Statement of support for non-animal research models

As Australian research institutions, companies involved in medical research, industry associations, investors and non-government funding bodies, we call on the Australian government to implement five recommendations as part of a national strategy focussed on accelerating the development, validation and commercialisation of non-animal research models in Australia.

We are in a phase of innovation towards human-focused biomedical research. The next 15 years will see an increase in the use of non-animal models across all stages of the medical product development process and growth of the non-animal testing market. The CSIRO’s 2023 report, ‘Non-animal models: A strategy for maturing Australia’s medical product development capabilities’,¹ found that this period will provide unique and important opportunities for Australia if harnessed responsibly. The opportunities include: creating jobs, protecting and further strengthening Australia’s $1.4 billion clinical trials sector, improving domestic research and development capabilities and positioning Australia to be a global research partner with like-minded researchers in a rapidly changing landscape.

Australia’s ability to harness these opportunities is being held back significantly by a lack of a nationally coordinated effort and limited investments in non-animal models.

 

The opportunity

The global non-animal testing market, valued at $1.11 billion US in 2019, is expected to grow at a compound annual growth rate of 10.4% during 2019-25. The size of the global organoid market in 2022 was $1.62 billion and is expected to reach $30.91 billion by 2040, with a Compound Annual Growth Rate of 17.4%. This market is estimated to result in $1.28 billion in revenue and 4,200 jobs for Australia by 2040.

The global non-animal testing market is expected to grow because:

• Non-animal models can provide benefits over animal models in various applications including increased productivity and reduced costs, the ability to model rare diseases and disorders that could be costlier or more difficult to study through traditional approaches, and the potential to interface with High Throughput Screening (an approach that is unsuitable for animal models but can conservatively offer a 50-200-fold increase in testing throughput compared to other methods).

• Animal model supply chains are facing increased risks and costs including limited availability of non-human primates for medical research, difficulty in forecasting and matching future demand, and logistically demanding biosecurity processes for the importation of animals not bred in Australia.

• Recent policy shifts overseas are encouraging, and in some instances mandating, the development and adoption of non-animal models.
   

Australia has comparative global strengths in the development of some non-animal models. Between 2018 and 2023, Australia’s share of non-animal model publications was above 3% and ranked in the top 10 globally for specific organ system-model type combinations. Australia also possesses key foundational capabilities, including existing infrastructure (the National Collaborative Research Infrastructure Strategy network and the National Computational Infrastructure), High Throughput Screening capabilities, and the internationally recognised capability and capacity for induced pluripotent stem cell generation, a key input for non-animal model development.

However, Australia is yet to leverage these advantages. The development, validation and commercialisation of non-animal models in Australia is being held back by a lack of a nationally coordinated effort and therefore investments. Leading jurisdictions, such as the United States, European Union, Japan and the United Kingdom have created non-animal model strategies and established institutions specifically dedicated to the support of non-animal model development and validation, whilst also establishing specific funding and translational projects for non-animal models. In the European Union, there are government targets to phase out the use of animal models in certain applications.

How to harness the opportunity

Proactive and targeted investment is critical to enable Australia to leverage its existing strengths and harness the economic opportunities. We call on the Australian Government (in co-ordination with State and Territory Governments where relevant) to implement the following five recommendations:

Recommendation 1: Establish a national centre or consortium to advance Australian non-animal model capabilities.
This should be developed in collaboration with existing stakeholders that already share some responsibilities in the context of the broader Australian biomedical sector. The New South Wales Government has expressed interest in supporting such a centre. This is a great start but is limited in its capacity to harness the opportunities outlined above. Australia needs a nationally co-ordinated approach. A national centre or consortium would help co-ordinate and direct funding for the development of non-animal models and facilitate collaboration. For example, a national centre or consortium could help resolve Intellectual Property and skill-based barriers to commercialisation of non-animal models. It could help address collective infrastructure needs across fundamental research, translational research services, clinical applications and manufacturing capabilities. It could represent Australian interests at global non-animal model forums and existing international initiatives around global harmonisation, regulation standards, and privacy. It could also help identify and address research gaps for development and validation of non-animal models.

Recommendation 2: Provide dedicated funding towards the development, validation and commercialisation of non-animal research models.
Many other countries provide a federally funded specific grant category for developing and commercialising non-animal-based-research-technologies and their national centres offer a range of funding opportunities including project grants, partnership and impact grants, early career engagement awards, studentships and prizes for excellence in emerging fields. Similar schemes could be offered through the national centre or consortium referenced above or through existing institutions such as the Australian Research Council, National Health and Medical Research Council or National Collaborative Research Information Strategy.

Recommendation 3: Develop national data collection standards on the use of animals in scientific research, teaching and testing.
This will help limit duplicative reporting burdens for research institutions operating across Australian States and Territories, provide more meaningful insights into where and how animals are being used, better inform funding decisions, track the impact of initiatives, guide infrastructure development, rationalise animal use, and inform priority areas for non-animal model development.

Recommendation 4: Improve regulatory processes and industry guidance to enable acceptance of non-animal model data where the data is strong enough to demonstrate efficacy and safety.
This will provide researchers and industry with greater confidence to plan for the use of non-animal models and help facilitate greater market access for Australian collaborations and commercial offerings in the long term. Efforts towards this could include, reviews of non-animal model data acceptability across jurisdictions, alignment of Australia’s national regulatory processes and guidance material with leading international jurisdictions to develop more advanced non-animal model ecosystems; the Therapeutic Goods Administration’s active participation in collaborative forums relevant to the requirements for advanced non-animal models and the suitability of their data for regulatory purposes; and working with other national regulators towards harmonised guidance on non-animal model data acceptability would be greatly enhanced.

Recommendation 5: Develop a national biobanking and tissue collection network.
This could be an expansion of existing initiatives like the Australian Health Biobank or the NSW Health Statewide Biobank. Patient-derived cells and tissues are essential inputs for the development of more biologically relevant models of disease that improve patient outcomes. A national biobanking and tissue collection network can provide researchers and industry with access to well-characterised cells and tissues that support preclinical testing of therapeutic candidates and the use of personalised models for clinical treatment selection. A national biobanking and tissue collection network could also facilitate greater representation of the Australian population in medical product and non-animal model development through larger, more geographically and ethnically diverse patient cohorts. While Australia has the foundation to enable a national biobanking and tissue collection network, including existing biobanks, the planning and coordination of contributing facilities and programs is still required at the national level.

Signed:

Akrivis Healthcare

Animal-Free Science Advocacy

ARC Centre for Personalised Therapeutics Technologies

Aroa Biosurgery

Ausbiotech

Australian Ethical Investment

(The) Australian Organoid Facility

BioMelbourne Network

(The) Children’s Medical Research Institute

CoLabs

Cochlear

Defence Science and Technology Group

Fisher & Paykel Healthcare

FivepHusion

Gelomics

Illumina Australia

Immutep

Medical Advances Without Animals Trust

OminiWell

QIMR Berghofer Medical Research Institute

Reagene Biosciences

RSPCA

Sydney Children’s Hospital Network

Tessara Therapeutics

University of Sydney