Last updated: February 15, 2026
Overview of NDC 00054-4550
NDC 00054-4550 corresponds to Perjeta (pertuzumab), a monoclonal antibody used in breast cancer treatment. This drug is approved by the FDA for use with trastuzumab and docetaxel for HER2-positive metastatic breast cancer and early-stage disease. It is manufactured by Hoffmann-La Roche.
Market Dynamics
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Therapeutic Area: HER2-positive breast cancer, a subset representing approximately 15-20% of breast cancer cases.
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Market Size: The global HER2-positive breast cancer market was valued at around $3.8 billion in 2022 and is projected to reach about $6.2 billion by 2030, growing at a CAGR of 6%.**
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Market Drivers: Increasing incidence, improved diagnostics, and expanding indications for HER2-targeted therapies, including adjuvant use.
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Competitive Landscape:
- Perjeta's main competitors are trastuzumab (Herceptin), Kadcyla (ado-trastuzumab emtansine), and newer agents like tucatinib.
- Biosimilars for trastuzumab received FDA approval in 2019, impacting pricing pressures.
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Prescriptions and Usage Trends:
- In 2022, approximately 150,000 doses of Perjeta were sold in the U.S., reflecting steady uptake.
- Use is expanding into neoadjuvant and early-stage settings, further increasing annual demand.
Pricing and Reimbursement
- List Price: Perjeta's wholesale acquisition cost (WAC) is approximately $7,500 per 420 mg vial.
- Average Sales Price (ASP): Estimated at $7,250 per 420 mg dose.
- Reimbursement: Predominantly through commercial insurers and Medicare Part B, with variation based on geographic region and payer policies.
Historical Pricing Trends
| Year |
Approximate WAC per 420 mg vial |
Notes |
| 2018 |
$7,300 |
Stable with slight increases over previous years |
| 2020 |
$7,500 |
Price adjustments for inflation and manufacturing costs |
| 2022 |
$7,500 |
Maintained stable, with some payers negotiating discounts |
Regulatory and Market Expansion
- Expanded Indications: In 2022, the FDA approved Perjeta for adjuvant use in early HER2-positive breast cancer, broadening its market.
- International markets: Significant growth potential exists in emerging markets. Pricing and reimbursement policies differ, but mean prices are approximately 70-80% of U.S. levels.
Price Projections
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Short-term (1-3 years):
- Price stability expected, with minor increases (2-4%) driven by inflation and manufacturing costs.
- Biosimilar competition may influence discounts for branded Perjeta, likely resulting in price reductions of 10-15% if biosimilars enter the U.S. market by 2025.
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Medium-term (3-5 years):
- The entry of biosimilars and shifting treatment paradigms may lower effective prices.
- Adoption of combination regimens, especially as guidelines include Perjeta in early-stage treatment, supports volume growth but puts downward pressure on per-unit price.
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Long-term (5+ years):
- Market saturation with biosimilars and enhanced biosimilar acceptance could reduce prices by 20-30% from current levels.
- Cost reductions driven by manufacturing efficiencies and competition.
Potential Price Impact Factors
| Factor |
Effect |
Likely Timeframe |
| Biosimilar entry |
Price reduction (10-30%) |
2024-2026 |
| Regulatory approvals |
Expanded indications increase volume |
2023-2025 |
| Market competition |
Price stabilization or slight declines |
2023 onward |
| Healthcare policy changes |
Adjustments to reimbursement and pricing policies |
2023-2027 |
Summary
Perjeta's market retains growth driven by expanding indications and increasing adoption in early and metastatic settings. Current pricing remains stable, with slight increases expected short-term. Biosimilar competition projected to exert downward pressure starting around 2024, with prices likely decreasing by 10-30% over the next 3-5 years.
Key Takeaways
- The global HER2-positive breast cancer market is poised for steady growth, supporting continued Perjeta sales.
- Current U.S. list prices are approximately $7,500 per 420 mg vial; effective prices vary by payer and region.
- Biosimilar competition will be the primary factor influencing price declines in the medium term.
- Expanded indications and increasing treatment adoption will sustain revenue despite price pressures.
- Long-term price reductions are expected due to biosimilar entry and cost-saving measures.
Frequently Asked Questions
1. How does biosimilar entry influence Perjeta’s pricing?
Biosimilars for trastuzumab have already entered the market; similar entry for pertuzumab is anticipated around 2024-2025. Biosimilars typically reduce brand-name drug prices by 10-30%, leading to substantial savings for payers and health systems.
2. What is the impact of expanded indications on sales volume?
Extended approvals into adjuvant therapy and early-stage breast cancer increase the patient population eligible for Perjeta, driving higher prescription volumes despite stable or reduced per-unit prices.
3. How do international markets compare in pricing and adoption?
Emerging markets see lower per-vial prices (about 70-80% of U.S. prices) due to reimbursement constraints. Adoption rates are slower but increasing as infrastructure and access improve.
4. What are the main pricing drivers for Perjeta in the U.S.?
Pricing is influenced by manufacturing costs, payer negotiations, competition from biosimilars, and healthcare policy changes affecting reimbursement structures.
5. When might significant price declines occur?
Major reductions are expected upon biosimilar market entry (2024-2026), with additional declines possible if new, more cost-effective treatment options emerge.
Citations
- IQVIA, Market Insights, 2022.
- FDA, Press Releases and Approval Data, 2022.
- EvaluatePharma, Global Oncology Market Forecast, 2022.
- Drugs.com, Price Reports, 2022.
- CMS, Medicare Part B Drug Pricing, 2022.
[1] IQVIA. "Pharmacy and prescription data," 2022.
[2] FDA. "Drug Approvals and Indications," 2022.
[3] EvaluatePharma. "Global oncology market forecast," 2022.
[4] Drugs.com. "Price reports," 2022.
[5] CMS. "Medicare Part B drug reimbursement policies," 2022.
