Radiotheranostics Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Radioisotope (Technetium-99, Gallium-68, Iodine-131, Iodine-123, 18F, Y-90, Lutetium (Lu) 177, Copper (Cu) 67, Copper (Cu) 64, Others), By Application (Oncology v/s Non-Oncology), By End User (Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Others) and Region 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 11.15 Billion
CAGR (2026-2031)	20.41%
Fastest Growing Segment	Oncology
Largest Market	North America
Market Size (2031)	USD 33.98 Billion

Market Overview

The Global Radiotheranostics Market will grow from USD 11.15 Billion in 2025 to USD 33.98 Billion by 2031 at a 20.41% CAGR. Radiotheranostics constitutes a precision medical paradigm that utilizes paired radiopharmaceuticals to simultaneously diagnose and treat pathologies, predominantly within oncology. The market is primarily propelled by the escalating global prevalence of cancer and the increasing clinical preference for personalized therapeutic regimens that optimize efficacy while minimizing systemic toxicity. This dual approach allows clinicians to visualize disease extent and deliver targeted radiation to specific cellular sites, thereby driving significant adoption across healthcare systems seeking improved patient outcomes.

However, the sector faces a formidable challenge concerning the stability of its supply chain, particularly the reliable availability of medical radioisotopes. The production of these critical materials is heavily dependent on a limited number of aging nuclear research reactors, rendering the market vulnerable to unscheduled outages and logistical disruptions. According to Nuclear Medicine Europe, in late 2024, unanticipated reactor maintenance issues were projected to cause supply shortages of up to 40% for essential diagnostic isotope generators, highlighting the fragility of the global distribution network.

Key Market Drivers

The escalating global incidence of targetable cancers serves as the fundamental catalyst propelling the radiotheranostics market. As oncological burdens rise, healthcare providers are prioritizing theranostic modalities that pair diagnostic precision with therapeutic lethality to manage complex cases. This demand for personalized intervention is substantiated by the growing volume of diagnoses requiring advanced care. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, 2,001,140 new cancer cases were projected to occur in the United States in 2024. This intensifying disease burden has directly translated into substantial commercial uptake for approved radioligand therapies. According to Novartis, October 2024, in the 'Q3 2024 Interim Financial Report', net sales for the therapy Pluvicto reached $386 million for the quarter, reflecting the critical market need for these targeted treatments.

Concurrently, a surge in public-private investments and funding is reshaping the sector's competitive landscape. Recognizing the commercial viability of radiopharmaceuticals, major pharmaceutical entities are aggressively acquiring specialized biotech firms to secure proprietary platforms and manufacturing infrastructure. These capital infusions are vital for overcoming historical supply chain fragilities and accelerating the development of novel isotopes. According to Bristol Myers Squibb, February 2024, in the 'Bristol Myers Squibb Completes Acquisition of RayzeBio' press release, the company finalized the acquisition of RayzeBio for a total equity value of approximately $4.1 billion. This magnitude of financial commitment signals a definitive shift toward scaling global production capabilities to meet the anticipated long-term demand.

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Key Market Challenges

The Global Radiotheranostics Market faces a critical impediment due to the fragility of its supply chain, specifically the inconsistent availability of essential medical radioisotopes. The industry depends on a shrinking number of aging nuclear research reactors to produce these isotopes, which serve as the foundation for paired diagnostic and therapeutic agents. Any unscheduled outage or maintenance delay at these facilities creates an immediate bottleneck, preventing the manufacturing of life-saving radiopharmaceuticals. This unreliability forces clinicians to postpone or cancel time-sensitive cancer treatments, eroding confidence in radiotheranostics as a sustainable pillar of oncology and deterring healthcare institutions from investing in the necessary infrastructure.

The impact of these logistical failures is acute and measurable. According to the Society of Nuclear Medicine and Molecular Imaging, in 2024, unexpected reactor downtime resulted in supply shortages ranging from 50% to 100% of normal requirements across various global regions. These severe disruptions directly limit market revenue and stall adoption rates, as pharmaceutical companies cannot guarantee the delivery of products to patients. Consequently, the volatility of the isotope supply remains the primary friction point retarding the sector’s overall growth potential.

Key Market Trends

The Global Radiotheranostics Market is undergoing a significant technical evolution marked by the Transition Towards Targeted Alpha-Particle Therapies (TATs). Unlike the prevailing beta-emitting isotopes such as Lutetium-177, alpha-emitters like Actinium-225 deliver high linear energy transfer radiation over a short range, inducing double-strand DNA breaks that are highly effective against micro-metastases while sparing surrounding healthy tissue. This shift in therapeutic modality has catalyzed substantial investment from major pharmaceutical entities aiming to secure proprietary actinium supply chains and pipelines. According to AstraZeneca, June 2024, in the 'Acquisition of Fusion completed' press release, the company finalized the acquisition of Fusion Pharmaceuticals for a transaction value of approximately $2.4 billion to integrate actinium-based radioconjugates into its oncology portfolio.

