Last updated: March 12, 2026
What Is the Drug Identified by NDC 27241-0031?
NDC 27241-0031 corresponds to Balversa (erdafitinib), developed by Janssen Pharmaceuticals. It is an oral tyrosine kinase inhibitor approved by the FDA in April 2019 for the treatment of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations.
Market Overview
Therapy Area and Competitive Landscape
Urothelial carcinoma represents approximately 5% of all cancers globally, with an estimated 570,000 cases diagnosed annually[1]. FGFR alterations are present in about 15-20% of metastatic urothelial carcinoma (mUC) cases[2].
Balversa targets FGFR mutations, positioning it uniquely among bladder cancer treatments. Key competitors include:
- Erdafitinib (Balversa): First FDA-approved FGFR inhibitor for bladder cancer.
- Infigratinib: Investigational FGFR inhibitor.
- Rogaratinib: Under development for similar indications.
Market Drivers
- Increasing diagnosis rates: Rising incidence of bladder cancer, particularly among aging populations.
- Genetic testing adoption: Growing use of molecular profiling to identify FGFR alterations.
- Unmet need: Limited options after chemotherapy, which triggers high demand for targeted therapies.
Market Challenges
- Pricing pressures: Negotiations with payers pressure list price sustainability.
- Regulatory and reimbursement: New indications may face slow approval processes; insurance coverage varies.
- Competitive pipeline: Other FGFR inhibitors in development could impact market share.
Price Analysis
Current Pricing Framework
As of 2023, the average wholesale price (AWP) for erdafitinib is approximately $16,500 per month per patient, based on federal drug pricing sources[3]. The list price is comparable to other targeted oral oncology therapies approved for similar indications.
Cost Structure and Payer Dynamics
- Gross price: $16,500/month.
- Average treatment duration: 6 to 12 months.
- Reimbursement rates: Vary; fib wages and insurance policies influence reimbursement.
Pricing Trends and Potential Adjustments
- Price stabilization: Over the past three years, prices have remained stable, with minor reductions related to discounts and rebates.
- Post-approval pricing strategies: Market entry pricing often aims at recouping R&D investments, then may see reductions with increased competition or biosimilar entries.
Market Size and Revenue Projections
Estimated Patient Population
- Treatment-eligible patients: Approximately 85,000 in the U.S. with advanced bladder cancer; 15-20% harbor FGFR alterations, equating to roughly 13,000 to 17,000 patients annually.
- Market penetration: Assuming 25-50% of eligible patients receive erdafitinib, the target population is around 3,250 to 8,500 patients per year.
Revenue projections (2023-2027)
| Year |
Assumed Patients (Low) |
Assumed Patients (High) |
Average Monthly Price |
Estimated Revenue Range |
| 2023 |
3,250 |
8,500 |
$16,500 |
$655M - $1.7B |
| 2024 |
4,100 |
9,200 |
$16,500 |
$810M - $1.8B |
| 2025 |
4,800 |
10,200 |
$16,500 |
$960M - $2.0B |
| 2026 |
5,400 |
11,000 |
$16,500 |
$1.0B - $2.2B |
| 2027 |
6,000 |
12,000 |
$16,500 |
$1.2B - $2.4B |
These projections assume steady market growth, adoption, and no significant price reductions or entry of biosimilars.
Regulatory and Policy Impacts
- Anticipated expansions of approved indications could expand the market.
- Price regulations and negotiations may influence final net revenues.
- Potential for pricing adjustments in response to biosimilar development and payer discount pressures.
Key Takeaways
- NDC 27241-0031 (erdafitinib) operates in a niche but expanding segment within bladder cancer therapy.
- Estimated U.S. market size is between 3,250 to 12,000 treated patients annually.
- Current list price approximates $16,500 per month.
- Revenue projections suggest a market potential approaching $2.4 billion by 2027 under optimistic assumptions.
FAQs
-
What are the main competitors to erdafitinib?
In the U.S., infigratinib and rogaratinib are the main contenders, with other investigational FGFR inhibitors in pipeline.
-
How does FGFR testing influence erdafitinib prescribing?
Molecular testing for FGFR alterations is essential; only patients with identified mutations are eligible.
-
What are typical treatment durations?
Treatment generally lasts 6 to 12 months, depending on response and tolerability.
-
Are there upcoming regulatory changes that could affect pricing?
Payer negotiations, value-based pricing policies, and potential biosimilar competition could influence prices.
-
What is the potential for international market expansion?
Europe and Asia present growing markets, with regulatory pathways differing; approvals are ongoing or pending.
References
[1] Cancer Research UK. (2022). Bladder cancer incidence statistics. https://www.cancerresearchuk.org
[2] Nassar, P. K., et al. (2018). FGFR alterations in bladder cancer: biology and targeted therapy. Nature Reviews Urology, 15(8), 441-454.
[3] GoodRx. (2023). Price of erdafitinib. https://www.goodrx.com
Note: Prices and market projections are approximate and subject to change depending on regulatory decisions, market competition, and healthcare policies.
