Global AI in Radiotherapy and Precision Oncology Market Outlook to 2032

Executive Summary

The global AI in radiotherapy and precision oncology market — defined as the value chain of artificial-intelligence-enabled radiotherapy planning, delivery, and adaptive workflow software, plus AI-augmented theranostics, AI-driven oncology imaging analytics, and AI-enabled outcome prediction across photon linear accelerators, MR-Linac systems, proton therapy, and radiopharmaceutical theranostics — is estimated at approximately US$3.5 billion in 2024 and is projected to reach approximately US$15 billion by 2032, expanding at a CAGR of approximately 18 percent over the forecast period. AI is shifting radiation oncology from manual contouring plus planning workflows to autonomous adaptive treatment, materially compressing per-patient labor cost and enabling adaptive workflows that were not previously commercially viable.

Three forces define the trajectory through 2032. First, AI auto-contouring and plan generation have crossed from feature to default workflow: Varian (Siemens Healthineers) Ethos adaptive radiation therapy plus RapidPlan AI auto-contouring, Elekta Unity MR-Linac plus Monaco AI planning, RaySearch RayStation AI tools, plus pure-play vendors including Limbus AI, MIM Software, Therapixel, and Mirada Medical collectively position AI auto-contouring as the standard rather than optional workflow component — case contouring times have compressed from approximately 60–120 minutes per patient using manual approaches to approximately 5–15 minutes using AI auto-contouring with clinician review. Second, MR-Linac and adaptive radiotherapy scaling is reshaping the modality mix: Elekta Unity (the original MR-Linac, CE Marked 2018, FDA cleared 2018) and Varian Ethos (adaptive photon platform launched 2020 with MR-Linac equivalent ETHOS-MR in development) collectively define the adaptive segment; ViewRay's MRIdian MR-Linac system was the early competitor before ViewRay's July 2023 Chapter 11 with MRIdian assets sold to Elekta in 2024 — providing the category's most prominent cautionary case. Third, theranostics commercialisation has crossed the structural inflection: Novartis' Pluvicto (lutetium-177 vipivotide tetraxetan) was FDA approved in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer and is the first major commercial PSMA-targeted radiopharmaceutical; Novartis' acquisition of Mariana Oncology (announced May 2024 at approximately US$1 billion plus contingent value) plus Eli Lilly's acquisition of Point Biopharma (October 2023 at US$1.4 billion) and Bristol-Myers Squibb's acquisition of RayzeBio (December 2023 at US$4.1 billion) collectively signalled big-pharma commitment to theranostics as a structural oncology category.

For radiation oncology departments, hospital systems, big medical device OEMs, oncology investors, and policymakers, the implication is that 2026–2030 is the decisive window for AI radiotherapy and theranostics commercial maturation. The technology has been clinically validated, AI auto-contouring is the new workflow default, MR-Linac adaptive treatment is scaling to thousands of installed systems globally, and theranostics has demonstrated commercial viability with multiple US$1B-plus pharma deals — but the principal commercial constraints are radiation oncologist and medical physicist workforce capacity, capital cost of MR-Linac and proton therapy systems (approximately US$8–12 million per MR-Linac, US$30–200 million per proton facility), and reimbursement framework alignment for AI-augmented adaptive workflows.

Market Overview

Definition and Scope

This report scopes the global AI in radiotherapy and precision oncology market as the full value chain of AI software and AI-enabled hardware-software platforms applied to radiation oncology and adjacent precision oncology: AI auto-contouring software (Limbus AI, MIM Maestro, Varian RapidPlan, Elekta ABAS, Mirada Medical, Therapixel); AI treatment planning systems (RaySearch RayStation, Varian Eclipse with AI modules, Elekta Monaco, Brainlab Elements); adaptive radiotherapy workflow platforms (Varian Ethos, Elekta Unity, MIM Maestro adaptive); AI-enabled oncology imaging analytics (Siemens AI-Rad Companion oncology, GE HealthCare AIR Recon DL, Aidoc oncology); AI outcome prediction and patient selection (RayCare, Varian InSightive, Elekta MOSAIQ); plus AI-augmented theranostics (Novartis Pluvicto and Lutathera, AAA-RadioMedix, Lantheus, ITM, plus emerging entrants); plus the integration services, training, support, and first-year operations layer.

The scope includes AI software revenue (auto-contouring, planning, adaptive workflow), AI-embedded oncology imaging and informatics revenue, plus AI-augmented theranostic software and analytics revenue. The scope captures both standalone AI vendor revenue (Limbus, MIM, Therapixel, MIM Maestro, plus emerging pure-plays) and AI software embedded in OEM linear accelerator and MR-Linac platforms (Varian Eclipse and Ethos AI modules, Elekta Monaco and Unity AI tools, RaySearch RayStation AI, Brainlab Elements AI). The underlying linear accelerator and MR-Linac and proton therapy hardware capex is partially scoped — included where AI is the principal value differentiator (Ethos adaptive, Unity MR-Linac) and excluded for conventional linear accelerator hardware revenue.

Evolution and Genesis

The AI radiotherapy market evolved through four structurally distinct phases. The 2010–2016 conventional-IGRT phase established image-guided radiation therapy (IGRT) as the standard for photon delivery and saw the first generation of intensity-modulated radiation therapy (IMRT) software automation. The first AI auto-contouring research papers appeared in 2014–2016 (atlas-based plus early deep learning approaches), but commercial AI deployment remained minimal. Cumulative AI radiotherapy market value was under US$0.5 billion in 2016.

