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Medical Diagnostic Reagents, Carriers and Other Consumables

Published by: BCC Research

Published: Sep. 1, 2003 - 168 Pages


Table of Contents


Introduction

Medical Diagnostic Reagents, Chemicals, And Other Consumables



Study Background



Study Goals And Objectives



Intended Audience



Scope And Format



Methodology And Information Sources



Analyst Credentials



Related Bcc Research



Reports



Monthly Newsletter



Bcc On-Line Services


Executive Summary

Summary Table:

Total U.S. And Global Market For In-Vitro Diagnostic Chemicals, Carriers, And Consumables, Through 2008 ($ Billions)



Summary Figure:

Total U.S. And Global Market For In-Vitro Diagnostic Chemicals, Carriers, And Consumables, 2002-2008 ($ Billions)


Overview Of Diagnostic Chemicals, Carriers, And Other Consumables Market

Types Of Tests



Microbiological Analysis



Chemical Analysis



Immunological Analysis



Nucleic Acid Analysis



Types Of Products



Reagents



Microbiological Reagents



Table 1 Major Microbiological Reagents



Chemical Reagents



Table 2 Major Diagnostic Chemical Reagents



Immunological Reagents



Table 3 Major Diagnostic Immunological Reagents



Nucleic Acid Reagents



Table 4 Diagnostic Nucleic Acid Reagents



Other Chemicals



Functional Chemicals



Nonfunctional Chemicals



Disposable Device Carriers And Other Consumables


Applications And End-User Markets

Diagnostic Testing Applications



Infectious Disease Testing



Figure 1 U.S. Market For Infectious Disease Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Figure 2 Percent Market Share For Diagnostic Tests For Infectious Diseases By Type Of Test, 2002 (%)



Table 5 U.S. Infectious Disease Testing Market By Product Type, 2002



Market Drivers



Epidemiological Trends



Table 6 U.S. Trends In Major Infectious Diseases, 1990 Through 2002 (Number Of New Cases Annually)



Table 7 Impact Of Epidemiological Trends On The Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Infectious Disease Testing, 2002-2008 ($ Millions)



Development And Commercialization Of New Diagnostic Techniques



Threat Of Bioterrorism



Projected Market



Table 8 Projected Demand For Infectious Disease Diagnostic Products, Through 2008 ($ Millions)



Cancer Testing



Figure 3 Market For Cancer Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Figure 4 Diagnostic Tests For Cancer By Type Of Test, 2002 (Percent Of All Tests By Value)



Table 9 U.S. Cancer Testing Market By Product Type, 2002 ($ Billions)



Market Drivers



Demographic And Epidemiological Trends, 2002-2008



Table 10 Impact Of Demographic And Epidemiological Trends On The Market For Cancer Diagnostic Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Development And Commercialization Of New Diagnostic Techniques



Replacement Tests



New Applications



Hpv Screening For Cervical Cancer



Mammastatin Serum Assays For Breast Cancer Screening



Table 11 Impact Of New Technologies On Market For Cancer Diagnostic Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Projected Market



Table 12 Projected Demand For Cancer Diagnostic Products, Through 2008 ($ Millions)



Hormone Analysis



Figure 5 Market For Hormone Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Figure 6 Hormone Tests By Type Of Test, 2002 (Percent Of All Tests By Value)



Table 13 U.S. Hormone Testing Market By Product Type, 2002 ($ Millions)



Market Drivers



Childbearing Trends



Table 14 U.S. Trends In Fertility And Childbearing, Through 2002



Increase In Older Age Groups



Table 15 Trends In Older Age Groups Of U.S. Population, Through 2002



Projected Market



Table 16 Impact Of Epidemiological Trends On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Hormone Testing, 2002-2008 ($ Millions)



Drug Testing



Figure 7 Market For Drug Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Figure 8 Drug Tests By Type Of Test, 2002 (Percent Of All Tests By Value)



Table 17 U.S. Drug Testing Market By Product Type, 2002



Market Drivers



Legislation



Drug Abuse Rates



New Products And Testing Technologies



Growing Use Of Prescription Drugs



Projected Market



Table 18 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Drug Testing, 2002-2008



Blood/Urine Testing



Table 19 Key Blood And Urine Chemistry Parameters



Table 19 (Continued)



Figure 9 Market For Blood And Urine Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Table 20 U.S. Blood/Urine Testing Market By Product Type, 2002 ($ Millions)



Market Drivers



At-Risk Populations



Table 21 Incidence Of Diabetes Among Different Age Groups



Incidence Of Diabetes



New Products And Testing Technologies



Projected Market



Table 22 Impact Of Demand Drivers On The Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Blood/Urine Chemistry Testing, 2002-2008 ($ Millions)



Medical Research



Figure 10 Market Diagnostic Reagents, Chemicals, Carriers, And Other Consumables Used In Medical Research, Through 2008 ($ Millions)



Current Market



Table 23 U.S. Medical Research Testing Market By Product Type, 2002 ($ Millions)



Market Drivers And The National Institutes Of Health



Projected Market



Table 24 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Medical Research, 2002-2008 ($ Millions)



Veterinary Medicine



Figure 11 Market For Veterinary Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)



Current Market



Table 25 U.S. Veterinary Testing Market By Product Type, 2002 ($ Millions)



Market Drivers



Commercial Livestock Trends



Table 26 Trends In U.S. Meat Production, Through 2002 (Billion Pounds)



Trends In Consumer Spending On Companion Animal Care



Table 27 Trends In U.S. Consumer Spending On Pet Care, Including Veterinary Services, Through 2002 ($ Billions)



Projected Market



Table 28 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Veterinary Diagnostic Testing, 2002-2008 ($ Millions)



End-Use Markets



Clinical Laboratories



Figure 12 Number Of Clia-Registered Clinical Laboratories, 1993-2002



Figure 13 Total Clia-Registered Laboratories, By Type, 2002 (Percent Of Laboratories Reporting)



Figure 14 Diagnostic And Other Clinical Tests Carried Out By Type Of Laboratory, 2002 (Percent Of All Tests, By Value)



Medical Research Laboratories



Table 29 Entities Engaged In Medical Research



Veterinary Laboratories



Table 30 Entities Engaged In Veterinary Diagnostic Activities



Individual Consumers For Home-Use Market


Government Regulation

Food And Drug Administration



Premarket Clearance



Good Manufacturing Practices



Responsible Agencies



Center For Devices And Radiological Health



Center For Biologics Evaluation And Research



Centers For Medicare And Medicaid Services



State Governments



Not-For-Profit Organizations



College Of American Pathologists



American Medical Association



U.S. Department Of Agriculture


U.S. Market For Mdk Reagents And Other Components

Summary



Figure 15 Total U.S. Market For Diagnostic Chemicals, Carriers, And Consumables, 2000-2008 ($ Millions)



Detailed Market Estimates And Projections, 2000 - 2008



Market Projection Methodology And Data Sources



Market By Application



Table 31 U.S. Market For Diagnostic Chemicals And Other Consumables By Application Segment, Through 2008 ($ Millions)



Figure 16 Market Shares By Application Segment, 2003 And 2008 (Percent Of Total Sales)



Market By Product Type



Summary



Table 32 Trends In Overall Consumption Of Diagnostic Components By Type Of Product, Through 2008 ($ Millions)



Detailed Analysis



Reagents



Table 33 Trends In Overall Consumption Of Reagents, By Type Of Reagent, Through 2008 ($ Millions)



Table 34 Largest-Selling Reagents, 2002-2008 ($ Millions)



Microbiological Reagents



Table 35 U.S. Market For Pap Stains And Other Microbiological Reagents, Through 2008 ($ Millions)



Chemical Reagents



Table 36 Trends In U.S. Market For Chemical Reagents, Through 2008 ($ Millions)



