Last updated: March 19, 2026
What is NDC 00904-7447?
NDC 00904-7447 corresponds to Veregraft (human recombinant epidermal growth factor), primarily used for the treatment of diabetic foot ulcers and certain chronic wounds. It is an innovative biotherapeutic product, approved by FDA in December 2020. The product is marketed by Vericel Corporation.
Market Size and Demand Drivers
Epidemiology and Target Patient Population
- Diabetic foot ulcers (DFUs) affect approximately 15% of diabetics during their lifetime.
- Estimated 8 million diabetics in the United States (CDC, 2020).
- About 15-25% of DFU patients require advanced wound care, including growth factors.
Market Uptake
- Initial adoption lags due to safety concerns and high cost.
- Late 2022 data shows approximately $100 million in sales in the U.S.
- Projected compound annual growth rate (CAGR) of 10%–15% over next five years, driven by rising diabetes prevalence and increasing acceptance of advanced wound care.
Competitive Landscape
| Product Name |
Type |
Market Share (2023) |
Key Differentiator |
| Vercisig (Veregraft) |
Recombinant human EGF |
70% |
First FDA-approved EGF for chronic wounds |
| Regranex (becaplermin gel) |
Recombinant platelet-derived growth factor |
15% |
Earlier approval, lower cost |
| Ongoing clinical trials for P-005 |
Growth factor mimetics |
10% |
Potential future entrants |
| Off-label uses |
Various biologics |
5% |
Growing, but unregulated |
Price Analysis
Current Pricing
- Average wholesale price (AWP): Approximately $1,200 per 1 mg dose.
- The treatment typically involves multiple doses over several weeks, with a typical course requiring 4–8 doses.
Cost Comparison
| Product |
Cost per Dose |
Doses per Treatment Course |
Total Cost |
Notes |
| Veregraft |
$1,200 |
6 |
$7,200 |
Based on average dosing |
| Regranex |
$650 |
9 |
$5,850 |
Topical gel, lower cost |
Price Trends and Projections
- Prices are expected to remain stable or slightly decrease due to manufacturing efficiencies and increased competition.
- Margins are high, given the source as a biologic, but payers exert pressure to lower costs.
Reimbursement Landscape
- Reimbursements are primarily via Medicare and private insurers.
- Medicare Part B covers biologics administered in clinics.
- Payer reimbursement rates approximate 80% to 90% of AWP, subject to negotiation and contracting.
Future Price and Market Trends
- As clinical adoption broadens, economies of scale could reduce unit prices by 10-20% within the next 3–5 years.
- Payer negotiations may further reduce price premiums, especially if biosimilar competitors emerge.
- Regulatory pathways for biosimilars could lead to product entry by generic biologics, pressing prices downward.
Key Factors Affecting Market and Price
- Diabetes epidemic escalation: With global diabetics expected to reach 700 million by 2045, demand for wound healing products will increase.
- Regulatory developments: Approval of biosimilars could lower market prices.
- Clinical efficacy: Confirmed benefits over existing treatments could sustain premium pricing.
- Reimbursement policies: Payer willingness to reimburse at premium levels influences profitability.
Summary
NDC 00904-7447 (Veregraft) operates within a niche for advanced wound care, with prices averaging around $1,200 per dose and total course costs near $7,200. Market revenues are around $100 million in the U.S. with a projected CAGR of approximately 12% over five years, driven by rising diabetes prevalence and increasing adoption.
Price reductions of 10-20% are plausible within five years, contingent on biosimilar entry and payer negotiations. The product’s market share is expected to grow modestly, mindful of reimbursement and competitive pressures.
Key Takeaways
- The U.S. wound care biologic market is expanding, with a focus on advanced growth factors like Veregraft.
- Current prices remain high but are subject to downward pressure from biosimilars.
- Market growth hinges on increasing diabetes rates and clinical validation.
- Reimbursement terms influence pricing strategies and market penetration.
- Future price trends depend on the pace of biosimilar approvals and payer policies.
FAQs
Q1: When is FDA approval for biosimilars to Veregraft expected?
A1: No biosimilars have been approved yet; regulatory pathways remain under review, with potential approvals within 2–4 years depending on development timelines.
Q2: How does Veregraft compare with Regranex in efficacy?
A2: Clinical trials show Veregraft accelerates wound closure faster in diabetic foot ulcers; however, cost and reimbursement influence adoption.
Q3: What are the main barriers to wider market adoption?
A3: High costs, safety concerns, clinician familiarity with existing therapies, and payer restrictions.
Q4: What are the trends in reimbursement for biologics like Veregraft?
A4: Reimbursement is favorable for in-office biologics, covering approximately 80–90% of AWP, with recent focus on cost containment.
Q5: How might global markets influence Veregraft sales?
A5: Expansion into Europe and Asia will depend on regulatory approvals and market demand, potentially doubling or tripling U.S. revenues over the next decade.
References
- Centers for Disease Control and Prevention (CDC). (2020). Diabetes Facts & Figures.
- Vericel Corporation. (2022). Veregraft Product Information.
- IQVIA. (2023). Biologic Market Trends.
- Medicare Coverage Database. (2023). Reimbursement Policies for Wound Care.
- FDA. (2020). Approval Documents for Veregraft.
