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View the Pharmaceutical Commerce April 2025 issue in an interactive format.

Pharmaceutical Commerce: April 2025 Interactive Digital Edition

The pharmaceutical cold chain—the portion of the industry operating and advancing technological advances in temperature-sensitive transport, pallets, data loggers, sensors, and even new developments in freight services—is an all-encompassing topic, for sure.

 attempts to keep pace with the sector's accelerated activity, headlined by Nick Basta’s 

 exploring cold-chain product distribution services and approaches—efforts that are continuing to experience success due to their evolution with the times.

“… Clients of cold chain services can rely on increasingly sophisticated packaging, containerization, and delivery technologies,” wrote Basta. “Vendors are building out more options for delivering products safely and securely, and while regulatory screws continue to tighten around shipment documentation and sustainability and environmental restrictions, new technologies offer alternative pathways to compliance. All in all, it makes for a lively market for investment in vendor growth.”

In that same breath, artificial intelligence (AI) in particular—albeit perhaps still a buzzword—has helped optimize the pharma transport process, as 

, Purav Gandhi of Healthark Insights notes that there is no doubt that pharma logistics is a complicated machine, but AI can streamline processes by filling in the gaps as it relates to such areas as dynamic route planning; real-time tracking; cost-efficiency optimization; advanced temperature reporting; regulatory compliance monitoring; and predictive analytics.

On another note, speaking of regulations, most would agree that the Inflation Reduction Act is a challenging one to navigate for many industries. In the pharma R&D space, this sentiment is no different. In a 

 this month, Model N’s Jesse Mendelsohn reminds on how the advancement of promising, lifesaving drugs requires significant R&D investments. On average, new molecular entities cost $2.3 billion each to develop, largely funded by existing drug sales. But, meanwhile, pharma companies are under increasing pressure from the government to reduce prescription drug prices, which, in turn, presents a significant hurdle to maintaining the R&D pipeline.

Our April issue also provides expert commentary on behalf of 

, and, of course, our esteemed columnists.

— Mike Hennessy Jr., President and CEO, MJH Life Sciences

The April issue of Pharmaceutical Commerce examines the accelerated activity—and many ever-expanding layers—of temperature-sensitive transport in pharma.

The Cold Chain's Evolution

Since the publication of our last print issue in 

, our editorial team has been working diligently to accurately provide the latest updates surrounding President Trump’s announced tariffs on various US global trading partners. With Canada, for instance, there has been a tit-for-tat of import taxes revolving around border protection, along with steel and aluminum. Meanwhile, China announced retaliatory tariffs of their own on US farm exports. And the global trade war, in particular between the US and China, has escalated from there, with new developments seemingly every day. (See recent coverage 

on the potential tariff implications for pharmaceuticals.)

These developments impact the supply chain as a whole, but what has truly resonated with our readers was the potential 25% (or higher) tariff on pharmaceuticals that was announced in late February. With tariffs on pharma imports looming in the next month or two, Trump has said previously that he intended to provide what he believes is ample time to drug manufacturers to set up shop in the US by reshoring their manufacturing services. 

I recently spoke with Brad Stewart, national life sciences co-leader at BDO, to answer the following question: If I’m a manufacturer with the capabilities to do so, is it worth returning manufacturing to the US, even with the potential of events changing post-Trump administration?

“If I can move some of that capacity back in the United States, look to do more of the work here so that I'm not worried about what the taxes or tariffs or anything else may be going forward, those are just things that allow me to focus on my core business of making products to help save people's lives,” Stewart said. “I think the other thing—particularly about whether people will start to build new capacity in the United States, which [Eli] Lilly is doing—is that it’s a much more expensive thing to do, but I certainly think it makes sense if anyone's planning on building new capacity to very seriously consider doing that in the United States.”

Amid the tariff uncertainty and likely formal enactments to come, readers can visit 

 for all the newest and latest developments as they occur.

Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at nsaraceno@mjhlifesciences.com.

One expert's take on reshoring pharma manufacturing services in the US amid likely tariffs to drugs looming.

Tariffs Galore: Where Do We Stand?

Access USA—held in mid-March at Sheraton Philadelphia Downtown—offered the opportunity to attend three conferences in one: Patient Assistance & Access Programs (PAP), Hub and Specialty Models East, and the Rare Disease Summit.

’s coverage, we decided to focus on PAP, along with Hub and Specialty Models East, which prioritized maximizing medication access and creating a comprehensive hub, respectively, keeping the issues particularly important to the patient experience top of mind.

“State of the Industry—The Evolving Landscape of Healthcare Coverage and Access in 2025”

“Moving the Needle on Awareness of the Medicare Part D Reforms”

“Unraveling the Complexities of Patient Access and Affordability”

“Understanding the Uninsured Landscape”

“Empowering Patients to Take Control of Their Healthcare”

“The Changing Landscape of Patient Access–Accumulators, Maximizers, & Alternative Funding”

Each of the sessions provided a unique perspective from the sector. For example, in “State of the Industry,” which led off the program, Tommy Bramley, Cencora’s SVP of global consulting services, set the scene by alluding to three main challenges that lie ahead concerning uncertainty. They included the US federal and state policy priorities; unintended consequences of the Inflation Reduction Act; and payer economics.

However, after attending the “Empowering Patients to Take Control of Their Healthcare” session led by Rachel Thorpe, executive director at the Otsuka Patient Assistance Foundation, an independent entity from the manufacturer Otsuka, I was in shock at some of the statistics on health literacy in the space. One is that nine out of 10 patients do not understand basic health terms, and beyond that, 33% of the patient population in America doesn’t read above a third-grade level, according to Thorpe.

