Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA-associated vasculitis) is a rare but serious autoimmune disease affecting small blood vessels. With a global prevalence estimated between 30-218 cases per million, it leads to inflammation of blood vessels and potential organ damage. Current treatments like cyclophosphamide, rituximab, and high-dose glucocorticoids have significant side effects and struggle to achieve complete remission in many patients.

TAVNEOS (avacopan) is a new drug approved in 2021 that offers a novel approach to treating ANCA-associated vasculitis. As the first approved oral drug targeting the C5a receptor, it blocks the interaction between C5a and C5aR, inhibiting neutrophil activation and migration that drives inflammation. Clinical trials demonstrated TAVNEOS's ability to induce remission and allow glucocorticoid tapering.

The Market Potential

Despite its recent 2022 approval, TAVNEOS has already generated over $220 million in revenue for its owners, with over 90% coming from the lucrative US market. However, this accounts for only 0.9-2.3% of the estimated 40,000-100,000 ANCA-associated vasculitis patients in the US. Worldwide, up to 1 million patients could benefit from TAVNEOS, representing a vast untapped market (We estimate that the theoretical number of patients who might get avacopan prescribed is 1,006,736 at most—with an annual increase of 966,565).

A Growing Opportunity

While 2023 sales topped $134 million, representing around 14kg of API demand (according to drugs.com, the cost for Tavneos oral 10 mg capsule of 30 capsules supply is around 2,829 USD), TAVNEOS is still in its launch phase. As adoption grows, API demand is projected to increase by over 0.7kg per quarter (the table below estimate the annual API demand under current Amgen revenue growth rate). This expands the opportunity for generic drug manufacturers to enter the supply chain for Avacopan and its intermediates after the patents expire.

With a novel mechanism of action, proven efficacy, and the potential to reduce steroid exposure, TAVNEOS holds promise as a safer, more effective treatment for ANCA-associated vasculitis. This market represents a significant revenue stream driven by a high-value drug addressing a clear unmet need. Unibest R&D partners have successfully synthesized avacopan's intermediates, including CAS No. 838-57-3, CAS No. 1357259-88-1 and CAS No. 1346623-11-7. Contact us today to discuss your manufacturing capabilities and secure your future role in the avacopan supply chain.

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