More than 40 million diagnostic nuclear medicine procedures are performed each year worldwide. About USD 14 billion in radioligand-therapy deals have been completed since 2022.

The FDA authorized 168 ML-enabled medical devices in 2024, with 159 (94.6%) cleared via 510(k) and 9 (5.4%) via De Novo.

There are more than 320 ongoing clinical trials worldwide exploring radioligand therapy. Novartis plans to expand its US manufacturing and R&D footprint with a USD 23 billion total investment over the next five years.

The Structural Shape of the Nuclear Medicine Market

OECD’s Health at a Glance 2023 flags that advanced diagnostic imaging use, including positron emission tomography (PET), rose across member countries. This reflects system-level demand for high-resolution, molecular-level diagnostics.

On the access-and-variation side, PET utilization rates ranged from 2.2% to 20.8% across US hospital referral regions.

 

Credit: Market.Us

 

The radiopharmaceutical therapeutics (RPT) segment is projected to reach USD 13.5 billion by 2032.

The market is expected to increase from USD 21.8 billion in 2025 to USD 52.3 billion by 2034, at a compound annual growth rate (CAGR) of 10.2% during the forecast period 2025 to 2034.

 

 

Startup Examples Driving Clinical and Production Innovation

Nuclide Therapeutics – Targeted Radionuclide Therapy

UK-based startup Nuclide Therapeutics develops precision radiotheranostic therapies that identify and eliminate therapy-resistant cancer cells. Its NTx platform combines a diagnostic or therapeutic radionuclide with a small-molecule ligand. This binds a defined biomarker expressed on resistant tumours to form a single compound capable of both imaging and treatment.

After intravenous administration, the compound selectively binds to therapy-resistant cancer cells. A diagnostic radionuclide then enables tumour detection through positron emission tomography (PET) and single photon emission computed tomography (SPECT) imaging.

Subsequently, the diagnostic radionuclide is replaced with a therapeutic radionuclide that delivers targeted radiotherapy while sparing healthy tissue. This dual-phase mechanism supports patient stratification, real-time monitoring, and individualized treatment decisions across diagnostic, therapeutic, and follow-up stages.

Hexium – Isotope Enrichment Technology

US-based startup Hexium builds isotope enrichment technology using atomic vapor laser isotope separation to supply high-purity isotopes for nuclear medicine. The technology vaporizes a metal stream and applies precisely tuned lasers to selectively ionize target isotopes.

Then, electric fields separate the ionized isotopes from neutral atoms and route them into purified output streams for collection. The process optimizes production output with contemporary laser designs and existing supply chain infrastructure to achieve low capital and operating costs.

It delivers high selectivity in a single pass, avoids centrifuges and chemical separation agents, and generates no hazardous waste while maintaining a compact, scalable footprint.

Lyla – Radiopharma QC Device

Dutch startup Lyla offers Lyla One, a direct alpha measurement thin-layer chromatography scanner and quality control device for radiopharmaceutical manufacturing.

The device combines dedicated hardware, integrated quality control software, and a sealed standardized cartridge. With this, it digitally measures alpha-emitting radionuclides without relying on gamma-based inference.

Further, Lyla One automates the measurement cycle with safe sample containment, processes results in near real time, and generates clear, reproducible reportswhile fitting into existing thin-layer chromatography workflows.

GAIASO Theranostics – Women Cancer Therapeutics

Australian startup GAIASO Theranostics develops theranostic radiopharmaceuticals designed for female cancers.

The startup’s platform is built on modular Affilin scaffolds, which are small, stable engineered binding proteins. These scaffolds deliver high tumour selectivity and support rapid development of targeted agents.

They can be quickly paired with PET tracers or therapeutic radioisotopes based on clinical need.

The approach leverages novel isotopes, new therapeutic targets, and adaptive ligand design to align imaging precision with therapeutic effectiveness while minimizing off-target effects.

