前立腺特異的膜抗原（PSMA）標的治療の世界市場：標的患者、競合情勢、市場予測-2034年

主なハイライト

• 前立腺がん細胞ではPSMAが高発現しています。PSMA標的療法は、PSMAに結合して抗原を傷害し、前立腺がん細胞を死滅させることで効果を発揮します。
• PSMAは前立腺がん細胞の表面で高発現していますが、正常組織では最小か全く発現していません。PSMA標的療法は、健康な細胞を温存しながらがん細胞を選択的に死滅させることができるため、従来の化学療法や放射線療法によく見られる副作用を軽減することができます。
• PSMA標的療法の主な利点は、前立腺がんの治療に役立ち、病気の広がりを遅らせ、前立腺がんの症状を改善することです。
• 2022年、米国食品医薬品局（FDA）は、アンドロゲン受容体経路阻害薬とタキサン系化学療法による前治療歴のあるPSMA陽性の転移性去勢抵抗性前立腺がん成人患者に対する初のPSMA標的療法として、PLUVICTO（ルテチウムLu 177ビピボタイド・テトラキセタン、または177 Lu-PSMA-617）を承認しました。
• PLUVICTOは全世界で約13億9,200万米ドルの売上を計上し、2024年にブロックバスターに認定されました。
• 2025年3月、Novartisは米国FDAがPSMA陽性転移性去勢抵抗性前立腺がんの治療に対するPLUVICTOの使用拡大を承認したと発表しました。
• 2023年4月、FDAはPSMA標的治療薬177Lu-PNT2002を転移性去勢抵抗性前立腺がん患者の治療薬としてファストトラック指定しました。
• 現在、いくつかのPSMA標的治療薬が臨床試験で評価されています。その一例がリリーの177Lu-PNT2002で、開発段階にあり、予測期間中に承認されると予想されています。
• Lantheus、Telix Pharmaceuticals、その他の複数の企業がPSMA標的治療薬の開発と生産に積極的に取り組んでおり、PSMA標的治療薬市場に大きな影響を与え、強化する可能性を秘めています。
• 2024年には、米国が主要7ヶ国の中でPSMA標的治療薬市場の最大シェアを占めます。

当レポートは、米国、EU4ヶ国（ドイツ、フランス、イタリア、スペイン）、英国、日本のPSMA標的療法の市場動向とともに、PSMA標的療法の歴史、競合情勢を詳細に紹介しています。

PSMA標的治療市場レポートは、現在の治療法、新薬、治療法の市場シェア、2020年から2034年までの主要7ヶ国のPSMA標的治療市場規模の現状と予測を提供します。また、PSMA標的療法の現在の治療法/アルゴリズムやアンメットメディカルニーズも網羅し、最良の治療機会を発掘し、市場の可能性を評価します。

対象地域

• 米国
• EU4ヶ国（ドイツ、フランス、イタリア、スペイン）および英国
• 日本

調査期間：2020年～2034年

PSMA標的治療の理解と治療アルゴリズム

PSMA標的療法の概要

PSMAは前立腺がん細胞の表面に存在するタンパク質です。PSMA標的療法は、放射性トレーサーを用いてPSMAを発現する細胞を特異的に探し出し、破壊する先進的ながん治療法です。通常、進行性または転移性の前立腺がんの治療、特に手術や放射線などの標準的な治療に反応しなくなった場合に使用されます。この治療法はがんを治癒させるものではありませんが、その主な目的は、症状を緩和し、腫瘍を小さくし、がんの進行を遅らせることです。

