Factors Contributing to the Growth of Radiopharmaceuticals: Q&A with Andrea Zobel and Marco Hogenboom

Radiopharmaceuticals are experiencing a period of growth, but that doesn’t mean this sector of the industry isn’t facing unique challenges. While these therapies offer unique treatments, they often introduce logistical challenges into the pipeline. The therapies are known for having short half-lives and shipment requires special safety requirements for safety purposes.

Andrea Zobel and Marco Hogenboom of World Courier, a global specialty logistics provider and part of Cencora, spoke with Pharmaceutical Executive about the growth of this sector and how companies are handling the logistic issues.

Pharmaceutical Executive: What factors are contributing to the growth of radiopharmaceuticals?
Andrea Zobel: We’re seeing the convergence of two major developments: tremendous innovation and advances in science, coupled with more advanced manufacturing capabilities for radioisotopes.

The market is expected to nearly triple over an 8-year span—increasing from $9.07 billion in 2023 to $26.51 billion in 2031, according to a recent report. That’s driven, in part, by the commercial success of recently approved products as well as a sharp increase in clinical trials.

Radioligand therapies, a targeted form of cancer therapy that destroys cancer cells by radiation, are used to treat specific, advanced common cancers like prostate cancer, pancreatic cancer and other cancers. With more than hundreds of clinical trials underway—including therapies in development that target oncology indications with larger patient populations—the rapidly growing market offers tremendous promise for patients.

PE: What unique logistic challenges do ‘second-generation’ radiopharma therapies introduce?
Marco Hogenboom: Radiopharmaceutical logistics is fundamentally different from traditional pharmaceutical supply chains. You’re managing multiple critical constraints simultaneously -- time and temperature sensitivity, short shelf-life, radiation safety, complex global supply chains and varying regulations – all within a very tight window. These therapies are tied to the half-life of the isotope, so the moment the product is manufactured, the clock is already ticking. Radioactive decay begins immediately, so any delays––even by a few hours––could mean the therapy is no longer usable. There is virtually no margin for error.

The transport of radiopharmaceuticals requires a dual mandate: protecting the product from temperature deviation while simultaneously shielding the radioactive materials to safeguard transport personnel.

So called Type A packaging is used for all shipments of radiopharmaceuticals from manufacturers to health care providers and must meet stringent containment integrity and shielding under transport conditions.

These unique challenges underscore the need for precision across the entire logistics chain. That’s why most mature radiopharma programs are built on GDP-embedded processes and disciplined deviation management with logistics partners, like World Courier, that can deliver at that level of performance.

PE: How can the pharmaceutical industry ensure these therapies reach patients in the necessary time frames?
Hogenboom: Coordination and clear communication across the entire value chain––from isotope production and drug manufacturing to shipping teams, radiopharmacies, healthcare providers and clinical sites. Stakeholders must be aligned around a strictly defined time window that ends with a scheduled patient appointment and treatment administration.

To make that work, companies need to design supply chains around that precision from the beginning. That means proactive planning, including clear routing strategies and contingency plans that enable teams to anticipate and quickly intervene, if needed, to ensure the material remains viable and is delivered on time.

As we continue to enhance the synchronization and efficiency of the logistics process, a key focus remains on establishing integrated systems that create greater connectivity and enhanced visibility across the value chain.

PE: How are companies navigating the regulatory landscape in the radiopharma space?
Zobel: Radiopharmaceuticals sit at the intersection of two regulatory frameworks: pharmaceutical regulations and radiation safety regulations. That overlap creates a unique level of regulatory complexity. Companies need to work with different authorities that are not always fully aligned, particularly when it comes to international clinical trials or cross-border shipments.

On top of that, even when there are international standards, they’re implemented differently at the country level. Variations in how the requirements are interpreted and applied across countries, airlines, airports and transport hubs can add further complexity and introduce delays if not managed carefully.

Companies are increasingly looking for partners who can help them anticipate potential issues, prepare for local requirements and ensure compliance across the full journey. As this pipeline expands, execution increasingly depends on logistics partners that can consistently manage country-specific regulatory requirements, while keeping a pulse on international changes.

PE: What new technologies are being incorporated into chain of custody?
Hogenboom: Digital tools, including real-time monitoring and tracking systems, are essential to ensure stakeholders have continuous visibility into the location, temperature and condition throughout transit. That’s particularly important as targeted diagnostic and therapeutic molecules can be specific to an individual, underscoring the importance of rigorous tracking and precise delivery.

Where we see the biggest opportunity going forward is in harmonizing orchestration. This heightened demand for integrated systems connects isotope manufacturers, drug manufacturers, logistics providers, and treatment centers into a single, coordinated platform. Better integration helps to ensure that radiopharmaceuticals are delivered on time and in the right condition, allowing physicians to treat their patients.