Radiopharmaceuticals play relevant roles in medical imaging, diagnosis, and treatment. Most radiopharmaceuticals currently used for diagnostic purposes are produced at the time of use due to the characteristics of the radionuclide that is normally used in these preparations. ^{1, 2}

This article provides information about radiopharmaceuticals in nuclear medicine and in-house vs. commercial production in key European markets.

Radiopharmaceuticals in Nuclear Medicine

Radiopharmaceuticals are normally used in nuclear medicine in three different ways: diagnostic imaging, diagnostic non-imaging, or metabolic radiotherapy (e.g., dual diagnosis and treatment and theranostics). ^{1, 2}

The industrial production of radionuclides has become widespread. Production is carried out either in nuclear reactors or by bombarding atomic nuclei with particles accelerated in a cyclotron or a linear accelerator. ^{1, 2} 

Radiopharmaceutical products include:

• radiopharmaceuticals themselves, which are ready-to-use radioactive medicines
• radionuclide generators, devices from which a short-lived radionuclide can be obtained from a longer-lived radionuclide
• reagent kits, non-radioactive preparations used for the extemporaneous preparation of a radiopharmaceutical once it is labelled with the radionuclide
• precursor radionuclides with which radiopharmaceuticals are labelled extemporaneously ^{1, 2}

As of 2024, all these radiopharmaceutical products are considered medicines in European countries, and industrially prepared products must be authorized as pharmaceuticals (e.g., authorized medicines for industrial manufacture). ^{1, 2}

In nuclear medicine, “in-house radiopharmaceutical” refers to radiopharmaceuticals or radioactive tracers that are prepared or synthesized within a medical facility or laboratory rather than being commercially manufactured and distributed. These are typically produced in small batches for specific uses, research purposes, or when commercially available options are either not accessible or not suitable for a particular need.

In-house radiopharmaceuticals allow for more flexibility and customization in nuclear medicine procedures, but they require a facility with the proper licenses, equipment, and expertise to safely handle and produce these radioactive materials.

Radiopharmaceuticals Production in Europe

Trends in Europe indicate a switch towards commercial solutions, but country-level regulation is diverse and its implementation fluid, which in turn coexists with in-house production activities.

EU4 and UK Markets

In the EU4 countries (France, Germany, Italy, Spain) and the United Kingdom (UK), in-house labeling of prostate-specific membrane antigen tracers is mostly the standard of care. Fierce competition between hospitals with in-house capabilities and lower production costs than commercial products pose a challenge for access. Future increase in demand would facilitate ready-to-use radiotracers adoption, at least in Germany and the UK.

Nordic and Baltic Markets

In the Nordics (Sweden, Norway, and Denmark) and Baltics (Latvia and Lithuania) generally, the existing regulation on medicines advises a mandatory switch to commercial radiopharmaceutical solutions once they are available, which should trigger the adoption of off-the-shelf licensed options. However, in the case of radiopharmaceuticals, the application of the regulation varies depending on the country, region, or even local/hospital rules. The rationale behind this approach for radiopharmaceuticals is often based on the investment in cyclotrons made by many centers/regions in recent years. However, the launch of a new radiotracer will not prevent hospitals from continuing to use cyclotrons and outweigh the return on the investment, since the in-house production of other products for a wide range of indications is already in place. The switch to commercial production might happen if diagnostic performance and price are similar to in-house production, but there is still some reluctance to change because of logistics and customer service issues.

Nordics
In the Nordics, big hospitals with cyclotrons are the marketing authorization holders (MAHs) of their in-house products, as long as they comply with the European Good Manufacturing Practices regulation. In Sweden, authorities enforce the switch to commercial options; in-house production is not possible, and hospitals must procure off-the-shelf options. In Norway, hospitals are cautious about creating a situation where a marketing authorization makes production in other hospitals impossible or illegal. Meanwhile, in Denmark, in-house production of tracers will continue over the next several years, justified by the aim to pay off the investments made in cyclotrons.

Baltics
In the Baltics, pharma companies are the only MAHs of radiopharmaceutical products, both diagnostic and therapeutic. Once the new cyclotron in Kaunas, Lithuania, is launched, it will open the door to transition from radiotracers procurement to local production and distribution methods in that country. On the other hand, Latvia currently lacks the capabilities to produce in-house radiotracers.

Conclusions

Radiopharmaceuticals play a crucial role in the nuclear medicine space, with significant innovations in oncology for diagnosis and therapy. While a shift towards commercial solutions is noticeable in Europe, in-house production practices fully remain in certain regions where in-house capabilities and investments in cyclotrons are present.

Moreover, different regulatory and Health Technology Assessment (HTA) landscapes and institutional priorities influence radiopharmaceutical production and use. In-house tracers offer flexibility and cost savings but are increasingly subject to scrutiny, especially when commercial solutions are available. However, economic factors such as the need to recover cyclotron investments are likely to maintain in-house production in many centers.

Finally, HTA and pricing negotiations can be challenging in markets with well-established in-house practices. Evidence generation plans, including real-world evidence and health economics and outcomes research models, could help address economic and clinical benefits and facilitate the shift towards ready-to-use products.

How Can Alira Health Help?

From manufacturing and logistics to clinical and commercial positioning in the US, EU, and APAC markets, we help our clients navigate every step with precision.

The development of radiopharmaceutical solutions, whether for diagnostics or therapeutics, is full of challenges. Companies must navigate diverse regulatory landscapes, a complex payer environment with high prices and cost pressures, and varying levels of nuclear medicine maturity across geographies.

Our team can accompany you on this complex development journey. We understand each step; from choosing the relevant regulatory pathway to delineating the reimbursement landscape and determining optimal clinical and competitive positioning of your product.