Mapping Cell & Gene Therapy in Australia

The mapping highlights clinical trials, Advanced Therapy (AT) developers, TGA-licensed manufacturers and other stakeholders. Download the report to get a detailed understanding of the stakeholders, initiatives, and resources driving this sector's growth in Australia.

Report Sponsor

LANDSCAPE MAPPING ISN'T ABOUT DATABASES OR SURVEYS, IT'S ABOUT STAKEHOLDER ENGAGEMENT, SYNERGISTIC DEVELOPMENT AND FUNCTIONING ECOSYSTEMS. THIS IS HOW WE BUILD ON OUR STRENGTHS TO ACCELERATE INNOVATIONS TO PATIENTS. THROUGH OUR MAPPING WE AIM TO GUIDE STAKEHOLDERS—RESEARCHERS, INDUSTRY LEADERS, FUNDERS AND POLICY-MAKERS—TOWARD A MORE INFORMED AND INCLUSIVE ECOSYSTEM THAT BUILDS ON EACH OTHERS STRENGTHS FOR THE BEST PATIENT OUTCOMES.

Heather Main - Author and Cofounder with HOYA​

Inside the Report: Visual Highlights of Australia’s CGT Landscape

  • GLOBAL OVERVIEW - CGT

  • ECOSYSTEM STAKEHOLDERS

  • CLINICAL TRIALS - RECRUITMENT ACTIVITY

  • CLINICAL TRIALS - GENDER BIAS

  • FOREWORD - PROF. CHRISTINE WELLS

REPORT HIGHLIGHTS

VICTORIA’S DOMINANCE​

Victoria leads Australia's clinical trial growth, particularly in Oncology and Genetic Disorders, driven by substantial industry funding, which underscores the commercial potential in these areas.​

CELL THERAPY FOCUS​

Cell Therapy trials, especially Ex Vivo gene CAR T therapies, are the most prominent, enrolling the majority of patients and making significant strides in cancer treatment.​

KEY PLAYERS IN CLINICAL TRIALS​

The majority of early-stage trials are concentrated in Victoria, with New South Wales and Queensland also playing crucial roles, highlighting these regions as key players in advancing Cell and Gene Therapy (CGT).​

RESEARCH TRANSLATION​

While there is strong clinical and basic research in Australia in Advanced Therapy (AT), there are few local commercial AT developers, most of whom are not represented in Australian AT trials. While patient availability to AT in Australia is through clinical trials and market approval is strong, local research translation is lacking.

Our CGT mapping report delivers critical insights for decision-makers navigating Australia's advanced therapy landscape. It provides a clear overview of clinical trial trends, key stakeholders, and TGA-licensed manufacturers, empowering stakeholders—from policy makers to industry leaders—with actionable intelligence to drive informed decisions and foster collaboration.

Values for Decision Makers -

Values for Decision Makers -

SPONSOR FOREWORD

HOYA and the University of Melbourne have partnered to review the Australian Advanced Therapies sector. This landscape review offers insights into the stakeholders, initiatives, and resources propelling growth in Australia, encompassing small companies, manufacturing facilities, and clinical trials. It outlines the diversity of therapeutic platforms in Advanced Therapies, highlighting Australian strengths and opportunities for future ecosystem enhancement.

This report inspires confidence in translating Australian research into innovative therapies that address global health challenges. At UoM, we invite collaboration to strengthen the Advanced Therapies network and accelerate treatment innovations for patients.

Melbourne University, situated in Parkville's biomedical precinct, excels in research, clinical trials, and cell and gene medicine development. Collaborating with national and international partners, we are creating courses in Contemporary Cell and Gene Therapies to connect students with industry leaders and expand the skilled workforce in this sector.

Professor Christine Wells

Chair, Stem Cell Systems

Faculty of Medicine, Dentistry and Health Sciences

The University of Melbourne

Meet the authors

Heather Main - Cofounder and Principal Consultant

Ajdin Jakupovic - Cofounder and Managing Partner

Gabriel Burcea - Associate Consultant

Get in touch.

Have questions about our reports or want to explore how our insights can support your projects? Or are you missing something in the Australia CGT Report? No matter, we’d love to hear from you! Fill out the form below, and our team will get back to you promptly. Let’s connect and discuss how we can drive your advanced therapy development forward and the entire CGT ecosystem worldwide.

HOYA - ABOUT

HOYA - ABOUT

HOYA is your strategic partner in advanced therapy, with deep expertise in pluripotent-derived cell therapies. We help our clients de-risk complex preclinical and commercial challenges, accelerating early research to broad patient access. Leveraging our extensive global network and tailoring solutions to each client’s unique needs, we help drive innovation forward.

Our Services

Advanced Therapy Translation

  • With deep knowledge of hPSC, we offer the hands-on technical expertise needed to advance your research from lab to clinic, ensuring the highest quality and compliance throughout the process.

  • We provide a roadmap for GMP compliance, ensuring your cell therapy products are manufactured with the highest standards of quality.

  • Our strong relationships with leading academic institutions, biotech companies, and industry regulators give you access to a powerful network that can accelerate the development of your ctherapies.

Research and Development

  • From concept to clinical trials, we guide the entire product development process for hPSC-derived therapies, focusing on the regulatory, technical, and commercial aspects. Our team is well-versed in overcoming the hurdles of product validation and GMP operations.

  • We connect academia with industry leaders to foster collaborations that push the boundaries of cell therapy innovation. By leveraging our extensive network of industrial partners, we help accelerate research into practical, market-ready solutions.

  • Navigating the transition from research to GMP manufacturing can be challenging. We provide pre-GMP support to ensure your processes, materials, and protocols are aligned with regulatory expectations, minimizing delays and ensuring smooth progression to full-scale production.

Finance and Growth

  • Stay ahead of the competition with our in-depth market analysis. We provide actionable insights into emerging trends, competitor activities, and market demands within the cell therapy landscape, empowering you to make informed business decisions.

  • Whether you're at the initial stages of development or looking to commercialize, we offer strategic guidance tailored to your specific needs. Our expertise covers regulatory pathways, product lifecycle management, and commercialization strategies to ensure your cell therapies succeed.

  • We help you identify and secure grant funding to propel your cell therapy projects forward. Our knowledge of funding programs and the right partners will assist in writing and submitting grants in a timely and efficient manner.

LEARN MORE ABOUT OUR EXPERT REPORTS

Vendor assessment of GMP hPSC start material providers

In the fast-growing field of PSC-derived cell therapies, choosing the right starting materials is critical to success. Our comprehensive evaluation of GMP hPSC lines offers a clear path forward, providing actionable insights into derivation technologies, IP, donor eligibility, and regulatory standards. With over 26 hiPSC lines analyzed, this report highlights the best options for clinical and commercial development. It is designed to help you avoid costly mistakes and accelerate the development of innovative hPSC-based therapies.

iPSC Patent Landscape Analysis

This patent landscape analysis offers a comprehensive overview of the technological trends in iPSC production, focusing on reprogramming factors, delivery methods, and source cell types. It provides key insights for making informed strategic decisions in the competitive field of iPSC technology. The report identifies leading players and maps the patent environment, helping businesses understand the state of the art and plan their next steps in this rapidly evolving sector.

Access invaluable insights that empower you to make strategic, data-driven decisions in the evolving Advanced Therapy landscape.

Ready to take your next step? Contact us to explore how we can support your success today.

Accelerate your Advanced Therapy Journey today!