Eli Lilly's Amyvid Label Expansion: A Strategic Move to Solidify Dominance in Alzheimer's Diagnostics

The Alzheimer's diagnostics market is undergoing a seismic shift as therapies targeting amyloid plaques—long considered a hallmark of the disease—gain traction. Eli Lilly's Amyvid (florbetapir), a positron emission tomography (PET) imaging agent, has been a stalwart in this space for over a decade. Now, with its recent FDA-approved label expansion in June 2025, Amyvid is poised to cement its role as a critical tool for guiding treatment decisions in an evolving landscape. The update not only strengthens Lilly's position but also highlights the growing demand for precise diagnostics to support emerging amyloid-targeted therapies like lecanemab (Leqembi) and donanemab (Kisunla).

The Label Expansion: A Precision Play

The FDA's approval of Amyvid's expanded label addresses two key gaps in Alzheimer's diagnosis: therapy selection and quantification of amyloid plaque density. These changes are strategically timed to align with the rising use of anti-amyloid drugs, which require patient-specific selection criteria. For instance, the new indication explicitly states that Amyvid can help identify patients eligible for therapies that reduce amyloid, such as Leqembi, which is only approved for early-stage Alzheimer's patients with confirmed amyloid pathology.

The addition of Centiloid-scale quantification—a standardized metric for plaque density—is equally significant. This shift from binary “positive/negative” interpretations to continuous measurements allows clinicians to assess disease severity more accurately. A patient with a Centiloid score of 40 versus 80, for example, might be prioritized for different therapeutic approaches, enhancing personalized care. This precision could reduce misdiagnosis rates and optimize treatment outcomes, making Amyvid a more compelling option for clinicians.

Competitive Landscape: A Battle for Diagnostic Supremacy

While Amyvid's expansion is a major win, the Alzheimer's diagnostics market is crowded. Competitors like GE Healthcare's Vizamyl (flutemetamol) and Avid Radiopharmaceuticals' Neuraceq (florbetapir) have also been vying for dominance. However, Amyvid's quantification capability and its established infrastructure—Lilly's network of radiopharmacies and partnerships with imaging centers—give it an edge.

The FDA's focus on Amyvid's role in therapy selection also underscores its unique value proposition. Anti-amyloid therapies like Leqembi carry risks, such as Amyloid-Related Imaging Abnormalities (ARIA), which necessitate rigorous patient screening. Amyvid's expanded use directly addresses this need, positioning it as a gatekeeper for costly and complex treatments. Meanwhile, Medicare's broad coverage of Amyvid (with some exceptions) ensures accessibility, further boosting its adoption.

Market Growth: Riding the Wave of Early Detection

The real opportunity lies in the expansion of amyloid-targeted therapies. Analysts estimate the global Alzheimer's drug market could exceed $10 billion by 2030, with diagnostics playing a gatekeeping role in every treatment decision. For every patient prescribed a therapy like Leqembi, an Amyvid scan is likely required. This creates a recurring revenue stream for Lilly, as patients may need repeat scans to monitor plaque reduction over time.

Moreover, the label's emphasis on clinical trial utility hints at Amyvid's role in future drug development. As biotechs test new anti-amyloid agents, Lilly could leverage its diagnostic to support partners, creating cross-selling opportunities. This synergy between diagnostics and therapeutics could become a moat against competitors.

Risks and Considerations

Despite its advantages, Amyvid faces hurdles. The quantification feature requires trained readers and standardized protocols, which may slow adoption in underserved regions. Additionally, newer entrants like TauRx's tau-targeted diagnostics or blood-based biomarker tests could erode demand over time. Investors should also monitor CMS coverage policies, as reimbursement changes could impact utilization.

Investment Takeaway: A Buy with a Long-Term Lens

Eli Lilly's Amyvid label expansion is a strategic move that solidifies its leadership in the Alzheimer's diagnostics space. With amyloid therapies becoming a cornerstone of early-stage treatment, the demand for precise diagnostic tools like Amyvid is set to grow. While competition and regulatory risks exist, Lilly's infrastructure and first-mover advantage in quantification make it a top pick for investors betting on the Alzheimer's revolution.

Recommendation: Consider a buy for investors with a 3–5 year horizon. Monitor near-term catalysts like Medicare coverage expansions and clinical trial updates for anti-amyloid therapies.

This analysis underscores the interplay between diagnostics and therapies in Alzheimer's care—Lilly is now at the center of both, and its success hinges on its ability to capitalize on this synergy.