Pharmaceutical Industry Today
Lutetium-177 Market Expansion Driven by Increasing Regulatory Approvals and Government Initiatives in Nuclear Medicine
InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Lutetium-177 Market Size, Share & Trends Analysis Report By Application (Oncology, Non-Oncology), Type (No-Carrier-Added (NCA) Lu-177, Carrier-Added (CA) Lu-177), Product Type (Approved Drugs, Pipeline Drugs, Investigational Drugs), Scale of Operation (Preclinical, Clinical, Commercial), End-user (Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Research Institutions/CROs), Production(Reactor-Based, Cyclotron-Based), Technology (Targeting Ligands, Production Innovations, Combination Therapies)- Market Outlook And Industry Analysis 2034"
According to the latest research by InsightAce Analytic, the Lutetium-177 Market is valued at USD 2.11 Bn in 2024, and it is expected to reach USD 7.41 Bn by the year 2034, with a CAGR of 11.6 during the forecast period of 2025-2034.
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Lutetium-177 (Lu-177) is a beta-emitting radioisotope utilized in targeted radionuclide therapy for the treatment of various cancers. It is produced through two primary methods: the direct (carrier-added, c.a.) approach, which involves the irradiation of Lu-176 and results in isotopic impurities, and the indirect (non-carrier-added, n.c.a.) approach, which employs Yb-176 irradiation to generate a higher-purity product with enhanced therapeutic efficacy.
Functioning as a theranostic agent, Lu-177 integrates both diagnostic and therapeutic capabilities. It is particularly effective in managing neuroendocrine tumors and prostate cancer by enabling precise tumor imaging followed by targeted radiation delivery to malignant cells, thereby minimizing collateral damage to healthy tissues. This dual functionality significantly improves treatment accuracy and overall patient outcomes.
The global Lu-177 market is expanding rapidly, driven by the rising incidence of cancer and the growing adoption of precision-based radiopharmaceutical therapies. Technological advancements in radiolabeling processes, coupled with improved accessibility to nuclear medicine infrastructure, are further supporting market growth.
Strategic collaborations between pharmaceutical companies, research organizations, and healthcare providers are key to sustaining this momentum. For instance, in June 2024, Curium entered a long-term partnership with the Institut Laue-Langevin (ILL) to scale up the production of non-carrier-added Lu-177, ensuring a consistent isotope supply for clinical applications. This collaboration aims to facilitate access to advanced cancer therapies for a broader patient population over the next several years. Such initiatives underscore the growing strategic importance of Lu-177 in the evolution of personalized oncology and nuclear medicine.
List of Prominent Players in the Lutetium-177 Market:
· Novartis AG
· Curium
· Telix Pharmaceuticals
· ITM Isotope Technologies
· Eli Lilly (via POINT Biopharma)
· Radiopharm Theranostics
· Advanced Accelerator Applications (AAA)
· Evergreen Theragnostics
· Nusano Inc.
· Nordic Nanovector
Read Overview Report- https://www.insightaceanalytic.com/report/lutetium-177-market-/3024
Market Dynamics: Lutetium-177 (Lu-177)
Drivers:
The Lutetium-177 (Lu-177) market is witnessing robust growth, primarily fueled by the increasing demand for targeted radionuclide therapies, particularly in the treatment of neuroendocrine tumors and prostate cancer. The isotope’s high therapeutic precision and low systemic toxicity make it a preferred option in advanced oncology care. Market expansion is further supported by continuous advancements in radiopharmaceutical technology, which enhance production efficiency, imaging precision, and delivery mechanisms. In addition, supportive regulatory frameworks and government-backed initiatives promoting cancer research and nuclear medicine development have streamlined approval processes and facilitated broader clinical integration of Lu-177-based therapies.
Challenges:
Despite promising growth prospects, the Lu-177 market faces several operational and structural challenges. The production of Lu-177 is a technically complex and resource-intensive process, heavily dependent on enriched ytterbium, which constrains large-scale manufacturing and increases production costs. Moreover, supply chain vulnerabilities, coupled with rigorous regulatory and quality assurance requirements, contribute to operational inefficiencies and limit scalability for producers. These challenges collectively hinder the rapid expansion of supply capabilities needed to meet growing global demand.
Regional Trends:
North America currently dominates the global Lu-177 market, supported by a highly developed healthcare infrastructure, strong research and development capabilities, and a favorable regulatory environment. The region benefits from the presence of advanced oncology centers and leading pharmaceutical manufacturers actively engaged in radiopharmaceutical innovation. Substantial public and private investment in cancer research and domestic isotope production—exemplified by initiatives such as SHINE Technologies’ facility in Wisconsin—has strengthened supply chain resilience and reduced dependency on international sources. Furthermore, the region’s high cancer incidence, with an estimated 2,001,140 new cases and 611,720 deaths projected in the United States for 2024, underscores the growing demand for precise and effective targeted therapies such as Lu-177.
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Recent Developments:
· In April 2024, The FDA approved Lutetium Lu 177 dotatate (Lutathera) for pediatric patients (12+) with SSTR-positive GEP-NETs, including foregut, midgut, and hindgut tumors. It had previously received approval for adults in 2018.
· In March 2022, The FDA approved Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had previously received androgen receptor pathway inhibition and taxane-based chemotherapy.
Segmentation of Trusted Platform Module Market-
By Application:
· Oncology
o mCRPC
o NETs
o RCC
o Other Cancers
· Non-Oncology
o Arthritis
o Other
By Type:
· Carrier-Added Lutetium-177
· No-Carrier-Added Lutetium-177
By Product Type:
· Approved Drugs
o Pluvicto (Pro)
o Lutathera (Pro)
· Pipeline Drugs
· Investigational Drugs
By Scale of Operation:
· Preclinical
· Clinical
· Commercial
By End-user:
· Hospitals & Clinics
· Pharmaceutical & Biotechnology Companies
· Research Institutions/CROs
By Production:
· Reactor-Based
· Cyclotron-Based
By Technology:
· Targeting Ligands
· Production Innovations
· Combination Therapies
By Region-
North America-
· The US
· Canada
· Mexico
Europe-
· Germany
· The UK
· France
· Italy
· Spain
· Rest of Europe
Asia-Pacific-
· China
· Japan
· India
· South Korea
· South East Asia
· Rest of Asia Pacific
Latin America-
· Brazil
· Argentina
· Rest of Latin America
Middle East & Africa-
· GCC Countries
· South Africa
· Rest of Middle East and Africa
About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.
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InsightAce Analytic Pvt. Ltd.
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