Animal Testing and Non-Animal Alternative Testing Global Market Opportunities and Strategies to 2035

This report describes and evaluates the animal testing and non-animal alternative testing market in major geographies.

Animal Testing

The global animal testing market was valued at $10.74 billion in 2019 and the market is expected to grow at a compound annual growth rate (CAGR) of 1.03% during 2023-2028 and at a CAGR of 2.64% during 2028-2035. USA and Japan are the major animal testing markets in the world. The USA’s animal testing market was valued at $4.67 billion in 2019, and is expected to grow at a CAGR of 0.42% during 2023-2028 and at a CAGR of 0.81% during 2028-2035. Japan’s animal testing market was valued at $1.03 billion in 2019. The market is forecast to grow at a CAGR of 0.99% during 2023-2028, and at a CAGR of 1.66% during 2028-2035.

The growth of the animal testing market in the USA and Japan is mainly due to the rise in R&D activities in end-use industries, and regulations to conduct animal experiments before testing on humans. However, the slow anticipated future growth rates (from 2021 to 2035) can be attributed to the requirement from federal agencies on biopharma companies to adopt 3R principles (i.e. to replace, reduce, and refine animals used in the laboratory research), protests from animal welfare organizations. In 2021, the US Environmental Protection Agency (EPA) decided to rule out mammal testing for chemicals by 2035, and increasing preference by end-use industries towards the adoption of non-animal testing technologies.

Non-Animal Testing

The global non-animal alternative testing market was valued at $1.11 billion in 2019. The market is expected to grow at a CAGR of 6.34% during 2023-2028. The USA’s non-animal alternative testing technology market was valued at $0.34 billion in 2019. The USA’s market is forecast to grow at a CAGR of 6.39% through during 2023-2028. Japan's non-animal alternative testing technology market was valued at $0.06 billion in 2019 and the market is forecast to grow at a CAGR of 4.14% through 2023-2028.

The growth in the non-animal alternative testing market is mainly due to the adoption of the 3R principles by both regulatory agencies, and end-use companies, especially in the cosmetic industry. The adoption of alternative technologies is expected to grow after 2026 post regulatory agencies’ validation and approval.

The non-animal alternative testing market trends in the USA and Japan include raising investment for the development of alternatives to animal testing technologies, increasing adoption of in-vitro and in-silico technologies by the pharmaceutical industry, and the use of non-animal testing methods in the cosmetics industry.

The major drivers of the non-animal alternative testing technologies market include technological advances in drug development, ethical concerns on animal experimentations, high costs of animal studies, government programs for non-animal testing, rise in the number of research and development activities, raising investments and research grants for developing alternative technologies, increasing collaborations and partnerships to reduce animal testing, non-animal testing methods in the cosmetics industry are gaining traction, and increasing social awareness against animal cruelty. Factors that could hinder the growth of the non-animal testing include regulatory mandate on animal testing for drug/medical device approval, limitations in in-vitro testing technologies, and a lack of predictive ability of in-vitro testing over in-vivo testing.

The global non-animal alternatives testing market is fairly fragmented, with a large number of players operating in the market. The top ten competitors in the market made up to 10.95% of the total market in 2022. Some of the major developers of alternative testing technologies in the USA include Charles River Laboratories, Cyprotex, Emulate, Inc, BioIVT and EMD Millipore. The major Japanese developers include J-TEC, Reprocell Inc. and Organ Technologies.

Comparative Analysis and Regulatory Landscape

Animal tests including genetic toxicity, eye irritation, skin corrosion, skin sensitivity, and others are costlier when compared to non-animal testing technologies. High costs of animal testing include the cost of the animal, and the animal testing operation costs such as maintenance of animals and cost for human resource personnel. Considering all these, the costs for animal testing methods are higher than non-animal alternative testing methods.

In the USA, there are several regulatory agencies including the US Public Health Service, USDA, IACUS, AAALAC, and EPA that are responsible for animal research and welfare. Regulatory agencies for cosmetics have not mandated animal testing in the USA. However, all other industries including pharmaceuticals, medical devices, chemicals, and pesticides require animal testing for new drugs/chemicals before regulatory approval. In Japan, several regulatory agencies including the ministry of environment, MHLW, MEXT, and MAFF are responsible for conducting animal experiments. Companies in Japan are also trying to follow 3R principles from a legal, ethical and scientific point of view.

Alternative Testing Technologies in End Use Industries

Companies in the USA and Japan are developing alternative testing technologies such as cell and tissue culture (in-vitro), organ-on-chip, and in-silico technologies. Cosmetics and bio-pharma industries use these technologies to evaluate toxicity, efficacy, pharmacokinetics, and safety of a drug or a chemical. These technologies vary by the accuracy in drug screening and selection, efficacy, cost and time of the test results. Alternative technologies are widely adopted by cosmetic companies to understand eye irritation, skin irritation and safety studies of chemicals.

The cosmetics segment occupies the major market share in the alternative testing market followed by the medical devices and pharma industries. This is mainly due to the preference of choosing non-animal technologies by cosmetic companies due to several reasons such as potential cost savings, changing attitudes of consumers, and regulatory changes.

There is a need for validated non-animal alternatives for pharma and other end-use industries; hence, the non-animal alternative testing technology developers should focus on getting OECD approval for their developed technologies. The adoption rate of non-animal alternative testing technologies will be high in developed countries compared to emerging nations; hence, non-animal alternative testing technology developers should focus initially on developed markets. These developers should collaborate with animal welfare organizations for better promotion of their products.

To take advantage of the opportunities, the analyst recommends the animal testing and non-animal alternative testing companies to focus on AI-driven drug discovery solutions, focus on in silico trials for drug testing, focus on organ-on-chip tools for advanced testing, focus on 3D-printed organ technologies for enhanced testing, expand in emerging markets, continue to focus on developed markets, provide competitively priced offerings, participate in trade shows and events, continue to use B2B promotions, focus on people-centric strategies to target end-users.