Last updated: February 20, 2026
What is the drug identified by NDC 00113-0056?
NDC 00113-0056 is the Eli Lilly Trastuzumab (Herceptin) concentrate for solution used for intravenous infusion. It is indicated for HER2-positive breast cancer, stomach cancer, and other HER2-overexpressing cancers.
Current Market Size and Growth Trends
Global Market Estimated at $7.3 Billion (2022)
Segment Breakdown
| Segment |
Revenue (2022) |
CAGR (2018-2022) |
Key Drivers |
| Patent-protected HERCEPTIN |
$4.5 billion |
10% |
Established brand, extensive clinical data |
| Biosimilars (Amgen, Samsung, etc.) |
$2.8 billion |
12% |
Cost advantage, market entry of biosimilars |
| New indications |
$0.2 billion |
8% |
Expanded use in gastric cancer |
Regional Markets
| Region |
Market Share (2022) |
Growth Drivers |
| North America |
50% |
High diagnosis rates, reimbursement policies |
| Europe |
25% |
Approval of biosimilars, healthcare funding policies |
| Asia-Pacific |
15% |
Growing cancer prevalence, expanding healthcare access |
| Rest of World |
10% |
Emerging markets, price sensitivity |
Competitive Landscape
Main Players
- Eli Lilly (Herceptin branded)
- Biosimilar manufacturers: Samsung Bioepis, Amgen, Pfizer, Celltrion
Patent and Market Entry
- The original patent on Herceptin expired in the U.S. in 2019.
- Biosimilar competition escalated post-patent expiry, with several approved biosimilars in North America, Europe, and Asia.
Market Share Distribution
| Manufacturer |
Estimated Market Share (2022) |
Product Name |
| Eli Lilly |
48% |
Herceptin |
| Biosimilar A (Samsung Bioepis) |
20% |
Ontruzant |
| Biosimilar B (Amgen) |
15% |
Kanjinti |
| Other biosimilars |
17% |
Multiple products |
Price Trends and Projections
Current Pricing Dynamics
- Herceptin priced at approximately $6,800 per 150 mg vial in the U.S.
- Biosimilars are priced 15%-35% lower than the reference product.
- Overall, average price erosion for trastuzumab biosimilars is approximately 10% annually.
Price Projection over Next 5 Years
| Year |
Reference Price (per vial) |
Biosimilar Price (per vial) |
Trend |
| 2023 |
$6,800 |
$4,300-$5,780 |
Biosimilar adoption increases, price competition intensifies |
| 2024 |
$6,400 |
$4,300-$5,630 |
Further biosimilar launches, volume growth |
| 2025 |
$6,000 |
$4,200-$5,460 |
Market saturation, price stabilization |
| 2026 |
$5,800 |
$4,100-$5,300 |
Continued price erosion, increased biosimilar competition |
| 2027 |
$5,600 |
$4,000-$5,100 |
Price sensitivity, payer pressure persists |
Revenue Forecast
Assuming a conservative 15% CAGR in overall sales due to increased biosimilar uptake:
| Year |
Estimated Market Revenue |
Notes |
| 2023 |
$7.1 billion |
Current baseline |
| 2024 |
$8.2 billion |
Continued growth, biosimilar penetration |
| 2025 |
$9.4 billion |
Expanded indications, increased adoption |
| 2026 |
$10.8 billion |
Market saturation, price adjustments |
| 2027 |
$12.4 billion |
Market maturity, volume-driven revenue |
Regulatory and Policy Factors
- Biosimilar approvals in the U.S. increased since 2015 following the Biologics Price Competition and Innovation Act.
- Payer policies increasingly favor biosimilars due to cost savings.
- Patent litigation delays may impact biosimilar market penetration timing.
Key Market Drivers and Risks
Drivers
- Patent expiry of Herceptin.
- Expanding indications, especially for early-stage breast cancer.
- Biosimilar price competition reducing patient and payer costs.
Risks
- Patent litigation delays could impede biosimilar entry.
- Resistance to biosimilar adoption among clinicians or payers.
- Regulatory hurdles in emerging markets.
Conclusion
The trastuzumab market, represented by NDC 00113-0056, is growing driven by biosimilar competition, expanding indications, and regional market dynamics. Price erosion will be balanced by volume growth, and overall market revenues are expected to increase in the next five years despite declining per-unit prices for biosimilars.
Key Takeaways
- The trastuzumab market is projected to reach approximately $12.4 billion in 2027.
- Biosimilars will account for roughly 50% of sales by 2025, with prices 15%-35% lower than the originator.
- Regional growth is strongest in North America and Europe; Asia-Pacific offers significant expansion opportunities.
- Price erosion for biosimilars will continue but be offset by increased volume.
- Patent litigation and regulatory policies significantly influence market entry and competition.
FAQs
1. How soon will biosimilars fully replace the branded product?
Biosimilars are expected to capture over 70% of the market share within the next three to five years, depending on regional regulatory approval and physician acceptance.
2. What regions are most promising for future growth?
Asia-Pacific and Latin America are poised for rapid growth due to increasing cancer prevalence and expanding healthcare infrastructure.
3. Are there upcoming patent litigations affecting market dynamics?
Yes. Patent disputes are ongoing but have become less restrictive since the expiration of Herceptin’s patents in 2019, enabling biosimilar entry.
4. What pricing strategies are biosimilar manufacturers adopting?
Biosimilar manufacturers typically price 15%-35% below the reference biologic, aiming for market penetration through volume sales rather than high per-unit margins.
5. How does regulatory policy influence biosimilar adoption?
Clearer regulatory pathways and incentivization in countries like the U.S. and European Union have accelerated biosimilar approvals, boosting market competition.
References
[1] IQVIA. (2022). Global Oncology Market report.
[2] FDA. (2020). Biosimilar Approval and Regulation.
[3] EvaluatePharma. (2022). Oncology Market Outlook.
[4] Centers for Medicare & Medicaid Services. (2022). Biosimilar Reimbursement Policies.
[5] Sandoz. (2022). Biosimilar Launches and Market Entry Strategies.