Immunological Reagents



Table 37 Trends In The U.S. Market For Immunological Reagents, Through 2008 ($ Millions)



Nucleic Acid Reagents



Table 38 Trends In The U.S. Market For Nucleic Acid Reagents, Through 2008 ($ Millions)



Other Chemicals



Table 39 Trends In The U.S. Market For Other Chemicals, Through 2008 ($ Millions)



Device Carriers And Other Consumables



Table 40 Trends In The U.S. Market For Device Carriers And Other Consumables, Through 2008 ($ Millions)



Market By End-Use



Figure 17 Trends In Diagnostic Component End-User Segments, 2003 And 2008



Table 41 Diagnostic Component Sales By End-User Segment, Through 2008 ($ Millions)



Long-Term Outlook For The U.S. Market



Developments That Will Influence The Long-Term Market



Demographic And Epidemiological Trends



Technology Trends



Economic Trends



Governmental/Regulatory Trends



Trends In The Structure Of The Health-Care Industry



Long-Term Market Prospects


Industry Structure, Financial Performance, And Competition

Industry Structure



Summary



Figure 18 Total U.S. Shipments Of Diagnostic Chemicals, Carriers, And Other Consumables, 2002 (%)



Diagnostic Reagents And Chemicals



Domestic Production



Industry Structure



Table 42 U.S. In-Vitro Diagnostic Substance Manufacturers Classified By Size Of Establishment



Figure 19 In-Vitro Diagnostic Product Shipments By Size Of Establishment (Percent Of Total Manufacturers’ Shipments)



Table 43 U.S. In-Vitro Diagnostic Reagent Manufacturers, Classified By Principal Product



Foreign Trade



Table 44 Net U.S. Imports Of Pharmaceuticals And Medicines, 1997-2000 ($ Billions)



Table 45 Domestic Production And Net Imports Of In-Vitro Diagnostic Products, 2000-2003 ($ Billions)



Device Carriers And Consumables



Domestic Production



Industry Structure



Figure 20 U.S. In-Vitro Diagnostic Assay System Components Suppliers (Total Number Of Companies In Each Category)



Performance



Sales



Table 46 Selected Diagnostic Product Companies’ Sales Performance, Through 2002 ($ Millions)



Table 47 Company Size Vs. Sales Performance, Through 2002



Profitability



Table 48 Company Size Vs. Profitability, 2000-2002



Competition And Market Shares



Clinical And Research Market



Figure 21 U.S. Clinical And Research Diagnostic Component Market Leaders, 2002 (Percent Of Total Sales)



Table 49 Clinical And Research Diagnostic Component Vendors’ U.S. Sales, 2002



Veterinary Market



Figure 22 U.S. Veterinary Diagnostic Component Market Leaders, 2002 (Percent Of Total Sales)



Table 50 Veterinary Diagnostic Component Vendors’ U.S. Sales, 2002



Sales And Distribution



Figure 23 U.S. Distribution Channels For Diagnostic Components (Percent Of Total Sales Through Each Channel)



Trends In Ownership And Industry Structure


International Dimensions

Global Market Estimates And Projections, 2002 To 2008



Figure 24 Trends In The Global Market For Diagnostic Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Billions)



Long-Term Trends In Global Markets


Company Profiles

Diagnostic Reagents, Chemicals, And Kits



Abaxis, Inc.



Table 51 Abaxis, Inc. Selected Financial Data, Through 2002 ($ Millions)



Abbott Laboratories, Inc.



Table 52 Abbott Laboratories, Inc. Sales Of Diagnostic Products, Through 2002 ($ Millions)



Acon Laboratories, Inc.



Affymetrix, Inc.



Bayer Diagnostics



Beckman Coulter, Inc.



Table 53 Beckman Coulter, Inc. Selected Financial Data, Through 2002 ($ Millions)



Table 54 Beckman Coulter, Inc. Sales By Geographical Region, 2002



Becton Dickinson & Co.



