Big Pharma's Radiopharmaceutical Race Heats Up as Market Potential Soars

The radiopharmaceutical landscape is rapidly evolving, with major pharmaceutical companies vying for dominance in a market projected to reach $13 billion by 2033. Novartis, AstraZeneca, Bristol Myers Squibb, Eli Lilly, and Bayer are all making strategic moves to capitalize on this promising therapeutic approach, which combines radioactive substances with biological agents for precise cancer treatment.

Novartis Leads the Pack with Expanding Portfolio

Novartis, the current frontrunner in radiopharmaceuticals, boasts two commercially available products: Lutathera for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Pluvicto for metastatic castration-resistant prostate cancer (mCRPC). The Swiss drugmaker continues to strengthen its position, having acquired Mariana Oncology for $1 billion in May 2024, adding MC-339, an actinium-based therapy for small cell lung cancer, to its pipeline.

Geoff Towle, vice president of Novartis' radioligand therapy solid tumor strategy, highlighted the company's ongoing efforts: "We've launched two pivotal trials for AAA817, a next-generation radiotherapy for prostate cancer with potentially higher potency than Pluvicto." Novartis is also seeking to expand Pluvicto's indications, with an FDA review for earlier-stage mCRPC expected in the first half of 2025.

New Entrants Make Bold Moves

AstraZeneca, Bristol Myers Squibb (BMS), and Eli Lilly have all made significant investments in radiopharmaceuticals over the past year:

• AstraZeneca acquired Fusion Pharmaceuticals for up to $2.4 billion in March 2024, gaining FPI-2265, an actinium-225-based therapy for PSMA-positive mCRPC currently in Phase II trials.

• BMS purchased RayzeBio for $4.1 billion in December 2023, obtaining RYZ-101, an actinium-225-based candidate in Phase III trials for GEP-NETs and Phase I studies for breast cancer and small cell lung cancer.

• Eli Lilly acquired Point Biopharma for $1.4 billion in October 2023, adding PNT2002, a lutetium-177-based therapy for mCRPC, to its portfolio. Lilly has since inked deals with Aktis Oncology and Radionetics Oncology to further expand its radiopharmaceutical capabilities.

Technological Advancements and Clinical Progress

The field is seeing rapid technological progress, with companies exploring various radioisotopes and targeting mechanisms. Ben Hickey, president of RayzeBio under BMS, emphasized the potential of alpha-emitting isotopes: "We believe alpha-emitting isotopes represent the next generation of therapeutic radionucleotides due to their higher potency compared to beta-emitting isotopes."

Clinical trials are advancing across multiple indications. Notable upcoming milestones include:

• AstraZeneca's FPI-2265 Phase II readout expected in the second half of 2025
• BMS's RYZ-101 data from a small cell lung cancer study later this year, with pivotal GEP-NET results anticipated in 2026
• Eli Lilly's regulatory filings for PNT2002, following mixed Phase III results in December 2023

As the radiopharmaceutical market expands, companies are also investing in manufacturing capabilities and exploring complementary technologies. AstraZeneca's Puja Sapra noted their focus on "molecular imaging and computational pathology" to enhance treatment delivery and monitoring.

With multiple players now competing in this space, the coming years promise to be transformative for cancer treatment, potentially establishing radiopharmaceuticals as a new pillar of oncology care.