Flow Cytometry Market worth 4.93 Billion USD by 2021 Flow Cytometry Market worth 4.93 Billion USD by 20 | Page 15
TABLE OF CONTENTS
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5.3.4 CHALLENGES................................................................................................................................................47
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5.3.4.1
INADEQUATE INFRASTRUCTURE FOR RESEARCH IN EMERGING COUNTRIES......................47
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5.3.4.2
COMPLEXITIES RELATED TO REAGENT DEVELOPMENT.........................................................47
5.4
REGULATORY CHALLENGES...........................................................................................................................................48
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5.4.1
CHALLENGING FDA REQUIREMENTS...........................................................................................................48
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5.4.2
STRINGENT ANALYTE-SPECIFIC REAGENT (ASR) RULE..............................................................................48
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5.4.3
VALIDATION CHALLENGES FOR CELL-BASED INSTRUMENTS....................................................................48
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5.4.4
ABSENCE OF ESTABLISHED LABORATORY-DEVELOPED TEST (LDT)
GUIDELINES ON CELL-BASED FLUORESCENCE ASSAYS............................................................................48
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5.4.5
CHANGING REGULATORY ENVIRONMENT....................................................................................................48
5.5
REIMBURSEMENT SCENARIO.........................................................................................................................................49
GLOBAL FLOW CYTOMETRY MARKET, BY TECHNOLOGY........................................................50
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6.1 INTRODUCTION...............................................................................................................................................................51
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6.2
CELL-BASED FLOW CYTOMETRY...................................................................................................................................52
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6.3
BEAD-BASED FLOW CYTOMETRY...................................................................................................................................53
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GLOBAL FLOW CYTOMETRY MARKET, BY PRODUCTS & SERVICES.......................................55
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7.1 INTRODUCTION...............................................................................................................................................................56
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7.1.1
REAGENTS AND CONSUMABLES..................................................................................................................57
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7.1.2
FLOW CYTOMETRY INSTRUMENTS..............................................................................................................59
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7.1.2.1
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CELL ANALYZERS.....................................................................................................................60
7.1.2.1.1
7.1.2.2
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CELL ANALYZERS MARKET, BY PRICE RANGE..................................................61
CELL SORTERS.........................................................................................................................61
7.1.2.2.1
CELL SORTERS MARKET, BY PRICE RANGE.....................................................62
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7.1.3 SERVICES......................................................................................................................................................63
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7.1.4 SOFTWARE....................................................................................................................................................64
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7.1.5 ACCESSORIES...............................................................................................................................................65
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