Radiotheranostics clinical adoption: what actually limits growth

Radiotheranostics clinical adoption: what actually limits growth

Radiotheranostics Clinical Adoption Market discussions often sound like a straight line: approvals happen, demand appears, and hospitals “scale”. That story skips the hard part.

Clinical adoption is not mainly a marketing problem. It is a capacity problem: can a system consistently move the right patient through referral, imaging, radio pharmacy, therapy administration, post-treatment imaging, dosimetry (where used), safety, and follow-up, and can it get paid for the full pathway.

This guide explains what radiotheranostics is, why adoption has accelerated through 2024–2025, what still blocks it in 2026, and what to measure if you want to forecast (or influence) real uptake.

Definition

Radiotheranostics is the use of matched (or biologically linked) radiopharmaceuticals to diagnose a tumor target with imaging and then treat it with targeted radiation delivered by a therapeutic radiopharmaceutical. The “thera” and “diagnostics” pairing is usually anchored in the same biological target (for example PSMA in prostate cancer), so imaging helps select patients likely to benefit, then therapy delivers radiation to those target-expressing sites.

Clinical adoption means more than “drug approved”. It means the pathway is routinely deliverable: enough trained staff, licensed facilities, reliable isotope supply, standard operating procedures, referral confidence from oncologists/urologists, and reimbursement that covers the true cost of care.

Where radiotheranostics is already real, and where it is still brittle

Two therapy families dominate day-to-day adoption:

• Neuroendocrine tumors (NETs): PRRT with Lu-177 DOTATATE (Lutathera) is established in many centers and continues to broaden, including an FDA approval for pediatric patients aged 12+ with SSTR-positive GEP-NETs in 2024.
• Prostate cancer: PSMA-targeted radioligand therapy expanded materially with the FDA approval in March 2025 that moved Pluvicto earlier, before chemotherapy, after an ARPI in PSMA-positive mCRPC.

These successes can hide how fragile the Radiotheranostics Clinical Adoption Market is in many regions. Even in well-funded systems, adoption can stall because one piece breaks: isotope deliveries, clean-room capacity, RAM licensing, inpatient bed access, radiation safety staffing, or a reimbursement rule that does not pay for imaging or handling.

If you want to judge “market readiness”, don’t start with how many oncologists are excited. Start with whether centers can staff and schedule therapy at predictable cadence, and whether the care pathway is funded end-to-end.

How decisions actually get made: the patient pathway and referral logic

A typical radiotheranostics pathway looks like this:

1. Case identification (medical oncology, urology, endocrinology, MDT)
2. Eligibility and target confirmation imaging (for example PSMA PET for PSMA-directed therapy)
3. MDT decision and scheduling (therapy slots are scarce; prioritization matters)
4. Radio pharmacy preparation and QA (time-critical, regulated, waste streams)
5. Therapy administration (radiation safety, nursing, authorized users)
6. Post-treatment imaging / response monitoring (often SPECT/CT for Lu-177 therapies)
7. Toxicity monitoring and follow-up, sometimes including dosimetry depending on local protocols and resourcing

What blocks adoption here is often human, not technical: referring clinicians are unsure when to refer, imaging access is limited, and centers have long lead times. The EANM policy work on radioligand therapy readiness calls out the same pattern: referral pathways and imaging access, workforce, infrastructure, isotope supply, and alignment of financial and regulatory frameworks.

A practical adoption indicator: referral confidence. If urologists and oncologists treat radiotheranostics as “experimental” rather than “standard next line”, volumes remain lumpy even with approval.

Theranostics centre infrastructure: the unglamorous gating factor

A Radiotheranostics Clinical Adoption Market forecast that ignores facilities is not a forecast, it is a hope.

Setting up and operating a theranostics center requires regulated infrastructure (controlled areas), radiation safety processes, trained staff, and licensing. The joint enabling guide from EANM, SNMMI and IAEA is explicit: it is about enabling stakeholders to safely initiate and operate theranostics centers across different regulatory and financial settings.

What “infrastructure” really means:

• Hot lab / radio pharmacy capability appropriate to the product model (in-house vs centralized supply)
• Radiation safety and waste management workflows that do not collapse under higher volumes
• Imaging capacity (PET/CT for selection, SPECT/CT post-therapy where used)
• Protected time and space for authorized users, medical physics, nursing, and QA
• Scheduling systems that respect isotope delivery timing and patient throughput

If you are trying to predict adoption, measure:

• therapy slots per week per center
• cancellation rates due to supply or staffing
• median lead time from referral to first cycle
  
  Those tell you more than “TAM”.

Radioisotope supply: Lu-177 is a strategic constraint, not a commodity

Radiotheranostics scales only as fast as isotopes and radiopharmaceutical manufacturing scale.

Lu-177 supply has been the focus because it underpins major therapies (PSMA RLT and PRRT). Industry activity reflects that constraint: partnerships and capacity investments to secure medical lutetium-177 supply have been repeatedly announced (for example ITM’s collaborations on manufacturing and supply, and other supplier expansions).

What matters for adoption is not just “isotope exists”, but:

• Reliability of weekly deliveries into your geography
• Form and specification (carrier-added vs non-carrier-added can matter depending on product and manufacturing model)
• Logistics and regulatory clearance for time-sensitive shipments
• Single points of failure (one reactor, one processor, one border delay)

A subtle adoption trap: as indications expand (like Pluvicto’s earlier-line use), demand grows faster than workforce and supply chains can adapt. The clinical need can be real and still not convert to delivered cycles.

Reimbursement: approvals create demand, payment rules create volume

Here is the uncomfortable truth: many centers can deliver radiotheranostics clinically, but cannot deliver it sustainably financially.

In the US, CMS payment policy changes for radiopharmaceuticals have been a major theme. CMS finalised a policy to pay separately for certain diagnostic radiopharmaceuticals in OPPS when per-day cost is above a threshold (notably discussed as $630 for CY 2025), rather than bundling everything into procedure payment.

Why this matters to adoption:

• imaging access drives therapy access (you cannot treat what you cannot select)
• if diagnostic agents are underpaid, hospitals ration scans or avoid offering them
• payment design affects whether systems invest in capacity (PET scanners, staff, radio pharmacy upgrades)

In Europe, the adoption conversation is often about heterogeneous reimbursement pathways and system readiness. EANM’s policy reporting highlights persistent uncertainty around reimbursement pathways and the need to align financial and regulatory frameworks as part of readiness.

If you want to estimate adoption, don’t ask “is it reimbursed”. Ask:

• who pays (national, regional, hospital budget)
• what is paid (drug only vs full pathway including imaging, dosimetry, waste)
• how long claims take, and whether shortfalls hit the department budget

Workforce and training: the hidden bottleneck that does not scale quickly

Radiotheranostics requires a cross-functional team: nuclear medicine physicians, radiochemists/radio pharmacists, medical physicists, technologists, nurses, radiation safety officers.

Multiple sources describing implementation barriers point to workforce scarcity as a core constraint.

IAEA is directly active here, running training initiatives and supporting member states in safe and effective radiation medicine practice, including dosimetry and professional development.
There are also published guiding principles emphasizing the need for comprehensive theranostics training programs and competency-based approaches.

Contrarian take: people underestimate how long this takes. You can buy equipment in months. You cannot create a confident, experienced theranostics team at the same speed, especially when global competition for the same talent pool is rising.

Standardisation and dosimetry: why “variation” limits confidence

Adoption accelerates when referring clinicians trust that outcomes and toxicity management are predictable.

That trust is built through:

• procedure guidelines (who is eligible, how therapy is delivered, what follow-up looks like)
• imaging standards (including post-treatment imaging protocols)
• dosimetry practices where feasible and appropriate

There are clear anchors here:

• Joint EANM/SNMMI procedure guideline for 177Lu-PSMA radioligand therapy (candidate identification, treatment procedures, follow-up and side effects).
• EANM dosimetry committee recommendations encouraging patient-specific dosimetry practice for Lu-177 therapies (within the scope of centers that can do it).
• SNMMI procedure standard for post-treatment imaging, reflecting practical realities of response evaluation and timing.

Practical implication: the Radiotheranostics Clinical Adoption Market grows faster where there is a shared playbook. Where every center improvises, referrals slow, payers resist, and outcomes are harder to compare.

