방사성 리간드 요법(RLT) 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the radioligand therapy (RLT) market size is expected to increase from USD 5.54 billion in 2025 to USD 6.18 billion in 2026 and reach USD 10.66 billion by 2031, growing at a CAGR of 11.52% over 2026-2031.

This report is Segmented by Product (Lu-177 Vipivotide Tetraxetan, Lu-177 Dotatate, Ra-223, Others), Target (Prostate-Specific Membrane Antigen and More), Indication (Prostate Cancer, Small Cell Lung Cancer, and More), End User (Tertiary Care, Nuclear Medicine Centers, Hospitals, Clinics, Others), and Geography (North America, Europe, and More). The Market Forecasts are in Value (USD).

Global Radioligand Therapy (RLT) Market Trends and Insights

Precision Oncology and Theranostic Adoption

The radioligand therapy market is supported by the closer use of companion diagnostics and targeted treatment, because both parts of care are planned around the same biological marker. A PSMA PET scan can identify eligible patients, show the distribution of disease, and help predict therapeutic response before treatment begins. This paired model shortens treatment selection, helps clinicians avoid treatment in unsuitable patients, and can reduce clinical attrition. FDA approvals for gallium-68 PSMA PET agents created a reimbursement precedent for related therapeutic use and lowered a practical access barrier. Radiology departments therefore have a larger role in treatment access and hospital procurement decisions, rather than serving only a diagnostic function. SSTR2 programs for neuroendocrine tumors and emerging FAP imaging programs show that this paired diagnostic and therapy approach extends beyond PSMA.

Label Expansion and Earlier-Line Treatment Use

Regulatory label extensions are expanding the treated population in the radioligand therapy market by moving approved therapies into earlier care settings. Each shift to an earlier treatment line can increase the eligible patient group by 2 to 3 times, which gives label decisions outsized commercial importance. The FDA approved Pluvicto in March 2025 for post-ARPI, pre-taxane mCRPC, opening a patient group 75% larger than the earlier post-taxane setting. Novartis anticipates a Q3 2026 FDA decision for Pluvicto in mHSPC based on the PSMAddition trial. Lutathera also gained from earlier-line use in approved GEP-NET settings in the United States and Japan during 2025, together with a pediatric indication. These repeat approval pathways let established products use the same chemistry, manufacturing base, and clinical network across more treatment settings.

Therapeutic Radioisotope Supply Constraints

The radioligand therapy market faces a continuing mismatch between growing demand and the time needed to increase isotope output. Reactor-based lutetium-177 depends on a limited number of production facilities, so disruption at one site can affect supply chains across several markets. Laurentis Energy Partners plans to begin commercial lutetium-177 production at Ontario Power Generation's Darlington Nuclear Generating Station in 2027. The facility is designed to supply 3 million doses, or treatment for 500,000 patients, annually. Actinium-225 availability is even more limited, which may restrict BMS-RayzeBio and AstraZeneca-Fusion programs despite favorable clinical results. Eden Radioisotopes submitted a 2026 NRC permit application for a United States lutetium-177 facility, but reactor projects require multiyear development and commissioning.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Cancer Burden and Aging Population
2. Increasing Radioisotope and RLT Manufacturing Capacity
3. Specialized Workforce and Treatment-Center Capacity Shortages

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Pluvicto held 45.31% of the product segment in 2025. Its expanding indication set and demand in United States pre-taxane mCRPC supported this position. Pluvicto sales reached USD 1,293 million in H1 2026, 57% above the prior-year period in constant currency. The March 2025 label expansion and growing access outside the United States supported sales. Lutathera is the fastest-growing product, with a 15.58% CAGR forecast from 2026 to 2031.

Lutathera generated USD 816 million in 2025, supported by pediatric approval and earlier-line use in the United States and Japan. Xofigo treats bone-metastatic CRPC through an alpha-emitting mechanism and does not require a companion diagnostic. Lantheus received FDA tentative approval for PNT2003, a radioequivalent of Lutathera, in March 2026. ITM-11 had an FDA PDUFA date of August 28, 2026, adding competitive pressure. Actinium-225 conjugates, lead-212 agents, and copper-64 theranostics will shape the commercial cycle beyond 2028.

PSMA-targeted agents accounted for 58.44% of the target segment in 2025. Pluvicto's commercial scale and established companion imaging infrastructure supported this position. SSTR remains central to GEP-NET treatment and lower per-cycle costs could increase treatment volumes. FAP is expressed in more than 90% of epithelial malignancies and has potential across multiple tumor types. Earlier FAPI therapeutics showed limited efficacy because tumor retention was short.

Cyclic peptide and albumin-binder modifications are improving dosimetry in active Phase 1 and Phase 2 studies. Eli Lilly's Point Biopharma, Telix Pharmaceuticals, and Novartis with AAA614 are active FAP developers. GRPR can address early-stage prostate and breast cancer when PSMA expression is insufficient. Novartis's AAA817, an actinium-225-PSMA-617 compound, targets post-lutetium-177 mCRPC. Sequential use of lutetium-177 and actinium-225 could extend treatment options and revenue per patient.

