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The Blood Industry

BCC Research
March 1, 2008
SKU: WA1726139

Abstract Table of Contents Related Reports

The goal of this study on the blood industry is to describe and analyze the current markets for blood products, blood tests, and blood processing equipment as well as present important new developments affecting every aspect of this industry. In addition, the report provides an analysis of market value forecasted through 2012 in constant dollars and participating company profiles. The study covers the major aspects of blood and plasma collection/transfusion, including autologous donations, apheresis, fractionation, blood salvage, and stem cells. The major plasma products such as coagulation factors, human serum albumin, and immunoglobulins are analyzed as well. The scope and character of the blood testing segment is constantly changing so the impact of new products, technologies, and equipment are analyzed.

The study also covers federal regulation of the blood supply, blood system management, an analysis of the companies serving these markets, the international developments in blood banking, and related areas as well as research and patents that will affect the future of the blood industry.

INTRODUCTION: STUDY GOAL AND OBJECTIVES; REASONS FOR DOING THIS STUDY; INTENDED READERSHIP; SCOPE OF REPORT; METHODOLOGY AND INFORMATION SOURCES; ANALYST’S CREDENTIALS; RELATED BCC REPORTS; BCC ONLINE SERVICES; DISCLAIMER
SUMMARY: MAJOR FINDINGS
OVERVIEW: THE BLOOD INDUSTRY; MARKET STRUCTURE AND SIZE; HISTORY OF THE BLOOD INDUSTRY; BLOOD AND ITS COMPONENTS; PLASMA; 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; HIV/AIDS; Hepatitis A; Hepatitis B; Hepatitis C; Hepatitis D; Hepatitis E; Human T Cell Lymphotropic Virus—(HTLV-I, -II); Cytomegalovirus; “Mad Cow Disease”—Creutzfeldt-Jakob Disease; (CJD); Syphilis; Chagas Disease; Chagas Disease (Continued); Current Status of Blood Donor Screening for; Chagas Disease; EFFORTS TO CREATE A VIRUS-FREE BLOOD SUPPLY; Plasma Treatments; Trinitrobutyl Phosphate and Sodium Cholate; Methylene Blue-treated Plasma; Amatosalen HCL—Treated Plasma; Platelet Treatments; RBCs; NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS; Negative Reactions from Blood … (Continued); BLOOD/PLASMA COMPONENT RISKS
THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING, AND USE: BLOOD COLLECTION; ORGANIZATIONS COLLECTING BLOOD; For-profit Blood Collection; Plasma Collection Centers; National Donor Deferral Registry; Nonprofit Blood Collection; American Red Cross; 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; 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 Crossmatch Techniques; Major Crossmatch; Minor Crossmatch; Antibody Screen; Coombs Test; TYPES OF TRANSFUSIONS; Whole Blood; Packed Red Blood Cells; Platelets; Leukocytes; Fresh Frozen Plasma (FFP); Cryoprecipitate; Coagulation Factors; Immune Serum Globulin/Intramuscular Immune; Globulins (IMIG)/Intravenous Immune Globulin; (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; 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; 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; 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; Team Biologics; HOW REGULATIONS GET IMPLEMENTED; Inspecting Blood Banks and Plasma Collection Facilities; OTHER ORGANIZATIONS INVOLVED IN BLOOD; REGULATION; 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; International Society for Blood Transfusion (ISBT) 128; THE FUTURE OF BLOOD REGULATION
