In-vitro Toxicology Testing Market - Product and Services (Consumables, Assays, Equipment, Software), Endpoint and Test (Genotoxicity, Cytotoxicity), Technology (Toxigenomics, Cell Culture), Method (Ex Vivo, In Silico), Industry – Global Forecast, 2024 - 2032

In-vitro Toxicology Testing Market Size

In-vitro Toxicology Testing Market size was valued at around USD 1.9 Billion in 2023 and is anticipated to register a CAGR of over 7.7% between 2024 and 2032. In-vitro toxicology testing refers to the scientific evaluation of the toxic effects of substances (such as chemicals, drugs, or other compounds) on biological systems outside of a living organism.
 

The in-vitro toxicology testing market is witnessing remarkable growth, driven by a confluence of factors shaping the pharmaceutical, chemical, and cosmetics industries. One of the primary drivers of market growth is the increasing regulatory scrutiny and stringent safety requirements imposed by governmental bodies worldwide. These regulations compel industries to adopt safer and more reliable testing methods, propelling the demand for in-vitro toxicology testing solutions.
 

Moreover, the incorporation of in-vitro toxicology testing in drug development and product safety assessment processes by pharmaceutical and cosmetics companies signifies a significant shift in industry practices. This transformation is driven by various factors that collectively contribute to advancing scientific methods, enhancing ethical considerations, and streamlining research and development efforts.
 

Additionally, advancements in technology, such as high-throughput screening and organ-on-a-chip models, are enhancing the efficiency and accuracy of in-vitro toxicology testing, further fueling market progress.
 

In-vitro Toxicology Testing Market Trends

Regulatory agencies are becoming more accepting of in-vitro testing methods. Guidelines and initiatives, such as the Tox21 program, are encouraging the use of alternative methods, contributing to greater regulatory acceptance of in-vitro toxicology data in safety assessments.
 

• The Tox21 (Toxicology in the 21st Century) program is a collaborative effort involving multiple U.S. federal agencies, including the National Institutes of Health (NIH), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA). Launched in 2008, Tox21 aims to improve the efficiency of toxicity testing by promoting the use of in-vitro methods and computational approaches.
   
• Tox21 focuses on advancing toxicology testing methods to better assess the safety of chemicals and drugs. The program aims to develop alternative testing strategies that are more predictive of human responses, reduce the need for animal testing, and provide quicker and more cost-effective results.
   

In-vitro Toxicology Testing Market Analysis

Based on product and services, the market is segmented into consumables, assays, equipment, software, and services. The consumables segment is poised for significant growth at a CAGR of 7.8% during the forecast period.
 

• There is an increasing demand for high-quality cell culture media and reagents that support the growth and maintenance of cells in in-vitro toxicology testing. This trend is driven by the growing use of cell-based assays and 3D cell culture models.
   
• The adoption of 3D cell culture which is estimated to reach USD 5.5 billion by 2032,  models has led to a surge in the demand for consumables specific to these applications. Scaffolds, matrices, and other 3D cell culture consumables are being increasingly utilized to create more physiologically relevant in-vitro environments.

Based on endpoint and test, the in-vitro toxicology testing market is segmented into absorption, distribution, metabolism, and excretion (ADME), skin irritation, corrosion, sensitization, genotoxicity, cytotoxicity, ocular toxicity, organ toxicity, phototoxicity, dermal toxicity, and other endpoints and tests. The ADME segment accounted for a revenue share of 23.4% in 2023 and is estimated to follow similar trend over the coming years.
 

• There has been a growing preference for in-vitro ADME models over traditional in-vivo methods. In-vitro ADME assays are considered cost-effective, faster, and more ethical alternatives to animal studies.
   
• High-throughput screening methods in ADME testing have gained prominence, allowing researchers to evaluate large numbers of compounds more efficiently. This trend aligns with the broader industry push toward automation and efficiency.

Based on technology, the in-vitro toxicology testing market is segmented into cell culture, high throughput, and toxicogenomics. The cell culture segment is poised for significant growth at a CAGR of 7.8% during the forecast period.
 

• The use of organoids, which are three-dimensional, miniature organs grown in vitro, has gained traction. Organoids provide a more complex and physiologically relevant platform for toxicity testing compared to traditional 2D cell cultures.
   
• Researchers are developing in-vitro models that simulate interactions between multiple organs, allowing for a more comprehensive understanding of systemic toxicity. Multi-organ systems contribute to a more accurate prediction of in-vivo responses.
   

