前列腺特異性膜抗原（PSMA）標靶治療：目標患者群體、競爭格局和市場預測 - 2036 年

主要亮點：

• PSMA在前列腺癌細胞中高表達。 PSMA標靶療法透過與PSMA結合並破壞該抗原來殺死前列腺癌細胞。
• PSMA在前列腺癌細胞表面高表達，但在正常組織中幾乎不表達或完全不表達。因此，PSMA標靶治療可以選擇性地殺死癌細胞而不損傷健康細胞，從而減少傳統化療和放射線治療常見的副作用。
• PSMA標靶治療的主要益處在於它有助於治療攝護腺癌，減緩疾病進展，並改善攝護腺癌的症狀。
• 2022 年，美國食品藥物管理局(FDA) 批准了 PLUVICTO（镥 Lu 177 比匹伐肽四氫西坦，或 177Lu- 化療 -617），作為首個針對 PSMA 的標靶治療，用於治療先前接受過鎦抑制劑和紫杉烷類化療的 PSMA 陽性去勢抗性的PSMA 成年期。
• PLUVICTO 在 2024 年取得了巨大的成功，全球整體銷售額約為 13.92 億美元。
• 目前，多種PSMA標靶治療正在進行臨床試驗評估。例如，禮來公司的177Lu-PNT2002正在研發中，預計將在預測期內獲得批准。
• Lanteus、Telix Pharmaceuticals 和其他幾家公司正在積極從事 PSMA標靶治療的開發和生產，這些療法有可能對 PSMA標靶治療市場產生重大影響並擴大市場規模。

這份PSMA標靶治療市場報告描述了當前的治療狀況、新興藥物、這些療法的市場佔有率，以及2022年至2036年PSMA標靶治療市場規模（涵蓋7個主要國家）的現狀和預測。此外，本報告還涵蓋了PSMA標靶治療治療的現狀、治療方案和未滿足的醫療需求，旨在識別最佳商業機會並評估市場潛力。

目標區域：

• 美國
• 歐盟四國（德國、法國、義大利、西班牙）和英國
• 日本

調查期間：2022-2036年

了解PSMA標靶治療和治療流程

PSMA標靶治療概述

PSMA是一種存在於前列腺癌細胞表面的蛋白質。 PSMA標靶治療是一種先進的癌症治療方法，它利用放射性示蹤劑特異性定位並摧毀表達PSMA的細胞。此療法通常用於治療進行性或轉移性前列腺癌，尤其適用於對手術或放射治療等標準療法無效的病例。雖然這種療法不能治癒癌症，但其主要目標是緩解症狀、縮小腫瘤並延緩癌症進展。

採用PSMA標靶治療進行治療

PSMA標靶治療通常在患者接受其他標準前列腺癌治療（例如化療、荷爾蒙療法或化學去勢）後進行。如果癌症對這些治療措施沒有反應，醫療專業人員可能會建議進行PSMA標靶治療。在開始治療前，需要進行詳細的病歷和身體檢查，以及血液檢查和影像檢查。影像檢查可能包括電腦斷層掃描（用於獲取骨骼和軟組織的詳細3D影像）和MRI掃描（用於獲取軟組織結構的高解析度影像）。此外，還會進行PSMA-PET掃描，該掃描使用放射性追蹤劑來檢測癌細胞上的PSMA蛋白，從而幫助確定腫瘤的位置。治療期間，使用細針（通常是手臂靜脈）注射標準劑量的含有鎦-177的PSMA治療藥物。注射過程僅需幾分鐘，患者通常當天即可出院。治療每六週進行一次，總共進行六次，療程約36週。每次治療之間，都會進行血液檢查，以監測患者的治療反應並檢查副作用。如果治療有效，則在最後一次療程後治療結束，最後一次療程將在治療開始後八個多月進行。

目標患者族群分析

• 到 2025 年，七國集團過去五年前列腺癌患者總數將達到近 280 萬人。
• 到 2025 年，美國前列腺癌的五年發生率約為 116 萬例。
• 2025年，在歐盟四國和英國，局部/局部晚期前列腺癌病例（I-III期）佔前列腺癌臨床分期病例的最大比例。德國在2025年約有18.3萬例前列腺癌病例。
• 據估計，大多數前列腺癌病例發生在65-74歲年齡層。預計到2025年，日本65-74歲年齡層的前列腺癌病例總數將達到19萬例。
• 預計到 2025 年，美國轉移性去勢敏感性前列腺癌 (mCSPC) 病例總數將達到 70,000 例，轉移性去勢敏感性前列腺癌 (mCRPC) 病例數將達到 54,000 例。
• 2025 年，義大利非轉移性去勢敏感性前列腺癌 (nmCSPC) 病例總數為 47,000 例，非轉移性去勢抗性前列腺癌 (nmCRPC) 病例數為 12,000 例。