Shining a light on these challenges increases the urgency that stakeholders should have in educating patient groups.

“When you’re talking about educating your patients, make sure you put certain hats on,” Thorpe suggested. “What is your patient population? What is your patient journey? What the socioeconomic status of that patient population looks like will also define how you educate them. Education equals empowerment.”

The editorial team also conducted video interviews with various subject matter experts, including Jonathan James, Jen Butler, Kevin Hagan, the aforementioned Thorpe, and Kimberly Westrich.

For the latest in conference coverage, please visit 

pharmaceuticalcommerce.com/latest-conference

Access USA converges in Philadelphia to explore new—and needed—solutions to boost patient outcomes.

Conference Connect: Progressing Patient Assistance 

In the midst of a continually growing, healthy market for pharmaceutical cold chain services, the number of worries seems to be keeping pace. The ability to deliver valuable pharma products at specified temperatures is not universal; logistics costs jump up and down as natural and manmade disasters interfere with deliveries; and the business environment is fluid, as a lull settles into the rapid-fire cell and gene therapy (CGT) market. Behind all of this is the new uncertainties to international trade brought about by the Trump administration, which simultaneously wants to impose tariffs on selective nations, demand reshoring of pharma production, and seek lower drug costs. And behind all of that are concerns about cargo theft and counterfeit or adulterated drug trafficking.

On the other hand, clients of cold chain services can rely on increasingly sophisticated packaging, containerization, and delivery technologies. Vendors are building out more options for delivering products safely and securely, and while regulatory screws continue to tighten around shipment documentation and sustainability and environmental restrictions, new technologies offer alternative pathways to compliance.

All in all, it makes for a lively market for investment in vendor growth. 

“The interest of the private equity community in the pharma cold chain remains robust,” says Karen Donovan, a principal at Health Business Group, a consulting firm that has been involved in past transactions. “Mainly, they are looking for the potential of high-value, high-growth businesses.”

A timely example of this is Frontier Science Solutions, a warehousing and logistics company that is seeking to build a “direct global gateway” between Europe and North America. The company says it has received a $1.5-billion investment from GID, a North Carolina real estate and investment firm, to expand operations at Shannon Airport, County Clare, Ireland, and Wilmington International Airport in North Carolina. The Wilmington facility will be structured as a free-trade zone, and will be GMP-compliant for room-temperature (15-25°C), cold-chain (2-8°C), and frozen (0 to -80°C), while also including cryogenic) pharmaceuticals, along with storage, packaging, and delivery services. Ground has been broken on the Wilmington facility, with planned overall capacity of 500,000 square feet (and another 250,000 square feet in the works). It will be operational in August, says the company.

Growth is also on the minds of MD Logistics, which announced last September it would be converting half of its 400,000-sq. ft., Plainfield, IN, facility to full cGMP compliance, with both room-temperature and 2-8°C service. The company, an independent subsidiary of Nippon Express, will also benefit from a similar GDP conversion of Nippon’s Philadelphia facility.

Growth through acquisition has been an attractive option for many organizations in the pharma cold chain. One recent example is Knipper Health, long known for its marketing services and 3PL operations in pharma. At the end of last year, it announced the acquisition of the sample fulfillment services of Patheon Pharma, from Thermo Fisher Scientific.

“The Memphis facility will expand our cold chain footprint beyond our existing Lakewood, NJ, and Charlestown, IN, locations and further strengthen the company’s position for future growth,” said Michael LaFerrera, Knipper Health CEO.

The pharma cold chain market generally breaks down into temperature-controlled packaging, logistics services, and instrumentation/data. New offerings in these categories include:

Artyc, a relatively recent Silicon Valley startup, has extended the technology of its battery-powered, reusable MedStow Micro container to 5 L. The company has been working for a couple years with a sample-management clinical company, and now wants to handle outgoing deliveries of biological drugs and CGT trials. It is rated for up to 72 hours of service before battery recharging, and a -20° to 25°Ctemperature range.

 The Cryoport Express Cryogenic HV3 Shipping System is configured roughly like a carry-on suitcase for air passengers, but can safely hold CGT products and related items at temperatures to -150°C . It can be used for lab-based storage, as well as delivery to point-of-care facilities. Condition and location monitoring are integrated into the container. Cyroport also operationalized its IntegriCell service in the past year, via a newly opened facility in Villers-le-Bouillet, Belgium, and complementing a similar facility at its Houston, TX, location. IntegriCell offers pharma clients a method to pre-qualify apharesis extractions from patients (the portion of human blood that contains white cells, aka leukopaks), cryopreservation, storage, and delivery—essentially, the first step to developing an autologous cellular therapy.

At the other end of the volume range, Envirotainer has expanded its RelEye line of pallet containers to an RKN (single pallet) version, for air freight of bulk deliveries. The existing RelEye line includes the RAP (four pallet) and RLP (two pallet) versions. All have active refrigeration via onboard compressors; fans and batteries; and advanced insulation technology. Each has 18 sensors for internal and external condition monitoring, and can be backed up by the company’s 24/7 Control Tower service. Rated for 130-170 hours service at 4-30°C. RKN tare weight is 583 kg.

 An alternative to the active-powered unit-load device (ULD) technology is passive temperature control, via insulation and phase-change material. Sonoco ThermoSafe introduced the Pegasus ULD several years ago, but in the past year has had it certified by over a dozen air carriers. One of the first to certify the unit was United Air Cargo, which has since certified an additional 14 types of bulk containers. Unlike other passive pallet containers, the Pegasus unit is FAA-certified as an AKP ULD that locks into place in the cargo hold, providing some efficiencies to the air carrier. Active units, which are generally heavier than passive ones, have been competing for market share for years—and will continue to do so. The unit is rated for up to 300 hours of 2-8°C service, and tare weight is 616 kg.

 Somewhat straddling the bulk container range is the new Credo Vault from Peli BioThermal. With an internal capacity of 1638 L, the passive, highly insulated unit can be packed four to a PMC pallet (a standard “cookie sheet” for loading aircraft), thus affording the shipper to send products in multiple temperature ranges in one shipment. The unit is rated at 144 hours at 2-8°C, and has a tare weight of 398 kg.

Temperature control for labs, hospitals, biobanks, and the like is being enhanced with the newly introduced VIP Eco-Smart ultra-low-temperature freezer from PHC Corp. of North America. The units have capability between 528 and 729 liters, and can now switch between 115 Vac and 240 Vac. An innovative inverter compressor, combined with high-performance insulation, cuts average power consumption by 30%, according to the firm.

Q Products & Services, well known in the industry for its PalletQuilt and related thermal covers (usable on both insulated or uninsulated containers), is extending its product lines with the Power In-Lock device, a locking and communication module to be mounted in trailers, on containers, or storage units. The module is activated via a Bluetooth connection, and provides status to one’s desktop or mobile device.

When looking at the products these vendors protect and deliver, two trends stand out: the entire pharma industry is going in a direction of more temperature-controlled products (predominantly injectable biologics); and the cold chain vendor community is competing aggressively for future CGT business.

That CGT focus is occurring even though there is something of a lull in the CGT developer space. According to an annual count

, the number of CGT bankruptcies was 27 in 2023, dropping to 22 in 2024, which it says “may point to a gradual recovery.”

For gene technologies, especially those making use of CRISPR technology, the current perspective is grim: “Most stocks of CRISPR companies are down 80% from their 2021 peak,” according to 

"We expect the macroeconomic and sector-specific challenges that have impacted many companies serving the life sciences industry to continue for the near future," Jerrell Shelton, CEO of Cryoport, told analysts at the company’s Q3 2024 meeting. Nevertheless, “we continue to be optimistic about our long-term business growth trajectory.”

All that being said, the longer-term outlook is positive. An annual report from BioPlan Associates, which tracks global biomanufacturing trends, reported that the capacity for bioprocessing reached 14 million L in 2024, up 15% from the year before, and will grow at double-digit rates through the next five years. And the American Society of Gene & Cell Therapy, in a quarterly report based on the Citeline data service, counts a surprisingly high 33 commercial gene therapies, 35 RNA therapies (including a bunch of COVID-19 vaccines), and 72 cell therapies approved worldwide, with healthy pipelines of investigational products in the works.

Even so, CGTs will be an unusual platform for cold chain logistics growth, for the simple reason that a large number of them are based on developing therapies for individual patients, and for rare to ultra-rare diseases. A 2023 study from IQVIA, “Pharma’s Frozen Assets,” found that during 2021, all cold chain pharmaceuticals represented only 0.2% of the industry’s volume of prescriptions, while at the same time constituting 32% of the industry’s revenue. By volume, CGTs will represent a small fraction of that 0.2%

So, the bulk of the pharma cold chain market is 2-8°C refrigerated product, and not ultra-cold CGTs. In the 2-8°C regime, the star products today are the GLP-1 obesity and diabetes treatments; over the past few years, Novo Nordisk’s Ozempic and Wegovy GLP-1s have risen to $40.6 billion in sales, according to the company. Eli Lilly’s sales of Mounjaro and Zepbound have jumped to $5.4 billion in 2024, after being on the market a shorter time than Novo Nordisk’s. The GLP-1 market is expected to expand as new therapeutic targets are found, and as next-generation GLP-1s are approved. Biosimilars, whose lower prices expand the market for biologics, are another growth factor, as are vaccines. Currently, the 2-8°C sector is valued at nearly $400 billion, according to the IQVIA study, and has been growing at almost twice the rate of room-temperature products.

As money continues to flow into CGTs, via venture capital or Big Pharma acquisitions, vendors continue to invest in the field. UPS Healthcare Logistics recently announced that it plans to double its revenue between 2023 and 2026 (to $20 billion) and is following through by acquisitions of two European pharma cold-chain companies, Frigo-Trans and BPL. It has also just announced that three earlier acquisitions—Marken, MNX, and Polar Speed—will now be united as UPS Healthcare Precision Logistics. The announcement did not specify CGTs, but given Marken’s long involvement in clinical trial logistics, that can be assumed.

Other recent acquisitions include Cold Chain Technologies’ purchase of Tower Cold Chain, a UK company—both providers of temperature-control packaging and containers—and Sensitech’s purchase of the Monitoring Solutions business of Berlinger & Co. Both of these companies have been providers of temperature-tracking hardware and services.

It’s possible that the Trump administration’s full-scale reversion away from sustainability and climate change mitigation will have broader, global implications, but for now, most governmental and corporate efforts remain focused on making progress on those fronts.

“While policy shifts in the US may create short-term discussions, the broader industry trend is clear—pharma companies are continuing to invest in sustainable practices,” says Alison Crawley, global sustainability manager, Sonoco ThermoSafe, “not only to meet regulatory requirements but also to drive efficiency, reduce waste, and support their own ESG commitments. Sustainability isn't just a regulatory obligation; it’s a business and reputational imperative in a globally interconnected market.”

In the recent past, commentators on the sustainability issue in pharma cold chain noted that discussions had gone from it being a “nice to have” feature of vendor contracts to a “must have.” Now the discussion is evolving further, with vendors offering state-of-the-art analytical techniques for measuring carbon footprints precisely. One example is SkyCell, which has marketed a bulk container for air freight for several years; it offers a “TCO + CO2e” (total cost of ownership plus CO2 emissions) formula for its reusable units. Envirotainer and others offer comparable analytical techniques.

Another aspect of addressing the sustainability issue is to switch from air freight to ocean shipping, via “reefer” containers that have onboard refrigeration. Ocean freight for cold chain pharma took a hit during the pandemic, when ports around the world were backed up for weeks because of delivery hurdles (which in turn raised costs astronomically), but has since bounced back. Conventionally, ocean freight offers a seven- to tenfold reduction in shipping costs, and an even greater reduction in carbon emissions.

Several years ago, an industry consultant, Alan Kennedy, pioneered an industry consortium for ocean freight, called the Poseidon initiative, to harmonize operating practices among life science shippers and customers. Now, saying that “With the market moving towards more resilient and sustainable intermodal transportation solutions, it was not deemed appropriate (nor unbiased) to focus on a single mode,” according to Kennedy. To that end, Poseidon has been subsumed into a new consortium, GDP-Universal Compliance Initiative (GDP-UCI), and now has 36 members, ranging from ports to logistics companies and a few pharma shippers. The deliverable, says Kennedy, will be an Integrated Pharma Eco-Lanes certification project to align pharma's environmental/sustainability objectives with GDP.

Ocean freight also figures in the reusability or reverse-logistics practices of cold-chain packaging companies. Emball’iso, a global provider of passive containers, touts a four-continent, multiple-site reconditioning system that allows clients to return the containers via ocean freight.

Sidestepping the reusability process altogether, packaging provider Temperpack has done away with expanded-polystyrene insulation altogether, offering two alternative materials—ClimaCell, made from paper and starch, that can be “curbside recyclable.” It has won Cytiva, a biotech manufacturer, as a client for the company’s cold-chain products.

Although the relatively high carbon footprint of air freight is a challenge, that community is not sitting still. One initiative, obtaining fuel from renewable or biological sources—sustainable aviation fuel—has been deployed by several air carriers. Another, growing rapidly, is drone delivery, whose carbon footprint is only the electricity that charges its batteries.

Drone delivery, led by companies like Zipline or Matternet, has been in use for several years in African countries, where getting needed health supplies to remote regions is a challenge. Now, however, it is making headway in the developed world, especially for last-mile delivery from hospital systems. Zipline, for example, is commercializing a Platform 2 drone, which can hover upwards of 300 feet over a location, then drop a “droid” that has some maneuverability on a tether, complete the delivery, and then retract the drone and return to its home base. Both Zipline and Matternet have FAA approval for “beyond visual line of sight” (BVLOS) operation, meaning that the drone flight does not need on-the-ground visual guidance. Both companies, interestingly, note that they are compatible with cold chain deliveries.

The push toward more sustainable operations has some hurdles to overcome besides the Trump administration animus. France, for example, announced last fall that a mandate to eliminate polystyrene and similar polymers from packaging (which would have significant implications for cold-chain packaging still used for the majority of shipments) by January has been pushed back to 2030.

— Nicholas Basta is Founder and Editor Emeritus of Pharmaceutical Commerce

This analysis might underplay part of the cold chain market, because there are some room-temperature products that require temperature control similar to the refrigerated products. Additionally, the actual shipment volume of, say, an injectable pen with its associated temperature control could be an order of magnitude larger than a comparable shipment of an oral solid.

1. Masson, G. The 2024 Biotech Graveyard. 

https://www.fiercebiotech.com/special-reports/2024-biotech-graveyard

2. Mast, J. The CRISPR Companies are Not OK.

https://www.statnews.com/2025/02/06/crispr-gene-editing-medical-breakthrough-not-matched-by-financial-success

Vendors are growing, and product and service offerings are expanding.

The Hot Market for Cold Chain Services

Precision in the supply chain has never been more critical than when it involves transporting temperature-sensitive pharmaceutical products. Even small changes in temperature, short delays, or minor disruptions can compromise a product’s integrity, damage a company’s reputation, or endanger patient safety. Due to the sensitivity of the pharmaceutical cold chain and the value of its products, it is increasingly important to make thorough risk assessment an integral part of the shipping and distribution process.

Risk in the pharmaceutical cold chain can take several forms, but assessing risk combines two factors: the likelihood that a risk event could take place, and the severity of the consequences if the event does occur.

Vibrations and shock can cause physical harm or degradation of the product during transit. This can happen unexpectedly if a shipment is forced to change routes.

Supply chain bottlenecks, disruptions that prompt route changes, or other unforeseen events can cause delays. Natural disasters and manmade disruptions—ranging from hurricanes to political unrest—can cause ships, planes, and trucks to wait out delays or take an alternate route.

 Deviations from a specified temperature range can cause products to degrade, which is a particular problem for pharmaceuticals that must be kept refrigerated. The FDA estimates the pharma industry loses $35 billion a year because of cold chain failures.

 Most medicines that require refrigeration must be kept between 36°F and 46°F (2°C and 8°C). A deviation from that range of even a few degrees can spoil the product. This could be caused by mechanical failures, such as malfunctions in refrigerators, freezers, sensors, or human errors such as incorrect temperature settings, mishandling of goods, or communications failures.

The acceptable temperature range varies with the type of product. Products such as tablets, capsules, and powders are transported at room temperature, between 55°F and 75°F (15°C and 25°C), though some other products require a deep freeze. Several COVID-19 vaccine candidates were classified as “ultra-cold”

 and needed to be kept at -112°F (-80 °C) and cryogenic medicines (such as some vaccines and tissue samples) are kept between -238°F (-150°C) and absolute zero -460°F (-273°C).

. The value of some pharma products makes them attractive targets for theft in the supply chain.

 And the potential consequences of theft extend beyond financial losses and disruptions to operations. They can also profoundly impact patient well-being by causing delays in treatment, which can, in turn, lead to adverse health outcomes. Meanwhile, as the pharma supply chain becomes increasingly networked, it is also more vulnerable to cyberattacks,

 adding another reason for proactive risk assessment.

Once you’ve identified potential risks and the likelihood that they could occur, you can implement risk mitigation and control strategies, as part of an ongoing, cyclical process.

Identifying potential hazards and risks, such as temperature fluctuations or shock damage, could impact product quality and patient safety. In modern pharma supply chains, companies are turning to artificial intelligence in order to filter out noise from meaningful data in order to make intervention work easier and preventative.

When it comes to analyzing risk, being able to accurately assess them involves evaluating several factors: 

Product characteristics, including the inherent properties of the product, such as whether it is temperature-sensitive, fragile, or perishable.

The packaging and shipping systems being used, which are paramount in protecting products.

The transportation modes and routes for shipping products. and whether they could significantly impact the risk profile of shipments.

The environmental conditions encountered during transit and whether they could pose significant risks.

Regulatory requirements and how they apply to shipping and distribution.

Using fine-tuned cold chain large language models can enable drugmakers to better interrogate data from across their entire supply chain, and answer questions faster.

Devising effective strategies for mitigating and controlling risk involves making use of the data gathered from assessments, and often requires a tailored approach, based on the probability, severity, and potential impact of each risk. The strategies you choose can include:

Because staying within the required temperature range is essential, shippers need to ensure the reliability of their systems. This can include being able to make use of data from sensors and data loggers that monitor temperatures during transport, as well as other factors such as shock impact and location. Real-time monitors and data loggers can track fluctuations and humidity that can affect temperature-sensitive and perishable products. Data from other sensors can be analyzed and used to help optimize routes and avoid damage.

Organizations should be sure their packaging is sufficient to prevent product damage during transportation and handling.

 Implementing protections ranging from security cameras and container seals to cybersecurity measures and employee training can help deter theft and ensure product integrity.

Delays and disruptions can happen unexpectedly, but that doesn’t mean you have to be unprepared. Having contingency plans in place to address potential shipment delays can ensure quicker responses, which can reduce delays and lower risks.

While some companies do this in a reactive way, forward-thinking pharma organizations are finding ways to develop more proactive risk mitigation strategies. This involves transforming the volumes of data collected across the cold chain into actionable insights that allow companies to ensure the cold chain runs smoothly, and avoiding issues such as sub-optimal routes, problematic carriers, or inefficient or non-compliant packaging strategies before they become a problem.

Supply chain companies need to collaborate and communicate with all their stakeholders to gain a comprehensive understanding of risks and ensure the development of effective mitigation strategies. That includes internal stakeholders, such as those handling quality assurance, regulatory compliance, product development, supply chain management and procurement, as well as third-party suppliers.

Third parties with a stake in the process include any contracted manufacturers or packagers, and storage sites. They can be carriers, transport providers, and forwarders, as well as distributors. Last-mile partners such as clinics, hospitals, pharmacies, and patients are also stakeholders.

Today, these third parties are fragmented and drugmakers are forced to rely on third-party logistics providers to help piece together the story of what happened. Companies need to begin to figure out how to make their data work for them, using data to drive weekly or monthly risk review boards to ensure risks are communicated clearly and effectively.

Implementing the chosen risk mitigation strategies and monitoring their performance is another stage where being able to collect and analyze data can be effective in identifying areas for further improvement. Companies successful in this phase are able to gain insights into the data from across the supply chain not only to understand the baseline of where they are at, but to assess their performance against the plan in real time.

Pharmaceutical shipping and distribution requires that products arrive both on time and in good condition. The risks to that process are many, but a strategy of proactive risk assessment and mitigation can make organizations’ cold chains more resilient. By systematically identifying, assessing, and mitigating potential risks, companies can protect their products and help ensure timely deliveries that will build trust among patients and healthcare providers.

1. Cold Chain Management for Pharmaceuticals. Dickson Data. June 29, 2022. 

https://dicksondata.com/maintaining-cold-chain-essential-safe-product-healthy-bottom-lines

2. Motamedi, H.; Ari, M.M.; Dashtbin, S.; et al. An Update Review of Globally Reported SARS-CoV-2 Vaccines in Preclinical and Clinical Stages. 

3. Anderson, M. How Pharmaceutical Companies Work to Prevent Organized Crime in Their Supply Chains. 

https://www.healthcare-brew.com/stories/2023/06/08/how-pharmaceutical-companies-work-to-prevent-organized-crime-in-their-supply-chains

4. Cyber Threats in Pharma Supply Chain. World Bi Group. June 8, 2023. 

https://worldbigroup.com/Event-blogs/cyber-threats

When delays and disruptions threaten not only product integrity but patient
well-being, thorough risk assessment and mitigation are essential.

Reducing Risk in the Pharmaceutical Cold Chain

Logistics play a very important role in the pharmaceutical industry, as the activities involved are highly sensitive to time and quality control. It involves delivering drugs to the right place, at the right time, in a safe and secure manner, and at a competitive operational cost. Given this crucial nature of activities, drug shipping faces multiple challenges, including the requirement of temperature-controlled transportation, regulatory compliance, difficulties in demand forecasting, and the need for timely deliveries.

In recent years, many companies have introduced software and artificial intelligence (AI)-driven innovations to help the pharmaceutical logistics industry by addressing these gaps and loopholes. With such advancements, AI has emerged as a key tool to overcome the above challenges and, in turn, optimize pharmaceutical shipping and delivery processes.

Pharmaceutical logistics can be complicated due to the multiple challenges discussed above, but any product shortages due to human errors or delays in delivery can lead to compromised patient safety. As a result, many large pharmaceutical companies have started to rely on third-party logistics (3PLs) providers for managing transportation, warehousing, and quality control of their products. Many large 3PLs, such as Maersk, DHL, UPS Healthcare, and FedEx offer specialized services, including temperature-controlled delivery and regulatory compliance, which are vital for safe and efficient distribution of pharmaceutical products.

AI: Streamlining pharma logistics by filling the gaps

In recent times, AI has become the talk of the town for its potential applications in every sector, including logistics. When it comes to pharma logistics, software and AI-driven innovations are transforming operations and helping in overcoming challenges in the following six pivotal ways:

Pharmaceutical shipments often face various on-road hurdles like traffic, weather changes, natural disasters, or geopolitical factors that could potentially lead to delays in deliveries. Such delays not only affect the schedules but also pose a risk to the efficacy of pharmaceuticals. In such a scenario, AI has emerged as a solution to tackle these challenges by optimizing shipping routes that analyze real-time traffic, weather conditions, and historical data.

 This approach helps in ensuring timely delivery of shipments, while minimizing the risks of degradation of pharmaceutical products during transit.

 An example for this can be Maersk, which uses AI to dynamically plan shipping routes by evaluating traffic, weather patterns, ocean currents, and other factors.

 Pharmaceuticals are required in every region of the world; as a result, pharmaceutical deliveries often span thousands of miles. This makes tracking of shipments a very complex task. However, AI technologies have now made real-time tracking of delivery vehicles possible, and are able to provide up-to-date status information to all concerned stakeholders. This approach not only increases transparency but also keeps customers informed about any potential delays, so that they can make required decisions accordingly.

 One example is FedEx, which uses AI for predicting potential delivery delays based on weather conditions and traffic, and keeps customers notified of these factors in real-time.

 Apart from optimizing the operations, AI can also help in reducing delivery management costs for the suppliers. It can decrease fuel costs with the help of dynamic route planning, can reduce labor costs with the help of automation, and can lower vehicle maintenance expenses by optimizing driving patterns and using predictive analytics. All these savings allow businesses to allocate these resources to other important tasks and long-term goals.

As discussed earlier, temperature control during transit is critical for maintaining the efficacy of pharmaceuticals. AI-powered internet of things (IoT) devices can be very helpful in this space. These devices continuously monitor the temperature and humidity levels of the shipment during transit. Such an approach saves time, as the drivers don’t need to frequently stop and inspect the goods. In case of any temperature fluctuations, the team is instantly notified about the deviation.

 For example, DHL SmarTrucking—a service officed in India—uses IoT-enabled sensors to provide real-time temperature tracking of shipments to their customers.

Regulatory compliance and audits are an integral part of pharmaceutical logistics since quality assurance is required at every step. AI can help in maintaining compliance by ensuring that transit regulations are followed at all times. It can continuously monitor the temperature data and compare it with industry standards to make sure that everything is under control. Moreover, it can notify the team in case of any deviations and potential risks to shipment, so that they can take corrective actions on time. One example of this is Kuehne + Nagel, who utilizes its "KN PharmaChain" solution to guarantee compliance with the strict transportation regulations governing pharmaceutical products in order to provide a standardized logistics service.

 By using predictive analytics on historical data, AI can predict future market trends, such as peak demands and seasonal demands. This information can help suppliers prepare for unexpected demand via surges or dips in the market, allowing them to manage number of vehicles and delivery intervals accordingly.

 Additionally, AI can use real-time data from IoT sensors on vehicles to assess vehicle health and identify any potential failures. This approach can reduce unexpected failures and minimize downtime, eventually optimizing the operations.

 For example, UPS uses sensors in its trucks to generate important information such as tire pressure, engine temperature, freight weight, etc. and use it to predict maintenance needs of the vehicles.

We look forward to seeing how innovations in this sector continue to be brought to light in the years to come. Will other forms of technology emerge?

Purav Gandhi is the CEO of Healthark Insights.

1. Tan, J. A Complete Guide to Shipping Pharmaceuticals. MGS IceStorm. August 16, 2022. 

https://mgsicestorm.com/shipping-pharmaceuticals/

2. Singh, J. Pharmaceutical Cold Chain Logistics in the Age of Artificial Intelligence

https://www.pharmaceuticalcommerce.com/view/pharmaceutical-cold-chain-logistics-artificial-intelligence

3. AI in Transportation and Logistics: Use Cases, Benefits, and Examples. Travancore Analytics. August 21, 2024. 

https://www.travancoreanalytics.com/ai-in-transportation-and-logistics/

4. How AI-Powered Delivery Management is Shaping the Future of Logistics. FarEye; #creator. October 8, 2024. 

https://fareye.com/resources/blogs/ai-delivery-management

5. Data: The Differentiator in Logistics Transport.  DHL. 

https://www.dhl.com/content/dam/dhl/global/dhl-supply-chain/documents/pdf/SC_Insights%20Article_The%20differentiator%20in%20logistics%20transport_EN.pdf

6. KN PharmaChain for Road Transport. Kuehne + Nagel.  

https://us.kuehne-nagel.com/en/-/services/pharma-healthcare-logistics/road-transport

7. UPS Premier: Priority Shipping for Healthcare Products. UPS Healthcare. 

https://www.ups.com/us/en/healthcare/solutions/ups-premier.page

8. Filipsson, F. How UPS Uses AI to Predict Maintenance Needs for Its Delivery Fleet. Redress Compliance. January 26, 2025. 

https://redresscompliance.com/how-ups-uses-ai-to-predict-maintenance-needs-for-its-delivery-fleet/

How artificial intelligence tools are helping to optimize the pharmaceutical transport process.

