Description
The global blood industry has experienced strong growth in recent years and although this brisk expansion will slow somewhat as products continue to mature and pricing pressures increase, growth will remain solid though 2017 as a result of aging populations in the U.S., Europe and Japan; ongoing technology advancements/new product introductions and indications; expansion of health coverage in the U.S. via health care reform; and continued strong promotion of blood donation by collection agencies.
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.
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). As of 2013, 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 – although other conditions such as variant Creutzfeldt-Jakob disease (vCJD) or HIV may pose high risk in certain regions.
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
The market for human blood and blood components continues to expand as a result of the growing and aging populations, particularly in the developed nations. Aside from RBCs, other blood products are also often required in such procedures. Organ transplants, for example, typically require platelets, cryoprecipitate and frozen plasma. Synthetic blood products are not derived from human blood, but instead represent oxygen-carrying volume-replacement solutions. Although efforts are underway to develop artificial cells or to culture red blood cells (RBCs) from stem cells, present synthetic blood products do not contain cells, antibodies, coagulation factors, or any of the other myriad components of blood itself. One of the primary reasons for their development is to ease the projected shortage in the blood supply.
Blood products covered in the report include:
- Red Blood Cells (RBCs)
- Immunoglobulins
- Albumin
- Other Plasma Products
- Synthetic HBOC and PFC Agents
- Recombinant Factors
Donated blood is collected by specialized collection centers. After collection, whole blood is separated into its three main components: red blood cells (RBCs), platelets, and plasma. Sometimes a fourth component called cryoprecipitate (a fraction of plasma highly concentrated in some clotting factors such as Factor VIII or antihemophilic factor, fibrinogen, and von Willebrand factor) is also generated. Several different types of organizations currently collect blood. While most operate on a not for profit basis, some pay donors.
Blood equipment revenues and forecasts are provided for:
- Blood Collection Equipment
- Automated Blood Collection Equipment
In addition to complete market data, including forecasts to 2017, the study reports:
- Product demand estimates by region
- Collection and transfusion estimates
- High-blood-loss procedure estimates
- Product pricing
- Reimbursement rates
- Epidemiology of key conditions requiring blood products
- 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; profiles of 23 major players in the industry are included.
The report profiles key companies in the industry, including:
- AABB
- Abbott Laboratories
- America’s Blood Centers
- American Red Cross
- Baxter International
- Bio-Rad Laboratories
- BioTime Inc.
- Gen-Probe Inc. /Hologic
- Fenwal/Fresenius Kabi
- Grifols Biologicals, Inc.
- Novartis Diagnostics
- Novo Nordisk A/S
- OPK BioTech
- Oxygen Biotherapeutics
- Perftoran
- Roche
- Sanguine Corp.
Sales estimates for each market segment represent global revenues and are expressed in current dollars. Estimates are provided for the historic 2007 to 2010 period and forecasts are provided through 2017. Historical information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives were conducted to capture the perspectives from industry participants’ point of view and assess trends, and form the basis of the forecasting and competitive analysis.
Specifically excluded from this report are blood testing products not used primarily for blood donation and collection. For example, tests for blood banking represent about 12% of all immunoassay infectious disease tests (which include tests for HIV, hepatitis B and C and syphilis) and about one quarter of all nucleic acid tests (which include assays for West Nile Virus, HIV and hepatitis C).
Table of Contents
TABLE OF CONTENTS ILIST OF EXHIBITS VIICHAPTER ONE: EXECUTIVE SUMMARYTHE GLOBAL BLOOD INDUSTRYSCOPE AND METHODOLOGYOVERVIEWBlood CollectionBlood Typing and Testing for Diseases
- Blood Testing
Blood Storage And ProcessingBlood TransfusionsBlood Management And Safety IssuesSynthetic Blood ProductsBlood Products MarketBlood Testing And Typing Products MarketPlasma and Blood Collection Equipment MarketSynthetic Blood Products MarketCHAPTER TWO: OVERVIEWThe Global Blood IndustryHistory 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 ProductsBlood Transfusions
- Diseases Contracted from Blood Transfusions and Related Identification Testing
- Donor Deferral and Special Populations of Donors
Efforts to Create a Virus-Free Blood Supply
- Plasma Treatment
- 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
CHAPTER THREE: THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING AND USEBlood CollectionOrganizations 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 DemographicsDonor RecruitmentBlood Screening and EvaluationMethods for Collecting Blood from Donors
- Manual Blood Collection
- Automated Blood Collection
- Plateletpheresis
- Leukopheresis
- Red Blood Cell Apheresis
Cord Blood CollectionPlasma 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)
- 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 TransfusionsTesting 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 IX and Factor IX Complex
- 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
- Biovigilence
- Other Safety Precautions
CHAPTER FOUR: THE HUMAN BLOOD AND BLOOD PRODUCTS MARKETDriving 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 TransfusionPlasma 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
- Novel Immunoglobulins
Albumin
- Albumin Market Dynamics
- Albumin Market Size
Prothrombin Complex ConcentratesAlpha-1 Proteinase InhibitorsFibrin SealantsClotting Factors and Factor VIIaCHAPTER FIVE: THE BLOOD TESTING AND TYPING MARKETSBlood Testing Products for Donor Screening
- Market Size
- Latin America
- China
- 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
CHAPTER SIX: SYNTHETIC BLOOD PRODUCTS MARKETDriving 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 DevelopmentHemopure (OPK BioTech)
- Oxygent (Sanguine Corp.)
- Oxycyte (Oxygen Biotherapeutics)
- Perftoran (Perftoran)
- PHER-O2 (Sanguine Corp.)