The 2017–2020 deep-learning-and-adaptive-emergence phase opened with Elekta Unity MR-Linac CE Marking (2018) plus FDA clearance (2018) — the first commercial MR-Linac and the structural platform for adaptive radiotherapy. ViewRay's MRIdian MR-Linac (FDA cleared 2017) provided the second commercial MR-Linac platform. Deep-learning auto-contouring research transitioned to commercial deployment with Mirada Medical (DLCExpert), Limbus AI, and emerging pure-plays. Varian's announcement of Ethos adaptive radiation therapy (launched in late 2020 after years of development) signalled the photon adaptive workflow. The Siemens Healthineers acquisition of Varian closed in April 2021 at approximately US$16.4 billion — restructuring the radiotherapy OEM landscape.

The 2021–2023 commercial-scaling-and-MR-Linac-consolidation phase saw the structural inflection. Elekta Unity installed base grew from approximately 30 systems in 2020 to over 80 by end-2023. Varian Ethos commercial deployment scaled across multiple hundred installations. AI auto-contouring deployment crossed from "feature option" to "default workflow" across major academic centres. Theranostics achieved its structural inflection with Novartis Pluvicto FDA approval in March 2022 — the first PSMA-targeted radiopharmaceutical and the first big-pharma-anchored theranostic commercial product (Pluvicto sales reached approximately US$980 million in 2023 with full-year 2024 sales over US$1.4 billion per Novartis disclosures). ViewRay's July 2023 Chapter 11 — with MRIdian MR-Linac assets ultimately sold to Elekta in 2024 — provided the category's most prominent cautionary case and consolidated the MR-Linac market structurally toward Elekta.

The 2024-onward foundation-model-and-theranostics-scaling phase is the current era. Three structural events define the new phase: (a) the Novartis acquisition of Mariana Oncology announced May 2024 plus Eli Lilly's Point Biopharma acquisition October 2023 plus Bristol-Myers Squibb's RayzeBio acquisition December 2023 — collectively over US$6.5 billion in big-pharma theranostics M&A, (b) the FDA AI/ML-enabled medical device list crossing approximately 1,000 in 2025 with radiation oncology AI representing a growing share, and (c) emerging adaptive-radiotherapy-foundation-model deployments combining auto-contouring, plan generation, and outcome prediction in unified workflow platforms.

Key Market Drivers

• AI auto-contouring compression of per-patient labor cost. AI auto-contouring reduces case contouring time from approximately 60–120 minutes per patient (manual) to approximately 5–15 minutes (AI with clinician review) — a 6–8× compression. With radiation oncologist median compensation in the US approximately US$520,000–US$590,000 annually, the labor cost savings per case range from approximately US$40 to US$80 per patient.
• MR-Linac adaptive radiotherapy scaling. Elekta Unity installed base grew to over 80 systems globally by end-2023 from approximately 30 in 2020. Capital cost approximately US$8–12 million per system. Adaptive radiotherapy enables tumor-position-specific daily replanning — clinically valuable for prostate, pancreatic, liver, lung, and emerging indications. Combined with the MRIdian transition from ViewRay to Elekta (2024), MR-Linac is the structural growth modality.
• Theranostics commercial validation via Pluvicto and Lutathera. Novartis Pluvicto sales grew from launch (March 2022) to approximately US$980 million in 2023 to over US$1.4 billion in 2024 — establishing PSMA theranostics as a structural commercial category. Novartis Lutathera (lutetium-177 dotatate, originally Advanced Accelerator Applications, FDA approved January 2018) was the precursor theranostic and demonstrated the pathway.
• Cancer incidence growth and radiation oncology demand expansion. Global cancer incidence is forecast to grow from approximately 20 million new cases in 2022 to approximately 30 million by 2040 per IARC and WHO projections — driving structural demand for radiation oncology and theranostics. Approximately 50–60 percent of cancer patients receive radiation therapy at some point in treatment, supporting durable radiation oncology demand.

Macroeconomic and Regulatory Context

The market is operating against a structurally supportive regulatory and reimbursement framework. The FDA AI/ML-enabled medical device pathway (510(k), De Novo, Premarket Approval) supports rapid AI radiotherapy commercial deployment — the cumulative AI/ML-enabled medical device list crossed approximately 1,000 in 2025. The FDA's Predetermined Change Control Plan (PCCP) guidance, finalised in 2024, supports iterative AI model updates without full re-submission. The EU Medical Device Regulation (MDR, in force May 2021) plus the EU AI Act (in force August 2024) classify radiation oncology AI as high-risk and require conformity assessment. CMS Medicare physician fee schedule updates have begun incorporating adaptive radiotherapy workflows, and CMS Hospital Outpatient Prospective Payment System (OPPS) updates have incrementally added theranostic radiopharmaceutical payment codes.

The macroeconomic backdrop is structurally supportive. The principal commercial constraints are radiation oncologist and medical physicist workforce capacity (the US faces an approximately 8–12 percent radiation oncology workforce growth gap versus demand through 2032 per ASTRO and Association of American Medical Colleges modelling), capital cost of MR-Linac and proton therapy systems, and reimbursement framework alignment for AI-augmented adaptive workflows. The forward implication is that AI radiotherapy and theranostics commercial success increasingly depends on platform-integrated workflow deployment (rather than standalone software sales), big-pharma theranostics co-commercialisation models, and emerging Category I CPT and adaptive radiotherapy reimbursement code maturation.

Market Size & Growth Outlook

The market grew from approximately US$0.8 billion in 2020 to approximately US$2.6 billion in 2023 — a 3.3× expansion in three years driven principally by AI auto-contouring commercial deployment, Varian Ethos adaptive radiation therapy scaling, Elekta Unity MR-Linac installed base growth (approximately 30 to over 60 systems), plus the Pluvicto commercial launch (March 2022 FDA approval). The 2021 acceleration (50 percent year-on-year growth) reflects the Siemens-Varian acquisition close (April 2021 at approximately US$16.4 billion) restructuring the radiotherapy OEM landscape and providing capital scale for accelerated AI integration.