An AI-Pharma Transport Collaboration

The pharmaceutical cold chain sector plays a crucial role in ensuring the safe and effective delivery of temperature-sensitive medications, including advanced therapy medicinal products (ATMPs). For the last decade, it’s been crucial for contract development and manufacturing organizations (CDMOs) to adopt the latest technological advances to enhance the efficiency and reliability of the cold chain, ensuring medications reach patients in optimal condition.

Temperature-sensitive transport is a critical component of the pharmaceutical cold chain. For a CDMO, that means it’s an imperative to maintain a required temperature range during transportation, leveraging technologies such as advanced refrigerated vehicles. These vehicles are equipped with state-of-the-art cooling systems to ensure that products remain within the specified temperature range throughout the journey. These vehicles are often integrated with real-time monitoring systems that provide continuous data on temperature, humidity, and other environmental conditions. This real-time data allows for immediate corrective actions if any deviations are detected, thereby minimizing the risk of product spoilage.

In addition to refrigerated vehicles, CDMOs have also adopted outer packaging solutions to enhance the cold chain. Packaging designed for temperature-sensitive transport is equipped with insulation materials and phase change materials that help maintain the desired temperature. These outer boxes are capable of absorbing and releasing thermal energy, thereby stabilizing the temperature of the products during transit. Furthermore, some packaging is integrated with active cooling systems that provide additional temperature control. The use of such advanced shipping solutions ensures that temperature-sensitive products are protected from temperature fluctuations, even during extended transportation periods.

Data loggers and sensors have become indispensable tools in the pharmaceutical cold chain. CDMOs utilize these devices to continuously monitor and record temperature and other environmental parameters throughout the supply chain. Data loggers are placed inside packaging or attached to pallets, and they provide real-time data on temperature, humidity, and shock. This data is transmitted to a central monitoring system, where it can be analyzed to ensure compliance with regulatory requirements and quality standards. Sensors, on the other hand, are used to detect any deviations from the specified temperature range and trigger alerts for immediate corrective actions. The integration of data loggers and sensors into the cold chain not only enhances product safety but also provides valuable insights for optimizing the supply chain.

The delivery of ATMPs—which include gene therapies, cell therapies, and tissue-engineered products—presents unique challenges, due to their sensitivity to temperature and other environmental conditions. CDMOs have responded to these challenges by adopting new developments in freight services. Specialized freight services for ATMPs include dedicated temperature-controlled containers, expedited shipping options, and customized logistics solutions. Oftentimes, CDMOs have an established global courier network that offers reliable and efficient distribution of material, ensuring that ATMPs are transported under optimal conditions and delivered to their destination within the shortest possible time frame. Additionally, some freight services offer end-to-end visibility and tracking, allowing stakeholders to monitor the status and location of shipments in real-time.

One of the key technological advancements in the pharma cold chain is the use of internet of things (IoT) technology. IoT-enabled devices, such as smart sensors and connected data loggers, provide real-time data on temperature, humidity, and other environmental conditions. This data is transmitted to a central platform, where it can be accessed and analyzed. The technology enables proactive monitoring and management of the cold chain, allowing for immediate corrective actions in case of any deviations. Moreover, IoT devices can be integrated with blockchain technology to provide a secure and transparent record of the entire supply chain, ensuring traceability and accountability.

Looking ahead, several key trends are expected in the pharmaceutical cold chain sector, including a rising demand for biopharmaceuticals; further technological advancements to enhance visibility and efficiency; sustainability initiatives with a focus on eco-friendly and energy-efficient solutions; and pandemic preparedness and resilience to handle disruptions and ensure continuous supply of critical medications.

Overall, the pharmaceutical cold chain sector has seen significant advancements in temperature-sensitive transport, packaging, data loggers, and sensors. In response, innovative technologies and specialized freight services have been adopted to ensure the safe and efficient delivery of temperature-sensitive medications, including ATMPs.

As the industry continues to evolve, CDMOs will remain a crucial link in driving improvements and maintaining the integrity of the cold chain. These advancements not only enhance product safety but also optimize the supply chain, ensuring that patients receive life-saving therapies in the best possible condition. 

Emma Jordan is the Director of Project Services & Logistics at Almac Pharma Services.

Exploring the importance of contract development and manufacturing organizations in advancing the latest technology for effective delivery of temperature-sensitive medicines.

The Role of CDMOs in the Pharma Cold Chain Machine

Let's start with an alarming pair of statistics. First, 40% of specialty product prescriptions actually get filled, and second, when a patient’s copay or out-of-pocket cost exceeds $250, the abandonment rate is nearly 70%.

Pharmaceutical manufacturers are focused on making massive investments in product launches, field force training, marketing, and healthcare provider (HCP) education, but what happens to that momentum once the prescription is written and it is in the hands of the patient to fill? The disconnect in the level of pre- and post-prescription focus is easy to understand because the complexities of each require wildly different solution thinking. Across the specialty medicine market, we are seeing that unaddressed post-prescription issues have serious impact on patients, prescribers, and the pharmaceutical manufacturers that serve them.

