Last updated: February 27, 2026
What is NDC 00713-0848?
NDC 00713-0848 is a specific drug listed in the National Drug Code Directory. It corresponds to Recomodulin (recombinant human erythropoietin), used primarily to treat anemia associated with chronic kidney disease, chemotherapy, or other conditions causing erythropoietin deficiency.
Market Overview
Current Market Size and Demographics
The erythropoietin market is driven by chronic kidney disease (CKD), oncology, and other anemia-related conditions. The key players include Amgen (Epogen, Aranesp), Roche (Mircera), and Johnson & Johnson (ProCRIT).
- Estimated global erythropoietin market value: $6 billion in 2022.
- Compound Annual Growth Rate (CAGR): approximately 5% (2023–2028).
- US market share: 60%, with a valuation of approximately $3.6 billion in 2022.
- CKD prevalence: over 37 million adults in the US, growing at an annual rate of 1.2%.
Competitive Landscape
| Company |
Product Names |
Market Share (2022) |
Pipeline Status |
| Amgen |
Epogen, Aranesp |
55% |
New biosimilars, biosimilar reformulations |
| Roche |
Mircera |
25% |
Biosimilar versions |
| Johnson & J. |
ProCRIT |
10% |
Maturing biosimilars |
| Others |
Multiple biosimilars |
10% |
Ongoing approvals and launches |
Regulatory Environment
The FDA approved biosimilar versions of erythropoietin from 2015 onwards, reducing costs and increasing competition. This has pressured pricing and margins but expanded market access.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per unit |
Market Trends |
| 2018 |
$25 |
Stable, dominated by branded drugs |
| 2020 |
$22 |
Slight decline due to biosimilar entry |
| 2022 |
$20 |
Continued decline, increased biosimilar presence |
Current Price Estimates
- Branded erythropoietin products: $20–$25 per unit.
- Biosimilar erythropoietin: $12–$16 per unit.
- Price reduction forecast: 5-8% annually over next 3–5 years due to biosimilar competition.
Projection Scenarios (2028)
| Scenario |
Price per Unit |
Justification |
| Conservative |
$14 |
Biosimilar proliferation, moderate R&D pipeline success |
| Moderate |
$12 |
Increased biosimilar market penetration |
| Aggressive |
$10 |
Rapid biosimilar adoption and regulatory pressures |
Market Drivers and Constraints
Drivers
- Rising CKD prevalence.
- Expanding oncology treatments creating demand for anemia management.
- Favorable reimbursement policies in key markets.
- Biosimilar market expansion lowering prices.
Constraints
- Patent expirations extending from 2020–2024.
- Stringent regulation of biosimilars.
- Physician and patient acceptance hurdles.
- Price-sensitive healthcare environments.
Key Opportunities
- Development of next-generation biosimilars with improved efficacy.
- Entry into emerging markets with limited existing access.
- Combination therapies reducing treatment costs and side effects.
Risks and Challenges
- Ongoing patent litigations delaying biosimilar launches.
- Regulatory restrictions affecting biosimilar approval.
- Market saturation with multiple biosimilars diluting revenue.
Investment and R&D Outlook
- Post-2024 biosimilar entry will depress standard pricing but expand volume.
- R&D investments focus on improved delivery, stability, and biosimilar licensing.
- Companies with early biosimilar approvals likely to capture significant market share.
Summary
The market for recombinant human erythropoietin (NDC 00713-0848) is characterized by a mature, highly competitive landscape with declining prices driven by biosimilar entries. The global market will see continued growth in demand driven by CKD and oncology, despite price pressures.
Key Takeaways
- The current price per unit for biosimilar erythropoietin is approximately $12–$16, with a projection downward to $10–$12 by 2028.
- The market size is approximately $6 billion globally, with growth driven by increasing disease prevalence.
- The main competitive threats stem from biosimilar proliferation, patent expiries, and regulatory changes.
- Investment opportunities center on biosimilar development and emerging markets expansion.
- Price declines of about 5–8% annually are expected over the next five years, influenced by biosimilar market penetration.
FAQs
Q1: When are biosimilar versions of erythropoietin expected to dominate the market?
A1: Biosimilars began market entrance around 2015–2018, with significant adoption projected through 2025. By 2028, biosimilars could account for over 70% of total erythropoietin sales.
Q2: How will regulatory policies impact the pricing of NDC 00713-0848?
A2: Regulatory approvals for biosimilars lower prices through competition, especially in markets with strong reimbursement policies. Stricter biosimilar regulations or patent disputes could delay or restrict market entry.
Q3: What is the potential for price rebound if patents are extended or new formulations are developed?
A3: Such developments could temporarily stabilize or increase prices. However, ongoing biosimilar competition makes sustained price increases unlikely.
Q4: Which geographic regions will see the fastest market growth?
A4: Emerging markets in Asia-Pacific and Latin America demonstrate rapid growth potential due to expanding healthcare infrastructure and lower biosimilar penetration compared to North America and Europe.
Q5: What are the key factors influencing R&D investment in this segment?
A5: Patent expiration timelines, biosimilar approval pathways, unmet clinical needs, and regional market penetrations are primary drivers for R&D investment.
Citations
- MarketWatch. (2023). "Global erythropoietin market size and forecast."
- IQVIA. (2022). "Biosimilar Market Insights."
- U.S. Food and Drug Administration. (2019). "Biosimilar Development and Regulation."
- Grand View Research. (2022). "Erythropoietin Market Size, Share & Trends."
- Centers for Disease Control and Prevention. (2022). "Chronic Kidney Disease in the United States."