PSMA標的治療

PSMA標的療法は通常、化学療法、ホルモン療法、化学的去勢など、他の標準的な前立腺がん治療を受けた患者に行われます。がんがこれらのアプローチに反応しない場合、医療提供者はPSMA標的療法を推奨することがあります。治療を開始する前に、患者さんの病歴の徹底的な確認と身体診察が行われ、血液検査や画像検査が行われます。画像検査には、骨や軟部組織の詳細な3D画像を得るためのCTスキャンや、軟部組織構造の高解像度画像を得るためのMRIが含まれます。がん細胞上のPSMAタンパク質を検出する放射性トレーサーを使用するPSMA PETスキャンも実施され、腫瘍の位置を正確に特定するのに役立ちます。治療では、ルテチウム177を含む標準量のPSMA療法を、通常は腕の静脈に小さな針で注射します。注射には数分しかからず、患者は通常その日のうちに退院できます。治療は6週間ごとに行われ、合計6回のセッションを約36週間にわたって行う。各セッションの間に血液検査が行われ、患者の反応をモニターし、副作用の有無をチェックします。治療が有効であれば、治療開始から8ヵ月強の最終セッション後に終了します。

PSMA標的治療薬の章

PSMA標的治療レポートの薬剤の章では、PSMA標的治療の市販薬および後期（第III相および第I/II相）パイプライン薬の詳細な分析を掲載しています。また、PSMA標的治療薬の臨床試験の詳細、表現力豊かな薬理作用、契約と提携、承認と特許の詳細、含まれる各薬剤の長所と短所、最新のニュースやプレスリリースの理解にも役立ちます。

市販薬

PLUVICTO（Lutetium LU-177 Vipivoide Tetraxetan） - Novartis

ルテチウム-177は前立腺がん細胞を破壊する放射性化学元素です。PSMA療法では、ルテチウム-177を前立腺がん腫瘍に直接投与するため、放射線が体の他の部分に及ぼす影響は最小限に抑えられます。

本剤は、アンドロゲン受容体経路阻害療法およびタキサン系化学療法による治療を受けたPSMA陽性の転移性去勢抵抗性前立腺がん（mCRPC）成人患者の治療に適応されます。

新薬

Lu-177-PNT2002 - Lantheus

PNT2002は、転移性去勢抵抗性前立腺がん（mCRPC）治療用にデザインされた低分子の放射性リガンド治療薬です。PSMA特異的リガンドであるPSMA-I&Tとβ線を放出するキャリアのない放射性同位元素であるルテチウム-177を組み合わせることにより、PSMA（前立腺特異的膜抗原）を標的とします。この標的アプローチにより、放射性リガンドはPSMAを発現するがん細胞に特異的に結合し、周囲の健康な組織へのダメージを最小限に抑えながら、腫瘍に直接放射線を照射することができます。PNT2002は現在、アンドロゲン受容体経路阻害剤1剤による治療が既に無効となった化学療法前のmCRPC患者を対象に、現在の標準治療と比較してその有効性を評価することを目的とした第III相臨床試験が実施されています。

177Lu-DOTA-ロソパタマブ・テトラキセタン（TLX591）- Telix pharmaceutical

TLX591は、ヒト化IgG1モノクローナル抗体ロソパタマブと、二官能性キレート剤DOTA-NHSエステルを介して低エネルギーβ線放出放射性同位元素ルテチウム-177が結合した放射性免疫複合体です。この薬剤はTelix Pharmaceuticalsによって開発されており、TLX591としても知られています。

この薬剤は、PSMAを発現しているがん細胞に放射性ペイロードであるルテチウム177を直接送達することによって作用します。この標的アプローチにより、周囲の健康な組織へのダメージを最小限に抑えながら、正確な放射線治療が可能になります。

臨床試験では、転移性去勢抵抗性前立腺がんを含む進行前立腺がんの治療において、TLX591の有望な結果が示されています。この治療法は、患者の腫瘍サイズの縮小と無増悪生存期間の延長の両方において有効性が実証されています。

PSMA標的療法の市場展望

PSMA標的療法市場は今後数年間で大きく成長すると予想されます。この背景には、前立腺がんと診断される患者数の増加、PSMA標的療法に対する認知度の向上、各社が臨床試験中のPSMA標的療法の増加などがあります。

細胞表面糖タンパク質PSMAは、前立腺悪性細胞で高発現していることから、前立腺がんにおける理想的な治療標的であることが証明されています。

現在承認されているPSMA標的治療薬には、NovartisのPLUVICTO（Lutetium LU-177 Vipivoide Tetraxetan）があります。これは、アンドロゲン受容体経路阻害剤およびタキサン系化学療法が無効となったPSMA陽性の転移性去勢抵抗性前立腺がんにおいて、規制当局から承認された唯一のPSMA標的放射性リガンド療法です。

現在、PSMA標的治療薬市場はPLUVICTOが支配的ですが、様々なPSMA標的治療薬が臨床研究中であり、将来的にはPLUVICTOの支配に大きく課題する可能性があります。

Lu-177-PNT2002の創始者であるPoint Pharmaを買収したEli Lillyは、前立腺がんの治療薬としてLu-177-PNT2002の第III相臨床試験を実施中です。

Point Biopharma／Eli Lilly、Telix Pharmaceuticalsなど複数の主な企業が、前立腺がんなどを適応症とするPSMA標的治療薬の開発に関与しています。

全体として、これは開発の大きな可能性を秘めたエキサイティングな新薬クラスです。今後数年間で現在の研究が成熟すれば、PSMA標的治療薬に対する理解が深まり、がん治療におけるPSMA標的治療薬の役割が明確になると思われます。

PSMA標的治療薬の取り込み

本セクションでは、2020～2034年に市場投入が期待される、承認済みおよび新興のPSMA標的治療薬の取り込み率に焦点を当てます。

PSMA標的治療薬のパイプライン開発活動

当レポートでは、第III相、第II相、第I相段階にあるさまざまな治療薬候補に関する洞察を提供するとともに、標的治療薬の開発に携わる主要企業を分析しています。

さまざまな段階にある数多くの薬剤の存在は、予測期間にわたってPSMA標的治療薬市場の成長に絶大な機会をもたらすと期待されています。

パイプライン開発活動

当レポートでは、PSMA標的治療の新興治療薬に関する共同研究、買収・合併、ライセンシング、特許の詳細に関する情報を網羅しています。

パイプライン製品の成長を強化するための主要市場参入企業間の戦略的提携の増加は、市場拡大を促進すると予想されます。例えば、2022年11月、Point Biopharmaは、PNT2002（PSMA標的治療薬）の商業化のため、Lantheusと戦略的提携および独占ライセンス契約を締結しました。Lantheusは、PNT2002の特定の地域を除く全世界での独占的権利を獲得しました。

本契約は、初回支払額として2億5,000万米ドル、米国規制当局からの承認取得を条件として2億5,000万米ドルの追加支払の可能性で最終決定されました。また、特定のマイルストーンを達成した場合には、米国で13億米ドルの売上高と売上高に対する20％のロイヤルティが追加で支払われる可能性があります。

KOLの見解

現在および将来の市場動向を把握するため、データのギャップを埋め、2次調査を検証するために、1次調査を通じて、この領域で活躍する業界専門家の意見を取り入れています。業界情勢の変化、従来の治療法に対する患者の依存度、患者の治療法切り替えの受容性、薬剤の取り込み、アクセシビリティに関する課題などについての洞察を得るため、業界専門家にコンタクトを取りました。

DelveInsightのアナリストは25人以上のKOLと接触して洞察を収集しましたが、インタビューは主要7ヶ国の10人以上のKOLに実施しました。Genomic Oncology Clinicなどのセンターです。

彼らの意見は、現在および新たな治療パターンやPSMA標的治療市場動向の理解と検証に役立ちます。これは、市場の全体的なシナリオとアンメットニーズを特定することで、今後の新規治療の可能性においてクライアントをサポートします。

定性分析

SWOT分析やコンジョイント分析など、様々なアプローチを用いて定性・マーケットインテリジェンス分析を行います。SWOT分析では、疾患診断におけるギャップ、患者の認知度、医師の受容性、競合情勢、費用対効果、治療法の地域情勢別アクセスなどの観点から、強み、弱み、機会、脅威を提供します。

コンジョイント分析では、安全性、有効性、投与頻度、投与経路、投与順序などの関連属性に基づいて、複数の承認済み治療薬と新興治療薬を分析します。これらのパラメータに基づいてスコアリングを行い、治療の有効性を分析します。

例えば、無イベント生存期間では、最も重要な主要評価項目の一つは無イベント生存期間と全生存期間です。

さらに、治療法の安全性が評価され、許容性、忍容性、有害事象が主に観察され、試験において薬剤がもたらす副作用を明確に理解します。さらに、スコアリングは成功確率と各治療法の対応可能な患者プールにも基づいています。これらのパラメータに基づき、最終的な重み付けスコアと新興治療薬のランキングが決定されます。

市場参入と償還

PSMAを標的とした治療に対する償還は、米国および他の主要7ヶ国諸国では普遍的に行われています。

調査範囲：

• 当レポートでは、主要イベント、エグゼクティブサマリー、PSMA標的治療の概要、調査範囲、承認薬、進行中の臨床試験などを解説しています。
• 競合情勢に関する包括的な考察、予測、診断率、疾患進行度、治療ガイドラインの将来的な成長可能性を提供しています。
• さらに、現在の治療法および新たな治療法の包括的な説明と、後期および著名な治療法の詳細なプロファイルは、現在の治療状況に影響を与える見込みです。
• PSMA標的治療薬市場の詳細なレビュー、市場規模実績と予測、PSMA標的治療薬の市場シェア、詳細な前提条件、アプローチの根拠は、主要7ヶ国の薬剤をカバーするレポートに含まれています。
• SWOT分析による動向、専門家の洞察/KOLの見解、主要7ヶ国のPSMA標的治療市場の形成と推進に役立つ治療嗜好を理解することで、事業戦略を策定する際の優位性を提供します。

PSMA標的療法レポートのインサイト

• PSMA標的治療ターゲット患者群
• 治療アプローチ
• PSMA標的療法パイプライン分析
• PSMA標的療法の市場規模および動向
• 既存および将来の市場機会

PSMA標的治療レポートの主な強み

• 11年間の予測
• 主要7ヶ国を対象
• 主要競合製品
• 薬剤の使用量と主な市場予測の前提条件

PSMA標的治療レポート評価

• 現在の治療法
• アンメットニーズ
• パイプライン製品プロファイル
• 市場の魅力
• 定性分析（SWOT）

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 PSMA標的療法のエグゼクティブサマリー

第4章 主要な出来事

第5章 市場予測の調査手法

第6章 主要7ヶ国におけるPSMA標的療法市場概要

• 2024年の適応症別市場シェア（％）分布
• 2034年の適応症別市場シェア（％）分布

第7章 PSMA標的療法：背景と概要

第8章 上市済み薬剤

• 主な競合
• PLUVICTO（ルテチウムLU-177ビピボイドテトラキセタン）：Novartis

第9章 新たな治療法

• 主な競合
• Lu-177-PNT2002：Lantheus
• 177Lu-DOTA-ロソパタマブテトラキセタン（TLX591）：Telix Pharmaceutical

第10章 PSMA標的療法：主要7ヶ国市場分析

• 主な調査結果
• 市場見通し
• 主要な市場予測の前提条件
• 主要7ヶ国におけるPSMA標的療法の総市場規模
• 米国の市場規模
• EU4ヶ国と英国の市場規模
• 日本の市場規模

第11章 市場アクセスと償還

第12章 SWOT分析

第13章 KOLの見解

第14章 アンメットニーズ

第15章 付録

第16章 参考文献

第17章 報告書の調査手法

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

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)

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