In-Vitro Toxicology Testing Market is Projected to Reach US$ 30.06 Bn by 2033

According to Precedence Research, the global in-vitro toxicology testing market size was valued at US$ 10.99 billion in 2023 and is expected to attain around US$ 30.06 billion by 2033, growing at a CAGR of 10.82% from 2024 to 2034. The in-vitro toxicology testing market is booming due to the widespread use of vitro toxicity assays in the testing of potential new drugs, agrochemicals, food products, and other potentially toxic chemical products.

The In-Vitro Toxicology Testing Market is rapidly developing as a vital part of contemporary biological and chemical research, providing ethical, efficient, and advanced alternatives to traditional animal testing. In-vitro toxicology uses laboratory methods involving cells, tissues, or organs to evaluate the toxicity of various substances, including pharmaceuticals, chemicals, and cosmetics. This approach is gaining popularity, especially as regulatory bodies, particularly in the European Union, enforce strict limitations on animal testing for products like cosmetics under regulations such as the EU Cosmetics Regulation.

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In-vitro toxicology involves the study of compounds and their toxicological properties using live cells or tissues grown in laboratories. In-vitro toxicology screening methods are essential tools that reduce drug attrition during discovery and development. Recent advances in developing physiologically relevant in vitro models show promise for improving predictions of adverse effects in humans.

Key Takeaways

·         The U.S. in-vitro toxicology testing market size is expected to hit around USD 12.25 billion by 2033 and growing at a CAGR of 10.48% from 2024 to 2033.

·         North America captured more than 47.12% of the revenue share in 2023.

·         By technology, the cell culture technology segment generated more than 43.28% of the revenue share in 2023.

·         By method, the cellular assay segment contributed more than 39.11% of revenue share in 2023.

·         By application, the genotoxicity segment accounted for more than 20.99% of revenue share in 2023.

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What are the Growth Factors of In-Vitro Toxicology Testing Market?

·         In-vitro toxicology testing is crucial in developing assays targeting critical biochemical and biomarker toxicity endpoints.

·         In-vitro toxicology testing is vital in evaluating organ-specific liabilities using advanced 3D tissue models. 

·         In-vitro toxicology testing is a popular and quick method used in generic toxicity investigations to assess the cytotoxicity and genotoxicity of chemicals.

North America dominated the global market

By region, North America dominated the global market in 2023. The United States is home to several big players in the biotechnology sector.  The region has a robust medical infrastructure, with several new medical developments powered by research and development efforts undertaken by American companies, institutes, and universities. The United States leads in biotech patents, with 39% of the total biotech patents filed in 2020 coming from the country. 

Asia Pacific market is growing faster

Asia Pacific market is growing at a significant CAGR during the forecast period, as the region is expected to see substantial healthcare spending, accounting for more than 20% of global spending, by 2030. Government initiatives have also contributed to growth in the in-vitro toxicology testing market. For Instance, in Singapore, the government has pushed for innovative healthcare solutions to address the challenges of an aging population and a reduction in birth rates. The rapid growth of Asia’s healthcare industry will contribute to the emergence of better healthcare infrastructures. Health technology is a constantly growing and evolving sector encompassing technological advancements such as medical wearables, centralized databases, medical applications, artificial intelligence (AI), and mobile developments pushing innovation.

In-Vitro Toxicology Testing Market, By Region, ($Million)

Improvements in In Vitro Cell-Based Toxicity Models

The growth of the in-vitro toxicology testing market is primarily driven by a shift from an insight-focused to a homeostatic-focused approach to cell-based toxicity models. This advancement allows for better preclinical and clinical data comparisons, deepening understanding of the human body and the biological effects of drugs. Improved in-vitro models enhance the ability to measure and predict drug toxicity by identifying previously undetected biomolecules that can serve as early markers of homeostasis deficiencies. These advancements lead to earlier diagnosis and support the industry's growth through more accurate and effective toxicity testing.

Improved In Vitro Drug Toxicity Testing with 3D hiPSC-CM Cardiac Tissues

The development of a novel method for generating three-dimensional cardiac tissue using human induced pluripotent stem cell-derived cardiomyocytes represents a significant opportunity for the in-vitro toxicology testing market. This technology enables the rapid creation of 3D heart tissue by layering extracellular matrix materials, such as fibronectin and gelatin nanofilms, on top of hiPSC-CM. These 3D-hiPSC-CT models provide a more accurate and functional simulation of heart tissue, improving the reliability of in vitro-derived cardiotoxicity testing. This innovation not only addresses the limitations of single hiPSC-CMs but also has the potential to improve the drug discovery process and expand the field of in-vitro toxicology testing market.

Complications In-Vitro Toxicity Testing

The growth of the in-vitro toxicology testing market is limited by significant issues related to the reproducibility of in-vivo testing procedures for processes such as repeated toxicity, carcinogenicity, and reproductive toxicity. Major challenges include the difficulty of integrating exogenous metabolism into in-vitro assays and the difficulty of capturing interactions between different cell types. These limitations hinder the ability of in-vitro models to fully simulate biological processes, thereby limiting in-vitro toxicology testing market expansion.

Recent Breakthroughs in In-Vitro Toxicology Testing Market

• In April 2023, Evotec SE announced that Cyprotex US, LLC, the U.S. division of Cyprotex (a business entity of Evotec), celebrated the grand opening of its new facility in Framingham, Massachusetts.
• In January 2023, Eurofins expanded its presence in the Indian market with a new state-of-the-art Hyderabad campus; the acquisition includes a facility to support international and Indian drug users as well as large and small biotech companies in the field of synthetic electronics, analytical R&D facilities, bioanalytical services. (large and small molecules), in-vitro pharmacology, safety toxicology, and formulation development.

Report Highlights                                 

By Applications

The systemic toxicology segment is expected to expand at a robust growth rate during the forecast period due to its ability to accurately determine the molecular pathways and biological processes affected by substances. Toxicology studies investigate the toxicity profile of candidate compounds in all animal tissues and organs.

On the other hand, the dermal toxicity segment is projected to grow significantly because it has proved instrumental in testing the hazards of drugs to humans. A growing need for dermatological testing is expected to drive growth in the segment, as in-vitro skin samples are widely being used to measure skin toxicity. 

By Technology

The cell culture technology segment is expected to dominate the market over the forecast period. Technological advancements in recent years have improved how researchers grow cells and create tissue-like structures more quickly. 3D cell culture has been used in regenerative medicine, disease modeling, and drug screening, leading to robust growth in the segment.

By Method

The cellular assay segment is expected to hold a key account share during the forecast period. It has advantages such as speed, cost reduction, automation capability, and the same testing using humans. Some in vivo animal experiments are more likely to be conducted.

On the other hand, the in-silico segment is projected to grow at a significant CAGR during the forecast period. This method is computationally focused and is used to identify, simulate, detect, or predict toxic chemicals in the in-silico toxicology segment.

By End User

The pharmaceutical industry segment is expected to capture a significant market share over the forecast period due to pharmaceuticals based on in-vitro toxicology. In-vitro toxicology studies can help reduce the liability associated with late failures in the drug discovery process. On the other hand, the diagnostics segment is expected to expand at a robust growth rate in the coming years as in vitro diagnostics (IVDs), which are clinical tests for analyzing samples collected from the human body, become more popular in clinical tests.

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Key Players In-Vitro Toxicology Testing Market

·         Charles River Laboratories International, Inc.

·         SGS S.A.

·         Merck KGaA

·         Eurofins Scientific

·         Abbott Laboratories

·         Laboratory Corporation of America Holdings

·         Evotec S.E.

·         Thermo Fisher Scientific, Inc.

·         Quest Diagnostics Incorporated

·         Agilent Technolgies, Inc.

·         Catalent, Inc.

·         Danaher Corporation

·         Bio-Rad Laboratories, Inc.

·         BioIVT

·         Gentronix

·         Labcorp Drug Development

·         Acea Biosciences Inc.

·         Cyprotex Plc

·         Ge Healthcare

·         Perkinelmer Inc.

·         Qiagen Nv

·         Biognosys Ag

·         Imquest Biosciences Inc.

·         Lonza Group Ltd.

·         Promega Corporation

·         Stemina Biomarker Discovery Inc.

·         Vistagen Therapeutics Inc.

·         Xenometrix Ag

·         MB Research Laboratories 

Market Segmentation

By Technology

• Cell Culture Technology
• High Throughput Technology
• Cellular Imaging
• OMICS Technology

By Application

• Genotoxicity
• Cytotoxicity
• Phototoxicity
• Carcinogenicity
• Neurotoxicity
• Dermal Toxicity
• Endocrine Disruption
• Ocular Toxicity
• Others

By Method

• Cellular Assay
• Live Cells
• High Throughput / High Content Screening
• Molecular Imaging
• Others
• Fixed Cells
• Biochemical Assay
• In-silico
• Ex-vivo

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

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