- MP4OX (Sangart)
- Advate (Baxter)
- Recombinant Factors
- Stem Cell Approaches
Other Research Initiatives
- Jerome H. Holland Laboratory
- Program in Cellular and Molecular Medicine
- National Blood Foundation
CHAPTER SEVEN: TOTAL BLOOD PRODUCTS MARKETThe Blood Products Industry
- Market Size
CHAPTER EIGHT: COMPANY PROFILESAABBAbbott LaboratoriesAmerica’s Blood CentersAmerican Red CrossBaxter InternationalBio-Rad LaboratoriesBioTime Inc.Gen-Probe Inc. /HologicFenwal/Fresenius KabiGrifols Biologicals, Inc.Novartis DiagnosticsNovo Nordisk A/SOPK BioTechOxygen BiotherapeuticsPerftoranRocheSanguine Corp.LIST OF EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARYExhibit 1-1
- Global Blood Products Market, 2012
Exhibit 1-2
- Total Global Market for Blood Collection Equipment: 2007 – 2017
Exhibit 1-3
- Recombinant Factor and High Blood Loss Market: 2012 – 2017
CHAPTER TWO: OVERVIEWExhibit 2-1
- Timeline of Global Blood Industry Development 1922 – 2013
Exhibit 2-2
- Composition of Blood Plasma
Exhibit 2-3
- Viral Inactivation Methods for Viruses Found in Platelets
Exhibit 2-4
- Viral Inactivation Methods for Viruses Found in Red Blood Cells
CHAPTER THREE: THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING AND USEExhibit 3-1
- Worldwide Annual Blood Collection by Component
Exhibit 3-2
- Basic Blood Types
Exhibit 3-3
- Blood Transfusion Compatibility
Exhibit 3-4
- PCR-Based Screening Tests Licensed by CBER
Exhibit 3-4 (cont’d.)
- PCR-Based Screening Tests Licensed by CBER
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, 2013
Exhibit 3-11
- Risk of Contamination
Exhibit 3-12
- Viral Inactivation by Procedure
CHAPTER FOUR: THE HUMAN BLOOD AND BLOOD PRODUCTS MARKETExhibit 4-1
- Geographical Distribution of RBC Demand by Region (United States, Europe, Japan, ROW), 2012
Exhibit 4-2
- Projected World Demand for RBCs, 2012-2017
Exhibit 4-3
- Worldwide Demand for RBCs for Acute and Chronic Conditions, 2012
Exhibit 4-4
- Number of High Blood Loss Surgical Procedures by Type, 2012
Exhibit 4-5
- Average Blood and Component Requirements by Condition
Exhibit 4-6
- Global Blood Products Market by Type, Number of Units, Average Price and Total Value, 2012
Exhibit 4-7
- Global Blood Collection and Transfusion Estimates (Millions of Units), 2012-2017
Exhibit 4-8
- Global Plasma Collection and Transfusion Estimates , 2012-2017
Exhibit 4-9
- Countries Conducting Routine Leukocyte Reduction, 2013
Exhibit 4-10
- Surgical Procedures Amenable to Autologous Blood Donation
Exhibit 4-11
- CMS Blood Product Reimbursement Rates, 2013
Exhibit 4-12
- CMS Blood Transfusion Reimbursement Rates, 2013
Exhibit 4-13
- Selected Plasma Derived Product Approvals, 2005 – 2012
Exhibit 4-14
- The Global Market for Plasma and Plasma Derived Products, 2007 – 2017
Exhibit 4-15
- Selected Plasma Industry Shifts, 2003 – 2012
Exhibit 4-16
- Sales and Market Shares of Leading Suppliers of Plasma and Plasma Derived Products, 2012
Exhibit 4-17
- Global Market for Immunoglobulins by Manufacturer 2012 – 2017
Exhibit 4-18
- Global Market for Human Albumin Products by Brand, 2012 – 2017
Exhibit 4-20
- Leading Factor IX Products, 2013
CHAPTER FIVE: THE BLOOD TESTING AND TYPING MARKETSExhibit 5-1
- Total Global Market for Immunoassay versus Nucleic Acid Testing Equipment: 2007 – 2017
Exhibit 5-2
- Global Blood Banking and Plasmapheresis Testing by Molecular Diagnostics: 2012 – 2017
Exhibit 5-3
- U.S. Blood Banking and Plasmapheresis Testing by Molecular Diagnostics: 2012 – 2017
Exhibit 5-4
- Global Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential: 2012 – 2017
Exhibit 5-5
- Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the United States: 2012 – 2017
Exhibit 5-6
- Selected Commercially Available Molecular (Nucleic Acid) Tests for Blood, Plasma and Organ Donor Screening in the United States, 2005 – 2012
Exhibit 5-7
- Total Global Market for Blood Collection Equipment: 2007 – 2017
Exhibit 5-8
- Global Market for Automated Blood Collection Equipment: 2007 – 2017
CHAPTER SIX: SYNTHETIC BLOOD PRODUCTS MARKETExhibit 6-1
- World Recombinant Factor Market by Brand, 2010 – 2017
Exhibit 6-2
- High Blood Loss Market HBOC and PFC Agent Revenues 2012 – 2017
Exhibit 6-3
- Leading Recombinant Factor Products in Clinical Trials, 2013
CHAPTER SEVEN: TOTAL BLOOD PRODUCTS MARKETExhibit 7-1
- Global Blood Products Market by Segment, 2012
Exhibit 7-2
- Global Blood Products Market Forecast by Segment, 2012 –
Exhibit 7-3
- Global Blood Products Market by Segment, 2017
CHAPTER EIGHT: COMPANY PROFILES