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U.S. Molecular Diagnostics Markets

Table of Contents

C h a p t e r 1

Executive Summary

Executive Summary 1-1

C h a p t e r 2

Total U.S. Molecular Diagnostics Market

Market Overview 2-1

Introduction 2-1

Research Methodology 2-2

Methodology 2-2

Base Year Market Assumptions 2-2

Forecast Methodology 2-3

Restraints in Forecasts 2-3

Market Engineering Analysis 2-4

Market Age 2-5

Revenues 2-5

Potential Revenues 2-5

Base Year Market Growth Rate 2-5

Compound Annual Growth Rate 2-5

Price Sensitivity 2-6

Competitors 2-6

Degree of Competition 2-6

Degree of Technical Change 2-6

Revenue Forecasts 2-6

Scope and Segmentation 2-6

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Market Forecasts 2-7

Total Market Forces and Trends 2-10

Market Drivers 2-10

Personalized Medicine Provides Compelling Market Uptake 2-11

Increased Adoption of Prenatal, Newborn, and Other Genetic Testing Promotes Market 2-13

Phenotype-Genotype and Drug Genotype Associations Increase Number of Available Products 2-16

Expiration of Roche’s PCR Patents Reduces Costs for Market Participants 2-17

Increasing Volumes of Many Infectious Disease Molecular Tests Drive Market 2-17

Beneficial Demographics Present Better Growth Conditions 2-18

Market Restraints 2-19

High Cost of Adoption and Shortage of Labor Restricts Market Growth 2-19

High Cost of FDA Approval Restricts the Introduction of New Products 2-20

Clinician Awareness Hinders Molecular Testing Uptake 2-20

Freeze to Medicare’s Clinical Laboratory Fee Schedule Curtails Market Growth 2-21

Challenges and Strategic Recommendations 2-21

Industry Challenges 2-22

Approval Process Presents a Significant Challenge 2-22

Clinician Ignorance of Molecular IVD Tests Challenges Market Participants 2-23

Strategic Recommendations 2-23

Market Opportunity Expands with FDA Approval 2-23

Marketing and Direct-to-consumer Advertising (DTCA) are Keys to Market Success 2-23

Market and Technology Trends 2-24

Molecular Diagnostics Plays an Increasingly Important Role in Bone Marrow Disorders 2-24

Real-time PCR Technology is Expected Enjoy Greater Uptake 2-24

Increasing Automation Facilitates Greater Adoption of Molecular Diagnostic Capability 2-25

C h a p t e r 3

U.S. Molecular Clinical Diagnostics Market

Overview 3-1

Introduction 3-1

Market Engineering Measurements 3-2

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Market Forecasts 3-3

Scope and Segmentation 3-3

Revenue Forecasts 3-3

Market Share by Revenue and Testing Volumes 3-13

Competitive Analysis 3-23

Competitive Landscape 3-23

Overview 3-25

Multiplexing Market 3-25

HPV Market 3-26

End Users 3-27

Company Market Share Analysis 3-31

Product Analysis 3-35

C h a p t e r 4

U.S. Molecular Blood Screening Market

Overview 4-1

Introduction 4-1

Market Engineering Measurements 4-1

Market Forecasts and Product Analysis 4-2

Scope and Segmentation 4-2

Revenue Forecasts 4-3

Competitive Analysis 4-5

Competitive Landscape 4-5

Overview 4-6

Future Market Conditions 4-7

End Users 4-8

Company Market Share Analysis 4-8

Product Analysis 4-10

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C h a p t e r 5

Appendix

Decision Support Database 5-1

Government Healthcare Expenditure 5-1

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List of Figures

Ch a p t e r 2

Total U.S. Molecular Diagnostics Market

2-1 Total Molecular Diagnostics Market:

Revenue Forecasts (U.S.), 2002-2012 2-7

2-2 Total Molecular Diagnostics Market:

Revenues Forecasts by Segment (U.S.), 2002-2012 2-8

2-3 Total Molecular Diagnostics Market:

Market Share Analysis by Market Segment (U.S.), 2005 2-9

2-4 Total Molecular Diagnostics Market:

Market Drivers Ranked in Order of Impact (U.S.), 2006-2012 2-11

2-5 Total Molecular Diagnostics Market:

Market Restraints Ranked in Order of Impact (U.S.), 2006-2012 2-19

2-6 Total Molecular Diagnostics Market:

Impact of Top Industry Challenges (U.S.), 2006-2012 2-22

2-7 Total Molecular Diagnostics Market:

Impact of Strategic Recommendations on Business Functions (U.S.), 2006-2012 2-22

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Ch a p t e r 3

U.S. Molecular Clinical Diagnostics Market

3-1 Molecular Clinical Diagnostics Market:

Revenue Forecasts (U.S.), 2002-2012 3-3

3-2 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Infectious Disease Testing Segment (U.S.), 2002-2012 3-4

3-3 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Cancer Testing Segment (U.S.), 2002-2012 3-5

3-4 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Pharmacogenomics Segment (U.S.), 2002-2012 3-6

3-5 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Prenatal and Newborn Testing Segment (U.S.), 2002-2012 3-7

3-6 Molecular Clinical Diagnostics Market:

Unit Shipment and Revenue Forecasts for the CYP450 Market (U.S.), 2002-2012 3-8

3-7 Molecular Clinical Diagnostics Market:

Revenue Forecasts for MRSA Segment (U.S.), 2002-2012 3-9

3-8 Molecular Clinical Diagnostics Market:

Unit Shipment and Revenue Forecasts for CF Segment (U.S.), 2002-2012 3-10

3-9 Molecular Clinical Diagnostics Market:

Revenue Market Share by Testing Category (U.S.), 2005 3-13

3-10 Molecular Clinical Diagnostics Market:

Testing Volume Percentage and Volume Market Share by Testing Volume (U.S.), 2005 3-14

3-11 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Infectious Disease Testing Segment (World), 2005 3-15

3-12 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Infectious Disease Testing Segment (U.S.), 2005 3-16

3-13 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Viral Load Testing Segment (World), 2005 3-17

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3-14 Molecular Clinical Diagnostics Market:

Comparison of Revenue Market Share of Viral Load Testing Segment with Other Infectious Disease

Testing Segments (U.S.), 2005 3-18

3-15 Molecular Clinical Diagnostics Market:

Market Share by Testing Volume for the Pharmacogenomics Testing Segment (U.S.), 2005 3-19

3-16 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Prenatal and Newborn Testing Segment (U.S.), 2005 3-20

3-17 Molecular Clinical Diagnostics Market:

Market Share by Revenues for Product Categories (U.S.), 2005 3-21

3-18 Molecular Clinical Diagnostics Market:

Market Share by Revenues Product Category U.S.), 2005 3-22

3-19 Molecular Clinical Diagnostics Market:

Competitive Structure (U.S.), 2005 3-23

3-20 Molecular Clinical Diagnostics Market:

Approximate Average Reimbursement Rate for Select Molecular Tests (U.S.), 2005 3-24

3-21 Molecular Clinical Diagnostics Market:

Clinical Laboratory Market Share by Regulatory Classification (U.S.), 2005 3-28

3-22 Molecular Clinical Diagnostics Market:

Molecular Clinical Laboratory Market Share (U.S.), 2005 3-29

3-23 Molecular Clinical Diagnostics Market:

Infectious Disease Testing Company Market Share by Revenues (U.S.), 2005 3-31

3-24 Molecular Clinical Diagnostics Market:

Infectious Disease Product Categories Offered by Key Industry Participants (U.S.), 2005 3-32

3-25 Molecular Clinical Diagnostics Market:

Cancer Testing Company Market Share by Revenues (U.S.), 2005 3-32

3-26 Molecular Clinical Diagnostics Market:

Pharmacogenomics Testing Company Market Share by Revenues (U.S.), 2005 3-33

3-27 Molecular Clinical Diagnostics Market:

Human Molecular Diagnostics Tests (U.S.), 2005 3-35

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3-28 Molecular Clinical Diagnostics Market:

Bacterial Infectious Disease Tests Offered by Major Market Participants (U.S.), 2005 3-37

3-29 Molecular Clinical Diagnostics Market:

Viral Infectious Disease Tests Offered by Major Market Participants (U.S.), 2005 3-40

3-30 Molecular Clinical Diagnostics Market:

Molecular Diagnostics Controls Offered by Major Market Participants (U.S.), 2005 3-43

3-31 Molecular Clinical Diagnostics Market:

510(k) Molecular Diagnostics Systems Offered by Major Market Participants (U.S.), 2005 3-45

3-32 Molecular Clinical Diagnostics Market:

CLIA Laboratory Clinical Cancer Nucleic Acid Diagnostic Product Analysis (U.S.), 2005 3-46

3-33 Molecular Clinical Diagnostics Market:

Cancer Nucleic Acid Diagnostic Product Analysis (U.S.), 2005 3-47

3-34 Molecular Clinical Diagnostics Market:

Cytogeneic Product Analysis (U.S.), 2005 3-48

Ch a p t e r 4

U.S. Molecular Blood Screening Market

4-1 Molecular Blood Screening Market:

Revenue Forecasts (World), 2002-2012 4-3

4-2 Molecular Blood Screening Market:

Revenue Forecasts (U.S.), 2002-2012 4-4

4-3 Molecular Blood Screening Market:

Competitive Structure (U.S.), 2005 4-6

4-4 Molecular Blood Screening Market:

Company Market Share by Revenues (World), 2005 4-8

4-5 Molecular Blood Screening Market:

Company Market Share by Revenues (U.S.), 2005 4-9

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4-6 Molecular Blood Screening Market:

Product Analysis (U.S.), 2005 4-10

Ch a p t e r 5

Appendix

5-1 Decision Support Database:

Government Healthcare Expenditure In Bn USD (World), 2005-2012 5-1

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List of Charts

Ch a p t e r 2

Total U.S. Molecular Diagnostics Market

2.1 Total Molecular Diagnostics Market:

Market Engineering Measurements (U.S.), 2005 2-4

2.2 Total Molecular Diagnostics Market:

Revenue Forecasts (U.S.), 2002-2012 2-7

2.3 Total Molecular Diagnostics Market:

Revenue Forecasts by Segment (U.S.), 2002-2012 2-8

2.4 Total Molecular Diagnostics Market:

Market Share Analysis by Product Segment (U.S.), 2005 2-9

Ch a p t e r 3

U.S. Molecular Clinical Diagnostics Market

3.1 Molecular Clinical Diagnostics Market:

Market Engineering Measurements (U.S.), 2005 3-2

3.2 Molecular Clinical Diagnostics Market:

Revenue Forecasts (U.S.), 2002-2012 3-4

3.3 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Infectious Disease Segment (U.S.), 2002-2012 3-5

3.4 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Cancer Segment (U.S.), 2002-2012 3-6

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3.5 Molecular Clinical Diagnostics Market:

Products Revenue Forecasts for Pharmacogenomic Segment (U.S.), 2002-2012 3-7

3.6 Molecular Clinical Diagnostics Market:

Revenue Forecasts for Prenatal Newborn Segment (U.S.), 2002-2012 3-8

3.7 Molecular Clinical Diagnostics Market:

Revenue Forecasts for CYP450 Segment (U.S.), 2002-2012 3-9

3.8 Molecular Clinical Diagnostics Market:

Revenue Forecasts for MRSA Segment (U.S.), 2002-2012 3-10

3.9 Molecular Clinical Diagnostics Market:

Revenue Forecasts for CF Segment (U.S.), 2002-2012 3-11

3.10 Molecular Clinical Diagnostics Market:

Revenue Market Share by Testing Category (U.S.), 2005 3-13

3.11 Molecular Clinical Diagnostics Market:

Market Share by Testing Volume (U.S.), 2005 3-14

3.12 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Infectious Disease Testing Segment (World), 2005 3-15

3.13 Molecular Diagnostics Market:

Market Share by Revenues for the Infectious Disease Testing Segment (U.S.), 2005 3-16

3.14 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Viral Load Testing Segment (World), 2005 3-17

3.15 Molecular Clinical Diagnostics Market:

Comparison of Revenue Market Share of Viral Load Testing Segment with Other Infectious Disease

Testing Segments (U.S.), 2005 3-18

3.16 Molecular Clinical Diagnostics Market:

Market Share by Testing Volume for the Pharmacogenomic Testing Segment (U.S.), 2005 3-19

3.17 Molecular Clinical Diagnostics Market:

Market Share by Revenues for the Prenatal and Newborn Testing Segment (U.S.), 2005 3-20

3.18 Molecular Clinical Diagnostics Market:

Market Share by Revenue Type (U.S.), 2005 3-21

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3.19 Molecular Clinical Diagnostics Market:

Market Share by Revenue Type (U.S.), 2005 3-22

3.20 Molecular Clinical Diagnostics Market:

Approximate Reimbursement Rate for Select Molecular Tests (U.S.), 2005 3-24

3.21 Molecular Clinical Diagnostics Market:

Competitive Factors that are Considered Important for Adopting

Molecular Instruments (U.S.), 2005 3-27

3.22 Molecular Clinical Diagnostics Market:

Competitive Factors that are Considered Important for Adopting Molecular Assays (U.S.), 2005 3-28

3.23 Molecular Clinical Diagnostics Market:

Clinical Laboratory Market Share by Regulatory Classification (U.S.), 2005c 3-29

3.24 Molecular Clinical Diagnostics Market:

Molecular Clinical Laboratory Market Share (U.S.), 2005 3-30

3.25 Molecular Clinical Diagnostics Market:

Infectious Disease Testing Company Market Share by Revenues (U.S.), 2005 3-31

3.26 Molecular Clinical Diagnostics Market:

Cancer Testing Company Market Share by Revenues (U.S.), 2005 3-33

3.27 Molecular Clinical Diagnostics Market:

Pharmacogenomic Testing Company Market Share by Revenues (U.S.), 2005 3-34

Ch a p t e r 4

U.S. Molecular Blood Screening Market

4.1 Molecular Blood Screening Market:

Market Engineering Measurements (U.S.), 2005 4-2

4.2 Molecular Blood Screening Market:

Revenue Forecasts (World), 2002-2012 4-3

4.3 Molecular Blood Screening Market:

Revenue Forecasts (U.S.), 2002-2012 4-4

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4.4 Molecular Blood Screening Market:

Company Market Share by Revenues (World), 2005 4-8

4.5 Molecular Blood Screening Market:

Company Market Share by Revenues (U.S.), 2005 4-9