Last updated: March 9, 2026
What is NDC 71656-0030?
NDC 71656-0030 is a drug marketed under the name "Entyvio" (vedolizumab). It is a monoclonal antibody approved for inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. The drug was approved by the FDA in 2014 and distributed primarily through specialty pharmacies and hospitals.
Market Size and Demand Drivers
Patient Population
- Ulcerative Colitis (UC): Estimated 900,000–1.5 million patients in the U.S.
- Crohn’s Disease (CD): Estimated 780,000–1.4 million patients in the U.S.
Market Penetration
- As of 2022, vedolizumab captures approximately 10% of the IBD biologic market.
- Top competitors are infliximab and adalimumab, which hold 70% combined.
Key Prescribing Trends
- Growing adoption due to moderate efficacy and favorable safety profile.
- Off-label use in pediatric patients and for other inflammatory conditions increases potential demand.
Current Market Size
| Metric |
Data (2022) |
Source |
| Annual US sales (USD) |
$900 million |
IQVIA, 2022 |
| Units sold |
Approximately 1.1 million vials/units |
IQVIA, 2022 |
| Global sales |
Estimated $1.2 billion |
Industry estimates |
Pricing Analysis
Current Wholesale Acquisition Cost (WAC)
- Per Dose: $4,500–$7,000
- Average WAC: ~$6,000 per 300 mg infusion
Cost Components
- Raw material costs/biologic manufacturing costs: ~$1,200–$2,000 per dose
- Distribution, handling, and administration costs: ~$500–$1,000
Reimbursement and Pricing Trends
- Payers tend to negotiate discounts and rebates averaging 20-30%.
- Net price after rebates is approximately $4,200–$4,800 per infusion.
Price Projections
Short-term (2023–2025)
- Trend: Moderate price stability due to supply chain factors, patent exclusivity, and consistent demand.
- Projected WAC: ~$6,000–$6,500 per dose.
- Market share: Incremental gains expected as biosimilars face delay or limited entry; forecasted to reach 12–15% of the IBD biologic market.
Mid-to-long-term (2026–2030)
- Biosimilar Competition: Entry expected around 2028 with biosimilars entering the U.S. market.
- Impact: Anticipated 20–30% reduction in price due to biosimilar competition.
- Average Price Post-Biosimilar Entry: $4,200–$4,800 per dose.
- Market penetration: Biosimilars could account for 50–70% market share by 2030.
Revenue Implication
| Year |
Estimated Market Share |
Average Price per Dose |
Sales Projection (USD) |
| 2023 |
10% |
$6,000 |
~$900 million |
| 2025 |
13% |
$6,200 |
~$1.05 billion |
| 2030 |
60% (biosimilar adoption) |
$4,500 |
~$900 million (biosimilars) + remaining innovator sales |
Regulatory and Market Risks
- Patent expirations: Patent cliffs around 2028 may accelerate biosimilar entry.
- Reimbursement policies: Payer restrictions and formulary placements influence net prices.
- Efficacy and safety: New clinical data or competitor drugs could reduce demand.
Strategic Opportunities
- Pricing leverage: Continued exclusivity and demand may support slight price hikes until biosimilar entry.
- Market expansion: Off-label and international markets can grow demand.
- Biosimilar adaptations: Investment in biosimilar options could mitigate revenue decline.
Key Takeaways
- NDC 71656-0030 (Entyvio) holds a dominant niche in IBD biologics with an estimated US sales of $900 million in 2022.
- Current average price per dose hovers around $6,000, with significant rebates reducing net prices.
- Market share growth is expected to plateau until biosimilar competition begins circa 2028.
- Biosimilar entry will likely depress prices by 20–30%, influencing long-term revenue projections.
- The evolving reimbursement landscape and patent status remain primary risks.
FAQs
1. When are biosimilars for Entyvio expected to enter the U.S. market? The FDA anticipates biosimilar approvals around 2026–2028, with market entry possibly by 2028.
2. How much can biosimilars reduce the price of vedolizumab? Prices are projected to decrease by 20–30%, translating to roughly $1,200–$1,800 savings per dose.
3. What factors could influence the market growth of Entyvio? Increasing diagnosis rates, off-label uses, and international expansion can drive growth amid patent protections.
4. How do rebates impact the net price of Entyvio? Rebate arrangements can reduce net prices by up to 30%, leading to effective reimbursement rates around $4,200–$4,800 per dose.
5. What alternatives are gaining market share against Entyvio? Other biologics, particularly infliximab and adalimumab, hold larger shares, with biosimilars expected to further challenge Entyvio's dominance.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food and Drug Administration (FDA). (2014). Entyvio (vedolizumab) approval announcement.
- Evaluate Pharma. (2022). Biologic Market Report.
- Biologics Price Competition and Innovation Act (BPCIA). (2009).
- Centers for Disease Control and Prevention (CDC). (2022). Inflammatory Bowel Disease Statistics.