THE BLOOD AND BLOOD PRODUCTS MARKET: DRIVING FORCES OF THE INDUSTRY; MARKET OVERVIEW; CHANGING PATTERNS OF TRANSFUSION PROCEDURES; Leukoreduction; Impact of Autologous Donations; Types of Autologous Transfusions; Risks of PABD; PRICING OF BLOOD; National Blood Exchange (NBE); RBCs and Leukoreduced RBCs; Platelets; Random Donor Platelets; Fresh Frozen Plasma (FFP); Cryoprecipitate; Washed Cells; Deglycerolized Cells; Other Blood Components; Granulocytes; Gamma-Irradiated Blood; AVERAGE COST OF TRANSFUSION; PLASMA AND PLASMA-DERIVED PRODUCTS; Plasma Market Size; Plasma Therapeutic Products; Albumin and Plasma Protein Fraction (PPF); FDA Notification Regarding Safety of; Albumin Administration in Critically Ill; Recombinant Human Albumin; Albumin Market Dynamics; TABLE 25 CURRENTLY MARKETED ALBUMIN AND PLASMA; PROTEIN FRACTION (PPF) PRODUCTS; Albumin and PPF Market Size; Clotting Factors; Hemophilia; Market Demand and Market Size; Factor VIII; Factor VIII (Continued); Factor IX; Factor VIIa; Other Factors; Prothrombin Complex Concentrates; Fibrin Sealants and Thrombin; Antithrombin III; Immunoglobulins; IVIG; Hyperimmunes; Other; IMIG; Immunoglobulin Market Size; 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; Alpha-1-Proteinase (Continued)
BLOOD TESTING AND TYPING MARKETS: MARKET SIZE; TYPES OF TESTING; POLYMERASE CHAIN REACTION (PCR) AMPLIFICATION; NUCLEIC ACID AMPLIFICATION TEST (NAT); IMMUNOASSAY; MARKET SIZE BLOOD TESTING PRODUCTS FOR DONOR; SCREENING; MARKET PARTICIPANTS DONOR SCREENING PRODUCTS; BLOOD TYPING; MARKET SIZE BLOOD TYPING; MARKET STRUCTURE AND PARTICIPANTS; Manual Typing Methods; Automated Blood Typing; Immucor; Ortho; Olympus; BLOOD COLLECTION/TRANSFUSION PRODUCTS AND PROCESSING EQUIPMENT AND SUPPLIES; COLLECTION PRODUCTS; PLASMA AND BLOOD COLLECTION EQUIPMENT; Blood Salvage; OTHER COLLECTION EQUIPMENT; MARKET PARTICIPANTS; Haemonetics; PCS2; TCD Total Containment Unit; MCS+ 8150 System; Cell Saver System; OrthoPAT System; ACP 215 System; Baxter; Autopheresis-C; Alyx Component Collection System; CS-3000 Plus Blood Cell Separator; Amicus Separator; Gambro BCT; PLASMA COLLECTION SETS; BLOOD BAGS; TRANSFUSION PRODUCTS; Transfusion Sets; Blood Filter Market; Accessories
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; Alternate EIA Methods; Second Antibody Precipitation Method; Double Antibody Sandwich Method; Reverse Sandwich Method; Reverse Sandwich Inhibition Method; Reverse Sandwich … (Continued)
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; GLOBAL MARKETS FOR BLOOD THERAPEUTICS; GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS; GLOBAL MARKETS FOR BLOOD PROCESSING EQUIPMENT AND ASSOCIATED PRODUCTS
BLOOD RESEARCH AND DEVELOPMENT: DEDICATED BLOOD RESEARCH FACILITIES; JEROME H. HOLLAND LABORATORY (ARC); NATIONAL BLOOD FOUNDATION (NBF); CENTER FOR BLOOD RESEARCH (CBR); Center for Blood Research (CBR)…(Continued); Center for Blood Research (CBR)…(Continued); Center for Blood Research (CBR)…(Continued); BLOOD SUBSTITUTES; BLOOD SUBSTITUTES (CONTINUED); FIBRIN SEALANT; THE VETERINARY BLOOD MARKET; THE VETERINARY BLOOD MARKET (CONTINUED)
