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

April 23, 2014

DUBLIN, April 23, 2014 /PRNewswire/ –

Research and Markets (http://www.researchandmarkets.com/research/3t5r4b/companion)
has announced the addition of the “Companion Diagnostics: Market Size, Segmentation,
Growth, Competition and Trends”
[http://www.researchandmarkets.com/research/3t5r4b/companion ] report to their offering.

http://photos.prnewswire.com/prnh/20130307/600769 )

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 lab), geography (U.S., Europe, Japan, APAC, ROW), and company (Qiagen, Abbott,
Dako, Roche, reference labs, others). We also identify growth drivers and moderators, as
well as challenges and opportunities for the CDx market.

Additionally, this report analyzes the coverage and reimbursement landscape, the
impact of macroeconomic events, and the current and future regulatory environment. In this
report we categorize CDx tests as either required,’ recommended,’ or information only’
depending on the regulatory status and testing instructions contained within the drug

Other key points discussed here include:

1) Competition and regulatory differences between manufacturers of FDA-approved IVDs
and clinical reference labs who offer lower priced laboratory developed tests (LDTs).
2) The expected organic growth of existing tests compared to revenues generated from novel
tests for new or expanded indications. 3) The impacts of the global economic slowdown,
Affordable Care Act, and Budget Control Act on CDx market growth. 4) CDx regulatory
history and current FDA outlook. 5) Potential growth opportunities in non-oncology
indications. 6) Physician awareness and adoption of pharmacogenetic testing.

Lastly, this report provides detailed analyses of the companies, biomarkers, and drugs
associated with companion diagnostic testing.

This report contains over 325 pages and over 40 exhibits of brand new, original
content. Please, visit our website for articles and insights regarding current topics and
news in companion diagnostics and other life-science areas, as well as additional research
reports in related markets including next generation sequencing, life science research
tools, and single cell genomics.

Key Topics Covered:

1. Executive Summary

2. Introduction

3. Companion Diagnostics Market Overview

4. CDx Market Size

5. Companion Diagnostics Competitors

6. Key Factors Impacting the CDx Market

7. CDx Regulation

8. CDx Business Models

9. CDx Opportunities and Challenges

10. Appendix

For more information visit


Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net



SOURCE Research and Markets

Source: PR Newswire

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