The recent article by the interprofessional association Pharma.Aero on the “market and logistics of cell and gene therapies” called for greater collaboration between the cell and gene therapy (CGT) sector and air transport players in the logistics sector in order to reduce the logistical complexities of the sector.
A non-profit organization made up of airports, pharmaceutical shippers and other cargo stakeholders, Pharma.Aero has launched its “Cell and Gene Therapy Project” to ensure the potential adaptations needed to prepare the industry air freight to ensure end-to-end quality. final transport of biopharmaceutical and CGT products by identifying its needs, its challenges, but also its opportunities. In the next steps, the association will likely launch a survey, a discussion among key players and stakeholders, and publish a white paper to share with the industry.
The scale of the sector
Clinical drug research has traditionally taken around 20 years of research and requires billions of dollars and hours of labor before they can be brought to market.
The report reveals that more than 900 companies worldwide are focusing on these advanced therapy drugs (ATMPs) and more than 1,000 CGT clinical trials are underway, leading the industry to potentially see up to 10-20 new therapy approvals per year from 2025.
According to the report, the global cell and gene therapy manufacturing market size was valued at $13.1 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 20.3% through 2028.
The CGT sector would be the most developed in North America with a large share of revenues (47% in 2020), mainly due to strong innovation, a favorable regulatory environment and access to large investments. Additionally, 57% of gene therapy clinical trials are taking place in the United States (by 2021).
China is also an important player in the sector and some European countries have also positioned themselves on the world industrial map (Belgium, United Kingdom and more recently France).
A “complex” supply chain
Revealing the complexities associated with the logistics of this sector, the report quotes: “Because these therapies are based on genetic cellular components and living cells linked to complex developmental pathways, CGT poses significant challenges to the current
clinical and commercial supply chain. The logistics sector must work directly with researchers and manufacturers to understand the specific needs and requirements of CGT products, and together define the solutions for safe and efficient transport. »
Highlighting an important aspect of transporting CGT products, the report reveals that a “closed loop” supply chain and distribution system is becoming inevitable due to the nature of these products.
He quotes: “The customized nature of CGT products requires a greater degree of operating model sophistication, pinned down to multiple functions leading to a ‘closed loop’ supply chain and distribution system. It is essential to understand the impact and the specificities of the coordination and supply chain of these innovative products.”
According to the report, the CGT sector has fundamental peculiarities that have a great influence in determining logistics solutions. These include starting material, scarcity of resources/suppliers, each patient is unique, there is no inventory, product shelf life is short, and lead time is critical and there is less equipment used and the product life cycle and transportation require combining different temperature ranges.
Air transport: a key element
The CGT sector presents a unique complexity in terms of supply chain and logistics flows. The report mentions that the main logistics challenges include process, traceability, technology, security and the risks involved.
“Challenges are found at every link in the chain, from planning and sourcing to distribution, and require simultaneous shipments at different temperatures. Global industry challenges, including cost control and standardization of industry, are the subject of many reflections and require significant improvements at the level of logistics”, he quoted.
“In this context, air transport is an essential link in the logistics chain and represents a key element on which to capitalize to streamline flows. It is important to encourage greater collaboration in the industry to facilitate the logistical improvements necessary to the CGT,” the report quoted.