Radioligand Therapy Development in 2025: Unleashing Precision Oncology’s Next Wave. Explore How Innovation and Expanding Indications Are Poised to Transform Cancer Care and Drive Market Expansion.

• Executive Summary: Radioligand Therapy’s 2025 Landscape
• Market Size, Growth, and 2025–2030 Forecasts (CAGR: ~15–18%)
• Key Players and Strategic Partnerships (e.g., novartis.com, bayer.com)
• Pipeline Analysis: Next-Generation Radioligands and Indications
• Regulatory Milestones and Global Approvals (FDA, EMA, etc.)
• Manufacturing, Supply Chain, and Isotope Production Advances
• Clinical Trial Highlights and Real-World Evidence
• Adoption Barriers: Access, Reimbursement, and Infrastructure
• Emerging Technologies: Theranostics, AI, and Companion Diagnostics
• Future Outlook: Investment, M&A, and Long-Term Market Opportunities
• Sources & References

Executive Summary: Radioligand Therapy’s 2025 Landscape

Radioligand therapy (RLT) is poised for significant advancement in 2025, driven by a convergence of clinical successes, regulatory momentum, and expanding industry investment. RLT leverages targeted radioactive molecules to deliver cytotoxic radiation directly to cancer cells, minimizing damage to healthy tissue. The field’s rapid evolution is exemplified by the recent approvals and late-stage clinical progress of several key therapies, particularly in prostate and neuroendocrine cancers.

A major milestone was the 2022 FDA approval of lutetium-177–labeled PSMA-targeted therapy for metastatic castration-resistant prostate cancer, developed by Novartis. This therapy, marketed as Pluvicto, has set a precedent for subsequent RLTs and catalyzed further research and development. In 2025, Novartis remains a dominant force, advancing additional indications for Pluvicto and expanding its radioligand pipeline, including therapies targeting other solid tumors and hematological malignancies.

• Bayer continues to build on its success with Xofigo (radium-223 dichloride), focusing on combination regimens and next-generation alpha-emitting radioligands. The company is investing in new manufacturing facilities to meet anticipated demand and support global distribution.
• Telix Pharmaceuticals is advancing a broad portfolio of radioligand candidates, with a focus on imaging and therapeutic agents for renal, prostate, and brain cancers. The company’s lead product, Illuccix (gallium-68 PSMA-11), is already approved for diagnostic use, and therapeutic candidates are progressing through pivotal trials.
• Curium and Advanced Accelerator Applications (a Novartis company) are expanding their manufacturing and supply chain capabilities, addressing the logistical challenges of radiopharmaceutical production and distribution.

The sector is also witnessing increased collaboration between pharmaceutical companies, nuclear medicine suppliers, and academic centers to accelerate clinical development and ensure reliable isotope supply. Regulatory agencies in the US, Europe, and Asia are prioritizing RLT review pathways, reflecting the therapies’ potential to address unmet medical needs.

Looking ahead, the next few years are expected to bring new approvals for radioligands targeting a broader range of cancers, improved patient access through expanded manufacturing, and the integration of RLT into earlier lines of therapy. The competitive landscape is intensifying, with established players and emerging biotech firms racing to develop novel ligands, isotopes, and combination strategies. As a result, 2025 marks a pivotal year for radioligand therapy, setting the stage for transformative growth and clinical impact.

Market Size, Growth, and 2025–2030 Forecasts (CAGR: ~15–18%)

Radioligand therapy (RLT) is rapidly emerging as a transformative modality in oncology, leveraging targeted radioisotopes bound to ligands for precise tumor cell destruction. As of 2025, the global RLT market is estimated to be valued at approximately $2.5–3.0 billion, with robust growth projected through 2030. The sector is expected to expand at a compound annual growth rate (CAGR) of roughly 15–18%, driven by increasing approvals, expanding indications, and growing investment in radiopharmaceutical manufacturing infrastructure.