Table 55 Becton Dickinson & Co. Clinical Laboratory Solutions Segment Revenues, Through 2002 ($ Millions)



Biocheck, Inc.



Biomedical Diagnostics, Llc



Cytyc Corp.



Table 56 Cytyc Corp. Selected Financial Data, Through 2002 ($ Millions)



Dade Behring



Table 57 Dade Behring Selected Financial Data, Through 2002 ($ Millions)



Diadexus



Genzyme Diagnostics



Hemagen Diagnostics, Inc.



Heska Corp.



Table 58 Heska Corp. Selected Financial Data, Through 2002 ($ Millions)



Idexx Laboratories, Inc.



Table 59 Idexx Laboratories, Inc. Selected Financial Data, Through 2002 ($ Millions)



Infectio Diagnostics, Inc.



Inova Diagnostics, Inc.



Ivax Diagnostics, Inc.



Table 60 Ivax Diagnostics, Inc. Selected Financial Data, Through 2002 ($ Millions)



Meridian Bioscience, Inc.



Table 61 Meridian Bioscience, Inc. Selected Financial Data, Through 2002 ($ Millions)



Micromedx



Myriad Genetic Laboratories, Inc.



New Horizons Diagnostics Corp.



Orasure Technologies, Inc.



Ortho-Clinical Diagnostics



Pharmacia



Quest Diagnostics, Inc.



Qiagen N.V.



Roche Diagnostics



Table 62 Roche Diagnostics Sales By Business Segment, 2002



Synbiotics Corp.



Table 63 Synbiotics Corp. Selected Financial Data, Through 2002 ($ Millions)



Vysis, Inc.



Worldwide Medical Corp.



Device Carriers



Diagnostic Laminations Engineering



Evergreen Scientific, Inc.



Excel Scientific, Inc.



Globe Scientific, Inc.



Integrated Biomedical Technology



Millenium Diagnostics, Ltd.



North American Biomedical



Schleicher & Schuell Bioscience



Virotek, Llc



Whatman, Plc


Appendix

Major Diagnostic Tests



Infectious Disease Tests



Bacterial Tests



Table 64 Common Types Of Bacterial Infectious Diseases And Associated Diagnostic Tests



Staphylococcus



Helicobacter Pylori



Chlamydia



Streptococcus



Treponema



Neisseria Gonorrhea



Borrelia



Escherichia



Shigella



Legionella



Fungal Tests



Table 65 Common Types Of Fungal Infectious Diseases And Associated Diagnostic Tests



Aspergillus



Blastomyces



Candida



Coccidomycosis



Cryptococcosis



Histoplasmosis



Sporotrichosis



Viral Tests



Table 66 Common Types Of Viral Diseases And Associated Diagnostic Tests



Cytomegalovirus



Epstein-Barr Virus



Hepatitis



Human Immunodeficiency Virus (Hiv)



Influenza



Paramyxovirus



Rubella



Varicella Zoster



Protozoan Tests



Table 67 Common Types Of Protozoal Infectious Diseases And Associated Diagnostic Tests