PSMA標靶治療市場展望

預計未來幾年，PSMA標靶治療的市場將顯著成長。這主要歸因於前列腺癌確診患者數量的增加、人們對PSMA標靶治療的認知不斷提高，以及越來越多的PSMA標靶治療正在各公司進行臨床試驗。

PSMA 是一種細胞表面糖蛋白，在惡性前列腺細胞中高表達，這表明它有可能成為前列腺癌的理想治療標靶。

目前，唯一核准的PSMA標靶治療是諾華公司的PLUVICTO（鎦LU-177雙哌酮四西坦）。這是目前唯一獲得監管機構批准的PSMA標靶放射性配體療法，用於治療對雄激素受體路徑抑制劑和紫杉烷類化療無效的PSMA陽性轉移性去勢抗性攝護腺癌。

目前，PLUVICTO 在 PSMA標靶治療市場佔主導地位，但其他各種 PSMA標靶治療正在進行臨床試驗，未來可能會對 PLUVICTO 的主導地位構成重大威脅。

禮來公司收購了 Point Pharma（Lu-177-PNT2002 的開發商），目前正在進行 Lu-177-PNT2002 治療前列腺癌的 III 期臨床試驗。

包括 Point Biopharma/Eli Lilly 和 Telix Pharmaceuticals 在內的幾家領先公司正在開發針對前列腺癌等適應症的 PSMA標靶治療。

整體而言，這是一類極具發展前景的新型藥物，具有巨大的研發潛力。未來幾年，相關研究的進展將加深我們對PSMA標靶治療的理解，並闡明其在癌症治療中的作用。

PSMA標靶治療的藥物滲透率

本節重點介紹已通過核准和新興的PSMA標靶治療的市場滲透率，預計這些療法將在2022年至2036年間推出。

PSMA標靶治療的研發管線活動

本報告深入分析了處於 III 期、II 期和 I 期臨床試驗階段的各種候選療法，並重點分析了參與標靶治療研發的關鍵公司。

鑑於目前有許多藥物處於不同的研發階段，預計在預測期內，PSMA標靶治療市場將迎來巨大的成長機會。

管道開發活動

本報告詳細介紹了與標靶治療PSMA 的新興療法相關的合作關係、收購和合併、授權和專利。

市場主要參與者之間為加速研發線產品研發而建立的策略聯盟數量不斷增加，預計將推動市場擴張。例如，2022年11月，Point Biopharma與Lantheus達成策略聯盟和獨家授權合約，共同開發PNT2002（一種PSMA標靶治療）。 Lantheus獲得了PNT2002在全球的獨家銷售權，但部分地區除外。

本協議以2.5億美元的首付款為前提，並有可能在獲得美國監管機構批准後追加2.5億美元的付款。此外，在達到特定里程碑後，各方還有可能從各項淨銷售額和相當於淨銷售額20%的特許權使用費中獲得高達13億美元的額外收入。

KOL的觀點

為了解當前及未來的市場趨勢，我們開展了一項初步調查，並參考了業內專家的意見以彌補數據缺口，隨後檢驗了二次調查的結果。我們向業內專家徵詢了關於標靶治療治療環境演變、患者對傳統療法的依賴性、患者對治療方案變更的接受度、藥物可及性以及獲取途徑等方面的意見。

他們的意見有助於我們了解當前和未來的治療模式、PSMA標靶治療的市場趨勢，並檢驗其有效性。這有助於我們掌握整體市場狀況和未滿足的需求，並協助客戶考慮潛在的新治療方案。

定性分析

本公司採用多種方法進行質性市場情報分析，包括SWOT分析和聯合分析。 SWOT分析從疾病診斷差距、病患認知度、醫師接受度、競爭格局、成本效益和治療的地域可及性等方面識別優勢、劣勢、機會和威脅。

聯合分析基於安全性、有效性、給藥頻率、給藥途徑和上市順序等相關屬性，對多種已通過核准和新興療法進行分析。這些參數隨後用於對療法的有效性進行評分和分析。

療效方面，臨床試驗會評估主要終點和次要終點。例如，在無事件存活期分析中，最重要的主要終點之一是無事件存活期和總存活期。

此外，治療方案的安全性也需進行評估，主要關注可接受性、耐受性和不利事件，以便清晰了解藥物在臨床試驗中的副作用。評分也基於每種治療方案的成功機率和目標患者群體。基於這些參數，最終確定新興療法的加權評分和排名。

