Pharmaceutical companies are bearing high costs involved with the development and commercialization of drugs and drug discoveries. Thus, there has been an increased focus by pharmaceutical companies on regulating the costs incurred by means of developing companion diagnostics along with therapeutic drugs. The strategy of co-development allows for the commercial availability of safe and effective drugs and thus, companion diagnostics are expected to materialize as efficient diagnostic tools that will be advantageous for pharmaceutical manufacturers.

Of late, there has been an increased demand for personalized medicines, which in turn is driving the demand for companion diagnostics, states a research report by Transparency Market Research (TMR). According to the report, the market for companion diagnostics is expected to expand at an 18.1% CAGR from 2013 to 2019.

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TMR analysts answer key questions that companies operating in the companion diagnostic market need to ask:

Q. How are companion diagnostics revolutionizing patient care?

Companion diagnostics help eliminate the possibility of side effects by identifying the patients who are most likely to be at risk of several side effects by the use of a particular therapeutic drug. They identify the patients who are most likely to benefit from a particular therapeutic drug and monitor the response of the patient to a treatment with a particular therapeutic drug.

Monitoring patients’ response to a medicine is done to enable adjustments in the treatment, for improved effectiveness and safety. For instance, the cobas 4800 BRAF V600 mutation test, which is a companion diagnostic for vemurafenib, helps in the detection of the BRAF V600E mutation in the DNA extracted from human melanoma tissue. Developed by Roche Holdings AG, a Switzerland-based biotech company, the test is intended to be used on selected melanoma patients whose tumors carry the BRAF V600R mutation.

Q. What are the factors challenging the growth of the companion diagnostics market?

The global companion diagnostics market is hampered to a great extent by prolonged developmental and approval period. The need to have both the drug and the device ready to be launched in the market at the same time, can potentially delay approvals. The delays in approvals of personalized medicines deprive the patients of these medicines for prolonged periods, thus hampering the uptake and sales of companion diagnostics.

Clinical societies have a huge influence on the acceptance of companion diagnostics by end users. The views and opinions of these societies can affect the market as they impart education by giving biased opinions on their own experience with companion diagnostics. These clinical societies pose as key opinion holders and can alter the preference for companion diagnostics among patients.

Q. What is the progress in the field of companion diagnostics?

Companion diagnostics have been highly successful in the oncology area. This success is encouraging the development of companion diagnostics for other indications such as metabolism disorders, central nervous system (CNS) disorders, and infectious diseases. There have been discoveries of biomarkers for newer indication areas, which is expected to lead to a high growth and increase the revenue generation of the companion diagnostics market.

Case in point, Exosome Diagnostics, Inc. has entered into a collaboration with Takeda Pharmaceuticals International Co. to develop an exosomal RNA sequencing platform for biomarkers. With a goal to develop a platform for serial analysis of gene expression patterns beyond oncology, the analysis of RNAs will provide an innovative tool for patient characterization to select patients. It will then monitor the disease and track the response to the therapeutic drug over the time of the treatment in the patient. This biomarker platform is expected to be an effective therapy for patients not just with cancer but with CNS disorders.

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