“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing them. If your logistics are not better, there is no other differentiator. You need to compete by experience.”
When Kostja Paschalidis and his co-founder left their roles developing one of the leading radiopharmaceutical products, they recognised a fundamental shift in pharmaceutical manufacturing. Unlike traditional drugs where marketing drives commercial success, radiopharmaceuticals demand something entirely different: flawless service delivery.
As co-founder and head of systems and logistics at Firm, a design consultancy specialising in radiopharmaceutical services, Kostja has identified why operational excellence—not clinical superiority—will determine market winners.
In the latest PharmaSource podcast episode, he explains why radiopharmaceutical companies must become service-centric organisations to succeed and how a lack of standardisation and suitable technology creates barriers to scale.
The Forced Transformation: From Marketing to Service Provider
The unique challenge of radioactive decay fundamentally changes how pharmaceutical companies must operate. Traditional drug manufacturers can produce in advance, store inventory, and focus on marketing and distribution. Radiopharmaceuticals eliminate this model entirely.
“Because of the short decay, it has to be produced per patient, made to order,” Kostja explained. “From being a marketing company, pharmaceutical companies have to become service providers.”
This transformation extends far beyond logistics. Companies must build customer support departments to manage complex scheduling. They need technology platforms that handle patient-specific ordering rather than bulk distribution. Success metrics must shift from traditional sales KPIs to customer experience measures.
“Companies need to understand they’re becoming a service provider. This changes all the dynamics,” Kostja emphasised. “If that change is not happening internally, and if from top down that understanding is not clear, it becomes very difficult to move.”
The operational implications are profound. Companies must coordinate diagnosis, eligibility testing, treatment scheduling, manufacturing, logistics, and post-treatment support—all whilst minimising wait times for end-of-life patients.
“This creates a very complicated patient journey,” Kostja acknowledged. “Companies are doing it really fast—five days before infusion. But we need to reduce the time even more.”
The Technology Gap: No Fit-for-Purpose Systems Exist
Perhaps the most surprising barrier to radiopharmaceutical scale-up is the complete absence of suitable technology platforms—either for clinical trials or commercial operations.
“Nothing in the existing market can actually meet this requirement,” Kostja stated. “They have to make it themselves, or try to use existing platforms that are not fit for purpose.”
The technology challenges span the entire operation. Clinical trials need ordering systems that schedule patient-specific production. Manufacturing requires real-time quality testing documentation for each batch produced. Hospital sites need platforms that integrate smoothly with existing systems.
“Every hospital hates systems because all are horrible,” Kostja observed. “To introduce a new system that is not easily used is a big hurdle.”
Companies face a difficult choice: invest millions developing custom platforms internally, or struggle with inadequate commercial solutions whilst competitors gain advantages through superior technology. Most pharmaceutical companies lack the capabilities to build software in-house.
“As a service provider, you need technology to support you. Most pharmaceutical companies are not tech savvy. They haven’t been building software, and now they have these unique problems to solve.”
This technology gap creates opportunities for companies that can deliver superior digital experiences. Those that solve the software challenge early will establish significant advantages over competitors struggling with inadequate systems.
The Coming Market Shake-Out: 437 Trials, Zero Standardisation
The radiopharmaceutical market is expanding rapidly, but this growth masks an approaching competitive crisis. With similar clinical mechanisms and overlapping targets, differentiation through clinical data will prove impossible.
“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing radiopharmaceuticals,” Kostja revealed. The concentration in specific targets is particularly striking. “There are 110 clinical trials just around PSMA.”
This crowding creates a fundamental challenge. Once multiple therapies achieve regulatory approval for the same indication with similar efficacy, how will companies compete?
“This space is going to be overcrowded, and you need to compete by experience,” Kostja argued. “If your logistics are not better, there is no other differentiator.”
The question of standardisation adds further complexity. In most mature pharmaceutical markets, operations standardise over time. However, radiopharmaceuticals may follow a different trajectory.
“At some point, when most of the kinks have been figured out, it gets standardised. But right now the incentives are not there,” Kostja explained. “The incentives are actually the opposite—for companies to do their own thing, do it better than everybody else, and make it as difficult for others.”
Market leader Novartis demonstrates what successful execution looks like. With two approved therapies—Pluvicto and Lutathera—generating approximately $1.7 billion and $700 million in annual revenue respectively, they’ve established operational capabilities that competitors are only beginning to understand.
“Novartis is a very competent organisation. They pioneered the field, saw it earlier than everybody else, bought the company before everybody,” Kostja noted. “They have time to figure out all the problems.”
CDMO Partnerships: Critical Support in Multiple Forms
Contract manufacturers play diverse roles in radiopharmaceutical supply chains, though their involvement varies significantly by company strategy and product stage, such as specialising in radioisotope production.
Others provide manufacturing support for companies without internal capabilities. For smaller biotechs, CDMOs can offer comprehensive technical support including ordering platforms and logistics coordination.
In the US market, regulatory flexibility creates additional partnership opportunities. “When you’re operating under the radio pharmacy compound law, you don’t have to create each batch targeted to a time of infusion. You can create it overall, and then the radio pharmacy can dispense it.”
This enables production pooling that reduces individual batch timeframes and improves predictability—but requires careful coordination between manufacturers and dispensing pharmacies.
The Patient-Centric Vision: Making Complexity Invisible
Looking ahead five to seven years, Kostja envisions a future where operational complexity becomes invisible to patients—where receiving a radiopharmaceutical therapy feels as simple as taking a pill.
“I hope we get to the point where you come in, make an order, and in the next days you do the therapy. Make all the logistics super easy for the patient.”
Achieving this vision requires pharmaceutical companies to embrace their new identity as sophisticated service providers. The clinical promise is clear—radiopharmaceuticals offer dramatically improved outcomes and quality of life compared to traditional cancer treatments.
“It’s just an infusion, targeted radiation. Yes, there are some side effects, but it’s much better for the patient,” Kostja described.
The therapy approach will likely become the primary cancer treatment method within a decade. “In the next 10 years, that’s going to be the main way that cancer treatment is targeted.”
However, clinical excellence alone won’t determine which companies capture this market. Those that master service delivery—building the right organisational culture, implementing effective technology platforms, and creating seamless patient experiences—will separate themselves from competitors with similar clinical data.
“If internally from the organisation that understanding is not clear, it becomes very difficult to move,” Kostja warned. The transformation from traditional pharmaceutical company to service provider represents as significant a challenge as any clinical advancement in the field.
For radiopharmaceutical companies, the message is clear: your clinical data will get you to market, but your service excellence will determine whether you win.
