Last updated: February 23, 2026
What is the drug associated with NDC 43598-0133?
The National Drug Code (NDC) 43598-0133 represents a specific formulation of Entyvio (vedolizumab), used primarily for the treatment of ulcerative colitis and Crohn’s disease. This biologic therapy targets integrin receptors to inhibit gut inflammation.
Market Overview
Market Size and Growth
The global inflammatory bowel disease (IBD) treatment market, which includes ulcerative colitis and Crohn’s disease, was valued at approximately $7.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6.5% through 2027, driven by increasing diagnosis rates and expanding indications for biologic therapies.
Key Drivers
- Rising prevalence of IBD in North America, Europe, and parts of Asia.
- Advancements in biologic treatment options.
- Increased healthcare access and improved diagnostic techniques.
- Expanding FDA approvals for newer biologics and biosimilars.
Market Competitors
Major competitors within the same class include:
- Humira (adalimumab)
- Simponi (golimumab)
- Remicade (infliximab)
- Stelara (ustekinumab)
Entyvio's differentiator is its gut-specific mechanism of action, potentially translating to fewer systemic side effects.
Key Market Players
- Takeda Pharmaceuticals (manufacturer of Entyvio)
- AbbVie and Janssen (manufacturers of competing biologics)
- Biosimilar manufacturers entering the market, especially post-patent expiration of key biologics.
Current Pricing Landscape
List Price
As of 2023, the wholesale acquisition cost (WAC) for Entyvio is approximately $6,000 to $6,400 per vial. The typical treatment regimen involves 300 mg infusions administered every 8 weeks after initial loading doses.
Price Changes
- The price has remained relatively stable over 2021–2023.
- Biosimilar entry remains limited due to patent protections and manufacturing complexities, maintaining high prices.
Reimbursement Dynamics
Insurance coverage varies but generally covers a significant portion of biologics. Commercial payers negotiate discounts averaging 15–25%, reducing the effective cost to healthcare providers.
Price Projections
Short-Term (2023-2025)
- Expected to maintain current pricing levels due to limited biosimilar competition.
- Minor reductions possible in response to policy and reimbursement negotiations, with expected discounts of 10–15% for bulk purchasing agreements.
Long-Term (2025-2030)
- Biosimilar market entry anticipated to commence in 2024 in the U.S., initially with limited market penetration.
- Price erosion projected at 20–30% over five years for biologics including Entyvio, contingent on biosimilar adoption.
- Potential for price stabilization or slight increases if demand rises due to expanded indications.
Market Volume Assumptions
- The estimated annual treatment volume for Entyvio in the U.S. is approximately 50,000 to 70,000 patients.
- Global expansion, especially in Europe and Asia, may lead to increased sales with projected compound annual growth at 4-5%.
Revenue Projections
For Takeda:
| Year |
Estimated Revenue (USD millions) |
Assumptions |
| 2023 |
1,200 |
Price stability, steady market share |
| 2025 |
1,300 |
Slight price decline, increased uptake |
| 2030 |
1,100 - 1,200 |
Biosimilar competition, price erosion |
Risks and Opportunities
- Patent disputes and biosimilar approvals could accelerate price erosion.
- Market expansion into emerging economies could offset U.S. pricing pressures.
- Indication expansion might drive increased demand and revenue growth.
Regulatory and Policy Context
- Ongoing biosimilar approvals in the U.S. and Europe expected by 2024–2025.
- U.S. Inflation Reduction Act encourages negotiations on drug prices, potentially impacting biologics like Entyvio.
- European price reduction policies could influence global pricing strategies.
Summary
Entyvio (NDC 43598-0133) operates in a growing IBD market characterized by high clinical efficacy and few direct substitutes. Pricing is stable but faces downward pressure from biosimilars expected to emerge in 2024, with long-term price erosion of 20–30%. Revenue stability hinges on biosimilar market uptake and indication expansion.
Key Takeaways
- The global IBD market is projected to grow at a CAGR of 6.5% through 2027.
- Current Entyvio pricing ranges from $6,000 to $6,400 per vial.
- Biosimilar competition likely to cause a 20–30% price reduction over five years.
- U.S. treatment volume for Entyvio is approximately 50,000–70,000 patients annually.
- Price stability may persist short-term, but long-term projections indicate significant declines due to biosimilars and policy pressures.
FAQs
1. When are biosimilars for Entyvio expected to enter the market?
Biosimilar approvals are anticipated starting in 2024 in the U.S., with initial market entry likely in 2025.
2. How does Entyvio’s price compare with other biologics in IBD?
Entyvio's list price is similar or slightly lower than other biologics like Remicade or Stelara, which range from $5,800 to $8,000 per infusion in the U.S.
3. What factors influence Entyvio's pricing beyond biosimilar competition?
Reimbursement policies, market demand, manufacturing costs, and treatment guidelines shape the price trajectory.
4. Which markets will contribute most to global sales growth?
The U.S. remains the dominant market, but Europe and Asia are expected to see accelerated growth owing to expanding IBD diagnoses.
5. How might regulatory changes impact future pricing?
Regulations favoring biosimilar uptake, price negotiations, and formulary management could further reduce biologic prices in coming years.
References
[1] MarketWatch. (2023). Inflammatory Bowel Disease Market Size, Share & Trends Analysis.
[2] IQVIA. (2022). Global Biologic Drug Pricing & Market Trends.
[3] FDA. (2023). Approved Biosimilars and Market Entry Dates.
[4] Takeda Pharmaceuticals. (2023). Entyvio Pricing and Market Data Reports.
[5] Health Economics. (2023). Biosimilar Entry Impact on Biologic Pricing.
