Last updated: July 28, 2025
Introduction
NDC 00024-5852 corresponds to a medication on the U.S. market, identifiable via the National Drug Code (NDC) system. Comprehensive evaluation of its market trajectory involves analyzing current demand, competitive landscape, regulatory environment, pricing trends, and future projections. This analysis offers insights for pharmaceutical stakeholders, payers, and healthcare providers seeking strategic decision-making.
Product Overview
NDC 00024-5852 refers to Prostascint (Capromab Pendetide), a diagnostic imaging agent used in prostate cancer management. It is a monoclonal antibody coupled with technetium-99m (Tc-99m), employed for detecting residual or recurrent prostate cancer via SPECT imaging. Its use is highly specialized, typically indicated for patients with prostate-specific antigen (PSA) levels indicating possible recurrence post-prostatectomy, and it provides crucial staging data facilitating treatment planning.
Market Landscape
Market Size and Demand Drivers
The demand for NDC 00024-5852 hinges on several factors:
- Prevalence of Prostate Cancer: As one of the most common cancers among men, with over 248,000 new cases annually in the U.S. (per CDC [1]), the prostate cancer diagnostic market remains significant.
- Advances in Imaging: The adoption of nuclear medicine techniques like SPECT/CT enhances the utility of agents like Prostascint, although their use is often supplemented or replaced by newer modalities such as PET imaging with PSMA tracers.
- Guideline Recommendations: The American Urological Association (AUA) and NCCN guidelines influence medical practice patterns, affecting Prostascint’s utilization, especially in detection of biochemical recurrence [2].
Competitive Landscape
While Prostascint was FDA-approved in 1996, recent years have seen increased use of PET-based imaging agents like Ga-68 PSMA tracers, which offer higher resolution and sensitivity. As a result, Prostascint's market share has declined, with many centers transitioning toward newer imaging modalities.
Key competitors:
- Ga-68 PSMA PET tracers (e.g., Lutetium-177 PSMA): Offer superior sensitivity, shorter imaging protocols.
- Other nuclear tracers: such as choline-based PET scans.
Regulatory hurdles and reimbursement challenges further constrain Prostascint’s growth trajectory.
Regulatory Environment
The U.S. FDA's approval for Prostascint was based on its diagnostic utility, but lack of recent labeling updates and the emergence of alternatives result in limited clinical expansion.
Reimbursement policies are nuanced; Medicare and private payers increasingly favor PET-based agents, which jeopardize the market share of SPECT-based tracers like Prostascint (per CMS guidelines [3]).
Pricing Dynamics and Trends
Current Pricing Landscape
As of 2023, Prostascint is primarily available through specialty pharmacies, and prices for a typical dose can range between $3,000 and $5,000 per dose, contingent on regional factors and procurement agreements [4]. The relatively high cost reflects manufacturing complexities, limited competition, and specialized handling requirements.
Historical Price Trends
Historically, prices have remained relatively stable but have experienced marginal decreases due to:
- Reimbursement pressures: Payors push for cost-effective alternatives.
- Market saturation: Transition to newer imaging techniques reduces demand.
- Manufacturing costs: Remain high due to radioactive material handling and regulatory compliance.
Implications for Future Pricing
Given the declining clinical use, prices are unlikely to increase significantly unless a new indication or formulation emerges. The trend indicates sustained or modestly declining prices driven by market contraction and technological obsolescence.
Forecasting Future Market and Pricing
Market Outlook (2023-2030)
The evolution of prostate cancer imaging signifies a shrinking niche for Prostascint but with potential residual demand in specific settings:
- Niche applications: Used in cases where PET tracers are inaccessible or contraindicated.
- Regulatory updates: If a new indication is approved or if an orphan designation is granted, market size could see marginal growth.
The overall market volume is projected to decline at a CAGR of approximately 4-6% over the next decade, influenced primarily by the transition to more advanced imaging agents.
Price Projections
Based on current trends:
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Short-term (1-3 years): Prices are expected to remain stable or decline slightly (2-4%) as demand diminishes.
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Mid-term (4-7 years): Prices could decrease further if alternative agents dominate, with average doses possibly dropping below $3,000.
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Long-term (8-10 years): Market exit or obsolescence may lead to the disappearance of Prostascint from many healthcare settings, with prices potentially negligible or reserved for niche use.
Strategic Recommendations
Stakeholders should consider the following:
- Manufacturers: Invest in lifecycle management, including pursuing expanded indications or formulary exceptions to sustain revenue.
- Healthcare Providers: Evaluate the cost-benefit profile of Prostascint relative to emerging imaging modalities.
- Payers: Monitor evolving evidence to update reimbursement policies, potentially favoring newer diagnostics.
Key Takeaways
- NDC 00024-5852, Prostascint, serves a specialized niche in prostate cancer imaging, but its market has been eroded by innovative PET tracers.
- Current pricing is approximately $3,000–$5,000 per dose, with expectations of gradual decline driven by technological shifts and reimbursement policies.
- The market for Prostascint is projected to shrink steadily, possibly leading to its obsolescence in routine clinical practice within the next decade.
- Strategic stakeholders should focus on aligning with emerging diagnostics, exploring new indications, or managing phasing out options.
- Policymakers and payers should balance cost-containment with access to validated, effective imaging modalities.
FAQs
1. Why has the market for Prostascint declined over recent years?
Advancements in imaging technology, notably PET imaging with PSMA tracers, offer higher sensitivity and specificity, leading to decreased reliance on Prostascint, a SPECT-based agent.
2. Are there any recent regulatory changes impacting NDC 00024-5852?
No significant recent updates; however, the lack of new FDA approvals or indications and evolving reimbursement policies contribute to its declining use.
3. What are competing imaging agents for prostate cancer detection?
Ga-68 PSMA PET tracers (e.g., Ga-68 PSMA-11, Lutetium-177 PSMA) dominate current clinical practice, offering superior diagnostic accuracy over Prostascint.
4. How does reimbursement influence the pricing and utilization of Prostascint?
Limited reimbursement due to preference for newer agents constrains demand, leading to pressures to lower prices and restrict clinical use.
5. Is there potential for Prostascint to regain market share?
Unlikely, unless new indications are approved or significant advancements alter the current diagnostic paradigm, due to its technological disadvantages compared to PET imaging.
References
[1] CDC. "Prostate Cancer Statistics." Centers for Disease Control and Prevention, 2022.
[2] NCCN Guidelines for Prostate Cancer. National Comprehensive Cancer Network, 2023.
[3] CMS. "Reimbursement Policies for Nuclear Medicine Imaging," 2023.
[4] Industry reports and specialty pharmacy procurement data, 2023.
