Early Toxicity Testing Market to Capture USD 2.53 Bn by 2034

Early Toxicity Testing Market Size, Growth Factors and Regional Analysis

The global early toxicity testing market was evaluated at US$ 1.16 billion in 2023 and is expected to attain around US$ 2.53 billion by 2034, growing at a CAGR of 7.34% from 2024 to 2034. The early toxicity testing market has grown because early-stage toxicology studies are an important part of drug development, helping to assess the potential safety and toxicity of drug candidates.

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Market Overview

The early toxicity testing market is growing rapidly because toxicity testing does not only check the safety of the test substance but also toxicity testing can be used to monitor treatment at superfund sites. Toxicity testing, in particular, can indicate that the source of contamination has been controlled and whether remedial measures have reduced toxicity. Chemical testing plays a role in determining the ability of the site to support a healthy ecological community after treatment. The goal of toxicology research is not, as is often denied, to reduce or eliminate harm, but to restore the power of transforming molecules that have failed in past discovery. It provides support for health outcomes resulting from exposure and effective risk management decisions. Toxicity testing for human health assessment usually involves studies on whole animals, most commonly mice, rats, dogs, and rabbits, although other species, including humans, may also be tested.

Rising Demand for Early Toxicity Testing Need to Mitigate Drug Development Failures

Increasing awareness of the significant impact of unexpected toxicity issues in the preclinical phase is driving the growth of the early toxicity testing market. Rejection or withdrawal of a drug candidate can further increase medical costs, especially when toxicity is detected after commercial launch. A good understanding of drug-target interactions is essential to assess drug interactions, and safety, and predict therapeutic efficacy and potential against poisons. Early toxicity testing can predict greater safety and allows researchers to identify potential risks before they become costly problems at a later stage. The need for increasingly accurate safety analysis is encouraging the use of advanced toxicity methods and expanding the market, as ensuring drug safety and efficacy is still the most important factor in drug manufacturing.

Market Trends

• In November 2023, the FDA's new Alternatives Program aims to promote the regulatory use of alternatives that can replace, reduce, and improve animal testing (3Rs) to help prevent products from entering the market with increased toxicological risk. Initiatives to facilitate the predictivity of nonclinical testing to streamline the development of FDA-regulated products have led to the growth of the first chemical industry.
• The concept of green chemistry and the EU strategy for a non-toxic environment can be considered as part of the global development goal. The promotion of alternative animal testing methods is one of the objectives of the REACH Regulation, as the use of alternative methods to avoid the use of these animals would lead to the development of an early toxicity testing market.
• In 2023, Labcorp developed an in vitro toxicology test that supports the language of the 3R principles as an alternative to animal toxicity testing to help reduce the cost of early drug development, leading to its first toxicity testing business.
• In 2023, the U.S. Environmental Protection Agency’s Toxicity Forecaster (ToxCast) program will release in vitro medium- and high-throughput chemical analysis data for the values ​​and hazards of thousands of chemicals, leading to the expansion of the early toxicity testing market.

Artificial Intelligence Is Transforming the Early Toxicity Testing Market

There have been several breakthroughs in the field of biotechnology in recent years thanks to the use of artificial intelligence and machine learning. New  AI-based tools are being developed to analyze the large amounts of data generated by the biomedical and biotechnology sectors, including electronic health records, genomic data, and clinical trial reports, to identify patterns. Machine learning algorithms are trained to identify patterns and predict factors for ADRs and toxicity.

Researchers are conducting predictive toxicology studies with the help of AI-powered tools to conduct Read-Across Structure Activity Relationship (RASAR) and Quantitative Structure-Activity Relationship (QSAR) studies. These tools use machine learning algorithms to compare the molecular structure of a given chemical molecule to similar chemicals to predict toxicity by analyzing the chemical and comparing it against a database. Traditional toxicity testing involves the use of expensive in vitro and in vivo experimentation over a larger time frame. AI is being deployed to speed up the analysis and comparison process tremendously.

• In March 2024, researchers used the QSAR model to predict the inhibition of ionic liquids towards the activity of Acetylcholinesterase by using Random Forest (RF) AND eXtreme Gradient Boosting (XGBoost) machine learning tools. Both models only used 14 of the most critical molecular descriptors, which could maintain the model's robustness and reliability.

Recent Technological Advances

Recent technological advances in areas such as induced pluripotent stem cells (iPSCs), 3D tissue modeling, microphysiological systems (MPS), and advanced imaging techniques have improved the power estimates of early toxicology testing. These innovations are revolutionizing drug discovery by providing convenient, human-relevant models for assessing toxicity and safety. Particularly in the field of agrochemical toxicology, MPS technology should always be adapted to in vivo animal models, allowing for early analysis of compounds. Evidence-based studies have shown that MPS can replace in vivo testing for some endpoints, helping manufacturers identify the best compounds from a library of drug analogs while reducing reliance on animal testing. These new technologies are increasingly being integrated into routine chemical analysis, offering significant opportunities for early commercialization of chemical compounds, enabling faster, more reliable, and direct fidelity to traditional methods.

