Therapeutic Radiopharmaceuticals: Clinical Research Landscape And CRO Enablers (2025)

Therapeutic radiopharmaceuticals are transforming precision oncology by delivering targeted radiation through radioisotopes bound to tumor-specific molecules. This precise mechanism minimizes off-target effects while enhancing efficacy across a range of cancers, including neuroendocrine tumors, prostate, thyroid, and hematologic malignancies.

Global clinical activity has accelerated rapidly — from only a handful of trials in 2018 to more than 80 by mid-2025 — driven by innovations in alpha and beta emitters, robust clinical outcomes, and increasing FDA designations. While most studies remain in early phases, late-stage programs are expanding, particularly in treatment-resistant tumors. Nevertheless, complex supply chains and the short half-lives of isotopes continue to pose barriers to large-scale adoption.

An expanding pipeline of agents such as Lutetium-177, Actinium-225, and Lead-212 is redefining therapeutic potential. Alpha-emitting therapies, in particular, deliver highly localized cytotoxicity with strong promise in sanctuary sites and micro-metastatic disease. To overcome logistical constraints and meet growing demand, innovation is focusing on delivery platforms, combination regimens, and manufacturing scale-up.

As radiopharmaceutical science evolves and new cancer indications emerge, global sponsor engagement is intensifying — fueling strategic partnerships with CROs to accelerate development and optimize trial execution.

Authored by Novotech, a leading global biotech CRO, this whitepaper provides an in-depth analysis of the clinical landscape, market dynamics, regulatory environment, and scientific innovations shaping the future of radiopharmaceutical development.