By Randy Goodman, PhD
In the evolving landscape of innovative therapeutics, radiopharmaceuticals stand out as a powerful modality to diagnose, target, and treat disease at the molecular level. This interest and excitement is reflected by clinical data and deployment of investment capital alike.
Given their utility in precision oncology, and potentially other therapeutic areas, including cardiovascular disease, thyroid disorders and neurodegenerative disease, few sectors are as promising as radiopharmaceuticals. This market is expected to grow at an impressive 8-10% annually over the next decade (KPMG) due in part to a clear market need for scaled tools and services to serve growing demand.
How Theranostics Innovation & Oncology Trends Are Driving Market Momentum
While the use of radiation for medical purposes is not new, more recent advances in tissue targeting, imaging and the wider availability of radioactive isotopes have allowed developers to target disease-affected tissues with deeper precision, improving efficacy and reducing the side effects associated with high-dose radiation.
From a diagnostic perspective, improvements in imaging technologies such as SPECT-CT, PET-CT, and PET-MRI have vastly improved the specificity and sensitivity of imaging agents. These innovations have paved the way for theranostics, allowing more clinicians to not only visualize disease with greater accuracy but also treat it in a more targeted manner. Theranostics enables real-time monitoring of treatment efficacy, enabling personalized adjustments based on individual response.
The targeted nature of radiopharmaceuticals mixed with their relatively established production and value-added chains (compared to other modalities such as cell and gene therapies) have resulted in a more expansive outlook for the wider market, valued at $14 billion by 2030. Much of this is driven by the rising prevalence across oncology conditions, technological advancements, and growing expectations from payers and regulators for more targeted therapies with minimal impacts to safety and quality of life. However, barriers to wider adoption and market penetration do exist, including regulatory complexities, logistical expenses, and up-front investment to develop production units.
5 Critical Steps to Consider When Planning for Commercialization
While regulatory processes remain a constant companion, a very robust framework for commercialization early in product development is crucial and provides a twofold advantage. First, it allows radiopharmaceutical companies to anticipate and address potential challenges before they escalate into major hurdles. Second, it enables alignment with changing market demands and regulatory requirements, essential for a seamless transition from development to market access. Strategic product launch planning empowers market success:
- Conduct a thorough market analysis and develop a comprehensive commercialization plan. This involves understanding the entire competitive landscape, identifying key competitors, and analyzing market needs and gaps. It is also crucial that developers understand the payer landscape and realistic opportunities for their product. By doing so, radiopharmaceuticals not only enhance their market potential but also position themselves as preferred choices among competitors.
- Develop partnerships and collaborations. Strategic alliances are essential because they provide access to crucial resources, expertise and networks that might otherwise remain out of reach, especially for smaller developers. Whether collaborating with universities and research centers for cutting-edge research and development or aligning with established contract developers, manufacturers and distributors, these relationships provide a foundation for future commercial success.
- Education and advocacy. For radiopharmaceuticals to gain widespread market acceptance, a concerted effort toward education is needed. Healthcare professionals and patients must be informed about the benefits and applications of these innovative treatments. Recent studies at Duke-Margolis Institute suggest a need to better educate patients on the benefits of these products and treatments over existing standards of care. For example, Novartis’ PLUVICTO demonstrated a clinically meaningful and statistically significant benefit in progression-free survival in PSMA-positive metastatic castration-resistant prostate cancer and reduced risk of progression or death by 60% compared to standard of care.
- Continuously monitor and adapt trends in this changing market, including regulatory changes, market demand fluctuations (patient preferences, competitor activities, healthcare policy changes, development of AI, economic factors).
- Anticipate future trends and opportunities. It is essential to monitor and understand what may come next in an industry rife with possibilities and opportunities, including advancements in theranostics, personalized medicine, and diagnostics.
Understanding the U.S. Payer Landscape
The U.S. payer landscape for radiopharmaceuticals is complex, with payers like Medicare, commercial insurers, and pharmacy benefit managers (PBMs) using a combination of prospective payment systems, negotiated prices, and cost-effectiveness evaluations. Recent rules from the Centers for Medicare and Medicaid (CMS) are adjusting reimbursement for diagnostic agents, while commercial payers use committees and evidence dossiers to evaluate asset value. The Inflation Reduction Act also impacts price negotiation for certain drugs, and organizations like the Institute for Clinical and Economic Review (ICER) which provide cost-effectiveness analysis that can influence payer decisions.
Medicare
Diagnostic radiopharmaceuticals are often bundled into the cost of the procedure under the Outpatient Prospective Payment System (OPPS), but new drugs can sometimes receive “pass-through status” for separate reimbursement for a specific period. CMS rule changes in 2025 included a separation of reimbursement for the radiopharmaceutical and a procedure that applies only for patients covered by Medicare and within an outpatient setting whose nuclear medicine diagnostic scan cost is over a certain threshold. Facilities are also now required to complete an extra coding step.
- Starting in January 2026, a new add-on payment of $10 per dose will be implemented for therapies using domestically produced Technetium-99m to support the supply chain.
- A Medicare rule from November 2024 established a $630 per day cost threshold for diagnostic agents, which encourages the development of advancing imaging products.
Commercial Insurers
As radiopharmaceuticals present new evidence and pricing challenges, U.S. payers are relying on developers and manufacturers to present dossiers that focus on clinical value, comparative effectiveness and economic considerations that include evidence generation costs, robust economic models that project the product’s potential economic consequences and impact on health outcomes. Dossiers must be tailored to relevant payer populations and specific market requirements.
Starting the dossier development process early allows time to identify and address evidence gaps and can facilitate earlier market access discussions. Dossiers should be concise and convey a clear value proposition.
Conclusion
In an increasingly challenging life sciences market that demands better efficacy, safety and targeting, radiopharmaceuticals have the potential to deliver on all three. Having already shown resilience in a biopharma down market, next-generation radioligand therapies have an efficacy track record and adaptability that can be applied to a plethora of conditions. In turn, increased demand for radiopharmaceuticals necessitates the creation of a secondary ecosystem of supporting tolls and services to enable delivery at scale.
References:
The JP Morgan Chase Healthcare Conference, 2024. San Francisco, CA
Centers for Medicare and Medicaid. Pricing landscape report. 2025.
Duke-Margolis Institute for Health Policy. Durham, North Carolina. Radiopharmaceutical Outlook, 2024-2030 in the U.S.
Radiopharmaceuticals Market Size, Share and Trends 2024-2033, Harvard T.H. Chan School of Public Health. Cambridge, MA 2024.
Novartis. PLUVICTO studies 2024.
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