Study: Cell & gene therapy cold chain market doubling to >$2.5 billion

New Delhi: Achievements in cell and gene therapies (CGT) will continue to shape the future of the human health market.

A recent market analysis now affirms an increase of cell and gene cold chain market to >$2.5 billion within the next years. Yet, there are unmet needs which prevent unlocking of its full potential.

Doubling the market size

Today, the estimated cold chain market for cell and gene therapies is $1.25 billion and includes the segments of consumables, fill & formulation, freeze & thaw and transportation & logistics. The market size will double within the next years to >$2.5 billion. The estimated growth rate for cold chain therefore keeps up with predictions of the expected CAGR of more than 23.5 % until 2030 of the total regenerative medicine industry.

Consumables were estimated to account for the largest share of the market size: With a current 60% share in the CGT cold chain market, the sterile consumables and single-use systems segment will continue to play a key role in the coming decade. The results were obtained from a market analysis conducted by a partnering consultancy firm specializing in cell and gene therapy, on behalf of Single Use Support GmbH.

Meeting needs (for advanced therapies)

In-depth results of market analysis have also revealed the challenges and unmet needs for the manufacturing process of advanced therapies. Cell therapies require precise and specialized freezing processes to maintain cell functionality and viability. But also, large volumes of a cellular drug product as essential components for gene-modified cell therapies (e.g. enveloped vector supply) require robust and reliable cold chain solutions and management.

Gene therapies need controlled and easily adaptable freeze & thaw cycles depending on vectors used: Enveloped vectors, such as lentivirus or gammaretrovirus, are sensitive and pose challenges for the freeze-thaw profile, while non-enveloped vectors, such as adeno-associated virus, are at risk of aggregation and capsid ruptures if frozen uncontrolled.

Modern medicines call for modern technology

Above all, the industry shares the common goal of delivering products at highest quality to patients using state-of-the-art process solutions. Overcoming technical challenges and responding to unmet needs through innovation will boost the growth of the CGT cold chain market.

Single Use Support is committed to pioneer technological advancement and to drive market growth for cell and gene therapies. With its protection system to reduce product loss in single-use systems and automated end-to end process platform systems, its vendor-agnostic solutions play a role for digital transformation in biopharmaceutical manufacturing of small-scale cell therapy and large-scale cell and gene therapies. Controlled freezing and thawing technologies include plate-based platform systems to freeze-thaw to -80 °C or with liquid nitrogen with less than -150 °C and small thaw systems to enable enhanced cell viability. Automated filling platform systems with a modular setup facilitate scalability by securing the highest filling accuracy and cGMP compliance throughout different scales.

Ref: Statista: Cell and Gene Therapy. 2018. In: Statista