Targeted Momentum: Navigating The Clinical And Commercial Future Of Pluvicto

Report Overview

The global Pluvicto market was valued at USD 1.39 billion in 2024 and is projected to reach USD 2.55 billion by 2033, with a CAGR of 5.99% from 2025 to 2033. Growth is supported by the increasing number of metastatic castration-resistant prostate cancer (mCRPC) cases, wider use of radioligand therapies, and broader clinical application of targeted radiopharmaceuticals.

Clinical outcomes continue to influence adoption. In June 2024, Novartis reported improved radiographic progression-free survival (rPFS) in PSMA-positive metastatic hormone-sensitive prostate cancer patients receiving Pluvicto. The PSMAfore trial showed reduced risk compared to androgen receptor pathway inhibitors (ARPI), along with early trends in overall survival. Data from earlier trials indicated improvements in both progression-free and overall survival in PSMA-positive mCRPC, contributing to changes in treatment guidelines and increased prescription volumes.

In January 2024, Novartis added production capacity by opening a 70,000-square-foot radioligand therapy (RLT) manufacturing facility in Indianapolis. This was the company’s second RLT site in the United States and fifth globally. Hospitals and cancer centers are modifying infrastructure to support radioligand therapy operations, including facility design and procedural workflows, which increases throughput and access.

Supply chain processes are becoming more structured. Manufacturing scale-up is reducing delivery delays and increasing availability of radiopharmaceuticals. In parallel, coordination between imaging developers and therapy manufacturers is improving patient selection. Use of PSMA-PET imaging is aligning with therapeutic targeting, which enhances identification rates. These combined efforts are increasing system efficiency and supporting growth in treatment volumes through 2030.

Trend Analysis

Label Expansion into Earlier Treatment Lines

The regulatory process for Pluvicto’s label expansion is leading to a market transition. In October 2023, the Phase III PSMAfore trial reported a hazard ratio of 0.41 for radiographic progression-free survival (rPFS) in the pre-taxane mCRPC population, indicating a 59% risk reduction. Median rPFS was 12.0 months for Pluvicto versus 5.6 months for patients switching to an androgen receptor pathway inhibitor (ARPI). In April 2024, Novartis confirmed its plan to submit a label expansion filing in the second half of 2024 based on updated overall survival data. The FDA accepted the supplemental application in late 2024, with a decision expected in the first half of 2025, pending final OS results. Approval would increase the number of patients eligible for Pluvicto. Market analysts project a potential threefold expansion in addressable patient volume, positioning Pluvicto in the earlier stages of treatment alongside oral ARPIs such as enzalutamide and abiraterone. This would increase product uptake and support future revenue growth.

Reimbursement And Pricing Pressures

Treatment costs in the U.S. remain elevated. The estimated list price of Pluvicto is approximately USD 42,500 per dose, with a treatment cycle of up to six doses. In the UK, the National Institute for Health and Care Excellence (NICE) issued a recommendation against NHS reimbursement in late 2022, based on cost-effectiveness assessments compared to standard therapies. This has limited patient access and influenced other public health systems. Advocacy groups noted the survival benefit lost to eligible patients. The decision highlights the difficulty of introducing high-cost therapies into cost-sensitive systems, particularly where long-term real-world data is limited. The outcome establishes a precedent for value assessments, which could delay market expansion unless pricing models are revised.

In contrast, Germany’s statutory health insurance approved reimbursement after a benefit assessment, setting a benchmark price above USD 162,257 annually. This has enabled Novartis to enter the German market, while access in other European countries remains uneven. To address this, Novartis is engaging with national payers on tiered pricing and outcomes-based reimbursement strategies, especially for earlier-line settings post-PSMAfore. Ongoing discussions in France, Italy, and Nordic countries depend on supporting clinical and economic evidence. In the absence of broader reimbursement, market penetration across

Inclusion In Clinical Guidelines And Treatment Algorithms

As of mid‑2022, Pluvicto was formally incorporated into major clinical guidelines, including those from the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) for the treatment of PSMA‑positive mCRPC in the post‑taxane setting. NCCN guidelines endorse the use of PSMA PET imaging with Ga‑68 or F‑18 tracers for selecting eligible patients, supporting broader identification across imaging platforms. ASCO’s updated mCRPC guidance, published in November 2022, recommends ^177Lu‑PSMA‑617 for patients previously treated with androgen receptor pathway inhibitors and chemotherapy, based on data from the VISION and TheraP trials. 

This institutional inclusion is influencing how and where Pluvicto is deployed. Oncology centers in the U.S. and parts of Europe have responded by expanding PSMA PET imaging capabilities and developing radioligand therapy units to manage increased patient volume. Regional cancer networks are training nuclear medicine personnel and implementing Pluvicto protocols for eligible mCRPC patients. Novartis reports that over 80% of mCRPC patients express PSMA, indicating a broad eligible population once diagnostic systems are in place. With studies like PSMAfore producing earlier-line data, updates to these guidelines are expected, potentially extending use into pre-taxane settings and expanding market coverage. Incorporating Pluvicto into treatment algorithms serves as a commercial driver supporting wider adoption across healthcare systems.

