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Blood: The Worldwide Market for Blood Products, Blood Testing, Blood Equipment, and Synthetic Blood Products

October 2014 | 225 pages | ID: BE9BD50AB36EN
Kalorama Information

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Kalorama Information's Blood: The Worldwide Market for Blood Products, Blood Testing, Blood Equipment, and Synthetic Blood Products provides an analysis of all the key market segments involved in this industry, including products, equipment and testing.

There is an expanding market for human blood and blood components as a result of the growing and aging populations, particularly in the developed nations. While some countries such as India and the Philippines set prices for blood and blood components, in many of the developed nations including the U.S., there is no uniform, fixed price for blood. Rather, the cost varies from country to country and region to region, with even nearby centers often charging different prices and fluctuations often occurring.

Blood products covered in the report include:
  • Red Blood Cells (RBCs)
  • Immunoglobulins
  • Albumin
  • Other Plasma Products
  • Synthetic HBOC and PFC Agents
  • Recombinant Factors
Although the blood supplies in the developed nations are, to a very high degree, free of disease-causing viruses, the risk of transfusion-related infection is nonetheless present. Because these supplies contain human blood, achieving 100% virus eradication is unlikely. A variety of infectious agents can be present in blood, including viruses (e.g., HIV-1, hepatitis B and C, HTLV, West Nile virus), bacteria, protozoans, Chagas disease, Lyme Disease and prions (e.g., the agent of variant Crueutzfeldt-Jakob disease, which is the human form of mad cow disease). Nonetheless, blood safety is relatively high, due to the widespread usage of blood testing. As of 2014, the main residual risk is due to hepatitis B virus - ranging from 10 in Spain to 1.6 per million donations in France and Germany.

Testing markets covered include:
  • Blood Banking and Plasmapheresis Testing
  • Blood Typing
  • Human Immunodeficiency Virus (HIV) Testing
  • Hepatitis A Virus Testing
  • Hepatitis B Virus Testing
  • Hepatitis C Virus Testing
  • Human T-Cell Leukemia Virus Testing
  • West Nile Virus Testing
  • Other Safety Testing
  • High-blood-loss procedure estimates
  • Product pricing
  • Reimbursement rates
  • Products on the market and in development
The report also provides discussions of the key trends, as well as the regulatory, business, and clinical challenges facing the various sectors.

The report profiles key companies in the industry, including:
  • 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.
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

Modern automatic plateletpheresis allows the blood donor to give a portion of his platelets, while retaining the red blood cells and a portion of the plasma. While the basic principles of the technique are the same as in the manual procedure, automatic plateletpheresis uses a computer-controlled machine to processthe donor’s blood in a sterile single-use centrifuge, and return unwanted components to the donor. This allows repetition of the draw-centrifuge-return cycle to obtain more platelets. Using this technique, six or more units of platelets are can be harvested in a single sitting, depending upon the donor’s platelet count.

Most newer apheresis devices can separate a dose of platelets in about 60 to120 minutes depending on the donor's health. Due to the length of the donation procedure and the size of the machine, though, most platelet donations are conductedin blood centers instead of during mobile blood drives.

Emerging devices attempt to address pathogens in harvested platelets. In Europe, for example, TerumoBCT has launched a pathogen reduction system forplatelets. The Mirasol system applies riboflavin and light to reduce the pathogen loadin blood products, and the company claims that it is the first technology to showindications of working in all three major blood components (platelets, plasma, and redblood cells). Studies have demonstrated Mirasol’s effectiveness on a broad range ofviruses, bacteria and parasites.

Platelet transfusions are typically given to those undergoing chemotherapy forleukemia, multiple myeloma, those with aplastic anemia, AIDS, hypersplenism,sepsis, bone marrow transplant, radiation treatment, organ transplant or surgeries such as cardiopulmonary bypass. Plateletpheresis may also be used therapeutically to treatdisorders resulting in extraordinarily high platelet counts such as essential thrombocytosis.



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