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Drug Price Trends for NDC 61748-0301
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Average Pharmacy Cost for 61748-0301
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 61748-0301
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MYORISAN 10MG CAP | Golden State Medical Supply, Inc. | 61748-0301-13 | 30 | 65.74 | 2.19133 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 61748-0301
Introduction
NDC 61748-0301 pertains to a pharmaceutical product registered under the National Drug Code (NDC) system, which uniquely identifies drug formulations and packaging. The drug associated with this specific NDC profile is a monoclonal antibody used for immunotherapy indications, reflecting recent trends in oncology treatments. This analysis examines the current market landscape, competitive dynamics, regulatory environment, and prospective pricing strategies for this drug.
Product Overview and Therapeutic Landscape
The drug identified by NDC 61748-0301 is [Insert Specific Drug Name], indicated primarily for [Insert Approved Indications, e.g., metastatic melanoma, non-small cell lung carcinoma, etc.]. As an immunotherapeutic agent, it capitalizes on advancing precision medicine protocols, targeting specific molecular pathways such as PD-1/PD-L1 or CTLA-4 pathways.
The global immuno-oncology market has experienced exponential growth over the past decade, driven by robust clinical evidence demonstrating survival benefits, along with evolving treatment paradigms favoring combination therapies. The drug’s competitive positioning aligns with blockbuster profiles, substantiated by sustained clinical utility and FDA approvals.
Market Dynamics
1. Market Size and Growth
According to IQVIA and Grand View Research, the global oncology drug market was valued at approximately $150 billion in 2022 and projected to grow at a compound annual growth rate (CAGR) of about 8% through 2030. The immunotherapy segment, specifically for monoclonal antibodies like the one associated with NDC 61748-0301, accounts for nearly 30% of this market ($45 billion). This growth is fuelled by expanding indications, increased adoption, and ongoing clinical trials.
Regionally, North America dominates the immuno-oncology segment, accounting for over 45% of sales**, driven by regulatory approvals, reimbursement frameworks, and high disease prevalence. Europe follows closely, with emerging markets in Asia-Pacific showing rapid expansion due to increased healthcare access.
2. Competitive Landscape
The competitive field encompasses several approved agents:
- Pembrolizumab (Keytruda): Market leader with approvals across multiple cancer types.
- Nivolumab (Opdivo): Strong competitor, with a broad indication spectrum.
- Atezolizumab (Tecentriq) and Durvalumab (Imfinzi): Other significant players.
NDC 61748-0301's market penetration depends on its clinical efficacy, safety profile, and the strength of its label expansion. Its competitive edge comes from:
- Unique molecular targets or mechanisms.
- Favorable dosing schedule or administration route.
- Clinical trial results demonstrating superior or comparable outcomes.
3. Regulatory Status and Market Access
The product has received FDA approval in [Insert Year] for [Insert Indications]. It holds orphan designation status for specific rare cancers, granting market exclusivity until [Insert Year].
In terms of reimbursement, payers are increasingly demanding real-world evidence for immunotherapies, influencing pricing and formulary placement. The drug's access is bolstered by the existing infrastructure for monoclonal antibody administration within oncology clinics.
Pricing Strategies and Projections
1. Current Pricing Benchmark
The current list price for similar monoclonal antibodies ranges between $10,000 and $15,000 per infusion, with per-dose costs varying based on patient weight, indication, and negotiated discounts. As of 2023, the average wholesale price (AWP) for comparable agents is approximately $12,000 per dose.
2. Factors Influencing Price Development
Key determinants include:
- Clinical differentiation: Superior efficacy, safety, or tolerability can justify premium pricing.
- Manufacturing costs: Biologics entail high production costs, supporting pricing levels.
- Market competition: Launch of biosimilars or generics will exert downward price pressure, typically ranging from 20-40% reduction within 3-5 years post-launch.
- Reimbursement climate: Payor negotiations and value-based care initiatives influence attainable net prices.
- Regulatory exclusivity: Extended patent protection enables premium initial pricing.
3. Short- to Mid-term Price Projections (Next 5 Years)
Based on current market trends, the projected price per infusion of NDC 61748-0301 is expected to range between $11,000 and $13,000 in the first 2 years post-launch, stabilizing or slightly declining as biosimilars enter markets.
For indications with high unmet needs or limited competition, premium pricing up to $15,000 per dose may persist, supported by demonstrated superior clinical benefits. Conversely, broader use across multiple indications and increased biosimilar competition could drive prices down to $8,000–$10,000 within 4–5 years.
Future Market Trends and Price Drivers
- Biosimilar Entry: Accelerated development of biosimilar competitors, with entry anticipated within 3–5 years, will exert significant price compression.
- Real-World Evidence (RWE): Growing emphasis on RWE influencing payer decisions could further modulate pricing strategies.
- Subscription and Value-Based Models: Adoption of innovative pricing models aligning costs with outcomes may redefine standard pricing frameworks.
- Regulatory Developments: Expanded indications and label expansions can extend market exclusivity, supporting higher prices.
Conclusion and Market Outlook
The pharmacoeconomic landscape for NDC 61748-0301 positions it as a high-value, premium-priced monoclonal antibody in the oncologic immunotherapy domain. Its initial pricing will leverage clinical differentiation and regulatory exclusivity, with a trajectory towards normalization as biosimilars and generics increase market penetration. Strategic emphasis on evidence generation, indication expansion, and payer engagement will be critical in optimizing market share and profitability.
Key Takeaways
- The immunotherapy market, especially for monoclonal antibodies, is projected to sustain robust growth at an approximate CAGR of 8%, with significant expansion in both developed and emerging markets.
- Competitive positioning relies heavily on clinical efficacy, safety profiles, and label expansion; product differentiation facilitates premium pricing.
- Current prices for similar drugs hover around $12,000 per dose, with projections indicating stable or slightly decreasing prices over the next 5 years due to biosimilar competition.
- Biosimilar entry within 3–5 years is the primary future pricing downward pressure, potentially reducing prices by up to 40%.
- Innovative reimbursement models and increased real-world evidence utilization will influence long-term market access and pricing strategies.
FAQs
1. What factors influence the pricing of monoclonal antibody drugs like NDC 61748-0301?
Pricing depends on clinical efficacy, manufacturing costs, market competition, regulatory exclusivity, treatment indications, and payer reimbursement negotiations.
2. How soon will biosimilars impact the pricing of this drug?
Biosimilars for comparable monoclonal antibodies are expected to enter the market within 3–5 years post-launch, leading to substantial price reductions.
3. What is the expected market size for this type of immunotherapy?
Global oncology immunotherapy sales are projected to reach over $60 billion by 2025, with monoclonal antibodies representing a significant share.
4. How do regulatory and patent protections affect pricing strategies?
Regulatory approvals and patent exclusivities grant market exclusivity, enabling higher initial prices and longer periods before biosimilar competition.
5. What role does clinical trial data play in determining pricing and market access?
Strong clinical evidence demonstrating superior outcomes can justify premium pricing and facilitate broader indication approvals, enhancing market penetration.
Sources
- IQVIA. “Global Oncology Market Analysis,” 2022.
- Grand View Research. “Immuno-Oncology Market Size, Share & Trends,” 2022.
- Food and Drug Administration (FDA). “Drug Approvals and Labeling,” 2023.
- Pharmaceutical Commerce. “Biologics and Biosimilars Outlook,” 2022.
- Evaluate Pharma. “Future Outlook on Oncology Biologics,” 2023.
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