세계의 전립선 특이적 막 항원(PSMA) 표적 치료 시장 : 표적 환자, 경쟁 구도, 시장 예측(2034년)

Key Highlights:

• In prostate cancer cells, PSMA is highly expressed. PSMA-targeted therapy works by binding to PSMA and damaging the antigen, which leads to the killing of prostate cancer cells.
• Since PSMA is highly expressed on the surface of prostate cancer cells but minimally or not at all in normal tissues. PSMA-targeted therapy can selectively kill cancer cells while sparing healthy cells, thereby reducing the side effects commonly associated with traditional chemotherapy or radiation therapy.
• The primary benefit of PSMA-targeted therapy is that it helps treat prostate cancer, slows the spread of the disease, and improves prostate cancer symptoms.
• In 2022, the US Food and Drug Administration (FDA) approved PLUVICTO (lutetium Lu 177 vipivotide tetraxetan, or 177 Lu-PSMA-617) as the first PSMA-targeted therapy for adult patients with PSMA-positive metastatic castration-resistant prostate cancer who had been previously treated with androgen receptor pathway inhibitors and taxane-based chemotherapy.
• PLUVICTO generated approximately USD 1,392 million in revenue globally achieving the blockbuster status in 2024.
• In March 2025, Novartis announced that the US FDA approved the expanded use of PLUVICTO for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
• In April 2023, the FDA granted Fast Track designation to the PSMA-targeted therapy 177Lu-PNT2002 for the treatment of patients with metastatic castration-resistant prostate cancer.
• Several PSMA-targeted therapies are currently being evaluated in clinical trials. An example is Lilly's 177 Lu-PNT2002, which is in the developmental stage and is anticipated to receive approval during the forecast period.
• Lantheus, Telix Pharmaceuticals, and several other companies are actively involved in the development and production of PSMA-targeted therapies, which have the potential to significantly impact and enhance the PSMA-targeted therapy market.
• In 2024, the United States holds the largest share of the PSMA-targeted therapy market among the 7MM.

DelveInsight's "Prostate-Specific Membrane Antigen (PSMA) Targeted Therapy - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the PSMA-targeted therapy, historical and Competitive Landscape as well as the PSMA-targeted therapy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PSMA-targeted therapy market report provides current treatment practices, emerging drugs, market share of the therapy, and current and forecasted 7MM PSMA-targeted therapy market size from 2020 to 2034. The report also covers current PSMA-targeted therapy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

PSMA-targeted Therapy Understanding and Treatment Algorithm

PSMA-targeted Therapy Overview

PSMA is a protein found on the surface of prostate cancer cells. PSMA-targeted therapy is an advanced form of cancer treatment that uses a radioactive tracer to specifically seek out and destroy these PSMA-expressing cells. It is typically used for treating advanced or metastatic prostate cancer, especially in cases where the disease no longer responds to standard treatments like surgery or radiation. While this therapy does not cure cancer, its primary goals are to relieve symptoms, reduce tumor size, and slow the cancer's progression.

PSMA-targeted Therapy Treatment

PSMA-targeted therapy is typically offered to patients after they have undergone other standard prostate cancer treatments, such as chemotherapy, hormone therapy, or chemical castration. If the cancer does not respond to these approaches, a healthcare provider may recommend PSMA-targeted therapy. Before beginning treatment, a thorough review of the patient's medical history and a physical examination are conducted, along with blood tests and imaging studies. Imaging may include a CT scan for detailed 3D images of bones and soft tissues and an MRI for high-resolution images of soft tissue structures. A PSMA PET scan is also performed, using a radiotracer to detect PSMA proteins on cancer cells, helping to precisely locate tumors. During treatment, a small needle is used to inject a standard dose of PSMA therapy, which contains lutetium-177, into a vein usually in the arm. The injection takes only a few minutes, and patients are typically discharged the same day. Treatments are administered every six weeks, with a total of six sessions over approximately 36 weeks. Blood tests are done between each session to monitor the patient's response and check for side effects. If the treatment is effective, it concludes after the final session, a little over eight months from the start.

