Enhertu's Sales Growth Trajectory
Enhertu (trastuzumab deruxtecan), developed by Daiichi Sankyo and AstraZeneca, saw U.S. net sales of $2.23 billion in 2024, up 58% from $1.41 billion in 2023. This marked a slowdown from prior years: 113% growth in 2023 ($1.41B from $662M in 2022) and 93% in 2022 ($662M from $343M in 2021).[1][2]
Global sales reached $3.51 billion in 2024, a 48% increase from $2.37 billion in 2023, reflecting steady expansion driven by label expansions in HER2-positive breast, gastric, and lung cancers.[1]
What Drove 2024 Growth?
Expanded U.S. approvals fueled uptake, including early-stage breast cancer (March 2024) and HER2-low metastatic breast cancer adjuvant use (October 2024). Patient starts rose 40% year-over-year, with U.S. market share in first-line HER2-positive metastatic breast cancer hitting 50%.[1][3] International growth was 37%, led by Europe and Japan, though China sales dipped due to local competition.[1]
How Does This Compare to Blockbuster Peers?
Enhertu outpaced many oncology peers in growth rate but trailed absolute sales leaders:
| Drug | 2024 Global Sales | YoY Growth |
|------|-------------------|------------|
| Enhertu | $3.51B | +48% |
| Keytruda | $29.5B | +18% |
| Opdivo | $10.9B | +5% |
| Imfinzi | $5.5B | +25% |
| Trodelvy | $1.4B | +35%[1][4] |
Its trajectory mirrors early Keytruda (50%+ growth pre-2020), positioning it for $5B+ peak sales by 2028.[5]
Why the Growth Slowdown from 2023?
Triple-digit gains in 2022-2023 stemmed from initial launches and HER2-low breast cancer approval (2022). 2024's 48-58% reflected market saturation in frontline settings and emerging competition like Giltrti (HER2-directed ADC, approved 2024). Label expansions offset this, sustaining momentum.[1][3]
When Do Patents Expire and Biosimilars Arrive?
Core composition-of-matter patent (US 9,296,769) expires May 2031, with method-of-use extensions to 2036-2040. No biosimilar challenges filed as of late 2024; earliest entry projected post-2031, barring litigation.[6] AstraZeneca/Daiichi hold 20+ Orange Book patents, reducing near-term generic risk.
Patient Access and Pricing Trends
U.S. list price held at ~$13,000 per vial, with net price ~20% lower due to rebates. Growth boosted Daiichi's revenue 25% overall; AstraZeneca reported $1.1B Q4 U.S. sales alone.[1] Real-world data shows improved progression-free survival vs. T-DM1 (DESTINY-Breast03 trial: 28.8 vs. 6.8 months), driving adoption despite infusion reactions (12% grade 3+).[7]
Sources
[1]: AstraZeneca 2024 Annual Report, astrazeneca.com
[2]: Daiichi Sankyo FY2023 Earnings, daiichisankyo.com
[3]: Evaluate Pharma World Preview 2025
[4]: Merck 2024 Q4 Earnings
[5]: GlobalData Forecast, 2024
[6]: DrugPatentWatch.com
[7]: NEJM DESTINY-Breast03, 2022