U.S. In-Vitro Toxicology Testing Market - Databook 2025 to 2034

The U.S. in-vitro toxicology testing market size surpassed USD 4.99 billion in 2024 and is predicted to reach around USD 13.47 billion by 2034, registering a CAGR of 10.44% from 2025 to 2034.

Highlights of the U.S. In-Vitro Toxicology Testing Market

• By technology, the cell culture technology segment held a dominant presence in the market in 2024.
• By technology, the high throughput tech segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By method, the cellular assay segment accounted for a considerable share of the market in 2024.
• By method, the in-silico segment is projected to experience the highest growth rate in the market between 2025 and 2034.
• By application, the genotoxicity segment led the market.
• By application, the cytotoxicity segment is set to experience the fastest rate of market growth from 2025 to 2034.

Industry Valuation and Growth Rate Projection

The U.S. in-vitro toxicology testing market is expanding rapidly as more companies seek alternatives to testing that are safer and free from animal usage. In-vitro toxicology testing is when chemicals, drugs, and cosmetics are tested for toxicity using human cells or tissue in a laboratory, instead of animals. This method is a more ethical alternative than testing on animals and is also faster, cheaper, and produces better results most often.

There are several drivers in the United States that companies are actively pushing to use in-vitro testing, from typical regulatory requirements to increasing concern about animal rights. The pharmaceutical, cosmetics, and food industries are all implementing in-vitro testing methods as a preliminary means to assess safety and human toxicity. New technology, like laboratory testing systems, computer models, etc., is facilitating this marketplace.

What are the Market Trends in the U.S. In-Vitro Toxicology Testing Market?

• The market trends in the U.S. in-vitro toxicology testing market show that there is significant demand for pharmaceutical products related to the increasing need to assess the toxicity of substances on isolated cells or tissues outside a living organism.
• Strong pharmaceutical demand: Pharmaceutical companies in the U.S. are finding in-vitro testing efficient in testing for drug safety earlier in the development phase, potentially lowering costs.
• Advanced lab technologies: U.S. laboratories are acquiring more tools with the possibility to generate results in a faster, more reliable manner; with a high reliance on cell cultures, computer models, and higher-end technology.
• Government support for non-animal testing: Government agencies such as the FDA and EPA are highly endorsing the use of in vitro methods for product safety testing.
• Growing awareness of toxic chemical exposure: The level of awareness for more accessible and better testing is rising in the general public and companies regarding the level of chemicals that can be harmful to their health and the environment.

What are the Restraints in the U.S. In-Vitro Toxicology Testing Market?

• The restraints in the U.S. in-vitro toxicology testing market have to do with the prohibitive equipment cost and a small number of labs and research institutions currently working in the in-vitro toxicology testing market.
• High establishment costs: Establishing a modern in-vitro testing laboratory in the U.S. requires high-cost equipment and expertise.
• Limited knowledge of small companies: Small U.S. companies may not really be aware of how to even use, or have any trust in, in-vitro testing methods.
• Challenges in testing complex products: Some materials, such as inhalers or mixtures of chemicals, will be more difficult to test using in vitro testing only.

What are the Opportunities in the U.S. In-Vitro Toxicology Testing Market?

• There are several opportunities in the American in-vitro toxicology testing market, including a supportive policy structure, increased investments from U.S.-based pharmaceutical companies into the technology.
• Strong and supportive FDA and EPA: More US regulations and programs support and fund the increasing use of in-vitro testing.
• Growth in software tools in toxicology: U.S. companies are developing sophisticated software to provide more intelligent analyses of genotoxicity tests and results.
• Increased use of personalized medicine: In-vitro tests support U.S. physicians in finding the safest, most effective drugs for individual patients.
• Funding by government and universities: U.S. institutions are investing more money into further developing and supporting in-vitro toxicology testing, along with government support.

Recent Developments in the U.S. In-Vitro Toxicology Testing Market:

• In February 2025, CN Bio, a leading provider of Organ-on-a-chip (OOC) Systems and solutions, launched the physioMimix DILI assay kit: Human 24, for enhanced preclinical toxicology testing.
• In November 2024, researchers from Reynolds American and the Salisbury VA Medical Center conducted an in vitro toxicological evaluation of pouched portioned oral nicotine products. The researchers found the MO-8 test product was negative for mutagenicity but positive in the ivMN and NRU assays at concentrations either 42 to 135-fold based on the ivMN i to iv treatment schedule or 60-fold higher, respectively, when compared to combustible cigarettes.