Last updated: February 22, 2026
What is the drug associated with NDC 00406-3243?
The drug identified by NDC 00406-3243 is Paclitaxel Albumin-bound (Abraxane). It is an anticancer agent used primarily for metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma.
Market Overview
Current Usage and Demand
- Indications: Approved for breast cancer, NSCLC, pancreatic cancer.
- Market size: Estimated global cancer therapeutics market at USD 157 billion in 2022, growing at a CAGR of 8–10% [1].
- Patient prevalence:
- Breast cancer: 2.3 million new cases globally annually.
- NSCLC: 2.2 million new cases globally annually.
- Pancreatic cancer: 495,000 new cases globally annually.
- Market penetration: Abraxane accounts for a significant share of albumin-bound chemotherapy agents, with estimated adoption in 60–70% of eligible patients in developed markets.
Competitive Landscape
- Main competitors: Docetaxel, Paclitaxel (non-albumin-bound), and generic formulations.
- Patent status: Patent exclusivity expired in the U.S. in 2019, increasing generic competition.
Regulatory Environment
- US: Approved by FDA since 2005.
- Europe: Approved by EMA since 2006.
- Patent expirations and biosimilar entries expected, affecting pricing and market share.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 100 mg vial |
Notes |
| 2018 |
USD 2,100 |
Brand name: Abraxane |
| 2020 |
USD 2,300 |
Slight increase due to inflation |
| 2022 |
USD 2,400 |
Post-patent expiry, limited discounting |
Current Pricing Factors
- Brand price: Stabilized around USD 2,300–2,400 per 100 mg vial.
- Generic entry: Prices for generics under development and some approved in Europe could reduce prices by 20–40%.
- Reimbursement policies: Insurers and healthcare providers shift to biosimilars and generics, pressuring brand pricing.
Short-term Price Projections (2023-2025)
- Brand price: Remains stable at USD 2,300–2,400, with potential slight decrease of 5–10% driven by increased generic competition.
- Generic versions: Prices could range USD 1,200–1,500 per 100 mg vial, reflecting a 30–50% discount relative to brand.
- Market share: Generic uptake could reach 35–50% in major markets within two years, further reducing overall pricing.
Long-term Price Outlook (2026–2030)
- Brand products: Prices could decrease by an additional 10–15% as biosimilar competition stabilizes.
- Biosimilars and generics: Expected to dominate the market, setting prices below USD 1,200 per 100 mg vial within five years.
- Pricing dynamics: Will vary based on regulatory changes, patent litigations, and healthcare policies promoting biosimilar use.
Price Comparison with Competitors
| Product |
Price per 100 mg vial |
Indication |
| Abraxane (brand) |
USD 2,350 |
Breast, lung, pancreatic |
| Generic (est.) |
USD 1,350 |
All indications, post-generic |
| Paclitaxel |
USD 150–300 |
Chemotherapy, non-albumin-bound |
Market Growth Drivers and Risks
Drivers
- Rising incidence of target cancers.
- Growing adoption of nanoparticle albumin-bound formulations.
- Entry of biosimilars reducing costs and expanding access.
- Payment models favoring cost-effective treatments.
Risks
- Accelerated biosimilar entry and pricing competition.
- Regulatory delays or restrictions.
- Claims of efficacy or safety issues with biosimilars.
Key Takeaways
- The drug’s market remains sizable due to high cancer prevalence; however, patent expiry has prompted a shift towards lower-cost biosimilars.
- Price per vial for Abraxane stable in the short term, around USD 2,300–2,400, with decline expected as generics and biosimilars proliferate.
- Generic options may reduce prices by up to 50%, potentially transforming market dynamics.
- Long-term pricing depends heavily on regulatory policies, biosimilar adoption, and healthcare reimbursement strategies.
FAQs
1. What factors influence the price of Abraxane?
Manufacturing costs, patent status, competition from biosimilars, regulatory approval, and reimbursement policies.
2. How soon will generics impact pricing?
Generics are expected to capture 35–50% of the market within two years of biosimilar approval, potentially dropping prices by 30–50%.
3. Are biosimilars available for Abraxane in the U.S.?
As of 2023, biosimilars are in development but have not yet received FDA approval; their arrival is imminent.
4. What is the outlook for Abraxane in emerging markets?
Prices will likely decline as biosimilars enter, with increased affordability and market expansion.
5. How does the target cancer prevalence affect market size?
High prevalence of breast, lung, and pancreatic cancers sustains strong demand, supporting the continued use of Abraxane despite price pressures.
References
[1] Grand View Research. (2022). Cancer Therapeutics Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). National Sales Data.
[3] FDA. (2023). Approved Biosimilars and Patent Expiry Date.