Non-animal models

A strategy for maturing Australia’s medical product 
development capabilities

Executive summary | 2023



Sponsors



Executive summary

This report assesses the potential of emerging non-animal models to complement or 
replace traditional approaches in medical product development over the next 15 years. 
The analysis includes specific opportunities and recommendations for Australia to 
strategically enhance capability in this field, improve research quality and productivity, 
strengthen sovereign capability, and generate new national revenue streams. 

The report defines non-animal models as biological 
models that use human-derived or humanised cells, 
tissues or data. While the scope of this analysis is 
restricted to non-animal model applications across 
the medical product development process, the 
report’s recommendations could benefit applications 
in other fields, such as veterinary and agricultural 
medicines, cosmetic testing, and eco-toxicology. 

The report was informed by consultation with 
103 individuals from 66 organisations across 
industry, research and government.

Why non-animal models? 

The complexity of non-animal models is rapidly 
increasing, equating to or surpassing the performance of 
traditionally used animal models in several applications. 
Due to their enhanced biological relevance, non-animal 
models can increase productivity and reduce costs 
by identifying unsuitable medical products earlier in 
development and re-investing savings in more promising 
candidates. These models also support broader global 
‘3Rs’ objectives to replace, reduce and refine the use 
of animals for research and testing purposes.

Why now? 

Recent policy shifts in the United States and Europe 
encourage the transition away from animal use. These shifts 
are likely to support the already strong growth in the 
global non-animal testing market, valued at USD 1.11 billion 
in 2019, and expected to grow at a compound annual 
growth rate of 10.4% during 2019–2025. At the same time, 
animal model supply chains face increased risks, prompting 
alternative approaches to become more valuable.

Why Australia? 

Australia has comparative global strengths in non‑animal 
models for several organ systems likely to disrupt the 
status quo about the use of animal models over the 
next 15 years, including cardiovascular, respiratory, 
and nervous systems. Australia also possesses key 
foundational capabilities, including existing infrastructure 
(the National Collaborative Research Infrastructure 
Strategy – NCRIS – network), high throughput screening 
capabilities, and internationally recognised capacity for 
induced pluripotent stem cell generation, a key input 
for non-animal model development. These emerging 
models will also be critical to protect and further 
strengthen Australia’s $1.4 billion clinical trials sector.



Australia must act now to secure a key role 
in this emerging capability. 

Despite relevant research and infrastructure strengths, 
Australia is still maturing and coordinating these 
national capabilities. This report seeks to support 
these coordination efforts. It discusses how Australia 
can accelerate non-animal model applications’ 
demonstration, scaling, and commercial success.

The next 15 years will see an increase in the 
use of non‑animal models across all stages of 
the medical product development process.

The most significant growth is likely to come from complex in 
vitro models such as organoids (3D) (estimated $1.28 billion 
in revenue for Australia by 2040) and organ-on-chip (OoC) 
technologies ($310 million in revenue).1 In silico models 
are also anticipated to be more widely applied throughout 
the development process; used in conjunction with in vitro 
models to complement and validate findings. Figure 1 
summarises the expected shifts in non-animal model use 
across stages of the medical product development process.

The organ systems most likely to see non-animal models 
replace the status quo include cardiovascular, respiratory, 
gastrointestinal, skin, eye, and liver.

Figure 1. Expected shifts in the use of models for medical product development

Four national opportunities pair Australian strengths with global needs.

Developing and applying non-animal models within these settings (Figure 2) can benefit the quality of domestic research 
and development (R&D) activities or create revenue streams for non-animal model applications by providing global 
services and partnerships. 

Figure 2. Four national opportunities

FUNDAMENTAL 
RESEARCH

DISCOVERY 
DEVELOPMENT

PRECLINICAL 
DEVELOPMENT

CLINICAL 
DEVELOPMENT

REGULATORY 
APPROVAL AND 
COMPLIANCE

1. Complex in 
vitro models for 
improving the 
R&D productivity 
of national drug 
discovery.


Adoption of more 
complex and 
biologically relevant 
high-throughput 
in vitro models like 
organoids.

2. Organ-specific 
models for 
preclinical 
development


Research and industry 
collaborations in areas 
of national strength 
to support time and 
animal use reductions 
in preclinical testing.

3. Personalised 
models for trial 
participant and 
clinical treatment 
selection.


Protecting and further 
strengthening the 
competitiveness of 
Australia’s clinical trials 
sector and advancing 
precision medicine 
goals by incorporating 
patient-specific 
models.

4. Onshore production of model components. 


Increasing production capability for critical non-animal model inputs such as human-derived stem cells, 
non-animal derived media, and hydrogels.







Ten recommendations to provide 
Australia with the foundation to 
pursue these opportunities.

While the opportunities were developed considering 
a 15-year time horizon, setting Australia on a path 
towards these opportunities would require actioning the 
recommendations within five years. Within these five years, 
recommendations can be grouped and ordered by themes, 
with those aimed at coordinating and updating existing 
processes considered the most important first steps by 
those consulted (Figure 3). These activities would set a 
strong foundation for the remaining recommendations, 
which aim to integrate local capabilities into medical 
product development before strengthening production 
and commercialisation. Recommendations for non-animal 
model validation data will provide the evidence base to 
generate momentum across all themes. More discrete R&D 
priorities, actioned in parallel to recommendations, will 
act as supporting cross-cutting activities to strengthen 
Australia’s non-animal models’ capabilities further.

Figure 3. Recommendations and R&D priorities

Coordinate and update 
existing processes

1. Establish a national 
consortium that coordinates 
and promotes Australia’s 
non‑animal model capabilities 
2. Develop national data 
collection standards on the 
use of animals in scientific 
research, teaching and testing
3. Align TGA processes and 
industry guidance with new 
FDA procedures for accepting 
non-animal model data


Integrate local capabilities

4. Develop a national biobanking 
and tissue collection network 
5. Integrate outputs from NCRIS 
platforms into a coordinated 
pipeline for non-animal models


Strengthen production 
and commercialisation

6. Facilitate IP management and 
material access for research 
and industry collaborations
7. Enhance commercial 
skillsets across the 
non‑animal model sector
8. Update biomedical R&D 
infrastructure to support 
non‑animal model capabilities


Validation data

9. Conduct retrospective studies that compare animal and non-animal model predictivity
10. Conduct systematic reviews of locally and internationally developed non-animal models 


R&D priorities

• Support the economic case for non-animal models in medical product development
• Improve analytics for increasingly complex in vitro models
• Advance the quality of model inputs and hardware
• Extend the capabilities of in vitro models for a closer recreation of 
human physiology across healthy and diseased states




For further information

CSIRO Futures

Greg Williams
+61 3 9545 2138
greg.williams@csiro.au
csiro.au/futures

As Australia’s national science agency, 
CSIRO is solving the greatest 
challenges through innovative 
science and technology.

CSIRO. Unlocking a better future 
for everyone.

Contact us

1300 363 400
+61 3 9545 2176
csiro.au/contact
csiro.au