In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing Size Analysis:

The In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing was valued at USD 1.72 billion in 2023 and is expected to reach USD 4.98 billion by 2032, growing at a CAGR of 12.57% over the forecast period of 2024-2032. This report emphasizes technological innovations and changing methodologies, with breakthroughs in high-throughput screening, organ-on-a-chip models, and AI-based data analysis improving the precision and effectiveness of toxicity tests. The research delves into regulatory and compliance trends geographically, as differing legal systems for cannabis and nicotine products impact testing protocols, safety assessments, and market approvals. Moreover, it studies healthcare and research expenditure trends, dissecting government, commercial, private, and out-of-pocket investments in toxicology research that fuel market growth and development.

The U.S. In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing was valued at USD 0.52 billion in 2023 and is expected to reach USD 1.37 billion by 2032, growing at a CAGR of 11.44% over the forecast period of 2024-2032. In the United States, the market is experiencing exponential growth as a result of growing federal and state government regulations on cannabis and tobacco products, escalating R&D spending on alternative nicotine products, and increasing demand for standardized toxicity testing to promote consumer safety and regulatory compliance.

In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing Dynamics

Drivers

• The increasing regulatory scrutiny and the rising prevalence of nicotine and cannabis consumption.

With more than 1.1 billion tobacco consumers globally and a fast-growing trend of cannabis legalization, the need for reliable toxicology testing is on the rise. Organizations like the FDA, WHO, and EMA have made it compulsory to carry out rigorous safety testing of such drugs, leading to an increased uptake of in-vitro assays. In addition, advances in mass spectrometry and 3D cell culture technology have enhanced the speed and precision of toxicity testing and lowered their dependence on animal models. Growth in the pharmaceutical industry, which uses these assays widely in drug development and safety assessment, pushes the market further. In addition, growing consumer consciousness of the health dangers of nicotine and cannabis products has resulted in greater testing by manufacturers to guarantee compliance and product safety. For example, the Global Tobacco Control Program has highlighted stricter regulations for nicotine product evaluation, impacting the demand for high-throughput in-vitro toxicology assays. In addition, the use of AI-based toxicology platforms is simplifying testing workflows, decreasing turnaround times, and improving predictive toxicology accuracy, which is anticipated to drive further market growth.

Restraints

• The market faces significant restraints, primarily related to high costs and limited standardization in toxicology testing methodologies.

Implementation of mass spectrometry and 3D cell culture assays necessitates costly laboratory equipment and qualified personnel, adding to the cost of operation. Small-scale testing laboratories and research centers lack the financial capabilities to invest in advanced toxicology assay systems, limiting their implementation. Additionally, differences in testing regulations across geographical locations cause uniformity in product evaluation criteria. For example, the U.S. FDA requires the rigorous toxicological testing of e-cigarettes, and in some developing countries, regulatory environments are continually changing, creating variable requirements for testing.

Opportunities

• The increasing shift toward alternative toxicity testing methods presents lucrative opportunities for market growth.

The prohibition of animal testing in areas such as the EU and increasing ethical issues have sped up the need for in-vitro models that offer reliable human-relevant toxicity information. Organ-on-chip and high-content screening (HCS) technologies are transforming toxicology testing, providing predictive information on cannabis and nicotine toxicity with increased accuracy. Also, the emerging trend of personalized medicine is stimulating demand for individualized toxicity testing solutions based on specific genetic profiles. The emerging cannabis-based pharma industry, expected to grow exponentially in the next decade, presents additional opportunities for sophisticated toxicity assays. In addition, collaborations between pharmaceutical firms and research centers are promoting innovation in assay development, driving market penetration. The growing acceptance of AI and machine learning-based toxicology platforms is another promising direction, enabling automated toxicity predictions and enhanced data analysis and lowering assay turnaround times. Additionally, the growth of point-of-care (POC) and home-use testing kits for nicotine and cannabis toxicology testing is likely to extend market reach, making products more accessible to a wider consumer population. These advances as a whole build a positive setting for the development of the in-vitro toxicology assays market.

Challenges

• The lack of universally accepted regulatory guidelines poses a major challenge to market growth, as varying regional compliance standards complicate market entry for assay providers.

While the U.S. FDA requires stringent premarket approval for nicotine and cannabis testing, other geographies have dispersed regulatory environments with resultant inconsistencies in assay validation procedures. Furthermore, technological integration issues impede smooth uptake, especially within resource-constrained laboratories where automated and AI-driven toxicology testing is underexploited. The second major challenge is the reproducibility of data—as new 3D cell culture models and biochip technologies pick up pace, having consistent and reproducible test results is an issue. Legacy toxicology testing methods, e.g., classic biochemical assays, are highly relied upon and cause the shift to more sophisticated, non-animal alternatives to take longer. In addition, public doubt about the validity of new toxicology tests prevents their universal application, particularly in industries where approved historical data from traditional methods are still the standard.

In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing Segmentation Analysis

By Type

The nicotine testing segment led the market in 2023 and captured 53.1% of the overall revenue share. This is due to the extensive consumption of nicotine products, such as traditional cigarettes and e-cigarettes, that have driven the need for stringent regulations requiring testing. Rising health issues and government regulations for nicotine toxicity testing have also boosted demand for in-vitro toxicology assays in this segment.