Evidence and regulatory momentum: what changed through 2024–2025

Two evidence signals matter for adoption: expanded labels and stronger selection logic.

• Pluvicto label expansion (FDA, March 2025): earlier use before chemotherapy in PSMA-positive mCRPC after ARPI therapy. This is not just “more patients”. It changes the operational load on centers.
• Selection ecosystem expansion: imaging agents and label updates around patient selection for PSMA-directed therapy reinforce the “image then treat” model.
• Lutathera paediatric approval (FDA, April 2024): expands PRRT use to pediatric patients 12+ with SSTR-positive GEP-NETs, which also increases the need for appropriately trained teams and controlled-area workflows.

Regulatory momentum matters, but adoption still depends on service design. Even a strong trial result will not increase delivered cycles if there are not enough therapy slots or if isotope deliveries are inconsistent.

A practical segmentation table: “adoption readiness” levers

Use this to evaluate countries, hospital networks, or investment theses.

Anchors for this framing appear repeatedly in readiness and implementation guidance (workforce, infrastructure, supply, reimbursement, standardization).

Common pitfalls (what slows adoption even in “ready” systems)

1. Treating adoption like a drug launch. It behaves more like building a service line.
2. Ignoring selection bottlenecks. If PSMA PET access is limited, therapy volume caps.
3. Underestimating radio pharmacy and QA load. Time-critical workflows do not tolerate staffing gaps.
4. Building for one indication only. Indication expansion can triple eligible patients, and your center becomes the constraint.
5. Assuming reimbursement covers the pathway. Often it covers pieces; the gaps land on hospitals.
6. No plan for waste, scheduling, and bed flow. These are operational limiters, not “admin details”.
7. Lack of standardized protocols. Variation increases referring clinician hesitation and payer pushback.

Checklist: how to evaluate (or build) a scalable program

If you are a hospital system / provider network

• Map the pathway end to end (referral → imaging → therapy → follow-up) using the enabling guide as a baseline.
• Secure isotope supply with redundancy where possible, and track cancellations by root cause.
• Establish written protocols aligned to EANM/SNMMI guidelines and local regulation.
• Build a workforce plan (training, coverage, back-up roles) using recognized training principles and national requirements.
• Quantify economics per cycle including imaging, handling, monitoring, and waste, not just drug acquisition.

If you are an investor / strategy team

• Underwrite capacity (slots/week), not just eligible patients.
• Check payer mechanics and timelines (especially for imaging).
• Stress test isotope supply concentration risk.
• Look for evidence of standardization adoption (guidelines, post-treatment imaging, QA).

If you are a manufacturer / supplier

• Design support around operations: scheduling playbooks, radiation safety training, and realistic throughput planning.
• Expect adoption to cluster around centers that already run PRRT/PSMA programs.

Key Insights

• Radiotheranostics adoption is gated by service capacity, not awareness.
• Pluvicto’s 2025 label expansion shifts demand earlier and raises throughput requirements.
• Imaging access (like PSMA PET) is a first-order constraint on therapy volume.
• Workforce shortages span multiple roles and are repeatedly cited as adoption blockers.
• Lu-177 supply reliability is strategic; disruptions translate directly into cancelled cycles.
• Guidelines reduce variation and raise referring clinician confidence.
• Dosimetry is encouraged where feasible, but resourcing often determines how far centers go.
• Reimbursement needs to cover the whole pathway, not only the drug.
• CMS OPPS policy for diagnostic radiopharmaceutical payment thresholds affects imaging viability in the US.
• “More approvals” without “more centers” creates waiting lists, not access.
• The fastest adopters usually already have nuclear medicine therapy operations in place.
• Global access gaps are driven by equipment, staffing, and supply chain fragility.

If you are benchmarking countries, service lines, or vendor strategy, explore the reports we have on our platform.

FAQs

1) What is radiotheranostics in plain English?

Radiotheranostics pairs a targeted scan with a targeted radiation treatment. A molecule that binds to a tumor target is used first for imaging to confirm the target is present, then a related therapeutic radiopharmaceutical delivers radiation to those target-expressing sites. It is “image-guided systemic radiation”, delivered through biology rather than external beams.

2) Why is radiotheranostics adoption accelerating now?

Because multiple therapies have moved from niche to mainstream indications, and regulators expanded labels and selection tools through 2024–2025. The Pluvicto label expansion (March 2025) is a good example: it materially increases the pool of eligible patients, pushing hospitals to expand capacity.

3) What is the biggest bottleneck in clinical adoption?

Usually capacity, not demand: limited therapy slots, staffing constraints, radio pharmacy throughput, and isotope delivery reliability. Implementation guidance and readiness work consistently identify workforce, infrastructure, supply, and financial alignment as the limiting factors.

4) How are patients selected for PSMA radioligand therapy?

Selection typically relies on PSMA PET imaging to confirm predominantly PSMA-positive disease and identify patients likely to benefit. Guidance and reviews emphasize the importance of using PSMA PET appropriately for eligibility decisions and subsequent therapy planning.

5) Do centers need patient-specific dosimetry for Lu-177 therapies?

Not always as a strict requirement for every labelled use, but dosimetry is widely discussed as a way to personalize therapy and manage organ-at-risk exposure. EANM dosimetry recommendations encourage patient-specific dosimetry practices within the scope of centers that can implement them.

6) What does it take to set up a theranostics center?

You need licensed controlled areas, radiation safety and waste processes, imaging access, radio pharmacy capability, trained authorized users, and an operating model that can schedule time-critical therapy reliably. The joint EANM/SNMMI/IAEA enabling guide is the clearest single reference for the practical steps and stakeholder roles.

7) Why does reimbursement matter so much if the therapy works?

Because hospitals must fund the whole pathway: selection imaging, administration, monitoring, post-treatment imaging, handling, and waste, not just the drug. In the US, CMS OPPS payment policy for diagnostic radiopharmaceuticals (including the CY 2025 threshold approach) shows how payment design can change imaging viability and, indirectly, therapy access.

8) Is Lu-177 supply still a real constraint?

Yes, reliability and redundancy remain central. Partnerships and facility expansions exist precisely because the field expects higher demand and needs secure supply. For adoption planning, what matters is not “global supply exists” but “your center can get predictable deliveries”.

9) How should a strategy team size the Radiotheranostics Clinical Adoption Market?

Start with delivered capacity: therapy slots per week, staffing coverage, radio pharmacy throughput, and imaging access, then layer on eligible population and reimbursement conversion. Papers on readiness and healthcare system capacity explicitly warn that delivery capacity can be insufficient even when patient need is high.

10) What’s different about adoption in lower-resource settings?

Constraints are amplified: fewer scanners per capita, fewer trained teams, fragile supply chains, and limited funding pathways. Work discussing global challenges and LMIC contexts highlights equipment scarcity, isotope shortages, and staffing constraints as structural barriers.

Key Facts

• FDA approved Pluvicto for earlier use (before chemotherapy) in PSMA-positive mCRPC in March 2025.
• FDA approved Lutathera for pediatric patients aged 12+ with SSTR-positive GEP-NETs on 23 April 2024.
• EANM/SNMMI published a joint procedure guideline for 177Lu-PSMA radioligand therapy, covering candidate identification, treatment procedures, and follow-up.
• The joint EANM/SNMMI/IAEA enabling guide provides an overarching framework to initiate and operate theranostics centers across varied regulatory and financial settings.
• EANM dosimetry committee recommendations aim to encourage patient-specific dosimetry practice for Lu-177-labelled therapies (within capable centers).
• CMS finalized a CY 2025 OPPS policy to pay separately for diagnostic radiopharmaceuticals with per-day cost greater than $630 (with packaging below the threshold).
• EANM policy work on readiness highlights key adoption barriers: referral and imaging access, workforce training, specialized infrastructure, isotope supply, and financial/regulatory alignment.
• SNMMI published a post-treatment imaging procedure standard (2025) addressing timing and response evaluation considerations in theranostic care.
• Multiple implementation-focused reviews explicitly list workforce shortages (physicians, radio pharmacy, physics, nursing) as a major barrier to broad radiotheranostics implementation.
• Supplier announcements and collaborations (example: ITM and research partners) reflect active efforts to expand and secure medical Lu-177 supply.