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 or experiment on animals done in the early stages of drug development and for toxicity and safety assessment of medical devices, chemicals, pesticides, cosmetics, and food compounds. Animal experiments are necessary before testing on humans mainly to evaluate toxicity, pharmacokinetics, and safety of a drug or a chemical. However, there is an increasing pressure from the animal welfare organizations on governmental agencies and companies to use non-animal alternative testing technologies. These technologies include in-vitro cell and tissue cultures, organ-on-chip, computer simulations, 3D bio printing of tissues, and synthetic skin substitutes, among others. Industries such as pharmaceuticals, medical devices, chemicals and pesticides and food are increasingly adopting these technologies to replace animal testing.

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 3.38% during 2019-2025 and at a CAGR of 2.13% during 2025-2035. 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 1.27% during 2019-2025 and at a CAGR of 0.63% during 2025-2035. Japan’s animal testing market was valued at $1.03 billion in 2019. The market is forecast to grow at a CAGR of 3.12% during 2019-2025, and at a CAGR of 1.25% during 2025-2035.

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 11.13% during 2019-2025. 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 13.09% through during 2019-2025. 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 7.67% through 2025.

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 non-animal alternative testing market is fragmented, with a large number of small players in the market. The top ten competitors in the market made up to 8.58% of the total market in 2021. Some of the major developers of alternative testing technologies in the USA include Emulate Inc, Organovo Holdings, MatTek Corporation & 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 publisher recommends the animal testing and non-animal alternative testing companies to focus on development of 3D-printed organs for testing, focus on development of OOC (organ-on-chip) for testing, focus on pricing based on economies, provide competitively priced offerings, focus on developing economies, expand in developed markets, continue to focus on business-to-business (B2B) promotions and collaborate with end-user companies.