Conversely, cannabis testing is expected to be the most rapidly expanding segment during the forecast period. Increased legalization of cannabis for medicinal and recreational purposes has required sophisticated toxicology assays to assure product safety and compliance. Moreover, increased research into the possible toxicological impacts of cannabinoids has resulted in higher demand for in-vitro solutions for testing.

By Technology

The mass spectrometry segment captured the highest revenue share in 2023 at 29.7% of the market. Its success is mainly attributed to its high sensitivity, precision, and capability to identify trace amounts of toxins in intricate biological samples. Mass spectrometry is now the standard in toxicology testing, especially for nicotine and cannabis assays, to guarantee accurate quantification and identification of toxins.

At the same time, 3D cell culture technology is the most rapidly expanding segment. The growing use of 3D cell cultures in toxicology testing is being fueled by their capacity to mimic human physiological conditions better than conventional 2D cultures. This technology improves the validity of toxicity predictions, decreasing dependence on animal testing while offering more relevant information for regulatory and safety evaluations.

By Application

The cytotoxicity testing segment led the market in 2023 with a 23.9% share in revenues. The reason behind this leadership is the enormous demand for cytotoxicity assays to assess the toxic impact of cannabis and nicotine substances on cellular life. Such agencies and pharmaceutical firms use these assays to establish the level of toxicity of chemicals so as to guarantee consumer safety as well as adhere to industry specifications.

The segment of genetic toxicity testing is the most rapidly growing in this category. The rising awareness of genetic damage due to long-term exposure to nicotine and cannabis constituents has driven the demand for in-vitro assays evaluating mutagenic and genotoxic hazards. Increased research into the long-term consequences of cannabinoids and nicotine on DNA integrity is further driving this segment's growth.

By Method

The cellular assay category held the highest share of the market in 2023, generating 54.9% of revenues. Cellular assays are commonly utilized because they can show real-time views of toxicological effects on the cellular level, a function that makes them critical for high-throughput screening in toxicological research. The growing need for effective and precise toxicity screening has cemented their market leadership.

On the other hand, the "Others" segment is anticipated to be the fastest-growing during the forecast period. This segment comprises emerging technologies like organ-on-chip technology and high-content screening, which provide sophisticated, physiologically relevant models for toxicity testing. The transition towards more predictive and advanced testing approaches is fueling the strong growth of this segment.

In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing Regional Insights

North America held a leading share of the In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing in 2023 due to robust regulatory environments, huge testing demands, and cutting-edge research facilities. The U.S. FDA and Health Canada follow strict safety checks on nicotine and cannabis products, which makes it more probable to adopt in-vitro toxicology assays. Moreover, the increasing legalization of cannabis in more than 40 states in the U.S. has increased the demand for toxicity testing, especially in the pharmaceutical and forensic sectors. The availability of major industry players, well-facilitated laboratories, and massive investments in AI-based toxicology platforms also further establish the region as the market leader.

Nevertheless, the Asia-Pacific region is the highest-growth region, with an increasing CAGR, due to growing tobacco and cannabis markets, increasing government regulation, and growing investment in research. China, Japan, and India are increasing toxicology testing as a result of increased nicotine use and regulatory requirements on e-cigarettes. In China, the largest tobacco producer and consumer in the world, more stringent regulations on nicotine toxicity testing have fueled market expansion. Additionally, Japan's expanding pharmaceutical industry and India's increasing investments in clinical research are driving the need for in-vitro assays. The use of mass spectrometry and 3D cell culture technology is increasing in the region, bolstered by the rise in toxicology research funding. This spate of regulation drives and technology upsurge has made the Asia-Pacific the most profitable growth opportunity in the outlook period.

Key Players and their respective products related to the In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing:

• Stemina Biomarker Discovery, Inc. – devTOX quickPredict

• Broughton – In Vitro Toxicological Testing, Toxicological Risk Assessments

• Labstat International Inc. – ToxTracker, Ames Test, Neutral Red Uptake, Mouse Lymphoma Assay, Micronucleus Test

• LifeNet Health LifeSciences – Human-derived cell and Tissue-Based Models

• TOXIKON – In Vitro Toxicology Assay Portfolio

• Integrated Lab Solutions GmbH – Customized In Vitro Toxicology Testing

• Enthalpy Analytical – Analytical and In Vitro Toxicology Testing Services

• PBR Laboratories, Inc. – In Vitro Toxicology Assays for Cannabis and Nicotine

• Charles River Laboratories – In Vitro Toxicology Testing Services

• Eurofins Scientific – In Vitro Toxicology Assays

Recent Developments in the In-Vitro Toxicology Assays Market for Cannabis and Nicotine Testing

In March 2025, CN Bio launched the PhysioMimix DILI Assay Kit: Human 24, enhancing preclinical toxicology testing with its advanced liver microphysiological system. This innovation provides human-relevant drug safety insights, supporting better clinical decision-making and reducing risks in drug development.

In Nov 2024, Emulate, Inc. launched the Chip-R1 Rigid Chip, a low-drug-adsorptive polymer-based Organ-Chip designed to enhance ADMET applications by reducing drug uptake and improving biological modeling. This innovation strengthens human dose prediction capabilities, advancing drug research and toxicity assessments.