North America Nuclear Medicine Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

North America Nuclear Medicine Market Trends and Insights

Rising burden of cancer & CVD

Cancer incidence continues to climb across North America, with cardiovascular disease remaining the leading cause of mortality, sustaining demand for accurate diagnostic and therapeutic nuclear medicine procedures. Demographic aging amplifies this need as prostate, breast, and lung cancer prevalence rises sharply beyond age 60. Pediatric indications now grow following FDA approval of lutetium Lu 177 dotatate for patients aged 12 and above, opening new addressable populations^{[1]Source: U.S. Food and Drug Administration, “FDA approves lutetium Lu 177 dotatate for pediatric patients,” fda.gov} . While traditional SPECT cardiac volumes ebb, PET myocardial perfusion imaging gains favor for its higher specificity. The convergence of oncology and cardiology applications enables providers to streamline care pathways and cross-sell services, anchoring multi-specialty revenue streams.

Hybrid imaging (SPECT/CT, PET/CT) adoption surge

North American healthcare systems increasingly adopt these technologies, with cardiac PET imaging gaining significant traction among US cardiologists as demonstrated by expanding clinical adoption and improved reimbursement frameworks under Centers for Medicare & Medicaid Services reforms in 2025 that provide separate payment pathways for advanced diagnostic radiopharmaceuticals. GE HealthCare’s Flyrcado tracer, with a 109-minute half-life, broadens stress testing feasibility and attracts outpatient cardiology centers. Detector advances such as cadmium zinc telluride improve resolution while trimming radiation dose, addressing clinician and patient safety. Artificial intelligence algorithms automate lesion quantification, reducing interpretation variability and accelerating report turnaround.

Domestic Mo-99 supply build-out (NorthStar, etc.)

The U.S. Department of Energy funds multiple initiatives that target 75% self-sufficiency in molybdenum-99 production. SHINE Technologies and NorthStar advance facilities designed to replace historically imported supply, shielding providers from international reactor outages. Canada complements regional resilience through cobalt-60 production at Darlington, diversifying isotope availability. These projects shorten logistics chains, stabilize pricing, and improve predictability for high-volume imaging centers.

Accelerated pathways support agents such as 225Ac-FL-020 and 64Cu-SAR-bisPSMA, cutting development timelines and de-risking capital allocation. The agency’s approval of Flyrcado for coronary artery disease illustrates readiness to endorse tracers with clear clinical benefit. Health Canada mirrors these processes, enabling synchronized launches and larger first-year revenue bases for manufacturers. Regulatory momentum draws venture funding and catalyzes M&A activity around pipeline assets.

Short half-life logistics bottlenecks

Many diagnostic isotopes decay within hours, demanding just-in-time distribution. Fluorine-18’s 6-hour half-life restricts shipment zones to roughly 200 miles. In 2024, unexpected European reactor downtime created 50-100% shortages in technetium-99m across multiple U.S. states, delaying elective scans^{[2]Source: Society of Nuclear Medicine and Molecular Imaging, “Imminent Mo-99/Tc-99m Shortage,” snmmi.org} . Cold-chain compliance adds cost, and rural sites often cannot meet delivery windows, limiting service availability. Longer-lived copper-64 offers partial relief, though widespread clinical adoption hinges on additional infrastructure and trial data.

High CAPEX & regulatory hurdles for cyclotrons

Installing a 70 MeV cyclotron costs USD 17 million, while annual operating expenses can top USD 1.9 million. Dual oversight by FDA and NRC necessitates exhaustive documentation and multi-year licensing, discouraging smaller providers. Jubilant Radiopharma’s USD 50 million deal for five KIUBE 180 units underscores the financial barrier to entry. These constraints concentrate production among large academic centers and commercial radiopharmacies, perpetuating geographic disparities.

*Our forecasts treat driver/restraint impacts as directional, not additive. The impact forecasts reflect baseline growth, mix effects, and variable interactions.

Segment Analysis

By Product Type: Therapeutics Reshape Market Dynamics

Diagnostic radiopharmaceuticals retained 60.23% share of the North America nuclear medicine market in 2025, supported by entrenched reimbursement and entrenched clinician familiarity. Therapeutic agents, however, are growing much faster at an 15.62% CAGR as radioligands like lutetium-177 PSMA address advanced metastatic disease with favorable safety profiles. The North America nuclear medicine market size for therapeutics is set to surpass USD billion by 2031, reflecting accelerating adoption among oncologists. SPECT remains dominant in routine bone scans, while PET’s superior resolution wins neurology and oncology referrals. Artificial intelligence-driven dosimetry improves treatment precision, reinforcing payer confidence in premium reimbursement tiers.

