Companion Diagnostics: Future of Personalized Medicine

Albany, NY -- (SBWire) -- 09/02/2016 --Companion diagnostics (CDx) refer to a type of in vitro diagnostic tests intended to assist physicians or medical professionals to make effective treatment decisions based on the patient response to a targeted therapy. These tests map a patient's likely response to the ongoing therapy thereby, enabling the optimization of appropriate dosing concentrations and possible course of treatment. With the increasing popularity of personalized medicine, pharmaceutical companies are shifting their focus towards the development of individualized treatment products rather than conventional therapeutics (blockbuster drugs). This promises for the emergence of highly specific and efficient targeted therapies thereby reducing the costs involved in drug discovery and commercialization processes, which in turn augments the acceptance and uptake of CDx by patients and healthcare professionals.

Companion diagnostics are developed either after the commercialization of the drugs or along with the drugs in investigation. According to the regulatory guidance stated by the U.S. FDA in July 2011, the agency recommends simultaneous approval of targeted therapeutics along with their companion diagnostic. Furthermore, the other international regulatory agencies such as European Medicines Agency (EMA) and Japanese regulatory authorities are encouraging the development and use of companion diagnostics worldwide by providing CDx development guidelines. These well structured guidelines favor the growth of the companion diagnostics market. In addition, companion diagnostics ensure the development of safer and efficient targeted therapeutics which in turn increases the chances of approval and can aid in streamlining of the drug development process (such as fasten the approval process). Transparency Market Research, a leading U.S. based market research firm analyses the global market for companion diagnostics and predicts a CAGR of 18.1% for the period 2013-2019.

Presently, pharmaceutical manufacturers are focusing on the development of CDx tests in various therapeutic areas such as oncology, metabolism, CNS disorders, etc. The most popular CDx tests available in the market serve the oncology segment, the reason being rising incidence of cancers worldwide followed by extensive research and discovery of cancer-specific biomarkers. According to the data enumerated by World Health Organization, the number of deaths due to cancers will reach around 13.1 billion by 2030 and the cancer prevalence will further shoot up by 75% from 2008 to 2030. With the focus on developing novel and robust diagnostic methodologies, various pharma and diagnostic companies are adopting co-development of diagnostic and therapeutic. The roots of companion diagnostics are also spreading towards unexplored therapeutic areas such as lethal infectious diseases [Hepatitis C virus infection, Human Immunodeficiency Virus (HIV)/AIDS] and CNS disorders (Alzheimer's and Parkinson's disease).

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The extensive discovery of disease-specific biomarkers, increasing demand and uptake of precision therapeutics, rising awareness about novel diagnostic procedures and high preference for efficient and reliable in vitro diagnostic tests are some of the factors which strongly support the growth of the companion diagnostics market. Hence, it can be concluded that in future the companion diagnostics market holds immense growth potential with the introduction of precise and stable regulatory policies and improvised healthcare reforms encouraging the use of companion diagnostics worldwide.

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