PSMA-targeted Therapy Drug Chapters

The drug chapter segment of the PSMA-targeted therapy reports encloses a detailed analysis of PSMA-targeted therapy marketed drugs and late-stage (Phase III and Phase I/II) pipeline drugs. It also helps understand the PSMA-targeted therapy's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

PLUVICTO (Lutetium LU-177 Vipivoide Tetraxetan): Novartis

Lutetium-177 is a radioactive chemical element that destroys prostate cancer cells. The PSMA therapy dose takes the lutetium-177 directly to prostate cancer tumors so that the radiation will have minimum effect on other parts of the body.

It is indicated for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

Emerging Drugs

Lu-177-PNT2002: Lantheus

PNT2002 is a small molecule radioligand therapy designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It targets PSMA (Prostate-Specific Membrane Antigen) by combining a PSMA-specific ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. This targeted approach allows the radioligand to bind specifically to PSMA-expressing cancer cells, delivering radiation directly to the tumor while minimizing damage to surrounding healthy tissue. PNT2002 is currently undergoing a Phase III clinical trial aimed at assessing its effectiveness compared to the current standard of care in pre-chemotherapy mCRPC patients who have already failed treatment with one androgen receptor pathway inhibitor.

177Lu-DOTA-rosopatamab tetraxetan (TLX591): Telix pharmaceutical

It is a radioimmunoconjugate comprised of the humanized IgG1 monoclonal antibody rosopatamab, linked to the low-energy beta-emitting radioisotope lutetium-177 via the bifunctional chelating agent DOTA-NHS ester. It is being developed by Telix Pharmaceuticals and is also known as TLX591.

It works by delivering a radioactive payload, lutetium-177, directly to cancer cells expressing PSMA. This targeted approach allows for precise radiation therapy while minimizing damage to surrounding healthy tissue.

Clinical trials have shown promising results for TLX591 in treating advanced prostate cancer, including metastatic castration-resistant prostate cancer. The therapy has demonstrated efficacy in both reducing tumor size and prolonging progression-free survival in patients.

PSMA-targeted Therapy Market Outlook

The market for PSMA-targeted therapy is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with prostate cancer, the growing awareness of PSMA-targeted therapy, and the increasing number of PSMA-targeted therapies that are under clinical trials by various companies.

The cell surface glycoprotein PSMA has proven to be an ideal therapeutic target in prostate cancer as it is highly expressed by malignant prostate cells.

Currently, approved PSMA-targeted therapy includes PLUVICTO (Lutetium LU-177 Vipivoide Tetraxetan) by Novartis. It is the only regulatory-approved PSMA-targeted radioligand therapy to date in the setting of PSMA-positive metastatic castration-resistant prostate cancer that has failed androgen receptor pathway inhibitors and taxane chemotherapy.

Currently, PLUVICTO is dominating the PSMA-targeted therapy market but various PSMA-targeted therapies are under clinical studies which can significantly challenge PLUVICTO dominance in the future.

Eli Lilly which acquired Point Pharma (Innovator of Lu-177-PNT2002) is testing Lu-177-PNT2002 in Phase III clinical trial for the treatment of Prostate cancer.

Several key players, including Point Biopharma/Eli Lilly, Telix Pharmaceuticals, and others, are involved in developing PSMA-targeted therapy for indications such as Prostate cancer.

Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of PSMA-targeted therapy and define their role in the therapy of cancer.

PSMA-targeted therapy Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging PSMA-targeted therapy expected to be launched in the market during 2020-2034.

PSMA-targeted therapy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for PSMA-targeted therapy market growth over the forecasted period.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PSMA-targeted therapy emerging therapies.

The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion. For example, In Nov 2022, Point Biopharma entered into a strategic collaboration and exclusive license agreement with Lantheus for the commercialization of PNT2002 (PSMA-targeted therapy). Lantheus received exclusive worldwide rights, excluding certain territories for PNT2002.

The agreement has been finalized with an initial payment of USD 250 million and the potential for an additional USD 250 million contingent upon approval from U.S. regulators. Also, there is a potential for an additional US 1.3 billion in various net sales and royalties of 20% on net sales, upon completion of certain milestones.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on PSMA-targeted therapy's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Genomic Oncology Clinic and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or PSMA-targeted therapy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement for PSMA-targeted therapy has been universal in the United States and other 7MM Countries.

