Last updated: February 24, 2026
What is NDC 69616-0280?
NDC 69616-0280 corresponds to Entyvio (vedolizumab). Approved by the FDA in 2014, it is indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adult patients. It is a monoclonal antibody targeting integrin α4β7, used to regulate immune responses within the gastrointestinal tract.
Market Overview
Market Size and Growth
- The global inflammatory bowel disease (IBD) therapeutics market, which includes vedolizumab, was valued at approximately USD 8.4 billion in 2022.
- Expected Compound Annual Growth Rate (CAGR): 6.2% from 2023 to 2028 (Source [1]).
Key Competitors
- Humira (adalimumab): Biologics first-line.
- Stelara (ustekinumab): Approved for Crohn's and ulcerative colitis.
- Remicade (infliximab): Long-established biologic therapy.
- Entyvio: Niche targeting gut-specific immune pathways.
Market Penetration
- As of 2022, Entyvio holds roughly 17% of the overall biologics market for ulcerative colitis and Crohn's, behind Humira (~38%) and Stelara (~22%).
Growth Drivers
- Increasing diagnosis rates of IBD.
- Competitive positioning due to gut-specific targeting and reduced systemic immunosuppression effects.
- Expanding approved indications and off-label use.
Challenges
- High cost of biologics (average list price: USD 3,000–USD 4,000 per dose).
- Biosimilar entry for competitor biologics.
- Market saturation and payer restrictions.
Price Projections
Current Pricing Dynamics
Factors Impacting Future Pricing
- Patent expirations: Patent for Entyvio expires in 2033 in the U.S., opening the market to biosimilar competitors.
- Biosimilar development: Several biosimilars are in development or have entered markets in Europe, which could pressure prices starting from 2026–2028.
- Market competition: Increased adoption of biosimilars for Humira and Stelara can impact Entyvio pricing.
Price Forecast (2023–2028)
| Year |
Estimated Per Dose Price |
Estimated Annual Revenue |
Comment |
| 2023 |
USD 4,000 |
USD 1.2 billion (global) |
Stable pricing; high demand |
| 2024 |
USD 3,950 |
USD 1.2 billion |
Small discounts; price stabilization |
| 2025 |
USD 3,900 |
USD 1.1 billion |
Price erosion due to increased payer pressure |
| 2026 |
USD 3,800 |
USD 1.0 billion |
Biosimilar entry in Europe; U.S. debates begin |
| 2027 |
USD 3,750 |
USD 950 million |
Biosimilar dominance possible in Europe, U.S. |
| 2028 |
USD 3,700 |
USD 900 million |
Entry of biosimilars, potential price competition |
Assumptions
- Market share remains relatively stable until biosimilar entry significantly impacts prices.
- Payer negotiations and discounts persist at 15–20%.
- No major regulatory or clinical event alters demand.
Market Entry and Development Outlook
- Biosimilars: Several biosimilar candidates are under FDA review, with anticipated market entry between 2026–2028.
- Regulatory pathways: Pathways for bios pupose approval will influence market dynamics.
- Pipeline extensions: Research into additional indications and formulation improvements could enhance revenue.
Strategic Implications
- Timing of biosimilar entry impacts pricing and market share recovery.
- Pricing strategies now focus on maintaining market share through patient support programs and payer negotiations.
- Opportunities exist for combination therapies or new delivery modes.
Key Takeaways
- The U.S. biologics market for IBD treatments totals USD 8.4 billion, with Entyvio occupying a significant segment.
- Pricing is currently stable but faces decline starting around 2026 due to biosimilar competition.
- Revenue projections show gradual decline from USD 1.2 billion in 2023 to USD 900 million in 2028.
- Patent expiration and biosimilar development are primary drivers of future market dynamics.
- Strategic focus should be on differentiation and preparing for increased competition.
FAQs
Q1: When will biosimilars for Entyvio be available?
A1: Biosimilars are expected between 2026 and 2028, contingent on FDA approval timelines.
Q2: How does Entyvio’s pricing compare globally?
A2: Prices are generally aligned but vary due to local rebates, healthcare policies, and market structures. European prices can be 20–30% lower than U.S. levels.
Q3: What factors could accelerate price declines?
A3: Entry of biosimilars, policy shifts favoring generics, and payer negotiations.
Q4: Is there potential for new indications?
A4: Ongoing research explores additional IBD subsets and other autoimmune conditions, potentially expanding revenue streams.
Q5: What strategies protect Entyvio’s market position?
A5: Innovation in formulations, patient support, contracting negotiations, and expanding indications.
References
[1] Grand View Research. (2023). Inflammatory Bowel Disease Therapeutics Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/inflammatory-bowel-disease-ibd-therapeutics-market
