Radioligand Therapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Prostate Cancer, Neuroendocrine Tumor, Others), By Product (Lutathera, Zytiga, Xtandi, Xofigo), By Biomarker (Prostate-Specific Membrane Antigen, Ki 67 Expression and Grading, Cytochrome P450 17A1 Inhibitor), By End User (Biotechnology & Pharmaceutical Companies, Academic & Research Institutions, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Radioligand Therapy Market was valued at USD 12.57 billion in 2024 and is expected to reach USD 17.15 billion by 2030 with a CAGR of 5.31% during the forecast period. The global market for Radioligand Therapy is experiencing significant growth, driven by rising incidence of various types of cancers and increasing awareness of alpha radioimmunotherapy are propelling the growth of the market. Radioligand therapy is an advanced approach to treat certain kinds of cancer. It provides radiation to targeted cancer cells, with a negligible effect on healthy cells. This therapy provides life-enhancing treatment for patients with cancer who have inadequate therapeutic options. The other factors supporting the market’s growth are, growing world population, large patient pool, rising product innovation and development due to technological advancements, increasing government investments, increasing radioisotopes in healthcare, rising per capita health care expenditure, growing number of mergers and strategic acquisitions, and large number of clinical trials.

Key Market Drivers

Expanding Clinical Approvals and Demonstrated Survival/Clinical Benefits

Radioligand therapies have shifted from niche experimental treatments into evidence-based, approved cancer therapies — and those regulatory approvals are a powerful market driver. FDA approvals such as lutetium-177 dotatate (Lutathera®) for somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (approved January 2018) and lutetium-177 vipivotide tetraxetan (Pluvicto®) for PSMA-positive metastatic castration-resistant prostate cancer (approved March 2022) have validated the clinical utility of targeted radioligand approaches. These approvals were supported by randomized phase-3 data showing clinically meaningful improvements in progression-free endpoints and, in some studies, overall outcomes or quality-of-life measures — evidence that motivates oncologists, payers and health systems to incorporate RLT into standard treatment algorithms. Because regulatory approval opens reimbursement pathways and hospital adoption, a handful of high-profile approvals have a disproportionate effect on market adoption: they create clinical guidelines, stimulate imaging (companion PET) demand, and justify capital investment in radiopharmacies, shielding, and trained staff required to deliver RLT at scale. The combined effect is that each major approval becomes a durable demand engine, converting research interest into predictable, recurring therapy volumes in eligible cancer populations.

Rising Global Cancer Burden and Integration of Theranostics Into National Strategies

The scale and trajectory of cancer incidence are structural tailwinds for RLT demand. Global cancer incidence and mortality remain large and are projected to grow substantially as populations age and exposure to risk factors continues; the IARC/WHO GLOBOCAN data document roughly 20 million new cancer cases worldwide in 2022 with nearly 10 million cancer deaths, and projections indicate a continuing rise in absolute case numbers in the coming decades. Because theranostic RLTs target specific molecular features (e.g., somatostatin receptors, PSMA), their potential patient pool grows as imaging and molecular diagnostics identify eligible subsets within common cancers (neuroendocrine tumors, prostate cancer and others). Public-health systems and national cancer control programs are increasingly adopting genomic/imaging-driven precision oncology strategies — a policy environment that favours investment in theranostic pathways (diagnostic PET imaging, multidisciplinary tumor boards, and dedicated treatment capacity).

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Key Market Challenges

Isotope Supply, Short Half-Lives and Fragile Global Production Chains

A fundamental operational challenge for RLT is the dependence on timely, reliable supplies of medical radioisotopes (for example lutetium-177, iodine-131, actinium-225, gallium-68). Radioisotopes have finite half-lives and cannot be stockpiled for long; production is concentrated in a relatively small number of reactors or accelerator facilities and often requires complex processing and logistics (including cross-border transport under strict regulation). International reviews and agency reports have repeatedly warned about supply fragility for key isotopes: interruptions at one or two producers (reactors or processing sites) can cascade into clinical shortages that force appointment cancellations or therapy delays. The OECD-NEA and IAEA documents on medical isotope supply highlight vulnerabilities (reactor outages, limited processing capacity, transport/ customs bottlenecks) and recommend diversification and resilience investments.

Workforce, Regulatory Complexity and Infrastructure Barriers To Clinical Scale-Up

Delivering RLT safely and effectively requires specialized multidisciplinary teams (nuclear medicine physicians, radiopharmacists, medical physicists, technologists, radiation-safety officers) and dedicated infrastructure (hot labs, shielded treatment rooms, PET/CT access for companion diagnostics). Many health systems — particularly in low- and middle-income countries — lack sufficient trained personnel and certified facilities to scale RLT beyond pilot programmes. Recent surveys and commissioned reviews emphasize that the global nuclear medicine workforce and theranostics capability are unevenly distributed; training pipelines and credentialing frameworks have not yet expanded at the pace of clinical demand.

Regulatory frameworks also add complexity. Radiopharmaceuticals sit at the intersection of drug, radioactive material and radiation-safety regulations; manufacturers, radiopharmacies and hospitals must navigate medicine regulators (FDA, EMA, NMPA, etc.), nuclear/radiation safety authorities, and transport/licensing regimes. These multi-agency requirements lengthen timelines for clinical adoption, complicate cross-border supply and create compliance costs that can be particularly burdensome for smaller hospitals or nascent national programmes. Furthermore, payer policies vary widely — even after regulatory approval, reimbursement mechanisms for RLT (and for precursor diagnostic PET imaging) may lag, limiting uptake. Taken together, workforce shortages, complex multi-agency regulation and the capital intensity of required infrastructure remain major practical constraints on broad RLT roll-out.

Key Market Trends

Theranostics Convergence: Companion Diagnostics, Imaging Integration and Earlier-Line Use

A major clinical and commercial trend is the integration of molecular imaging (PET diagnostics) with therapeutic radioligands to create true “theranostic” pathways: imaging agents (e.g., Ga-68 PSMA, Ga-68 DOTATATE) identify receptor/target expression and select patients who are most likely to benefit from the corresponding therapeutic radioligand (e.g., Lu-177 PSMA, Lu-177 DOTATATE). Regulators and guideline bodies increasingly accept companion imaging as standard selection criteria, and trials are testing RLT earlier in treatment algorithms (not only late-line disease). The result is a systematic pipeline: diagnostic PET → multidisciplinary review → RLT administration → imaging-guided response assessment. This convergence raises per-patient value (better selection, fewer non-responders) and expands clinical indications as imaging makes it feasible to identify suitable targets in more patients and in earlier disease stages.

Technological Innovation: Novel Isotopes, Alpha-Emitters and Generator/Cyclotron Production Routes

Technological innovation is diversifying the RLT toolbox and changing production economics. New radioisotopes (including alpha-emitters such as actinium-225 and astatine-211) offer higher linear energy transfer and potentially greater tumour-kill per decay, which is driving R&D for hard-to-treat cancers and micrometastatic disease. Concurrently, improvements in isotope production — cyclotron-based routes, enriched target processing, and new reactor or accelerator capacity — aim to reduce dependency on a small number of aging reactors and to scale supply for isotopes like lutetium-177 and actinium-225. The IAEA, OECD-NEA and national programs have prioritized alternative production pathways and supply-chain resilience as strategic goals; commercial initiatives (new production facilities, public-private partnerships) are emerging in response.

Segmental Insights

Indication Insights

Based on Indication, prostate cancer holds the largest market share in the global radioligand therapy (RLT) market. This dominance is primarily due to the high global prevalence of prostate cancer and the increasing adoption of radioligand therapies, particularly lutetium-177–based treatments, for patients with advanced or metastatic castration-resistant prostate cancer (mCRPC). According to the World Health Organization’s GLOBOCAN 2020 data, prostate cancer was the second most common cancer among men worldwide, with 1.41 million new cases and over 375,000 deaths recorded in that year alone. The burden is particularly high in developed regions such as North America and Europe, but cases are also rapidly rising in Asia-Pacific, further strengthening the demand for effective treatments like RLT.

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Regional Insights

Based on the region, North America holds the dominant share of the global radioligand therapy (RLT) market, driven by its advanced healthcare infrastructure, strong nuclear medicine capacity, and favorable regulatory environment. The United States Food and Drug Administration (FDA) has been at the forefront of approving RLT products, including lutetium-177 dotatate (Lutathera®) for gastroenteropancreatic neuroendocrine tumors and lutetium-177 vipivotide tetraxetan (Pluvicto®) for prostate cancer. These approvals have not only accelerated adoption in U.S. oncology centers but also set global benchmarks for clinical practice. Additionally, reimbursement frameworks from Centers for Medicare & Medicaid Services (CMS) have supported broader patient access, which further consolidates the region’s leading position.

Recent Developments

• In September 2024, Sanofi entered in an exclusive licensing agreement with RadioMedix and Orano Med to develop AlphaMedix (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) (next-generation radioligand medicine) for treating progressive neuroendocrine tumors (NETs)
• In May 2024, Novartis entered in an agreement to acquire Mariana Oncology aimed at strengthening its radioligand therapy pipeline to treat cancers.
• In March 2023, Telix Pharmaceuticals Limited (Australia) received approval for Illuccix (a kit for the preparation of gallium Ga 68 gozetotide injection), which is utilized to treat metastatic prostate cancer. The expanded indication of Illuccix will create a lucrative growth opportunity for the company.

Key Market Players

• Novartis AG
• Johnson & Johnson
• Pfizer, Inc.
• Amneal Pharmaceuticals LLC.
• POINT Biopharma Global Inc
• Fusion Pharmaceuticals Inc.
• Clovis Oncology, Inc.
• Telix Pharmaceuticals Limited
• Lantheus Holdings, Inc.
• Progenics Pharmaceuticals

Report Scope:

In this report, the Global Radioligand Therapy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Radioligand Therapy Market, By Indication:

o   Prostate Cancer

o   Neuroendocrine Tumor

o   Others

• Radioligand Therapy Market, By Product:

o   Lutathera

o   Zytiga

o   Xtandi

o   Xofigo

• Radioligand Therapy Market, By Biomarker:

o   Prostate-Specific Membrane Antigen

o   Ki 67 Expression and Grading

o   Cytochrome P450 17A1 Inhibitor

• Radioligand Therapy Market, By End User:

o   Biotechnology & Pharmaceutical Companies

o   Academic & Research Institutions

• Radioligand Therapy Market, By Region:

o   North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Radioligand Therapy Market.

Available Customizations:

Global Radioligand Therapy Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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