Complete Report Scope:

• By Product
  • Lutetium-177 Vipivotide Tetraxetan (Pluvicto)
  • Lutetium-177 Dotatate (Lutathera)
  • Radium-223 Dichloride (Xofigo)
  • Other Product Types
• By Target
  • Prostate-Specific Membrane Antigen
  • Somatostatin Receptor
  • Fibroblast Activation Protein
  • Gastrin-Releasing Peptide Receptor
  • Other Targets
• By Indication
  • Prostate Cancer
  • Gastroenteropancreatic Neuroendocrine Tumors
  • Small Cell Lung Cancer
  • Hepatocellular Carcinoma
  • Breast Cancer
  • Other Indications
• By End User
  • Tertiary Care Academic and Comprehensive Cancer Centers
  • Specialized Nuclear Medicine Centers
  • Hospitals
  • Specialized Clinics
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 80.61% of the global market in 2025. Early commercial activity, established nuclear medicine infrastructure, and reimbursement pathways supported its position. The United States has FDA-approved commercial products and a mature PSMA PET network. Novartis is investing USD 23 billion in United States manufacturing over 5 years, including 5 domestic RLT facilities. Canada is developing domestic lutetium-177 capacity through the planned Darlington facility, which is expected to begin commercial operation in 2027.

Europe is the second established region for the radioligand therapy market. EMA approvals for Pluvicto and Lutathera support use across Germany, France, the United Kingdom, Italy, and Spain. Curium announced a EUR 32 million investment (USD 36.5 million), at its Saclay facility in June 2026 for a European lutetium-177 PSMA-I&T production line. Reimbursement differences across EU member states continue to limit wider use outside established academic programs.

Asia-Pacific is the fastest-growing region, with a 15.85% CAGR forecast for 2026 to 2031. China approved Pluvicto in late 2025, its first licensed PSMA-targeted radioligand treatment. Novartis is constructing a Zhejiang facility at CNY 600 million (USD 84.6 million), for commissioning by the end of 2026. Japan is reviewing Telix's Illuccix application after Phase 3 enrollment finished in July 2026. Australia has approved Pluvicto, while GCC and Brazilian academic investment could support access in the Middle East, Africa, and South America from 2028 to 2031.

1. Actinium Pharmaceuticals, Inc.
2. Ariceum Therapeutics GmbH
3. AstraZeneca
4. Bayer
5. Bristol-Myers Squibb
6. Clarity Pharmaceuticals Limited
7. Convergent Therapeutics, Inc.
8. Curium Pharma
9. Eli Lilly and Company
10. ITM Isotope Technologies Munich SE
11. Lantheus Holdings, Inc.
12. NorthStar Medical Radioisotopes, LLC
13. Novartis
14. Nusano, Inc.
15. Orano Med
16. Perspective Therapeutics, Inc.
17. RadioMedix, Inc.
18. Radiopharm Theranostics Limited
19. SHINE Technologies, LLC
20. Telix Pharmaceuticals Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Precision Oncology and Theranostic Adoption
  • 4.2.2 Label Expansion and Earlier-Line Treatment Use
  • 4.2.3 Rising Cancer Burden and Aging Population
  • 4.2.4 Increasing Radioisotope and RLT Manufacturing Capacity
  • 4.2.5 Patient-Specific Dose Planning and Decentralized RLT Delivery
• 4.3 Market Restraints
  • 4.3.1 Therapeutic Radioisotope Supply Constraints
  • 4.3.2 Specialized Workforce and Treatment-Center Capacity Shortages
  • 4.3.3 Complex Radiation Logistics and Short Product Half-Lives
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Lutetium-177 Vipivotide Tetraxetan (Pluvicto)
  • 5.1.2 Lutetium-177 Dotatate (Lutathera)
  • 5.1.3 Radium-223 Dichloride (Xofigo)
  • 5.1.4 Other Product Types
• 5.2 By Target
  • 5.2.1 Prostate-Specific Membrane Antigen
  • 5.2.2 Somatostatin Receptor
  • 5.2.3 Fibroblast Activation Protein
  • 5.2.4 Gastrin-Releasing Peptide Receptor
  • 5.2.5 Other Targets
• 5.3 By Indication
  • 5.3.1 Prostate Cancer
  • 5.3.2 Gastroenteropancreatic Neuroendocrine Tumors
  • 5.3.3 Small Cell Lung Cancer
  • 5.3.4 Hepatocellular Carcinoma
  • 5.3.5 Breast Cancer
  • 5.3.6 Other Indications
• 5.4 By End User
  • 5.4.1 Tertiary Care Academic and Comprehensive Cancer Centers
  • 5.4.2 Specialized Nuclear Medicine Centers
  • 5.4.3 Hospitals
  • 5.4.4 Specialized Clinics
  • 5.4.5 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Actinium Pharmaceuticals, Inc.
  • 6.3.2 Ariceum Therapeutics GmbH
  • 6.3.3 AstraZeneca plc
  • 6.3.4 Bayer AG
  • 6.3.5 Bristol-Myers Squibb Company
  • 6.3.6 Clarity Pharmaceuticals Limited
  • 6.3.7 Convergent Therapeutics, Inc.
  • 6.3.8 Curium Pharma
  • 6.3.9 Eli Lilly and Company
  • 6.3.10 ITM Isotope Technologies Munich SE
  • 6.3.11 Lantheus Holdings, Inc.
  • 6.3.12 NorthStar Medical Radioisotopes, LLC
  • 6.3.13 Novartis AG
  • 6.3.14 Nusano, Inc.
  • 6.3.15 Orano Med
  • 6.3.16 Perspective Therapeutics, Inc.
  • 6.3.17 RadioMedix, Inc.
  • 6.3.18 Radiopharm Theranostics Limited
  • 6.3.19 SHINE Technologies, LLC
  • 6.3.20 Telix Pharmaceuticals Limited

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment