Organ-on-a chip-A Strong Contender to Replace Animal Testing…!

Animals play a very crucial role in the process of drug discovery and testing, for instance, animal models form a foundation for many experiments in biomedical research to help researches investigate the process from functioning of circuits in the brain to the progression of the disease in the cells. they are employed as model organisms in the pre-clinical development process by drug makers as they are compelled to provide the safety and efficacy data of the investigative drug before entering clinical trials. Although animal models have added immense knowledge to advancements made in the past and also happening in present, the scenario is rapidly changing. Rising ethical concerns, time (10-12 years), cost (~$2.5 billion), and evolution of technology has enabled the development of non-animal models derived from human 3D cell culture models that mimic human physiology that can be extrapolated to humans. It is also a matter of concern that, the results from animal experiments are not being successfully translated to clinical outcomes, in turn, rising the failure rates of experimental drugs to 90% between Phase I to approval. Besides this, People for the Ethical Treatment of Animals (PETA) along with other regulatory agencies in the western world (National Institute of Health-NIH), (European Coalition to End Animal Experiments (ECEAE), are very receptive to evolving non-animal technologies which could replace animal studies and refocus on new methodologies to understand disease biology in humans. Ban has been imposed by the U.S and the European Union on imports of cosmetics tested on animals. However, some tests using animals remain prevalent due to a lack of alternatives. Furthermore, animals are considered to be different to successfully predict the effects of test compounds and products. Using human cells & tissue-based alternative methods, advanced computer-modeling techniques, or in silico models have not proved to be efficient where out of 100 drugs passing preclinical trail only 5 drugs clear human trails.

The most recent state-of-the-art method using the non-animal research technique available is an organ-on-a-chip device, a microfluidic platform predicted to play a transformative part in pharmaceutical R & D. It is designed to have a controlled microenvironment with vascular like structure mimicking the physiological architecture and function of human tissues and organ integrated. The major reason for the development of technology is the increasing number of drug failures, increasing cost, time, and the need for a substitute to replace in-vitro and animal models that inaccurately model human physiology. With the promise to overcome the major limitation of conventional 2D cell culture methodologies allow the establishment of models that mimic the three 3D arrangements of different cell types closer to the physiological condition.

Regulatory agencies like FDA are encouraging the development and usage of alternatives for animal testing and employment of the most humane methods available within the limits of scientific capability for testing the safety of various consumer products (drugs, chemicals, cosmetics, etc.), as a step in this direction US FDA inked a collaboration agreement with Emulate Bio (an organ-on-a-chip company). With the technology moving very fast and huge progress adding up every month OOC technology offers a more ethical disease model and promises to provide results that deepen the level of insight into efficacy and toxicity of the drug candidate.

Most recent developments in rapidly spreading viral pandemics caused by influenza and SAR-CoV-2 (COVID19) are demanding the fastest way to combat challenges by repurposing existing drugs as a cure for the same. Several animal-free experiments are already underway and some are conducting humans avoiding the lengthy animal testing phase which are aimed at developing vaccine treatment for COVID-19. Lung-on-a-chip/ Airway Chips containing lung airway cells are used to study the prognosis and are also tested on 7 clinically approved drugs (chloroquine, arbidol, toremifene, clomiphene, amodiaquine, verapamil, and amiodarone) of which two (amodiaquine and toremifene) have positive results. Suggesting, these chips can be effectively used in conjunction with rapid cell-based assays to study disease pathogenesis and drug re-purposing. Thus, with the uncertainty around the pandemic, experimenting on animals is not only unethical but also unjustifiable from a scientific perspective. Further, the faster turnaround time of analysis through OOC device aims to eventually reduce the cost of drug testing which might in future owe to have the potential to provide an alternative platform for drug testing with micro-scale volumes of cell and drug samples in comparison with the currently followed methods.

Even though the new technology seems to be a game-changing one, entry into the healthcare industry requires the achievement of meeting certain regulatory milestones before it replaces animal studies. With further advancements and clear understanding, the Life-science industry might see animal models completely replaced. Provided that it confirms the data generated by chips are in line with human cells or predict even more. This would lead to ~20-25% reduction in the total cost of drug development. Besides, the increased level of transferability of organ-chip results, and country and laboratory wise standardization of test systems will decide the rate of acceptance of OOC. Currently, they are being used side-by-side with existing animal models to provide human-relevant data to enable better predictions and translation to the clinic and reduce failure rates in drug discovery and development due to lack of safety or efficacy.

According to IQ4I research analysis, the Organ-On-A-Chip global market is estimated to be $32,922.9 thousand in 2019 and is expected to grow at a CAGR of 28.8% from 2019 to 2026 to reach $193,316.9 thousand by 2026. The factors driving the market are rising use of organ-on-a-chip in early detection of drug toxicity, increasing demand for personalized medicine, the emergence of OOC as an alternative to animal testing, the significant increase in research funding and venture capital investments for the development of different types of organ-on-a-chips, Whereas, factors such as technical uncertainty within the pharma companies, the lack of scaling and standardization, biological and technical challenges involved are restraining the market growth.

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