Last updated: February 25, 2026
What is the drug associated with NDC 00378-6961?
NDC 00378-6961 corresponds to Filgrastim (Granulocyte Colony-Stimulating Factor), marketed under the brand name Neupogen. It is primarily used to treat neutropenia caused by chemotherapy, bone marrow transplants, and certain disorders affecting white blood cell production.
Market Overview
Market Size and Growth
The global hematopoietic growth factors market, encompassing drugs like filgrastim, stands at approximately $2.4 billion in 2023. It is expected to grow at a compounded annual growth rate (CAGR) of 4.2% through 2028.
The U.S. holds around 55% of the market share, driven by high cancer incidence, advanced healthcare infrastructure, and broad reimbursement coverage. The expansion of indications, including application in stem cell mobilization and infection management, further sustains growth.
Key Market Drivers
- Increasing cancer prevalence: The U.S. recorded approximately 1.9 million new cancer cases in 2023 (SEER data). Chemotherapy-induced neutropenia remains prevalent, expanding filgrastim's use.
- Expanding indications: Use in stem cell mobilization and severe chronic neutropenia broadens the total addressable market.
- Reimbursement policies: Coverage by Medicare and private insurers enhances treatment accessibility.
- Biosimilar entry: Several biosimilars launched since 2015 have increased market competition, exerting downward pressure on prices.
Competitive Landscape
Major players include Amgen (Neupogen), Sandoz (Zarxio), Fresenius (Ratiograstim), and others. Biosimilars account for approximately 30% of sales in 2023. Amgen maintains a leading position but faces pricing pressures from biosimilar competition and cost-conscious healthcare systems.
Price Projections
Current Pricing Dynamics
- Brand-name Neupogen: The average wholesale price (AWP) is approximately $5,100 per 1 mL (vial), with typical regimens requiring multiple doses. Insurance coverage reduces patient out-of-pocket costs.
- Biosimilars: Priced around 15-20% lower than the brand, roughly $4,000 per vial.
Future Price Trends
Analysts project:
- Price decline of 10-15% over the next 3-5 years due to biosimilar proliferation.
- Per-dose prices are expected to stabilize around $3,500 - $4,200 in secondary markets.
- Market penetration of biosimilars will influence further price reductions, especially in outpatient settings and in markets with cost-sensitive reimbursement policies.
Factors Impacting Pricing
- Regulatory approvals: Increased FDA approvals of biosimilars will accelerate price erosion.
- Reimbursement policies: Payer policies favoring lower-cost biosimilars will favor price declines.
- Manufacturing costs: Advances in bioprocessing reduce production costs, supporting lower prices.
- Patent expirations: Although Neupogen’s primary patents expired in 2015, patent litigations or exclusivity extensions could influence market dynamics.
Pricing Comparison Table
| Product Type |
Approximate Price (per vial) |
Market Share (2023) |
Notes |
| Brandname (Neupogen) |
$5,100 |
70% |
Leading product, higher price |
| Biosimilars (Zarxio) |
$4,000 |
30% |
Compete on price, gaining market share |
Strategic Implications
- Market entry: Biosimilars will capture increasing market share as patents and exclusivities end or face challenge.
- Pricing strategy: Manufacturers should anticipate further price compression, emphasizing cost-efficient manufacturing.
- Healthcare policies: Reimbursement reform favors biosimilars, influencing future pricing and adoption rates.
Key Takeaways
- The filgrastim market will sustain growth driven by expanding indications and cancer prevalence.
- Prices are poised to decrease by 10-15% over five years due to biosimilar competition.
- Biosimilars currently account for about 30% of market sales and will increasingly challenge brand-name products.
- The U.S. leads the market, but cost-containment policies globally will shape future pricing strategies.
FAQs
Q1: How will biosimilar entry affect the price of Neupogen?
A1: Biosimilars tend to reduce prices by 15-20%, intensifying price competition and driving overall market prices downward.
Q2: Are there significant regulatory barriers to biosimilar success?
A2: No; the FDA approves biosimilars based on similarity, reducing time and costs compared to original biologic approval.
Q3: What is the primary driver for increasing use of filgrastim?
A3: The rising incidence of chemotherapy-induced neutropenia and expanded indications in stem cell mobilization.
Q4: How does reimbursement policy impact pricing?
A4: Insurers incentivize the use of lower-cost biosimilars, encouraging price competition and affecting brand-name drug pricing.
Q5: What are the main factors influencing future market growth?
A5: Patent expirations, biosimilar adoption, healthcare policies, and technological advances in manufacturing.
References
[1] SEER Cancer Statistics Review 2023. National Cancer Institute.
[2] EvaluatePharma. (2023). Hematopoietic growth factors market report.
[3] FDA. (2022). Approval of biosimilar products and market entry.
[4] IQVIA. (2023). U.S. pharmacy transaction data on biologic drugs.
[5] Amgen Inc. Annual Report 2022.
