|[February 07, 2014]
Research and Markets: Companion Diagnostics Report: Market Size, Segmentation, Growth, Competition and Trends
DUBLIN --(Business Wire)--
Research and Markets (http://www.researchandmarkets.com/research/gcpn3v/companion)
has announced the addition of the "Companion
Diagnostics: Market Size, Segmentation, Growth, Competition and Trends"
report to their offering.
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 216 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
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.
1. Executive Summary
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
For more information visit http://www.researchandmarkets.com/research/gcpn3v/companion
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