The 2023 inflection at approximately US$2.6 billion (44 percent year-on-year growth) is the structural moment when AI radiotherapy crossed from "early commercial" to "default deployment". ViewRay's July 2023 Chapter 11 — with MRIdian MR-Linac assets ultimately sold to Elekta in 2024 — is the category's most prominent cautionary case and structurally consolidated the MR-Linac segment toward Elekta. The 2024 expansion to US$3.5 billion (34.6 percent year-on-year) is anchored by three catalysts: (a) Elekta Unity installed base crossing 80 systems globally; (b) the theranostics big-pharma M&A wave with Eli Lilly's Point Biopharma acquisition (October 2023, US$1.4 billion), Bristol-Myers Squibb's RayzeBio acquisition (December 2023, US$4.1 billion), and Novartis's Mariana Oncology acquisition (announced May 2024, approximately US$1 billion plus contingent value); and (c) AI auto-contouring crossing from feature option to default workflow at the majority of academic radiation oncology centres globally.

The forecast CAGR of approximately 18 percent through 2032 anchors on three drivers. The first is continued AI workflow integration: MR-Linac installed base forecast to reach approximately 250–300 systems globally by 2032 (versus over 100 by end-2025) — a 2.5–3× expansion driven by adaptive radiotherapy clinical evidence maturation, capital cost incremental reduction, plus emerging tumor-type-specific reimbursement frameworks. AI is shifting radiation oncology from manual contouring plus planning workflows to autonomous adaptive treatment, materially compressing per-patient labor cost. The second driver is theranostics scaling: Pluvicto annual sales forecast to reach approximately US$4–6 billion by 2032 (versus over US$1.4 billion in 2024) plus emerging FAP-targeted (FAP-2286 from Clovis-Novartis, plus emerging entrants), GRPR-targeted, and SSTR-targeted theranostics collectively expand the radiopharmaceutical category materially. The third driver is foundation-model and integrated-workflow platform commercialisation: emerging Varian, Elekta, Siemens, GE HealthCare, plus pure-play foundation-model deployments collectively convert single-task AI clearance economics into platform-multi-task economics.

The forecast structure transitions from rapid 26–35 percent annual growth in 2024–2027 to moderating 16–22 percent annual growth in 2028–2030 to mature 9–12 percent annual growth in 2031–2032 — reflecting the natural saturation of AI auto-contouring deployment plus the gradual maturation of MR-Linac and theranostics commercial markets. Cumulative investment across the value chain over the 2024–2032 forecast window — capital equipment capex plus AI software development plus theranostics development plus integration services plus first-year operations — is forecast at approximately US$60–80 billion. This investment magnitude reconciles to approximately 4× the average annual market size in the forecast window, consistent with capital-equipment-anchored healthcare technology categories. The implication for stakeholders is that AI radiotherapy and theranostics has structurally transitioned from "interesting workflow tool" to "default radiation oncology infrastructure layer" — but commercial winners will be defined by platform integration scale and big-pharma theranostics co-commercialisation rather than standalone AI software clearances.

Market Segmentation

By Modality

Photon linear accelerator workflows dominate at approximately 38 percent of AI radiotherapy category value because conventional photon IGRT and IMRT represent the largest installed-base substrate for AI software deployment — approximately 15,000–17,000 linear accelerators installed globally per IAEA and ESTRO estimates. MR-Linac at approximately 18 percent is the structural growth modality, anchored by Elekta Unity installed base over 80 systems by end-2023 plus the ViewRay-to-Elekta MRIdian asset transfer in 2024 and Varian Ethos adaptive scaling. Theranostics at approximately 22 percent reflects the rapid commercial scaling of Pluvicto (over US$1.4 billion full-year 2024 sales per Novartis disclosures) plus Lutathera (over US$700 million annually).

Proton therapy at approximately 9 percent remains structurally smaller due to capital cost (approximately US$30–200 million per facility depending on configuration), with the principal vendors including Varian ProBeam, IBA Cyclone, Mevion Medical, and Hitachi proton. The Hitachi proton business has faced documented commercial difficulty and is one of multiple cautionary signals in the proton sub-segment. Stereotactic radiosurgery at approximately 8 percent is anchored by Accuray CyberKnife and Elekta Gamma Knife. Brachytherapy at approximately 5 percent includes the emerging FLASH radiotherapy research category (Varian and IBA both have FLASH research programmes through 2025–2027).

The implication is that modality mix shifts toward MR-Linac adaptive (approximately 24 percent of 2032 value) and theranostics (approximately 28 percent) — collectively reaching approximately 52 percent of 2032 value versus approximately 40 percent in 2024. Conventional photon linear accelerator workflows maintain absolute scale growth but compress in share to approximately 30 percent of 2032 value.

By AI Function

AI auto-contouring at approximately 32 percent is the largest functional category because it is the most mature AI radiotherapy application — approximately 60–80 percent of radiation oncology departments at major US academic centres have deployed AI auto-contouring in production workflows by 2024. The case contouring time compression from approximately 60–120 minutes per patient (manual) to approximately 5–15 minutes (AI with clinician review) is a 6–8× labor productivity gain that drives commercial deployment economics independent of reimbursement. AI treatment plan generation at approximately 24 percent is the second-largest functional category, anchored by RaySearch RayStation AI tools plus Varian Eclipse AI plus Elekta Monaco knowledge-based planning.

