Last updated: February 23, 2026
What is the Drug Associated with NDC 76282-0214?
NDC 76282-0214 corresponds to Sipuleucel-T (Provenge), an autologous cellular immunotherapy approved for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). It was approved by the FDA in April 2010[1].
Market Size and Patient Demographics
Target Population
- Patients with metastatic castration-resistant prostate cancer (mCRPC).
- Estimated U.S. patient population: approximately 50,000 annually[2].
- Market penetration remains limited due to logistical challenges related to manufacturing and administration.
Current Market Penetration
- Estimated adoption: 25% of eligible patients.
- Currently, about 12,500 patients receive the therapy annually[3].
Market Drivers
- Growing awareness of immunotherapies.
- Increasing incidence of prostate cancer, with over 164,000 new cases diagnosed in the U.S. in 2020[4].
- Reimbursement policies expanding access.
Market Constraints
- High manufacturing costs due to personalized production.
- Complex logistics and administration process.
- Competition from newer agents and emerging immunotherapies.
Competitive Landscape
Key Competitors
- Immunotherapies: Pembrolizumab (Keytruda) for MSI-high tumors, improving in prostate cancer and potentially affecting the market.
- Hormonal and Chemotherapy Agents: Enzalutamide, Abiraterone.
- Emerging Therapeutics: Other vaccine-based and cellular therapies entering the pipeline.
Market Share
- Provenge holds an estimated 15-20% share within the targeted mCRPC immunotherapy segment.
Price Projections and Revenue Estimates
Current Pricing
- List Price: Approximately $93,000 per treatment course (based on initial approval pricing)[5].
- Price adjustments over time have been modest, reflecting manufacturing costs and reimbursement negotiations.
Revenue Projections (Next 5 Years)
| Year |
Estimated Patients Treated |
Revenue (USD billions) |
Assumptions |
| 2023 |
12,500 |
1.16 |
No significant product price change, steady penetration |
| 2024 |
13,750 |
1.27 |
Slight increase in patient numbers, stable pricing |
| 2025 |
15,000 |
1.39 |
Growth in adoption rate, no major price increases |
| 2026 |
16,500 |
1.53 |
Market expansion, continued stable pricing |
| 2027 |
18,000 |
1.66 |
Increased access, competitive pressures limit price growth |
Note: These projections assume no major shifts in manufacturing costs or reimbursement policies.
Price Sensitivity Factors
- Potential for price reductions due to payer negotiations.
- Introduction of biosimilars or interchangeable products could further pressure pricing.
- Expanded indications or combination therapies might raise price points.
Policy and Regulatory Impact
Reimbursement Policies
- Medicare and private insurers reimburse at rates aligned with importance and cost.
- CMS covers Provenge under Part B, influencing pricing strategies and access[6].
Regulatory Developments
- No current FDA plans to modify the approved indication.
- Future approvals for combination therapy could expand market size.
Risks and Opportunities
Risks
- Competition from emerging immunotherapies and personalized medicine.
- Manufacturing complexities limiting supply expansion.
- Potential pricing pressures from payers and healthcare providers.
Opportunities
- Expansion into other indications or earlier treatment lines.
- Development of biosimilars or cost-reduction strategies.
- Integration into combination regimens with other prostate cancer therapies.
Key Takeaways
- The prostate cancer immunotherapy market is limited but stable, with Provenge holding a significant niche.
- Current price point around $93,000 per treatment course remains stable, constrained by manufacturing costs and reimbursement negotiations.
- Market growth depends on increased adoption, new indications, and logistical efficiencies.
- Competition and regulatory developments could impact future pricing and market share.
- Revenue estimates project growth aligned with increased patient access and steady market penetration.
FAQs
1. Will the price of Provenge decrease in the next few years?
Potentially. Price reductions may occur due to payer negotiations and emerging biosimilars.
2. Are there any new approvals for Provenge?
No recent FDA approvals; future expansion depends on ongoing trials and regulatory reviews.
3. What factors could significantly affect Provenge's market?
Emergence of competing therapies, improvements in manufacturing, and changes in reimbursement policies.
4. How does Provenge compare cost-wise to other prostate cancer treatments?
It remains one of the most expensive, with treatment costs averaging over $90,000 per course.
5. Is Provenge likely to expand into other indications?
Possible, but no current approvals are under review for other cancers or indications.
References
[1] U.S. Food and Drug Administration (2010). FDA approves Provenge to treat certain forms of prostate cancer.
[2] American Cancer Society. Prostate cancer facts & figures 2020.
[3] Industry reports, IQVIA, 2022.
[4] Siegel, R. L., Miller, K. D., & Jemal, A. (2020). Cancer statistics, 2020. CA: A Cancer Journal for Clinicians.
[5] Manufacturer pricing data, 2022.
[6] CMS. Medicare coverage of prostate cancer immunotherapies.
