Cold chain logistics is undergoing a fundamental transformation as pharmaceutical development shifts toward increasingly temperature‑sensitive, individualized therapies and more patient‑centric distribution models. 

According to a recent report by Roots Analysis, the global cold chain market size for pharmaceuticals was valued at $6.6 billion in 2025 and is projected to reach $9.6 billion by 2035, growing at a CAGR of 3.8% from 2026 to 2033.

What was once viewed primarily as a technical or compliance function has become a critical enabler of patient access, directly influencing whether advanced therapies reach patients safely, on time, and in a usable condition. As biologics, cell and gene therapies, and mRNA products move from controlled clinical environments into real‑world settings, the margin for error has narrowed dramatically.

At the same time, the rise of direct‑to‑patient (DTP) and decentralized trial models is reshaping how the pharmaceutical industry thinks about cold chain design. Delivering to hospitals and depots offers predictability; delivering to patients’ homes introduces variability in routes, environments, handoffs, and end‑user handling. To succeed, supply chains must be designed not to resist variability, but to absorb it—through robust packaging, precise orchestration, and real‑time visibility that allows for intervention before patient impact occurs.

Cold chain logistics is no longer just about meeting temperature specifications—it has become central to ensuring timely, reliable patient access to increasingly temperature‑sensitive therapies. This article explores current cold chain logistics trends from a CDMO perspective, including how DTP distribution is forcing the industry to redesign cold chain systems, the next-gen therapies driving complexity, mitigating risks outside controlled clinical settings and more.

Current State of Cold Chain Logistics in the Pharmaceutical Manufacturing Industry

“Cold chain logistics is becoming more complex, regulated, and sustainability driven,” says Joseph Plampin, CCO, TITAN Containers. He cites regulatory uncertainty, more fragmented supply chains and stricter compliance requirements as factors driving demand for more flexible, validated storage solutions.

According to Caitlyn Clauss and David Ergot, Supply Chain Managers at Almac Clinical Services, “The cold chain has fundamentally shifted from a technical requirement to a patient-access enabler. As more therapies become temperature-sensitive, the ability to maintain product integrity is directly tied to whether patients can reliably receive treatment.”

“Nearly half of all new pharmaceutical products launched globally through 2027 are expected to require cold chain storage,” adds Kelly Frend, Senior Manager, Personalized Supply Chain, World Courier by Cencora. “This shift has elevated cold chain management far beyond ‘a box and dry ice.’”

According to Frend, lane design, packaging performance, and qualification processes are far more sophisticated today, supported by unprecedented choice in materials and technology. She says, “Demand spans all temperature ranges, as sponsors move toward fit for purpose solutions tailored to each product’s profile, route risk, and journey duration rather than generic approaches.”

Aidan McCauley, President of Dawsongroup tcs USA, believes cold chain logistics in the pharmaceutical industry is undergoing a “significant transformation.”

“Traditional cold storage infrastructures, which have long been characterized by large-scale, centralized warehouses, are being challenged by a new paradigm driven by the increasing demand for temperature-sensitive products like biologics, vaccines and advanced therapies,” McCauley observes.

McCauley also sees a shift towards more agile, decentralized systems. He says, “These solutions are not only more flexible but also better positioned to handle fluctuations in patient needs, regulatory requirements and the inherent risks of temperature excursions. However, much of the industry still struggles with a reactionary mindset, often waiting until crises arise to implement the needed changes.”

Advanced & Next-Gen Therapies Raising the Stakes

The experts agree that cell and gene therapies, mRNA products, radiopharmaceuticals, and biologics are raising the bar for precision, traceability, and temperature control—often at the individual patient level. 

“As the cold chain becomes increasingly complex with the rise of mRNA platforms and cell therapies, innovation in temperature monitoring, modular storage solutions and data integration will become essential to ensure the industry’s long-term sustainability and compliance,” remarks Dawsongroup’s McCauley.

“Radiopharmaceuticals continue to expand, bringing unique, time sensitive and packaging led requirements,” adds Cecora’s Kelly Frend. “Meanwhile, the growth of cell and gene therapies (CGTs) is accelerating demand for cryogenic logistics and storage.”