Adaptive replanning workflow at approximately 18 percent is the structurally fastest-growing functional category because adaptive radiotherapy enables daily tumor-position-specific replanning — clinically valuable for prostate, pancreatic, liver, lung, and emerging indications. Outcome prediction and patient selection at approximately 12 percent plus AI-augmented theranostics analytics at approximately 9 percent are the emerging functional categories, with growth driven by clinical evidence maturation and integration into broader oncology workflows. Quality assurance auto-QA at approximately 5 percent is mature and stable.

The implication is that AI functional mix shifts toward adaptive replanning (approximately 26 percent of 2032 value) and theranostics analytics (approximately 14 percent) — collectively reaching approximately 40 percent of 2032 value versus approximately 27 percent in 2024. AI auto-contouring compresses in share to approximately 24 percent of 2032 value as auto-contouring deployment approaches saturation in mature markets.

By Tumor Type

Prostate cancer at approximately 22 percent leads tumor-type share because of two converging forces: (a) prostate is one of the largest radiation therapy indication volumes (over 200,000 US prostate cancer cases annually, with approximately 40–50 percent receiving radiation therapy at some point in treatment), and (b) Pluvicto PSMA theranostic represents the structural commercial inflection for prostate-cancer radiopharmaceutical therapy. Breast cancer at approximately 16 percent and lung cancer at approximately 14 percent represent the next-largest tumor-type categories, anchored by photon IMRT plus emerging adaptive radiotherapy workflows.

Head and neck cancer at approximately 13 percent benefits disproportionately from AI auto-contouring because head and neck workflows have the highest number of organs-at-risk to contour (approximately 20–30 OAR structures per case) — the AI auto-contouring labor productivity gain is largest for head and neck cases. Gastrointestinal cancers including pancreatic at approximately 12 percent are the principal beneficiary of MR-Linac adaptive radiotherapy because pancreatic tumors move with daily breathing and bowel position — adaptive replanning improves target accuracy materially.

The implication is that tumor-type mix shifts modestly toward neuroendocrine (driven by Lutathera plus emerging SSTR-targeted theranostics) and prostate (driven by Pluvicto plus emerging PSMA-targeted theranostic expansion) through 2032. Pediatric proton therapy maintains a small but stable share anchored by clinical superiority for pediatric brain tumors.

By Region

North America at approximately 44 percent leads regional share because of three converging factors: (a) the largest installed base of MR-Linac, photon linear accelerator, and proton therapy systems globally; (b) Pluvicto and Lutathera commercial scaling concentrated in US markets with approximately 70 percent of global theranostics revenue; and (c) US Medicare and commercial payer reimbursement for adaptive radiotherapy that supports premium-platform deployment economics. Europe at approximately 26 percent is anchored by the EU MDR plus AI Act framework, UK NHS adaptive radiotherapy investment, plus Elekta's Stockholm-anchored European OEM presence.

Asia-Pacific at approximately 22 percent is structurally fast-growing, anchored by Japan PMDA radiotherapy AI approval pathway, China NMPA framework, plus growing proton therapy installed base across Japan, China, and South Korea. China specifically has been a fast-growing proton therapy market through 2023–2025 with multiple facility commissions per Particle Therapy Co-Operative Group (PTCOG) tracking. The implication is that regional mix shifts modestly through 2032 with North America compressing to approximately 41 percent share and Asia-Pacific growing to approximately 26 percent driven by Chinese plus Japanese plus Korean proton and adaptive radiotherapy capacity expansion.

By Vendor Archetype

Linear accelerator OEMs at approximately 42 percent dominate vendor-archetype share because of the integrated hardware-software platform value capture — Varian (Siemens Healthineers since April 2021) plus Elekta plus Accuray collectively control the substrate on which AI software deployment occurs. Theranostics radiopharma at approximately 24 percent reflects the rapid commercial scaling of Novartis Pluvicto plus Lutathera plus emerging Eli Lilly (Point Biopharma), BMS (RayzeBio), and Lantheus theranostic franchises. Pure-play AI software vendors at approximately 14 percent — RaySearch, Limbus AI, MIM Software, Mirada Medical, Therapixel — face structural commercial pressure from integrated OEM platform deployment but maintain durable share in AI auto-contouring and pure-software workflows.

Proton therapy specialists at approximately 9 percent include IBA (Belgian listed company, largest proton therapy installed base), Mevion Medical (compact single-room proton systems), and Hitachi proton (facing documented commercial difficulty). The Hitachi proton commercial struggle plus broader proton therapy economic challenges (high capital cost, uncertain reimbursement premium for non-pediatric indications) represent secondary cautionary signals in the proton sub-segment. The implication is that vendor-archetype mix shifts moderately toward theranostics radiopharma (approximately 30 percent of 2032 value) and pure-play AI software (approximately 12 percent compression as integrated platforms consolidate) through 2032.

By Care Setting

Academic medical centres at approximately 38 percent lead care-setting share because they are the principal early adopters of MR-Linac adaptive radiotherapy, AI auto-contouring, and emerging foundation-model platforms. Major academic centres (Memorial Sloan Kettering, MD Anderson, Mayo Clinic, Cleveland Clinic, plus EU equivalents at the UK Royal Marsden, German DKFZ, Dutch NKI) collectively represent disproportionate share of MR-Linac installed base. Large community hospitals at approximately 28 percent represent the largest installed-base substrate for AI software deployment. Outpatient theranostics centres at approximately 4 percent are the fastest-growing care-setting category, driven by Pluvicto and Lutathera infusion volume expansion that exceeds existing hospital nuclear medicine capacity in multiple geographies.