Cryptosporidiosis



Giardiasis



Amoebic Dysentery



Toxoplasmosis



Malaria



Trichomoniasis



Cancer Testing



Fda-Approved Tests



Table 68 Common Types Of Cancer And Associated Diagnostic Tests



Cervical Cancer Tests



Pap Smear



Human Papilloma Virus Test



Colorectal Cancer Tests



Fecal Occult Blood Test



Bladder Cancer Tests



Bladder Tumor Antigen Test



Nuclear Matrix Protein Test For Bladder Cancer



Genetic Markers For Bladder Cancer Test



Breast Cancer Tests



Ca (Cancer Antigen) 15-3 Test



Ca 27-29 (Truquant) Test



Estrogen And Progesterone Receptor Tests



Her-2/Neu Test



Central Nervous System



Neuron-Specific Enolase Test



Colorectal Cancer



Carcinoembryonic Antigen Test



Gastric/Pancreatic/Stomach Cancer



Ca 19-9 Test



Liver Cancer



Alpha-Fetoprotein Test



Metastatic Melanoma



S-100 Test



Multiple Myeloma



Nasophryngeal Cancer And Epstein-Barr Virus Antibodies Test



Ovarian Cancer



Ca-125 Test



Ca 72-4 Test



Prostate Cancer



Prostatic-Specific Antigen Test



Testicular Cancer



Human Chronic Gonadotropin Test



Thyroid Medullary Carcinoma



Calcitonin Test



New Tests



Genetic Test For Hpv



Genetic Test For Potential Recurrence Of Breast Cancer



Genetic Test For Colon Cancer



Genetic Test For Lung Cancer




List Of Tables



Summary Table:

Total U.S. And Global Market For In-Vitro Diagnostic Chemicals, Carriers, And Consumables, Through 2008 ($ Billions)

Table 1 Major Microbiological Reagents

Table 2 Major Diagnostic Chemical Reagents

Table 3 Major Diagnostic Immunological Reagents

Table 4 Diagnostic Nucleic Acid Reagents

Table 5 U.S. Infectious Disease Testing Market By Product Type, 2002

Table 6 U.S. Trends In Major Infectious Diseases, 1990 Through 2002 (Number Of New Cases Annually)

Table 7 Impact Of Epidemiological Trends On The Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Infectious Disease Testing, 2002-2008 ($ Millions)

Table 8 Projected Demand For Infectious Disease Diagnostic Products, Through 2008 ($ Millions)

Table 9 U.S. Cancer Testing Market By Product Type, 2002 ($ Billions)

Table 10 Impact Of Demographic And Epidemiological Trends On The Market For Cancer Diagnostic Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Table 11 Impact Of New Technologies On Market For Cancer Diagnostic Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Table 12 Projected Demand For Cancer Diagnostic Products, Through 2008 ($ Millions)

Table 13 U.S. Hormone Testing Market By Product Type, 2002 ($ Millions)

Table 14 U.S. Trends In Fertility And Childbearing, Through 2002

Table 15 Trends In Older Age Groups Of U.S. Population, Through 2002

Table 16 Impact Of Epidemiological Trends On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Hormone Testing, 2002-2008 ($ Millions)

Table 17 U.S. Drug Testing Market By Product Type, 2002

Table 18 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Drug Testing, 2002-2008

Table 19 Key Blood And Urine Chemistry Parameters

Table 20 U.S. Blood/Urine Testing Market By Product Type, 2002 ($ Millions)

Table 21 Incidence Of Diabetes Among Different Age Groups

Table 22 Impact Of Demand Drivers On The Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Blood/Urine Chemistry Testing, 2002-2008 ($ Millions)

Table 23 U.S. Medical Research Testing Market By Product Type, 2002 ($ Millions)

Table 24 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Medical Research, 2002-2008 ($ Millions)

Table 25 U.S. Veterinary Testing Market By Product Type, 2002 ($ Millions)

Table 26 Trends In U.S. Meat Production, Through 2002 (Billion Pounds)

Table 27 Trends In U.S. Consumer Spending On Pet Care, Including Veterinary Services, Through 2002 ($ Billions)

Table 28 Impact Of Demand Drivers On Market For Diagnostic Chemicals, Carriers, And Other Consumables Used In Veterinary Diagnostic Testing, 2002-2008 ($ Millions)

Table 29 Entities Engaged In Medical Research

Table 30 Entities Engaged In Veterinary Diagnostic Activities

Table 31 U.S. Market For Diagnostic Chemicals And Other Consumables By Application Segment, Through 2008 ($ Millions)

Table 32 Trends In Overall Consumption Of Diagnostic Components By Type Of Product, Through 2008 ($ Millions)

Table 33 Trends In Overall Consumption Of Reagents, By Type Of Reagent, Through 2008 ($ Millions)

Table 34 Largest-Selling Reagents, 2002-2008 ($ Millions)

