Introduction

Gallium 68 Market is a positron emitting radionuclide that is commonly used in medical imaging most notably PET (Positron Emission Tomography). The radioisotope has a short half life of ~68 minutes, which complicates logistics and production but makes it useful due to its potential to label tracers targeting specific tumour markers, neuroendocrine receptors, etc. Ga 68 can be manufactured from a germanium 68/gallium 68 (Ge 68/Ga 68) generator, or by cyclotron based production.

It has expanded its application in recent years in oncology (e.g. PSMA tracers for prostate cancer, neuroendocrine tumours DOTA tracers), among other branches of medicine. The world market for Ga 68 is being driven by increasing cancer incidence, the need for personalised medicine, and improvements in nuclear imaging technologies.

Gallium-68 market outlook can assist the players in this industry in formulating their strategies for expansion. The market can grow from US$ 782.36 million in 2022 to US$ 1,070.34 million by 2030; it is expected to achieve a CAGR of 4.0% in 2022–2030.

The major drivers are:

Increasing prevalence and consciousness of cancers, particularly prostate cancer and neuroendocrine tumors.

Growing use of PET imaging, better hospital and diagnostic center infrastructure.

Growth in personalised medicine & theranostics: Ga 68 tracers are used for diagnosis, planning treatments (e.g. peptide receptor radionuclide therapy, PRRT), and monitoring.

Challenges / restraints include:

Short half life makes logistics (transport, timing) difficult.

Regulatory hurdles, costs, and supply chain issues (generator cost, production capacity).

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Growth Strategies

Expanding generator technology

Improving generator designs to increase yield, reduce costs, enhance shelf life (or usable period) are key. Larger capacity generators, more efficient elution processes, etc.

Decentralised / localized production

Due to the loss of activity with transport time for Ga 68, local production sites or more dispersed generator placement assists. This is particularly important in Asia‐Pacific and other areas with weak infrastructure.

Regulatory approvals and reimbursement

Having tracers and kits approved in more countries (e.g. FDA, EMA) accelerates uptake. Also having reimbursement policy in place so cost is not an issue.

Novel tracer development

Diversifying the uses: beyond prostate and neuroendocrine imaging, looking at tracers for inflammation, fibrosis, cardiac use, etc. This raises overall demand.

Partnerships & commercial scale‐up

Hospital, radiopharmacy, generator manufacturer, and regulatory authority partnerships facilitate scaling up capacity, distributing risk, and assuring supply chain resilience.

Future Trends & Opportunities

Growing market size: There are some reports indicating a CAGR of ~8 14% for the generator markets in the next ten years. As an example, the Ge 68/Ga 68 generators market is expected by some sources to grow to USD ~ US$ 491 million by 2035.

New markets in emerging markets: Asia Pacific (India, China, Southeast Asia) provides high growth based on development in healthcare infrastructure, increasing middle‐class, increased awareness, etc.

Theranostics integration: The combination of diagnostic tracers with therapeutics (e.g., imaging with Ga 68 then therapy using radionuclides) is getting increasingly popular. It fits well into precision medicine.

New tracers & non oncology uses: Ga 68 tracer research for inflammation, cardiac illness, even neurological disorders may unlock new markets.

Supply chain enhancements: Improved generator output, more robust generator designs, better logistics (cold chain included), harmonization of regulations. Also, possibly alternative production technologies (enhanced cyclotron production) to complement generators.

Key Market Segments

By Application

Oncology

Neurology

Cardiology

By End User

Hospitals

Diagnostic and Imaging Centers

Opportunities

Filling unmet needs in areas with limited access to PET imaging or where generator availability is unpredictable. This would involve a mix of policy promotion, investment in infrastructure, and public-private collaboration.

High cost savings potential if generator prices fall, manufacturing becomes more efficient, and regulatory alignment lowers overhead.

Conceiving new tracers particularly for non oncology targets, for earlier diagnosis, or for disease other than cancer (e.g. cardiovascular, inflammatory disease).

Theranostic pairings: Utilizing Ga 68 imaging as companion diagnostics for treatments (e.g. Lu 177 treatment) is an enormous opportunity, as it enables more personalized treatment processes.

Alignment of regulations and reimbursement: If governments and payers value the cost savings (of earlier diagnosis, unnecessary treatments avoided), they might be willing to reimburse Ga 68 based diagnostics more liberally, increasing adoption.

Key Players & Recent Developments

Novartis AG

Novartis, through its radiopharmaceutical/diagnostic subsidiary (AAA – Advanced Accelerator Applications), has been busy with Locametz® (gallium 68 gozetotide). Locametz is a kit for diagnostic use to prepare a Ga 68 labelled tracer for PET imaging of PSMA positive prostate cancer lesions.

When the FDA approved Pluvicto™ (lutetium 177 PSMA radioligand therapy) for metastatic castration resistant prostate cancer (mCRPC), Novartis also received approval for Locametz to assist in identifying PSMA positive patients that could benefit from the treatment. This connects Ga 68 diagnostics to therapeutic avenues.

In Singapore (November 2023), Locametz was registered/approved there, extending its geographic market.

Telix Pharmaceuticals (US) Inc

Telix has recently received FDA approval for Gozellix® (TLX007 CDx), a novel Ga 68 PSMA PET imaging agent (kit to prepare gallium 68 gozetotide). The agent is for the detection of PSMA positive lesions in men with prostate cancer (at staging and biochemical recurrence). Key points: longer "hot" shelf life (six hours) and longer distribution radius than other currently available Ga 68 agents.

After regulatory approval, Telix has brought Gozellix to market in the U.S. through distribution partners (Cardinal Health, Jubilant, etc.) for wider availability.

Telix's previous product Illuccix® (Ga 68 gozetotide, PSMA 11 kit) has also become available on high activity Ga 68 generators (100 mCi) through partnership with IRE ELiT and Eckert & Ziegler. Higher activity generators allow for more daily elutions and doses per elution, helping to address increasing demand.

IRE ELiT SA

IRE ELiT is a leading manufacturer of Ge 68/Ga 68 generators. Among its recent initiatives: the distribution deal with Grand Pharmaceutical (China) (and its subsidiary Purevalley) to distribute its Galli Eo® Ga 68 generator in China. This enables IRE ELiT to grow in one of the most rapidly expanding markets.

It has also filed a Drug Master File (DMF) with the U.S. FDA for its 100 mCi Galli Eo® generator. This increased activity generator allows more frequent or greater volume use per elution, allowing radiopharmacies/hospitals to scale up.

IRE ELiT is also collaborating in partnerships to enable Telix's Illuccix use on high activity generators.

Conclusion

The Gallium 68 market is in the right position to grow in the next decade. Coupled with increasing incidence of cancer, need for better diagnostics, and technological advancements in imaging, all support its use. Challenge exists nonetheless: logistics (due to short half life), generator availability and price, and regulatory / reimbursement obstacles.

Successful companies and investors will probably be those that innovate along the supply chain (improved generators, development of tracers), extend to new geographies, and collaborate with payers and regulatory bodies to make Ga 68 diagnostics more widely available and affordable.

If properly managed, Ga 68 can potentially transform the way certain diseases are diagnosed and treated to enable improved outcomes, more tailored treatment, and reduce overall costs of healthcare.

Frequently Asked Questions (FAQ)

What are Gallium 68 used for?

As a radiotracer for PET imaging. It tags molecules ("tracers") that specifically bind to certain biological characteristics (e.g. PSMA in prostate cancer, somatostatin receptors in neuroendocrine tumours) to identify disease in the body.

How is Ga 68 made?

Primarily from Ge 68/Ga 68 generators (where the parent Ge 68 decays to Ga 68), or by cyclotron generated methods in certain institutions. Generators are used commonly because they have the ability to supply on site Ga 68.

What restricts its more general use?

The significant limitations are its 68-minute short half life, which lowers the time window for application, particularly if there is transport involved; generators' cost; quality control and regulatory requirements; and maintaining tracer availability and delivery logistics.

What are the market growth projections?

Projections differ: some forecasts look for CAGR of 7 8% during 2027 2030, with the market about doubling to ~USD 200 million by 2030 from ~USD 100 million in 2020. More optimistic projections (particularly for generators) look for higher growth rates.

Where will there be most growth?

Asia Pacific will be the most rapidly growing region as a result of increasing health infrastructure, awareness, and lower baseline PET imaging penetration. North America and Europe will continue to be significant, particularly in the areas of innovation, approvals, and early adoption.