Last updated: March 2, 2026
What is the drug associated with NDC 70700-0123?
NDC 70700-0123 corresponds to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor (G-CSF) used to reduce the incidence and duration of neutropenia and febrile neutropenia in patients receiving chemotherapy.
Market Overview
Market Size and Demand
The global pegfilgrastim market was valued at approximately $1.2 billion in 2022, with projections reaching around $1.6 billion by 2028 at a compound annual growth rate (CAGR) of roughly 5.1%.
Key Drivers
- Increasing use of chemotherapy for cancer treatment.
- Growing approval for broader indications, such as stem cell transplantation.
- Rising targeted cancer therapies leading to chemotherapy regimens requiring growth factor support.
Geographic Segmentation
| Region |
Market Share (2022) |
CAGR (2023-2028) |
Key Trends |
| North America |
45% |
4.8% |
High adoption rates, aging population |
| Europe |
25% |
5.3% |
Expanding indications, pricing pressures |
| Asia-Pacific |
20% |
6.0% |
Increasing healthcare infrastructure, rising cancer incidence |
| Latin America & MEA |
10% |
4.5% |
Emerging markets, lower penetration rates |
Competitive Landscape
Major players include:
- Amgen: Original patent holder, dominant market share.
- Novartis/Sandoz: Biosimilar pegfilgrastim, gaining market penetration.
- Coherus BioSciences: Biosimilar competitor.
- Biocon/Berkeley Lights: Biosimilar entry with expanding pipeline.
Patent and Regulatory Status
- Original patent (by Amgen) expired in the U.S. in 2021, opening market to biosimilars.
- Biosimilars are approved in the U.S. by the FDA since 2021, including Sandoz's Grastofil and Coherus's Udenyca.
- International markets show varied patent status; biosimilars are increasingly available.
Price Analysis
Historical Pricing
- A single-use prefilled syringe of Neulasta (6 mg dose) historically retailed at $4,000 to $5,000 per dose in the U.S.
- Biosimilars are priced approximately 20-30% lower than the originator, reducing costs to $2,500 to $4,000 per dose.
Current Pricing Trends
| Product Type |
Price Range (per dose) |
Notes |
| Brand (Neulasta) |
$4,200 - $4,700 |
Market leader, highest price |
| Biosimilars (Sandoz, Coherus, etc.) |
$2,500 - $3,500 |
Price competition increasing, some discounts seen |
Future Price Projections
- Biosimilar competition is expected to continue exerting downward pressure.
- Price reductions of 10-20% over the next 2-3 years are likely as market penetration increases.
- Original product prices may stabilize at a lower level if biosimilar uptake accelerates.
Market Entry and Pricing Strategies
- Biosimilar makers face challenges related to physician and patient acceptance.
- Tendering processes in government and institutional settings favor lower-cost biosimilars.
- Payer pressure in the U.S. might lead to reimbursement cuts, driving pricing down further.
Regulatory and Policy Factors Impacting Pricing
- U.S. Biosimilar pathway established by the Biologics Price Competition and Innovation Act (2010) has facilitated biosimilar approvals.
- Price negotiations and formulary decisions heavily influence net market prices.
- International reference pricing can affect biosimilar pricing on global markets.
Key Takeaways
- The pegfilgrastim market remains robust, driven by chemotherapy use and expanding indications.
- Biosimilar competition has emerged significantly since patent expirations, pushing prices downward.
- Prices in the U.S. have declined for biosimilars, with further reductions anticipated.
- Market growth continues despite pricing pressures, supported by increasing cancer treatment rates and biosimilar adoption.
- Regulatory and reimbursement policies will influence future pricing dynamics.
FAQs
1. How will biosimilar entry affect Neulasta’s market share?
Biosimilars are expected to capture a substantial portion of the market, potentially exceeding 50% in the U.S. within the next 3-5 years, due to lower prices and increasing acceptance.
2. What factors could slow down price declines?
Brand loyalty, physician familiarity, and limited biosimilar awareness in some regions can slow adoption and price reductions.
3. How are international markets differing in biosimilar uptake?
European and Asian markets generally show faster biosimilar adoption due to earlier approval processes and European health policies encouraging cost-effective treatments.
4. Are there upcoming regulatory changes that could influence pricing?
Yes. Continued policy discussions on Medicare negotiation authority and international trade agreements could impact pricing strategies.
5. What is the forecast for Neulasta’s revenue in the next 5 years?
Global revenue is projected to grow modestly at a CAGR of about 5%, reaching approximately $1.9 billion by 2028, but actual figures depend on biosimilar market penetration and policy developments.
References
[1] IQVIA. (2022). Global Biosimilar Market Report.
[2] U.S. Food and Drug Administration. (2021). Biosimilar Product Approvals.
[3] EvaluatePharma. (2023). Oncology Biologics Market Forecast.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Biosimilars.
[5] European Medicines Agency. (2022). Biosimilar Approvals and Recommendations.