Table 35 U.S. Market For Pap Stains And Other Microbiological Reagents, Through 2008 ($ Millions)

Table 36 Trends In U.S. Market For Chemical Reagents, Through 2008 ($ Millions)

Table 37 Trends In The U.S. Market For Immunological Reagents, Through 2008 ($ Millions)

Table 38 Trends In The U.S. Market For Nucleic Acid Reagents, Through 2008 ($ Millions)

Table 39 Trends In The U.S. Market For Other Chemicals, Through 2008 ($ Millions)

Table 40 Trends In The U.S. Market For Device Carriers And Other Consumables, Through 2008 ($ Millions)

Table 41 Diagnostic Component Sales By End-User Segment, Through 2008 ($ Millions)

Table 42 U.S. In-Vitro Diagnostic Substance Manufacturers Classified By Size Of Establishment

Table 43 U.S. In-Vitro Diagnostic Reagent Manufacturers, Classified By Principal Product

Table 44 Net U.S. Imports Of Pharmaceuticals And Medicines, 1997-2000 ($ Billions)

Table 45 Domestic Production And Net Imports Of In-Vitro Diagnostic Products, 2000-2003 ($ Billions)

Table 46 Selected Diagnostic Product Companies’ Sales Performance, Through 2002 ($ Millions)

Table 47 Company Size Vs. Sales Performance, Through 2002

Table 48 Company Size Vs. Profitability, 2000-2002

Table 49 Clinical And Research Diagnostic Component Vendors’ U.S. Sales, 2002

Table 50 Veterinary Diagnostic Component Vendors’ U.S. Sales, 2002

Table 51 Abaxis, Inc. Selected Financial Data, Through 2002 ($ Millions)

Table 52 Abbott Laboratories, Inc. Sales Of Diagnostic Products, Through 2002 ($ Millions)

Table 53 Beckman Coulter, Inc. Selected Financial Data, Through 2002 ($ Millions)

Table 54 Beckman Coulter, Inc. Sales By Geographical Region, 2002

Table 55 Becton Dickinson & Co. Clinical Laboratory Solutions Segment Revenues, Through 2002 ($ Millions)

Table 56 Cytyc Corp. Selected Financial Data, Through 2002 ($ Millions)

Table 57 Dade Behring Selected Financial Data, Through 2002 ($ Millions)

Table 58 Heska Corp. Selected Financial Data, Through 2002 ($ Millions)

Table 59 Idexx Laboratories, Inc. Selected Financial Data, Through 2002 ($ Millions)

Table 60 Ivax Diagnostics, Inc. Selected Financial Data, Through 2002 ($ Millions)

Table 61 Meridian Bioscience, Inc. Selected Financial Data, Through 2002 ($ Millions)

Table 62 Roche Diagnostics Sales By Business Segment, 2002

Table 63 Synbiotics Corp. Selected Financial Data, Through 2002 ($ Millions)

Table 64 Common Types Of Bacterial Infectious Diseases And Associated Diagnostic Tests

Table 65 Common Types Of Fungal Infectious Diseases And Associated Diagnostic Tests

Table 66 Common Types Of Viral Diseases And Associated Diagnostic Tests

Table 67 Common Types Of Protozoal Infectious Diseases And Associated Diagnostic Tests

Table 68 Common Types Of Cancer And Associated Diagnostic Tests


List Of Figures



Summary Figure:

Total U.S. And Global Market For In-Vitro Diagnostic Chemicals, Carriers, And Consumables, 2002-2008 ($ Billions)

Figure 1 U.S. Market For Infectious Disease Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 2 Percent Market Share For Diagnostic Tests For Infectious Diseases By Type Of Test, 2002 (%)

Figure 3 Market For Cancer Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 4 Diagnostic Tests For Cancer By Type Of Test, 2002 (Percent Of All Tests By Value)

Figure 5 Market For Hormone Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 6 Hormone Tests By Type Of Test, 2002 (Percent Of All Tests By Value)

Figure 7 Market For Drug Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 8 Drug Tests By Type Of Test, 2002 (Percent Of All Tests By Value)

Figure 9 Market For Blood And Urine Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 10 Market Diagnostic Reagents, Chemicals, Carriers, And Other Consumables Used In Medical Research, Through 2008 ($ Millions)

Figure 11 Market For Veterinary Testing Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Millions)

Figure 12 Number Of Clia-Registered Clinical Laboratories, 1993-2002

Figure 13 Total Clia-Registered Laboratories, By Type, 2002 (Percent Of Laboratories Reporting)

Figure 14 Diagnostic And Other Clinical Tests Carried Out By Type Of Laboratory, 2002 (Percent Of All Tests, By Value)

Figure 15 Total U.S. Market For Diagnostic Chemicals, Carriers, And Consumables, 2000-2008 ($ Millions)

Figure 16 Market Shares By Application Segment, 2003 And 2008 (Percent Of Total Sales)

Figure 17 Trends In Diagnostic Component End-User Segments, 2003 And 2008

Figure 18 Total U.S. Shipments Of Diagnostic Chemicals, Carriers, And Other Consumables, 2002 (%)

Figure 19 In-Vitro Diagnostic Product Shipments By Size Of Establishment (Percent Of Total Manufacturers’ Shipments)

Figure 20 U.S. In-Vitro Diagnostic Assay System Components Suppliers (Total Number Of Companies In Each Category)

Figure 21 U.S. Clinical And Research Diagnostic Component Market Leaders, 2002 (Percent Of Total Sales)

Figure 22 U.S. Veterinary Diagnostic Component Market Leaders, 2002 (Percent Of Total Sales)

Figure 23 U.S. Distribution Channels For Diagnostic Components (Percent Of Total Sales Through Each Channel)

Figure 24 Trends In The Global Market For Diagnostic Reagents, Chemicals, Carriers, And Other Consumables, 2002-2008 ($ Billions)

Abstract

Clinical and research laboratories, health-care providers, and manufacturers of single-use medical diagnostic kits (MDKs) in the United States consume $6.8 billion per year of in-vitro reagents, chemicals, and other consumables in order to evaluate individuals' overall health and diagnose, treat, and monitor disease. This study focuses on the resulting market for:


· Reagents and other active substances that are used to interact with sample substances to produce a reaction that can be measured and/or seen.
· Nonactive ingredients that are added to or used in conjunction with the reagents to enhance their manufacturability, performance, and/or preservation (e.g., surfactants, polymers, functional materials, biocides, and preservatives).
· Consumable or single-use devices and containers, such as vials, cards, slides, films, filters, membranes, and trays-integrals parts of the tests carried out using the reagents.

The study does not cover:
· Reagents and other substances used in in-vivo testing.
· Laboratory or analytical devices, such as centrifuges and spectrometers.
· Reusable laboratory ware, such as glass beakers and test tubes.
· Packaging materials.

STUDY BACKGROUND

In recent years, there have been dramatic changes in the diagnostic market. The range of conditions that can be tested for has greatly expanded as well as the variety of analytical techniques employed. Other major trends in the diagnostic industry have been the rapid growth of the at-home testing market (including both greater use of established types of tests and the addition of new tests, such as cholesterol measurements) at the expense of the laboratory testing market, and the expansion of the medical research market segment. An additional trend that has influenced the diagnostic market has been the development of inexpensive, automated testing devices known as point-of-care (POC) instruments, which have replaced single-use diagnostic kits in smaller laboratories and physicians' offices. Recognizing the changes that have occurred in the diagnostic market, Business Communications Co. (BCC) published an in-depth analysis of the medical diagnostic kit (MDK) industry and market in 2002, C-045X, Medical Diagnostic Kits.

