Challenges and opportunities in the CGT supply chain

Cell and gene therapies (CGT) offer a revolutionary approach to the treatment, prevention and potential cure of diseases. These advanced medical treatments provide hope for patients suffering from conditions that have historically been poorly understood and widely considered incurable, including genetic diseases and cancers. A recent survey¹ of healthcare industry professionals showed that CGT is expected to have the most significant impact on the pharmaceutical industry in 2024. However, the success of CGT depends on a robust and reliable supply chain, which is a sensitive logistical challenge for the global scientific community.

Supply chain challenges

Cell and gene therapies are fragile, invaluable, and potentially lifesaving. Such complex medical treatments demand a specialised approach to logistics, as any disruption to the supply chain could compromise treatments and risk the lives of patients.

The CGT supply chain presents unique challenges, from regulatory compliance and temperature and time control to customs clearance and security.

“The critical nature of these treatments, many of which can transform or even save the lives of patients, adds to the challenge, meaning that a personalised logistics solution is crucial,” says Anton James, Cell and Gene Therapies Logistics Specialist at Biocair.

He outlines five key challenges in the CGT supply chain including:

1. Regulatory compliance: The supply chain must comply with the complex regulations governing the transport of CGT materials, including GDP and IATA requirements. This also includes the completion of critical shipping paperwork.
2. Temperature and time: CGT materials are often time-and-temperature sensitive, and their viability is vulnerable to fluctuations in schedule or conditions. Strict temperature and time control must be maintained at all stages of the supply chain, including handover, transit and within the clinical setting.
3. Customs clearance: Cross-border shipping can be subject to delays at customs. Preventative measures should be implemented to reduce any potential delays which could prove disastrous for patients.
4. Communication and coordination: A successful supply chain relies on clear and straightforward communication. All parties involved must strictly adhere to instructions, and clear communication makes this much easier to manage.
5. Security and chain of custody (COC): Robust security measures can prevent the risk of crucial CGT materials being compromised in any way. Appropriate measures should be taken to maintain security throughout the supply chain and ensure the chain of custody always remains intact.

Trends in the CGT supply chain

The global CGT supply chain and logistics market is expected to reach $3.12 billion by 2031, having been valued at $1.23 billion in 2022.²

“In this new era of medicine, when tailored therapies are being developed to target individual cases of disease, the potential for CGT is almost limitless. As more organisations home in on promising therapies, there’s lots to be excited about,” says James.  

“CGT is still very much in its discovery phase, so it is important that those in the supply chain keep up to date with emerging therapies and evolving logistical demands. As CGT revolutionises medicine, it is spurring change in the sector too, and logistics becomes ever-more crucial to the health and wellbeing of patients,” he reflects. 

Scalability is another factor that will define the logistics landscape in 2024 and beyond. “Existing life sciences supply chains need to be upscaled at all stages to cope with increasing demand,” says James.

“However, it is important to balance scalability with personalised solutions. Just as cell and gene therapies can be tailored to an individual patient, the supply chain also needs to be tailored to individual requirements.”

Artificial intelligence (AI) could also play a part in the future of the sector, however its application is not imminent. “The personalised nature of the industry means that AI is yet to have a tangible impact. It is essential that we retain the human side of our work to meet the specific needs of each patient and therapy,” notes James. 

“With the rapid development of AI, the sector will inevitably change, but this must happen gradually so any new technology can be rigorously assessed and carefully integrated into the supply chain,” he adds. 

A promising future for the CGT supply chain

Cell and gene therapy heralds a new age of medicine which promises life-changing, potentially lifesaving results for patients around the world. As momentum around CGT continues to grow through greater investment and innovation, partners working with the sector are also seeing increased opportunities for growth despite the unique challenges of life sciences.

A robust, adaptable supply chain might not grab the headlines in the way that an innovative new treatment might. But it is key to getting these treatments to the patients that need them, safely, securely and on time.

Sustainability crucial for pharma’s supply chain future

References

1. State of the Biopharmaceutical Industry in 2024 – Thematic Intelligence. [Internet] GlobalData. 2023. [cited 2024May]. Available from: https://www.globaldata.com/store/report/state-of-biopharmaceutical-industry-analysis/.
2. Cell and Gene Therapy Supply Chain/Logistics Market Size, Share & Trends Analysis Report By Application area, By Type of software solution, By Mode of Deployment, By End-user (Biobank, Cell therapy lab, Hospital, Research institute, Commercial organization) , By Region, And By Segment Forecasts, 2024-2031. [Internet] InsightAce Analytic Pvt. Ltd. 2024. [cited 2024May]. Available from: https://www.insightaceanalytic.com/report/cell-and-gene-therapy-supply-chain-logistics-market/1694