Marken Provides Customized Ultra-Low Temperature and Dedicated Air Logistics Solutions for Cell and Gene Therapies
Logistics Innovation Required in the Era of Customized Therapies
The emergence of patient-specific cell and gene therapies (CGT) necessitates a new supply chain paradigm that is completely different from the logistics of conventional finished pharmaceutical products. Autologous therapies, such as CAR-T, are manufactured for a single patient, so even minor errors during the distribution process can directly threaten the patient's life and lead to the loss of the therapy. If logistics fail, manufacturers must re-manufacture the therapy from scratch, and patients must undergo leukapheresis again, resulting in significant costs and time losses. Therefore, in this field, specialized logistics partners that can respond with extreme precision and agility, beyond simple transportation, are becoming essential.
Ultra-Low Temperature Storage and Real-Time Monitoring Technology
The use of liquid nitrogen (LN2) cryogenic transport containers, which provide an ultra-low temperature environment of -150 degrees Celsius or lower, is becoming common to maintain the activity of cell and gene therapies. Marken, a logistics specialist, has built a flexible platform that operates independently of packaging materials and temperature monitoring devices to support perfect temperature control. In particular, the 24/7 CGT control tower monitors temperature, location, illumination, and impact in real-time, and proactively intervenes when anomalies occur. The Live-View-Link (LVL) software provides customers with accumulated real-time data, maximizing supply chain transparency and preventing accidents.
Managing Distribution Risks Through Dedicated Air Logistics
Traditional commercial aircraft are vulnerable to passenger-centric schedules and route congestion, making them unsuitable for transporting sensitive biologics with a short shelf life of around 48 hours. Marken leverages the strong in-house aircraft network of its parent company, United Parcel Service (UPS), to eliminate the risk of delays caused by overbooking or late arrivals. In fact, it has successfully transported shipments to remote areas such as southern Italy (e.g., Sicily) and the Middle East, which has significant geopolitical risks, by operating a special courier network and alternative routes. Even in complex geographical conditions and conflict zones, it demonstrates supply chain stability by closely cooperating with civil aviation authorities to obtain rapid customs clearance and transportation approvals.
Compliance with Regulations and Securing Ecosystem Trust
Global regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require strict standards for CGT distribution. The integrity of the Chain of Identity (COI), which proves the ownership of the product throughout the supply chain, and the Chain of Custody (COC), which proves the storage process, has become paramount. Marken is responding by thoroughly revising its global Good Distribution Practice (GDP) and Standard Operating Procedures (SOP). This proactive regulatory compliance helps pharmaceutical companies reduce uncertainty in the distribution phase when pursuing new drug approvals, enabling faster market entry.
Growth Prospects and Investment Value of the CGT Logistics Market
The global cell and gene therapy (CGT) market is expected to grow rapidly to approximately $10 billion to $45 billion by 2026. Accordingly, the specialized logistics segment, the CGT third-party logistics (3PL) market, is also expected to surge to $2.27 billion by 2026. Logistics is now recognized as a critical clinical tool that determines the success or failure of drug approval and commercialization, rather than simply an administrative and support function. Therefore, platform companies with unique ultra-low temperature logistics technology and in-house transportation infrastructure, such as Marken, are strong candidates to provide significant growth momentum to bio-sector investors.
With the global cell and gene therapy (CGT) market expected to grow rapidly to $45 billion by 2026, specialized logistics infrastructure that maintains temperatures below -150 degrees Celsius and ensures supply chains within 48 hours is identified as a key bottleneck in the commercialization of new drugs. Marken, in conjunction with its parent company, United Parcel Service (UPS)'s global in-house aircraft network, secures superior supply chain control compared to competitors such as World Courier and FedEx Custom Critical, making it a key solution for pharmaceutical companies in Phase 3 clinical trials and commercialization. In the short term, it can reduce the failure rate of commercialization in the pipeline by ensuring smooth distribution and customs clearance during the drug approval phase, and in the medium to long term, it can acquire access to therapies for patients in remote areas and around the world, fully realizing the developer's potential market size. In particular, the real-time monitoring platform for Chain of Identity (COI) regulatory compliance is more than just a logistics service; it is a clinical tool that overcomes regulatory hurdles and is expected to have a ripple effect as a distribution standard in the bio-tech ecosystem.