The Global Companion Diagnostics Marketis growing with the rapid pace; mainly due to the improvement in regulatory policies. According to a recent study report published by the Market Research Future, The global companion diagnostics is booming and expected to gain prominence over the forecast period growing rapidly .The market is forecasted to demonstrate a spectacular growth by 2022, surpassing its previous growth records in terms of value with a striking CAGR during the anticipated period (2017 – 2022).
Companion diagnostics are an indispensable part of medicine industry and will likely increase rapidly in number and application to disease areas. The commercial success of drugs such as Gleevec® (imatinib) by Novartis, and Herceptin® (trastuzumab) by Roche, has moved the entire companion diagnostic field forward as both the drugs require companion diagnostics testing.
Notably, rising discovery of biomarkers, and increasing R&D expenditure in the Pharmaceutical Industry are the key factors driving the companion diagnostics Market. In the year of 2016, the R&D expenditure in the Pharmaceutical Industry was EUR 35000 million, suggested by European Federation of Pharmaceutical Industries and Association. Other factors such as rising adoption rate, and improvement in regulatory policies are also fuelling the growth of the market. In 2014, FDA issued a document on Companion Diagnostics Devices consisting of an outcome prediction as well as therapy monitoring with companion diagnostics.
Despite these significant driving factors, doubts over the quality, and cost associated with drug development are expected to decline the market growth. Outside the U.S. and Europe new legislations have been implemented for companion diagnostics.
On considering the recent trends, it is observed that companion diagnostics have proved to be an important tool in the drug development process, and for the treatment purpose in the clinic. However, the number of companion diagnostics are still relatively low, but the number is expected to increase in the coming years, especially within oncology.
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Global Companion Diagnostics Market – Competitive Analysis
The Global Companion Diagnostics Market is currently dominated by various players. Abbott Laboratories is one of them by holding a strong share in the market. Abbott is a global leader that develops and manufactures pharmaceuticals and medical products. The prime emphasis of the company is on research & development sector to introduce innovative medical products. The company has received FDA approval for various companion diagnostic products. For instance, on Aug 01, 2017, Abbott Laboratories received FDA approval for RealTime IDH2 Assay which detects mutations in blood, and bone marrow samples.
Roche Molecular Systems Inc. is also one of the leading player in companion diagnostics market. On November 07, 2017, Roche received FDA approval for the companion diagnostics, i.e. VENTANA ALK (D5F3) CDx Assay. The VENTANA ALK (D5F3) CDx Assay is the only FDA-approved test for ALECENSA.
On June 29, 2017, Praxis Extended RAS Panel by Illumina, Inc. has also received marketing approval from FDA. This is the first FDA-approved next generation sequencing NGS test to detect multiple RAS gene mutations.
Abbott Laboratories (U.S.), Agilent Technologies (U.S.), ARUP Laboratories (U.S.), F. Hoffmann-La Roche AG. (Germany), Ventana Medical Systems, Inc. (U.S.), Illumina, Inc. (U.S.), Life Technologies Corporation (U.S.), Invivoscribe Technologies, Inc. (U.S.), Foundation Medicine, Inc. (U.S.), Myriad Genetics Inc. (U.S.), QIAGEN N.V. (Germany), and Thermo Fisher Scientific Inc. (U.S.) are some of the prominent players at the forefront of competition in the companion diagnostics market and are profiled in MRFR Analysis.
Global Companion Diagnostics Market – Regional Analysis
Most of the existing market players are concentrated in the Americas owing to well-established market and high healthcare expenditures. According to the Centers for Medicare & Medicaid Services, in 2015, U.S. healthcare spending increased 5.8% reaching USD 3.2 trillion Canadian healthcare specifically was stressed by an advancing demographic move. The increase of insurance coverage because of health care reform (Affordable Care Act, 2010) in the U. S. additionally prompted an expansion in health care spending.
Companion Diagnostics adoption is also rising in Asia Pacific region. Japan has introduced a new legislation to encourage pharma and diagnostic companies to cooperate during the drug development process in order to finalize the companion diagnostics development before approving the corresponding drug. Furthermore, including biomarker-negative patients during early phase clinical studies is mentioned in the Japanese regulations.
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