Key drivers of this growth include the success of therapies such as lutetium-177 (Lu-177) and actinium-225 (Ac-225) based agents, particularly for prostate cancer and neuroendocrine tumors. The 2022 FDA approval of Pluvicto (Lu-177 vipivotide tetraxetan) for metastatic castration-resistant prostate cancer marked a pivotal milestone, with its developer, Novartis, reporting strong commercial uptake and ongoing expansion of production capacity. Novartis is also advancing additional RLT candidates in its pipeline, targeting a broader range of solid tumors.

Other major players are scaling up their radioligand portfolios and manufacturing capabilities. Bayer is investing in next-generation RLTs, building on its experience with Xofigo (radium-223 dichloride) and expanding into new indications. Curium, a global leader in nuclear medicine, is enhancing its supply chain for medical isotopes and collaborating on novel radioligand constructs. Telix Pharmaceuticals is advancing both diagnostic and therapeutic radiopharmaceuticals, with a focus on prostate, kidney, and brain cancers.

The market outlook is further buoyed by increased investment in isotope production. Nordion and ITM Isotope Technologies Munich are expanding their production of key medical isotopes such as Lu-177 and Ac-225, addressing supply bottlenecks that have historically constrained RLT adoption. These efforts are supported by public-private partnerships and government initiatives to secure domestic isotope supply chains, particularly in North America and Europe.

Looking ahead to 2030, the RLT market is expected to benefit from ongoing clinical trial readouts, regulatory approvals for new indications (including breast, lung, and hematologic cancers), and the entry of additional pharmaceutical and biotechnology companies. The convergence of improved targeting ligands, next-generation isotopes, and scalable manufacturing is anticipated to sustain double-digit growth, positioning radioligand therapy as a cornerstone of precision oncology in the coming years.

Key Players and Strategic Partnerships (e.g., novartis.com, bayer.com)

Radioligand therapy (RLT) development is currently driven by a dynamic landscape of established pharmaceutical leaders and emerging biotechnology firms, with strategic partnerships and acquisitions shaping the sector’s trajectory through 2025 and beyond. The field is characterized by a focus on targeted cancer therapies, leveraging radioisotopes conjugated to ligands that bind specific tumor markers, offering precision treatment with minimized off-target effects.

A central player is Novartis, which has solidified its leadership through the acquisition of Advanced Accelerator Applications (AAA) and Endocyte, bringing to market Lutathera® (lutetium Lu 177 dotatate) for neuroendocrine tumors and Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) for metastatic castration-resistant prostate cancer. Novartis continues to expand its RLT pipeline, investing in next-generation radioligands and broadening indications, with multiple phase III trials ongoing and regulatory submissions anticipated in the next few years.

Bayer is another major force, building on the success of Xofigo® (radium-223 dichloride) for prostate cancer. Bayer is actively developing a pipeline of alpha- and beta-emitting radiopharmaceuticals, including investigational agents targeting prostate-specific membrane antigen (PSMA) and other tumor-associated antigens. The company’s strategic collaborations, such as with Noria Therapeutics and RayzeBio, are expected to accelerate the development of novel RLT candidates through 2025.

Emerging biotech firms are also shaping the competitive landscape. Telix Pharmaceuticals is advancing TLX591-CDx and TLX591 for prostate cancer, with pivotal trials underway and commercial launches targeted in the near term. Curium, a global leader in nuclear medicine, is investing in both manufacturing capacity and R&D partnerships to support the growing demand for radioligand therapies.

Strategic partnerships are a hallmark of the sector’s growth. For example, Siemens Healthineers and GE HealthCare are collaborating with pharmaceutical companies to advance theranostics, integrating diagnostic imaging with therapeutic radioligands. These alliances are critical for scaling production, ensuring supply chain reliability, and supporting clinical development.

Looking ahead, the next few years are expected to see further consolidation, with large pharma companies seeking to acquire or partner with innovative RLT developers. The sector’s outlook is robust, driven by expanding clinical evidence, regulatory momentum, and increasing investment in manufacturing infrastructure and global distribution networks.

