Global Radiopharmaceutical Theranostics Market Size, Share, Trends and Forecasts 2031

Key Findings

• The radiopharmaceutical theranostics market integrates diagnostic imaging agents and matched therapeutic radioligands to enable targeted detection and treatment within the same molecular pathway.

• Growing adoption in oncology—especially prostate-specific membrane antigen (PSMA) and somatostatin receptor (SSTR) pathways—anchors clinical demand and reimbursement momentum.

• Platform advances in generator systems, chelators, and isotopes (e.g., ^68Ga/^18F for PET diagnostics and ^177Lu/^225Ac for therapy) are improving availability, safety, and clinical outcomes.

• Hospital radiopharmacies and centralized production hubs are expanding capacity to manage time-sensitive synthesis, quality control, and last-mile logistics.

• Companion diagnostics embedded in clinical pathways accelerate therapy selection, shorten time-to-treatment, and lift response rates versus empiric regimens.

• Regulatory agencies increasingly recognize theranostics as precision medicine, with expanding labels and pathways that support broader indications and earlier lines of therapy.

• Venture and strategic investment into CDMOs, isotope supply chains, and novel targets are intensifying competition and pipeline breadth.

• Standardization of GMP, cold-chain, and radiation safety protocols is critical as health systems scale outpatient radioligand therapy.

• AI-enabled imaging quantification and dosimetry automation are enhancing patient selection, personalization, and outcome prediction.

• Multi-target strategies beyond PSMA/SSTR—such as FAP, GRPR, CXCR4, and integrins—are opening the next wave of clinical opportunities across solid tumors.

Radiopharmaceutical Theranostics Market Size and Forecast

The global radiopharmaceutical theranostics market was valued at USD 3.8 billion in 2024 and is projected to reach USD 11.9 billion by 2031, registering a CAGR of 17.6%. Growth reflects rapid clinical uptake in metastatic prostate cancer and neuroendocrine tumors, expanding isotope supply, and the maturing ecosystem of PET/CT infrastructure in tertiary centers. Reimbursement alignment for companion diagnostics and therapy administration is unlocking wider patient access. As manufacturing shifts to modular, GMP-compliant radiochemistry suites and CDMO partnerships, throughput and geographic coverage are improving. Pipeline expansion into earlier disease stages and additional tumor targets will continue to expand the treatable population through 2031.

Market Overview

Radiopharmaceutical theranostics pair a diagnostic tracer that images a molecular target with a chemically analogous therapeutic agent that delivers cytotoxic radiation to the same target. This closed-loop paradigm enables precise patient selection, dosimetry-guided therapy planning, and real-time assessment of response. Clinical adoption is strongest in PSMA-positive prostate cancer and SSTR-expressing neuroendocrine tumors, where PET imaging guides ^177Lu or ^225Ac therapy. The value chain spans isotope production (reactor/cyclotron/generator), radiochemistry, quality control, aseptic dispensing, and coordinated hospital workflows. Success depends on reliable radioisotope supply, validated chelators/linkers, and compliant logistics. As evidence accumulates from randomized trials and real-world registries, payers and guidelines are increasingly endorsing theranostics for defined lines of therapy.

Future Outlook

The next phase emphasizes earlier-line use, new targets, alpha therapy, and automation. Label expansions into biochemical recurrence and oligometastatic settings will broaden eligible cohorts. Alpha-emitting isotopes with high linear energy transfer (e.g., ^225Ac, ^213Bi) are poised to complement or supersede beta emitters in refractory disease. Automated radiochemistry modules, standardized kits, and AI-assisted dosimetry will compress synthesis times and personalize activity per patient. Global isotope resilience—via diversified generators, cyclotrons, and LEU-based reactor strategies—will mitigate supply shocks. Strategic alliances among pharma, isotope suppliers, and CDMOs will shape scale, while integrated diagnostic-therapeutic bundles will streamline adoption across health systems.

Radiopharmaceutical Theranostics Market Trends

• Shift From Single-Target To Portfolio-Based Oncology Strategies
  Developers are moving beyond monolithic PSMA or SSTR programs toward portfolios covering multiple antigens such as FAP, GRPR, and CXCR4. This diversification spreads clinical risk across heterogeneous tumor biology and enables combination approaches within and across targets. Health systems prefer suppliers that can support diagnostic-therapy pairs across several tumor boards, improving procurement leverage and operational consistency. Portfolio breadth also improves trial recruitment by offering options to patients who screen negative on a given target. Over time, platform companies with modular chelators and interchangeable isotopes will set pace and pricing power. Clinical guidelines will increasingly reflect multi-target algorithms that direct patients to the best-matched theranostic route.

