Mithila Samachar

DelveInsight’s “Radioligand Therapy Market Size, Target Population, Competitive Landscape, and Market Forecast – 2036” report delivers an in-depth understanding of Radioligand Therapy, historical and forecasted epidemiology as well as the Radioligand Therapy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Radioligand Therapy Market Report

• The Radioligand Therapy market across the 7MM is expected to witness significant growth during the forecast period, driven by increasing cancer prevalence, growing demand for targeted oncology treatments, and the emergence of novel therapies for indications like metastatic castration-resistant prostate cancer (mCRPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

• Emerging therapies such as 177Lu-PSMA-I&T, Lu-PNT2002, FPI-2265, 225Ac-PSMA-Trillium, VMT-α-NET, CONV01-α, and others are expected to intensify competition by offering differentiated radioisotope mechanisms, improved targeting precision, and the potential to expand treatment access across broader cancer indications.

• Gene therapies and next-generation alpha-emitting radioligand candidates are attracting substantial industry interest due to their potential to deliver superior cytotoxicity through highly targeted radiation while minimizing damage to surrounding healthy tissues.

• LUTATHERA recorded more than USD 450 million in sales in the first nine months of 2023, with a growth rate of 34% year over year, and Novartis believes LUTATHERA could notch more than USD 1 billion in peak sales as a first-line therapy.

• Upon approval in 2022, PLUVICTO generated full-year sales of USD 980 million, narrowly missing blockbuster status in its first full year on the market.

• The leading Radioligand Therapy companies include Novartis, Curium Pharma, Lantheus, Eli Lilly and Company, Fusion Pharmaceuticals, AstraZeneca, Clarity Pharmaceuticals, Bayer, ITM Isotope Technologies, ARTBIO, Convergent Therapeutics, Perspective Therapeutics, PRECIRIX, Ariceum Therapeutics, Nuclidium, and others.

• Despite recent therapeutic advances, substantial unmet needs remain in radioligand therapy, including treatment access for chemotherapy-naïve patients, expansion to rare cancer types, and development of next-generation alpha-emitting therapies, creating significant opportunities for pipeline developers and investors.

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Radioligand Therapy Marketed Drugs

The marketed Radioligand Therapy landscape is rapidly evolving following the introduction of novel targeted radiopharmaceuticals for oncology indications. The approval and commercial launch of these products has validated the market’s potential and paved the way for next-generation therapies with differentiated mechanisms, improved targeting precision, and broader cancer coverage.

• LUTATHERA (lutetium Lu 177 dotatate): AAA USA/Novartis

LUTATHERA is the first radioligand therapy approved specifically for children with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), now offering new hope to young patients living with this rare cancer. It is also approved in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults, and in Japan for SSTR-positive NETs. LUTATHERA works by binding to somatostatin receptors present in certain tumors; after binding, the drug enters the cell allowing radiation to damage tumor cells. In 2018, the US FDA first approved LUTATHERA, making it the first radiopharmaceutical approved for GEP-NETs, and in 2024, the FDA further approved it for pediatric patients with GEP-NETs.

• PLUVICTO (lutetium lu-177 vipivotide tetraxetan): Novartis

PLUVICTO is the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with metastatic castration-resistant prostate cancer (mCRPC) that combines a targeting compound (ligand) with a therapeutic radioisotope. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177, which is linked to a moiety that binds to PSMA, a transmembrane protein expressed in prostate cancer, including mCRPC. Upon binding to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to those cells and surrounding cells, inducing DNA damage that can lead to cell death. PLUVICTO was approved by the FDA in 2022 and recorded sales of more than USD 950 million in its first full year on the market.

Radioligand Therapy Emerging Drugs

• 177Lu-PSMA-I&T: Curium

177Lu-PSMA-I&T targets prostate-specific membrane antigen (PSMA), which is expressed in greater than 85% of prostate cancer cells. Because the medicine is highly selective for that antigen, the radioisotope only targets these cancer cells. Once the medicine attaches itself to the cancer cell, the radioisotope is internalized within the cancer cell, where the radioactive properties break the DNA strand of the cancer cells, thus killing the prostate cancer cell. The therapy is currently in Phase III clinical development.

• Lu-PNT2002: Eli Lilly/Point Biopharma

Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy candidate that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus Holdings holds exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2002 from POINT, in-licensed in December 2022. In April 2023, the FDA granted Fast Track designation for 177Lu-PNT2002 for the treatment of mCRPC. The therapy is currently in Phase III clinical development and is anticipated to receive approval during the forecast period.

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Latest Highlights from the Radioligand Therapy Market

• In March 2026, ITM Isotope Technologies Munich SE presented post-hoc subgroup analyses from the Phase 3 ITM-11 COMPETE trial involving patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

• In March 2026, Lantheus Holdings, Inc. announced that the FDA had granted tentative approval to its Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of LUTATHERA (lutetium Lu 177 dotatate).

• In January 2026, Zonsen PepLib Biotech Inc. announced a global licensing agreement with Novartis for an undisclosed peptide-based candidate in the radioligand therapy (RLT) space, with Novartis securing exclusive worldwide rights for development and commercialization.

• In January 2026, Swiss Rockets AG and Alloy Therapeutics, Inc. entered into a Master Research Agreement (MRA) to initiate a multi-target partnership focused on the discovery and development of next-generation radioligand therapeutics (RLTs) for oncology, to be carried out through Swiss Rockets’ radiotherapeutics subsidiary, Torpedo Pharmaceuticals AG.

• In January 2026, ARTBIO, Inc. began dosing two US-based patient cohorts in the ARTISAN Phase 1 trial of AB001, an alpha radioligand therapy designed to treat metastatic castration-resistant prostate cancer (mCRPC), enrolling patients with and without prior Lu177-PSMA targeted therapy exposure.

• In November 2025, ITM Isotope Technologies Munich SE announced that the US Food and Drug Administration had completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide, also referred to as ITM-11.

Discover key developments and opportunities in the Radioligand Therapy Market @ Radioligand Therapy Market Size

Radioligand Therapy Companies

Radioligand Therapy Companies include Novartis, Curium Pharma, Lantheus, Eli Lilly and Company, Fusion Pharmaceuticals, AstraZeneca, Clarity Pharmaceuticals, Bayer, ITM Isotope Technologies, ARTBIO, Convergent Therapeutics, Perspective Therapeutics, PRECIRIX, Ariceum Therapeutics, Nuclidium, and others.

Radioligand Therapy Market Outlook

The treatment landscape for Radioligand Therapy has historically been limited to conventional modalities such as chemotherapy and external radiation, with limited options for patients with advanced or metastatic disease. The approved therapies – LUTATHERA, PLUVICTO, XOFIGO, and ZEVALIN – represent a paradigm shift toward precision oncology by delivering targeted radiation directly to cancer cells expressing specific receptors, while minimizing damage to surrounding healthy tissues.

The pipeline for Radioligand Therapy is rapidly evolving, with emerging therapies focusing on novel radioisotopes and broader cancer targets beyond PSMA and somatostatin receptors. 177Lu-PSMA-I&T and Lu-PNT2002 target PSMA-expressing prostate cancer cells with high selectivity, while FPI-2265 by Fusion Pharmaceuticals and AstraZeneca expands the mCRPC treatment frontier further into Phase II/III development. Alpha-emitting radioligand candidates such as 225Ac-PSMA-Trillium and CONV01-α highlight a broader shift toward next-generation radioisotopes with greater cytotoxic potential. Novartis alone has 15+ radioligand therapy clinical trials underway or planned, and major acquisitions – including AstraZeneca’s acquisition of Fusion Pharmaceuticals and Eli Lilly’s USD 1.4 billion acquisition of Point Biopharma – underscore the growing strategic importance of this therapeutic class. Overall, the emergence of both approved radioligand therapies and a diverse pipeline of targeted candidates marks a significant transition from conventional cancer treatment to highly targeted, disease-modifying radioligand strategies.

Scope of the Radioligand Therapy Market Report

Coverage: 7MM

Study Period: 2022–2036

Radioligand Therapy Companies: Novartis, Curium Pharma, Lantheus, Eli Lilly and Company, Fusion Pharmaceuticals, AstraZeneca, Clarity Pharmaceuticals, Bayer, ITM Isotope Technologies, ARTBIO, Convergent Therapeutics, Perspective Therapeutics, PRECIRIX, Ariceum Therapeutics, Nuclidium, and others.

Radioligand Therapy Pipeline Therapies: 177Lu-PSMA-I&T, Lu-PNT2002, FPI-2265, 225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, VMT-α-NET, VMT01, CONV01-α, CAM-FAP-Ac-225, ITM-11, AB001, NU101, NU201, and others.

Radioligand Therapy Competitive Intelligence Analysis: SWOT analysis, Conjoint analysis, and Market entry strategies.

Radioligand Therapy Unmet Needs, KOL’s views, Analyst’s views, Radioligand Therapy Market Access and Reimbursement.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Radioligand Therapies

4. Key Events

5. Radioligand Therapies Market Overview At A Glance

6. Background And Overview

7. Target Population

8. Radioligand Therapies Marketed Drugs

9. Radioligand Therapies Emerging Drugs

10. Radioligand Therapies: The 7MM Analysis

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Radioligand Therapy Market Access and Reimbursement

15. Appendix

16. DelveInsight Capabilities

17. Disclaimer

18. About DelveInsight

How DelveInsight’s Radioligand Therapy Market Report Helps CXOs and Business Leaders

• Evaluate the current and future market opportunity across the United States, EU4, the United Kingdom, and Japan through detailed epidemiology and market forecasts.

• Benchmark emerging radioligand therapy assets through comprehensive competitive intelligence, pipeline assessment, clinical trial analysis, and probability of success evaluation.

• Identify potential licensing, acquisition, co-development, and partnership opportunities by tracking key innovators and late-stage pipeline assets, including recent high-value transactions such as the Eli Lilly–Point Biopharma and AstraZeneca–Fusion Pharmaceuticals acquisitions.

• Assess the impact of upcoming clinical readouts, regulatory milestones, and expected launches on future market share, pricing, reimbursement, and commercial strategy.

• Support strategic decision-making with insights into KOL perspectives, unmet needs, treatment algorithms, patient segmentation, and evolving market dynamics across the Radioligand Therapy landscape.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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