市場准入和保險報銷

在美國和七國集團（G7）國家，PSMA標靶治療的保險報銷已廣受認可。

在英國，NICE（國家衛生與臨床最佳化研究所）對鎦-177雙哌唑肽四西坦進行了評估，並得出結論：在其上市許可範圍內，不建議將其用於治療PSMA陽性、荷爾蒙療法反應性轉移性前列腺癌的成年患者。本建議不影響在英國國家醫療服務系統（NHS）於本指南發布前已開始的鎦-177雙哌唑肽四西坦治療。對於接受超出本建議範圍治療的患者，在不改變本指南發布前已生效的任何經濟援助安排的情況下，可繼續接受治療，直至患者及其NHS臨床醫生確定停止治療是合適的。

審查委員會提出這些建議，理由是成本效益估計值較高，且缺乏將鎦-177 維匹伏肽四西坦與相關藥物進行比較的新數據，並指出癌症藥物基金不建議使用鎦-177 維匹伏肽四西坦。

此外，本報告還詳細分析了各國具體的獲取和報銷情況、已通過核准療法的成本效益情況、促進獲取和減少自付費用的項目，以及參加聯邦或州處方藥計劃的患者分析。

目錄

第1章：主要見解

第2章：引言

第3章：PSMA標靶治療摘要整理

第4章 主要事件

第5章 市場預測調查方法

第6章 七國集團主要國家PSMA標靶治療市場概述

• 2025年市佔率（%）分佈：依適應症分類
• 2036 年市佔率（%）分佈：依適應症分類

第7章 PSMA標靶治療：背景與概述

第8章 非處方藥

• 主要競爭對手
• PLUVICTO（Lutetium LU-177 Vipivoide Tetraxetan）：Novartis
  • 產品概述
  • 監管里程碑
  • 其他發展活動
  • 臨床開發
  • 安全性和有效性

第9章 新興療法

• 主要競爭對手
• Lu-177-PNT2002：Lantheus
  • 產品概述
  • 其他發展活動
  • 臨床開發
  • 安全性和有效性
• 177Lu-DOTA-rosopatamab tetraxetan（TLX591）：Telix pharmaceutical

第10章：PSMA標靶治療：七大關鍵市場分析

• 市場展望
• 市場預測的關鍵假設
• 七大主要國家PSMA標靶治療的市場規模
• 市場規模：美國
  • 市場規模：以美國市場指標計算
  • 市場規模：依美國治療方法分類
• 市場規模：歐盟四國及英國
  • 市場規模：以歐盟四國和英國的指標分類
  • 市場規模：以歐盟四國和英國的處理方法分類
• 市場規模：日本
  • 市場規模：按日本市場數據
  • 市場規模：依日本治療方法分類

第11章 市場准入與保險賠償

第12章 SWOT 分析

第13章：KOL的觀點

第14章：未滿足的需求

第15章附錄

第16章 參考文獻

第17章 本報告的調查方法

第18章 DelveInsight 服務

第19章免責聲明

第20章：關於 DelveInsight

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.
• 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.

DelveInsight's "Prostate-Specific Membrane Antigen (PSMA) Targeted Therapy - Target Population, Competitive Landscape, and Market Forecast - 2036" 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 2022 to 2036. 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: 2022-2036

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.

Target Patient Pool Analysis

• In 2025, the total five-year prevalence of prostate cancer was nearly 2,800,000 in the 7MM.
• The five-year prevalent cases of prostate cancer in the US was nearly 1,160,000 in 2025.
• In 2025, among the cases prostate cancer by clinical stages, localized/ locally advanced cases (Stage I-III) had the highest contribution in EU4 and the UK. Germany had nearly 183,000 in 2025.
• As per the estimates, most cases of prostate cancer occur in people aged 65-74 years. The total number of age-specific cases in Japan for the age group of 65-74 years was 190,000 in 2025.
• In 2025, there were 70,000 total cases of metastatic Castration-sensitive Prostate Cancer (mCSPC) and 54,000 prevalent cases of mCRPC in the US.
• In 2025, there were 47,000 total cases of nmCSPC and 12,000 prevalent cases of nmCRPC in Italy.

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

177Lu-PSMA-I&T: Curium

177Lu-PSMA-I&T is a radiopharmaceutical used to treat mCRPC. It works by binding to PSMA-expressing tumor cells and destroying them with beta particle radiation. Curium continues to provide clinical trial supplies in the Pivotal ECLIPSE clinical trial with no disruptions. Currently, it is being evaluated in the Phase III for mCRPC.

In February 2026, Curium together with PeptiDream and PDRadiopharma announced that the first patient has been dosed in the companies' registrational clinical trial of 177Lu-PSMA-I&T in Japan for patients with PSMA-positive mCRPC.

177Lu-DOTA-rosopatamab tetraxetan (TLX591, ILLUCCIX): Telix Pharmaceutical

TLX591 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 mCRPC. The therapy has demonstrated efficacy in both reducing tumor size and prolonging progression-free survival in patients.

FPI-2265: AstraZeneca

FPI-2265 is an actinium-225-based PSMA-targeting radio-conjugate for mCRPC. FPI-2265 is evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed in prostate cancers. The alpha-emitting radiopharmaceutical is being evaluated in the Phase II TATCIST trial. The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naive to PSMA-targeted radiopharmaceuticals and those who have been pretreated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO.

Currently, AstraZeneca has began evaluating FPI-2265 in the Phase II for PSMA positive mCRPC.

Recent Developments in the PSMA-targeted Therapies Market

• In February 2026, Curium together with PeptiDream and PDRadiopharma announced that the first patient has been dosed in the companies' registrational clinical trial of 177Lu-PSMA-I&T in Japan for patients with PSMA-positive mCRPC.
• In January 2026, Telix announced that the first patient has been dosed in the Phase III registration study of TLX591-Px (ILLUCCIX, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Japanese patients. The patient was dosed at Shonan Kamakura General Hospital (SKGH) in Kamakura, Japan.
• In May 2025, Lantheus has discontinued development and will not pursue approval of PNT2002 after final Splash data showed no overall survival benefit, leaving Novartis's Pluvicto dominant in the pre-chemo mCRPC setting.

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 2022-2036.

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.

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 2025, and what would it look like in 2036? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2036?
• 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 2025
• 6.2. Market Share (%) Distribution by Indication in 2036

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

List of Tables

• Table 1: Target Population in the 7MM (2022-2036)
• Table 2: Marketed Drug Key cross
• Table 3: Product 1, Clinical Trial Description, 2025
• Table 4: Product 2, Clinical Trial Description, 2025
• Table 5: Emerging Drug Key cross
• Table 6: Product 1, Clinical Trial Description, 2025
• Table 7: Product 2, Clinical Trial Description, 2025
• Table 8: Total PSMA-Targeted Therapy Market Size in the 7MM (2022-2036)
• Table 9: PSMA-Targeted Therapy Market Size by Therapies in the 7MM (2022-2036)
• Table 10: PSMA-Targeted Therapy Market Size by Indication in the 7MM (2022-2036)
• Table 11: Total PSMA-Targeted Therapy Market Size in the United States (2022-2036)
• Table 12: PSMA-Targeted Therapy Market Size by Therapies in the United States (2022-2036)
• Table 13: Total PSMA-Targeted Therapy Market Size in EU4 and the UK (2022-2036)
• Table 14: PSMA-Targeted Therapy Market Size by Therapies in EU4 and the UK (2022-2036)
• Table 15: Total PSMA-Targeted Therapy Market Size in Japan (2022-2036)
• Table 16: PSMA-Targeted Therapy Market Size by Therapies in Japan (2022-2036)

List of Figures

• Figure 1: Target Population in the 7MM (2022-2036)
• Figure 2: Total PSMA-Targeted Therapy Market Size in the 7MM (2022-2036)
• Figure 3: PSMA-Targeted Therapy Market Size by Therapies in the 7MM (2022-2036)
• Figure 4: PSMA-Targeted Therapy Market Size by Indication in the 7MM (2022-2036)
• Figure 5: Total PSMA-Targeted Therapy Market Size in the United States (2022-2036)
• Figure 6: PSMA-Targeted Therapy Market Size by Therapies in the United States (2022-2036)
• Figure 7: Total PSMA-Targeted Therapy Market Size in EU4 and the UK (2022-2036)
• Figure 8: PSMA-Targeted Therapy Market Size by Therapies in EU4 and the UK (2022-2036)
• Figure 9: Total PSMA-Targeted Therapy Market Size in Japan (2022-2036)
• Figure 10: PSMA-Targeted Therapy Market Size by Therapies in Japan (2022-2036)