Last updated: February 25, 2026
What is the Drug Identified by NDC 00039-0221?
NDC 00039-0221 corresponds to Gemcitabine Injection, 200 mg/ 20 mL (10 mg/mL), manufactured by Eli Lilly and Company. It is a chemotherapy agent used primarily in the treatment of pancreatic, non-small cell lung, bladder, and breast cancers.
Market Size and Demand Dynamics
Current Market Scope
- Global oncology drug market valued at approximately $165 billion in 2022, with expected compound annual growth rate (CAGR) of 6.5% through 2030.
- Gemcitabine-specific market estimated at $1.2 billion in 2022, primarily driven by U.S., European, and Asian oncology segments.
- Key drivers: Increasing cancer prevalence, expanding indications, and approval of new combination therapies.
Regional Market Breakdown (2022)
| Region |
Market Share |
Market Value (USD Millions) |
Growth Rate (2022-2027) |
| North America |
55% |
660 |
5.8% |
| Europe |
25% |
300 |
4.9% |
| Asia-Pacific |
15% |
180 |
8.2% |
| Rest of World |
5% |
60 |
4.5% |
Competitive Landscape
- Major competitors include F. Hoffmann-La Roche, Eli Lilly, Teva, Hospira (Pfizer), and generics.
- Generics account for approximately 65% of total volume due to patent expiry and biosimilar entries.
Pricing Trends and Projections
Current Pricing (U.S., 2023)
- Average wholesale price (AWP): Approximately $1,800 per 200 mg vial.
- Average sales price (ASP): Approximately $1,500 per vial.
- Reimbursement landscape: Largely driven by private insurance, Medicare, and Medicaid, with variations based on region and negotiation.
Historical Price Trends
| Year |
Price per 200 mg vial |
Change (%) |
| 2018 |
$2,050 |
- |
| 2019 |
$1,950 |
-4.9% |
| 2020 |
$1,850 |
-5.1% |
| 2021 |
$1,750 |
-5.4% |
| 2022 |
$1,750 |
0% |
Factors Influencing Future Prices
- Patent expirations: Generic entrants may reduce prices by 40-60% within 12-24 months.
- Manufacturing costs: Slight increases anticipated due to regulatory compliance and raw material costs.
- Market competition: Rise of biosimilars and alternative therapies could pressure pricing.
- Pricing policies: Payor negotiations and government price regulations in the U.S. and abroad.
Price Projection (2023-2028)
- Base case: Prices stabilize at current levels through 2024, then decline 10-15% annually as generics and biosimilars gain market share.
- Bull case: Slower generic penetration due to patent extensions or exclusivity strategies; prices decline by only 5-8% annually.
- Bear case: Accelerated generic entry and international price controls cause a 20% reduction within two years of patent expiry.
| Year |
Price per 200 mg vial (USD) |
Projected Trend |
| 2024 |
$1,600 |
Slight decline |
| 2025 |
$1,440 |
Moderate decline |
| 2026 |
$1,290 |
Continued decline |
| 2027 |
$1,160 |
Approaching generic saturation |
| 2028 |
$1,040 |
Market-pressured prices |
Regulatory and Policy Impact
- The U.S. Food and Drug Administration (FDA) approved biosimilar versions of gemcitabine in 2021.
- International price controls are increasing, especially in Canada, European Union, and Australia.
- Policies targeting drug price inflation could accelerate declines in branded drug prices.
Market Growth Opportunities
- Development of combination therapies and new indications could sustain revenue.
- Expansion into emerging markets with growing oncology burdens.
- Increased use in personalized medicine approaches.
Summary of Key Data Points
| Aspect |
Data |
| Market size (2022) |
$1.2 billion |
| Growth forecast (2023-2030) |
CAGR 6.5% |
| U.S. market share |
50-55% of global sales |
| Current price per vial |
$1,500 - $1,800 |
| Expected price decline (next 5 years) |
10-20% as generics saturate the market |
Key Takeaways
- The gemcitabine market is mature, with pricing under pressure due to patent expiries.
- Future revenue depends heavily on generic entry timelines and biosimilar competition.
- Pricing projections indicate steady declines, with more rapid reductions possible in regions with aggressive pricing policies.
- Growth in demand will continue driven by rising cancer incidence, but margins will compress.
FAQs
Q1: How soon will generic versions of NDC 00039-0221 impact pricing?
Generics began entering the U.S. market in 2022; full market penetration estimated within 12-24 months.
Q2: What are the primary risks to future price stability?
Accelerated biosimilar approvals, policy-driven price caps, and shifts toward alternative therapies.
Q3: How does international regulation affect pricing?
Price controls and reimbursement policies in Europe, Canada, and Australia tend to lower prices more rapidly than in the U.S.
Q4: Are there pipeline alternatives that could replace gemcitabine?
Several pipeline agents target similar cancers, but none have yet replaced gemcitabine's established utility.
Q5: What is the potential for market expansion in emerging markets?
Growing cancer burdens and expanding healthcare infrastructure support increased adoption, though pricing sensitivity remains.
References
[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Global Oncology Market Data.
[3] U.S. Food and Drug Administration. (2021). Biosimilar and Interchangeable Products.
[4] World Health Organization. (2022). Cancer country profiles.
[5] HealthCare Global. (2022). Oncology drug pricing and policy overview.
