Bewältigung beispielloser Komplexität und beispielloser Unsicherheiten in der Lieferkette für fortschrittliche Therapien.

The advanced therapy medicinal products (ATMP) market is poised to take the leap from promising yet incremental gains to rapid, explosive growth. In 2024, nine cell and gene therapies were approved by the U.S. Food and Drug Administration (FDA), with three more completing approval through Q3 in 2025.

There are currently over 4,400 ATMPs in development or investigational stages with nearly halfconsisting of gene therapies. In fact, this elevated market presence is already reflected in the therapies likely to gain approval soon, which skew decisively toward rare disease regimens, CAR-T breakthroughs and other advanced oncology treatments. 

Advanced therapies require advanced supply chains, capabilities and execution; challenges only exacerbated by the current global trade and logistics environment. In so nascent a medical science discipline, factors like raw material sourcing and unpredictable tariff policies would present obstacles to maintaining the status quo, let alone supporting the growth surge this mission-critical sector is primed to experience.

Considering the revolutionary potential of ATMPs, the elevated logistics practices they require can be considered "good problems" - the industry is demanding near perfection to support the patients at the end of these shipments because failure is not an option. But good problems are problems nonetheless, and meeting the ATMP moment will take strategic planning, fine-tuned best practices and nimble troubleshooting.

The cost and effort are well worth it. Many ATMPs are paving the long, winding road from merely treating life-threatening diseases to essentially curing them. And as global biotech companies stand upon the shoulders of each other's rapidly progressing discoveries, a solid secondary benefit is a substantial uptick in high-paying jobs.

This "health plus wealth" combination brings one uncompromising conclusion: The ATMP market momentum is far too vital and valuable to let impediments to manufacturing and movement stunt its full potential. As therapies improve, so must logistics partners across the entire production and supply chain.

Early Successes and Teaching Moments

With the logistical complexities ATMPs pose, both myriad and mission-critical, it is helpful to simplify the discussion by starting with an idyllic goal: bespoke, on-demand therapies cost-effectively manufactured with ample materials supply, and delivered to patients with fail-safe security and comprehensive transparency…  all in the briefest possible timespan.

Though this best-case scenario may seem daunting, let's consider an inspiring - and informative - recent precedent: the rapid development and widespread proliferation of mRNA vaccines to combat the global COVID-19 pandemic. And while mRNA therapies don't quite meet the levels of manufacturing and supply chain demands that ATMPs exhibit, the fortunate fact remains that pharma companies and their supply chain partners deftly pivoted to produce and proliferate billions of doses of life-saving drugs in a strikingly condensed timeframe. Starting as early as late 2020, each person vaccinated against the highly contagious virus was a feather in the cap of pharma companies and their logistics partners. And just half a decade later, medicines that initially seemed like the stuff of science fiction have become household names and their distribution common practice.

Though flawless supply chain execution for ATMPs is definitely a taller task, there are already success stories to note, including an infant who received the first-ever customized in vivo CRISPR gene-edited therapy for an ultrarare disorder. Both the FDA approval fast-tracking and the expedited yet intricate steps to take that treatment from production to patient reflect the next-level collaboration and agility in both manufacturing and supply chain readiness that ATMPs demand. Another example is the newfound ability to manufacture and deliver certain CAR-T cell therapies in just two days, or in the case of in vivo CAR-T,  removing cells from the equation altogether, furthering the progress of hyper-personalized, ultra-effective, and rapidly manufactured oncology treatments based on a patient’s own genetically modified immune cells.

Notably, in the case of the on-demand CRISPR therapy for CPS1 deficiency mentioned above, an accelerated approval was granted by the FDA within just one week given the rarity of the disease, even in the absence of data from a randomized clinical trial (RCT).

A logical (and logistical) next step would be expanding such accelerated approvals, for instance, to the production and delivery of other advanced therapies with broader reach, such as allogeneic therapies from healthy donors to diseased patients, therapy enabling larger patient populations to be treated with off-the-shelf therapies. The industry has already demonstrated manufacturing and logistical feasibility in the personalized space; now it needs the levers to execute these best practices at scale to enable even wider adoption.

A Steep Hill to Scale: The Road to Mainstreaming ATMPs

Undoubtedly, there are several hurdles to overcome en route to a fully honed, market-ready ATMP manufacturing and supply chain landscape. Given the time crunch inherent to such therapies, it is by no means hyperbolic to assert that ATMPs have a more intimate, even symbiotic relationship between manufacturing and logistics than any other pharma niche.

Upon ATMP manufacture, wasted time inevitably becomes wasted therapies and possibly patient lives on the line, and any number of supply chain complications can lead to those unacceptable outcomes. Tariffs and trade conflicts, development and infrastructure cost concerns, geopolitical tensions, and even IT disruptions like 2024's CrowdStrike episode all present real-world issues with a negative impact. Navigating these concerns will require far-reaching logistical innovation, investment and incentives to ensure seamless supply chain resilience.

Manufacturing is also impacted by many of these challenges. For example, geopolitical tensions make a consistent supply of certain rare raw materials exceptionally difficult. For many biopharma companies, such procurement and scalability pitfalls become difficult to square with economics. Clearly, wherever possible, supplier diversification becomes a keystone element. Throughout an ATMP's lifespan, then, logistics issues substantially intersect with manufacturing concerns. To showcase this interwoven dynamic, we need look no further than the global supply chain topic: tariffs.

Supply chains thrive in stability and, from an economic standpoint, rarely have we seen a more unstable landscape. With tariff figures in seemingly constant limbo and the potential fallout too multifaceted to fathom, the potential for disruption to patient life is real and ever-present. The excessive costs to import and export raw materials and finished drug products are being passed on ultimately to the pharma companies who manufacture the therapies, or subsequently to patients, hospitals or insurance companies who pay for them, adding uncertainty to the cost of goods sold in an already cost-burdened ATMP landscape.  It’s also forcing people, perhaps somewhat serendipitously, to rethink about how to manufacture in countries (or even locally) where tariffs are minimized or eliminated altogether. Will a biopharma company with operations in a foreign country be constrained by raw materials tariffs? If so, will additional tariffs be incurred reciprocally should a finished or near-finished product be reshored? Particularly for US-based biopharma companies, answers may come on a largely luck-dependent basis; for example, materials from Canada may incur a 25% to 35% tariff (except those exempted under CUSMA/USMCA), while those from China could be subject to tariffs approaching a whopping 250%.

The longer tariff uncertainty lingers, the more crucial it will become for biopharma companies to mitigate potential disruptions through materials supply diversification, as well as regionalized manufacturing that pairs ATMPs with their prime patient population. Leveraging expert partners to advise on factors like tariff exemption optimization also becomes critical, as biopharma companies struggle to square the heightened demands of ATMP production with the unique geopolitical, economic and logistical challenges they present.

All this leads to the most pressing question: How does the biopharma sector and its logistics partners take ATMPs from fledgling to full-scale? There are no easy answers, but there is help. The savviest biopharma companies will continue to push the boundaries of ATMP manufacturing and logistics by collaborating with the right partners.

There’s No Simple Solutions – Only Meaningful Partnerships

Absent definitive long-term answers, biopharma companies manufacturing ATMPs must choose their logistics partners more wisely than ever. Their patients deserve no less.

While no one-size-fits-all solution exists in the customized and microtargeted space of  ATMPs, the most capable supply chain partners have already begun adapting to the emerging, unique logistics infrastructure advanced therapies demand, while looking ahead to a near-future when such therapies will be manufactured and delivered on an exponentially greater scale.

First and foremost, the right personnel to implement next-generation processes are critical for delivering knowledgeable logistic solutions. Staff must be trained then routinely retrained to understand not only the unparalleled logistical challenges ATMPs bring, but also the value they deliver. The goal is a tiger team of pharma supply chain experts steeped in best practices, with knowledge of the science behind the payload they are transporting and instilled with a mindset that the cost of failure could mean a patient's life. 

Another supply chain partner necessity is agile infrastructure. Rapid manufacture scheduling, lane mapping and verification, equipment validation, import/export expertise, and risk management all combine to help avoid common pitfalls and facilitate seamless execution.

ATMP therapies also bring heightened demands for real-time and flexible tracking solutions, such as those measuring key parameters like temperature, GPS position, shock, light exposure, vibration and tilt. This is coupled to next-level cryogenic capabilities, like liquid nitrogen or dry ice filling stations in key hubs around the world to mitigate cold chain disruption risks. This enables agile actions in the face of data-driven decision making.

And since nearly all ATMP therapies will be shipped by air freight or ground freight and across long distances, including across international borders, 24/7 control tower oversight capabilities become crucial to ensure handoffs between sites of care, drivers, and cargo staff are seamlessly executed, with contingencies in place. Each of these solutions share a common goal: reducing the cumbersome complexities related to speed, chain of custody, identity and condition.

The journey from lab to patient for these highly sensitive personalized therapies demands innovation in every facet of the supply chain, from cryogenic storage and real-time monitoring to secure chain of custody. Future growth hinges on scaling bespoke logistics solutions and ensuring global accessibility and patient safety relies on our ingenuity. Ultimately, continuous investment in these cutting-edge logistics capabilities is not merely a competitive advantage, but a fundamental necessity for successfully delivering an ultrasensitive, next generation of medicine.