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The Blood IndustryPublished by: BCC Research Published: Nov. 1, 2005 - 222 Pages Table of ContentsINTRODUCTION STUDY GOAL AND OBJECTIVES REASONS FOR DOING THIS STUDY CONTRIBUTION OF THE STUDY AND FOR WHOM SCOPE AND FORMAT METHODOLOGY AND INFORMATION SOURCES ANALYST'S CREDENTIALS RELATED BCC WORK CREDENTIALS RELATED BCC REPORTS BCC ONLINE SERVICES DISCLAIMER SUMMARY MAJOR FINDINGS Summary Table: U.S. PRIMARY AND SECONDARY BLOOD MARKET, THROUGH 2010 ($ MILLIONS) Summary Figure: U.S. PRIMARY AND SECONDARY BLOOD MARKET, 2005 AND 2010 ($ MILLIONS) OVERVIEW THE BLOOD INDUSTRY MARKET STRUCTURE AND SIZE Table 1 U.S. BLOOD AND PLASMA PRODUCTS AND COLELCTION AND PROCESSING PRODUCTS MARKET, THROUGH 2010 ($ MILLIONS) HISTORY OF THE BLOOD INDUSTRY Table 2 TIMELINE OF THE BLOOD INDUSTRY BLOOD AND ITS COMPONENTS PLASMA Table 3 COMPOSITION OF BLOOD CELLULAR ELEMENTS Red and White Blood Cells Platelets IMMUNOGLOBULIN PRODUCTS THE DANGERS OF TRANSFUSED BLOOD TRANSFUSION ASSOCIATED RISKS Diseases Contracted from Blood Transfusions and Related Identification Testing Table 4 MAJOR DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS HIV/AIDS Table 5 CBER LICENSED HIV DONOR SCREENING TESTS Hepatitis A Table 6 CBER LICENSED SCREENING TESTS FOR HEPATITIS B Table 7 CBER LICENSED SCREENING TESTS FOR HEPATITIS C Table 8 CBER LICENSED SCREENING TESTS FOR HTLV-I AND HTLV-II Table 9 CBER LICENSED SCREENING TESTS FOR CMV "Mad Cow Disease"-Creutzfeldt-Jakob Disease (Cjd) Syphilis EFFORTS TO CREATE A VIRUS-FREE BLOOD SUPPLY Plasma Treatments Trinitrobutyl Phosphate and Sodium Cholate Platelet Treatments RBCs NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS BLOOD/PLASMA COMPONENT RISKS THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING AND USE BLOOD COLLECTION ORGANIZATIONS collecting blood For-Profit Blood Collection Table 10 NUMBER OF FDA LICENSED/UNLICENSED BLOOD ESTABLISHMENTS-FISCAL YEAR 2002* National Donor Deferral Registry Non-Profit Blood Collection Community Blood Banks Hospitals Other Blood Collection Sites BLOOD DONATION DEMOGRAPHICS DONOR RECRUITMENT AND REGULATIONS BLOOD SCREENING AND EVALUATION METHODS FOR COLLECTING BLOOD FROM A DONOR Manual Collection Automated Collection Plasmapheresis Plateletpheresis Leukopheresis Red Blood Cell Apheresis PLASMA COLLECTION Commercial Nature of Plasmapheresis Global Nature of the Plasma Industry Plasma Fractionators Distributors/Brokers BLOOD TYPING AND TESTING FOR DISEASES Blood Typing Table 11 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS Table 12 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS Methods of Typing Manual Blood Typing Methods Slide/Tile Testing Tube Testing Microplate Automated Blood Typing and Screening Methods Blood Testing Blood Storage BLOOD PROCESSING Preparation and Use of the Components Red Blood Cell Components Platelets BLOOD TRANSFUSIONS Testing Before Transfusion Manual Cross-Match Techniques Major Cross-Match Minor Cross-Match Antibody Screen