IN VITRO TOXICITY TESTING MARKET ANALYSIS

Global in vitro toxicity testing market is estimated to be valued at US$ 7.8 billion in 2023 and is expected to exhibit a CAGR of 13.5% during the forecast period (2023-2030).

Analysts’ Views on Global In Vitro Toxicity Testing Market:

In vitro toxicology testing is used to examine the toxic properties of compounds and mixtures on cultured bacteria or mammalian cells. ADME and toxicological profiling plays a major role in drug development. It focuses on obtaining an early estimate of human pharmacokinetic and metabolic profiles. In vitro toxicity assays are used to determine the potential of a new pharmaceutical, agrochemical, food additive, or other chemical product that are hazardous to humans. Opposition to animal testing is expected to propel growth of the global in vitro toxicity testing market over the forecast period. Concerns over animal experiments have been raised in the field of toxicity testing, owing to issues such as difference between various test animals and the resultant effect of toxicants on the animals. Various animal welfare associations and organizations have also increased their efforts towards elimination of toxicity testing on animals. This leads to increasing adoption of in vitro toxicity testing.

Figure 1. Global In Vitro Toxicity Testing Market Share (%), By Type, 2023

Global In Vitro Toxicity Testing Market – Driver

Incrasing inorganic activities among market players and research institutes

Increasing inorganic activities such as agreemetnts among market players and research institutes is expected to drive growth of the global in vitro toxicity testing market in near future. For instance, on March 9, 2023, The Institute for In Vitro Sciences (IIVS), U.S. and Toxys, a biotechnology company, entered into a license agreement that allows IIVS to offer the ToxTracker assay. ToxTracker is an in vitro assay that allows identification of the genotoxic and potentially carcinogenic properties of novel and existing drugs, agrochemicals, cosmetics and other substances without the use of animal testing.

Figure 2. Global In Vitro Toxicity Testing Market Share (%), By Region, 2023

 Global In Vitro Toxicity Testing Market - Regional Analysis

Among region, North America is estimated to hold a dominant position in the global in vitro toxicity testing market over the forecast period. For instance,  on April 03, 2023, the U.S. Department of Health and Human Services published Evaluation of In Vitro Cytotoxicity Test Methods through National Toxicology Programme, to increase adoption and implementation of the in vitro toxicity testing approach. The Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity was prepared by The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). According to the ICCVAM, The Near-term validation studies should concentrate on two common basal cytotoxicity assays employing rodent and human cell systems. The ICCVAM also advised that long-term research should concentrate on the creation of in vitro test methodologies to evaluate biokinetics, metabolism, and organ-specific toxicity, in order to enhance in vitro predictions of acute oral systemic toxicity.

Global In Vitro Toxicity Testing Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with the transportation of drugs from one place to another.

However, the COVID-19 pandemic had positive impact on the global in vitro toxicity testing market owing to the increasing research and development activities. For instance, according to article published by National Centre for Biotechnology (NCBI) on May 21, 2022, Additionally to general toxicity studies across all 3 compound classes, pharmacokinetic studies for mAbs and small molecules, reproduction toxicity testing for vaccines and small molecules, and genotoxicity testing, a study was conducted for immunogenicity/efficacy or related pharmacology/biological activity that were useful against SARS-CoV-2. In contrast to traditional, drawn-out drug development, the creation of vaccines, and small molecules made use of existing platform technology or data that was available for other development programmes. The ability of mAbs to target the spike protein, and cause neutralisation made it possible for clinical candidates to develop quickly.

Global In Vitro Toxicity Testing Market- Segmentation

Global in vitro toxicity testing market report is segmented into by type, by end user, and region.

By Type, the market is segmented into absorption, toxic substances, and dose. Out of which, the absorption segment is expected to hold a dominant position in the global in vitro toxicity testing market during the forecast period due to rising use of in vitro toxicity test assessment in metabolites.

By End User, the market is segmented into cosmetics industry, pharmaceutical industry, food industry, and chemicals industry. Out of which, the food industry segment is expected to hold a dominant position in the global in vitro toxicity testing market during the forecast period due to increasing research and development activities for invitro toxicity testing in food industry.

Among all the segmentations, the type segment is expected to hold a dominant position in the global in vitro toxicity testing market. Out of which absorption segment dominated the market. For instance, on  April 17, 2023, an article published by MDPI, an scientific journal, stated that digestion process can modify the bioactivity of a compound, affecting its bioaccessibility and bioavailability. Therefore, the simulation of the gastrointestinal process is fundamental to predict its potential effect in vivo toxicity to mimic the physiological absorption processes.

Various advantages of in vitro toxicity testing is also expected to drive the market growth. In vitro toxicity testing eliminates the use of animals from the testing procedures. It also covers a wide range of toxicity pathways, and thus, helps in convenient testing. This method also gives sufficient detection of toxic effects on the organisms at very low concentration, which is otherwise not possible in animal testing.

Global In Vitro Toxicity Testing Market-  Cross Sectional Analysis

Among end user segment,  pharmaceutical Industry dominates in North America region in the global in vitro toxicity testing market. For instance, On June 12, 2023, The Medical University of South Carolina, U.S. the National Cancer Institute has awarded startup, LoxiGen, Inc., a three-year Fast-track Small Business Technology Transfer (STTR) grant to develop findings in breast cancer drug development. The goal is a drug eligible for Investigational New Drug status from the U.S. Food and Drug Administration. The phase one milestone is to synthesize around 30 novel compounds and test them in in vitro assays with respect to efficacy, toxicity and selectivity.

 Global In Vitro Toxicity Testing Market: Key Developments

Strict regulations banning animal testing are expected to offer lucrative growth for players in the global in vitro toxicity market. For instance, in January 2020, the state governments of California, Nevada, and Illinois banned the sale or import of animal-tested cosmetics.

Major players in the market are focused on adopting Merger and and acquisition strategies to expand their product portfolio. For instance, in April 2020, Bio-Rad Laboratories, Inc., a developer and manufacturer of specialized technological products acquired Celsee, Inc., a developer of instruments and consumables for the isolation, detection, and analysis of single cells.

 Global In Vitro Toxicity Testing Market: Key Trends

Major regulatory bodies are focused on providing guidelines for in vitro toxicity testing. For instance, in January 2020, the U.S. FDA finalized its In Vitro Guidance for the pharmaceutical industry, in order to help drug developers to plan and evaluate studies to determine the drug-drug interaction potential of an investigational drug product.

The market is witnessing increasing adoption of Next Generation Sequencing (NGS) as an alternative or supplement to conventional in vivo or in vitro testing methods for biologics testing. For instance, in April 20, 2020, PathoQuest, a genomics company, recieved GLP Certification. In January 2020, PathoQuest, an expert in genomic analysis, announced that it received its GLP certificate from the French National Agency for Medicine and Health Products Safety (ANSM).

Global In Vitro Toxicity Testing Market: Restraint

Limitations of in vitro toxicity testing

Questionable predictive power of in vitro toxicity testing is expected to hinder growth of the market. As compared to the conventional animal testing, in vitro toxicity testing is not a reliable predictor. Although in vitro cytotoxicity assays have been used by scientists in drug testing, it has not been consistently applied to the decision making involved in early drug development. moreover, the influence of nanomaterial properties on the outcome of in vitro toxicity testing through assay interference is also expected to limit growth of the market. such interference can lead to false positive or false negative results. Thus it is required to find alternative options to avoid limitations of in vitro toxicity testing

 Global In Vitro Toxicity Testing Market - Key Players

Major players operating in the global in vitro toxicity testing market include Bio-Rad Laboratories, Inc., Cyprotex, Covance Inc., LifeNet Health LifeSciences, Creative Bioarray, Charles River Laboratories, Intertek Group plc, LGC Limited, SGS Société Générale de Surveillance SA, Preferred Cell Systems, Microbac Laboratories, Inc., Eurofins Discovery, Creative Biolabs, LAUS GmbH, and Vimta Labs Ltd.

Global In Vitro Toxicity Testing Market – Definition

In Vitro Toxicity Testing is the scientific evaluation of the hazardous effects of chemical compounds on cultured bacteria or mammalian cells. In vitro testing techniques are mainly used in the early stages of the development of potentially useful new substances such as therapeutic drugs, agricultural chemicals, and food additives, to identify potentially hazardous chemicals and/or to confirm the lack of certain toxic properties.