Last updated: February 14, 2026
What Is the Market Outlook for NDC 82260-0508?
NDC 82260-0508 corresponds to Tisotumab vedotin-tftv, an antibody-drug conjugate (ADC) approved by the FDA for cervical cancer. The drug was approved in September 2021 for adult patients with recurrent or metastatic cervical cancer that progressed after chemotherapy. Its market potential depends on its clinical position, competition, and regulatory landscapes.
Market Size and Demand Drivers
Current Incidence and Market Penetration
- The incidence of cervical cancer in the U.S. stood at approximately 14,100 new cases in 2023, with an estimated 4,280 deaths.[1]
- Recurrent or metastatic cases represent around 40-50% of diagnosed patients, translating into roughly 6,000-7,000 eligible patients annually.
- The initial uptake of Tisotumab vedotin is expected to be approximately 15-25% of this population within two years, assuming a competitive landscape similar to other ADCs.
Growth Opportunities
- The global cervical cancer therapeutics market was valued at approximately USD 1.1 billion in 2022 and is projected to expand at a CAGR of 7% through 2030.[2]
- Market expansion factors include increased awareness, broader acceptance of immuno-oncology combinations, and expanding indications, such as earlier lines of therapy or other tumor types.
Competition and Market Share
Key Competitors
- Bevacizumab (Avastin) combined with chemotherapy.
- Pembrolizumab (Keytruda) for PD-L1 positive tumors.
- Other ADCs and targeted therapies in late-stage development.
Differentiation
- Tisotumab vedotin's approval in cervical cancer provides it with a first indication advantage.
- Its side-effect profile (e.g., reversible conjunctivitis, neutropenia) influences outpatient use and patient compliance.
- Clinical trials have also explored combining Tisotumab with other agents, potentially broadening its use.
Price Projections
Current Pricing Strategy
- List price for Tisotumab vedotin has been established at approximately USD 17,000 per vial.[3]
- The typical treatment regimen involves administering multiple doses (e.g., every 3 weeks), with an average patient cycle count ranging from 4 to 6 doses.
Revenue Calculations
| Parameter |
Estimate |
| Price per vial |
USD 17,000 |
| Doses per patient |
4–6 |
| Patients treated per year (initial) |
900–1,750 (assumed 15-25% of eligible) |
| Total annual revenue |
USD 61–177 million (initial projection) |
Price Trajectory
- Price reductions of 10-15% are likely in the next 2-3 years due to payer negotiations and market entry of biosimilars or generics.
- Higher pricing is sustainable only if clinical benefits significantly outperform competitor therapies.
Key Regulatory and Policy Factors
- Price regulations may impact U.S. and international markets, particularly in countries with cost-effectiveness thresholds.
- Payer reimbursement policies influence access and utilization, impacting revenue projections.
Summary of Price and Market Projections
- Initial U.S. annual sales are estimated between USD 60 million to USD 180 million.
- Early adoption will depend on clinical positioning, pricing strategies, and competitive dynamics.
- Long-term growth hinges on expanded indications, combination regimens, and global market penetration.
Key Takeaways
- NDC 82260-0508, Tisotumab vedotin, has a niche in recurrent/metastatic cervical cancer with limited competition.
- The U.S. market could generate USD 60–180 million in initial annual revenue.
- Pricing is approximately USD 17,000 per vial, with expected moderate discounts as uptake accelerates.
- Market opportunities expand with clinical trials for earlier lines of therapy and broader indications.
- Regulatory and payer landscapes will influence long-term market share and pricing strategies.
FAQs
1. What is the primary indication for NDC 82260-0508?
Recurrent or metastatic cervical cancer post-chemotherapy failure.
2. How many patients are eligible for this drug in the U.S.?
Approximately 6,000–7,000 annually, based on incidence and disease progression rates.
3. What is the expected price per treatment course?
Between USD 68,000 to USD 102,000, assuming 4–6 doses at USD 17,000 each.
4. Who are the main competitors for this drug?
Bevacizumab in combination with chemotherapy and pembrolizumab in PD-L1 positive cases.
5. What factors could influence the market growth for this drug?
Clinical efficacy, regulatory support, pricing negotiations, expansion of indications, and adoption of combination therapies.
References
[1] American Cancer Society. Cancer statistics, 2023.
[2] Grand View Research. Cervical Cancer Therapeutics Market Size, 2022.
[3] Manufacturer pricing data, 2023.
