前列腺特異性薄膜抗原(PSMA)標靶治療的全球市場:標的患者，競爭情形，市場預測-2034年

重點

• PSMA 在前列腺癌細胞中高表達。 PSMA 標靶治療透過結合 PSMA，破壞抗原並殺死前列腺癌細胞發揮作用。
• PSMA 在前列腺癌細胞表面高表達，但在正常組織中表達極少或不表達。 PSMA 標靶治療可以選擇性地殺死癌細胞，同時保留健康細胞，從而減少傳統化療和放療常見的副作用。
• PSMA 標靶治療的主要優點在於它有助於治療攝護腺癌，減緩疾病擴散並改善攝護腺癌症狀。
• 2022年，美國食品藥物管理局 (FDA) 批准 PLUVICTO（镥 Lu 177 比匹博肽四環素，或 177 Lu-PSMA-617）作為首個針對 PSMA 的標靶療法，用於治療既往接受過雄激素受體通路抑制劑和紫杉烷類類轉移治療的 PSMA 陽性化療患者。
• 預計 PLUVICTO 將在 2024 年創造約 13.92 億美元的全球銷售額，並成為重磅藥物。
• 2025 年 3 月，諾華宣布美國 FDA 已批准 PLUVICTO 擴大用於治療 PSMA 陽性轉移性去勢抵抗性前列腺癌。
• 2023年4月，FDA授予PSMA標靶療法177Lu-PNT2002快速通道資格，用於治療轉移性去勢抵抗性前列腺癌患者。
• 目前，多種PSMA標靶藥物正在臨床試驗中進行評估。禮來公司的177Lu-PNT2002就是其中一個例子，該藥物正在開發中，預計將在預測期內獲得批准。
• 包括Lantheus、Telix Pharmaceuticals等多家公司正在積極參與PSMA標靶藥物的開發和生產，這有可能對PSMA標靶藥物市場產生重大影響並使其更加強勁。
• 到2024年，美國將在七個主要國家中佔據PSMA標靶藥物市場的最大佔有率。

本報告詳細介紹了PSMA標靶治療的發展歷史、競爭格局以及美國、歐盟四國（德國、法國、義大利、西班牙）、英國、日本等國PSMA標靶治療的市場趨勢。

PSMA標靶治療市場報告提供了當前的治療方法、新藥、治療方法的市場佔有率以及2020年至2034年七個主要國家/地區PSMA標靶治療市場規模的現狀和預測。報告還涵蓋了PSMA標靶治療的現有治療方法/演算法和未滿足的醫療需求，以發現最佳治療機會並評估市場潛力。

目標地區

• 美國
• 歐盟四國（德國、法國、義大利、西班牙）和英國
• 日本

研究期間：2020-2034

了解PSMA標靶治療與治療演算法

PSMA標靶治療概論

PSMA是一種存在於攝護腺癌細胞表面的蛋白質。 PSMA標靶治療是一種晚期癌症治療方法，它使用放射性示蹤劑特異性地尋找並摧毀表達PSMA的細胞。它通常用於治療晚期或轉移性前列腺癌，尤其是在對手術和放射治療等標準治療失去反應的情況下。這種治療方法並不能治癒癌症，其主要目的是緩解症狀、縮小腫瘤並減緩癌症進展。

PSMA標靶治療

PSMA標靶治療通常用於已接受其他標準攝護腺癌治療（例如化療、荷爾蒙治療和化學去勢）的患者。如果癌症對這些療法沒有反應，您的醫療保健提供者可能會建議PSMA標靶治療。在開始治療之前，醫生會進行全面的病史詢問和身體檢查，以及血液檢查和影像檢查。影像學檢查包括CT掃描（用於獲取骨骼和軟組織的詳細3D影像）和MRI（用於獲取軟組織結構的高解析度影像）。此外，還將進行PSMA PET掃描，該掃描使用放射性追蹤劑檢測癌細胞上的PSMA蛋白，以幫助確定腫瘤的位置。治療包括以小針頭注射標準劑量的含镥-177的PSMA療法，通常注射到手臂靜脈。注射過程只需幾分鐘，患者通常可在當天出院。治療每六週進行一次，共六個療程，持續約36週。每次療程之間都會進行血液檢測，以監測患者的反應並檢查是否有任何副作用。如果治療有效，療程將在最後一次療程後結束，即治療開始後八個多月。

PSMA標靶治療章節

PSMA標靶治療報告的藥物章節詳細分析了已上市和後期（III期和I/II期）研發的PSMA標靶治療藥物。它還有助於了解PSMA標靶治療藥物的臨床試驗細節、表達藥理學、協議與合作、批准和專利細節、每種藥物的優缺點以及最新的新聞和新聞稿。

上市藥物

PLUVICTO（镥LU-177 Vipivoide Tetraxetan）- 諾華

镥-177是一種放射性化學元素，會破壞攝護腺癌細胞。在PSMA治療中，镥-177直接注射到前列腺癌腫瘤，因此放射線對身體其他部位的影響被最小化。

此藥物適用於治療已接受雄性激素受體路徑阻斷及紫杉烷類化療治療的PSMA陽性轉移性去勢抗性攝護腺癌（mCRPC）成年患者。

新藥

镥-177-PNT2002 - Lantheus

PNT2002 是一種小分子放射性配體治療藥物，用於治療轉移性去勢抵抗性前列腺癌 (mCRPC)。它透過將 PSMA 特異性配體 PSMA-I&T 與發射 β 射線的無載體放射性同位素镥-177 相結合，靶向 PSMA（前列腺特異性膜抗原）。這種標靶方法使放射性配體能夠特異性地與表達 PSMA 的癌細胞結合，從而使放射線能夠直接遞送至腫瘤，同時最大限度地減少對周圍健康組織的損傷。 PNT2002 目前正在進行 III 期臨床試驗，旨在評估其在先前接受過化療且單一雄性激素受體路徑抑制劑治療失敗的轉移性去勢抵抗性前列腺癌 (mCRPC) 患者中，相對於現有標準治療方案的療效。

177Lu-DOTA-羅帕他單抗四環素 (TLX591) - Telix 製藥

TLX591 是一種放射免疫偶聯物，由人源化 IgG1 單株抗體羅帕他單抗和低能量 β 發射放射性同位素镥-177 透過雙功能螯合劑 DOTA-NHS 酯連接而成。該藥物由 Telix 製藥公司開發，也稱為 TLX591。

該藥物透過將放射性有效載荷镥-177 直接遞送至表達 PSMA 的癌細胞來發揮作用。這種標靶方法可以實現精準放射治療，同時最大限度地減少對周圍健康組織的損傷。

臨床試驗表明，TLX591 在治療晚期前列腺癌（包括轉移性去勢抵抗性前列腺癌）方面取得了良好的療效。該療法已被證明能夠有效縮小腫瘤體積並延長患者的無惡化存活期。

PSMA 標靶治療市場展望

預計未來幾年 PSMA 標靶治療市場將大幅成長。這得益於前列腺癌確診患者數量的不斷增長、PSMA 標靶治療認知度的不斷提升，以及各公司臨床試驗中 PSMA 標靶治療的數量不斷增加。

細胞表面糖蛋白 PSMA 在惡性前列腺細胞中高表達，已被證明是前列腺癌的理想治療標靶。

目前已核准的 PSMA 標靶治療包括諾華公司的 PLUVICTO（Lutetium LU-177 Vipivoide Tetraxetan）。它是監管機構批准的唯一一種針對PSMA陽性轉移性去勢抵抗性前列腺癌的靶向PSMA的放射性配體療法，適用於雄激素受體通路抑製劑和紫杉烷類化療失敗後的治療。

目前，PSMA標靶藥物市場以PLUVICTO為主，但多種PSMA標靶藥物正在進行臨床研究，未來可能對PLUVICTO的主導地位構成重大課題。

收購了Lu-177-PNT2002原廠公司Point Pharma的禮來公司，目前正在進行Lu-177-PNT2002用於治療攝護腺癌的III期臨床試驗。

包括Point Biopharma/Eli Lilly和Telix Pharmaceuticals在內的多家大型公司都參與了針對前列腺癌等適應症的PSMA標靶藥物的開發。

總體而言，這是一個令人興奮的新藥類別，具有巨大的發展潛力。隨著未來幾年現有研究的日益成熟，我們對PSMA標靶藥物的理解將會加深，其在癌症治療中的作用也將更加清晰。

PSMA標靶藥物的吸收

本節重點介紹2020年至2034年期間預計將上市的已核准和新興PSMA標靶藥物的吸收率。

PSMA標靶藥物研發管線開發活動

本報告深入分析了處於III期、II期和I期的各種潛在藥物，並分析了參與標靶藥物研發的關鍵公司。

預計大量處於不同階段的藥物將為預測期內PSMA標靶藥物市場的成長提供巨大的機會。

產品線開發活動

本報告涵蓋了針對PSMA標靶藥物的新興藥物的合作、收購、合併、授權和專利細節資訊。

主要市場參與者之間日益增多的策略聯盟，旨在促進產品線的成長，預計將推動市場擴張。例如，2022年11月，Point Biopharma與Lantheus達成策略聯盟及獨家授權協議，以商業化PNT2002（一種PSMA標靶療法）。 Lantheus獲得了PNT2002的全球獨家授權（不包括某些地區）。

該協議最終確定了2.5億美元的首付款，並在獲得美國監管機構批准後可能額外支付2.5億美元。此外，在實現某些里程碑後，美國銷售額還可能增加13億美元，並獲得20%的銷售額特許權使用費。

KOL的見解

為了了解當前和未來的市場趨勢，我們透過一手資料研究與活躍於該領域的行業專家合作，以填補數據空白並驗證我們的二次研究。我們聯繫了行業專家，深入了解不斷變化的行業格局、患者對傳統療法的依賴性、患者對轉換療法的接受度、藥物吸收、可及性課題等。

DelveInsight 分析師已聯繫了 25 多位關鍵意見領袖 (KOL) 收集見解，並採訪了來自 7 個主要國家/地區和基因組腫瘤診所等中心的 10 多位關鍵意見領袖。

他們的觀點有助於理解和驗證 PSMA 標靶治療市場中當前和新興的治療模式和趨勢。這透過識別整體市場情景和未滿足的需求，幫助我們的客戶掌握未來新療法的機會。

定性分析

我們採用 SWOT 分析和聯合分析等各種方法進行定性和市場情報分析。 SWOT分析法能夠從疾病診斷、病患認知度、醫師接受度、競爭格局、成本效益以及治療的地理可及性等方面，提供優勢、劣勢、機會和威脅。

聯合分析法是基於安全性、有效性、給藥頻率、給藥途徑和給藥順序等相關屬性，對多種已核准和新興療法進行分析。根據這些參數，給予評分以分析治療的有效性。

例如，在無事件存活期中，最重要的主要終點之一是無事件存活期和總存活期。

此外，也會評估治療的安全性，主要觀察藥物的可接受性、耐受性和不良事件，以清楚了解藥物在試驗中引起的副作用。此外，評分也基於每種療法的成功機率和可涵蓋的患者群體。基於這些參數，確定新興療法的最終加權分數和排名。

市場准入與報銷

PSMA標靶治療在美國和其他七國集團（G7）國家已實現全民報銷。

範圍：

• 本報告詳細分析了競爭格局、預測、診斷率、疾病進展以及治療指南的未來成長潛力。
• 此外，本報告全面描述了當前和新興的療法，並詳細介紹了預計將影響當前治療格局的晚期和重點療法。
• 本報告詳細回顧了PSMA標靶治療市場，包括市場規模、表現和預測、PSMA標靶治療市場佔有率、詳細假設以及方法論，涵蓋了七國集團（G7）國家的藥物。
• 透過 SWOT 分析、專家見解/KOL 觀點和治療偏好來了解趨勢，這將有助於塑造和推動 7 個主要國家的 PSMA 標靶治療市場，使您在製定業務策略時佔據優勢。

PSMA標靶治療報告的見解

• PSMA標靶治療目標患者群
• 治療方法
• PSMA標靶治療開發平台分析
• PSMA標靶治療的市場規模及趨勢
• 現有及未來市場機會

PSMA標靶治療報告主要的優勢

• 11年的預測
• 主要7個國家對象
• 主要競爭產品
• 藥物的使用數量和主要市場預測的前提條件

PSMA標靶治療報告評估

• 目前治療方法
• 未滿足需求
• 開發中產品簡介
• 市場魅力
• 定性分析(SWOT)

目錄

第1章 重要的洞察

第2章 報告書的簡介

第3章 PSMA標靶治療的摘要整理

第4章 主要事件

第5章 市場預測的調查手法

第6章 的PSMA標靶治療市場概要主要7個國家

• 2024年的各適應症市場佔有率(%)分佈
• 2034年的各適應症市場佔有率(%)分佈

第7章 PSMA標靶治療:背景和概要

第八章：已上市藥物

• 主要競爭對手
• PLUVICTO（镥 LU-177 聯吡啶四丙酮）：諾華

第九章：新興療法

• 主要競爭對手
• Lu-177-PNT2002：Lantheus
• 177Lu-DOTA-Losopatamab Tetraxetan (TLX591)：Telix Pharmaceutical

第10章 市場分析PSMA標靶治療:主要7個國家

• 主要調查結果
• 市場預測
• 主要的市場預測的前提條件
• 主要7個國家的PSMA標靶治療的整體市場規模
• 美國的市場規模
• EU4個國家和英國的市場規模
• 日本的市場規模

第11章 與市場進入償付

第12章 SWOT分析

第13章 KOL的見解

第14章 未滿足需求

第15章 附錄

第16章 參考文獻

第17章 報告書的調查手法

第18章 DelveInsight的服務內容

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.
• 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

List of Tables

• Table 1: Target Population in the 7MM (2020-2034)
• Table 2: Marketed Drug Key cross
• Table 3: Product 1, Clinical Trial Description, 2024
• Table 4: Product 2, Clinical Trial Description, 2024
• Table 5: Emerging Drug Key cross
• Table 6: Product 1, Clinical Trial Description, 2024
• Table 7: Product 2, Clinical Trial Description, 2024
• Table 8: Total PSMA-Targeted Therapy Market Size in the 7MM (2020-2034)
• Table 9: PSMA-Targeted Therapy Market Size by Therapies in the 7MM (2020-2034)
• Table 10: PSMA-Targeted Therapy Market Size by Indication in the 7MM (2020-2034)
• Table 11: Total PSMA-Targeted Therapy Market Size in the United States (2020-2034)
• Table 12: PSMA-Targeted Therapy Market Size by Therapies in the United States (2020-2034)
• Table 13: Total PSMA-Targeted Therapy Market Size in EU4 and the UK (2020-2034)
• Table 14: PSMA-Targeted Therapy Market Size by Therapies in EU4 and the UK (2020-2034)
• Table 15: Total PSMA-Targeted Therapy Market Size in Japan (2020-2034)
• Table 16: PSMA-Targeted Therapy Market Size by Therapies in Japan (2020-2034)

List of Figures

• Figure 1: Target Population in the 7MM (2020-2034)
• Figure 2: Total PSMA-Targeted Therapy Market Size in the 7MM (2020-2034)
• Figure 3: PSMA-Targeted Therapy Market Size by Therapies in the 7MM (2020-2034)
• Figure 4: PSMA-Targeted Therapy Market Size by Indication in the 7MM (2020-2034)
• Figure 5: Total PSMA-Targeted Therapy Market Size in the United States (2020-2034)
• Figure 6: PSMA-Targeted Therapy Market Size by Therapies in the United States (2020-2034)
• Figure 7: Total PSMA-Targeted Therapy Market Size in EU4 and the UK (2020-2034)
• Figure 8: PSMA-Targeted Therapy Market Size by Therapies in EU4 and the UK (2020-2034)
• Figure 9: Total PSMA-Targeted Therapy Market Size in Japan (2020-2034)
• Figure 10: PSMA-Targeted Therapy Market Size by Therapies in Japan (2020-2034)