Intense Competition Emerges in ATTR Amyloidosis Market as New Entrants Challenge Pfizer's Dominance

The ATTR amyloidosis market is heating up as Alnylam Pharmaceuticals and BridgeBio Pharma secure FDA approvals for their respective treatments, challenging Pfizer's long-standing dominance in the field. This development marks a significant shift in the landscape for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM), a condition that causes stiffening of cardiac muscle and heart failure.

Pfizer's Tafamidis Faces New Competitors

Pfizer's tafamidis, marketed as Vyndaqel, Vyndamax, and Vynmac, has been the sole player in the ATTR-CM market for five years. However, the recent approvals of BridgeBio's Attruby in November 2024 and Alnylam's Amvuttra in March 2025 have disrupted this monopoly. Attruby shares the same mechanism of action as tafamidis, while Amvuttra represents a new class of treatment as the first silencer approved for ATTR-CM.

Despite the new competition, Pfizer remains bullish on its position. CEO Albert Bourla expressed confidence in the company's ability to maintain a "lion's market share" for new prescriptions and dominate current prescriptions. Pfizer reported $5.4 billion in tafamidis sales for 2024, a 60% year-on-year increase. However, the company acknowledges that Vyndaqel's growth will be tempered due to the impact of the Inflation Reduction Act and new competition in the U.S.

Alnylam and BridgeBio Enter the Fray

Alnylam is positioning Amvuttra as a potential new standard of care in ATTR-CM. The company is targeting the first-line market, arguing that patients will prefer Amvuttra's quarterly subcutaneous dosing as initial therapy, given that cardiac function cannot be regained once lost. Alnylam has set an annual list price of $476,000 for Amvuttra, significantly higher than its competitors, but plans to reduce the net price through rebates and value-based agreements.

BridgeBio's Attruby, priced at $244,500 annually, has shown promising early adoption. In its first two months on the market, around 500 healthcare providers wrote prescriptions for more than 1,000 patients. BridgeBio emphasizes the convenience of oral administration for ATTR-CM patients, many of whom are seniors already taking multiple daily medications.

Market Dynamics and Future Outlook

The ATTR-CM market is expected to accommodate multiple assets, with an estimated 240,000 patients in the U.S. alone. Competition for both switching patients and newly diagnosed individuals is intensifying. Approximately 24,000 people are currently on tafamidis, with 30% to 40% potentially progressing on the treatment.

Looking ahead, the competitive landscape may shift further when Pfizer's tafamidis loses patent protection in the U.S. in 2028. However, Pfizer is developing a new tafamidis tablet formulation that could extend patent protection through 2043. Additionally, the availability of generics may open up possibilities for combination therapies.

As Alnylam, BridgeBio, and Pfizer continue to invest in the ATTR-CM market, and with generic companies waiting in the wings, the stage is set for intense competition and potential blockbuster sales in the coming years.