COMPANY PROFILES: ABBOTT LABORATORIES; AMERICA’S BLOOD CENTERS; AMERICAN ASSOCIATION OF BLOOD BANKS (AABB); AMERICAN RED CROSS (ARC); BAXTER INTERNATIONAL, INC.; BIO-RAD LABORATORIES; CSL BEHRING; GRIFOLS BIOLOGICALS, INC; GRIFOLS BIOLOGICALS, INC. (CONTINUED); HAEMONETICS, INC.; IMMUCOR; MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABS; MEDIMMUNE CORPORATION; ORTHO-CLINICAL DIAGNOSTICS; OLYMPUS DIAGNOSTIC SYSTEMS; TALECRIS BIOTHERAPEUTICS
PATENT ANALYSIS
APPENDIX
PATENTS: BLOOD TRANSFUSIONS—11 PATENTS; Blood Transfusions—11 Patents /Continued); Blood Transfusions—11 Patents /Continued); Blood Transfusions—11 Patents /Continued); Blood Transfusions—11 Patents /Continued); BLOOD DERIVATIVES—(SEPTEMBER 1986 TO PRESENT)—; SEVEN PATENTS; Blood Derivatives…(Continued); Blood Derivatives…(Continued); Blood Derivatives…(Continued); NUCLEIC ACID AMPLIFICATION (MARCH 2000 TO; PRESENT) — 40 PATENTS; Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued); Nucleic Acid Amplification…(Continued)
FDA-LICENSED SOURCE PLASMA FACILITIES: FDA-LICENSED SOURCE PLASMA … (CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED); FDA-LICENSED SOURCE PLASMA …(CONTINUED)
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
LIST OF TABLES: SUMMARY TABLE U.S. BLOOD MARKET, THROUGH 2012; ($ MILLIONS); TABLE 1 U.S. BLOOD PRODUCTS AND COLLECTION AND; PROCESSING PRODUCTS MARKET, THROUGH 2012 ($ MILLIONS); TABLE 2 TIMELINE OF THE BLOOD INDUSTRY; TABLE 3 COMPOSITION OF BLOOD; TABLE 4 MAJOR DISEASES CONTRACTED FROM BLOOD; TRANSFUSIONS; TABLE 5 CBER-LICENSED HIV DONOR SCREENING TESTS; 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; TABLE 10 CBER-LICENSED SCREENING TESTS FOR WEST NILE; TABLE 11 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS; TABLE 12 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS; TABLE 13 SELECTED USES OF FFP; TABLE 14 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE; TABLE 15 FACTORS TO REDUCE RISKS OF TRANSFUSIONASSOCIATED; DISEASES; TABLE 16 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S.; BLOOD SAFETY; TABLE 17 FDA AUTHORITY IN REGULATING BLOOD BANKING AND; BLOOD PRODUCTS; TABLE 18 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE; FDA; TABLE 19 14 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD; FACILITIES; TABLE 20 U.S. BLOOD COLLECTION AND TRANSFUSION DATA,; THROUGH 2012 (MILLION UNITS/PTS.); TABLE 21 U.S. PLASMA COLLECTION DATA, THROUGH 2012; (MILLION UNITS/L); TABLE 22 COST OF BLOOD COMPONENTS, THROUGH 2012 ($); TABLE 23 AVERAGE COST OF TRANSFUSION TO PATIENT BY; PRODUCT TYPE, 2007 ($); TABLE 24 U.S. MARKET SIZE PLASMA THERAPEUTIC DERIVATIVES; BY TYPE, THROUGH 2012 ($ MILLIONS); TABLE 25 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN; FRACTION (PPF) PRODUCTS; TABLE 26 U.S. MARKET FOR HUMAN SERUM ALBUMIN AND PPF,; THROUGH 2012 (UNITS, PRICE, AND VALUE); TABLE 27 BLOOD CLOTTING FACTORS; TABLE 28 WORLDWIDE AND U.S.HEMOPHILIA STATISTICS, 2007; TABLE 29 U.S. MARKET FOR PLASMA-DERIVED AND RECOMBINANT; CLOTTING FACTORS, THROUGH 2012 ($ MILLIONS); TABLE 30 FDA-APPROVED FACTOR VIII PRODUCTS; TABLE 31 U.S. MARKET SHARE FACTOR VIII COMPANIES, 2007; TABLE 32 FDA-APPROVED FACTOR IX PRODUCTS; TABLE 33 FDA-APPROVED PROTHROMBIN COMPLEX CONCENTRATE; PRODUCTS; TABLE 34 U.S. MARKET FOR FIBRIN/THROMBIN, THROUGH 2012; ($ MILLIONS); TABLE 35 U.S. MARKET FOR ANTITHROMBIN III—THROMBATE,; THROUGH 2012 ($ MILLIONS); TABLE 