“Cell and gene therapies are redefining expectations because they are inherently patient-specific,” explain Almac’s Clauss and Ergot. “In many cases, that shipment represents a single patient’s treatment there is no fallback, no replacement, and no tolerance for error.”

As a result, they claim the industry has been forced to move “beyond scale and into precision.” 

“mRNA therapies accelerated infrastructure development, but cell and gene therapies are challenging us to rethink control, traceability, and responsiveness at an individual patient level. This is less about logistics evolution and more about a fundamental redesign of how supply chains support care,” they argue.

Direct to Patient Distribution & The Redesign of Supply Chain Models

“The Direct-to-patient delivery model is redefining cold chain considerations for advanced therapies by extending the logistics challenge beyond the clinic and into the home,” says World Courier’s Kelly Frend.

She explains, “The packaging utilized to support a delivery to a patient’s home setting must be robust enough for extended, less predictable transport routes, and suitable for the tighter handling demands of advanced therapy products. Just as important, execution matters as much as design. Precise handoffs, clear instructions, and timed deliveries to the correct patient, caregiver, or nurses involved, are essential to protect product integrity and patient safety.”

Also, since sponsors may be blinded to patient identities or locations but still accountable for temperature assurance and GxP compliance, “data privacy and consent workflows must be considered throughout,” Frend adds.

“DTP is forcing the industry to rethink cold chain through a patient lens rather than a site-centric one,” remark Clauss and Ergot of Almac. “Delivering to a hospital is predictable; delivering to a patient’s home is not.”

According to Clauss and Ergot, this shift exposes a critical truth: traditional supply chain models were never designed for the last mile. To make DTP work, we need to design systems that absorb variability rather than resist it—through more resilient packaging, tighter delivery orchestration, and real-time visibility. 

Ultimately, they conclude, “success in DTP is measured not by delivery, but by whether the patient receives therapy safely, on time, and without added burden.”

Challenges

According to Dawsongroup’s McCauley, “Maintaining temperature integrity outside clinical settings is undoubtedly one of the most challenging aspects of modern cold chain logistics, especially with the rise of DTP distribution.” 

He claims that one of the key challenges is “ensuring that products maintain the required temperature during the last mile; from the distribution hub to the patient’s doorstep.”

Almac’s Clauss and Ergot also emphasize the last mile as “where supply chain meets reality and patient experience is either enabled or compromised.”

“Homes are not controlled environments, and patients are not logistics professionals,” they emphasize. “Expecting the same conditions as a clinical site is unrealistic, which means the responsibility shifts entirely to the supply chain.” 

“The challenge is not just managing risk, but designing it out through robust packaging, precise delivery coordination, and the ability to intervene in real time,” they add. “If the system relies on the patient to compensate for complexity, it’s the wrong system.”

According to World Courier’s Frend, “Issues commonly stem from selecting packaging based on cost instead of lane conditions, inconsistent conditioning of phase change materials, and variable handoff quality during transfers or last mile delivery.”

The solution, she says, lies in “disciplined, data-driven lane design and working with specialized partners at every step.”

“Furthermore, as trials embrace decentralized/DTP models, packaging now needs to accommodate smaller, individualized payloads with the same precision and protection once reserved for larger or bulk shipments. Durability, temperature stability, and usability are now weighted equally, particularly when deliveries occur at patients’ homes or non-traditional care sites,” Frend remarks.

“Unlike clinical sites and depots, which rely on validated cold rooms and qualified refrigerators, at-home storage conditions are unqualified and highly variable, creating a significant risk to temperature integrity,” adds Yves Massicotte, President & CEO, Ropack. “In addition, once the medication is shipped, there is often limited or delayed visibility of temperature excursions, making real-time assurance difficult. Finally, end users are not trained GDP operators, which increases the risk of incorrect storage or handling.” 

“To address these challenges, advancements in real-time temperature monitoring and digital tracking systems have become critical,” Massicotte says. These advancements enable “continuous visibility, rapid detection of excursions, and more effective end-to-end control across the supply chain.”

“The industry has had to move away from the idea that DTP is an exception,” say Almac’s Clauss and Ergot. “It is simply another endpoint in a regulated supply chain—arguably the most critical one.”

They add, “Maintaining chain of custody in this context is about ensuring that regulatory rigor translates into patient confidence. That means absolute clarity in who is responsible at every step, seamless documentation, and the ability to demonstrate control even in decentralized environments.”

“If we cannot prove control to the patient level, we have not truly extended the supply chain,” they conclude.

Real Time Monitoring and Traceability

According to Frend of World Courier, “Sponsors increasingly expect frictionless visibility. Secure portals, live data feeds, and milestone alerts (order creation, pickup, in transit, delivered) now streamline information flow.”

“Sponsors today expect comprehensive, real-time traceability that offers complete transparency into the temperature, location and handling of their products,” adds Dawsongroup’s McCauley. “The requirement goes beyond simple arrival confirmation to include an auditable digital trail of every movement, temperature reading and action taken throughout the supply chain.”

McCauley says advancements in cloud-based tracking platforms, coupled with IoT-enabled devices, “have made it possible to provide this level of traceability.” 

“Sponsors can access real-time data and receive automatic alerts if any deviation from the required conditions occurs, providing them with the ability to act swiftly and ensure product integrity. These technologies ensure that sponsors maintain full compliance with regulatory requirements while enhancing operational efficiency,” he explains.

Ropack’s Massicotte agrees that real-time monitoring technologies and compliant electronic systems play a key role in guaranteeing data integrity, providing secure, time-stamped, and attributable records in line with requirements such as 21 CFR Part 11 and EU Annex 11. 

He says, “Real-time temperature monitoring advancements now enable continuous tracking during transport and storage, with data instantly accessible from remote locations. 

“In the event of a temperature excursion, automated alerts support rapid intervention, helping to prevent product loss. In addition, tight temperature monitoring helps avoid biases in clinical studies that could arise from deviations affecting the stability of medicinal products. From a regulatory perspective, it also ensures that stability requirements are consistently maintained and properly documented, supporting compliance and data integrity.”

“The move to real-time monitoring has been a turning point because it changes the role of data from retrospective validation to active risk management,” posits Clauss and Ergot of Almac.

“In a DTP model, waiting to discover an excursion after delivery is no longer acceptable,” they say. “Real-time visibility allows intervention before the patient is impacted, which is where true value lies. The next step is not just more data, but better use of it integrating monitoring into operational decision-making so that patient protection is proactive, not reactive.”

Future Outlook

McCauley of Dawsongroup predicts that DTP distribution will continue to evolve significantly over the next 3–5 years and become “a foundational component of pharmaceutical logistics.”

“The industry will see increased adoption of modular, scalable cold storage solutions, which can be rapidly deployed closer to patient populations, minimizing transportation distances and improving product safety,” he says.

“The integration of AI-powered predictive analytics and smart packaging will further enhance the efficiency of the cold chain, ensuring that products are delivered at the right time, under the right conditions and with full traceability,” he continues. “As these technologies become more advanced, we will also witness a shift towards sustainability-focused solutions that reduce the environmental impact of DTP distribution, making it both economically and environmentally viable on a larger scale.”

TITAN Containers’ Joseph Plampin expects DTP distribution to grow, driven by “patient-centric care models and efficiency gains.” He says, “This will increase requirements for documentation, compliance, and supply chain visibility.”

Almac’s Clauss and Ergot predict that “DTP will move from being a flexible option to a foundational component of clinical trial design.” 

“Patient expectations are changing, and trial models will need to adapt accordingly,” they explain. “We will see a shift toward more segmented, therapy-specific logistics strategies, as well as greater reliance on real-time data to enable proactive intervention. But the biggest change will be philosophical: success will no longer be measured by operational efficiency alone, but by how effectively the supply chain supports the patient experience.”

According to Clauss and Ergot, “providers that lead will be those who can combine precision, scalability, and a deep understanding of patient needs because in the end, DTP is not about decentralizing logistics, it’s about personalizing access to treatment.”