Procedures
Leukocyte Reduction
Impact of Autologous Donations
Types of Autologous Donations
Pricing of Blood
National Blood Exchange
RBCs and Leukoreduced RBCs
Washed Red Blood Cells
Deglycerolized Red Blood Cells
Single-Donor Platelets and Random-Donor Platelets
Fresh Frozen Plasma and Pooled Frozen Plasma
Cryoprecipitate
Granulocytes
Gamma-Irradiated Blood
Average Cost of Transfusion
Plasma and Plasma Derived Products
Plasma Market Size
Market Dynamics
Immunoglobulins
Immunoglobulin Market Dynamics
Immunoglobulin Market Size
Hepatitis B Immunoglobulin
RhoD Immunoglobulin
Tetanus Immunoglobulin
Rabies Immunoglobulin
Varicella Immunoglobulin
Vaccinia Immunoglobulin
Neurology and Other Immunoglobulins
Albumin
Albumin Market Dynamics
Albumin Market Size
Other Products
Alpha-1 Proteinase Inhibitors
Fibrin Sealants
Clotting Factors, Factor VIIa and Factor VIII
Factor XIII
Total Market
FIVE: The Blood Testing and Typing Markets
Blood Testing Products for Donor Screening
Market Size
Immunoassays
Nucleic Acid Testing
Market Participants
Immunoassays
Nucleic Acid Testing
Blood Typing Products
Market Size
Market Participants
Plasma and Blood Collection Equipment
Market Size
Market Participants
SIX: Synthetic Blood Products Market
Driving Forces of the Synthetic Blood Products Industry
Variables Influencing the Supply and Demand of Donated Blood
Recombinant Factor Market
Market Size
Market Participants
Oxygen Carrier Market
Market Size
Synthetic Blood Products in Clinical Development
Hemopure (OPK BioTech)
Oxycyte (Oxygen Biotherapeutics)
Advate (Baxter)
Recombinant Factors
Stem Cell Approaches
Other Research Initiatives
Jerome H. Holland Laboratory
Program in Cellular and Molecular Medicine
National Blood Foundation
SEVEN: Total Blood Products Market
The Blood Products Industry
Market Size
EIGHT: Company Profiles
AABB
Abbott Laboratories
Akers Biosciences
America’s Blood Centers
American Red Cross
Baxter International
Bayer AG
BD
BDI Pharma
Beckman Coulter
Beijing Tiantan Biological Products, Ltd
Bharat Serums and Vaccines Ltd.
Bio-Rad Laboratories
Biotest Pharmaceuticals
BioTime Inc.
CHINA BIOLOGIC
CSL BEHRING
DiaSorin
Emergent Biosolutions
Ethicon Biosurgery
Fenwal/Fresenius Kabi
Gen-Probe Inc./Hologic
Grifols Biologicals, Inc.
HAEMONETICS, INC.
HUALAN BIOLOGICAL ENGINEERING
IMMUCOR
Kamada
Lanzhou Institute of Biological Products Nordisk
LFB
Micronics
Novo Nordisk A/S
Octapharma AG
OPK BioTech
ORTHO CLINICAL DIAGNOSTICS
Oxygen Biotherapeutics
Pfizer
ProMetic Biosciences
Reliance Life Sciences
Roche
Ronsen Pharma
Shanghai RAAS Blood Products Co., Ltd
Shire plc
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.
Sinosource Biopharmaceutical, Inc.
Takeda
Terumo BCT
Walvax Biotechnology Co., Ltd.