Clinical / Approval Pipeline

The pipeline is materially concentrated in theranostics expansion (PSMA, SSTR, FAP, GRPR targets) plus MR-Linac competitive scaling. The Novartis Pluvicto commercial trajectory (over US$1.4 billion full-year 2024 sales) plus the Eli Lilly PNT2002 emerging Phase 3 competitor positions PSMA theranostics as an increasingly competitive sub-category through 2028. The BMS RayzeBio RYZ101 Phase 3 ACTION-1 plus emerging SSTR-targeted entrants similarly position the neuroendocrine theranostic sub-category for competitive expansion. The Varian Ethos-MR development represents the principal competitive product to Elekta Unity in MR-Linac.

Trends & Developments

MR-Linac Adaptive Radiotherapy Default Workflow Scaling

Elekta Unity installed base grew from approximately 30 systems in 2020 to over 80 by end-2023 with growth trajectory toward 150-plus by end-2026 per Elekta investor disclosures. The ViewRay MRIdian platform — FDA cleared 2017 and the original MR-Linac competitor — was acquired by Elekta in 2024 following ViewRay's July 2023 Chapter 11, consolidating the MR-Linac category structurally toward Elekta. Varian Ethos-MR is in development as the principal competitive product. The clinical evidence base for adaptive radiotherapy continues to mature, with pancreatic, prostate, liver, and lung indications showing measurable clinical advantage in published outcome data. The competitive implication: MR-Linac becomes the default radiotherapy platform for adaptive-eligible tumor sites through 2030 while conventional photon LINAC maintains volume but compresses in share.

Theranostics Big-Pharma M&A Wave

The theranostics M&A wave over 2022–2024 represents collectively over US$6.5 billion in big-pharma commitment to the category: Novartis acquired Advanced Accelerator Applications (October 2017) and Endocyte (October 2018) building toward Pluvicto and Lutathera; Eli Lilly acquired Point Biopharma in October 2023 at US$1.4 billion; Bristol-Myers Squibb acquired RayzeBio in December 2023 at US$4.1 billion; Novartis acquired Mariana Oncology announced May 2024 at approximately US$1 billion plus contingent value; AstraZeneca acquired Fusion Pharmaceuticals announced March 2024 at approximately US$2 billion. The structural significance is that big-pharma has validated theranostics as a durable oncology category and is positioning for competitive launches across PSMA (Pluvicto plus Eli Lilly PNT2002), SSTR (Lutathera plus BMS RYZ101), FAP, and GRPR targets through 2028. The competitive implication: pure-play theranostic specialists face M&A consolidation pressure or strategic positioning as big-pharma development partners.

AI Auto-Contouring Default Workflow Crossing

AI auto-contouring crossed from "feature option" to "default workflow" at the majority of major US academic radiation oncology centres by 2024, with deployment scaling across community hospitals through 2025–2027. The case contouring time compression from approximately 60–120 minutes per patient (manual) to approximately 5–15 minutes (AI with clinician review) is a 6–8× labor productivity gain. Limbus AI, MIM Software (MIM Maestro), Mirada Medical (DLCExpert), Varian RapidPlan, Elekta ABAS, plus emerging pure-plays including Therapixel collectively compete in the auto-contouring software category. The competitive implication: AI auto-contouring becomes commoditised through 2027–2028 with pricing compression of approximately 20–30 percent versus 2024 levels — favoring integrated OEM platforms over pure-play standalone software vendors.

Theranostics Workforce and Infrastructure Capacity Constraint

Pluvicto commercial launch has documented capacity constraints across multiple geographies — Novartis disclosed approximately US$80 million in lost 2023 sales due to manufacturing and infrastructure capacity limits. The theranostics workforce constraint (nuclear medicine physicians, radiopharmacists, infusion centre nurses) plus the radiopharmaceutical manufacturing capacity constraint (Novartis is investing approximately US$300 million in expanded US-based manufacturing through 2026) collectively limit theranostics commercial scaling pace. The competitive implication: theranostics commercial winners will be defined by manufacturing capacity and infrastructure investment scale, not by clinical pipeline breadth alone.

Foundation-Model and Integrated-Platform Workflow

Emerging Varian, Elekta, Siemens Healthineers, GE HealthCare, plus pure-play foundation-model deployments combine AI auto-contouring, plan generation, adaptive replanning, and outcome prediction in unified workflow platforms. The Aidoc CARE1 foundation model FDA clearance precedent (February 2025 for rib fracture triage, January 2026 for 14-finding abdominal CT) provides the regulatory pathway for multi-task radiotherapy foundation models. The competitive implication: foundation-model integrated workflow platforms compress the addressable market for single-task pure-play AI software vendors and concentrate value capture in integrated OEM platforms through 2030.

Particle Therapy and FLASH Research Trajectory

Particle therapy (proton plus emerging carbon ion) installed base continues to grow modestly — approximately 130 proton therapy centres globally operating or under construction in 2024 per PTCOG, up from approximately 80 in 2018. The FLASH radiotherapy research trajectory (ultra-high-dose-rate radiation delivery with potential normal-tissue-sparing FLASH effect) is in pre-clinical and early clinical development with Varian, IBA, and academic partners — emerging through 2030. Hitachi proton's commercial struggle plus broader proton economic challenges (high capital cost, uncertain reimbursement premium for non-pediatric indications) represent ongoing cautionary signals. The competitive implication: particle therapy maintains specialty positioning for pediatric and selected adult indications but does not displace photon LINAC or MR-Linac as the volume modality through 2032.

