標的α射線治療的全球市場:市場規模，藥物核准，專利技術，臨床試驗相關洞察(2028年)

放射免疫療法代表了現代醫學的重大進步，它使用放射性同位素專門針對並消除患病組織。傳統上，β和γ發射核素已廣泛用於各種治療應用，包括治療癌症、甲狀腺疾病和某些神經系統疾病。 β粒子因其中等穿透能力而被認為在對抗細胞惡性腫瘤方面發揮著重要作用。另一方面，伽馬射線可以更深入地穿透組織，因此經常用於成像和治療幹預。然而，儘管它們有效，但這些輻射具有某些缺點，例如對鄰近健康組織的潛在損害以及難以獲得精確的局部效果。

α發射核素的引入徹底改變了放射性藥物領域。這些粒子的特徵是高線性能量轉移 (LET) 和非常有限的穿透深度，在消除癌細胞的同時不傷害周圍的健康組織，提供卓越的精確度。這一特性使得α發射粒子在針對微轉移性疾病或孤立的惡性細胞時特別有利，並且代表了相對於傳統β射線和伽馬射線療法的顯著改進。

標靶α療法（TAT）領域的一項重要成就是Xofigo（二氯化鐳223）的核准。這種α發射放射性藥物已被批准用於治療具有症狀性骨轉移但無內臟轉移的去勢抵抗性前列腺癌（CRPC）患者。此次批准基於關鍵的 3 期 ALSYMPCA 試驗，該試驗證明了在患者生存和疼痛緩解方面的顯著優勢，為晚期前列腺癌的疼痛管理建立了新標準。 Xofigo 目前已在 50 多個國家/地區獲得批准，以支援全球臨床和商業成功。

儘管 Xofigo 是目前唯一獲準的 α 發射療法，但 α 標靶治療領域正在快速發展，特別是對於實體腫瘤。研究人員正在積極研究各種α發射物質，以提高治療效果並擴大治療應用。其中，Lead-212 已成為一個特別有前途的選擇，在許多臨床前和臨床研究中顯示出潛力。此外，猶他大學最近的研究正在評估標靶α療法在治療阿茲海默症等神經退化性疾病的有效性。這證明了α發射設備在解決各種複雜的醫療問題方面的適應性和廣泛潛力。

對 TAT 的興趣不僅限於現有公司；新進業者正在引入新機制並增加 α 發射療法的種類，從而改變競爭環境。創新的興起正在推動合作夥伴關係、投資和合作研究計劃，為進一步的臨床和商業進步創造動力。隨著市場的發展，阿爾法發射設備在精準醫療中的重要性預計將不斷增長，這使得人們對多種疾病的更有效、侵入性更小的治療方案感到樂觀。憑藉著標靶α療法的潛力，放射性藥物的未來似乎有望解決現代醫學中一些最迫切的挑戰。

本報告提供全球標的α射線治療市場相關調查，提供市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及加入此市場的主要企業競爭情形等資訊。

目錄

第1章 標的α射線治療的簡介

第2章 標的α射線治療- 結構與作用機制

• 結構
• 作用機制

第3章 標的α射線治療的應用，癌症

• 造血惡性腫瘤
• 固態腫瘤

第4章 全球標的α射線治療市場洞察

• 目前市場情勢
• 未來的成長的道

第5章 標的α射線治療市場洞察，各地區

• 美國
• 歐洲
• 中國
• 日本
• 澳洲

第6章 標的α射線治療的臨床試驗相關企業，國家，適應症，各期的考察

• 研究
• 前臨床
• 第一階段
• 第一/二階段
• 第二階段
• 第二/三階段
• 第三階段

第7章 企業，國家，各適應症看了的市售的標的α射線治療的臨床性洞察

第8章 Xofigo- 最初已批准標的α射線治療

第9章 標的α射線治療- 企業獨自的技術平台

第10章 全球標的α射線治療市場動態

• 促進因素和機會
• 課題與阻礙因素

第11章 競爭情形

• Actinium Pharma
• AdvanCell
• Bayer
• Fusion Pharma
• Johnson & Johnson
• Modulation Therapeutics
• Orano Med
• Perspective Therapeutics
• RayzeBio
• Telix Pharmaceuticals

Global Targeted Alpha Therapy Market Size, Drugs Approval, Proprietary Technologies & Clinical Trials Insight 2028 Report Highlights:

• Global Targeted Alpha Therapy Market Insight By Region
• Approved Targeted Alpha Therapy Dosage & Pricing Insight
• Number Of Targeted Alpha Therapy In Clinical Trials: > 20 Drugs
• Targeted Alpha Therapy Clinical Trials Insight By Company, Country, Indication & Phase
• Marketed Targeted Alpha Therapy Clinical Insight By Company, Country & Indication
• Targeted Alpha Therapy Proprietary Technology Platform Insights By Company

Radioimmunotherapy marks a notable progression in modern medicine, utilizing radioactive isotopes to specifically target and eliminate diseased tissues. Traditionally, beta and gamma emitters have been extensively employed across various therapeutic applications, such as in the treatment of cancer, thyroid disorders, and certain neurological ailments. Beta particles, recognized for their moderate penetration capabilities, have played a crucial role in addressing cellular malignancies, whereas gamma rays, which penetrate deeper into tissues, are frequently used for both imaging and therapeutic interventions. Nonetheless, despite their effectiveness, these radiation types are accompanied by certain drawbacks, including potential damage to adjacent healthy tissues and difficulties in achieving precise localized effects.

The introduction of alpha emitters has transformed the field of radiopharmaceuticals. These particles, distinguished by their high linear energy transfer (LET) and very limited penetration depths, provide exceptional accuracy in eliminating cancer cells while preserving surrounding healthy tissues. This characteristic renders alpha emitters particularly advantageous for targeting micrometastatic diseases and isolated malignant cells, offering a significant improvement over conventional beta and gamma therapies.

A significant achievement in the realm of targeted alpha therapy (TAT) is the approval of Xofigo (radium-223 dichloride). This alpha-emitting radiopharmaceutical has been approved for the treatment of patients with castration-resistant prostate cancer (CRPC) who exhibit symptomatic bone metastases without known visceral metastases. Its approval, based on the pivotal Phase 3 ALSYMPCA trial, demonstrated considerable survival advantages and pain alleviation for patients, establishing a new benchmark for the management of advanced-stage prostate cancer. Presently, Xofigo holds approval in over 50 countries, underscoring its global clinical and commercial success.

While Xofigo currently stands as the sole approved alpha emitting therapy, the field of targeted alpha therapy is experiencing rapid growth, particularly for solid tumors. Researchers are diligently exploring various alpha emitters to improve treatment effectiveness and expand therapeutic applications. Among these, Lead-212 has emerged as a notably promising option, demonstrating potential in numerous preclinical and clinical investigations. Additionally, researchers are examining uses beyond oncology, highlighted by a recent study from the University of Utah that assessed the efficacy of targeted alpha therapies in treating neurodegenerative diseases such as Alzheimer's. This illustrates the adaptability and extensive potential of alpha emitters in tackling a wide range of complex medical issues.

The landscape of clinical trials for TAT is both dynamic and competitive. Companies such as RayzeBio are at the forefront, with their candidate RYZ101 progressing to Phase 3 trials for patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. These tumors, which have advanced following previous Lutetium-177-based treatments, represent a significant unmet medical need. The advancement of RYZ101 highlights the increasing emphasis on alpha emitters as viable alternatives to current radiopharmaceuticals. Furthermore, the market has seen a surge of innovative preclinical candidates. In January 2024, Cellectar Biosciences reported promising preclinical results for CLR 121225, an alpha-emitting phospholipid radiotherapeutic conjugate aimed at pancreatic cancer. This development signifies a continued dedication to innovation and the potential for broadening TAT applications into previously unexplored areas.

Interest in TAT is not limited to established companies; new entrants are transforming the competitive environment by introducing novel mechanisms and expanding the array of alpha-emitting therapies. This surge of innovation is fostering partnerships, investments, and collaborative research initiatives, thereby generating momentum for additional clinical and commercial advancements. As the market progresses, the significance of alpha emitters in precision medicine is expected to increase, providing optimism for more effective and less invasive treatment options for a wide range of diseases. With the potential of targeted alpha therapy, the future of radiopharmaceuticals appears well-positioned to tackle some of the most urgent challenges in contemporary medicine.

Table of Contents

1. Introduction To Targeted Alpha Therapy

• 1.1 Overview
• 1.2 Alpha Radiation vs. Beta & Gamma Radiation In Cancer Therapy

2. Targeted Alpha Therapy - Structure & Mechanism Of Action

• 2.1 Structure
• 2.2 Mechanism Of Action

3. Targeted Alpha Therapy Applications By Cancer

• 3.1 Hematological Malignancies
• 3.2 Solid Tumors

4. Global Targeted Alpha Therapy Market Insight

• 4.1 Current Market Scenario
• 4.2 Future Growth Avenues

5. Targeted Alpha Therapy Market Insight By Region

• 5.1 US
• 5.2 Europe
• 5.3 China
• 5.4 Japan
• 5.5 Australia

6. Targeted Alpha Therapy Clinical Trials Insight By Company, Country, Indication & Phase

• 6.1 Research
• 6.2 Preclinical
• 6.3 Phase I
• 6.4 Phase I/II
• 6.5 Phase II
• 6.6 Phase II/III
• 6.7 Phase III

7. Marketed Targeted Alpha Therapy Clinical Insight By Company, Country & Indication

8. Xofigo - 1st Approved Targeted Alpha Therapy

• 8.1 Overview & Patent Insight
• 8.2 Pricing & Dosing

9. Targeted Alpha Therapy - Proprietary Technology Platform By Company

10. Global Targeted Alpha Therapy Market Dynamics

• 10.1 Drivers & Opportunities
• 10.2 Challenges & Restraints

11. Competitive Landscape

• 11.1 Actinium Pharma
• 11.2 AdvanCell
• 11.3 Bayer
• 11.4 Fusion Pharma
• 11.5 Johnson & Johnson
• 11.6 Modulation Therapeutics
• 11.7 Orano Med
• 11.8 Perspective Therapeutics
• 11.9 RayzeBio
• 11.10 Telix Pharmaceuticals

List of Figures

• Figure 2-1: Targeted Alpha Therapy - Structure
• Figure 2-2: Targeted Alpha Therapy - Mechanism Of Action
• Figure 3-1: LIN-AC225-AML02 Phase 1/2 (NCT03867682) Study - Initiation & Completion Year
• Figure 3-2: AcTRESS Phase 1 (NCT06411301) Study - Initiation & Completion Year
• Figure 3-3: RG1121028 Phase 1 (NCT04579523) Study - Initiation & Completion Year
• Figure 3-4: 225Ac-DOTA-daratumumab Phase 1 (NCT05363111) Study - Initiation & Completion Year
• Figure 3-5: PAnTHA Phase 1 (NCT06217822) Study - Initiation & Completion Year
• Figure 3-6: PSMA-617-100 Phase 1 (NCT04597411) Study - Initiation & Completion Year
• Figure 3-7: BAY3546828 Phase 1 (NCT06052306) Study - Initiation & Completion Year
• Figure 3-8: VMT-a-NET-T101 Phase 1/2a (NCT05636618) Study - Initiation & Completion Year
• Figure 3-9: FPI-2059-101 Phase 1 (NCT05605522) Study - Initiation & Completion Year
• Figure 4-1: Factors Influencing Future Market of Targeted Alpha Therapies
• Figure 4-2: Global - Targeted Alpha Therapy Market Opportunity (US$ Million), 2025 & 2028
• Figure 9-1: Fusion Pharma - Fast-Clear(TM) Linker Technology
• Figure 9-2: AdvanCell - Proprietary 212Pb Production Technology
• Figure 9-3: Cellectar Biosciences - Phospholipid Ether (PLE) Platform Technology
• Figure 9-4: Perspective Therapeutics - Proprietary Technology & Pb-212 Isotope

Generator VMT-a-NET

• Figure 10-1: Global Targeted Alpha Therapy Market - Drivers & Opportunities
• Figure 10-2: Global Targeted Alpha Therapy Market - Challenges & Restraints

List of Tables

Table 1 1: Alpha Radiation vs. Beta & Gamma Radiation In Cancer Therapy

• Table 4-1: Efforts to Increase Radioisotope Production Capacity
• Table 4-2: Recent Collaborations for Targeted Alpha Therapy Development
• Table 6-1: Targeted Alpha Therapies In Research Stage, 2024
• Table 6-2: Targeted Alpha Therapies In Preclinical Stage, 2024
• Table 6-3: Targeted Alpha Therapies In Phase I, 2024
• Table 6-4: Targeted Alpha Therapies In Phase I/II, 2024
• Table 6-5: Targeted Alpha Therapies In Phase II, 2024
• Table 6-6: Targeted Alpha Therapies In Phase II/III, 2024
• Table 6-7: Targeted Alpha Therapies In Phase III, 2024
• Table 7-1: Marketed Targeted Alpha Therapies, 2024
• Table 8-1: Xofigo - Decay Correction Factor