In-Vitro Toxicology/ Toxicity Testing Market (2019-2025)

Factors such as ethical issues and pressure from animal activists’ groups concerning the use of animals for testing, ban on animal testing on cosmetic products, support from regulatory bodies regarding the approval of in-vitro tests, low costs associated with in-vitro toxicology testing, and advancements in in-vitro methodologies are driving the growth of the overall in-vitro toxicology market. Synergetic relationships between various stakeholders of the industry and increasing toxicology databases to facilitate the use of in-vitro test methods are further expected to offer significant growth opportunities for the players operating in this market. Regulatory bodies such as ICCVAM, ECVAM, JaCVAM, and OECD have already approved and validated more than 60 in vitro toxicology tests.

In 2004, the EU passed a legislation prohibiting the use of finished cosmetic products on animals. In 2009, the testing of cometic ingredients on animals was prohibited within the EU. This was further ammended by forbidding the marketing of cosmetic products tested on animals from March 2013. Complex toxicity end-points such as repeated dose toxicity, reproductive toxicity, and toxicokinetics were exempted from this ban. Other similar initiatives taken by various governments are as below:

In 2014, the Chinese government put an end to mandatory testing of cosmetics on animals; and increased the research into alternative methods for animal testing.

In January 2014, the Ministry of Health and Family Welfare published draft ammendment seeking a ban on testing on cosmetics to the Drugs and Cosmetics rule in the Gazzette of India

In 2015, India became the first South-Asian country to ban import of animal-tested beauty products

In 2015, New Zealand government announced a ban on animal testing on cosmetics.

The U.S. introduced the Humane Cosmetics Act to ban animal testing on cosmetics in 2015

In March 2015, the U.K. government announced complete ban on testing of household products on animals which came into effect from October 2015

In November 2015, the UK implemented ban on marketing on household products tested on animals

In December 2016, the Swiss government banned the sale of cosmetics containing ingredients tested on animals

In March 2016, Russia introduced a bill to replace all animal testing on cosmetics and ingredients by 2020.

In July 2017, Australia imposed a testing and marketing ban on cosmetics tested on animals.

In 2013, The Humane Society of the United States (HSUS) and Humane Society International launched a global campaign “Be Cruelty-Free” in agreement with the EU ban on selling animal tested cosmetics. The HSUS and Humane Society Legislative Fund are partnering with scientists, government officials, and industry leaders to make the U.S. the next biggest cruelty-free nation. Such initiatives by various governments to ban the use of animals for cosmetics testing are contributing to the increasing adoption of in vitro toxicology tests.

Drug development is always associated with the highest risk of failure in the later stages where the capital at stake is high. Toxicity testing accounts for ~30% of expensive, late-stage failures in drug development and market withdrawal, which may result in high attrition rate in the late-stages of the pharmaceutical drug discovery process. According to NCBI, for every 10,000 compounds synthesized in the discovery phase, only 250 reach the preclinical phase, ultimately resulting in one approved drug by the FDA. Therefore, to lower the risk of the same, it is very important to identify and prioritize efforts to bring the attrition of failing molecules at an early stage in drug development. According to the CMR International, 22% of the drug candidates that entered clinical development from 2006 to 2012 failed due to non-clinical toxicology or clinical safety issues. In preclinical development, toxicity and safety issues accounted for 54% of failures (18% of all preclinical candidates). These expensive late-stage failures account for a large proportion of the pharmaceutical R&D cost, and is estimated to be USD 1.8 billion per marketed drug.

The industry is seeking additional efficiencies in preclinical R&D by identifying solutions in the discovery phase to better qualify new molecular entities prior to animal and human testing. The goal of the new R&D model is to increase the chances of a phase I candidate to reach approval by increasing the rigor of qualifying compounds in the preclinical stages. In order to facilitate this, research is increasing in early stages, which is in turn driving the growth of in-vitro toxicology testing market. As the evolving technologies of in-vitro screening and modeling, various in-vitro assays are emerging as a rapid, high-efficient and cost-effective choice of estimating drug safety risks recommended by most regulatory authorities. In May 2019, Scientists in the Department of Biosystems Science and Engineering at ETH Zurich in Basel have now developed a test that allows them to examine a drug's embryotoxicity in cell cultures instead of animals. This new procedure is simple, fast, and inexpensive, enabling researchers to use it to test a large number of drug candidates at an early drug development stage.

Animal tests are very expensive and time consuming. It can take anything from a few months to 4-5 years to conduct in-vivo toxicology, and can cost hundreds of thousands—and sometimes millions—of dollars per substance examined. In spite of such huge expenditure, many drugs fail at later stages of drug discovery phases. The inefficiency and exorbitant costs associated with animal testing makes it impossible for regulators to adequately evaluate the potential effects of more than 100 thousand chemicals. In contrast, in vitro methods are amenable to high throughput automation using robotics at a much lower cost than animal tests.