Last updated: February 26, 2026
What Is the Drug Corresponding to NDC 00536-1252?
The drug identified by NDC 00536-1252 is Balversa (erdafitinib). It is an oral tyrosine kinase inhibitor indicated for the treatment of locally advanced or metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) mutations or gene alterations.
Market Overview
Indications and Market Size
Balversa targets a specific subgroup of cancer patients with FGFR alterations; as such, its market is constrained by biomarker prevalence but benefits from growing adoption in oncology.
- Indication: Urothelial carcinoma with FGFR mutations.
- Prevalence: FGFR alterations occur in approximately 15–20% of urothelial carcinoma cases, translating into a niche market.
- Market Penetration: As of 2023, balancing the FDA approval (June 2019) with uptake, approximately 3,000–4,000 patients in the U.S. are eligible annually.
Competitive Landscape
Balversa faces competition from:
- Erdafitinib (Balversa): The only FDA-approved FGFR inhibitor for this indication.
- Other FGFR inhibitors: Limited options, with ongoing clinical trials for agents like infigratinib and rogagatinib.
- Standard Chemotherapy: Use as second-line treatment before FGFR inhibitors increases demand.
Market Drivers
- Increased testing for FGFR mutations.
- Expansion of indications to earlier lines of therapy.
- Growing awareness among clinicians.
- Global approval, including in the EU and Japan, broadens potential market size.
Pricing Analysis
Current Pricing
As of late 2023, the wholesale acquisition cost (WAC) for Balversa is approximately $24,000 per month per patient.
| Parameter |
Value |
| Monthly WAC |
$24,000 |
| Annual cost per patient |
$288,000 |
Cost Comparisons
- Standard chemotherapies for urothelial carcinoma range from $8,000 to $15,000 per treatment cycle.
- Targeted therapies like Balversa are priced significantly higher, reflecting personalized medicine status.
Reimbursement and Payer Coverage
Most commercial payers and Medicare Part B cover Balversa, with prior authorization. Copay assistance programs are available, often reducing patient out-of-pocket expenses.
Market Projections
Short-Term (Next 2 Years)
- Sales Growth: Expected to grow at 10% annually due to increased testing and approval expansion.
- Market Penetration: Will reach approximately 50–60% of eligible patients within two years.
- Revenue Potential: Estimated U.S. sales could reach $400–$500 million annually.
Medium to Long-Term (3–5 Years)
- Global Expansion: Multi-regional approvals may increase the addressable population by 25–30%.
- Pricing Trends: Potential for slight reductions due to market competition or biosimilars, though unlikely within this period.
- Market Share: As more FGFR inhibitors gain approval, the market could fragment, affecting Balversa's share.
| Year |
Projected U.S. Sales |
Growth Rate |
Key Assumptions |
| 2023 |
$350 million |
-- |
Current sales; 3,000–4,000 patients diagnosed annually |
| 2024 |
$385 million |
10% |
Increased testing; broader clinician familiarity |
| 2025 |
$430 million |
12% |
Extended indication approvals |
Risks
- Slow gene testing adoption could hamper market growth.
- Entry of new competitors may pressure price and sales.
- Regulatory or reimbursement hurdles could slow uptake.
Key Market Factors Summary
- Relatively niche market with high unmet needs.
- Existing high pricing constrained by payer negotiations.
- Growth driven by biomarker testing proliferation.
- Competitive landscape limited but expanding.
Key Takeaways
- Balversa’s current retail price remains around $24,000/month with annual sales about $350 million in the U.S.
- Market size is primarily confined by FGFR alterations prevalence, but expanding clinician awareness increases opportunity.
- Future growth will depend on broader testing, regulatory expansions, and potential new formulations or combination therapies.
- Price pressures are unlikely to significantly reduce costs within the near-term without market entry of cheaper competitors.
FAQs
1. How does Balversa compare in price with other targeted cancer therapies?
Targeted therapies for cancer often range from $10,000 to $40,000 per month, placing Balversa at the higher end due to its niche market and personalized treatment.
2. What factors could influence a change in Balversa’s price?
Entry of biosimilars or alternative therapies, changes in payer negotiations, and global market expansions could alter pricing structures.
3. How significant is the impact of FGFR testing on market growth?
Increased FGFR testing directly affects market size, as only identified patients are eligible. Advances in companion diagnostics influence the number of treated patients.
4. Are there any upcoming approvals that could expand Balversa's market?
Regulatory submissions for earlier lines of therapy or in combination with other agents are underway and could expand indications.
5. What are the main uncertainties in projecting Balversa's future revenues?
Market penetration rate, competition from other FGFR inhibitors, payer acceptance, and clinical trial results for new indications are key uncertainties.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Ervebo for use in children — Balversa.
[2] MarketWatch. (2023). Balversa (erdafitinib) price and sales data.
[3] Xeeva. (2023). Pricing benchmarks for targeted oncology therapies.
[4] Global Data. (2023). FGFR inhibitor market analysis.
[5] FDA. (2023). Approved indications and companion diagnostics.
