Cell & Gene Therapy Manufacturing Services Market Trends

Growth Drivers

• Increasing prevalence of genetic disorders and other rare diseases: The rising number of genetic disease cases is driving the cell & gene therapy manufacturing services market, as it boosts demand for targeted treatments, that can address the root cause of these diseases. Genetic disorders such as muscular dystrophy, cystic fibrosis, and various cancers lack effective treatments, creating a need for treatment therapies. This rising global burden is influencing biotech and pharmaceutical companies to accelerate development efforts for cell and gene therapies. This, in turn, drives the demand for specialized manufacturing services, supporting complex production and regulatory needs.
• Growth in partnerships between biotech companies: These partnerships allow the firms to leverage the specialized expertise and facilities of CMOs, avoiding the need to build costly infrastructure in-house. Through these collaborations, the companies can accelerate production, maintain high-quality standards, and focus more resources on research and development. For instance, in July MaxCyte, Inc. and Vittoria Biotherapeutics announced collaboration for a strategic platform license (SPL) of MaxCyte’s Flow Electroporation technology and ExPERT platform to Vittoria Biotherapeutics. In this collaboration, Vittoria will attain non-exclusive clinical and commercial rights to use MaxCyte’s platforms.

Challenges

• High cost and scalability issues: These services require highly specialized facilities, equipment, and materials, making the initial setup and operational expenses substantial. Additionally, since these treatments are often personalized, scaling production to serve larger populations while maintaining affordability is a complex challenge. The customization required for each patient can limit batch sizes, further driving up costs, and requiring innovative approaches to reduce expenses without compromising quality.
• Quality control and standardization difficulties: These complications occur due to the intricate nature of cell and gene therapies, which are often derived from live cells or complex genetic materials. Ensuring consistency in potency, purity, and safety across different batches is a major challenge, especially given the variability of biological materials. Standardizing protocols that comply with regulatory requirements while accommodating the unique aspects of each therapy is difficult. This makes it essential to develop rigorous quality control systems that can detect and manage variability efficiently.