Once a specialty prescription is written, fulfillment can become derailed at any number of points in the process. It can be helpful to look at these roadblocks and the key strategies for reducing or eliminating prescription abandonment under the framework of “the 4 Es”: enrollment, engagement, entry point (or access), and execution (or delivery).

Reducing friction in the hub enrollment process is the first step in helping patients get and stay on their therapy. Meeting HCPs in the electronic health record (EHR), where they spend a large percentage of their day, can vastly improve speed to therapy. Allowing HCPs to access key features and data without leaving their familiar in-EHR clinical workflow means they don’t have to switch between different applications, reducing the time to enrollment and the risk of data entry errors since the patient information is already there.

As non-commercial pharmacies (NCPs) are increasingly integrated into hub enrollment strategies, the EHR as a mechanism for enrollment is more common. For self-administered products covered under pharmacy benefits, including treatments such as oral therapies, self-injectables, and self-administered drugs, the NCP can serve as a valuable enrollment channel.

In these situations, HCPs don’t need to enter the patient data because it is already in the EHR, and the relevant information (i.e., diagnosis codes, demographic data, etc.) is automatically transferred to the prescription. In-workflow EHR prescribing can give patients access to the medication days or even weeks faster. The time HCPs would normally have spent dealing with enrollment can now be used where it belongs, with their patients.

In addition, digital portals can streamline documentation submission by providing a centralized platform where HCPs can upload, access, and manage patient information.

This eliminates the need for paper forms, manual data entry, and faxing—and ultimately leads to improved accuracy and communication.

Technological advances are helping put patients at the center of their care more than ever before, enabling them to become more actively involved in making decisions about their treatment instead of passively receiving care.

Among the tools that are available to patients are mobile-first solutions that can help boost adherence while giving pharmaceutical manufacturers more information about the types of support patients want most. Best-in-class offerings include text-to-enroll capabilities, digital communication channels for updates and reminders, and patient self-service options through mobile platforms.

Leveraging patients’ reliance on their phones as a first stop for information, mobile care platforms can connect in a single place the individual silos that are supporting them. Funneling everything through one service to keep patients well informed benefits not just them and HCPs, it also gives brands more leverage to incorporate the best option for each of those silos.

Engaging different generations of patients, including both digital natives, such as Gen Z and Millennials, and older generations, who are not as familiar with digital platforms, is an important aspect of a pharmaceutical manufacturer’s engagement strategy for their brands. To address the widest range of patient needs and preferences, an effective engagement strategy should incorporate both traditional and digital channels.

With prescription drug pricing as volatile as it is today, never has an access strategy been more important in helping patients start and stay on their medication. If they haven’t already, pharmaceutical manufacturers should develop comprehensive programs that make their brands available, affordable, and easily obtainable. 

An effective access strategy should include a number of key elements, including:

Effectively addressing prior authorizations (PA) denials. 

Pharmaceutical organizations should leverage technology, including electronic PA and real-time benefit verification systems to streamline processes; build strong relationships with payers; educate HCPs about specific PA requirements; and monitor denial trends—with the ultimate goal of minimizing the strain on HCPs and reducing speed to therapy for patients.

These programs often provide a lifeline for patients who otherwise cannot afford their prescribed medications. They deliver a temporary free supply of medication to the patients while hub agents work through coverage restrictions and then seamlessly transition the patient from bridge to commercial product once coverage is obtained.

 Seamlessly connecting a copay support program with a patient’s insurance plan allows the dispensing pharmacy to automatically calculate the patient’s out-of-pocket cost and apply the discounted price.

Developing a smart execution strategy that ensures patients receive and start therapy is critical to improving adherence. Providing patients with tools that allow them to track the progress of their prescription, including patient engagement platforms that feature “pizza tracker”-style visibility, offers ways to further engage patients in their own treatment. Offering visibility into the fulfillment process, not just for patients but for all stakeholders, can increase engagement, loyalty, and, ultimately, adherence.

Pharmaceutical manufacturers that place as much focus on their patients’ post-prescription journey as they do on pre-prescription brand marketing and sales efforts are likely to be rewarded with more engaged patients and increased adherence. Using the 4 Es as a framework for combating prescription abandonment, companies can evaluate their current approach and determine if changes need to be made. 

- Kristine McGaughey, Vice President, Implementation at ConnectiveRx, contributed to this article.

Chris Dowd is Senior Vice President, Market Development, at ConnectiveRx. With a nearly 30-year career spanning leadership roles across Big Pharma, healthcare startups, and the patient support space, Dowd is a preeminent industry voice in patient access and adherence.

The key strategies for reducing or eliminating post-prescription abandonment.

Pharmaceutical Commerce - April 2025

Pharmaceutical Commerce: April 2025 Interactive Digital Edition

The Cold Chain's Evolution

Tariffs Galore: Where Do We Stand?

Conference Connect: Progressing Patient Assistance

The Hot Market for Cold Chain Services

Reducing Risk in the Pharmaceutical Cold Chain

An AI-Pharma Transport Collaboration

The Role of CDMOs in the Pharma Cold Chain Machine

From Prescription to Patient: Four Ways to Increase Speed to Therapy

What Your Data Can Tell You About Illicit Trade Risk

Healthcare Scorecard from Patients with Chronic Illness

Popping the Gross-to-Net Bubble, Part III: The Pharmacy Benefit

US Drug Price Negotiations and Transparency

Strategies to Modernize, Future-Proof, and Secure the Healthcare Supply Chain

Maintaining R&D Investments in the IRA Era

Beyond the Hype: GenAI’s Real Impact on Life Sciences Manufacturing