36 SELECTED CONDITIONS TREATED BY IVIG; TABLE 37 FDA-APPROVED IMMUNOGLOBULINS; TABLE 38 FDA-APPROVED HYPERIMMUNE IMMUNOGLOBULINS; TABLE 39 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE,; THROUGH 2012 ($ MILLIONS); TABLE 40 VALUE U.S. BLOOD TYPING AND BLOOD SCREENING; MARKET, THROUGH 2012 ($ MILLIONS); TABLE 41 CBER-LICENSED PCR SCREENING TESTS; TABLE 42 CBER-LICENSED NAT DONOR SCREENING TESTS; TABLE 43 IMMUNOASSAY CBER-LICENSED SCREENING TESTS; TABLE 44 AVERAGE COST OF DONOR BLOOD TESTING, 2007 AND; 2012 ($ MILLIONS); TABLE 45 THE U.S. BLOOD DONOR SCREENING TESTING MARKET; BY TYPE OF TESTS, THROUGH 2012 ($ MILLIONS); TABLE 46 LIST OF SUPPLIERS DONOR SCREENING TESTS; TABLE 47 THE U.S. BLOOD TYPING MARKET—INSTRUMENTS AND; SUPPLIES BY TYPE, THROUGH 2012 ($ MILLIONS); TABLE 48 U.S. MARKET FOR BLOOD AND PLASMA; COLLECTION/TRANSFUSION PRODUCTS, THROUGH 2012; ($ MILLIONS); TABLE 49 U.S. MARKET FOR COLLECTION PRODUCTS BY; TYPE, THROUGH 2012 ($ MILLIONS); TABLE 50 U.S. MARKET FOR BLOOD AND PLASMA; COLLECTION EQUIPMENT BY TYPE, THROUGH 2012; ($ MILLIONS); TABLE 51 U.S. MARKET FOR OTHER PLASMA COLLECTION; PRODUCTS, THROUGH 2012 ($ MILLIONS); TABLE 52 U.S. MARKET FOR PLASMA COLLECTION SETS, THROUGH; 2012 ($ MILLIONS); TABLE 53 U.S. MARKET FOR BLOOD BAGS, THROUGH 2012; ($ MILLIONS); TABLE 54 U.S. MARKET FOR TRANSFUSION PRODUCTS BY TYPE,; THROUGH 2012 ($ MILLIONS); TABLE 55 U.S. MARKET FOR TRANSFUSION SETS, THROUGH 2012; ($ MILLIONS); TABLE 56 U.S. MARKET FOR FILTERS, THROUGH 2012 ($ MILLIONS); TABLE 57 U.S. MARKET FOR TRANSFUSION ACCESSORIES,; THROUGH 2012 ($ MILLIONS); TABLE 58 PROJECTED GLOBAL (U.S. AND OTHER MARKETS); PLASMA COLLECTIONS, THROUGH 2012 ($ BILLIONS, MILLIONS; LITERS); TABLE 59 PROJECTED WORLD (U.S. AND OTHER MARKETS) SALES; OF PLASMA PRODUCTS*, THROUGH 2012 ($ BILLIONS); TABLE 60 PROJECTED GLOBAL (U.S. AND OTHER) MARKETS FOR; BLOOD TYPING AND SCREENING PRODUCTS, THROUGH 2012; ($ MILLIONS); TABLE 61 PROJECTED WORLD SALES OF BLOOD COLLECTION AND; PROCESSING EQUIPMENT AND CONSUMABLES, THROUGH 2012; ($ MILLIONS); TABLE 62 SELECTED ADVANCES IN ADULT STEM CELL THERAPIES; TABLE 63 REGIONAL VETERINARY BLOOD BANKS; TABLE 64 RECENTLY ISSUED PATENTS; TABLE 65 PATENTS BY COMPANY ASSIGNEE
LIST OF FIGURES: SUMMARY FIGURE U.S. BLOOD MARKET, 2007 AND 2012; ($ MILLIONS); FIGURE 1 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND; FOR BLOOD FOR TRANSFUSION; FIGURE 2 BLOOD MARKET COST AND PRICING ANALYSIS; FIGURE 3 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 2005-; 2012 (MILLION UNITS/PTS.); FIGURE 4 U.S. PLASMA COLLECTION DATA, 2005-2012 (MILLION; UNITS/L); FIGURE 5 SHARE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,; 2007 AND 2012 (%); FIGURE 6 U.S. SHARE FOR PLASMA-DERIVED AND RECOMBINANT; CLOTTING FACTORS, 2007 AND 2012 (%); FIGURE 7 MARKET SHARE OF FACTOR VIII COMPANIES, 2007 (%); FIGURE 8 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, 2007; AND 2012 ($ MILLIONS); FIGURE 9 VALUE AND MARKET SHARE OF U.S. BLOOD TYPING AND; BLOOD SCREENING MARKET, 2007 AND 2012 (%); FIGURE 10 U.S. BLOOD DONOR SCREENING TESTING MARKET BY; TYPE, 2007 AND 2012 ($ MILLIONS); FIGURE 11 SHARE OF U.S. MARKET FOR BLOOD AND PLASMA; COLLECTION PRODUCTS BY TYPE, 2007 AND 2012 (%); FIGURE 12 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS

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