Challenges in Extrapolation and Data Relevance

One of the major constraints limiting the growth of the early toxicity testing market is the ongoing competition between clinical data and the human toxicity landscape. While toxicity testing data provide useful information, it remains difficult to determine the best way to translate findings from laboratory testing to human exposure. Although pharmacokinetic data are useful in understanding the relationship between exposure and dose, comparisons between experimental species and humans remain difficult. In addition, these extrapolation methods often need to be developed based on population-based studies examining human effects and in some cases can reduce or eliminate the need for animal-only testing data. These problems in providing reliable data and utilization have hindered the widespread use and effectiveness of the early toxicity testing market, limiting the growth potential of the market.

Regional Insights

By regional insights North America dominated the medical early toxicity testing market share by 39% in 2023 as it is at the forefront of new treatments and medical devices by investing heavily in research. It also provides medical education that trains specialist physicians who can centrally manage patients in a freely chosen manner. The new healthcare industry in the United States is by far the largest in the world. Medical technology and life science companies are taking advantage of changing lifestyles and changing demographics. North America has experienced steady economic growth over the past decade, with some countries growing faster than others. Increased trade and investment by North American countries, particularly the United States and Canada, as well as advances in technology and innovation, particularly in the United States and Canada, are playing a significant role in the automotive industry’s advancement in North America. The governments of these countries are actively working to increase manufacturing and expand their export sectors, particularly in North America.

Asia Pacific is expected to witness significant growth in the early toxicity testing market during the forecast period due to the growing potential of the regional healthcare sector and innovations by companies. Asia is poised for rapid healthcare reform due to changing demographics, rising consumer expectations, technological innovations, and limited access to traditional medical care. Healthcare providers in Asia Pacific are increasingly using digital technologies, including AI and cloud technologies, in their care models. As healthcare costs continue to rise, some Asia Pacific countries are providing incentives for health screening to improve early diagnosis and treatment of diseases. The Asia Pacific region is increasingly receiving significant support in markets such as Japan, South Korea, and Taiwan, with many robot-assisted surgeries now covered by public insurance.

Segmental Insights

By Type

By type, in-vivo segments constitute the early toxicity testing market, as in vivo testing requires small amounts of drugs to be effective for decision-making and rapid discovery for simple chemistry studies; and be flexible and provide results relevant to the development plan tailored to each target, drug class, and/or indication. The in vitro segment is the fastest-growing segment in the early toxicity testing market, as in vitro toxicology involves the analysis of compounds and their toxicological properties using the capture or growth of cells or tissues based on clinical investigation. In vitro toxicology studies are performed using biological materials (tissues or cells) that are isolated, grown, or maintained under controlled conditions.

By Application

In terms of application, the pharmaceutical industry dominates the early toxicity testing market, such as early in vivo toxicity testing in drug discovery toxicology. Preclinical or nonclinical toxicology involves the study of the toxicological behavior of early-stage drug candidates. Preclinical toxicology studies include clinical trials, including in vivo preclinical toxicology studies. Whereas the diagnostics segment is fastest growing as whole blood, serum, or plasma are often preferred for most results, and can be used to assess signs and symptoms of toxicity.

Recent Developments

• On July 2, 2024, The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL, once-monthly intravenous infusion) from Eli Lilly and Company for the treatment of patients with early Alzheimer's disease (AD), including people with mild cognitive impairment (MCI) and people with mild forms of AD with established amyloid pathology.
• In March 2024,  Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi, a chimeric antigen receptor (CAR) T-cell therapy directed against CD19 for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor and B-cell lymphoma 2 (BCL-2).
• In May 2024, Lantern Pharma Inc., a leading artificial intelligence (AI) oncology drug discovery and development company announced an AI-driven collaboration with French biotechnology company Oregon Therapeutics to develop its first-in-class protein disulfide isomerase (PDI) inhibitor drug candidate XCE853 in novel and targeted cancer indications.
• In September 2024, Scantox, together with its majority shareholder Impilo, completed the acquisition of Gentronix Ltd, a UK-based GLP-compliant genetic toxicology contract research organization (“CRO”).

Top Companies in Early Toxicity Testing Market

• Thermo Fisher Scientific
• BD Biosciences
• Covance
• Agilent Technologies
• Bio-Rad
• Sigma Aldrich
• Quest Diagnostics
• Charles River Laboratories

Segments Covered in the Early Toxicity Testing Market

By Type

• In-vivo
• In-vitro
• In-Silico

By Application

• Pharmaceuticals
• Diagnostics
• Foods and Beverages
• Chemicals
• Cosmetics
• Others

By Geography

• North America
• Europe
• Asia Pacific
• Middle East & Africa
• Latin America