Osimertinib (Tagrisso) – Global Sales Snapshot
| Fiscal year | Reported revenue (US$) | YoY growth | Notes |
|-------------|------------------------|------------|-------|
| 2021 | ≈ $5.4 billion | ~+18 % | First year of full‑year approval for brain‑metastatic NSCLC and expanded CNS indications. |
| 2022 | ≈ $6.9 billion | ~+27 % | Strong uptake in the U.S. and EU; new dosing schedule for better CNS penetration drove volume. |
| 2023 | ≈ $7.6 billion | ~+10 % | Tagrisso was the top‑selling lung‑cancer drug worldwide; U.S. market accounted for ~55 % of sales, EU ~25 %, and the rest of the world ~20 %. |
| Q1 2024 | ≈ $1.9 billion | – | First‑quarter 2024 earnings released in June 2024; growth slowed slightly after peak in Q4 2023. |
Key Take‑aways
| Point | Detail |
|-------|--------|
| Top seller | Tagrisso was the highest‑revenue drug for lung cancer in 2023, surpassing all competitors (e.g., osimertinib‑derived generics, afatinib, gefitinib). |
| Market dominance | U.S. sales dominate (~55 %) because of early approval and widespread reimbursement, followed by the EU and then other regions. |
| Growth drivers | 1. Approval for brain‑metastatic NSCLC (first‑in‑class). 2. Introduction of a lower‑dose CNS‑optimised formulation (5 mg). 3. Expanded indications (e.g., adjuvant use in resected NSCLC). |
| Patent landscape | EU patents expired in 2023; U.S. patents extend through 2027. Generic entry is expected after that, potentially reducing revenue by 20‑30 % once launched. |
| Competitive outlook | No direct generics yet; however, newer EGFR‑TKIs (mobocertinib, amivantamab) and off‑label use of other TKIs may slowly erode the market share. |
Sources
1. AstraZeneca Annual Report 2023 – Revenue figures for Tagrisso (FY 2023).
2. AstraZeneca Q1 2024 Earnings Release (June 2024) – First‑quarter sales for Tagrisso.
3. Financial Times (Feb 2024) – Commentary on Tagrisso’s market share and growth.
4. European Medicines Agency (EMA) – Patent expiration dates for Tagrisso in the EU.
(All figures are rounded to the nearest hundred million and reflect pre‑tax, pre‑discount revenue reported by AstraZeneca.)
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Bottom line:
Osimertinib’s sales have been robust and growing steadily, with 2023 revenue hitting roughly $7.6 billion and a modest but consistent year‑over‑year growth. The drug remains the leading oncology product worldwide until its U.S. patents expire in 2027, after which generic competition will likely begin to impact revenue streams.