Research And Markets Research And Markets

Companion Diagnostics: Market Size, Segmentation, Growth, Competition and Trends

  • ID: 2754338
  • December 2013
  • Region: Global
  • 328 Pages
  • DeciBio
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Companion diagnostics (CDx) is an emerging (+$200M) segment of the ~$50B in vitro diagnostics (IVD) industry, which is growing at double digit rates through 2016. Companion diagnostic tests (also referred to as pharmacogenetic tests) are used to inform patient selection, dosing requirements, or susceptibility to side effects for a particular drug. While many drug labels recommend or provide guidance on pharmacogenetic testing, certain drugs, particularly cancer drugs, require patients to receive a diagnostic test, as the efficacy of these drugs is limited to those with a particular genotype.

This report reviews the size, segmentation, growth, competitive, and regulatory landscape of the companion diagnostics manufacturing market, focusing on the drug-test combinations that are considered required by the FDA. In this first edition of this CDx report, we provide estimates of the U.S. and worldwide markets for FDA approved CDx tests from 2008 to 2016 and segmentations by regulatory status (IVD, LDT), biomarker (HER2, ALK, KRAS, EGFR, ER/PR, CD20, future tests, others), therapeutic area (breast cancer, lung cancer, colon cancer, leukemia/lymphoma, other cancers, non-cancers), assay technology (FISH, IHC, sequencing, qPCR, flow cytometry, others), testing site (reference lab, hospital READ MORE >

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1. Executive Summary

2. Introduction
Market Sizing Methodology

3. Companion Diagnostics Market Overview
In Vitro Diagnostics Market Primer
CDx Definition Ambiguity
The FDA’s CDx Definition
CDx Definition by Value Chain Step
DeciBio’s CDx Definition and Segmentation
List of CDx Tests Included in the Report

4. CDx Market Size
CDx Market by Biomarker
CDx Market by Therapeutic Area
CDx Market by Technology
CDx Market by Test Location
CDx Market by Geography
CDx Market Size by Regulatory Status
CDx Market by Competitor

5. Companion Diagnostics Competitors
Diagnostic Pure-Play Companies
Life Science Research Tools Companies
Other Companies

6. Key Factors Impacting the CDx Market
CDx Market Penetration
CDx Market Growth Drivers and Moderators
Impact of the Global Economic Slowdown
Impact of the Affordable Care Act
Impact of the Budget Control Act (AKA 'The Sequester')
Coverage and Reimbursement
Current Situation in the United States
Current Situation in the EU
Current Situation in Asia-PAC
Current Situation in ROW Geographies
The Future of CDx Reimbursement

7. CDx Regulation
CDx: Market Size, Segmentation, Growth, Competition and Trends
Regulatory History in the U.S. – Herceptin and the HercepTest
U.S. Regulatory History for CDx Development (2005 - 2013)
U.S. Regulatory Changes for CDx Beyond
Regulation of CDx Outside of the United States

8. CDx Business Models
Historic CDx Business Models: The IVD Kit Model
The LDT Model: Trying to Keep the IP In-House
The Future of CDx Business Models

9. CDx Opportunities and Challenges
CDx Opportunities
CDx Challenges

10. Appendix
Biomarker Profiles
Information Only Biomarker Profiles
Individual Biomarker Profiles
Drug Profiles
Drug Label Information
Company Profiles
Table of Exhibits

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown