In Vitro Toxicology Assays Market Size, Share & Trends Analysis Report By Test Type (Cannabis Testing, Nicotine Testing), By Technology (3D Cell Culture Technology, Mass Spectrometry, Flow Cytometry, Others), By Application (Genetic Toxicity Testing, Carcinogenicity Testing, Cytotoxicity Testing, Mutagenicity Testing, Others), By Method (Cellular Assay, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global in vitro toxicology assays market size was valued at USD 1.52 billion in 2022. It is estimated to reach USD 3.85 billion by 2031, growing at a CAGR of 10.9% during the forecast period (2023–2031). The increased usage of cannabis for medical purposes and increasing awareness regarding the potential hazards of nicotine consumption are the factors stimulating market growth.

In vitro toxicology assays are laboratory techniques used to evaluate the potentially toxic effects of substances on living cells or tissues outside of an organism (in vitro). These assays mimic the biological conditions and responses within the human body, allowing researchers to assess the safety and potential risks associated with various chemicals, drugs, or environmental agents. The primary goal of in vitro toxicology assays is to provide early and efficient screening of substances to identify potential hazards, assess their toxicity levels, and guide further testing or decision-making processes. These assays are essential in various industries, including pharmaceuticals, cosmetics, chemicals, and food and beverages, where product safety and regulatory compliance are critical.

In vitro toxicology assays employ a wide range of techniques and methodologies to assess different aspects of toxicity, such as cell viability, genotoxicity, cytotoxicity, mutagenicity, and organ-specific toxicity. Some commonly used assays include cell viability assays (e.g., MTT assay, LDH release assay), genotoxicity assays (e.g., Ames test, comet assay), and high-throughput screening assays using various cellular models and biomarkers. These assays utilize different types of cells, tissues, or cell lines that can be derived from human or animal sources. Advances in technology have also enabled the use of human-derived stem cells, organoids, and micro-physiological systems (such as 3D cell cultures) to better replicate human physiological conditions and responses.

Market Dynamics

Global in vitro toxicology assays market drivers

Increase usage of cannabis for medical purposes

In recent years, public awareness of medical uses has increased of cannabis (marijuana), like appetite enhancement, pain management, and reducing eye pressure. In addition, cannabis is used to treat chronic ailments such as cancer, Alzheimer’s, Parkinson’s, arthritis, and neurologic problems like anxiety, depression, and epilepsy. The number of nations legalizing medical cannabis in various parts of the world is continuously increasing because of this. For example, most U.S. states have legally approved the use and commercialization of medical cannabis, and Many nations have made the plant legal for recreational usage.

The number of nations allowing medicinal marijuana usage will increase in the coming years. This can be attributed to growing public support and a rapidly increasing number of cannabis stocks. Another reason why more and more counties legalize cannabis for medicinal use is the potential for considerable tax income.

Increasing awareness regarding the potential hazards of nicotine consumption

According to WHO statistics, nicotine (tobacco) consumption is a leading cause of death, accounting for more than 8 million individuals annually. Direct tobacco consumption is the cause of death for over 7 million individuals, and passive smoking is a cause of around 1.2 million deaths. Low- and Middle-income nations are responsible for over 80% of the world's 1.3 billion tobacco users. Thus, increasing mortality due to nicotine-induced chronic ailments, such as cancer, has increased awareness regarding nicotine consumption's potential hazards.

Developing nations such as Nigeria and Indonesia remain the epicenter of rising consumption. According to Tobacco Atlas, the number of tobacco smokers is expected to increase by 7 million in Nigeria and 24 million in Indonesia from 2015 to 2025. Moreover, China accounts for over 40% of all cigarettes consumed globally. Owing to the abovementioned trends in nicotine consumption, the need for nicotine testing is expected to increase in the coming years, driving the market growth.

Global in vitro toxicology assays market restraints

Suspension of nicotine-based products

Various nicotine-based products are available in the market, such as electronic nicotine delivery systems, known by various names, including vaporizers, vapes, vape pens, e-pipes (ENDS), and e-cigarettes. Non-combustible tobacco products are called Electronic Nicotine Delivery Systems (ENDS). Certain regulatory guidelines are hindering market growth. For instance, in August 2021, the FDA rejected about 55,000 flavored e-cigarette product marketing applications due to a lack of evidence that they adequately protect public health. In addition, for illegally marketing ENDS goods without a license, the FDA issued a warning letter to a corporation with over 15 million cigarette products listed with the FDA, including several flavored e-liquids.

Global in vitro toxicology assays market opportunities

Increasing focus on environmental toxicology

The global in vitro toxicology assays market presents significant opportunities driven by the increasing focus on environmental toxicology. Environmental pollution and chemical exposure have become major concerns worldwide, with growing awareness of their impact on human health and the environment. This has led to a heightened demand for accurate and efficient methods to assess the toxic effects of environmental contaminants.

In vitro toxicology assays offer a valuable solution for evaluating the toxicity of environmental pollutants, pesticides, industrial chemicals, and other substances. These assays involve using cultured cells, tissues, or cellular components to mimic biological responses and assess the potential toxic effects of various compounds. They provide a controlled and reproducible environment for studying the interactions between environmental toxins and biological systems.

Regional Analysis

Based on region, the global in vitro toxicology assays market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North america dominates the global market

North America is the most significant global in vitro toxicology assays market shareholder and is estimated to grow at a CAGR of 11.2% over the forecast period. The expansion of North America is led by the U.S. and is expected to maintain its position in the future. Its dominance can be attributed to high healthcare expenditure, well-established healthcare infrastructure, and stringent FDA and Health Canada regulations. The existence of research facilities and initiatives supported by Health Canada will likely boost the market by a small margin. For instance, in 2019-20, Health Canada funded a research project titled In Vitro to In Vivo Extrapolation Toxicokinetic of CMP chemicals. This research can assist Health Canada in developing tools and support data to foresee the toxicity of chemicals for risk assessment with in vitro to in vivo extrapolation and help identify chemicals to be considered safe for health.

Europe is anticipated to exhibit a CAGR of 11% over the forecast period. Key drivers of the European market include the development of cannabis and nicotine-related products and regulatory requirements of toxicology testing by an independent entity. In 2014, there were fewer regulations to govern e-cigarettes in the UK and other parts of Europe, considering the strong influence of e-cigarette regulations on the growth of its market and overall economy of nations in terms of monetary. EU members decided to take a grey approach and avoided a complete ban on nicotine and cannabis-related products. E-cigarettes have become a new trend among the younger population, as their consumption increased from 7.2% in 2012 to 14.6% in 2017. Other cannabis-related product makers across Europe are allowed to advertise their products.

Asia-Pacific's in vitro toxicology assays market for cannabis and nicotine testing will likely witness the fastest growth over the forecast period. Legalizing cannabis and nicotine-related products will be the key market driver over the forecast period. India is forecasted to be the fastest-growing market for in vitro toxicology assays in the region.

In Latin America, the in vitro toxicology assays market for cannabis and nicotine testing is developing in Brazil, Mexico, and Argentina. Increasing investments by regional market participants, proximity to North America, and free-trade agreements with major countries such as the U.S., Canada, and other European countries are anticipated to boost the Latin American market during the forecast period. However, the low influence of international entities and restrictions on developing cannabis and nicotine products may hinder the market and increase the probability of the proliferation of unregistered and non-regulated sales.

Middle Eastern countries, like Saudi Arabia, have prospering economies. Advancements in the development of cannabis and nicotine products are expected to increase the demand for in vitro toxicology assays in the region. However, some African countries lack the required action or regulatory measures to form strict laws for cannabis and nicotine testing, which can hinder the market.

Segmental Analysis

The global in vitro toxicology assays market is bifurcated into test type, technology, application, and methods.

Based on test type, the global market is bifurcated into cannabis and nicotine testing.

The cannabis testing segment dominates the global market and is projected to exhibit a CAGR of 10.9% over the forecast period. Cannabis has several known pollutants, including pesticides, mycotoxins, residual solvents, and heavy metals. To determine potency and effect, it is essential to validate strain and test for the presence of cannabinoids and terpenes. Many states and countries have recently decriminalized cannabis, driving scientists and government organizations to set up testing procedures and laws. Rising government initiatives to enhance awareness about cannabis testing are expected to boost market demand in the coming years. For instance, in July 2020, the National Institute of Standards and Technology launched the Cannabis Quality Assurance (CannaQAP) Program to assist laboratories in producing consistent measurement readings, improving product labeling accuracy, and aiding forensic labs in distinguishing between hemp and marijuana.

Based on technology, the global market is bifurcated into 3D cell culture technology, mass spectrometry, flow cytometry, and others.

The 3D cell culture technology segment dominates the global market and is projected to exhibit a CAGR of 11.2% over the forecast period. The popularity of 3D culture has increased over the years as it offers significant potential for drug development and toxicity testing in diseases ranging from cancer to fibrosis to cardiac and neurological disorders. Cigarette Smoke (CS) significantly impacts lung biology and can lead to diseases like Chronic Obstructive Pulmonary Disease and lung cancer. As lung tissue sampling is complex and invasive, it is difficult to implement in epidemiological investigations. In such cases, tissue culture models can help assess exposure's effects on lung tissue. Therefore, the segment is expected to grow due to the adoption of this technology in various applications.

Based on application, the global market is bifurcated into genetic toxicity testing, carcinogenicity testing, cytotoxicity testing, mutagenicity testing, and others.

The genetic toxicity testing segment dominates the global market and is projected to exhibit a CAGR of 11.8% over the forecast period. Various assays are performed to determine the genetic toxicity of nicotine and cannabis products. For example, the mouse lymphoma assay evaluates tobacco and nicotine products, such as tobacco heating items and e-cigarettes. It is an in vitro genotoxicity test to evaluate various tobacco and nicotine products. Various research findings suggest opting for genetic toxicity testing for nicotine-containing products. For instance, the research article published in Food and Chemical Toxicology reviewed the comparative study of cigarettes against commercial e-liquid and e-cigarette (commercial THP) to assess the genotoxicity of tobacco products.

Based on methods, the global market is bifurcated into cellular assay (live cells [high throughput / high content screening, molecular imaging, others], fixed cells), and others.

The cellular assay segment dominates the global market and is projected to exhibit a CAGR of 10.7% over the forecast period. Cellular assays, also known as cell-based assays, can efficiently assess the cytotoxicity, biochemical processes, biological activity, and off-target interactions in biomedical research and drug development screening applications. Cell-based assays can facilitate the generation of complex and biologically relevant data. Compared to standard biochemical assays, cell-based assays are more physiologically relevant and can simultaneously analyze compound properties.

Furthermore, the increasing adoption of high-throughput screening (HTS) technologies has fueled the growth of the cellular assay segment. HTS allows for rapid screening of many compounds against cellular targets, enabling efficient toxicity profiling and compound prioritization. Cellular assays combined with automation and robotics streamline the testing process, reduce costs, and accelerate the identification of potential toxicants.

Recent Developments

• June 2023- Thermo Fisher Scientific announced the launch of its new Tox21 Assay Platform. The platform is a suite of in vitro assays designed to assess the safety of chemicals and drugs.
• May 2023- Covance announced the expansion of its in vitro toxicology capabilities. The expansion includes the addition of new assays and the launch of a new service for the development of custom in vitro assays.