A reinforcing loop exists between diagnostic and therapeutic revenues: positive imaging experiences facilitate patient enrollment in companion therapeutics. Novartis’s Pluvicto reached USD 1 billion in U.S. sales during the first nine months of 2024, validating commercial appetite for high-value radiotheranostics. CMS payment reform in 2025 created a separate APC for diagnostic tracers above USD 630, improving hospital margins and encouraging inventory expansion. The North America nuclear medicine industry now positions therapeutic innovation as a primary differentiator among manufacturers that once concentrated on diagnostic agents.

By Application: Neurology Gains Momentum Beyond Oncology Dominance

Oncology represented 53.81% of the North America nuclear medicine market in 2025, reflecting its central role in tumor staging and therapy monitoring. The North America nuclear medicine market size for oncology applications is forecast to cross USD 8.97 billion in 2031 at an 14.69% CAGR. Neurology is the fastest-growing application, expanding 11.42% annually as amyloid and tau PET increase Alzheimer’s diagnostic accuracy. CMS travel policy updates in 2025 lowered out-of-pocket costs for Medicare beneficiaries, further encouraging scan uptake.

Neuroimaging demand spurs supply chain adjustments for fluorine-18 tracers like Neuraceq, recently added through Lantheus’s USD 750 million acquisition of Life Molecular Imaging. Advanced AI algorithms shorten interpretation time from 12 minutes to 4 minutes per scan, addressing neuroradiologist shortages. Cardiology maintains relevance through PET perfusion imaging, which grew 6% year-over-year in 2024 despite SPECT declines. Endocrinology remains steady, with thyroid uptake studies and iodine-131 therapy stable across major U.S. academic centers.

By Radioisotope: Actinium-225 Disrupts Technetium Dominance

Technetium-99m delivered 55.70% of procedure volume in 2025, underpinning core cardiology and bone applications. The North America nuclear medicine market share of technetium-based diagnostics is expected to contract to 47.20% by 2031 as alternative tracers gain ground. Actinium-225 is surging at 10.98% CAGR, supported by new domestic production capacity in Wisconsin and Missouri. The North America nuclear medicine market size for actinium-225 therapeutics could reach USD 1.18 billion by 2031, pending successful late-phase trials.

Lutetium-177 benefits from approved products like Pluvicto and Lutathera, while gallium-68 generators broaden access for community sites lacking cyclotrons. Fluorine-18 diversifies beyond FDG into cardiac perfusion and neuroreceptor imaging, increasing throughput at PET-CT sites. NorthStar’s 52,000-square-foot CDMO facility accelerates actinium-225 and lutetium-177 supply, giving smaller biotechs a rapid path to clinical lot manufacturing.

By End User: Imaging Centers Challenge Hospital Dominance

Hospitals captured 65.11% of revenue in 2025, anchored by integrated service lines and established inpatient referrals. Diagnostic imaging centers, however, lead growth at an 15.71% CAGR through 2031 as payers redirect routine scans to lower-cost settings. The North America nuclear medicine market size attributable to imaging centers is projected to reach USD 4.23 billion by 2031. Academic institutes contribute high complexity research and early adopter volumes, while pharmaceutical companies invest in captive facilities to secure trial supply continuity.

IMV survey data show total nuclear medicine procedure volumes falling 5.7% between 2021 and 2023, but non-hospital sites increased 2.5%, foreshadowing sustained outpatient migration. CMS Condition of Participation 42 CFR 482.53 sets uniform quality benchmarks, allowing independent centers to compete on equal footing with hospital departments [ECFR.GOV]. Theranostics capability penetration reached 14% of North American sites in 2024, predominantly within specialty outpatient centers due to streamlined approval pathways and shorter patient stays.

Geography Analysis

The United States accounted for 88.90% of the North America nuclear medicine market in 2025 and is advancing at an 11.10% CAGR, reaffirming its dominance in clinical trial activity, isotope manufacturing, and reimbursement leadership. Medicare’s 2025 payment separation for high-cost tracers enhances provider profitability and supports nationwide adoption of advanced agents. Central Indiana’s cluster effect attracts global manufacturers, offering same-day distribution to two-thirds of the U.S. population, enhancing supply reliability.

Canada holds a smaller but strategically significant share. Health Canada’s alignment with FDA’s accelerated pathways facilitated approvals for Illuccix and NETVision, opening high-growth neurology and neuroendocrine segments. Domestic cobalt-60 production at Darlington strengthens isotope sovereignty, while PET-CT scanner density remains below OECD average, indicating expansion potential. Provincial funding initiatives in Ontario and British Columbia earmark capital for new cyclotrons and radiopharmacy upgrades.

