Companion Diagnostics Industry Key Manufacturers Analysis with Sales, Price, Revenue, Gross Margin Forecasts To 2026
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Companion
diagnostic (CDx) is a diagnostic tool used to determine the
suitability of a drug therapy to the patient. It has become a
critical part of targeted cancer therapy that allows for development
of personalized therapy can be developed and administered to the
patient. Whole blood samples, tissues samples, or buccal samples are
collected and tested for diagnosis and identification of targeted
disease biomarker. CDx is usually utilized in identifying genetic
mutations and the health and treatment approach implications. In July
2016, the U.S. FDA released a draft guideline for development of a
therapeutic product accompanying an IVD companion diagnostic.
Companion diagnostics include Gleevec (imatinib mesylate) and BCR-ABL
LDT and DAKO C-KIT PharmDx, Herceptin (trastuzumab) and DAKO
Herceptest; and Nolvaldex (tamoxifen) and laboratory-developed
estrogen receptor positive test.
Market Dynamics
Companion
diagnostics are beneficial for pharmaceutical companies who face
challenges with respect to high drug development cost, safety and
outcome of clinical trials, and long product approval time. Companion
diagnostics lowers development costs, improves time to market and
enhances drug safety by enabling rapid identification of target
biomarker and the most effective drug therapy. For patients, the
technology provides better treatment outcomes and lower morbidity
risk. Use of technologies such as PCR, immunohistochemistry, and gene
sequencing has enabled accurate diagnosis and determination of
targeted cancer therapy. As the CDx tests also aid in revealing the
off-target effects of a drug along with identification of a molecular
target, CDx have become and indispensable tool for oncologists.
Market Taxonomy
This report segments
the global companion diagnostics market on the basis of application,
technology, and geography. On the basis of application, the market is
categorized into breast cancer, lung cancer, colorectal cancer,
gastric cancer, melanoma, and others. On the basis of technology, the
market is segmented into immunohistochemistry, real-time PCR, gene
sequencing, Fluorescence in situ hybridization (FISH), and others.
For comprehensive understanding of market dynamics, the global
companion diagnostics market is analyzed across key geographical
regions namely North America, Europe, Asia Pacific, Latin America,
Africa, and Middle East. Each of these regions is analyzed on basis
of market findings across major countries in these regions for a
macro-level understanding of the market.
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Low cost and
clinical benefits of companion diagnostics is expected to drive
growth of the market
The ecosystem of
pharmaceuticals industry is one of the major factors driving growth
of the companion diagnostics market. The providers of healthcare
products and services, and patients who utilize these products and
services is expected to be benefitted by a collaborative approach.
The innovation of CDx helped drug developers in reducing the
development costs, developing highly effective therapeutic products,
and improving the time to market by identifying the effectiveness of
a drug against particular biomarkers. Moreover, better treatment
outcomes and lower morbidity risk are benefits offered to the
patients. Also, accurate diagnosis and determination of targeted
cancer therapy has become much easier due to advanced technologies
such as PCR, immunohistochemistry, and gene sequencing.
Advancements in
technology and increasing research on CDx has resulted in increasing
approval of drug therapies with diagnostic tests alongside it. As per
the Regulatory Affirms Professionals Society (RAPS), the share of
drugs and biologics approved alongside a diagnostic test, by the U.S.
FDA, increased from 20% in 2014 to 28% in 2015.
Key companies
covered as a part of this study include Abbott Laboratories, Inc.,
Agilent Technologies, Inc., Danaher Corporation, GE Healthcare,
Qiagen N.V., Roche Diagnostics, Myriad Genetics, Inc., bioMérieux
SA, Illumina, Inc. and Siemens Healthcare
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