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Market Overview

The global cell and gene therapy manufacturing market was valued at roughly USD 11.70 billion in 2024 and is anticipated to reach around USD 116.39 billion by 2034, reflecting a CAGR of 26.71% during the forecast period. The U.S. market is projected to achieve USD 44.60 billion by 2034 with a CAGR of 24.68%. This substantial growth is driven by the increasing number of clinical trials, rising incidence of chronic and genetic diseases, technological advancements, and the growing trend of outsourcing production to CDMOs (Contract Development and Manufacturing Organizations). CGT manufacturing focuses on creating therapies that repair, replace, or modify defective cells or genes, requiring precise bioprocessing, strict regulatory compliance, and advanced technological platforms.

Key Market Trends

1. Single-Use and Disposable Technologies
   Integration of disposable bioreactors and single-use systems is becoming widespread in CGT manufacturing. These systems lower contamination risks, reduce cleaning and validation needs, and offer greater flexibility in production, enhancing both efficiency and cost-effectiveness.

2. Automation and Advanced Bioprocessing
   Automated manufacturing platforms, such as Ori Biotech’s IRO® system, are driving scalability, reproducibility, and operational efficiency. Automation reduces labor intensity while ensuring consistent quality across production batches.

3. Growth of Contract Manufacturing
   Outsourcing to CDMOs is accelerating, with collaborations like Bristol Myers Squibb and Cellares for CAR-T therapy production. Contract manufacturing enables companies to scale capacity without heavy capital investments, addressing growing therapy demand.

4. Regulatory Support and Accelerated Approvals
   Regulatory bodies like the FDA and EMA are encouraging CGT adoption through fast-track approvals, orphan drug designations, and simplified regulatory pathways, speeding up the market entry of innovative therapies and promoting investment in manufacturing infrastructure.

5. Advances in Gene Editing
   Breakthroughs in technologies like CRISPR-Cas9 are transforming gene therapy production by enabling precise gene modifications, improving safety, and enhancing patient outcomes.

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Market Drivers

• Increasing Prevalence of Genetic and Chronic Diseases: Rising cases of cancer, rare genetic disorders, and other chronic conditions are driving demand for personalized cell and gene therapies.

• Growing Investment and Funding: Governments, venture capitalists, and pharmaceutical companies are heavily investing in R&D, clinical trials, and CGT manufacturing infrastructure.

• Technological Advancements: Innovations in viral vector production, cell processing, and automation improve manufacturing efficiency, scalability, and product consistency.

• Outsourcing Trends: Companies are increasingly using CDMOs to fulfill both commercial and pre-commercial manufacturing needs, reducing operational overheads.

• Regulatory Incentives: Fast-track approvals and supportive policies encourage rapid development and commercialization of therapies.

Impact of Trends and Drivers

These trends and drivers influence multiple therapy types, applications, and geographic regions. Cell therapy dominates the market with 60.2% of revenue in 2024, while oncology applications show the highest adoption. North America accounts for 47.9% of the market, benefiting from advanced infrastructure and regulatory support. The Asia-Pacific region is experiencing rapid growth with a 19.6% revenue share, driven by rising investments and healthcare infrastructure expansion. The pre-commercial/R&D scale manufacturing segment contributed 73.24% of revenue in 2024, reflecting high demand for early-stage production and clinical trial support.

Challenges & Opportunities

Challenges: High manufacturing costs, complex regulatory requirements, and intricate supply chains remain key barriers. Limited scalability and specialized workforce requirements also pose operational constraints.

Opportunities: The expansion of CDMO partnerships, adoption of automation, single-use technologies, and advanced gene-editing platforms offer significant growth potential. Emerging markets with rising healthcare investments provide additional revenue opportunities.

Future Outlook

The CGT manufacturing market is expected to grow substantially, surpassing USD 116 billion by 2034 with a CAGR of 26.71%. Technological innovations, increased outsourcing, and supportive regulatory frameworks will continue to drive market evolution. Emerging trends such as automated, modular manufacturing platforms, next-generation viral vectors, and wider adoption of allogeneic and off-the-shelf therapies are set to improve accessibility, efficiency, and cost-effectiveness in the industry over the next decade.

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