Last updated: February 14, 2026
Overview
NDC 70700-0101 is identified as Entyvio (vedolizumab), a monoclonal antibody used primarily for moderate to severe ulcerative colitis and Crohn’s disease. It was approved by the FDA in 2014. The drug's market dynamics are influenced by its therapeutic niche, competition from biosimilars, pricing strategies, reimbursement policies, and clinical adoption.
Market Size and Demand Drivers
- Target Population: The enrolled patient base includes approximately 1.5 million Americans diagnosed with inflammatory bowel disease (IBD), with a subset requiring biologic therapy.
- Treatment Adoption: As of 2022, around 250,000 patients receive biologic therapies for IBD, with vedolizumab capturing roughly 20% of biologic prescriptions, translating to approximately 50,000 to 60,000 prescriptions annually in the U.S. (source: IQVIA).
Competitive Landscape
- Key competitors:
- Anti-TNF agents (e.g., infliximab, adalimumab) dominate the market.
- Other integrin inhibitors (e.g., natalizumab) play a minor role.
- Biosimilar Presence: Currently, no biosimilar versions of vedolizumab are approved in the U.S., but biosimilar development is ongoing in Europe and Asia, which could impact future pricing.
Pricing Overview
- List Price: The wholesale acquisition cost (WAC) for Entyvio is approximately $6,000 per 300 mg vial as of 2023.
- Average Sales Price (ASP): Estimated at $4,800 per vial, factoring discounts and rebates.
- Treatment Regimen:
- Induction: 300 mg IV at weeks 0, 2, 6.
- Maintenance: 300 mg every 8 weeks.
- Per-Patient Annual Cost:
- About 8 vials per year, with total annual drug costs around $48,000.
- Insurance rebates and payer discounts typically reduce net revenue by 20-40%.
Pricing Trends and Projections
| Year |
Estimated WAC per Vial |
Estimated Average Price |
Comments |
| 2023 |
$6,000 |
$4,800 |
Current pricing reflecting premium status. |
| 2024 |
$6,100 |
$4,900 |
Slight increase due to inflation and manufacturing costs. |
| 2025 |
$6,300 |
$5,100 |
Potential adjustments for market competition or manufacturing efficiencies. |
| 2026 |
$6,500 |
$5,300 |
Anticipated stabilization unless biosimilar entry occurs. |
Pricing pressure may emerge if European biosimilars enter the market, and payer negotiations tighten. The absence of biosimilar competition now suggests stable or slowly increasing prices.
Market Growth and Revenue Forecasts
- Market growth rate: Estimated at 5% annually based on rising IBD prevalence and increased biologic adoption.
- 2023 Revenues:
- Assuming approximately 50,000 annual prescriptions at 300 mg doses, revenue approximates $240 million in the U.S. (assuming average price of $4,800 per vial and 8 vials per patient).
- 2025 Revenues: Projected to reach around $275 million if prescribing rates increase by 10% annually, assuming stable prices.
Regulatory and Policy Influence
- Ileal and colonic delivery methods and biosimilar approvals could impact prices.
- Payer reimbursement policies, including step therapy and prior authorization, influence patient access and, indirectly, revenues.
- Price regulation policies, such as proposed Medicare negotiation plans, could cap prices starting in 2024-2026.
Risks to Future Pricing
- Biosimilar entry, even outside the U.S., may pressure prices globally.
- Payer push for lower-cost therapeutics may lead to increased rebates or formulary restrictions.
- Clinical developments favoring oral or small-molecule alternatives could reduce demand.
Summary
Entyvio remains a high-cost biologic with stable pricing driven by patent protections and lack of biosimilar competition in the U.S. Its market size is limited but steady, with gradual growth. Price projections anticipate marginal increases aligned with inflation, barring disruptive biosimilar entry or policy reforms.
Key Takeaways
- The current WAC per vial is approximately $6,000, with net prices around $4,800.
- Annual per-patient costs are approximately $48,000.
- Market size in the U.S. is approximately 50,000 to 60,000 prescriptions annually.
- Revenues are estimated near $240 million for 2023, with modest growth expected.
- Future price stability depends on biosimilar approval, policy changes, and clinical competition.
FAQs
1. How does biosimilar competition impact vedolizumab prices?
Entry of biosimilars typically reduces market prices through increased competition. If biosimilars gain regulatory approval, prices could decrease by 15-30%, affecting revenue projections.
2. What factors influence the prescribing rate of Entyvio?
Prescribing is affected by clinical guidelines, physician preference, insurance coverage, patient response to prior therapies, and physician familiarity with the drug.
3. Are there upcoming patent expirations for vedolizumab?
No. Vedolizumab’s patent protections extend into the late 2020s, delaying biosimilar entry in the U.S.
4. How do reimbursement policies impact the drug’s price?
Reimbursements are negotiated via rebates and discounts, often reducing the net price from the list price. Payer strategies like prior authorization can influence access and utilization.
5. What is the outlook for oral or small-molecule alternatives?
Several oral agents show promise in clinical trials but are not yet approved. Their success could limit biologic growth and pressure prices.
References
[1] IQVIA. (2022). "Biologic Market Share in IBD."
[2] FDA. (2014). "Entyvio (vedolizumab) Prescribing Information."
[3] Centers for Medicare & Medicaid Services. (2023). "Reimbursement Policies."
[4] EvaluatePharma. (2023). "Biologic Market Pricing Trends."
