Australia Cell and Gene Therapy Market Trends for 2026

The Australia and New Zealand cell and gene therapy market is expected to grow from USD 76.8 million in 2025 to USD 427.3 million by 2035, with a CAGR of 18.70% throughout the forecast period from 2025 to 2035.

Quick Facts

• Global cell and gene therapy industry poised to reach USD 10.44 billion by 2026.
• North America leads the global market due to strong R&D, advanced healthcare infrastructure, and supportive regulatory frameworks.
• United States dominates North America with a robust biotech ecosystem, high clinical trial activity, and favorable government initiatives.
• Asia-Pacific is the fastest-growing region driven by large patient populations, rising healthcare investments, and supportive policies.
• Japan accelerates growth through fast-track approval systems for regenerative therapies.
• China boosts the market with heavy investments and initiatives like Made in China 2025.
• Europe experiences strong growth due to increasing government funding, regulatory support, and CAR-T therapy adoption.
• United Kingdom leads regional growth with expanding clinical trials and significant CGT investments.
• Latin America is emerging rapidly due to rising chronic disease burden and increasing adoption of advanced therapies.
• Brazil drives regional growth with a growing biotech base and high prevalence of rare diseases.
• Middle East & Africa shows strong growth potential supported by healthcare investments and increasing adoption of advanced therapies.
• United Arab Emirates leads in the region with government support and early adoption of gene therapies.
• Cell therapy dominated the market with a 55% share in 2025 driven by increasing clinical trials, stem cell applications, and growing R&D activities
• Infectious diseases led the market in 2023 due to rising disease prevalence and growing adoption of advanced technologies like CRISPR-Cas9
• Oncology is expected to grow at the highest CAGR supported by increasing cancer prevalence, continuous innovation, and favorable government initiatives
• In vivo delivery accounted for 60% market share in 2025 owing to its cost-effectiveness and direct administration approach
• Hospitals held the largest market share in 2023 due to the availability of advanced infrastructure and skilled healthcare professionals
• It's expected to be worth billions of dollars in the coming years due to advancements in personalized medicine.
• Gene editing tools like CRISPR are revolutionizing treatment approaches.
• CAR-T cell therapy is proving highly effective for cancers like leukemia and lymphoma.
• Originally focused on rare genetic disorders and cancer, now expanding into neurological, cardiovascular, and autoimmune diseases.
• Growing interest in using gene therapy for conditions like sickle cell disease, blindness, and muscular dystrophy.
• Governments and regulatory bodies (FDA, EMA) are fast-tracking approvals for promising therapies.
• Big pharma and biotech companies are heavily investing, making this sector highly competitive.
• With more clinical trials, technological advancements, and investments, the future looks promising.

Cell and Gene Therapy Market Growth

The cell and gene therapy market is a rapidly growing sector within the healthcare industry that involves the use of cellular and genetic materials to treat various diseases and medical conditions. Cell therapy involves the transplantation or administration of live cells into a patient's body to restore or improve cellular function, while gene therapy involves the introduction or alteration of genetic material to treat genetic disorders or modify the function of cells.

Cell and gene therapies have the potential to revolutionize the treatment of a wide range of diseases. They can be used for conditions such as cancer, genetic disorders, cardiovascular diseases, neurodegenerative diseases, and autoimmune disorders, among others. This broad applicability enhances the market's growth potential. 

Oncology continued to be the most active therapeutic area of research across all stages of development, including preclinical through preregistration. In the field of gene and cell therapy, there were more than 1,300 candidates reported in development specifically for oncology in 2021. This highlights the significant focus and investment in developing innovative therapies to address cancer and improve patient outcomes.

Top Companies in Cell and Gene Therapy

• Alnylam Pharmaceuticals Inc 
• Amgen Inc 
• Biogen Inc 
• CORESTEM Inc 
• Dendreon Pharmaceuticals LLC 
• Helixmith Co. Ltd 
• JCR Pharmaceuticals Co. Ltd 
• Kolon TissueGene Inc 
• Novartis AG 
• Pfizer Inc

Segments Covered in the Report

By Therapy Type

• Cell Therapy
  
  • Stem Cell Therapy
    
    • Hematopoietic Stem Cells (HSC)
    • Mesenchymal Stem Cells (MSC)
    • Induced Pluripotent Stem Cells (iPSC)
  • Immune Cell Therapy
    
    • CAR-T Cell Therapy
    • TCR (T-cell Receptor) Therapy – targets intracellular antigens
    • TIL (Tumor Infiltrating Lymphocyte) Therapy
    • NK (Natural Killer) Cell Therapy
    • Macrophage Therapies
    • Dendritic Cell Therapy
  • Others
• Gene Therapy
  
  • In-vivo Gene Therapy
  • Ex-vivo Gene Therapy
    

By Indication / Therapeutic Area

• Oncology
  
  • Hematologic Malignancies
    
    • Acute Lymphoblastic Leukemia (ALL)
    • Non-Hodgkin Lymphoma (NHL)
    • Chronic Lymphocytic Leukemia (CLL)
  • Solid Tumors
    
    • Glioblastoma
    • Pancreatic Cancer
    • Melanoma
    • Prostate, Breast, Lung Cancer
  • Others
    
    • Head and Neck cancer
    • Sarcomas
    • Ovarian cancer (with experimental CGT trials)
• Genetic Disorders
  
  • Hemophilia A and B
  • Spinal Muscular Atrophy (SMA)
  • Duchenne Muscular Dystrophy (DMD)
  • Beta-thalassemia
  • Sickle Cell Disease
  • X-linked Adrenoleukodystrophy (X-ALD)
  • Others
• Neurological Disorders
  
  • Parkinson’s Disease
  • Alzheimer’s Disease
  • Batten Disease
  • Huntington’s Disease
  • ALS (Amyotrophic Lateral Sclerosis)
  • Others
• Cardiovascular Diseases
  
  • Heart Failure
  • Myocardial Infarction
  • Peripheral Artery Disease
  • Critical Limb Ischemia
  • Others
• Ophthalmology
• Musculoskeletal / Orthopedic Disorders
• Infectious Diseases
• Metabolic Disorders
• Others

By Vector Type (Gene Delivery Method)

• Viral Vectors
  
  • Adeno-Associated Virus (AAV)
  • Lentivirus
  • Retrovirus
  • Herpes Simplex Virus (HSV)
  • Adenovirus
  • Others
• Non-Viral Vectors
  
  • Lipid Nanoparticles (LNPs)
  • Naked DNA/RNA Plasmids
  • Electroporation
  • Gene gun / microinjection
  • CRISPR-Cas Delivery Systems (non-viral)
  • Others
    

By Manufacturing Type

• In-house (Biotech/Pharma-Owned Facilities)
• Contract Development & Manufacturing Organizations (CDMOs)
• Hybrid Models (e.g., early stage in-house, scale-up outsourced)

By End Use

• Hospitals and Specialty Clinics (administering therapies)
• Cancer Treatment Centers
• Research Institutes