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市场调查报告书
商品编码
1916502
全球放射治疗诊断市场:市场规模、份额、成长率、产业分析、按类型、应用和地区划分的考量因素以及未来预测(2026-2034)Radiotheranostics Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034 |
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由于癌症发生率的上升和核医学的不断进步,全球放射治疗诊断市场正经历快速扩张。根据2025年的数据,预计2025年全球放射治疗诊断市场规模将达到47.5亿美元,2026年将成长至61.8亿美元,到2034年将达到442.6亿美元。从2026年到2034年,该市场预计将以27.90%的复合年增长率成长,这反映了标靶放射性药物疗法在肿瘤学领域的快速普及。
放射诊疗一体化是指将诊断影像与标靶放射治疗结合,使用同一种分子标靶药物。这些疗法能够实现精准的肿瘤检测和同步治疗,显着改善临床疗效,同时减少对健康组织的伤害。个人化医疗和分子影像技术的日益普及,进一步推动了整个医疗保健系统对放射诊疗一体化产品的需求。
市场驱动因素
全球癌症负担的日益加重是市场成长的主要驱动因素。摄护腺癌、神经内分泌肿瘤、乳癌和肺癌发生率的上升,使得标靶放射性配体疗法的需求强劲。人口老化和生活方式相关的风险因素也导致需要接受先进癌症治疗的患者群体不断扩大。此外,PET和SPECT影像平台的普及也加速了放射诊治疗整合技术在临床上的应用。
政府资助和公私合作正在推动进一步的创新。 2024年6月,Clarity Pharmaceuticals获得了660万美元的研发资助,用于支持针对多种癌症适应症的标靶铜疗法的开发。这显示机构对放射性药物研究给予了强有力的支持。
市场限制因子
儘管成长潜力巨大,但高昂的生产和研发成本仍然是主要障碍。放射性药物的生产需要专门的基础设施、迴旋加速器、热室以及严格的监管合规性,这增加了资本支出。此外,某些放射性同位素的半衰期较短,需要快速的物流和本地生产设施,从而提高了营运成本。某些国家严格的报销政策也限制了患者获得新疗法的机会,尤其是在新兴市场。
市场机会
随着放射性诊疗技术扩展到新的癌症适应症,存在着巨大的机会。正在进行的临床试验正在探索其在胶质母细胞瘤、大肠癌、卵巢癌和小细胞肺癌中的应用。个人化癌症治疗模式的日益普及推动了对客製化放射性配体疗法的需求。分子标靶药物和同位素生产技术的进步可望进一步提高治疗的精准度和生产规模。
2024年7月,Aryceum Therapeutics启动了一项针对復发性胶质母细胞瘤的PARP靶向放射性药物的I期临床试验,这标誌着放射性诊疗产品线正从前列腺癌和神经内分泌肿瘤领域向其他领域不断多元化发展。
市场挑战
关键同位素(例如锕-225)的全球短缺构成了重大的供应挑战。有限的产能以及对核反应器和粒子加速器的依赖限制了临床和商业用途的同位素供应。此外,放射性药物严格的监管审批流程增加了研发时间和成本,导致产品上市延迟,并在某些地区市场渗透率有限。
市场趋势
人工智慧 (AI) 和机器学习正日益融入放射性诊疗一体化药物的研发中。 AI 被用于优化成像、患者选择、治疗计划和剂量预测,从而提高治疗精度。将影像数据与基因组和临床数据结合,可以实现更有效的个人化治疗方案。 2024 年 11 月,GE 医疗与 DeepHealth 合作,推动 AI 驱动的医学影像技术,以改善放射性药物治疗流程。
按放射性同位素划分,镥-177 占据市场主导地位,预计到 2026 年将占据 55.49% 的市场份额,这主要归功于其在治疗前列腺癌和神经内分泌肿瘤方面的高临床疗效。儘管镭-223和碘-131仍用于某些治疗,但新兴同位素正透过扩大临床试验而备受关注。
依应用领域划分,前列腺癌占据主导地位。这得归功于诊断率的提高以及PSMA标靶放射性配体疗法获准数量的增加。神经内分泌肿瘤也占据了相当大的市场份额,这主要归功于胜肽受体放射性核素疗法(PRRT)的高反应率。其他应用领域,包括乳癌和肺癌,也正透过扩大临床研究而获得发展动力。
按最终用户划分,拥有专业核医基础设施和训练有素人员的医院和诊所是主要用户。由于诊断影像测试数量的增加,诊断中心和研究机构也推动了需求成长。
北美地区拥有先进的医疗基础设施、完善的报销系统和较高的肿瘤治疗支出,预计到2025年将占据全球市场60.80%的份额。北美市场规模预计到2025年将达到28.9亿美元。
欧洲市场预计到2026年将达到10.9亿美元,主要得益于癌症防治宣传活动的增加和强劲的药物研发活动。
亚太地区预计到2026年将达到9.9亿美元,这主要得益于临床试验的增加、监管审批的推进以及癌症患者数量的增长。
预计到 2025 年,世界其他地区(中东和非洲)的市场规模将达到 2.8 亿美元,主要得益于中东国家对核子医学基础设施投资的增加。
The global radiotheranostics market is witnessing rapid expansion due to rising cancer prevalence and continuous advancements in nuclear medicine. According to the 2025 report year data, the global radiotheranostics market size was valued at USD 4.75 billion in 2025 and is projected to grow to USD 6.18 billion in 2026, reaching USD 44.26 billion by 2034. The market is expected to grow at a CAGR of 27.90% from 2026 to 2034, reflecting strong adoption of targeted radiopharmaceutical therapies across oncology applications.
Radiotheranostics refers to the integration of diagnostic imaging and targeted radiotherapy using the same molecular targeting agents. These therapies enable precise tumor detection and simultaneous treatment, which significantly improves clinical outcomes and reduces damage to healthy tissues. Growing acceptance of personalized medicine and molecular imaging technologies is further strengthening demand for radiotheranostic products across healthcare systems.
Market Drivers
The increasing global cancer burden is a primary driver of market growth. Higher incidence rates of prostate cancer, neuroendocrine tumors, breast cancer, and lung cancer are creating strong demand for targeted radioligand therapies. Aging populations and lifestyle-related risk factors are also contributing to the expanding patient pool requiring advanced oncology treatments. Moreover, improved access to PET and SPECT imaging platforms is accelerating clinical adoption of radiotheranostic procedures.
Government funding and public-private collaborations are further enhancing innovation. In June 2024, Clarity Pharmaceuticals received USD 6.6 million in R&D incentives to support development of targeted copper theranostics for multiple cancer indications, demonstrating strong institutional backing for radiopharmaceutical research.
Market Restraints
Despite strong growth potential, high production and development costs remain major barriers. Radiopharmaceutical manufacturing requires specialized infrastructure, cyclotrons, hot cells, and strict regulatory compliance, which increases capital expenditure. Additionally, short half-lives of several radioisotopes require rapid logistics and local production facilities, raising operational costs. Limited reimbursement policies in certain countries also restrict patient access to newer therapies, particularly in emerging markets.
Market Opportunities
Significant opportunities exist through the expansion of radiotheranostics into new cancer indications. Ongoing clinical trials are exploring applications in glioblastoma, colorectal cancer, ovarian cancer, and small cell lung cancer. Increasing adoption of personalized oncology treatment models supports demand for customized radioligand therapies. Advancements in molecular targeting agents and isotope production technologies are expected to further improve treatment precision and scalability of manufacturing.
In July 2024, Ariceum Therapeutics initiated a Phase-1 clinical trial for a PARP-targeting radiopharmaceutical in recurrent glioblastoma, indicating growing diversification of radiotheranostic pipelines beyond prostate and neuroendocrine tumors.
Market Challenges
The global shortage of critical isotopes such as actinium-225 presents a major supply challenge. Limited production capacity and dependency on nuclear reactors and particle accelerators restrict isotope availability for clinical and commercial use. In addition, stringent regulatory approval processes for radiopharmaceuticals increase development timelines and costs, delaying product launches and limiting market penetration in certain regions.
Market Trends
Artificial intelligence and machine learning are increasingly being integrated into radiotheranostics development. AI is used to optimize imaging interpretation, patient selection, treatment planning, and dose prediction, enhancing therapeutic accuracy. Integration of imaging data with genomic and clinical datasets enables more effective personalized therapy protocols. In November 2024, GE HealthCare partnered with DeepHealth to advance AI-powered medical imaging technologies that support improved radiopharmaceutical treatment workflows.
By radioisotope, Lutetium-177 dominated the market, accounting for 55.49% market share in 2026 due to strong clinical efficacy in prostate cancer and neuroendocrine tumor treatments. Radium-223 and Iodine-131 continue to be used in selected therapies, while emerging isotopes are gaining attention through expanded clinical trials.
By application, prostate cancer represents the leading segment, supported by rising diagnosis rates and increasing approvals of PSMA-targeted radioligand therapies. Neuroendocrine tumors also hold substantial market share due to high response rates with peptide receptor radionuclide therapy (PRRT). Other applications, including breast and lung cancer, are gaining momentum through expanded clinical research.
By end-user, hospitals and clinics dominate due to availability of specialized nuclear medicine infrastructure and trained personnel. Diagnostic centers and research institutions also contribute to growing demand as diagnostic imaging volumes continue to rise.
North America dominated the global market with a 60.80% share in 2025, supported by advanced healthcare infrastructure, strong reimbursement systems, and high oncology treatment spending. The North American market size reached USD 2.89 billion in 2025.
Europe is projected to reach USD 1.09 billion in 2026, driven by rising cancer awareness programs and strong pharmaceutical research activity.
Asia Pacific is expected to reach USD 0.99 billion in 2026, supported by expanding clinical trials, regulatory approvals, and growing oncology patient populations.
Rest of the World reached USD 0.28 billion in 2025, with increasing investments in nuclear medicine infrastructure in Middle Eastern countries.
Competitive Landscape
Major players including Novartis AG, Bayer AG, Lantheus, Telix Pharmaceuticals, Clarity Pharmaceuticals, and Radiopharm Theranostics dominate the market through strong radioligand portfolios and active clinical pipelines. Strategic partnerships, acquisitions, and manufacturing expansions remain key competitive strategies to secure isotope supply and accelerate product commercialization.
Conclusion
The global radiotheranostics market is positioned for exceptional growth, rising from USD 4.75 billion in 2025 to USD 6.18 billion in 2026 and further expanding to USD 44.26 billion by 2034, driven by strong clinical demand for targeted cancer therapies and continuous innovation in radiopharmaceutical development. Dominance of Lutetium-177, growing adoption in prostate cancer and neuroendocrine tumors, and leadership of hospitals and clinics as primary end users highlight the market's strong clinical integration. North America's 60.80% market share in 2025 reflects advanced healthcare infrastructure and high oncology spending, while Asia Pacific's rapid growth indicates expanding access to nuclear medicine technologies. Although challenges such as isotope shortages, high manufacturing costs, and regulatory complexities remain, ongoing investments, strategic collaborations, AI integration, and expanding therapeutic applications are expected to strengthen long-term market momentum and broaden global adoption of radiotheranostic solutions across oncology care pathways.
Segmentation By Radioisotope
By Application
By End-User
By Region