LIST OF EXHIBITS
ONE: Executive Summary
Exhibit 1-1: Global Blood Products Market, 2013 (RBCs, Immunoglobulins, Albumin,
Other Plasma Products)
Exhibit 1-2: Total Global Market for Blood Collection Equipment: 2008 – 2018
Exhibit 1-3: Recombinant Factor and High Blood Loss Market: 2013 – 2018
TWO: Overview
Exhibit 2-1: Timeline of Global Blood Industry Development 1922 – 2014
Exhibit 2-2: U.S. Expectation of Life at Birth, by Sex and Race, 2014
Exhibit 2-3: Composition of Blood Plasma
Exhibit 2-4: Viral Inactivation Methods for Viruses Found in Platelets
Exhibit 2-5: Viral Inactivation Methods for Viruses Found in Red Blood Cells
THREE: The Blood Management System: Blood Collection, Processing and Use
Exhibit 3-1: Worldwide Annual Blood Collection by Component (Plasma, Platelets, Red Cells, Whole Blood)
Exhibit 3-2: Basic Blood Types
Exhibit 3-3: Blood Transfusion Compatibility
Exhibit 3-4: PCR-Based Screening Tests Licensed by CBER (West Nile Virus [WNV], Human Immunodeficiency Virus-1 [HIV-1], Hepatitis C Virus [HCV], Hepatitis B
Virus [HBV])
Exhibit 3-5: Comparison of Direct and Indirect ELISA Tests
Exhibit 3-6: Results of Cohn Fractionation Method
Exhibit 3-7: Plasma Proteins of Therapeutic Interest
Exhibit 3-8: Factor VIII Products in Development, 2014
Exhibit 3-9: Factor IX Products in Development, 2014
Exhibit 3-10: Factor VII Products in Development, 2014
Exhibit 3-11: Risk of Contamination
Exhibit 3-12: Viral Inactivation by Procedure
FOUR: The Human Blood and Blood Products Market
Exhibit 4-1: Geographical Distribution of RBC Demand by Region, 2013 (United
States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America,
ROW, Total)
Exhibit 4-2: Projected World Demand for RBCs, 2013-2018
Exhibit 4-3: Worldwide Demand for RBCs for Acute and Chronic Conditions, 2013
Exhibit 4-4: Number of High Blood Loss Surgical Procedures by Type, 2013 (Gastrointestinal, Cardiovascular, Orthopedic, Urologic, Thoracic, Other, Total)
Exhibit 4-5: Average Blood and Component Requirements by Condition (Automobile Accident, Heart Surgery, Organ Transplant, Bone Marrow Transplant, Burn)
Exhibit 4-6: Global Blood Products Market by Type (RBCs, Immunoglobulins, Albumin, Other Plasma Products), Number of Units, Average Price and Total Value, 2013
Exhibit 4-7: Global Blood Collection and Transfusion Estimates, 2013-2018
Exhibit 4-8: Global Plasma Collection and Transfusion Estimates, 2013-2018
Exhibit 4-9: Countries Conducting Routine Leukocyte Reduction, 2014
Exhibit 4-10: Surgical Procedures Amenable to Autologous Blood Donation
Exhibit 4-11: CMS Blood Product Reimbursement Rates, 2014
Exhibit 4-12: CMS Blood Transfusion Reimbursement Rates, 2014
Exhibit 4-13: Selected Plasma Derived Product Approvals, 2007 – 2014
Exhibit 4-14: The Global Market for Plasma and Plasma Derived Products, 2008 – 2018
Exhibit 4-15: Selected Plasma Industry Shifts, 2003 – 2014
Exhibit 4-16: Sales and Market Shares of Leading Suppliers of Plasma and Plasma Derived Products, 2013
Exhibit 4-17: Global Market for Immunoglobulins by Manufacturer, 2013 – 2018
Exhibit 4-18: Global Market for Human Albumin Products by Brand, 2013 – 2018
Exhibit 4-19: Global Market for Other Plasma Products, 2013 – 2018
Exhibit 4-20: Prevalence of Conditions Requiring Prothrombin Complex Concentrates
Exhibit 4-21: Leading Factor IX Products, 2014
Exhibit 4-22: Global Market for Other Plasma Products, 2013 – 2018 (RBCs, Immunoglobulins, Albumin, Other Products, Total)
Exhibit 4-23: Geographical Distribution of Human Plasma Products, 2013 (United States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America, ROW, Total)
FIVE: The Blood Testing and Typing Markets
Exhibit 5-1: Total Global Market for Immunoassay versus Nucleic Acid Testing
Equipment, 2008 – 2018
Exhibit 5-2: Geographical Distribution for Immunoassay versus Nucleic Acid Testing Equipment, 2013 (United States, Germany, UK, France, Spain, Japan,
China, Other Asia, Latin America, ROW, Total)
Exhibit 5-3: Global Blood Banking and Plasmapheresis Testing by Molecular
Diagnostics, 2013 – 2018 (HIV, HCV, HBV, HAV, HTLV, WNV, Others, Total)
Exhibit 5-4: U.S. Blood Banking and Plasmapheresis Testing by Molecular
Diagnostics, 2013 – 2018 (HIV, HCV, HBV, HAV, HTLV, WNV, Others, Total)
Exhibit 5-5: Global Projected Blood Banking and Plasmapheresis Molecular
Diagnostics Testing Market Potential, 2013 – 2018 (HIV, HCV, HBV, HAV, HTLV, WNV, Others, Total)
Exhibit 5-6: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the United States, 2013 – 2018 (HIV, HCV, HBV, HAV, HTLV, WNV, Others, Total)
Exhibit 5-7: Geographical Distribution for Blood Banking and Plasmapheresis
Molecular Diagnostics, 2013 (United States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America, ROW, Total)
Exhibit 5-8: Selected Commercially Available Molecular (Nucleic Acid) Tests for Blood, Plasma and Organ Donor Screening in the United States, 2005 – 2014
Exhibit 5-9: Sales and Market Shares of Leading Suppliers of Blood Testing
Products for Donor Screening, 2013
Exhibit 5-10: Total Global Market for Blood Typing Equipment, 2008 – 2018
Exhibit 5-11: Geographical Distribution for Blood Typing Equipment, 2013 (United
States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America,
ROW, Total)
Exhibit 5-12: Sales and Market Shares of Leading Suppliers of Blood Typing
Equipment, 2013
Exhibit 5-13: Total Global Market for Blood Collection Equipment, 2008 – 2018
Exhibit 5-14: Geographical Distribution for Blood Collection Equipment, 2013 (United States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America, ROW, Total)
Exhibit 5-15: Global Market for Automated Blood Collection Equipment, 2008 – 2018
Exhibit 5-16: Geographical Distribution for Automated Blood Collection Equipment, 2013 (United States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America, ROW, Total)
Exhibit 5-17: Sales and Market Shares of Leading Suppliers of Blood Collection Equipment, 2013
SIX: Synthetic Blood Products Market
Exhibit 6-1: World Recombinant Factor Market by Brand, 2012 – 2018
Exhibit 6-2: Geographical Distribution for World Recombinant Factor Market, 2013 (United States, Germany, UK, France, Spain, Japan, China, Other Asia, Latin America, ROW, Total)
Exhibit 6-3: High Blood Loss Market HBOC and PFC Agent Revenues,
2013 – 2018
Exhibit 6-4: Leading Recombinant Factor Products in Clinical Trials, 2014
SEVEN: Total Blood Products Market
Exhibit 7-1: Global Blood Products Market by Segment, 2013
Exhibit 7-2: Total Global Blood Products Market Forecast by Segment, 2013 – 2018(RBCs and Other Plasma Products, Recombinant Factors, Immunoglobulins, Blood
Collection Equipment, Molecular Diagnostic Tests, Albumin, Blood Typing Reagents and Instruments, HBOCs and PFCs, Total)
Exhibit 7-3: Global Blood Products Market by Segment, 2018
Exhibit 7-4: Total Global Blood Products Market by Region, 2013
Exhibit 7-5: Global Blood Products Market Forecast by Segment and Region, 2013 (United States; Germany; UK; France; Spain; Japan; China; Other Asia; Latin America; ROW; Total; RBCs, Immunoglobulins, Albumin and Other Plasma Products; Recombinant Factors; Blood Collection Equipment; Molecular Diagnostic
Tests; Blood Typing Reagents and Instruments; Total)
Exhibit 7-6: Global Blood Products Market by Segment and Region, 2013
Exhibit 7-7: Global Blood Products Market by Region and Segment, 2013
Exhibit 7-8: Sales and Market Shares of Leading Suppliers of Plasma and Plasma Derived Products, 2013
EIGHT: Company Profiles
Exhibit 8-1: Key Global, National and Regional Blood Industry Players, 2013