• Acceleration Of Alpha-Emitter Programs For Refractory Disease
  Interest in high-LET alpha emitters is rising due to their short path length and potent DNA double-strand break activity in micrometastatic disease. Early signals suggest potential efficacy in beta-refractory patients, although xerostomia and marrow toxicity require careful management. Manufacturing alpha emitters demands specialized handling, isotope supply assurance, and robust dosimetry frameworks to balance benefit and risk. Sponsors are optimizing linker stability and off-target uptake to minimize collateral tissue damage. Combination sequencing with beta therapy and immuno-oncology is being explored to deepen responses. As clinical protocols mature, centers will need alpha-capable shielding, staff training, and post-therapy monitoring pathways.

• Standardization And Automation Of Radiochemistry Workflows
  Consistent product quality under tight half-life constraints is pushing adoption of closed-system synthesizers and cassette-based kits. Automation reduces operator variability, contamination risk, and batch-to-batch inconsistency while increasing throughput. Harmonized SOPs across multi-site networks simplify tech transfer and regulatory audits, enabling faster geographic expansion. Vendors are integrating inline QC, barcoding, and electronic batch records to streamline release decisions. This infrastructure supports rapid scale-up during shortages or demand spikes without compromising GMP. Over time, automated lines will lower COGS per dose and enable sustainable pricing models for broader access.

• Surge In Dosimetry And AI-Guided Personalization
  Quantitative PET metrics and patient-specific organ dosimetry are moving from research to routine, supporting optimized activity selection per cycle. AI tools trained on imaging and clinical covariates can predict responders, flag toxicity risk, and propose adaptive dose schedules. These capabilities align with payer expectations for demonstrable value and outcome tracking. Automated segmentation and kinetic modeling shorten interpretation times and reduce inter-reader variability across sites. As software becomes device-agnostic, hospitals can standardize theranostic decision support within their PACS ecosystems. The net effect is higher response rates, fewer adverse events, and more efficient resource utilization per treated patient.

• Verticalization Of Supply: Isotopes, CDMOs, And Cold-Chain Logistics
  Sponsors increasingly secure upstream isotope supply through long-term contracts or equity stakes to de-risk shortages. CDMOs specializing in short-lived tracers and therapeutic radioligands provide flexible capacity, tech transfer, and regional lot release. Cold-chain logistics with just-in-time delivery and redundant routes mitigate half-life waste and site cancellations. Digital track-and-trace and radiation compliance tooling ensure chain-of-custody and audit readiness. Vertical integration improves margin capture and service reliability during demand surges. Health systems prefer partners that can guarantee dose availability and rapid resupply across multi-center networks.

• Expansion Beyond Oncology Into Cardiology, Neurology, And Inflammation
  While oncology dominates, theranostic concepts are advancing in cardiac innervation, amyloidosis, and inflammatory targets where diagnostic uptake may identify candidates for targeted radiotherapy. Early programs explore beta or alpha payloads to ablate pathogenic cell populations identified on PET. Success will hinge on precise targeting to avoid unacceptable off-target toxicity in sensitive organs. Multidisciplinary teams will be required to design endpoints, safety monitoring, and long-term follow-up. If validated, these indications can diversify revenue and reduce dependence on oncology cycles. Over time, non-oncology theranostics could establish new hospital service lines and referral patterns.

Market Growth Drivers

• Clinical Evidence Demonstrating Superior Patient Selection And Outcomes
  Randomized and real-world studies show that imaging-confirmed target expression enriches responders, elevating objective response rates versus non-stratified therapy. Health technology assessments increasingly favor modalities that reduce futile treatment exposure. Hospital tumor boards now embed PET criteria before authorization of radioligand therapy, accelerating adoption. As survival and quality-of-life data accumulate, earlier-line use becomes more defensible to payers. This evidence loop incentivizes sites to invest in PET capacity, trained staff, and therapy rooms. The virtuous cycle reinforces volume growth and learning effects that further improve outcomes.

• Growing Installed Base Of PET/CT And Trained Nuclear Medicine Workforce
  Rapid PET/CT expansion in tertiary centers reduces access bottlenecks for companion diagnostics. Training pipelines for radiochemists, medical physicists, and nuclear pharmacists are widening, enabling reliable multi-shift operations. Larger installed bases improve scheduling efficiency and patient throughput per scanner day. Availability of standardized radiochemistry modules shortens onboarding at new sites. As more regions meet minimum infrastructure thresholds, referral networks expand, and catchment areas shrink. This structural readiness converts latent demand into treated patient volumes across indications.

• Isotope Supply Chain Investments And Generator Technologies
  New cyclotrons, generator platforms, and reactor capacity expansions stabilize availability of key isotopes like ^68Ga, ^177Lu, and emerging alpha emitters. Long-term supply agreements lower volatility and enable confident multi-year program planning. Improved specific activity and radionuclidic purity support safer dosing and tighter QC windows. Generator systems reduce reliance on proximity to cyclotrons, opening access for community hospitals. As logistics mature, wastage from decay and transit delays decreases, improving gross margins. Reliable supply unlocks broader site activation and smoother clinical operations.

• Favorable Reimbursement And Guideline Integration
  Inclusion in national and international guidelines legitimizes use, while dedicated procedure codes streamline billing and prior authorization. Payer acceptance of companion diagnostics as mandatory gatekeepers reduces inappropriate utilization. Bundled reimbursement pilots covering imaging, drug, and administration simplify contracting for hospitals. Value-based arrangements aligned to response or progression metrics incentivize optimal patient selection. As coding clarity improves, sites can forecast revenue with greater confidence and justify capital allocations. This policy scaffolding accelerates diffusion beyond academic centers to community networks.

• Platform Chemistry And Modular Manufacturing Lower Barriers
  Universal chelators, click-chemistry linkers, and cassette-based synthesis platforms shorten development cycles and tech transfers. Sponsors can iterate targets and isotopes without rebuilding entire manufacturing stacks. CDMOs leverage modular cleanrooms and standard equipment to onboard new programs quickly. These efficiencies compress time-to-clinic and time-to-market while enabling geographic replication. Lower CMC complexity reduces regulatory friction and inspection timelines. Collectively, platformization makes theranostics more scalable and capital-efficient across pipelines.

• Personalized Oncology And Multidisciplinary Care Models
  Health systems are reorganizing around precision oncology pathways that privilege biomarker-driven decisions. Theranostics naturally fit these models by linking imaging, dosimetry, and therapy within one continuum. Multidisciplinary tumor boards facilitate rapid triage from scan to treatment in days, not weeks. Patient satisfaction improves with clearer eligibility criteria and measurable on-treatment response. As outcomes and experience scores rise, institutions expand dedicated theranostic clinics. This organizational alignment sustains referral growth and repeatable care pathways at scale.

Challenges in the Market

• Isotope Production Constraints And Supply Volatility
  Dependence on limited reactors, cyclotrons, and generator suppliers creates bottlenecks and regional inequities. Planned maintenance or unplanned outages can cancel therapy days and erode clinician confidence. Lead-time variability complicates scheduling, staffing, and inventory buffers for short half-life products. Sponsors must diversify sources, hold safety stock where feasible, and design contingency logistics. Without resilient supply, expansion into community settings remains risky. Long-term contracts and public-private investments are essential but slow to materialize.

• Workforce Shortages And Training Requirements
  Scaling programs requires radiochemists, nuclear pharmacists, qualified operators, and radiation safety officers—roles already in short supply. Training timelines and certification pathways are lengthy relative to demand growth. Cross-training existing pharmacy and imaging staff can help but may strain other service lines. Burnout risk rises when centers run long days to accommodate decay windows. Vendors must design user-friendly systems that reduce manual steps and cognitive load. Sustainable growth hinges on workforce pipelines, curricula, and retention incentives.

• Regulatory Complexity And CMC/QA Burden
  Radiopharmaceuticals face rigorous GMP, radiation, and environmental standards, with variations across jurisdictions. Chemistry-manufacturing-controls require meticulous validation, stability data, and change control under time pressure. Multi-site networks multiply audits, documentation, and deviation management. Delays in assay validation or method transfer can cascade into missed patient slots. Sponsors and CDMOs need digital QMS, robust tech transfer playbooks, and inspection readiness at all times. Regulatory agility must not compromise patient safety or product integrity.

• Economic Pressures And Reimbursement Variability
  High fixed costs for PET/CT, hot cells, shielding, and staff compete with constrained hospital budgets. Reimbursement rates may lag true delivery costs, especially for early adopters outside major metros. Prior authorization hurdles can delay care and increase administrative overhead. Payers may restrict indications pending long-term outcomes, capping initial volumes. Providers must quantify total value—reduced downstream costs, fewer ineffective cycles—to defend pricing. Financial fragility can deter smaller centers from activating services.

• Operational Complexity: Cold-Chain, QC, And Scheduling
  Tight half-life windows make logistics and scheduling brittle; a delayed courier or failed QC can scrap a full therapy day. Coordinating patient prep, scanner access, and therapy rooms demands precise orchestration. Redundant shipping lanes, backup lots, and real-time tracking mitigate but add cost. Electronic scheduling with decay-aware algorithms helps optimize dose usage per batch. Even with digitization, last-minute clinical changes can create waste. Operational excellence is as critical as scientific efficacy for sustainable scale.

• Safety, Dosimetry, And Long-Term Risk Management
  While targeted, radioligands still pose risks to salivary glands, kidneys, marrow, and gonads, necessitating robust screening and mitigation protocols. Accurate patient-specific dosimetry remains variable across sites despite guidance. Survivorship care requires registries to monitor late effects, second malignancies, and fertility impacts. Clear patient education and radiation safety at home reduce caregiver exposure. As alpha programs expand, toxicity profiles will need careful characterization. Safety governance must evolve alongside innovation to maintain public trust.

Radiopharmaceutical Theranostics Market Segmentation

By Isotope Type

• Beta Emitters (^177Lu, ^131I)

• Alpha Emitters (^225Ac, ^213Bi)

• Diagnostic PET Isotopes (^68Ga, ^18F)

• SPECT Isotopes (^111In, 99mTc)

By Target/Pathway

• PSMA (Prostate Cancer)

• SSTR (Neuroendocrine Tumors)

• FAP (Fibroblast Activation Protein)

• GRPR, CXCR4, Integrins, Others

By Application

• Oncology—Prostate, Neuroendocrine, Breast, Pancreatic, Others

• Non-Oncology—Cardiology, Neurology, Inflammation (Emerging)

By End User

• Hospitals & Academic Centers

• Specialty Theranostic Clinics

• Contract Radiopharmacies & CDMOs

By Geography

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa

Leading Key Players

• Novartis (Advanced Accelerator Applications)

• Telix Pharmaceuticals

• Lantheus

• Curium

• GE HealthCare

• Bayer

• POINT Biopharma (Eli Lilly)

• Cardinal Health (Nuclear & Precision Health Solutions)

• Eckert & Ziegler

• SOFIE Biosciences

Recent Developments

• Novartis expanded radioligand therapy manufacturing capacity with new GMP lines and regional distribution hubs to support PSMA and SSTR programs.

• Telix Pharmaceuticals advanced its prostate and renal imaging-therapy pairs, including new PET tracers aligned to downstream therapeutic candidates.

• Lantheus launched AI-enabled imaging analytics partnerships to standardize quantification and improve patient selection across PET networks.

• POINT Biopharma integrated into Eli Lilly, accelerating late-stage radioligand programs and global commercial infrastructure.

• Eckert & Ziegler signed long-term isotope supply and CDMO agreements to bolster secured access to ^177Lu and emerging alpha emitters.

This Market Report Will Answer the Following Questions

• Which clinical targets and isotopes will drive the largest incremental growth through 2031?

• How will alpha-emitter programs reshape efficacy-toxicity trade-offs and site readiness requirements?

• What operating models (in-house vs. CDMO vs. hybrid) best balance cost, capacity, and compliance?

• How should providers mitigate isotope supply risk and schedule brittleness tied to half-life constraints?

• Which reimbursement and guideline shifts unlock earlier-line adoption and community site activation?

• How will AI-driven imaging, dosimetry, and workflow automation influence outcomes and throughput?

• What workforce and training frameworks are required to scale safely across regions?

• Where are the most attractive partnership opportunities across isotope supply, logistics, and software?

• How can sponsors de-risk regulatory and CMC complexity across multi-site, multi-jurisdiction networks?

• What non-oncology indications are most likely to validate theranostic approaches over the next cycle?