Molecular Diagnostics: Market Landscape

This report Molecular Diagnostics: Market Landscape analyzes the emerging sector of molecular diagnostics. It provides a clear classification, assessing the leading technologies and key tests that are positioned in this exciting area of diagnostics. The current MDx market size and leading players are analyzed, with a market forecast of the MDx segment as well as the total in vitro diagnostic market over 2010-16 provided.

Table Of Contents

ABOUT DATAMONITIOR HEALTHCARE
About the PharmaVitae Company Analysis team

ABOUT THIS REPORT
Chapter structure
Classification of molecular diagnostics
Regulation and reimbursement of molecular diagnostics
The molecular diagnostics market

EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings

CLASSIFICATION OF MOLECULAR DIAGNOSTICS
Key findings
Datamonitor’s classification of molecular diagnostics
Level 1 classification
Level 2 classification
Level 3 classification
Level 4 classification
MDx subclassification
Key applications of pharmacogenetics – introducing "personalized medicine"

REGULATION AND REIMBURSEMENT OF MOLECULAR DIAGNOSTICS
Key findings
Regulatory landscape
The FDA operates a risk-based assessment
CLIA – regulation of clinical laboratories through the CMS
Four strategic routes to approval of a diagnostic test in the US
The EU: a more simplified approach – gaining the CE mark
The diagnostics market is much smaller than the prescription pharmaceutical market…
…although it can offer some attractions to investors
However, some hurdles exist
Challenges facing the molecular diagnostics industry: US reimbursement
Challenges facing the MDx industry: intellectual property

THE MOLECULAR DIAGNOSTICS MARKET
Key findings
Introduction
The global in vitro diagnostic and molecular diagnostic markets
Historical IVD and molecular diagnostic performance, 2004–10
Current market leaders: introduction to the key players
Forecast IVD and MDx performance, 2010–16
Overview of US-approved molecular diagnostics tests

APPENDIX
The key technologies
Table of US-approved/cleared molecular diagnostic tests
References
Exchange rates