Coombs Test TYPES OF TRANSFUSIONS Whole Blood Packed Red Blood Cells Platelets Leukocytes Fresh Frozen Plasma (FFP) Table 13 SELECTED USES OF FFP Cryoprecipitate Coagulation Factors Table 14 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE Immune Serum Globulin/IMIG/IGIV Factor VIII Factor IX and Factor IX Complex Factor VIIa Fibrin/Thrombin Therapeutic Apheresis BLOOD MANAGEMENT ISSUES AVAILABILITY ISSUES BLOODLESS SURGERY SAFETY ISSUES-RISK MANAGEMENT Table 15 FACTORS TO REDUCE RISKS OF TRANSFUSION-ASSOCIATED DISEASES Better Donor Screening Better Viral Screening Tests Get More Repeat Donors Develop Better Viral Inactivation Processes Selective Use of Blood Derivative Products REGULATION OF THE BLOOD BUSINESS REGULATION OF THE U.S. BLOOD BUSINESS Table 16 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S. BLOOD SAFETY STATUTORY AUTHORITY OF THE FDA Center for Biologics Evaluation and Research Office of Regulatory Affairs (ORA) Office of Biologics, The Division of Blood and Blood Products Table 17 FDA AUTHORITY IN REGULATING BLOOD BANKING AND BLOOD PRODUCTS THE MAJOR REGULATIONS AND POLICY MATTERS CONCERNING THE U.S. BLOOD SUPPLY The Clinical Laboratory Improvement Act of 1988 (CLIA) The FDA'S Five Layers The FDA Blood Action Plan Table 18 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE FDA Team Biologics HOW REGULATIONS GET IMPLEMENTED Inspecting Blood Banks and Plasma Collection Facilities Table 19 14 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD FACILITIES National Heart, Lung, and Blood Institute (NHLBI) Blood Diseases and Resources Program Occupational Safety and Health Administration (OSHA) Health Care Financing Administration (HCFA) The Department of Defense State Regulatory Agencies VOLUNTARY REGULATION BY PROFESSIONAL AND TRADE ASSOCIATIONS American Association of Blood Banks American Blood Resources Association America's Blood Centers (ABC) PPTA: Plasma Products Therapeutics Association THE EUROPEAN UNION (EU) BLOOD DIRECTIVE ISBT 128 THE FUTURE OF BLOOD REGULATION THE BLOOD AND BLOOD PRODUCTS MARKET DRIVING FORCES OF THE INDUSTRY Figure 1 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND FOR BLOOD FOR TRANSFUSION MARKET SIZE Table 20 U.S. WHOLESALE BLOOD AND BLOOD COMPONENTS MARKET BY TYPE; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Figure 2 VALUE OF U.S. WHOLESALE BLOOD AND BLOOD COMPONENTS MARKET, 2005 AND 2010 ($ MILLIONS) Figure 3 BLOOD MARKET COST AND PRICING ANALYSIS BLOOD COLLECTION DATA Table 21 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, THROUGH 2010 (MILLION UNITS/PINTS) Figure 4 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 1999-2010 (MILLION UNITS/PINTS) Table 22 U.S. PLASMA COLLECTION DATA, THROUGH 2010 (MILLION UNITS/LITERS) Figure 5 U.S. PLASMA COLLECTION DATA, 1999-2010 (MILLION UNITS/LITERS) CHANGING PATTERNS OF TRANSFUSION PROCEDURES Leukoreduction Table 23 ESTIMATED PERCENTAGE OF BLOOD SUPPLY LEUKOREDUCE, 1998-2002 (%) Impact of Autologous Donations Table 24 TRENDS IN PRE-OPERATIVE AUTOLOGOUS (PABD) BLOOD COLLECTIONS, THROUGH 2005 (MILLIONS OF UNITS/PINTS) Types of Autologous Transfusions Risks of PABD PRICING OF BLOOD Table 25 COST OF BLOOD COMPONENTS, THROUGH 2010 ($) Table 26 ESTIMATED MARKET SIZE BLOOD COMPONENTS BY TYPE FOR TRANSFUSION, THROUGH 2010 (MILLIONS OF UNITS) National Blood Exchange (NBE) RBCs and Leukoreduced RBCs Table 27 U.S. WHOLESALE RBCS AND LEUKOREDUCED RBCS MARKET; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Figure 6 VALUE U.S. WHOLESALE RBCS AND LEUKOREDUCED RBCS, 2005 AND 2010 ($ MILLIONS) Platelets Table 28 VALUE U.S. WHOLESALE PLATELETS MARKET; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Figure 7 PLATELETS AS A SHARE OF U.S. WHOLESALE BLOOD AND BLOOD COMPONENTS MARKET, 2005 AND 2010 (%) Random Donor Platelets Fresh Frozen Plasma (FFP) Table 29 U.S. WHOLESALE VALUE OF FRESH FROZEN PLASMA MARKET; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Figure 8 VALUE U.S. WHOLESALE FRESH FROZEN PLASMA, 2005 AND 2010 ($ MILLIONS) Cryoprecipitate Table 30 VALUE OF U.S. WHOLESALE CRYOPRECIPITATE, THROUGH 2010 ($ MILLIONS) Washed Cells Table 31 U.S. WHOLESALE WASHED RBCS; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Deglycerolized Cells Table 32 U.S. WHOLESALE DEGLYCEROLIZED RBCS; NUMBER OF TRANSFUSIONS, AVERAGE PRICE AND VALUE, THROUGH 2010 Other Blood Components Granulocytes Gamma-Irradiated Blood AVERAGE COST OF TRANSFUSION Table 33 AVERAGE COST OF TRANSFUSION TO PATIENT BY PRODUCT TYPE ($) PLASMA AND PLASMA DERIVED PRODUCTS Plasma Market Size Market Dynamics Plasma Therapeutic Products Table 34 U.S. MARKET SIZE PLASMA THERAPEUTIC DERIVATIVES BY TYPE, THROUGH 2010 ($ MILLIONS) Figure 9 SHARE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE, 2005 AND 2010 (%) Albumin and Plasma Protein Fraction (PPF) FDA Notification Regarding Safety of Albumin Administration In Critically Ill Recombinant Human Albumin Albumin Market Dynamics Table 35 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN FRACTION (PPF) PRODUCTS Albumin and PPF Market Size Table 36 U.S. MARKET FOR HUMAN SERUM ALBUMIN AND PPF, THROUGH 2010 (UNITS, PRICE AND VALUE) Clotting Factors Table 37 BLOOD CLOTTING FACTORS Hemophilia Table 38 WORLDWIDE AND U.S.HEMOPHILIA STATISTICS, 2004 Market Demand and Market Size Table 39 U.S. MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING FACTORS, THROUGH 2010 (UNITS, PRICE AND VALUE) Figure 10 U.S. SHARE FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING FACTORS, 2005 AND 2010 (%) Factor VIII Table 40 FDA APPROVED FACTOR VIII PRODUCTS Table 41 MARKET SHARE FACTOR VIII COMPANIES, 2005 Figure 11 MARKET SHARE OF FACTOR VIII COMPANIES, 2005 (%) Factor IX Table 42 FDA APPROVED FACTOR IX PRODUCTS Factor VIIa Other Factors Prothrombin Complex Concentrates Table 43 FDA APPROVED PROTHROMBIN COMPLEX CONCENTRATE PRODUCTS Fibrin Sealants and Thrombin Table 44 U.S. MARKET FOR FIBRIN/THROMBIN, THROUGH 2010 ($ MILLIONS) Antithrombin III Table 45 U.S. MARKET FOR ANTITHROMBIN III-THROMBATE, THROUGH 2010 ($ MILLIONS) Immunoglobulins