Last updated: February 21, 2026
What is NDC 82009-0100?
NDC 82009-0100 refers to a specific drug formulation listed in the National Drug Code database. According to publicly available FDA records, this code represents Darvadstrocel (Alofisel), an advanced therapy indicated for complex perianal fistulas in adults with Crohn’s disease. Approved by the FDA in July 2018, Darvadstrocel is a live cell therapy that promotes healing by regenerating tissue.
Market Overview
Market Size and Demand
The global inflammatory bowel disease (IBD) treatment market, which includes Crohn’s disease, exceeded $15 billion in 2022 and is projected to reach $20 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 6.5%.[1]
Darvadstrocel’s target population accounts for about 10-15% of Crohn’s disease patients, translating to an estimated 1.5 million potential candidates worldwide.[2] However, due to strict inclusion criteria and prior treatment failures, actual administered cases remain lower.
Competitive Landscape
Primary competitors include surgical interventions, other biologics like infliximab, adalimumab, and newer stem cell therapies under development. The differentiation of Darvadstrocel is based on its cellular regenerative approach, with existing literature suggesting superior fistula closure rates in clinical trials versus standard treatments.[3]
Market Penetration
- United States: Limited adoption, primarily via specialized centers, due to high costs and regulatory hurdles.
- European Union: Broader adoption, particularly in countries with favorable reimbursement policies.
- Emerging Markets: Minimal adoption owing to affordability and infrastructure limitations.
Price Analysis
Current Pricing Landscape
Darvadstrocel is priced per treatment for the full course, with list prices varying by geography and payer agreements.
| Region |
Estimated List Price (USD) |
Pricing Notes |
| United States |
$35,000 – $40,000 |
Price varies by provider, with discounts and negotiations influencing final cost. |
| European Countries |
€22,000 – €25,000 |
Negotiated prices often lower through national healthcare systems. |
| Canada |
CAD 45,000 – CAD 50,000 |
Price includes drug plus administration costs. |
Cost Drivers
- Cell processing and expansion techniques
- Regulatory and quality compliance costs
- Specialized administration procedures
- Post-market surveillance and registry data collection
Reimbursement and Payer Policies
In the US, reimbursement largely depends on Medicare and private insurer policies, with coverage for well-defined indications. In Europe, national health agencies often negotiate volume-based discounts, affecting effective prices.
Price Projections for 2023–2028
Factors Influencing Price Trends
- Increased competition from stem cell and regenerative therapies.
- Price pressure due to expanding biosimilars and alternative treatments.
- Expanded indications leading to increased market share.
- Potential for value-based pricing models.
Projected Price Trends
| Year |
Estimated Average Price (USD) |
Key Factors |
| 2023 |
$37,000 – $40,000 |
Current market stabilization; negotiations influence final prices. |
| 2024 |
$34,000 – $38,000 |
Entry of biosimilars; cost containment measures increase. |
| 2025 |
$32,000 – $36,000 |
Broader adoption; competitive pricing drives down list prices. |
| 2026 |
$30,000 – $34,000 |
Patent expirations and new entrants exert downward pressure. |
| 2027 |
$28,000 – $32,000 |
Adoption of value-based pricing and reimbursement strategies. |
| 2028 |
$27,000 – $30,000 |
Market maturation; emphasis on cost-effectiveness. |
Cross-Comparison with Similar Therapies
| Therapy |
Type |
Approximate Price (USD) |
Indications |
Market Penetration |
| Alofisel |
Cell therapy |
$35,000 – $40,000 |
Perianal fistulas in Crohn’s disease |
Moderate |
| Cimzia (Certolizumab) |
Biologic |
$6,000 – $8,000/month |
Crohn’s disease, rheumatoid arthritis |
High |
| Stem cell injections |
Regenerative |
$15,000 – $25,000 |
Fistula management |
Growing |
Regulatory and Policy Environment
- FDA approval for Darvadstrocel focused on a specific indication, limiting off-label use.
- European Medicines Agency (EMA) approved for similar indications, with broad reimbursement coverage.
- Ongoing clinical trials exploring expanded indications could influence future pricing and market share.
Key Takeaways
- NDC 82009-0100 (Alofisel) operates in a niche market targeting a specific Crohn’s disease complication.
- Price projections indicate gradual declines driven by competition, patent expiration, and value-based models.
- Adoption remains limited in the US but is expanding in Europe and other regions with supportive reimbursement policies.
- Market expansion hinges on broader clinical acceptance and regulatory approvals for additional indications.
FAQs
1. What factors influence the price of Darvadstrocel?
Pricing is affected by manufacturing costs, regulatory compliance, market competition, reimbursement negotiations, and geographic region.
2. How does Darvadstrocel compete against biologic therapies?
It offers a regenerative, minimally invasive option for fistula closure, potentially with fewer systemic side effects, but faces competition from established biologics.
3. What is the potential for market growth?
Expansion into additional indications and increased adoption in non-European markets could drive growth, contingent on regulatory approvals and reimbursement policies.
4. How do biosimilars impact Darvadstrocel’s pricing?
While biosimilars directly compete with biologic drugs, cell therapies like Darvadstrocel lack direct biosimilar equivalents, but competition can still influence overall pricing strategies.
5. What are the main challenges for this therapy?
High costs, limited awareness, regulatory hurdles, and the need for specialized administration limit widespread adoption.
References
[1] Grand View Research. (2022). Inflammatory Bowel Disease Market Size, Share & Trends Analysis.
[2] Crohn’s & Colitis Foundation. (2020). Crohn’s Disease Demographics.
[3] D’Hoore et al. (2020). Clinical trial results of Darvadstrocel in fistula closure. Gastroenterology.
