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.
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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.
Research
collaborations to improve the time to market the product
An
integrated and more evidence-based approach is driving partnerships
in the global companion diagnostics market. According to Wildwood
Ventures Ltd., the number of global deal in companion diagnostics
market has increased from 13 in 2007 to 66 in 2013. Since, developing
CDx test along with drug therapy is a capital intensive and complex
process, industry players are collaborating to leverage on each
other’s expertise. For instance:
•
Invivoscribe Technologies Inc., collaborated with Novartis AG and
Astellas Pharma Inc. to develop companion diagnostics for their drugs
under pipeline.
•
Invivoscribe also announced a long-term partnership with Thermo
Fisher Scientific in January 2017, develop and commercialize IVD
assays for Applied Biosystems® 3500 Dx Series Genetic Analyzers.
Invivoscribe Technologies Inc. is a global company engaged in
providing clonality and biomarker test solutions for oncology and
personalized molecular diagnostics.
•
AstraZeneca plc entered into a deal with Abbott Laboratories, Inc. in
2015, to develop a companion diagnostic test for tralokinumab, used
for treating severe asthma.
•
Singulex, Inc. entered into a strategic collaboration with QIAGEN
N.V. in January 2017 to develop companion diagnostics using
Singulex's proprietary Single Molecule Counting (SMC)
immunodiagnostic platform
Increasing
number of research collaborations is expected to improve the time to
market of highly effective targeted drug therapies. This would
in-turn augment the growth of companion diagnostics market.
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.
Detailed
Segmentation:
Global
Companion Diagnostics Market, By Application:
•
Breast Cancer
•
Lung Cancer
•
Colorectal Cancer
•
Gastric Cancer
•
Melanoma
•
Others
Global
Companion Diagnostics Market, By Technology:
•
Immunohistochemistry
•
Real-time PCR
•
Gene Sequencing
•
FISH
•
Others
Global
Companion Diagnostics Market, By Geography:
•
North America
•
Latin America
•
Europe
•
Asia Pacific
•
Middle East
•
Africa
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