The rapid growth of radiopharmaceuticals is creating pressure on the manufacturing and supply infrastructure needed to support new diagnostic and cancer treatments. The global radiopharmaceutical market is estimated to be worth approximately $11 billion in 2026 and is projected to exceed $20 billion by 2030, says GlobalData, a leading intelligence and productivity platform.

GlobalData’s monthly Bio/Pharmaceutical Outsourcing report reveals that manufacturing capacity is becoming a key constraint for the radiopharmaceutical sector, affecting clinical development, commercial supply and patient access.

The challenge is particularly significant because radiopharmaceutical manufacturing requires specialized facilities with radiation shielding and controlled areas. The short half-life of many isotopes adds further pressure. Products must often move rapidly through manufacturing, testing and distribution, leaving little flexibility when manufacturing or logistics disruptions occur.

Novartis’s experience with Pluvicto highlights these challenges, as manufacturing disruptions led to temporary treatment delays while the company worked to restore supply.

Edita Hamzic, Healthcare Analyst at PharmSource, says: “Radiopharmaceutical manufacturing cannot be scaled in the same way as conventional pharmaceutical production. Specialized infrastructure, limited isotope supply and the short half-life of many isotopes mean that companies need to plan manufacturing and supply capacity well ahead of commercial launch.”

Companies are responding by strengthening their supply chains and investing in domestic isotope production. Novartis and Bristol Myers Squibb are expanding specialized manufacturing capacity while Niowave and TerraPower Isotopes are investing in actinium-225 production.

Hamzic concludes: “The industry will need to build capacity across the radiopharmaceutical value chain, from isotope production through to finished-dose manufacturing and distribution. Companies that secure reliable access to critical isotopes and multiple manufacturing locations will be better positioned to support the growing clinical pipeline.”