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市场调查报告书
商品编码
1745753
前列腺特异性薄膜抗原(PSMA)标靶治疗的全球市场:标的患者,竞争情形,市场预测-2034年Prostate-Specific Membrane Antigen (PSMA) Targeted Therapy - Target Population, Competitive Landscape, and Market Forecast - 2034 |
重点
本报告详细介绍了PSMA标靶治疗的发展历史、竞争格局以及美国、欧盟四国(德国、法国、义大利、西班牙)、英国、日本等国PSMA标靶治疗的市场趋势。
PSMA标靶治疗市场报告提供了当前的治疗方法、新药、治疗方法的市场占有率以及2020年至2034年七个主要国家/地区PSMA标靶治疗市场规模的现状和预测。报告还涵盖了PSMA标靶治疗的现有治疗方法/演算法和未满足的医疗需求,以发现最佳治疗机会并评估市场潜力。
研究期间:2020-2034
PSMA标靶治疗概论
PSMA是一种存在于摄护腺癌细胞表面的蛋白质。 PSMA标靶治疗是一种晚期癌症治疗方法,它使用放射性示踪剂特异性地寻找并摧毁表达PSMA的细胞。它通常用于治疗晚期或转移性前列腺癌,尤其是在对手术和放射治疗等标准治疗失去反应的情况下。这种治疗方法并不能治癒癌症,其主要目的是缓解症状、缩小肿瘤并减缓癌症进展。
PSMA标靶治疗
PSMA标靶治疗通常用于已接受其他标准摄护腺癌治疗(例如化疗、荷尔蒙治疗和化学去势)的患者。如果癌症对这些疗法没有反应,您的医疗保健提供者可能会建议PSMA标靶治疗。在开始治疗之前,医生会进行全面的病史询问和身体检查,以及血液检查和影像检查。影像学检查包括CT扫描(用于获取骨骼和软组织的详细3D影像)和MRI(用于获取软组织结构的高解析度影像)。此外,还将进行PSMA PET扫描,该扫描使用放射性追踪剂检测癌细胞上的PSMA蛋白,以帮助确定肿瘤的位置。治疗包括以小针头注射标准剂量的含镥-177的PSMA疗法,通常注射到手臂静脉。注射过程只需几分钟,患者通常可在当天出院。治疗每六週进行一次,共六个疗程,持续约36週。每次疗程之间都会进行血液检测,以监测患者的反应并检查是否有任何副作用。如果治疗有效,疗程将在最后一次疗程后结束,即治疗开始后八个多月。
PSMA标靶治疗报告的药物章节详细分析了已上市和后期(III期和I/II期)研发的PSMA标靶治疗药物。它还有助于了解PSMA标靶治疗药物的临床试验细节、表达药理学、协议与合作、批准和专利细节、每种药物的优缺点以及最新的新闻和新闻稿。
上市药物
PLUVICTO(镥LU-177 Vipivoide Tetraxetan)- 诺华
镥-177是一种放射性化学元素,会破坏摄护腺癌细胞。在PSMA治疗中,镥-177直接注射到前列腺癌肿瘤,因此放射线对身体其他部位的影响被最小化。
此药物适用于治疗已接受雄性激素受体路径阻断及紫杉烷类化疗治疗的PSMA阳性转移性去势抗性摄护腺癌(mCRPC)成年患者。
新药
PNT2002 是一种小分子放射性配体治疗药物,用于治疗转移性去势抵抗性前列腺癌 (mCRPC)。它透过将 PSMA 特异性配体 PSMA-I&T 与发射 β 射线的无载体放射性同位素镥-177 相结合,靶向 PSMA(前列腺特异性膜抗原)。这种标靶方法使放射性配体能够特异性地与表达 PSMA 的癌细胞结合,从而使放射线能够直接递送至肿瘤,同时最大限度地减少对周围健康组织的损伤。 PNT2002 目前正在进行 III 期临床试验,旨在评估其在先前接受过化疗且单一雄性激素受体路径抑制剂治疗失败的转移性去势抵抗性前列腺癌 (mCRPC) 患者中,相对于现有标准治疗方案的疗效。
TLX591 是一种放射免疫偶联物,由人源化 IgG1 单株抗体罗帕他单抗和低能量 β 发射放射性同位素镥-177 透过双功能螯合剂 DOTA-NHS 酯连接而成。该药物由 Telix 製药公司开发,也称为 TLX591。
该药物透过将放射性有效载荷镥-177 直接递送至表达 PSMA 的癌细胞来发挥作用。这种标靶方法可以实现精准放射治疗,同时最大限度地减少对周围健康组织的损伤。
临床试验表明,TLX591 在治疗晚期前列腺癌(包括转移性去势抵抗性前列腺癌)方面取得了良好的疗效。该疗法已被证明能够有效缩小肿瘤体积并延长患者的无恶化存活期。
预计未来几年 PSMA 标靶治疗市场将大幅成长。这得益于前列腺癌确诊患者数量的不断增长、PSMA 标靶治疗认知度的不断提升,以及各公司临床试验中 PSMA 标靶治疗的数量不断增加。
细胞表面糖蛋白 PSMA 在恶性前列腺细胞中高表达,已被证明是前列腺癌的理想治疗标靶。