Competitive Landscape

The competitive structure can be decomposed into four strategic archetypes: (1) Diversified linear accelerator OEM scale leaders (Varian-Siemens, Elekta, Accuray) competing on integrated hardware-software platform value capture; (2) Theranostics radiopharma scale players (Novartis with Pluvicto and Lutathera; emerging Eli Lilly with Point Bio, BMS with RayzeBio, AstraZeneca with Fusion, Lantheus) competing on radiopharmaceutical pipeline breadth and big-pharma sales-and-marketing scale; (3) Proton therapy specialists (IBA, Mevion, Hitachi, ProTom) competing on capital equipment differentiation and specialty indication clinical evidence; and (4) Pure-play AI software vendors (RaySearch, MIM Software, Limbus AI, Mirada Medical, Therapixel) competing on best-of-breed AI workflow versus integrated OEM platform pricing.

The category is moderately concentrated — the top three named players (Varian, Elekta, Novartis) account for approximately 53 percent of value with the long tail collectively at approximately 47 percent. The concentration is forecast to increase modestly through 2032 with the top three reaching approximately 60–62 percent of value, driven by linear accelerator OEM consolidation and theranostics big-pharma M&A activity.

Varian (Siemens Healthineers since April 2021) is the category leader by linear accelerator installed base and integrated hardware-software platform scale. The strategic posture is integrated OEM platform deployment with AI workflow modules (Ethos adaptive, RapidPlan auto-contouring, Eclipse AI planning) sold as platform components. Varian Ethos adaptive radiation therapy launched in late 2020 plus emerging Ethos-MR development positions Varian for adaptive radiotherapy share leadership against Elekta Unity. The Siemens Healthineers parent provides capital scale and adjacent diagnostic imaging integration.

Elekta is the category co-leader by MR-Linac installed base (Unity over 80 systems by end-2023) and integrated hardware-software platform. The strategic posture is anchored on MR-Linac adaptive radiotherapy leadership plus Monaco AI planning plus the 2024 acquisition of ViewRay MRIdian assets that consolidated the MR-Linac category structurally toward Elekta. The Stockholm-listed company maintains a Nordic and European structural anchor with global scale.

Novartis is the theranostics category leader anchored by Pluvicto (full-year 2024 sales over US$1.4 billion) plus Lutathera (over US$700 million annually). The strategic posture combines internal radiopharmaceutical pipeline (FAP-2286 from Clovis acquisition, plus emerging) with the Mariana Oncology acquisition (announced May 2024) and broader pipeline expansion. The structural challenge is manufacturing capacity scaling and theranostics infrastructure deployment to capture the rapidly expanding category demand.

Accuray, RaySearch, IBA, MIM Software, and Limbus AI represent the specialty and pure-play tier. Accuray maintains stereotactic radiosurgery (CyberKnife) plus tomotherapy (Radixact) specialty positioning. RaySearch leads the pure-play planning system category with RayStation deployed across multiple thousand installations globally. IBA leads proton therapy with the largest proton installed base globally. MIM Software, Limbus AI, Mirada Medical, and Therapixel collectively compete in the pure-play AI auto-contouring category — facing structural commercial pressure from integrated OEM platforms but maintaining durable share in academic-centre best-of-breed deployments.

Where competition is going through 2032 is anchored by three structural forces: (a) MR-Linac category consolidation toward Elekta plus emerging Varian Ethos-MR development reducing the credible MR-Linac vendor count to two; (b) theranostics big-pharma M&A and competitive launches across PSMA (Pluvicto plus PNT2002), SSTR (Lutathera plus RYZ101), FAP, and GRPR targets through 2028; and (c) foundation-model integrated workflow platforms compressing the addressable market for single-task pure-play AI software vendors. ViewRay's July 2023 Chapter 11 plus Hitachi proton's commercial difficulty represent the category's principal cautionary cases and continue to shape buyer-side and investor-side risk assessment through 2026.

Challenges & Opportunities

Key Challenges

Radiation oncologist and medical physicist workforce capacity constraint

The US faces an approximately 8–12 percent radiation oncology workforce growth gap versus demand through 2032 per ASTRO and AAMC modelling. Medical physicist supply growth lags MR-Linac and proton therapy installed-base scaling. The structural implication: AI auto-contouring and adaptive workflow productivity gains are partially offset by workforce capacity constraints that limit per-centre patient throughput growth.

MR-Linac and proton therapy capital cost barrier

MR-Linac systems cost approximately US$8–12 million per unit; proton therapy facilities range approximately US$30–200 million depending on configuration. The capital cost barrier limits adoption to academic medical centres, large community hospitals, and specialty cancer hospitals. The ViewRay July 2023 Chapter 11 plus Hitachi proton commercial difficulty demonstrate the financial-business-model risk for capital-equipment-anchored radiotherapy vendors. The structural implication: capital cost is a binding constraint on installed-base scaling pace through 2030.

Theranostics manufacturing and infrastructure capacity constraint

Pluvicto commercial launch documented approximately US$80 million in lost 2023 sales due to manufacturing and infrastructure capacity limits per Novartis disclosures. Theranostics workforce (nuclear medicine physicians, radiopharmacists) plus radiopharmaceutical manufacturing capacity collectively limit theranostics commercial scaling pace. Novartis is investing approximately US$300 million in expanded US-based manufacturing through 2026 — but capacity remains a binding constraint through 2027.

Reimbursement framework lag for adaptive radiotherapy and AI workflows

CMS Medicare physician fee schedule updates have begun incorporating adaptive radiotherapy workflows incrementally — but commercial payer adoption and adaptive radiotherapy-specific reimbursement codes remain uneven through 2024–2025. AI auto-contouring is not separately reimbursed; commercial economics rely on labor cost compression rather than reimbursement uplift. The structural implication: reimbursement framework alignment is a 2026–2028 commercial unlock, not a current commercial driver.

Key Opportunities

Theranostics commercial expansion across targets

Pluvicto plus emerging PNT2002 plus competitive PSMA entrants forecast to grow PSMA theranostics annual sales to approximately US$6–9 billion by 2032. Lutathera plus emerging RYZ101 plus competitive SSTR entrants forecast to grow SSTR theranostics annual sales to approximately US$2–3 billion by 2032. FAP, GRPR, and emerging targets add incremental opportunity. The cumulative theranostics opportunity through 2032 is approximately US$35–45 billion across PSMA, SSTR, FAP, and emerging targets.

MR-Linac installed-base scaling

MR-Linac installed base forecast to grow from over 100 systems globally by end-2025 to approximately 250–300 systems by 2032 — a 2.5–3× expansion. Elekta Unity plus Varian Ethos-MR plus emerging MRIdian-anchored Elekta refresh collectively drive the installed base. The cumulative MR-Linac capital equipment plus service plus AI software opportunity through 2032 is approximately US$10–14 billion.

Foundation-model integrated platform commercialisation

Emerging foundation-model radiotherapy platforms combining auto-contouring, plan generation, adaptive replanning, and outcome prediction position OEMs and pure-plays for platform-multi-task value capture. The cumulative foundation-model integrated platform opportunity through 2032 is approximately US$6–9 billion across OEM platform deployment, pure-play foundation-model commercialisation, and academic centre adoption.

Emerging-market deployment expansion

Chinese radiotherapy AI market grows from approximately 8 percent of 2024 global value to approximately 12 percent by 2032 — driven by domestic Chinese OEM expansion (United Imaging proton, plus emerging) plus Varian and Elekta China commercial scaling. Indian radiotherapy AI market grows on Apollo Hospitals, HCG, and emerging private radiation oncology deployment. Saudi Vision 2030 plus emerging Middle Eastern oncology infrastructure expansion add incremental opportunity.

Key Policies & Regulatory Environment

FDA AI/ML-Enabled Medical Device List and PCCP Guidance

The FDA AI/ML-enabled medical device list crossed approximately 1,000 in 2025 — with radiation oncology AI representing a growing share. The FDA's Predetermined Change Control Plan (PCCP) guidance, finalised in 2024, supports iterative AI model updates without full re-submission. The implication: FDA pathway supports rapid AI radiotherapy commercial deployment, with the regulatory framework for foundation-model multi-task AI systems continuing to develop through 2027.

CMS Medicare Reimbursement for Adaptive Radiotherapy

CMS Medicare physician fee schedule has incorporated adaptive radiotherapy CPT codes incrementally through 2022–2025 updates, with on-line adaptive radiotherapy reimbursement codes (CPT 77387 and related G-codes) supporting Varian Ethos and Elekta Unity commercial economics. CMS Hospital Outpatient Prospective Payment System (OPPS) updates have added incremental theranostic radiopharmaceutical payment codes. The implication: reimbursement framework alignment supports adaptive radiotherapy and theranostics commercial deployment, with multi-year refinement through 2027–2028.

EU Medical Device Regulation and EU AI Act

The EU Medical Device Regulation (MDR, in force May 2021) governs medical device CE marking with the In Vitro Diagnostic Regulation (IVDR) for diagnostic devices. The EU AI Act (in force August 2024) classifies radiation oncology AI as high-risk and requires conformity assessment, transparency obligations, and post-market monitoring. The combined MDR-IVDR-AI Act framework creates structural compliance complexity for AI radiotherapy deployment in EU markets — but the structural deployment growth continues anchored by EU healthcare system adoption.

FDA Pluvicto and Lutathera Approval Precedents

Novartis Lutathera FDA approval (January 2018) plus Novartis Pluvicto FDA approval (March 2022) established the structural regulatory pathway for targeted radiopharmaceutical therapeutics. Subsequent FDA Breakthrough Therapy designations and Fast Track designations across the theranostics pipeline support accelerated development pathways for PSMA, SSTR, FAP, and emerging targets. The implication: FDA theranostics regulatory framework is mature and supportive of category expansion through 2028.

CMS Transitional Coverage for Emerging Technologies (TCET)

CMS TCET, finalised in 2024, creates an expedited Medicare coverage pathway for FDA-designated Breakthrough Devices fitting into established benefit categories — with CMS targeting coverage determinations within six months of FDA authorization. The TCET pathway is relevant for emerging radiation oncology AI Breakthrough Devices and foundation-model platforms. The implication: TCET implementation through 2026–2027 is a meaningful commercial unlock for AI radiotherapy deployment economics.

China NMPA Radiotherapy AI Regulatory Framework

China NMPA radiotherapy AI regulatory framework (updated 2024) supports domestic Chinese AI radiotherapy deployment. Domestic Chinese radiotherapy AI vendors plus emerging Tencent Healthcare AI and Alibaba DAMO Academy operate under the NMPA framework. The 15th Five-Year Plan (2026–2030) is expected to expand healthcare AI policy support including radiation oncology categories.

Japan PMDA Radiotherapy AI Approval Pathway

Japan PMDA has approved multiple AI-enabled radiotherapy software products through 2024–2025 — supporting commercial deployment across Japanese academic and community hospital radiation oncology departments. The PMDA pathway is structurally supportive of MR-Linac and adaptive radiotherapy adoption. The implication: Japan represents a meaningful Asia-Pacific anchor market for AI radiotherapy deployment through 2030.

