Last updated: February 24, 2026
What is NDC 29300-0131?
NDC 29300-0131 references a specific drug product listed in the National Drug Code database. It corresponds to Balversa (erdafitinib), a kinase inhibitor indicated for metastatic or locally advanced urinary bladder cancer with FGFR genetic alterations. Approved by the FDA in June 2019, Balversa addresses a niche high-impact oncology market.
Market Size and Demand Dynamics
Epidemiology
- Urothelial carcinoma (bladder cancer) affects approximately 81,400 new patients annually in the United States.
- FGFR alterations are identified in approximately 15-20% of bladder cancer cases, equating to roughly 12,000–16,000 potential qualifying patients per year.
- The subset of patients suitable for Balversa remains smaller, due to eligibility, prior treatment history, and molecular testing requirements.
Competitive Landscape
- Prior to Balversa, treatment options for FGFR-altered bladder cancer were limited, mainly comprising chemotherapy, immunotherapy, and targeted agents like erdafitinib entered newcomer to fill an underserved segment.
- Other FGFR inhibitors (e.g., AZD4547, in clinical development) have not gained approval, consolidating Balversa's market position.
Sales and Adoption Trends
- Initial launch in mid-2019 saw modest sales driven by early adoption, with significant growth forecasted through 2024.
- The market faces challenges from biomarker testing delays, payer coverage, and clinician familiarity.
Pricing and Reimbursement
Current Pricing
- The wholesale acquisition cost (WAC) for Balversa is approximately $14,000 per month.
- The average annual wholesale price approximates $168,000, based on a typical treatment duration of 12 months.
Reimbursement Policies
- Coverage generally aligns with FDA approval indications.
- Payer restrictions include prior authorization and molecular testing proof.
- Commercial insurers tend to reimburse at negotiated rates, often 10-25% discounted from WAC.
| Pricing Parameter |
Estimated Value |
| WAC per month |
$14,000 |
| Typical annual cost |
$168,000 |
| Negotiated rebate |
10-25% |
| Out-of-pocket for patients |
Varies by insurance plan, estimated $50-$300 per month |
Comparison With Similar Agents
| Agent |
Typical Price (per year) |
Market Position |
| Erdafitinib (Balversa) |
$168,000 |
First FDA-approved FGFR inhibitor in bladder cancer |
| Pemirogenev (if applicable) |
Varies |
In development, potential competitor |
Future Projections and Market Growth
Factors Influencing Future Growth
- Market penetration: Expected to increase as molecular testing becomes routine pre-treatment.
- Pricing adjustments: Potential for discounts and pay-for-performance agreements.
- Additional indications: Ongoing studies might expand the label, opening markets in other FGFR-driven cancers (e.g., cholangiocarcinoma).
- Biomarker testing reimbursement: Critical for expanding eligible patient pool.
Sales Forecast (2023–2027)
| Year |
Estimated U.S. Sales |
Comments |
| 2023 |
$200 million |
Growth driven by increased testing and adoption |
| 2024 |
$300 million |
Market penetration deepens |
| 2025 |
$400 million |
Additional approvals or expanded indications |
| 2026 |
$500 million |
Market stabilization, price negotiations |
| 2027 |
$600 million |
Potential new markets or competitors emerge |
Risks to Projections
- Slow adoption due to testing delays or payer restrictions.
- Competitive pressure if other FGFR inhibitors are approved.
- Patent or regulatory challenges impacting market exclusivity.
Key Takeaways
- NDC 29300-0131 (Balversa) is a targeted therapy with a niche but growing market.
- Current pricing aligns with other precision oncology agents, priced at approximately $168,000 annually.
- Market value is driven by increased molecular testing, expanded indications, and payer coverage.
- Sales are projected to grow at a compounded annual rate of roughly 20-25% through 2027.
- Market entry barriers remain, chiefly related to testing infrastructure and reimbursement schemes.
FAQs
1. How does the pricing of Balversa compare to other targeted cancer therapies?
Balversa’s annual cost of approximately $168,000 aligns with similar kinase inhibitors and targeted agents such as Keytruda or Tagrisso, which range from $150,000 to $200,000 annually.
2. What factors could cause market growth to accelerate or slow?
Faster growth depends on routine biomarker testing adoption and expanded approvals. Delays in testing infrastructure or restrictive payer policies could slow growth.
3. Are there any existing or upcoming patent protections for Balversa?
Eli Lilly’s patent portfolio for Erdafitinib extends into the mid-2030s, supporting market exclusivity. Patent challenges could impact long-term pricing.
4. How do payer policies influence drug marketability?
Payor reimbursement depends on FDA approval, molecular testing confirmation, and prior authorization. Denials or delays can limit sales expansion.
5. What additional indications could influence Balversa’s future market?
Research ongoing in cholangiocarcinoma and other FGFR-driven tumors could potentially expand the addressable market, pending successful trials and approval.
References
- U.S. Food and Drug Administration. (2019). FDA approves erdafitinib for urothelial carcinoma. [Link]
- IQVIA. (2022). Oncology market trend reports. [Link]
- Eli Lilly and Company. (2019). Balversa (erdafitinib) prescribing information. [Link]
- Centers for Disease Control and Prevention. (2021). Cancer statistics. [Link]
- Milliman. (2022). Oncology drug pricing analysis. [Link]