目前已核准的 PSMA 标靶治疗包括诺华公司的 PLUVICTO(Lutetium LU-177 Vipivoide Tetraxetan)。它是监管机构批准的唯一一种针对PSMA阳性转移性去势抵抗性前列腺癌的靶向PSMA的放射性配体疗法,适用于雄激素受体通路抑製剂和紫杉烷类化疗失败后的治疗。
目前,PSMA标靶药物市场以PLUVICTO为主,但多种PSMA标靶药物正在进行临床研究,未来可能对PLUVICTO的主导地位构成重大课题。
收购了Lu-177-PNT2002原厂公司Point Pharma的礼来公司,目前正在进行Lu-177-PNT2002用于治疗摄护腺癌的III期临床试验。
包括Point Biopharma/Eli Lilly和Telix Pharmaceuticals在内的多家大型公司都参与了针对前列腺癌等适应症的PSMA标靶药物的开发。
总体而言,这是一个令人兴奋的新药类别,具有巨大的发展潜力。随着未来几年现有研究的日益成熟,我们对PSMA标靶药物的理解将会加深,其在癌症治疗中的作用也将更加清晰。
本节重点介绍2020年至2034年期间预计将上市的已核准和新兴PSMA标靶药物的吸收率。
PSMA标靶药物研发管线开发活动
本报告深入分析了处于III期、II期和I期的各种潜在药物,并分析了参与标靶药物研发的关键公司。
预计大量处于不同阶段的药物将为预测期内PSMA标靶药物市场的成长提供巨大的机会。
产品线开发活动
本报告涵盖了针对PSMA标靶药物的新兴药物的合作、收购、合併、授权和专利细节资讯。
主要市场参与者之间日益增多的策略联盟,旨在促进产品线的成长,预计将推动市场扩张。例如,2022年11月,Point Biopharma与Lantheus达成策略联盟及独家授权协议,以商业化PNT2002(一种PSMA标靶疗法)。 Lantheus获得了PNT2002的全球独家授权(不包括某些地区)。
该协议最终确定了2.5亿美元的首付款,并在获得美国监管机构批准后可能额外支付2.5亿美元。此外,在实现某些里程碑后,美国销售额还可能增加13亿美元,并获得20%的销售额特许权使用费。
KOL的见解
为了了解当前和未来的市场趋势,我们透过一手资料研究与活跃于该领域的行业专家合作,以填补数据空白并验证我们的二次研究。我们联繫了行业专家,深入了解不断变化的行业格局、患者对传统疗法的依赖性、患者对转换疗法的接受度、药物吸收、可及性课题等。
DelveInsight 分析师已联繫了 25 多位关键意见领袖 (KOL) 收集见解,并采访了来自 7 个主要国家/地区和基因组肿瘤诊所等中心的 10 多位关键意见领袖。
他们的观点有助于理解和验证 PSMA 标靶治疗市场中当前和新兴的治疗模式和趋势。这透过识别整体市场情景和未满足的需求,帮助我们的客户掌握未来新疗法的机会。
定性分析
我们采用 SWOT 分析和联合分析等各种方法进行定性和市场情报分析。 SWOT分析法能够从疾病诊断、病患认知度、医师接受度、竞争格局、成本效益以及治疗的地理可及性等方面,提供优势、劣势、机会和威胁。
联合分析法是基于安全性、有效性、给药频率、给药途径和给药顺序等相关属性,对多种已核准和新兴疗法进行分析。根据这些参数,给予评分以分析治疗的有效性。
例如,在无事件存活期中,最重要的主要终点之一是无事件存活期和总存活期。
此外,也会评估治疗的安全性,主要观察药物的可接受性、耐受性和不良事件,以清楚了解药物在试验中引起的副作用。此外,评分也基于每种疗法的成功机率和可涵盖的患者群体。基于这些参数,确定新兴疗法的最终加权分数和排名。
市场准入与报销
PSMA标靶治疗在美国和其他七国集团(G7)国家已实现全民报销。
PSMA标靶治疗报告的见解
PSMA标靶治疗报告主要的优势
PSMA标靶治疗报告评估
Key Highlights:
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.
Study Period: 2020-2034
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.
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.
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.
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.
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
PSMA-targeted Therapy report insights
PSMA-targeted therapy report key strengths
PSMA-targeted therapy report assessment