IVIG Table 46 SELECTED CONDITIONS TREATED BY IVIG Table 47 FDA APPROVED IMMUNOGLOBULINS Hyperimmunes Table 48 FDA APPROVED HYPERIMMUNE IMMUNOGLOBULINS Other IMIG IVIG Market Size Table 49 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, THROUGH 2010 ($ MILLIONS) Figure 12 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, 2005 AND 2010 ($ MILLIONS) RSV CMV Immunoglobulin Hepatitis B Immune Globulin RhoD Immunoglobulin Tetanus Immunoglobulin (TIG) Rabies Immunoglobulin Varicella Immunoglobulin Vaccinia Immune Globulin Intravenous (VIG) Alpha-1-Proteinase Inhibitor BLOOD TESTING AND TYPING MARKETS MARKET SIZE Table 50 VALUE U.S. BLOOD TYPING AND BLOOD SCREENING MARKET, THROUGH 2010 ($ MILLIONS) Figure 13 VALUE AND MARKET SHARE OF U.S. BLOOD TYPING AND BLOOD SCREENING MARKET, 2005 AND 2010 (%) TYPES OF TESTING Table 51 NUMBER OF TESTS BY TYPE, 2005 POLYMERASE CHAIN REACTION (PCR) AMPLIFICATION Table 52 CBER LICENSED PCR SCREENING TESTS NUCLEIC ACID AMPLIFICATION TEST (NAT) Table 53 CBER LICENSED NAT DONOR SCREENING TESTS IMMUNOASSAY Table 54 IMMUNOASSAY CBER LICENSED SCREENING TESTS MARKET SIZE BLOOD TESTING PRODUCTS FOR DONOR SCREENING Table 55 THE U.S. BLOOD DONOR SCREENING TESTING MARKET BY TYPE OF TESTS, THROUGH 2010 ($ MILLIONS) Figure 14 U.S. BLOOD DONOR SCREENING TESTING MARKET BY TYPE, 2005 AND 2010 ($ MILLIONS) MARKET PARTICIPANTS DONOR SCREENING PRODUCTS Table 56 COMPANY MARKET SHARE OF DONOR SCREENING TESTS, 2005 (%) Figure 15 COMPANY MARKET SHARE OF DONOR SCREENING TESTS, 2005 (%) Table 57 LIST OF SUPPLIERS DONOR SCREENING TESTS BLOOD TYPING MARKET SIZE BLOOD TYPING Table 58 THE U.S. BLOOD TYPING MARKET-INSTRUMENTS AND SUPPLIES BY TYPE, THROUGH 2010 ($ MILLIONS) MARKET STRUCTURE Manual Typing Methods Automated Blood Typing Immucor Ortho Olympus MARKET SHARE BLOOD TYPING COMPANIES Table 59 MARKET SHARE OF BLOOD TYPING COMPANIES, 2005 Figure 16 MARKET SHARE OF BLOOD TYPING COMPANIES, 2005 (%) BLOOD COLLECTION/TRANSFUSION PRODUCTS AND PROCESSINGEQUIPMENT AND SUPPLIES Table 60 U.S. MARKET FOR BLOOD AND PLASMA COLLECTION/TRANSFUSION PRODUCTS, THROUGH 2010 ($ MILLIONS) COLLECTION PRODUCTS PLASMA AND BLOOD COLLECTION EQUIPMENT Table 61 U.S. MARKET FOR BLOOD AND PLASMA COLLECTION EQUIPMENT BY TYPE, THROUGH 2010 ($ MILLIONS) Figure 17 SHARE OF U.S. MARKET FOR BLOOD AND PLASMA COLLECTION PRODUCTS BY TYPE, 2005 AND 2010 (%) Blood Salvage OTHER COLLECTION EQUIPMENT Stem Cell Isolation Equipment Table 62 U.S. MARKET FOR OTHER PLASMA COLLECTION PRODUCTS, THROUGH 2010 ($ MILLIONS) MARKET PARTICIPANTS Haemonetics PCS2 TCD Total Containment Unit MCS®+ 8150 SYSTEM Cell Saver® System Baxter Autopheresis-C Baxter Cs-3000 Plus Blood Cell Separator Amicus Separator Alyx System Gambro PLASMA COLLECTION SETS Table 63 U.S. MARKET FOR PLASMA COLLECTION SETS, THROUGH 2010 ($ MILLIONS) BLOOD BAGS Table 64 U.S. MARKET FOR BLOOD BAGS, THROUGH 2010 ($ MILLIONS) TRANSFUSION PRODUCTS Table 65 U.S. MARKET FOR TRANSFUSION PRODUCTS BY TYPE, THROUGH 2010 ($ MILLIONS) Transfusion Sets Table 66 U.S. MARKET FOR TRANSFUSION SETS, THROUGH 2010 ($ MILLIONS) Blood Filter Market Table 67 U.S. MARKET FOR FILTERS, THROUGH 2010 ($ MILLIONS) Accessories Table 68 U.S. MARKET FOR TRANSFUSION ACCESSORIES, THROUGH 2010 ($ MILLIONS) TECHNOLOGY CLASSICAL FRACTIONATION METHODS COHN FRACTIONATION ADVANCED FRACTIONATION METHODS AMPLIFICATION METHODS POLYMERASE CHAIN REACTION (PCR) NUCLEIC AMPLIFICATION TECHNOLOGY (NAT) IMMUNOASSAY ENZYME IMMUNOASSAY (EIA) Basic EIA Figure 18 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS Alternate EIA Methods Second-Antibody Precipitation Method Double-Antibody Sandwich Method Reverse-Sandwich Method Reverse-Sandwich Inhibition Method BLOOD INDUSTRY: INTERNATIONAL ANALYSIS GLOBAL MARKETS FOR WHOLE BLOOD COLLECTIONS LOCAL EFFORTS AND IMPROVEMENTS South America Asia Cuba India Pacific Region Australia New Zealand Africa South Africa Canada Europe Austria Britain France Germany Italy Switzerland Turkey Russia GLOBAL MARKETS FOR SOURCE PLASMA COLLECTIONS Table 69 PROJECTED GLOBAL (U.S. AND OTHER MARKETS) PLASMA COLLECTIONS, THROUGH 2010 ($ BILLIONS, MILLIONS LITERS) Figure 19 REGIONAL SHARE OF PROJECTED GLOBAL PLASMA COLLECTIONS, 2005 AND 2010 (%) GLOBAL MARKETS FOR PLASMA DERIVED PRODUCTS Table 70 PROJECTED WORLD (U.S. AND OTHER MARKETS) SALES OF PLASMA PRODUCTS*, THROUGH 2006 ($ BILLIONS) Figure 20 PROJECTED WORLD SALES OF PLASMA PRODUCTS*, 2005 AND 2010 ($ BILLIONS) GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS Table 71 PROJECTED GLOBAL (U.S. AND OTHER) MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS, THROUGH 2010 ($ MILLIONS) Figure 21 REGIONAL SHARE OF PROJECTED GLOBAL MARKET SHARE FOR BLOOD TYPING AND SCREENING PRODUCTS, 2005 AND 2010 (%) GLOBAL MARKETS FOR BLOOD PROCESSING EQUIPMENT AND ASSOCIATED PRODUCTS Table 72 PROJECTED WORLD SALES OF BLOOD PROCESSING EQUIPMENT AND CONSUMABLES, THROUGH 2010 ($ MILLIONS) Figure 22 REGIONAL SHARE OF PROJECTED WORLD MARKET FOR BLOOD PROCESSING EQUIPMENT AND CONSUMABLES, 2005 AND 2010 (%) BLOOD RESEARCH AND DEVELOPMENT DEDICATED BLOOD RESEARCH FACILITIES JEROME H. HOLLAND LABORATORY (ARC) NATIONAL BLOOD FOUNDATION (NBF) CENTER FOR BLOOD RESEARCH (CBR) Table 73 SELECTED RECENT ADVANCES IN ADULT STEM CELL THERAPIES BLOOD SUBSTITUTES FIBRIN SEALANT THE VETERINARY BLOOD MARKET Table 74 REGIONAL VETERINARY BLOOD BANKS CORPORATE PROFILES ABBOTT LABORATORIES AMERICA'S BLOOD CENTERS AMERICAN ASSOCIATION OF BLOOD BANKS (AABB) AMERICAN RED CROSS (ARC) BAXTER INTERNATIONAL INC. BAXTER-HYLAND DIVISION BIO-RAD LABORATORIES GRIFOLS BIOLOGICALS INC HAEMONETICS, INC. IMMUCOR MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABS MEDIMMUNE CORPORATION ORTHO CLINICAL DIAGNOSTICS OLYMPUS DIAGNOSTIC SYSTEMS TALECRIS BIOTHERAPEUTICS ZLB BEHRING PATENT ANALYSIS Table 75 RECENTLY ISSUED PATENTS Table 76 PATENTS BY COMPANY ASSIGNEE APPENDIX PATENTS BLOOD TRANSFUSIONS-11 PATENTS BLOOD DERIVATIVES-(SEPTEMBER 1986 TO PRESENT)-7 PATENTS NUCLEIC ACID AMPLIFICATION (MARCH 2000 TO PRESENT)-40 PATENTS FDA LICENSED SOURCE PLASMA FACILITIES GUIDANCE FOR INDUSTRY RECOGNITION AND USE OF A STANDARD FOR THE UNIFORM LABELING OF BLOOD AND BLOOD COMPONENTS INTRODUCTION BACKGROUND FDA REVIEW AND CONCLUSIONS REPORTING REQUIREMENTS FOR LICENSED ESTABLISHMENTS SUMMARY AbstractINTRODUCTIONA safe and adequate blood supply is essential to the practice of modern medicine. New advances, particularly in the area of automation, have enhanced both safety and blood availability and it is the purpose of this study to detail these advances and their impact on the blood industry. Since BCC last looked at this market in 2001 there have been mergers, consolidations and acquisitions among the major companies as well as advances in technology that have allowed for obtaining more red blood cells from fewer donors. Technological advances have also allowed for greater economies and increased safety in the blood supply. This study describes and analyzes the current markets for blood products, blood tests and blood processing equipment, as well as important, new developments affecting every aspect of this industry. In addition, the report provides an analysis of market value forecasted through 2010 in constant dollars and participating company profiles. The scope and character of the blood-testing segment is constantly changing so the impact of new products, technologies and equipment are analyzed. SCOPE OF STUDY The report contains coverage of:
Data for this study were collected using both primary and secondary data research techniques. A literature search of BCC's extensive library, as well as scientific, medical and business libraries was conducted. On-line databases and government sources were consulted as well. Extensive interviews with industry personnel, scientists, professional and trade organizations, government agency personnel, observers, scientists, and industry professionals were conducted. Data collected were analyzed by BCC personnel to determine specific findings and forecasts. Once these forecasts were obtained they were validated with industry experts; consequently, all estimates provided in this report represent a consensus of BCC personnel, industry participants, and industry observers. Since some segments of this report are not routinely measured, BCC derived estimates from a variety of analogous sources. Whenever market estimates are derived they are fully noted. It should be pointed out that while many factors were considered in constructing different models, the projections are ultimately speculative. As a composite of the opinions and assessments of interviewees, the author, other analysts, and secondary sources, these projections represent something of a consensus. However, all recognize that the relative importance of selected factors could change at any time with new technologies and new products, and thus change the direction of the market projections. All forecasts use constant 2005 dollars. Get Full Details About This Report >> |
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