In Vitro Toxicology Testing Market

Market Overview

The global in vitro toxicology testing market size was valued at USD 11.2 billion in 2022. It is estimated to reach USD 28.19 billion by 2031, growing at a CAGR of 10.8% during the forecast period (2023–2031). The opposition to animal testing and ongoing developments to advance toxicology research will promote market expansion.

A scientific technique called in vitro toxicology testing is used to assess a substance's toxicity on living cells or tissues not inside an organism. It is an essential part of preclinical safety assessment in the pharmaceutical and chemical sectors and regulatory organizations. The main goal is to discover and evaluate compounds' harmful effects on human health, giving important insights into their possible risks and assisting in creating safer goods. This testing method involves isolating isolated cells, tissues, or organ systems and observing how they react to the test chemical.

Cell viability assays, genotoxicity assays, enzyme activity assays, and receptor binding studies are just a few of the methods used. Cytotoxicity, oxidative stress, mutagenicity, and other toxicological endpoints can all be measured by researchers. In vitro toxicology testing offers quick answers and eliminates the necessity for animal testing, enabling scientists to screen many substances quickly. Additionally, it enables the research of particular toxicity pathways and aids in understanding the cellular and molecular mechanisms at play. Understanding the intricate relationships between organs and systems within living organisms requires in vivo testing.

Market Dynamics

Global In Vitro Toxicology Testing Market Drivers:

Opposition to Animal Testing

Animal testing has traditionally been the foundation for new chemical safety assessments. Preclinical animal testing is required to screen potential drug candidates, which is time-consuming and expensive. In the aerospace, biomedical, automotive, consumer product testing, military, cognitive research, and agricultural sectors, over 100 million animals are used for labor; 95% of these animals are not legally protected. However, several nations have recently pushed for a ban on chemical testing using animals.

Additionally, it is believed that when taking into account typical low-dose exposure, the traditional animal-based risk assessment methodologies are insufficient to evaluate the possible harm associated with any particular chemical thoroughly. Therefore, new prediction and testing models built on in vitro and computer modeling are needed for a more effective safety evaluation.

Ongoing Developments to Advance Toxicology Research

Regulatory agencies have become increasingly receptive to in vitro and alternative toxicology testing methods in recent years. The development of 3D cell culture due to technological advancements enables in vitro safety testing of new compounds. Researchers are developing animal-free technologies such as direct peptide reactivity assays, ARE-Nrf2 Luciferase assays, and the Human Cell Line Activation Test (h-CLAT). This market is also influenced by the expanding trend of outsourcing toxicology testing services. High-throughput chemical toxicity testing has been investigated due to new food additives and food contact substance development innovations. Constrained financial resources have prompted the adoption of cost-effective technologies for animal-free in vitro high-throughput screening (HTS).

Global In Vitro Toxicology Testing Market Restraint:

Lack of in Vitro Models

The investigation of immunotoxin effects relies significantly on various animal models to characterize sensitization and immunosuppression. In vitro models are promising for advancing toxicological research; however, developing in vitro models, such as 3D constructs, is laborious and requires attentive care to preserve specificity and physiology similarity with the host. This is the case even though in vitro models have substantial potential for advancing toxicology research. In addition, if the development of tissue constructs does not go as intended, there may be substantial financial and time losses.

Global In Vitro Toxicology Testing Market Opportunities:

More Toxicology Databases Become Available to Businesses

The desire to expedite the toxicological examination of compounds, utilize fewer animals, and use less expensive tools has significantly impacted predictive toxicology and structure-based approaches. To increase the effectiveness of predictive toxicology techniques, the discipline requires access to the largest corpus of preliminary toxicological data, which must also be comparable and interoperable.

The efficient use of alternative toxicological testing methods will be aided by databases that contain information on chemical safety profiles, modes of action, genetic effects, fatal dose information, diverse formulations, and toxicogenomic data. These databases will also minimize animal testing requirements because they eliminate the necessity for repeated toxicity experiments on the same substances for safety evaluation.

Regional Analysis

North America Dominates the Global Market

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

North America is the most significant global in vitro toxicology testing market shareholder and is estimated to exhibit a CAGR of 11.60% over the forecast period. North America's in vitro toxicology testing market was the largest global market. This was achieved due to several factors, including an increase in the amount of money spent on healthcare, an increase in the focus of government bodies on drug discovery, and the provision of suitable infrastructure for the growth and development of technologies related to drug discovery. The manufacturing of chemicals, cosmetics, and medical devices are just some industries that have recently benefited from the rapid development of novel, cost-effective, and non-animal testing procedures to determine the level of risk posed by new products.

Asia-Pacific is anticipated to exhibit a CAGR of 10.81% over the forecast period. A significant source of revenue is anticipated to come from the Asia Pacific region because of nations like China, India, and Korea. To encourage the use of in vitro toxicity testing throughout Asian nations, several organizations have been founded. For instance, the Center of Alternative Methods for Safety Evaluation of Cosmetics (CAMSEC) was founded in Korea to present innovative, trustworthy alternatives to animal testing. From the Ministry of Food and Drug Safety, CAMSEC receives money. The launch of numerous regional programs is expected to affect the organizations engaged in toxicological testing positively. The Singapore-based TÜV SÜD PSB, which provides testing and product certification services, including services for in vitro toxicity, is one such organization that is expected to gain.