Pipeline Analysis: Next-Generation Radioligands and Indications

Radioligand therapy (RLT) is experiencing rapid innovation, with a robust pipeline of next-generation agents targeting a broader range of cancer indications. As of 2025, the field is moving beyond established therapies such as lutetium-177–labeled PSMA-targeted agents for prostate cancer, with multiple companies advancing novel radioligands into clinical development.

A key driver is the expansion of RLT into new tumor types. While prostate cancer remains the most mature indication, several companies are developing radioligands for neuroendocrine tumors, breast cancer, small cell lung cancer, and hematologic malignancies. For example, Novartis—a leader in the space—continues to advance its pipeline beyond Pluvicto (lutetium-177 vipivotide tetraxetan) and Lutathera (lutetium-177 dotatate), with investigational agents targeting fibroblast activation protein (FAP), HER2, and other novel antigens. The company’s FAP-targeted radioligand, currently in early-phase trials, is designed to address a range of solid tumors with high stromal content.

Similarly, Bayer is progressing its own next-generation radioligand therapies, including alpha-emitting agents such as actinium-225–labeled compounds. Alpha emitters are of particular interest due to their high linear energy transfer and potential for greater tumor cell kill with reduced off-target toxicity. Bayer’s pipeline includes agents for prostate cancer and other solid tumors, with several candidates in preclinical and early clinical stages.

Emerging players are also contributing to the diversification of the RLT pipeline. Telix Pharmaceuticals is developing radioligands for renal cell carcinoma, glioblastoma, and other indications, leveraging both beta and alpha emitters. Curium and Advanced Accelerator Applications (a Novartis company) are expanding their portfolios with new targets and isotopes, including copper-64 and terbium-161, which offer different physical and biological properties for tailored therapy.

Looking ahead, the next few years are expected to see multiple pivotal trial readouts and potential regulatory submissions for these novel agents. The focus is on improving efficacy, safety, and patient selection through companion diagnostics and personalized dosing. The competitive landscape is intensifying, with collaborations between pharmaceutical companies and radiopharmaceutical manufacturers to secure isotope supply and scale up production. As the pipeline matures, radioligand therapy is poised to become a cornerstone of precision oncology across a wider spectrum of cancers.

Regulatory Milestones and Global Approvals (FDA, EMA, etc.)

Radioligand therapy (RLT) has rapidly advanced from experimental stages to mainstream oncology, with significant regulatory milestones shaping its global trajectory. As of 2025, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) remain pivotal in setting standards for safety, efficacy, and market access for these therapies.

A landmark event was the FDA’s approval of Novartis’s Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in 2022 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), following positive clinical trial outcomes. This approval established a regulatory pathway for subsequent RLTs targeting other malignancies. The EMA followed with its own authorization, reinforcing the therapy’s acceptance in Europe. Both agencies have since issued guidance on radiopharmaceutical development, emphasizing robust clinical data, manufacturing controls, and post-marketing surveillance.

In 2024 and 2025, regulatory agencies have accelerated review processes for RLTs addressing high unmet needs. The FDA granted Breakthrough Therapy and Fast Track designations to several pipeline candidates, including next-generation PSMA-targeted agents and novel radioligands for neuroendocrine tumors. Bayer, a leader in radiopharmaceuticals with its established product Xofigo® (radium-223 dichloride), is advancing new alpha-emitting therapies, with regulatory submissions anticipated in late 2025. Telix Pharmaceuticals is also progressing with its TLX591-CDx and TLX250-CDx programs, with regulatory filings expected in the U.S., Europe, and Asia-Pacific regions.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada have begun harmonizing their review criteria with FDA and EMA standards, expediting access to RLTs in their respective markets. The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) are collaborating with national regulators to standardize radioligand production and distribution, addressing global supply chain and safety challenges.

Looking ahead, the regulatory landscape for RLT is expected to evolve rapidly. Agencies are developing adaptive approval frameworks to accommodate the unique characteristics of radiopharmaceuticals, such as short half-lives and complex logistics. The next few years will likely see approvals for new indications, combination regimens, and theranostic pairs, further expanding patient access. Industry leaders like Novartis, Bayer, and Telix Pharmaceuticals are poised to drive these advances, supported by ongoing regulatory innovation and international collaboration.

Manufacturing, Supply Chain, and Isotope Production Advances

Radioligand therapy (RLT) development in 2025 is marked by significant advances in manufacturing, supply chain logistics, and isotope production, all of which are critical to meeting the growing clinical demand for targeted radiopharmaceuticals. The sector is experiencing rapid expansion, driven by the increasing adoption of therapies such as lutetium-177 (Lu-177) and actinium-225 (Ac-225) labeled agents for cancer treatment.

A key trend in 2025 is the scaling up of isotope production capacity. Nordion, a long-established supplier of medical isotopes, continues to invest in reactor-based and accelerator-based production methods to ensure a stable supply of Lu-177, which is essential for therapies targeting neuroendocrine tumors and prostate cancer. Similarly, Curium has expanded its manufacturing footprint in Europe and North America, focusing on both the production of therapeutic isotopes and the development of advanced radiolabeling technologies to improve product consistency and safety.

The supply chain for radioligand therapies is uniquely complex due to the short half-lives of many isotopes, necessitating just-in-time manufacturing and rapid distribution. Novartis, a leader in commercial RLTs, has invested in vertically integrated supply chains, including dedicated radiopharmaceutical manufacturing sites and specialized logistics networks. This integration is designed to minimize delays and ensure that patients receive high-quality, potent doses. In 2025, Novartis is also collaborating with regional partners to localize production, reducing reliance on transcontinental shipments and mitigating risks associated with geopolitical disruptions.

Emerging players are also contributing to the sector’s dynamism. POINT Biopharma is commissioning new facilities in North America, aiming to provide both clinical and commercial-scale radioligand manufacturing. Their approach emphasizes modular, flexible production lines capable of handling multiple isotopes and ligands, which is increasingly important as the pipeline of RLT candidates diversifies.

On the isotope innovation front, IONETIX and TerraPower are advancing cyclotron and reactor technologies, respectively, to boost the availability of alpha-emitting isotopes like Ac-225. These efforts are expected to alleviate current supply bottlenecks and support the next generation of high-potency RLTs.

Looking ahead, the outlook for 2025 and beyond is characterized by continued investment in infrastructure, strategic partnerships between isotope producers and pharmaceutical companies, and the adoption of digital supply chain management tools. These advances are poised to enhance reliability, scalability, and global access to radioligand therapies, supporting their integration into mainstream oncology care.

Clinical Trial Highlights and Real-World Evidence

Radioligand therapy (RLT) continues to gain momentum in 2025, with a growing body of clinical trial data and real-world evidence supporting its use in oncology, particularly for prostate and neuroendocrine tumors. The most prominent advances center on prostate-specific membrane antigen (PSMA)-targeted therapies and somatostatin receptor (SSTR)-targeted agents.

A key milestone in recent years has been the global expansion of PSMA-targeted RLT, notably Novartis‘s Lutetium-177 PSMA-617 (Pluvicto™). Following its initial approvals in the US and Europe for metastatic castration-resistant prostate cancer (mCRPC), ongoing phase III trials such as PSMAfore and PSMAddition are evaluating its use in earlier lines of therapy and in combination regimens. Early 2025 readouts suggest improved progression-free survival and manageable safety profiles, reinforcing its role in the treatment paradigm.

Parallel to PSMA-targeted agents, SSTR-targeted RLT, such as Novartis‘s Lutathera® (Lutetium-177 dotatate), continues to demonstrate durable responses in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Real-world registries and post-marketing surveillance in Europe and North America are providing additional safety and efficacy data, supporting broader adoption and reimbursement.

Emerging players are also advancing novel radioligands. Bayer is progressing with its investigational alpha-emitting radioligand, Ac-225-PSMA, in early-phase trials, aiming to address resistance mechanisms seen with beta-emitters. Meanwhile, Telix Pharmaceuticals is expanding its clinical pipeline with TLX591 (177Lu-DOTA-rosopatamab) and other candidates targeting renal cell carcinoma and glioblastoma, with pivotal trials expected to report results by 2026.

Real-world evidence is increasingly shaping clinical practice. Data from large-scale registries and compassionate use programs, particularly in Europe and Australia, are informing patient selection, dosing strategies, and long-term safety monitoring. These insights are critical as RLT moves into earlier disease settings and combination regimens with immunotherapies and novel hormonal agents.

Looking ahead, the next few years are expected to see further expansion of RLT indications, with multiple phase III trials underway and new radioligand constructs entering the clinic. The integration of RLT into multidisciplinary cancer care, supported by robust clinical and real-world data, is poised to transform outcomes for patients with otherwise limited treatment options.

Adoption Barriers: Access, Reimbursement, and Infrastructure

Radioligand therapy (RLT) is emerging as a transformative modality in oncology, but its widespread adoption faces significant barriers related to access, reimbursement, and infrastructure, particularly as the field advances into 2025 and the following years. Despite promising clinical outcomes, several systemic challenges must be addressed to ensure equitable patient access and sustainable integration into healthcare systems.

One of the primary barriers is the limited number of specialized treatment centers equipped to handle radioligand therapies. RLT requires facilities with advanced radiopharmacy capabilities, radiation safety protocols, and trained multidisciplinary teams. As of 2025, expansion efforts are underway, but the distribution of such centers remains uneven, especially outside major urban areas. Companies like Novartis, a leader in commercialized RLTs such as Lutathera® and Pluvicto™, are investing in expanding manufacturing and distribution networks to improve supply chain reliability and reach more treatment centers globally. However, the need for specialized infrastructure continues to slow adoption in less-resourced regions.

Reimbursement remains a complex and evolving challenge. The high cost of RLTs, driven by the expense of radionuclide production, drug development, and specialized delivery, often leads to protracted negotiations with payers. In the United States and Europe, reimbursement policies are still adapting to the unique value proposition of RLT, which combines targeted therapy with radiopharmaceuticals. Bayer, which markets Xofigo® (radium-223 dichloride), has engaged with health authorities to demonstrate cost-effectiveness and clinical benefit, but coverage decisions can vary widely by country and insurer. The lack of standardized reimbursement pathways can delay patient access and discourage investment in new RLT indications.

Infrastructure challenges also extend to the supply of medical isotopes, which are essential for RLT production. The global supply chain for isotopes such as lutetium-177 and actinium-225 is constrained by limited production capacity and regulatory hurdles. Efforts by companies like Curium and ITT Inc. to scale up isotope manufacturing are ongoing, but demand is expected to outpace supply in the near term, potentially leading to treatment delays.

Looking ahead, the outlook for overcoming these adoption barriers is cautiously optimistic. Industry collaborations, public-private partnerships, and regulatory initiatives are being pursued to streamline reimbursement, expand infrastructure, and ensure a stable isotope supply. As more RLTs receive regulatory approval and real-world evidence accumulates, stakeholders anticipate gradual improvements in access and affordability, though significant disparities may persist without coordinated policy and investment efforts.

Emerging Technologies: Theranostics, AI, and Companion Diagnostics

Radioligand therapy (RLT) is rapidly evolving, driven by advances in theranostics, artificial intelligence (AI), and companion diagnostics. As of 2025, the field is witnessing a surge in both clinical development and commercial investment, with a focus on expanding indications beyond prostate cancer and neuroendocrine tumors. The integration of emerging technologies is expected to accelerate the pace of innovation and improve patient outcomes in the coming years.

Theranostics—the combination of diagnostic imaging and targeted therapy—remains central to RLT development. The use of radiolabeled molecules for both imaging and treatment enables precise patient selection and real-time monitoring of therapeutic response. Companies such as Novartis are at the forefront, with their radioligand therapies like Lutathera® (lutetium Lu 177 dotatate) and Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) already approved for neuroendocrine tumors and metastatic castration-resistant prostate cancer, respectively. In 2025, Novartis and other industry leaders are expanding clinical trials to target additional tumor types, including breast, lung, and gastrointestinal cancers.

AI is increasingly being leveraged to optimize radioligand therapy development. Machine learning algorithms are used to analyze imaging data, predict patient response, and personalize dosing regimens. This is particularly relevant for companion diagnostics, where AI-driven image analysis can enhance the accuracy of patient selection. Companies such as Siemens Healthineers and GE HealthCare are developing advanced imaging platforms and software that integrate AI to support theranostic workflows, from radiotracer production to post-therapy assessment.

Companion diagnostics are essential for the success of RLT, ensuring that only patients with the appropriate molecular targets receive therapy. The development of new radiotracers and diagnostic assays is a key focus for manufacturers like Curium and Theragnostics, who are investing in next-generation PET and SPECT agents. These diagnostics are being co-developed with therapeutic agents to streamline regulatory approval and clinical adoption.

Looking ahead, the next few years are expected to bring further integration of theranostics, AI, and companion diagnostics, resulting in more personalized and effective radioligand therapies. The ongoing collaboration between pharmaceutical companies, imaging technology providers, and diagnostic developers will be crucial in expanding the reach of RLT to new cancer types and patient populations, solidifying its role as a cornerstone of precision oncology.

Future Outlook: Investment, M&A, and Long-Term Market Opportunities

Radioligand therapy (RLT) is poised for significant growth and transformation in 2025 and the coming years, driven by robust investment, strategic mergers and acquisitions (M&A), and expanding long-term market opportunities. The sector’s momentum is underpinned by the clinical success of targeted radioligand therapies, particularly in oncology, and the increasing interest from both established pharmaceutical giants and specialized radiopharmaceutical companies.

Investment activity in RLT is expected to intensify as more late-stage clinical data emerges, especially for prostate-specific membrane antigen (PSMA)-targeted therapies and novel indications beyond prostate cancer. Major pharmaceutical companies such as Novartis have already demonstrated strong commitment to the field, with their acquisition of Advanced Accelerator Applications and the subsequent commercial success of Lutathera® and Pluvicto™. These products have set benchmarks for regulatory approval and market adoption, encouraging further capital inflow into RLT research, manufacturing infrastructure, and supply chain resilience.

M&A activity is anticipated to remain high as large pharma seeks to expand their radioligand portfolios and secure access to innovative targeting ligands, radioisotope production capabilities, and distribution networks. Companies like Bayer, with its established Xofigo® franchise, and Curium, a global leader in nuclear medicine, are actively exploring partnerships and acquisitions to strengthen their positions. Additionally, radiopharmaceutical CDMOs such as Sotera Health and isotope suppliers like Nordion are likely to see increased demand and strategic interest as the need for reliable radioisotope supply chains grows.

Long-term market opportunities are expanding as RLT moves beyond its initial focus on neuroendocrine tumors and prostate cancer. Pipeline candidates are targeting a broader range of solid tumors, including breast, lung, and gastrointestinal cancers, as well as hematological malignancies. The development of next-generation ligands, alpha-emitting isotopes, and combination regimens is expected to further enhance efficacy and safety profiles, opening new therapeutic frontiers. Regulatory agencies in the US, Europe, and Asia are also adapting frameworks to facilitate faster approvals and broader patient access, which will be critical for sustained market growth.

In summary, the future outlook for radioligand therapy development is characterized by escalating investment, dynamic M&A activity, and a widening spectrum of clinical and commercial opportunities. As the competitive landscape evolves, companies with integrated R&D, manufacturing, and distribution capabilities—such as Novartis, Bayer, and Curium—are well positioned to lead the next phase of RLT innovation and market expansion.

Sources & References

• Novartis
• Curium
• Advanced Accelerator Applications
• ITM Isotope Technologies Munich
• Noria Therapeutics
• RayzeBio
• Siemens Healthineers
• GE HealthCare
• IONETIX
• Theragnostics