Mexico remains an emerging participant. Regulatory reforms under COFEPRIS align medical device quality standards with international benchmarks, improving market access for imaging equipment vendors. Rising middle-class healthcare spending and public-private partnerships support pilot PET-CT centers in Mexico City and Monterrey. While current procedure volume is modest, double-digit growth trajectories position Mexico as a future outperformer once infrastructure and trained personnel scale.

Overall, geographic concentration in the United States accelerates innovation but introduces risk exposure to U.S. policy shifts. Canada and Mexico offer diversification pathways and incremental volume growth that moderate regional cyclicality

Regulatory Landscape

In North America, nuclear medicine products sit across drug, device, and radioactive materials oversight. In the United States, the FDA Office of Combination Products (OCP) coordinates jurisdiction for combination products and assigns a lead center (CDER/CBER/CDRH) based on primary mode of action, while cGMP expectations for combination products are anchored in 21 CFR Part 4. Radiopharmaceutical research pathways can also use the Radioactive Drug Research Committee (RDRC) mechanism (with IRB oversight) for certain human studies that do not proceed through a full IND route, which can speed early clinical imaging work at academic and research centers.

In Canada, radiopharmaceuticals are regulated as Schedule C drugs under the Food and Drugs Act and the Food and Drug Regulations, and combination products must meet requirements that apply to both the drug and the medical device components under the Medical Devices Regulations. Health Canada GMP guidance for positron-emitting radiopharmaceuticals, along with frameworks for drug-medical device combination products, affects manufacturing and quality-system readiness for PET tracers and radiotheranostic agents. Across both countries, compliance is intensified by the need to align clinical imaging performance controls (including imaging charters and standardized acquisition and interpretation protocols) with specialized facility, personnel, and radiation safety requirements.

Value Chain Analysis

The North America nuclear medicine value chain starts upstream with stable isotope and precursor supply, irradiation or particle-acceleration services (reactors, cyclotrons, and generator-based systems), and radiochemical processing into clinical-grade radioisotopes (including Mo-99/Tc-99m and emerging alpha-emitters). Midstream, radiopharmaceutical manufacturing follows combination-product quality requirements, with batch release and QA/QC, and nuclear pharmacy compounding. After production, time-sensitive cold-chain distribution depends on short half-lives and air-ground logistics constraints. Downstream, demand is concentrated in hospitals and diagnostic imaging centers operating PET/CT and SPECT/CT, along with oncology networks scaling theranostics programs that require coordinated scheduling, dosimetry, and waste handling.

Supply resilience is a recurring theme. U.S. initiatives to localize Mo-99 production, including SHINE Technologies progress on its Chrysalis facility in Janesville, Wisconsin (reported at about 75% completion in 2025), address historical reliance on foreign reactors and the vulnerability of Tc-99m availability to international outages. Policy and reimbursement mechanics feed back into the chain as well. CMS proposed an add-on payment for radiopharmaceuticals derived from domestically produced Mo-99 in the CY2026 hospital outpatient setting, linking upstream localization to downstream purchasing behavior. The overall chain stays capital- and compliance-intensive, with high cyclotron installation costs and multi-agency oversight (FDA for drugs/biologics, NRC for nuclear materials, plus state-level requirements) favoring scaled manufacturers and commercial radiopharmacies that can support just-in-time distribution.

Market Opportunities and Future Outlook

Whitespace is expanding in outpatient and community access models that can reliably deliver short-lived PET tracers and support theranostics workflows outside tertiary hospitals. Product and pathway activity in 2026 points to competitive openings in prostate cancer imaging, as multiple manufacturers advance alternative formulations and generics through FDA routes such as 505(b)(2) and ANDA. FDA approval of Lantheus PYLARIFY TruVu (piflufolastat F 18) and FDA ANDA approval for Ga-68 PSMA-11 from Ionetix are complemented by additional U.S. approvals for generic Ga-68 PSMA-11 manufacturing from RadioMedix, which broadens sourcing options for imaging centers and integrated delivery networks.

A second opportunity area is hardening the supply chain for critical isotopes and precursors, where active government-backed infrastructure programs and upstream process innovations are already visible. DOE actions to expand stable isotope production capabilities at Oak Ridge National Laboratory, including enrichment for ytterbium-176 (a lutetium-177 precursor), reinforce domestic inputs for radioligand therapy supply chains. Financing also supports localization themes that are influencing procurement decisions, including the DOE conditional loan commitment to SHINE Technologies for the Chrysalis facility. For alpha-emitters, commercial pathways for precursor constraints are starting to emerge, including Actineer (CNL and ITM joint venture) reporting a closed-loop radium-226 recycling process, which could improve predictability for actinium-225 availability and scheduling reliability for CDMOs, radiopharmacies, and therapy providers.