Toxicity is an extent to which a particular substance can damage the living organism; it is important parameter to be evaluated during all stages of drug development. Toxicity is one of the major reasons for failure of drug development and rejection of drug candidate. Toxicity can be because of dosage, form, half life and other parameters of drug. Since long time toxicity is measured at the later stage of the drug development process but considering higher rejection rate of drug in recent years citing high toxicity level and cost impact of later stage failure, companies started early toxicity testing and taken measures accordingly to reduce the attrition rate in drug discovery.
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Early toxicity testing can be of three types namely in vivo, in vitro and in silico. In vivo toxicity testing is performed on living animals, in in vitro technique testing is performed in laboratories using biochemical assays and cellular assays without animals whereas in in silico technique testing is done by data analysis on computer with the help of data mining and data modeling tools. Out of all these techniques, there are significant advancements happened in in vivo technique; while other two techniques are still in development stage. According to industry leader, cost of drug those get rejected because of late toxicity is 40% of overall drug development spending, where there is around USD 50 billion spend on drug development put together. Many organizations which are working towards environment and animal protection are opposing in vivo approach, and are pressurizing governments to make companies opt for in silico approach. Several initiatives such as FDA’s Critical Path Initiative and the European Union’s Seventh Research Framework Programme are aimed at improving toxicity evaluation process during drug development stages.
Therefore in coming years there may be considerable shift of paradigm from in vivo to in vitro and in silico. There are some studies conducted for usage of nanoparticles in toxicological testing, along with this developments are also in progress for producing 3 dimensional human tissues for toxicity testing. Organovo is one of the players focused on replacing animal testing and biological assays by producing model of human liver. This model mimics the form and functions of human liver and therefore can be used for toxicological testing.
Early toxicity testing market can be segmented in various categories such as on the basis of regional geography, approach of technique and according to market share by major companies. According to technical approach early toxicity testing market is segmented in in vivo, in vitro and in silico, among all these in vivo market contributing highest followed by in vitro and in silico. Pharmaceutical companies, chemical companies and companies related to food products are main customers for early toxicity detection testing players.
Some of the market players in this industry segment are Accelrys, BD Biosciences, Beckman Coulter, Inc., Charles River Laboratories, Gene Logic, Invitrogen, Covance, IDBS, Thermo Fisher.