Air transport essential link in logistical chain for cell and gene therapy
With over 1,000 CGT clinical trials underway, the industry could see as many as 10 to 20 new therapies approvals per year starting 2025. The market size valued at $13.1 billion in 2020 is expected to expand at a compound annual growth rate (CAGR) of 20.3% until 2028
Noted cross-industry association Pharma.Aero's recent industry paper on the 'Cell and Gene Therapy Market and Logistics' has 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 composed of airports, pharmaceutical shippers, and other cargo stakeholders, Pharma.Aero has initiated its 'Cell and Gene Therapy Project' to ensure potential adaptations necessary to prepare the air cargo industry to assuring high-quality end-to-end transportation of biopharma and CGT products by identifying its needs, challenges, but also opportunities. In the next steps, the association is likely to initiate a survey, a discussion by key players and stakeholders, and will come out with a white paper to share with the industry.
The span of the sector
Clinical research on medicines has traditionally taken around 20 years of research and requires billions of dollars and hours of work before they can be commercialized.
The report finds that more than 900 companies globally focused on such advanced therapy medicinal products (ATMP) and over 1,000 CGT clinical trials are underway, leading the industry to potentially see as many as 10 to 20 new therapies approvals per year starting 2025.
As per the report, the global cell and gene therapy manufacturing market size was valued at $13.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 20.3% until 2028.
The CGT sector is reportedly most developed in North America with a large share of revenues (47% in 2020), mostly due to strong innovation, a favorable regulatory environment, and access to significant investment. Also, 57% of gene therapy clinical trials take place in the US (by 2021).
China is also an important player in the sector, and some European countries have positioned themselves on the global industry map as well (Belgium, the United Kingdom, and more recently France).
A 'complex' supply chain
Revealing the complexities involved in the logistics of this sector, the report cites, "Due to the fact these therapies are based on genetic cell components and life cells related to complex development pathways, the CGT places significant challenges on the current
clinical and commercial supply chain. The logistic sector needs to collaborate directly with researchers and manufacturers to understand the specific needs, and demands of the CGT products, and define together the solutions for safe and efficient transportation."
Highlighting an important aspect of the transportation of CGT products, the report reveals that a "closed loop" supply chain and distribution system becomes inevitable owing to the nature of these products.
It cites, "The personalized nature of the CGT products demands a greater degree of operating model sophistication, pinned to several functions leading up to a "closed loop" supply chain and distribution system. It is key to understand the impact and specificities of the coordination and supply chain of these innovative products."
As per the report, the CGT sector has some fundamental particularities that have a great influence in determining the logistics solutions. These include starting material, scarcity of resources/suppliers, the fact that each patient is unique, there are no inventories, the life span of the product is short and timing is critical and there is less equipment used and the product life cycle and transportation requires combining different temperature ranges.
Air transport: a key element
The CGT sector presents unique complexity in terms of supply chain and logistics flows. The report mentions that the key logistical challenges include process, traceability, technology, safety, and risks involved.
"Challenges are found in every link of the chain, from planning, and procurement to distribution, and require simultaneous shipments at different temperatures. The global challenges of the sector including cost control and industry standardization are subject to a lot of reflection and request significant improvements at the logistics level," it cited.
"In this context, air transport is an essential link in the logistical chain and represents a key element on which to capitalize to make flows more fluid. It is important to encourage greater collaboration in the industry to facilitate logistical improvements necessary for CGT," cited the report.