Last updated: March 1, 2026
What is the drug associated with NDC 50742-0113?
NDC 50742-0113 corresponds to Entyvio (vedolizumab), a monoclonal antibody indicated for the treatment of inflammatory bowel diseases, specifically ulcerative colitis and Crohn's disease.
How large is the market for vedolizumab?
Clinical and market scope
The global inflammatory bowel disease (IBD) market, driven by ulcerative colitis and Crohn's disease, is expanding. The market size for biologic therapies like vedolizumab was valued at approximately $4.7 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030, reaching over $9.4 billion.
Competitive landscape
Vedolizumab competes primarily with:
- Infliximab (Remicade) — $4.6 billion in 2022 sales
- Adalimumab (Humira) — $20 billion in 2022, across multiple indications
- Ustekinumab (Stelara) — approximately $4.8 billion in 2022
Market share for vedolizumab has increased due to its gut-selective mechanism, with sales rising from $600 million in 2018 to an estimated $1.9 billion in 2022.
Key usage areas
- Ulcerative colitis
- Crohn’s disease
- Previously failed on or intolerant to anti-TNF agents
What are current pricing trends for vedolizumab?
List price and reimbursement
- Average Wholesale Price (AWP): approximately $5,000 per 300 mg dose (based on 2022 data)
- Average sales price (ASP): around $4,600 per administration
- Average patient dosing: 300 mg intravenously every 8 weeks
Cost per year
For a typical adult patient:
- Dosing frequency: 6 doses annually
- Annual drug cost: approximately $27,600 ($4,600 x 6)
Reimbursement rates vary by payer and region, with commercial insurers often covering 80–90% of the costs.
What are the price projection factors?
Drivers of price and revenue
- Market penetration: Growth depends on the adoption rate among gastroenterologists
- Competitive dynamics: Entry of biosimilars may pressure prices, although vedolizumab’s patent exclusivity extends until at least 2032
- Regulatory approvals: Expanded indications could increase usage volumes
- Pricing pressure: Payers and pharmacy benefit managers (PBMs) seek discounts and rebates
Future pricing outlook
- Potential decreased list prices: 5–10% over the next 5 years due to biosimilar entries and payer negotiations
- Rebates and discounts: likely to reduce net prices by 20–30%
- Market volume growth: driven by increased diagnosis rates, which are projected to grow at 3–4% annually
Valuation estimate (2023–2030)
| Year |
Estimated Annual Revenue |
Pricing Adjustment |
Volume Growth |
Notes |
| 2023 |
$2 billion |
- |
10% |
Current market share, new patient uptake |
| 2025 |
$2.4 billion |
-10% |
12% |
Biosimilar competition begins impacting prices |
| 2027 |
$2.8 billion |
-15% |
10% |
Biosimilar impact increased, payer discounts rise |
| 2030 |
$3.4 billion |
-20% |
8% |
Market stabilization, expanded use |
Key considerations for investors and manufacturers
- Patent protections extend until 2032, delaying biosimilar market share pressure.
- Cost reductions via manufacturing efficiencies could influence net prices.
- Regulatory developments in biosimilar approvals in the U.S., Europe, and other regions may accelerate price declines.
- Market growth and unmet needs continue to support revenue expansion, especially in regions with lower penetration.
Conclusions
The drug associated with NDC 50742-0113, vedolizumab, remains a key player in IBD biologics. Pricing will likely decline gradually over the next decade due to biosimilar competition and payer negotiations. Revenue growth will depend on increased diagnosis, treatment adoption, and potential indications expansion.
Key Takeaways
- The market for vedolizumab is expected to grow at a CAGR of approximately 7.2% through 2030.
- The average annual price per patient is around $27,600, with potential reductions due to biosimilar entry.
- Market share gains depend on physician adoption, stability of patent protections, and approval of biosimilars.
- Price pressures are expected to reduce net revenues by 20–30% through 2030.
- Future success hinges on regulatory developments, expanded indications, and patient access.
FAQs
1. What is the main competitive advantage of vedolizumab?
Its gut-selective mechanism results in fewer systemic side effects compared to anti-TNF agents, making it preferable for some patients.
2. How do biosimilars affect vedolizumab's market?
While biosimilars are expected to enter by 2032, patent protections delay significant price competition. Once biosimilars enter, prices and market share could decline sharply.
3. Are there any upcoming regulatory changes that could impact pricing?
Approval of biosimilars or additional indications could increase competition and pressure prices downward.
4. What are the main factors influencing future sales growth?
Increasing diagnosis rates, wider adoption among treatment-naive and refractory patients, and expansion into new regions influence sales growth.
5. How does regional pricing variation impact revenue?
Pricing varies significantly by region, with U.S. prices higher than in Europe or Asia. Reimbursement policies and payer negotiations further impact net revenues.
References
[1] Evaluate Pharma. (2022). Global Biologic Market Report.
[2] IQVIA. (2022). BioPharma Trends and Insights.
[3] U.S. Food and Drug Administration. (2021). Biosimilar Development and Approvals.
[4] Maru, Y., et al. (2021). Pricing trends for biologics in inflammatory bowel disease. Health Economics Review, 11(1), 3.
[5] FDA. (2022). Vedolizumab (Entyvio) Prescribing Information.
