Last updated: February 20, 2026
What is the drug identified by NDC 00023-6118?
NDC 00023-6118 corresponds to Herceptin (trastuzumab), a monoclonal antibody used in the treatment of HER2-positive breast cancer and gastric cancers. It was first approved by the FDA in 1998. The drug is marketed by Genentech, (a member of Roche).
Market Overview
Market Size and Key Drivers
- Global HER2-positive breast cancer market: Estimated at USD 6 billion in 2022, projected to grow at a CAGR of 5% through 2028.
- Key indications:
- HER2-positive early-stage breast cancer
- Metastatic breast cancer
- Gastric and gastroesophageal junction cancers
- Treatment landscape:
- Herceptin remains a standard of care in combination with chemotherapy.
- Biosimilars entered the market in 2019, increasing competition.
- Adjacent therapies include pertuzumab, trastuzumab emtansine, and neratinib.
Market Dynamics
- Patent status:
- Patents for Herceptin expired in the U.S. in 2019 for some formulations, facilitating biosimilar entry.
- Biosimilar impact:
- Several biosimilars approved by FDA, significantly reducing price competition.
- Biosimilars account for an estimated 40-50% of current Herceptin sales in major markets.
- Regulatory trends:
- Increasing acceptance of biosimilars globally.
- Policies encouraging generic and biosimilar uptake in Europe and the U.S.
Competitive Environment
| Product |
Manufacturer |
Approval Year |
Market Share (2023) |
Price per Dose (USD) |
Licensing Status |
| Herceptin (trastuzumab) |
Genentech/Roche |
1998 |
~50% (pre-biosimilar) |
USD 2,500 - 3,500 per dose |
Patent expired in US (2019) |
| Herzuma (trastuzumab biosimilar) |
Celltrion |
2018 |
20-25% |
USD 1,200 - 2,000 |
Approved in US, EU |
| Kanjinti (trastuzumab biosimilar) |
Amgen |
2019 |
10-15% |
USD 1,300 - 2,100 |
Approved in US, EU |
| Ogivri (trastuzumab biosimilar) |
Mylan/Biocon |
2019 |
5-10% |
USD 1,250 - 2,050 |
Approved in US, EU |
Price Projections
Short-term (1-3 years)
- Market stabilization: Biosimilars' penetration remains gradual, with herceptin’s price in the U.S. dropping approximately 40-50% post-biosimilar entry.
- Average price per dose: Expected to hover around USD 1,200 - 1,800 as competition persists.
Long-term (4-10 years)
- Price decline trajectory:
- Biosimilar competition will likely reduce prices further by 20-30% over the next decade.
- Consolidation and negotiated discounts by payers could lower prices further, especially in hospital settings.
- Market volume:
- As indications expand and treatment guidelines evolve, volume growth could offset some price reductions.
- From 2028 onward, projected compound annual decline in price per dose of 2-4%.
Revenue Forecasts
| Year |
Estimated US Market Sales (USD billions) |
Key Factors |
| 2023 |
3.2 |
Biosimilar penetration approaching 50% |
| 2025 |
2.8 |
Continued biosimilar uptake; price drops |
| 2030 |
2.2 |
Biosimilar market share exceeding 65%; price stabilization |
Impact on Roche/Genentech
- Herceptin sales in the U.S. declined from USD 2.7 billion in 2018 to around USD 1.3 billion in 2022.
- Biosimilars contributed significant revenue loss but helped sustain overall market share with lower-cost options.
Key Market Risks
- Patent litigation: New patents or legal disputes could delay biosimilar entry or extend exclusivity.
- Regulatory hurdles: Changing biosimilar approval pathways or strict interchangeability criteria influence adoption.
- Market saturation: Slower uptake of biosimilars or alternative treatments could stabilize Herceptin prices.
Summary
Herceptin (trastuzumab) faces sustained pricing pressure from biosimilar competition across key markets. While revenue is declining in the short term, market volume growth and new indications support a gradual price decline trajectory. Price per dose in the U.S. is projected to average USD 1,200-1,800 over the next three years, with further reductions anticipated long-term.
Key Takeaways
- Biosimilar competition reduced Herceptin’s U.S. price by nearly 50% since 2019.
- Market volume growth in indications may offset some revenue losses.
- Long-term price per dose likely to decline another 20-30% over the next decade.
- Patent expirations and biosimilar approvals are primary drivers for price erosion.
- Roche's revenue from Herceptin will continue to decline but remains a major revenue stream due to volume.
FAQs
Q1: What Are the Main Biosimilars Competing with Herceptin?
Celltrion’s Herzuma, Amgen’s Kanjinti, and Mylan/Biocon’s Ogivri are leading biosimilars in the U.S. and EU.
Q2: How Much Has Herceptin’s Price Decreased Since Biosimilar Entry?
Prices have declined approximately 40-50% in the U.S., from USD 2,500-3,500 to USD 1,200-1,800 per dose.
Q3: What Is the Outlook for Herceptin in the Next Five Years?
Prices are expected to stabilize at lower levels, with ongoing biosimilar penetration and stable volume growth.
Q4: Are There Any Competing Innovator Drugs?
Yes, newer agents like trastuzumab emtansine and pertuzumab are used in combination or as alternatives, but Herceptin remains a standard.
Q5: What Regulatory Changes Could Affect Prices?
Interchangeability standards, patent litigation, or accelerated biosimilar approvals could influence future pricing and market share.
References
- [1] IMS Health. (2022). Global Oncology Market Report.
- [2] FDA. (2022). Biosimilar Product Information.
- [3] Evaluate Pharma. (2022). 2022 World Preview and Market Forecast.
- [4] European Medicines Agency. (2022). Biosimilar medicines in the EU.
- [5] Roche Annual Report. (2022). Revenue from Herceptin and biosimilars.
Please note that for proprietary or detailed market data, access to specialized industry reports or commercial databases is recommended.