Pipeline Analysis

As of mid‑2022, Pluvicto was incorporated into clinical guidelines issued by the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) for the treatment of PSMA‑positive mCRPC in the post‑taxane setting. NCCN guidelines support the use of PSMA PET imaging with Ga‑68 or F‑18 tracers to identify eligible patients across multiple imaging platforms. ASCO’s updated guidance, released in November 2022, recommends ^177Lu‑PSMA‑617 for patients previously treated with androgen receptor pathway inhibitors and chemotherapy, referencing findings from the VISION and TheraP trials.

This institutional inclusion is influencing deployment strategies. Oncology centers in the U.S. and selected European markets have expanded PSMA PET imaging infrastructure and developed radioligand therapy units to address growing demand. Regional cancer networks have initiated training programs for nuclear medicine staff and integrated Pluvicto protocols for eligible mCRPC patients. According to Novartis, over 80% of mCRPC patients express PSMA, indicating a sizable addressable population when diagnostic pathways are implemented. Ongoing studies such as PSMAfore are expected to inform future updates to guidelines, potentially extending use to earlier lines of therapy. Guideline-based inclusion is acting as a commercial enabler, supporting adoption across clinical settings.

Trials In Prostate Cancer

Source: Grand View Research 

Patent Epiration

The patent expiration of Pluvicto in both the U.S. and EU in 2034 is projected to alter the prostate cancer treatment landscape. Post-exclusivity, biosimilar products are expected to enter the market, offering lower-cost alternatives and exerting downward pressure on pricing. This development may reduce revenue contributions from Pluvicto for Novartis while expanding access across key regions. Prescribing behavior may shift in favor of cost-competitive substitutes, particularly within budget-constrained healthcare systems. Market participation may expand to include firms with existing radioligand manufacturing and distribution infrastructure, increasing competitive intensity. The 2034 expiration is positioned to transition Pluvicto from a protected therapeutic asset to a widely accessible radioligand option.

Pluvicto Patent Expiration Timeline

Source: Grand View Research 

Pluvicto Faces Setback in PSMAfore Trial

Despite achieving a reduction in radiographic progression or death in the PSMAfore trial, Pluvicto’s interim data raised concerns due to a 16% increase in overall mortality. This outcome introduces uncertainty regarding the clinical benefit in earlier-stage prostate cancer. The FDA may not consider crossover-adjusted analyses, which suggested a 20% reduction in mortality, as a substitute for the unadjusted data. The high crossover rate in the control group complicates interpretation but does not negate the observed increase in mortality. Without confirmed survival benefit, regulatory approval in the pre-chemotherapy setting remains uncertain. The trial results do not establish overall survival advantage, limiting the case for expansion into earlier lines of therapy. Consequently, market growth projections may be adjusted downward, and revenue expectations may be revised based on the current regulatory outlook.

Eligibility and Administration Guidelines for Pluvicto

Pluvicto is indicated for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received hormone therapy or a combination of hormone therapy and chemotherapy. It is administered as a radioligand therapy that targets PSMA-expressing cancer cells, with eligibility determined through PSMA-PET imaging. Due to its radioactive content, the therapy requires adherence to safety protocols post-administration, including limiting close physical contact with others, particularly children and pregnant individuals, for several days. Patients are instructed to maintain adequate hydration and urinate frequently to support the elimination of radioactive substances. The treatment is associated with risks such as reduced blood cell counts, renal function impairment, and potential effects on reproductive health, necessitating regular clinical monitoring. Pluvicto serves as a treatment option in cases where alternative standard therapies have been utilized.

Key Pluvicto Company Insights

Novartis AG holds control over the Pluvicto market through exclusive development and commercialization of the PSMA-targeted radioligand therapy for prostate cancer. The company’s position is supported by regulatory approvals in major markets including the U.S. and Europe, along with a growing global distribution network for radiopharmaceuticals. Ongoing investments in manufacturing capacity, including new facilities in Indiana and New Jersey, have increased output and addressed prior supply limitations. Novartis is pursuing label expansion via clinical trials such as PSMAfore, aimed at extending use into earlier treatment lines. In the current landscape, the absence of other branded PSMA-targeted therapies allows Novartis to determine pricing and manage distribution channels. Over time, the competitive environment is expected to shift as additional radiopharmaceuticals, biosimilars, and targeted therapies enter the market.

Recent Developments

• In May 2025, Novartis received FDA approval for Pluvicto to treat PSMA-positive mCRPC patients who progressed on ARPI and are ineligible for or haven’t received taxane chemotherapy. The approval was based on PSMAfore trial results showing improved radiographic progression-free survival.

• In April 2023, Novartis received FDA approval for commercial production of Pluvicto at its Millburn, New Jersey facility. This marks the second U.S. manufacturing site, aimed at improving supply reliability and meeting rising demand. The move supports broader access and reinforces Novartis’ global radioligand therapy manufacturing strategy.

Pluvicto Market Report Scope

Global Pluvicto Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global Pluvicto market report based on region:

• Regional Outlook (Revenue, USD Billion, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait