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市場調查報告書
商品編碼
1916502
全球放射治療診斷市場:市場規模、份額、成長率、產業分析、按類型、應用和地區劃分的考量因素以及未來預測(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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由於癌症發生率的上升和核醫學的不斷進步,全球放射治療診斷市場正經歷快速擴張。根據2025年的數據,預計2025年全球放射治療診斷市場規模將達到47.5億美元,2026年將成長至61.8億美元,到2034年將達到442.6億美元。從2026年到2034年,該市場預計將以27.90%的複合年增長率成長,這反映了標靶放射性藥物療法在腫瘤學領域的快速普及。
放射診療一體化是指將診斷影像與標靶放射治療結合,使用同一種分子標靶藥物。這些療法能夠實現精準的腫瘤檢測和同步治療,顯著改善臨床療效,同時減少對健康組織的傷害。個人化醫療和分子影像技術的日益普及,進一步推動了整個醫療保健系統對放射診療一體化產品的需求。
市場驅動因素
全球癌症負擔的日益加重是市場成長的主要驅動因素。攝護腺癌、神經內分泌腫瘤、乳癌和肺癌發生率的上升,使得標靶放射性配體療法的需求強勁。人口老化和生活方式相關的風險因素也導致需要接受先進癌症治療的患者群體不斷擴大。此外,PET和SPECT影像平台的普及也加速了放射診治療整合技術在臨床上的應用。
政府資助和公私合作正在推動進一步的創新。 2024年6月,Clarity Pharmaceuticals獲得了660萬美元的研發資助,用於支持針對多種癌症適應症的標靶銅療法的開發。這顯示機構對放射性藥物研究給予了強有力的支持。
市場限制因子
儘管成長潛力巨大,但高昂的生產和研發成本仍然是主要障礙。放射性藥物的生產需要專門的基礎設施、迴旋加速器、熱室以及嚴格的監管合規性,這增加了資本支出。此外,某些放射性同位素的半衰期較短,需要快速的物流和本地生產設施,從而提高了營運成本。某些國家嚴格的報銷政策也限制了患者獲得新療法的機會,尤其是在新興市場。
市場機會
隨著放射性診療技術擴展到新的癌症適應症,存在著巨大的機會。正在進行的臨床試驗正在探索其在膠質母細胞瘤、大腸癌、卵巢癌和小細胞肺癌中的應用。個人化癌症治療模式的日益普及推動了對客製化放射性配體療法的需求。分子標靶藥物和同位素生產技術的進步可望進一步提高治療的精準度和生產規模。
2024年7月,Aryceum Therapeutics啟動了一項針對復發性膠質母細胞瘤的PARP靶向放射性藥物的I期臨床試驗,這標誌著放射性診療產品線正從前列腺癌和神經內分泌腫瘤領域向其他領域不斷多元化發展。
市場挑戰
關鍵同位素(例如錒-225)的全球短缺構成了重大的供應挑戰。有限的產能以及對核反應器和粒子加速器的依賴限制了臨床和商業用途的同位素供應。此外,放射性藥物嚴格的監管審批流程增加了研發時間和成本,導致產品上市延遲,並在某些地區市場滲透率有限。
市場趨勢
人工智慧 (AI) 和機器學習正日益融入放射性診療一體化藥物的研發中。 AI 被用於優化成像、患者選擇、治療計劃和劑量預測,從而提高治療精度。將影像數據與基因組和臨床數據結合,可以實現更有效的個人化治療方案。 2024 年 11 月,GE 醫療與 DeepHealth 合作,推動 AI 驅動的醫學影像技術,以改善放射性藥物治療流程。
按放射性同位素劃分,镥-177 佔據市場主導地位,預計到 2026 年將佔據 55.49% 的市場份額,這主要歸功於其在治療前列腺癌和神經內分泌腫瘤方面的高臨床療效。儘管鐳-223和碘-131仍用於某些治療,但新興同位素正透過擴大臨床試驗而備受關注。
依應用領域劃分,前列腺癌佔據主導地位。這得歸功於診斷率的提高以及PSMA標靶放射性配體療法獲準數量的增加。神經內分泌腫瘤也佔據了相當大的市場份額,這主要歸功於勝肽受體放射性核素療法(PRRT)的高反應率。其他應用領域,包括乳癌和肺癌,也正透過擴大臨床研究而獲得發展動力。
按最終用戶劃分,擁有專業核醫基礎設施和訓練有素人員的醫院和診所是主要用戶。由於診斷影像測試數量的增加,診斷中心和研究機構也推動了需求成長。
北美地區擁有先進的醫療基礎設施、完善的報銷系統和較高的腫瘤治療支出,預計到2025年將佔據全球市場60.80%的份額。北美市場規模預計到2025年將達到28.9億美元。
歐洲市場預計到2026年將達到10.9億美元,主要得益於癌症防治宣傳活動的增加和強勁的藥物研發活動。
亞太地區預計到2026年將達到9.9億美元,這主要得益於臨床試驗的增加、監管審批的推進以及癌症患者數量的增長。
預計到 2025 年,世界其他地區(中東和非洲)的市場規模將達到 2.8 億美元,主要得益於中東國家對核子醫學基礎設施投資的增加。
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