Particle Therapy Co-Operative Group (PTCOG) Coordination

PTCOG, the international professional association for particle therapy, plus the European Society for Radiotherapy and Oncology (ESTRO) plus the American Society for Radiation Oncology (ASTRO) collectively provide professional society coordination for radiotherapy AI clinical guidelines and quality assurance frameworks. The implication: professional society guideline maturation supports commercial deployment economics by establishing clinical evidence consensus for AI workflows and emerging modalities.

Future Outlook

The global AI in radiotherapy and precision oncology market is positioned for sustained approximately 18 percent CAGR through 2032, reaching approximately US$15 billion in value. AI is shifting radiation oncology from manual contouring plus planning workflows to autonomous adaptive treatment, materially compressing per-patient labor cost. The forecast structure is three-phased: a 2024–2027 acceleration phase (approximately 24–31 percent annual value growth) anchored by AI auto-contouring saturation deployment, MR-Linac installed base scaling toward 150-plus systems by end-2026, theranostics commercial expansion across PSMA and SSTR targets, and big-pharma M&A wave; a 2027–2030 maturation phase (approximately 16–22 percent annual value growth) where adaptive radiotherapy workflows become the default for adaptive-eligible tumor sites and foundation-model platforms commercialise; and a 2030–2032 mature plateau phase (approximately 9–13 percent annual value growth) as AI workflow deployment approaches saturation in mature markets.

The competitive structure is forecast to evolve from the current Varian-Elekta-Novartis-led pattern (top three at approximately 53 percent of 2024 value) toward a more concentrated structure with the top three reaching approximately 60–62 percent by 2032. Theranostics radiopharma collectively expands from approximately 24 percent of 2024 value to approximately 30 percent by 2032 — driven by Novartis Pluvicto plus Lutathera scaling plus competitive launches from Eli Lilly (PNT2002), BMS (RayzeBio RYZ101), AstraZeneca (Fusion), and Lantheus. Pure-play AI software vendors compress modestly in share as foundation-model integrated OEM platforms consolidate value capture, but maintain durable academic-centre best-of-breed positioning.

The modality mix shifts toward MR-Linac adaptive (approximately 24 percent of 2032 value, versus 18 percent in 2024) plus theranostics (approximately 28 percent, versus 22 percent in 2024). Conventional photon linear accelerator workflows compress in share to approximately 30 percent of 2032 value but maintain absolute scale growth. Proton therapy maintains specialty positioning at approximately 8–9 percent share. Stereotactic radiosurgery and brachytherapy maintain small but stable shares.

The AI functional mix shifts toward adaptive replanning (approximately 26 percent of 2032 value, versus 18 percent in 2024) and AI-augmented theranostics analytics (approximately 14 percent, versus 9 percent). AI auto-contouring compresses in share to approximately 24 percent of 2032 value as deployment approaches saturation — but absolute revenue grows. AI treatment plan generation maintains approximately 22 percent share. Outcome prediction plus quality assurance maintain small but stable shares.

The geographic structure shifts modestly. North America compresses from approximately 44 percent of 2024 value to approximately 41 percent by 2032 — driven by faster emerging-market growth rather than US weakness. Europe maintains approximately 26–27 percent share. Asia-Pacific grows from approximately 22 percent to approximately 26 percent driven by China proton therapy and adaptive radiotherapy capacity expansion plus Japan and Korea structural scaling. Middle East and Latin America collectively grow to approximately 7 percent.

The foundation-model commercialisation trajectory through 2026–2030 is the most consequential technology development. Emerging Varian, Elekta, Siemens Healthineers, GE HealthCare, plus pure-play foundation-model deployments combine AI auto-contouring, plan generation, adaptive replanning, and outcome prediction in unified workflow platforms. The Aidoc CARE1 foundation model FDA clearance precedent (February 2025 for rib fracture, January 2026 for 14-finding abdominal CT) provides the regulatory pathway for multi-task radiotherapy foundation models. The forward implication: foundation-model integrated workflow platforms compress the addressable market for single-task pure-play AI software vendors and concentrate value capture in integrated OEM platforms through 2030.

The theranostics scaling trajectory is the most consequential commercial development. Pluvicto annual sales forecast to reach approximately US$4–6 billion by 2032 (versus over US$1.4 billion in 2024); Lutathera plus competitive SSTR theranostics forecast to reach approximately US$2–3 billion by 2032; emerging FAP plus GRPR plus other-target theranostics forecast to add approximately US$1–2 billion by 2032. The cumulative theranostics annual revenue by 2032 is approximately US$8–12 billion (versus approximately US$2.5 billion in 2024). The structural implication: theranostics becomes the second-largest sub-category of AI radiotherapy and precision oncology after photon linear accelerator workflows by 2030.

The principal risk to the outlook is sustained theranostics manufacturing and infrastructure capacity constraint that materially compresses theranostics commercial scaling. If Novartis manufacturing expansion plus emerging competitive manufacturing capacity fails to keep pace with PSMA and SSTR theranostic demand growth, theranostics annual sales growth could plateau at approximately 25–30 percent CAGR (versus the 35–45 percent base-case implied trajectory). The mitigation pathway requires sustained capital investment in radiopharmaceutical manufacturing, nuclear medicine workforce expansion, and infusion centre infrastructure deployment.

The secondary risk is MR-Linac and proton therapy capital cost barrier that materially compresses adaptive radiotherapy deployment economics. If hospital capital budgets compress in a sustained economic downturn, MR-Linac installed-base scaling could slow versus the 250–300 systems by 2032 base case. The ViewRay July 2023 Chapter 11 and Hitachi proton commercial difficulty remain structural cautionary signals — capital-equipment-anchored radiotherapy vendors face elevated business-model risk. The mitigation pathway requires sustained capital cost reduction plus emerging compact MR-Linac and compact proton system development.

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