The global cell and gene therapy (CGT) market is expanding at a rapid rate, and will be worth $76bn by 2030, up from $8.7bn in 2024, according to market intelligence firm GlobalData.[i] However, achieving this 44% compound annual growth rate (CAGR) depends on the entire pharmaceutical supply chain adapting to manage the delivery of these sensitive drugs.
As the supply of commercial CGTs increases, third-party logistics (3PL) providers need to provide specialized storage and transportation, including complete cold-chain solutions, so that the life-saving therapies can reach patients safely. Failure to do so will result in spoiled shipments or regulatory breaches, something to be avoided at all costs when CGT batches cost hundreds of thousands of dollars to manufacture and global supply chains are already fraught with challenges.
To avoid unnecessary losses, pharma companies must partner with expert 3PL providers who have invested in specialized CGT services. Their complete understanding of the complex challenges faced when storing and transporting cell and gene therapies could make all the difference as the CGT market expands.
Challenges in the CGT supply chain
Scalable temperature-controlled logistics, real-time monitoring, and specialized handling procedures are all essential to the safe transportation of CGTs. The drugs need to be stored in advanced packaging materials and containers that can ensure a consistent temperature, even down to cryogenic levels where necessary.
Furthermore, mishandled CGT shipments can be held at borders if they don’t meet local regulations. As these regulations continue to differ around the world, failure to comply could result in costly delays that will only become more expensive if the products have been spoiled through incorrect storage methods. Cell and gene therapies are extremely expensive to manufacture; failure to comply with logistics best practices can lead to wasted materials and increased costs, negatively impacting pharmaceutical companies and jeopardizing the lives of patients worldwide who could benefit from these transformative drugs.
All this must be done against an extremely complex global supply chain backdrop, which continues to fluctuate dramatically. Geopolitical conflicts, trade wars, labor shortages, and the digital transition continue to impede deliveries around the world. When transporting products as valuable as CGTs, pharma companies cannot take any chances.
The time- and temperature-sensitive nature of CGTs means they must obtain reliable 3PL partners whose expertise in specialized logistics can help maximize efficiency even within this uncertain environment.
3PL providers invest in CGT services
With CGT supply chains spanning many countries and continents, 3PL providers provide a critical service. Ensuring safe transportation and implementing stringent quality control measures, these contractors comply with regulatory standards so that all shipments are traceable and secure. By trusting an experienced 3PL with their warehousing, inventory management, and order fulfillment requirements, pharma companies can focus on their core competencies while leveraging external expertise.
However, as CGT logistics ramps up, 3PLs need to invest in new technology to better manage delivery of these critical drugs. The complex temperature profile of CGTs requires layers of packaging, which can be adapted in line with manufacturers’ wishes. Up to four layers of packaging, from cryobags through to liquid nitrogen or dry ice shippers, can be used in the safe storage and transportation of these drugs. Cold storage facilities may even be required if the product’s full journey cannot be completed in one step.
3PL experts can provide these services and further expertise besides, helping to enforce regulatory compliance. Leading providers are investing further in their services to prepare for the CGT scale-up. For example, IoT devices are a key innovation that have helped advance 3PL logistics, capable of providing real-time location and temperature updates to ensure the integrity of packaged products is maintained effectively.
“Advanced technologies, such as Internet of Things (IoT) devices for real-time tracking, are essential to modern transport logistics,” explains Krystal Haynes, international 3PL business development lead at ICS. “With that data, we can implement robust analytics to enhance overall supply chain efficiency.”
The right 3PL provider can streamline processes to ensure successful outcomes at launch, taking into account key factors such as patient dosing, the number of vials per delivery, regulatory packaging and labeling requirements, and end-to-end temperature conditions. Additionally, they plan for excursion allowances, delivery windows, and expected receiving and outbound volumes for at least three years out.
Haynes notes that upskilling workers will also be critical for logistics partners to support CGT expansion worldwide. “We’re expanding our capabilities in cold-chain management and developing specialized training programs for staff so that they’re equipped to handle these drug product characteristics or nuances specific to CGTs that might throw a wrench in a ‘cut and paste’ logistics strategy,” she adds.
A partner that can make a difference
Leading partners in this field are Cencora, who leverage extensive specialty 3PL experience to guide their clients through this process. This collaboration has helped them develop strong risk mitigation strategies, and to prepare for potential client or regulatory audits.
Part of the Cencora family of companies, Alloga and ICS are leading third-party logistics (3PL) providers with a proven track record of delivering value to pharmaceutical companies. Alloga, with its pan-European presence, and ICS, with its strong foothold in North America, offer a comprehensive suite of 3PL services tailored to the unique needs of the industry. With collective resources spanning the entire healthcare ecosystem, they maximize the impact of therapies from beginning to end to create healthier futures for patients everywhere.
“ICS and Alloga are unique due to our extensive experience in managing complex supply chains and our commitment to innovation in logistics,” says Haynes. “Our dedicated focus on cell and gene therapies, combined with our robust automated infrastructure and expertise in cold-chain management, positions us effectively to address the challenges of CGT logistics.
“Furthermore, our partnerships with leading pharmaceutical manufacturers and our proactive approach to regulatory compliance ensure that we are well-prepared to adapt as the market evolves. We are a high-performance partner that can can significantly enhance efficiency and minimize disruptions.”
3PL delivered by Alloga and ICS
ICS and Alloga combined form Cencora’s global 3PL offering, meaning they can provide an end-to-end service through courier depots and transport services. Access to Alloga’s extensive network of active potential ingredient (API) and drug storage facilities in Free Trade Zones (FTZ) worldwide gives ICS a significant strategic advantage, able to transport CGTs efficiently while minimizing costs and ensuring regulatory compliance.
“Partnering with Alloga allows us to implement fit-for-purpose storage and packing solutions that are essential for the safe handling of breakthrough therapies,” continues Haynes. “This collaboration empowers us to prepare for the future of CGTs by ensuring that we can deliver these innovations to any market faster and more efficiently.
“Clinical to commercial logistics differ across various economic zones. For instance, if clinical trials are conducted solely in the United States, we can educate on key logistics considerations a manufacturer should keep in mind when planning product launches in Europe.”
By continuing to invest back into its services through new technology and upskilling programs, ICS’s collaboration with Alloga is setting new standards for 3PL logistics for CGTs. As the market continues to expand their expertise gives companies in the specialty field an essential logistical advantage in the delivery of these cutting-edge drugs. To learn more, download the free whitepaper below.
[i] GlobalData, The State of the Biopharmaceutical Industry