PAIRE – Software as a Medical Device

French startup PAIRE builds Pionus, an AI-based software as a medical device (SaMD) that supports diagnostic workflows in nuclear medicine. Pionus automatically detects, segments, and quantifies anomalies on fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET-CT) examinations using advanced medical image processing and convolutional neural network models.

The software integrates into existing nuclear medicine viewers to deliver automated measurements, lesion contours, and quantitative indicators within routine clinical reading. It increases diagnostic reliability by reducing manual variability, eliminating repetitive tasks, and providing consistent access to metabolic tumour metrics across oncology applications.

The Technologies Reshaping Nuclear Medicine Delivery

From a geographic perspective, patent issuance is concentrated in leading innovation economies. China accounts for 48.55% of total patents, while the United States contributes 14.45%, making them the top two patent-filing jurisdictions.

This geographic concentration of patent activity is found in specialized nuclear medicine segments where innovation translates into clinical deployment.

 

 

Targeted Alpha Therapy

Targeted alpha therapy represents a high-precision treatment segment within nuclear medicine.

Our database identifies 50+ companies operating in this area, employing approximately 4100 professionals globally.

The annual growth rate of 2.38% points to steady but measured expansion, driven by increasing clinical interest in alpha-emitting radiopharmaceuticals for oncology applications.

The segment’s firmographic profile indicates early-stage scaling, where progress is shaped by clinical trial outcomes, isotope availability, and regulatory pathways rather than rapid commercial deployment.

Radiotheranostics

Radiotheranostics form a clinically integrated innovation segment that combines diagnostic imaging and targeted radionuclide therapy within a single treatment pathway.

The ecosystem comprises 30+ companies, supported by a workforce of around 8800 employees.

With an annual growth rate of 1.02%, radiotheranostics exhibits gradual development aligned with clinical validation timelines and adoption within specialized oncology centers.

The limited workforce growth reflects the segment’s dependence on highly specialized expertise in nuclear imaging, radiochemistry, and clinical oncology, as well as controlled scaling within regulated healthcare environments.

Radiation Dosimetry

Radiation dosimetry represents a foundational and safety-critical segment within nuclear medicine. The segment includes 115+ companies, employing approximately 6500 professionals worldwide.

Despite its importance, radiation dosimetry recorded an annual growth rate of -1.53%. This reflects mature measurement standards, slow replacement cycles, and regulatory-driven stability.

Nonetheless, dosimetry remains essential for ensuring patient safety, treatment accuracy, and regulatory compliance across diagnostic and therapeutic nuclear medicine applications.

Capital Flows, Strategic Buyers & Infrastructure Commitments

AstraZeneca’s acquisition of Fusion Pharmaceuticals disclosed a transaction value of USD 2.4 billion, including contingent value rights, with USD 2 billion upfront cash.

Bristol Myers Squibb’s RayzeBio acquisition included an equity value of USD 4.1 billion. This M&A involves the expansion of a radiopharmaceutical platform.

Eli Lilly acquired POINT Biopharma at USD 12.50 per share to expand radiopharmaceutical oncology capabilities.

Sanofi purchased a USD 300 million stake in OranoMed by valuing OranoMed at EUR 1.9 billion. This is a strategic investment in isotope-backed radioligand development.

On the diagnostics supply chain side, Siemens Healthineers signed a EUR 200 million deal to acquire the diagnostics arm of Novartis’ Advanced Accelerator Applications (AAA) to expand PET radiopharmaceutical operations into Europe.

 

 

The combined value invested by some of the above top investors exceeds USD 10.22 billion, showing concentrated capital deployment across major nuclear medicine innovators.

Research Method and Data

Nuclear medicine activity covers radioisotope production, radiopharmaceutical development, diagnostic imaging, and targeted radionuclide therapies. Investment and innovation trends indicate a shift from generalized diagnostics toward precision, image-guided, and personalized treatment pathways.

Further, nuclear medicine remains integral to advanced oncology and disease management. Companies expanding isotope availability, improving therapeutic precision, and strengthening supply chains will play a central role in balancing clinical outcomes, safety, and system scalability.

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