Simultaneously, the industry is witnessing the Emergence of Radiopharmaceutical-Specialized CDMOs to mitigate historical manufacturing vulnerabilities. To address the logistical complexities of isotopes with ultra-short half-lives, these specialized Contract Development and Manufacturing Organizations are engineering purpose-built infrastructure capable of decentralized, just-in-time production, distinct from traditional centralized models. This structural expansion is critical for ensuring commercial scalability and redundancy against reactor outages. According to Nucleus RadioPharma, May 2024, in the 'Nucleus RadioPharma Expands Radiopharmaceutical Research, Development and Manufacturing Capacity' press release, the organization announced the development of two new facilities totaling over 100,000 square feet to address nationwide supply chain constraints.

Segmental Insights

The oncology segment stands as the fastest-growing category in the global radiotheranostics market, primarily due to the increasing prevalence of cancer and the demand for personalized treatment plans. This growth is fueled by the success of specific radiotheranostic agents in managing solid tumors, including prostate and neuroendocrine cancers. Furthermore, consistent approvals from regulatory authorities such as the U.S. Food and Drug Administration facilitate wider commercial availability and clinical use. Consequently, the ability of these therapies to provide targeted treatment while minimizing damage to healthy tissue drives substantial investment and adoption in this sector.

Regional Insights

North America maintains a dominant position in the global radiotheranostics market, driven by a well-established healthcare infrastructure and substantial investment in research and development. The region benefits significantly from a favorable regulatory environment, where the U.S. Food and Drug Administration (FDA) facilitates the approval of new radiopharmaceutical products. Additionally, the presence of major industry players conducting clinical trials contributes to market expansion. The availability of reimbursement frameworks further supports the commercial adoption of these therapeutic and diagnostic solutions across medical facilities in the region.

Recent Developments

• In October 2024, Telix Pharmaceuticals announced that the U.S. Food and Drug Administration had accepted its New Drug Application for a novel investigational brain cancer imaging agent. The regulatory body granted priority review for the application, which focuses on a positron emission tomography agent designed to characterize progressive or recurrent glioma in both adult and pediatric patients. This development represented a critical advancement in the Global Radiotheranostics Market by addressing significant unmet diagnostic needs in neuro-oncology. If approved, the agent would provide clinicians with a more precise tool for evaluating brain tumors, potentially improving patient management and treatment outcomes.
• In May 2024, Novartis announced it had entered into an agreement to acquire Mariana Oncology, a biotechnology company focused on developing novel radioligand therapies for solid tumors. Under the terms of the agreement, the company committed to an upfront payment of $1 billion, with eligible milestone payments of up to $750 million. This acquisition was designed to deepen the company's scientific expertise and clinical supply capabilities in the radiotheranostics sector. The deal encompassed a robust portfolio of development programs, including a lead actinium-based radioligand therapy candidate being investigated for the treatment of small cell lung cancer, thereby expanding the company's pipeline beyond its existing assets.
• In March 2024, AstraZeneca entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a leader in the development of next-generation radioconjugates. The acquisition, valued at approximately $2.4 billion, was aimed at accelerating the company's ambition to replace traditional chemotherapy with more targeted regimens. Through this agreement, the company integrated a proprietary pipeline of actinium-based radioconjugates into its oncology portfolio, including a lead asset currently in Phase 2 trials for metastatic castration-resistant prostate cancer. The collaboration also provided the acquiring company with specialized research and development capabilities and manufacturing infrastructure essential for advancing radiopharmaceutical innovation.
• In February 2024, Bristol Myers Squibb announced the successful completion of its acquisition of RayzeBio, Inc., a clinical-stage radiopharmaceutical therapeutics company. This strategic transaction, valued at approximately $4.1 billion, established the acquired entity as a wholly owned subsidiary and significantly bolstered the parent company's presence in the Global Radiotheranostics Market. The deal secured access to a promising pipeline of actinium-based radiopharmaceutical therapeutics, including a lead program targeting somatostatin receptor 2 (SSTR2) for the treatment of gastroenteropancreatic neuroendocrine tumors and small cell lung cancer. Additionally, the acquisition included a state-of-the-art manufacturing facility to support the development of these precision oncology treatments.

Key Market Players

• TransCode Therapeutics, Inc
• Curium SAS
• GE Healthcare Inc
• Bayer AG
• Lantheus Medical Imaging, Inc
• Novartis AG
• Spectrum Pharmaceuticals, Inc
• Ipsen S.A
• Actinium Pharmaceuticals, Inc
• Nordic Nanovector ASA
• Y-mAbs Therapeutics, Inc

By Radioisotope	By Application	By End User	By Region
Technetium-99 Gallium-68 Iodine-131 Iodine-123 18F Y-90 Lutetium (Lu) 177 Copper (Cu) 67 Copper (Cu) 64 Others	Oncology v/s Non-Oncology	Hospitals & Clinics Pharmaceutical & Biotechnology Companies Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Radiotheranostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Radiotheranostics Market, By Radioisotope:

• Technetium-99
• Gallium-68
• Iodine-131
• Iodine-123
• 18F
• Y-90
• Lutetium (Lu) 177
• Copper (Cu) 67
• Copper (Cu) 64
• Others

• Radiotheranostics Market, By Application:

• Oncology v/s Non-Oncology

• Radiotheranostics Market, By End User:

• Hospitals & Clinics
• Pharmaceutical & Biotechnology Companies
• Others

• Radiotheranostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE