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The North America Companion Diagnostics Devices Market is segmented by Technology, Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Leukemia, Melanoma, Other Indications), and Geography.
The North American companion diagnostics devices market is expected to witness a CAGR of 18.5%, during the forecast period. Certain factors that are driving the market growth include increasing demand and awareness for personalized medicine and targeted therapy, increasing cases of adverse drug reactions, and technological demands.
The United States takes an exceptional approach in regulating the innovative companion diagnostic devices. The US FDA approved diagnostic assays play an important role in managing patients to extend lifespan, while also enhancing the quality of life. Diagnostic assays have been found to be essential for the safe and effective use of therapeutics.
Companion diagnostic tests provide information that is essential for the safe and effective use of a corresponding drug or biological product. As per the scope of the report, the market studied has been segmented by technology, indications, and geography. By technology, the market studied has been further segmented into immunohistochemistry, polymerase chain reaction, in-situ hybridization, real time-polymerase chain reaction, gene sequencing, and other technologies.
|Polymerase Chain Reaction (PCR)|
|In-situ Hybridization (ISH)|
|Real-time PCR (RT-PCR)|
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In-situ hybridization (ISH), especially fluorescence in-situ hybridization (FISH), is a reliable, reproducible, sensitive, and accurate procedure, which is less affected by tissue fixation and analytical variables, in comparison to immunochemistry and other techniques. It offers the benefit of simultaneous evaluation of morphology and gene amplification. FISH has been the method of choice for use in companion diagnostics for several cancer therapies, such as trastuzumab, lapatinib, and criotinib, which have been already approved by FDA and other therapies, like everolimus, ridaforolimus, bicatulamide, TBD, and other drugs, that are yet to obtain regulatory approval.
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The North American companion diagnostics devices market is highly competitive and consists of a few major players. Companies, like Abbott, Agilent Technologies Inc., Biomerieux SA, Danaher Corporation (Beckman Coulter Inc.), F. Hoffmann-La Roche Ltd, Qiagen NV, Siemens Healthcare, and Thermo Fisher Scientific Inc., among others, hold the substantial market share in the companion diagnostics devices market.
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Demand and Awareness for Personalized Medicine and Targeted Therapy
4.2.2 Increasing Cases of Adverse Drug Reactions
4.2.3 Technological Advancements in the Devices
4.3 Market Restraints
4.3.1 High Cost of Drug Development and Associated Clinical Trials
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
5.1.1 Immunohistochemistry (IHC)
5.1.2 Polymerase Chain Reaction (PCR)
5.1.3 In-situ Hybridization (ISH)
5.1.4 Real-time PCR (RT-PCR)
5.1.5 Gene Sequencing
5.1.6 Other Technologies
5.2.1 Lung Cancer
5.2.2 Breast Cancer
5.2.3 Colorectal Cancer
5.2.6 Other Indications
5.3.1 North America
22.214.171.124 United States
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Abbott Laboratories
6.1.2 Agilent Technologies Inc.
6.1.3 Biomerieux SA
6.1.4 Danaher Corporation (Beckman Coulter Inc.)
6.1.5 F. Hoffmann-La Roche Ltd
6.1.6 Qiagen NV
6.1.7 Siemens Healthcare
6.1.8 Thermo Fisher Scientific Inc.
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments