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Chapter-1: MEDICAL DIAGNOSTICS KITS

INTRODUCTION 1

STUDY GOALS AND OBJECTIVES 1

REASONS FOR DOING THE STUDY 1

INTENDED AUDIENCE 2

SCOPE OF REPORT 2

INFORMATION SOURCES 3

ANALYST CREDENTIALS 4

RELATED REPORTS 4

BCC ONLINE SERVICES 4

DISCLAIMER 4

SUMMARY 5

REPORT HIGHLIGHTS 6

TABLE 1 PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013 ($ MILLIONS) 7

FIGURE 1 PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, 2007-2013 ($ MILLIONS) 8

THE MDK INDUSTRY 8

WHAT ARE MDKS? 8

ADVANTAGES OF MDKS 9

USES FOR MDKS 10

Clinical Testing 10

Clinical Diagnostic Testing 10

Monitoring 10

Screening 11

Confirmatory Testing 11

Research 11

Home Use 11

Veterinary Diagnosis 11

MARKET SIZE 12

TABLE 2 PROJECTED U.S. MDK MARKET COMPARED WITH THE TOTAL DIAGNOSTIC TESTING INDUSTRY, THROUGH 2013 ($ BILLIONS) 12

Relation to Total Testing Market 13

FIGURE 2 MDK'S RELATIVE SHARE OF U.S. TESTING MARKET PROJECTED, THROUGH 2013 ($ BILLIONS) 13

ALTERNATIVE METHODS 13

TABLE 3 ALTERNATIVE METHODS TO MDKS AND AREA OF PRIMARY USE 14

Chemical Assay 14

Culture 14

Microscopy 15

Biological Assay 15

Chromatographic Separation 15

MDK APPLICATIONS 16

TABLE 4 SELECTED MDK APPLICATIONS 16

INDUSTRY STRUCTURE 17

Reagents 17

Device/Carrier 17

Packaging 17

Component Suppliers 18

FIGURE 3 COMPONENTS OF AN MDK 18

TABLE 5 SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION 19

END MARKETS 19

TABLE 6 MDK APPLICATIONS BY END-USE FACILITY 20

Clinical Testing Facilities 20

TABLE 7 U.S. CLINICAL TESTING FACILITIES WITH POTENTIAL FOR USING MDKS: CLIA VS.
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