The in-vitro toxicology testing market by method is categorized into cellular assays, biochemical assays, in silico models, and ex vivo models. The cellular assays segment accounted for around USD 748.1 million revenue size in 2023.
 

• High-content screening techniques, which involve the automated analysis of multiple parameters within individual cells, are on the rise. HCS provides a more detailed and comprehensive assessment of cellular responses to toxic substances.
   
• Genomic and transcriptomic assays are becoming more sophisticated and widely used in in-vitro toxicology testing. These assays provide insights into gene expression changes and molecular pathways affected by toxicants.
   
• Functional assays that measure specific cellular functions, such as mitochondrial function, oxidative stress, and apoptosis, are gaining prominence. These assays provide direct insights into the impact of toxicants on cellular processes.
   

The in-vitro toxicology testing market by industry is categorized into pharmaceuticals and biopharmaceuticals, cosmetics and household products, food, chemicals. The pharmaceuticals and biopharmaceuticals segment accounted for around USD 808.6 million revenue size in 2023.
 

• There is a growing trend in utilizing in-vitro toxicology testing during the early stages of drug development. The pharmaceutical industry is placing increased importance on identifying potential safety issues in the preclinical phase to reduce late-stage failures.
   
• As the market for biopharmaceuticals and biologics continues to grow, in-vitro toxicology testing is adapting to address the unique challenges associated with these complex molecules. Specialized assays are being developed for the safety assessment of biopharmaceuticals.

North America in-vitro toxicology testing market accounted for USD 857.2 million revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.
 

• In North America, there is a notable trend towards the increased adoption of in-vitro testing methods as an alternative to traditional animal testing. This is driven by ethical considerations, regulatory encouragement, and the development of more reliable in-vitro models.
   
• There has been an increase in funding for toxicology research in North America, including in-vitro testing initiatives. Government agencies, private institutions, and pharmaceutical companies are investing in research and development to advance in-vitro testing technologies.
   

In-vitro Toxicology Testing Market Share

The in-vitro toxicology testing industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. Some of the leading industry players including Abbott Laboratories, Inc., Merck KGaA, Danaher Corporation among others have a notable presence in the market. These companies compete based on factors such as product portfolio breadth, technological innovation, pricing strategies, and geographical presence. Additionally, partnerships, collaborations, and acquisitions are common strategies employed by players to strengthen their market position and expand their customer base.
 

In-vitro Toxicology Testing Market Companies

Some of the eminent market participants operating in the in-vitro toxicology testing industry include:

• Abbott Laboratories
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Catalent, Inc.
• Charles River Laboratories International, Inc.
• Danaher Corporation
• Eurofins Scientific
• Evotec S.E.
• Laboratory Corporation of America Holdings
• Merck KGaA
• Quest Diagnostics Incorporated
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific Inc.
   

In-vitro Toxicology Testing Industry News:

• In April 2023, Thermo Fisher Scientific launched the first of 37 CE-IVD-marked real-time PCR assay kits, primarily for infectious diseases, as part of its plan to introduce a full menu of company-branded test kits throughout the year. These assays were available in countries recognizing CE marking for use with the CE-IVD-marked QS5 Dx, a diagnostic testing platform compliant with the EU's new In Vitro Medical Devices Regulation (IVDR) framework. This product launch helped the company boost revenue and provided a competitive edge.
   
• In February 2023, Evotec revealed the relocation of its subsidiary, Cyprotex US, LLC, from Watertown to Framingham, U.S. The move was aimed at expanding the new facility to facilitate faster turnaround times.

In-vitro toxicology testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 – 2032 for the following segments:

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Market, By Product and Services

• Consumables
• Assays
  • Bacterial toxicity assays
  • Enzyme toxicity assays
  • Cell-based ELISA and western blots
  • Receptor binding assays
  • Tissue culture assays
  • Others assays 
• Equipment
• Software
• Services

Market, By Endpoint and Test

• Absorption, distribution, metabolism, and excretion (ADME)
• Skin irritation, corrosion, sensitization
• Genotoxicity
• Cytotoxicity
• Ocular toxicity
• Organ toxicity
• Phototoxicity
• Dermal toxicity
• Other endpoints and tests

Market, By Technology

• Cell culture
• High throughput
• Toxicogenomics

Market, By Method

• Cellular assays
• Biochemical assays
• In silico models
• Ex vivo model

Market, By Industry

• Pharmaceuticals and biopharmaceuticals
• Cosmetics and household products
• Food
• Chemicals

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa