A global shift in scientific and medical research is under way as countries hope to phase out experimentation on animals – but Australia risks being left behind.

The transition from using animals to alternatives based on human cells, tissue and data is driving multibillion-dollar growth in new technologies and methods. However, industry leaders and insiders warn Australia will miss those opportunities due to a lack of funding, opaque record keeping and national inconsistencies.

An estimated 192 million mice, rats, fish and other animals are used for research globally each year, a number countries in Europe and North America are aiming to cut back and phase out. The picture in Australia is grey and hazy.

Unlike comparable countries, Australia has no national centre or dedicated funding for alternatives to animal testing and no nationwide statistics on animal use, despite the recommendations of a 1989 Senate inquiry, a 2022 New South Wales inquiry and a 2023 CSIRO strategy.

Bella Lear, the CEO of Understanding Animal Research Oceania, says it is “an insane situation” that people don’t know how many or what types of animals are used for research in Australia.

If it passes, a US bill will require the Food and Drug Administration to support drug development methods that replace or reduce the use of animals. Similarly, the European Union wants to replace animals in research and to eliminate their use in chemical safety testing.

Canada recently passed laws to reduce chemical testing on animals, and the UK has pledged to phase out animal testing.

These measures are driving the growth of “non-animal” technologies. Two leading models based on human cells – organoids and organ-on-chip – were valued at $1.7bn in 2022 and are estimated to reach $42.4bn in 2040, according to the CSIRO.

Animal-Free Science Advocacy opposes the harmful use of animals in science and says Australia needs better coordination nationally.

“Recent years have seen increasing awareness of the scientific, economic and ethical benefits of using non-animal approaches in preclinical research,” says CEO Rachel Smith.

The group says Australia is one of only a few OECD countries without a central body to support alternatives to animal testing and no specific funding from the National Health and Medical Research Council or the Medical Research Future Fund to develop and validate these approaches.

Smith says along with policy drivers, scientific and cost advantages, there are ethical reasons supporting the take-up of animal-free technologies and methods, reflecting the public’s desire to avoid unnecessary harm to laboratory animals.

Even those who promote the benefits of animal research agree Australia needs a more cohesive approach to the issue, including national statistics.

Lear says a lack of data is a major problem.

“If you don’t know how many animals you’re talking about or which animals, then it becomes very hard to regulate nationally,” she says.

She explains there are four main ways animals are used. These include scientific understanding relating to biology; developing and testing new medicines and training surgeons and veterinarians; models for studying disease; and chemical and environmental testing.

She says replacing animals is important but not always achievable. Improving animal welfare and reducing the overall number of animals being used are equally important, she says.

Dr Malcolm France, a veterinarian who has worked in animal research, says greater transparency is needed. It is problematic, he says, that all states and territories, except South Australia, collect data on animal use in research but only NSW, Victoria and Tasmania make theirs publicly available – although it is in different formats that prevents tallying of the data.

“We have no idea of the animal numbers at a national level in Australia,” he says. France is trying to address this issue by developing options for national statistics with the Australian and New Zealand Council for the Care of Animals in Research and Teaching.

Along with the public expectation of transparency in industries that use animals, he says Australia lacks an “informed basis for decision-making” for policy and funding related to animal research, including measures to replace, reduce and refine their use.

Greg Williams, the health and biosecurity futures lead at CSIRO, says “non-animal models” based on human cells, tissues and data are increasingly being used worldwide as an alternative to testing on animals in developing medical products. He says the alternatives offer quality, time and cost benefits. “There’s so much to gain.”

A CSIRO strategy proposes actions for the next five years to help Australia to capture the opportunities. Recommendations include a national consortium to promote new technologies and methods, nationally standardised data on animal use and shared infrastructure such as biobanking and tissue collection.

A Therapeutic Goods Administration spokesperson says there is nothing in the regulatory framework that mandates the use of animals or forbids the use of alternative models.

Williams says a tangible example of progress at the state level is a $4.5m non-animal technologies network in NSW, which aims to accelerate alternative technologies and methods through better infrastructure, regulation and research. It is a “fantastic initiative” that will hopefully lay the groundwork for a national equivalent, he says.

Dr Shafagh Waters, a biomedical scientist at UNSW, is a participant in the NSW network. Her research develops mini-organs known as organoids, a type of three-dimensional tissue culture based on human stem cells, to test treatments for patients with cystic fibrosis.

Researchers collect biopsies from a patient’s nose, lung or gut and use these to create miniature versions of each organ. Testing treatments on these mini-organs helps patients avoid the “gamble” of whether a new drug works or has side-effects, she says.

Under the NSW initiative, Waters says eight universities and medical research institutes are working collaboratively instead of competitively. She hopes the network model can be adopted by other states and form the basis for an Australia-wide approach.

In her area of research, Waters says organoids have ethical and technical benefits. “I’m not a mouse, I’m not even a monkey,” she says. “When we are doing drug testing in animals, and then we take it into a clinical trial in humans we see a lot of drugs fail.”

This story was produced with the support of a travel grant from the Science Journalists Association of Australia.