Introduction
Targeted radioligand therapies for neuroendocrine tumors and prostate cancer, which have gained substantial sales traction in recent years, require diagnostic screening to assess patient eligibility. This typically involves evaluating SSTR2 expression for neuroendocrine tumors or prostate-specific membrane antigen (PSMA) expression for prostate cancer. Screening is performed using positron emission tomography (PET) imaging, a modality that has become increasingly central in nuclear medicine, especially in the United States (US), with approximately 1.8 million PET procedures performed in 2024 according to latest Definitive Healthcare data.¹
While the market for PET radiotracers is growing under favorable conditions, it is also becoming increasingly competitive. Given this situation, biopharma companies looking to develop a successful market strategy need to understand the competitive landscape and factors that can impact product uptake as the field matures. This white paper offers an in-depth review of the evolving PET radiotracers landscape, changes in the accessibility of the predominant isotopes, and emerging commercial dynamics shaping the field.
A Dynamic PET Imaging Field
In the US, 23 PET radiotracers were approved by the Food and Drug Administration as of August 2025, primarily addressing prostate and central nervous system (CNS) indications, with varying degrees of market adoption.
Distribution of FDA-approved Radiotracers by Application
The introduction of more targeted agents for prostate cancer, starting with Axumin® in 2017, catalyzed broader utilization for PET radiotracers. According to Definitive Healthcare data, more than 350 thousand PSMA PET exams were performed in the US in 2024, a number growing by over 30% vs. 2023². This volume was driven predominantly by patients with biochemical recurrence. Usage is expected to expand further due to revised 2025 National Comprehensive Cancer Network guidelines, which now recommend PSMA PET imaging as a potential alternative for both initial staging and assessment of disease progression.
Many PET radiotracers have benefited from Transitional Pass-Through (TPT) status, which provides temporary, unbundled Medicare reimbursement to support the adoption of novel and innovative drugs in the hospital outpatient (HOPD) setting. Typically lasting two to three years, TPT status has played a critical role in anchoring PSMA radiotracers in prostate cancer care and is likely to support expansion into additional indications. Notably, development pipelines now include late-stage candidates targeting novel biomarkers such as CAIX, FAP or CXCR, reflecting a broader shift beyond prostate and CNS applications.
These beneficial clinical and coverage conditions have driven the success of the PET radiotracers market to date and set up a promising future as indications and therapeutic areas expand.
A Market Dominated by Two Isotopes
PET radiotracers rely on radiolabelling biologically active molecules with isotopes such as Fluorine-18 (F-18), Gallium-68 (Ga-68), and Copper-64 (Cu-64). Each isotope offers distinct characteristics; the half-life being particularly critical, as it directly impacts logistics and distribution viability due to radioactive decay.
Overview of F-18, Ga-68 and Cu-64 Imaging Isotopes
Today, the US PET radiotracer market is primarily dominated by F-18 and Ga-68, each with unique logistical and production profiles. According to Definitive Healthcare, out of the circa 1.8 million PET procedures performed in the US in 2024, over 80% leveraged F-18, close to 10% leveraged Ga-68, while all other isotopes (Cu-64, Rb-82,C-11, N-13) combined accounted for less than 10%³.
Distribution of 2024 US PET Imaging Procedures by Isotope
F-18 is produced in cyclotrons, enabling high-yield, centralized manufacturing that supports scale, but require significant infrastructure investment. In contrast, Ga-68 is typically derived from generators (cyclotron manufacturing is possible), which are more accessible and better suited to decentralized or lower-volume environments, though current generator capacity is limited to 100 mCi.
Recent advancements – including the current development of higher-activity Ga-68 generators and commercialization of high-activity cold kits (e.g., Gozellix®) – have helped mitigate some of the disadvantages of Ga-68. Consequently, isotope selection is no longer the primary differentiator in product adoption. Instead, commercial strategy plays an increasingly decisive role, especially in saturated indications such as prostate cancer.
Commercial Execution: The Path to Success in Prostate Cancer
As of August 2025, most of the PET radiotracers approved by the FDA address prostate cancer (9 out of 23). The commercial performance of PET radiotracers in this indication – Pylarify® and Illuccix® achieved combined US sales exceeding $1.5 billion in 2024 – underscores the importance of strategic execution. Approved in 2016, Axumin was the first widely adopted PET radiotracer for prostate cancer, particularly in patients with suspected recurrence based on rising prostate-specific antigen levels. Axumin paved the way for the PSMA radiotracer wave that followed: Pylarify (F-18) and Illuccix (Ga-68) were approved in 2021, followed by Locametz® (Ga-68) in 2022, and, most recently, Posluma® (F-18) in 2023.
All these agents initially benefitted from TPT designation, which played a vital role in supporting early reimbursement and uptake. As of this writing in August 2025, Locametz and Posluma remain under TPT, while the others have transitioned to standard Mean Unit Cost-based reimbursement models in the HOPD setting.
PSMA PET Tracer TPT Status and Timeline
While market conditions for PET radiotracers in prostate cancer are favorable, the increasing number of products has intensified competition, leading imaging providers to weigh a wide range of factors beyond clinical efficacy. In addition, as TPT coverage expires for prostate cancer PET radiotracers, the ability to maintain market share or stimulate new demand hinges on proactive commercial strategies. Plus, advances in isotope production have reduced the role of isotope selection in product adoption.
While clinical performance and evidence remain foundational, pricing strategies, distribution logistics, and payer coverage have become pivotal to provider decision-making. PET radiotracers in prostate cancer with relatively similar imaging characteristics must now distinguish themselves through business model innovation and value-added services. For example, manufacturers can deploy tactics such as discounts, rebates, site-of-care optimization, and targeted customer engagement to preserve volume and protect them against commoditization.
This shift reflects a trend in the PET radiotracer market: commercial levers increasingly influence success, particularly as clinical differentiation narrows and markets mature.
Conclusion
The precision medicine paradigm has elevated the role of PET imaging in diagnostics, particularly through the use of highly sensitive and specific radiotracers in prostate cancer and CNS indications. The number of FDA-approved PET radiotracers continues to grow, and interest is accelerating in next-generation agents targeting biomarkers beyond current mainstream applications. With more than 500,000 target-specific PET scans performed in 2024⁴ – and volumes poised to increase due to updated guidelines – the landscape remains very dynamic.
As the PET radiotracers market becomes more competitive, commercial strategy is increasingly as crucial as scientific innovation, particularly in crowded indications such as prostate cancer. Success will increasingly depend on how effectively biopharma companies deploy commercialization strategies. The future of PET radiotracer growth will be shaped not only by molecular innovation but also by business agility and commercial excellence, especially in mature markets.
Sources
[1], [2], [3], [4] Source: Definitive Healthcare, data 2025.
Author:
Florent Chouvy,
Principal, Management Consulting Division
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