In Europe, it is projected that the market will expand significantly over the next several years as a direct result of the support offered by governments and non-governmental organizations for the research and development of novel therapies. It is predicted that new projects and programs will be started in the country to investigate alternative ways of evaluating the safety of chemicals. These initiatives, which will serve as a driver for the businesses now operating in this field, will result from the anticipation that these initiatives will be launched. The European Society of Toxicological in Vitro also works to establish contacts between organizations and individuals all over Europe interested in vitro toxicological applications.

Latin American countries are implementing the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations to standardize the development and approval of new drugs. Additionally, the Pan American Network for Drug Regulatory Harmonization (PANDRH), an initiative of the Pan American Health Organization (PAHO), enables LATAM nations to standardize drug development procedures throughout the region. The sizeable portion of the Latin American pharmaceutical market in global pharmaceutical sales drives the demand for toxicity screening. Drug research has expanded quickly in the region, largely because of continual improvements in regulatory enforcement organizations, qualified researchers, aggressive Good Clinical Practice (GCP), and policy development.

In The Middle East and Africa, Investments in medication research in the region are likely to increase as awareness of tropical diseases like malaria and tuberculosis grows. In the area, various safety studies are being carried out to assess a drug's effectiveness in treating conditions like malaria, HIV, and other bacterial illnesses. In addition, several measures are being implemented in Middle Eastern nations like Nigeria to increase domestic drug production. This will probably impact adopting in vitro toxicity testing services throughout the MEA.

Segmental Analysis

The global in vitro toxicology testing market is bifurcated into end use, technology, application, and method.

Based on the end-use, the global in vitro toxicology testing market is bifurcated into the pharmaceutical industry, cosmetics and household products, diagnostics, chemical industry, and food industry. 

The chemical industry segment dominates the global market and is projected to exhibit a CAGR of 11.34% over the forecast period. Chemical testing items must be developed due to the increasing use of chemical products. In-vitro toxicological testing provides crucial resources for a thorough understanding of the dangerous effects of chemicals and aids in predicting the consequences on people. Some businesses that provide toxicity profiling for chemical goods include MB Research Labs and Envi Go.

The evaluation of chemical dangers is currently experiencing a paradigm shift in toxicology. There are tens of thousands of compounds in use, many of which have scant or no knowledge regarding their hazards, and evaluating these chemicals is difficult due to a lack of resources (particularly time and money). High-throughput (in vitro) screening (HTS) without animals is now possible thanks to molecular and cellular biology developments, testing methods, and computational toxicology.

Based on technology, the global in vitro toxicology testing market is segmented into cell culture tech, high throughput tech, molecular imaging, and omics tech. 

The cell culture tech segment dominates the global market and is predicted to exhibit a CAGR of 10.23% during the forecast period. Due to its main advantages of uniformity and repeatability, cell culture is a great model for understanding how toxins affect cells. Cell culture technology during the drug development process helps identify toxicity early. Effectively removing any impacts of harmful substances in the early stages of the medication development process aids in understanding the mechanism.

Concerns about government-initiated animal testing are among the factors that have led to increased government support for the rapid development of cell culture technology that makes detecting toxicity at an early stage possible. The advantages of 3D cell culture models, such as function, differentiation, and higher cell proliferation, have acquired substantial momentum over time. Researchers are also eager to use mammalian cell culture to build novel therapeutic approaches since it helps with efficient cell function inquiry and chemical screening.

Based on application, the global in vitro toxicology testing market is bifurcated into systemic toxicology, dermal toxicity, endocrine disruption, ocular toxicity, and others. 

The Systemic Toxicology segment owns the highest market share and is predicted to exhibit a CAGR of 9.97% over the forecast period. Adoption is anticipated to increase with the use of adoption to detect undesirable effects happening quickly after treatment. The goal is to produce precise data like - the minimum dose that results in toxicity, maximum tolerated dose, plasma concentration that results in toxicity, and margin of safety used to make decisions. There are various systemic toxicity studies, including acute systemic toxicity, sub-acute systemic toxicity, sub-chronic systemic toxicity, and chronic systemic toxicity. The market is expected to rise due to the development of items like multiple organ plates with simulated blood flow for measuring systemic toxicity. Several organizations are working on substituting animal testing for acute systemic toxicity.

Based on the method, the global in vitro toxicology testing market is divided into cellular assay, biochemical assay, silica, and ex-vivo. 

The Cellular Assays segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 10.07% over the forecast period. Cell-based assays are essential for phenotypic output measurement and acute toxicity event prediction for drug discovery applications, including cell proliferation, plasma membrane permeability, and adenosine triphosphate content. Measurement of living and dead cells in cell culture populations and research into the effects of pharmacological drugs on cell cultures are made possible by in vitro toxicology cell assays, such as cytotoxicity tests. These tests are being utilized more frequently in oncological research to determine the toxicity of compounds and the suppression of tumor cell proliferation. They have benefits, including low cost, quickness, and automation possibilities.

Recent Developments

• June 2023- Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, announced it had acquired Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage technology platform for developing ADCs. This will help the company to expand its global presence.
• October 2022- Thermos Fisher Scientific Inc. announced that it would expand its laboratory operations in Highland Heights, Kentucky, helping customers deliver life-changing medicines to patients. The current facility, which includes central lab and biomarker operations, provides biopharma customers with high-quality laboratory services to accelerate drug development.