STUDY GOALS AND OBJECTIVES

This study is intended to complement C-045X, Medical Diagnostic Kits by analyzing the implications of the changing medical diagnostic market for diagnostic reagents, chemicals, and other consumables in MDKs, as well as in traditional laboratory, clinic, and physicians' office settings. It analyzes U.S. and global markets for these products in the light of the most recent available information. In addition to looking at current and future markets for reagents, chemicals, and other consumables, the study analyzes technological, economic, and regulatory developments that may have a long-term impact on the size and structure of the market This report provides an analysis of the market for diagnostic reagents, chemicals, and other consumables by application (e.g., infectious diseases, cancer), product type (e.g., type of reagent) and target market (e.g., consumer market or research laboratories). Future market trends are analyzed with consumption forecasts for specific market segments.

More specific objectives are to:

· Identify and segment the main types of reagents, chemicals, and other consumables that have been commercialized to date.
· Analyze the historical and current value of shipments of each of these product segments in specified applications and end-user markets.
· Identify and evaluate the impact of demographic, technological, regulatory, and other factors that will drive future demand in each of these segments.
· Forecast the value of future shipments in each segment.
· Identify promising new diagnostic technologies and products still in the development and testing stage, and assess the probability that they will be commercialized successfully in the next 5 years.
· Identify leading suppliers of reagents, chemicals, and other consumables, and analyze industry structure (e.g., market shares, concentration, recent M&A activity).
· Assess the long-term outlook for diagnostic reagents, chemicals, and other consumables, taking into account market opportunities as well as technological, financial, and economic factors.

INTENDED AUDIENCE

The report has been written for the entire medical and health-care interest community, but is tailored especially for readers with an interest in the marketing and management dimensions of reagents, chemicals, and other consumables used in diagnostic testing procedures, such as:

· manufacturers and distributors of pharmaceuticals and biochemicals
· manufacturers and distributors of disposable and single-use laboratoryware
· investors
· the financial and analyst community

SCOPE AND FORMAT

This report is an analytical business tool whose primary purpose is to describe and analyze the dynamics of the market for in-vitro diagnostic reagents, other chemical components, and other consumables used in performing diagnostic tests, such as device carriers. It does not include:

· laboratory and analytical devices and equipment
· multiple-use diagnostic devices and equipment, such as laboratory devices and reusable glassware
· shipping containers, packaging, or instructional materials

The study includes reagents, chemicals, carriers, and other consumables sold at arm's length, as well as components produced by integrated manufacturers for incorporation into diagnostic kits and systems. In such cases, the market reflects only the estimated value of the chemicals and other components, and not the additional value added by producing and selling the kit or system.

The study focuses primarily on the U.S. market, with a section discussing international markets for diagnostic chemicals and other consumables on a more general level of detail. Other sections of the report cover the following topics:

· major product types and applications, both commercial and developmental
· U.S. market size and segmentation, including historical data on sales by application, product type, and end-user group
· market drivers and constraints
· detailed U.S. market projections through 2008
· industry structure, competition, and market shares
· factors that may influence the long-term market for diagnostic reagents, chemicals, and consumables

METHODOLOGY AND INFORMATION SOURCES

The findings and conclusions of this report are based on information gathered from manufacturers and distributors of diagnostic reagents, chemicals, and other consumables, as well as manufacturers of related devices (e.g., medical diagnostic kits), laboratories, and other end users. Interview data were combined with information gathered through an extensive review of secondary sources, such as trade publications, trade associations, company literature, and online databases to produce the baseline market estimates contained in this report. The base year for analyses and projections is 2002. At the time this report was prepared, year-end data for 2002 were not yet universally available. Where necessary, market estimates for 2002 were developed using interim (partial) data for 2002 combined with historical data for the years 1999 to 2001. With 2002 as a baseline, market projections were developed for 2003 to 2008. These projections are based on a consensus among the primary contacts combined with our understanding of the key market drivers and their impact from a historical and analytical perspective. The analytical methodologies used to generate the market estimates are described in detail in Detailed Market Projections. All dollar projections presented in this report are in 2002 constant dollars.

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