DUBLIN, April 23, 2014 /PRNewswire/ --
Dublin -
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" report to their
offering.
(Logo:
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 label.
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
http://www.researchandmarkets.com/research/3t5r4b/companion
Media Contact: Laura Wood ,
+353-1-481-1716, press@researchandmarkets.net