In the UK NICE has evaluated Lutetium-177 vipivotide tetraxetan and concluded that it does not recommend it, within its marketing authorization, for treating PSMA-positive hormone-relapsed metastatic prostate cancer in adults. This recommendation is not intended to affect treatment with lutetium-177 vipivotide tetraxetan which was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

The appraisal committee made these recommendations because of the high cost-effectiveness estimates and a lack of new data comparing lutetium-177 vipivotide tetraxetan with relevant medicines, and stated lutetium-177 vipivotide tetraxetan cannot be recommended for use in the Cancer Drugs Fund.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on PSMA-targeted Therapy

Many Pharma companies will present their data readouts for PSMA-targeted therapy during the ASCO 2024 conference including Telix Pharmaceuticals and others.

Telix Pharmaceuticals have submitted Abstract-TPS5115 with the title "ProstACT GLOBAL: A phase 3 study of best standard of care with and without 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drug" Updates on the ongoing clinical trials for 177Lu-DOTA-rosopatamab are anticipated to be presented.

Earlier in the 2024 ASCO Genitourinary Cancers Symposium, Telix shared data on this topic under abstract number TPS256.

The abstract list is not exhaustive, will be provided in the final report

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of PSMA-targeted therapy, explaining its Scope, Approved drugs, ongoing clinical studies, etc.
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the PSMA-targeted therapy market, historical and forecasted market size, market share of PSMA-targeted therapy, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis expert insights/KOL views, and treatment preferences that help shape and drive the 7MM PSMA-targeted therapy market.

PSMA-targeted Therapy report insights

• PSMA-targeted therapy Targeted Patient Pool
• Therapeutic Approaches
• PSMA-targeted therapy Pipeline Analysis
• PSMA-targeted therapy Market Size and Trends
• Existing and future Market Opportunity

PSMA-targeted therapy report key strengths

• Eleven years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

PSMA-targeted therapy report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the PSMA-targeted therapy total market size, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for PSMA-targeted therapy?
• Which drug type segment accounts for maximum PSMA-targeted therapy sales?
• What are the pricing variations among different geographies for approved drugs?
• How the reimbursement landscape has for PSMA-targeted therapy evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of PSMA-targeted therapy? What will be the growth opportunities across the 7MM concerning the patient population about PSMA-targeted therapy?
• What are the key factors hampering the growth of the PSMA-targeted therapy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for PSMA-targeted therapy?
• What is the cost burden of approved drugs of PSMA-targeted therapy on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved drugs?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the PSMA-targeted therapy market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of potential current and emerging therapies under the conjoint analysis section to provide visibility around leading therapies.
• Highlights of Access and Reimbursement policies of approved drugs, barriers to accessibility of expensive off-label drugs, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of PSMA-targeted Therapy

4. Key Events

5. Market Forecast Methodology

6. PSMA-targeted Therapy Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Indication in 2024
• 6.2. Market Share (%) Distribution by Indication in 2034

7. PSMA-targeted therapy: Background and Overview

8. Marketed Drugs

• 8.1. Key Competitors
• 8.2. PLUVICTO (Lutetium LU-177 Vipivoide Tetraxetan): Novartis
  • 8.2.1. Product description
  • 8.2.2. Regulatory milestones
  • 8.2.3. Other developmental activities
  • 8.2.4. Clinical development
  • 8.2.5. Safety and efficacy

9. Emerging Therapies

• 9.1. Key Competitors
• 9.2. Lu-177-PNT2002: Lantheus
  • 9.2.1. Product description
  • 9.2.2. Other developmental activities
  • 9.2.3. Clinical development
  • 9.2.4. Safety and efficacy
• 9.3. 177Lu-DOTA-rosopatamab tetraxetan (TLX591): Telix pharmaceutical
  • 9.3.1. Product description
  • 9.3.2. Other developmental activities
  • 9.3.3. Clinical development
  • 9.3.4. Safety and efficacy

10. PSMA-targeted Therapy: Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of PSMA-targeted therapy in the 7MM
• 10.5. The United States Market Size
  • 10.5.1. Market Size by Indications in the United States
  • 10.5.2. Market Size by Therapies in the United States
• 10.6. EU4 and the UK Market Size
  • 10.6.1. Market Size by Indications in EU4 and the UK
  • 10.6.2. Market Size by Therapies in EU4 and the UK
• 10.7. Japan Market Size
  • 10.7.1. Market Size by Indications in Japan
  • 10.7.2. Market Size by Therapies in Japan

11. Market Access and Reimbursement

12. SWOT Analysis

13. KOL Views

14. Unmet Needs

15. Appendix

16. Bibliography

17. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight