In 2001 about $3 Billion was spent globally on ADME/Tox (Absorption, Distribution, Metabolism, and Excretion/Toxicology). These four criteria influence the drug levels and kinetics of drug exposure to the tissues and hence influence the performance and pharmacological activity of the compound as a drug. Given this amount spent on ADME/Tox, it is estimated that $1.5 Billion was spent in the US, with $1.3 Billion on in vivo animal testing and $0.2 billion on in vitro screening. According to recent reports, the ADME/Tox market is projected to increase to $10 Billion by 2017 globally with a compounded annual growth rate of 8% (2001-2017). Based on this data we can estimate the size of today’s global ADME/Tox market at $9.3 Billion.
One of the most important issues in clinical pharmacology that perhaps has not received sufficient attention in research, as well as in the day-to-day clinical care setting, is the remarkably large inter-individual variability in drug responses and side effect profiles. Such variability, which can be 40-fold or more, has been demonstrated with practically all classes of drugs, making it difficult to formulate rational guidelines for the dosing and the interpretation of biological parameters (such as the plasma or serum drug concentrations) that might be associated with therapeutic response. Although much remains unknown, a number of factors have been demonstrated to be important determinants of such variability. These include not only genetics, disease state, nutritional status, concurrent use of drugs, and other pharmacoactive substances, but also demographic factors such as age, gender, and genetic diversity. Using Next Gen sequencing and its patient derived stem cell repository, Jeevan Biosciences has experience and expertise in ADME/toxicology evaluations of drug candidates as substrates, inhibitors and inducers of drug-metabolizing enzymes. Our cell models provide significant value to our customers by putting a human disease in a dish, increasing efficacy, reducing time to market, and making a significant contribution in the growing field of personalized medicine. Our cell models do not require FDA approvals.
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