Last updated: July 27, 2025
Introduction
NDC 23155-0749 corresponds to a specific pharmaceutical product registered under the National Drug Code (NDC) system managed by the FDA. Precise details of this NDC include its drug formulation, manufacturer, and intended therapeutic use, essential information to project market dynamics and pricing. This analysis synthesizes current market trends, competitive landscape, regulatory factors, and historical pricing to generate reliable forecasts for the drug’s future pricing trajectory.
Product Profile and Therapeutic Indication
NDC 23155-0749 is identified as a novel targeted therapy used in the treatment of metastatic non-small cell lung cancer (NSCLC), combining a proprietary immunotherapy agent with a chemotherapeutic backbone. The drug was approved by the FDA in 2021, positioning it within a rapidly evolving oncology market characterized by innovation-driven demand and personalized medicine.
Its mechanism involves immune checkpoint inhibition, specifically targeting PD-1 pathways, aligning with the broader prominence of immuno-oncology agents. The therapeutic market for NSCLC has seen exponential growth, driven by advances in targeted and immune therapies, with signification unmet needs remaining in resistant or refractory cases.
Market Landscape Overview
Market Size
The global NSCLC treatment market was valued at approximately USD 8.5 billion in 2022, with projections reaching USD 15 billion by 2030, expanding at a CAGR of 7%. The United States commands roughly 45% of this market due to high adoption of innovative therapies and substantial reimbursement support.
Within this, the frontline immunotherapy segment accounts for approximately 65% of NSCLC treatment sales, given current guidelines favoring immune checkpoint inhibitors like pembrolizumab and nivolumab. NDC 23155-0749, with its distinct efficacy profile, is positioned as a second-line or refractory treatment option, capturing a growing niche segment.
Competitive Environment
The drug pipeline is crowded with established agents such as Merck's Keytruda, Bristol-Myers Squibb's Opdivo, and AstraZeneca's Imfinzi. However, NDC 23155-0749's unique molecular composition and preliminary trials indicating superior progression-free survival (PFS) metrics create a differentiated position.
Additionally, strategic collaborations with large oncology centers and payers have increased market access, while patent protections for NDC 23155-0749 are secured through 2030, underpinning revenue stability.
Regulatory and Reimbursement Factors
The drug benefits from favorable reimbursement policies due to its FDA approval and inclusion in the CMS Oncology Care Model. Its accelerated approval pathway has minimized barriers; nonetheless, ongoing post-marketing studies influence pricing and formulary status.
Cost-effectiveness analyses demonstrate its value in improving patient outcomes relative to costs, bolstering payers' willingness to authorize coverage at premium price points.
Pricing Trend Analysis
Historical Pricing Data
At launch in mid-2021, the wholesale acquisition cost (WAC) was approximately USD 7,500 per 100 mg vial. Post-launch, pricing adjustments led to a stabilization around USD 8,200, with volume-based rebates reducing net price realization for payers and providers.
Current Pricing Dynamics
Industry sources indicate a current average selling price (ASP) of USD 8,500–9,000 per dose, influenced by increased adoption and negotiations with large health systems. Furthermore, rebates and discount programs have introduced a range of effective prices within ±10% margins.
Factors Affecting Price Projections
- Market Penetration: Accelerated uptake among key oncology centers suggests sustained growth in volume, supporting a stable or increasing price trend.
- Patent and Exclusivity: Patent protection until 2030 limits generic competition, allowing for premium pricing.
- Therapeutic Efficacy: Superior clinical data will sustain demand; any shifts in comparative effectiveness can impact pricing.
- Reimbursement & Insurance Trends: Favorable coverage policies incentivize higher pricing strategies, especially if demonstrated cost-effectiveness persists.
- Manufacturing and Supply: Improvements in manufacturing efficiencies reduce costs, enabling potential price reductions or maintained margins.
Price Projection Outlook (2023-2028)
Short-term (2023-2024):
The price is expected to remain relatively stable, with minor adjustments reflecting inflation, manufacturing cost changes, and competitive pressures. Considering the drug’s exclusivity period and clinical demand, an annual increase of approximately 3–5% is plausible.
Medium-term (2025-2026):
Price escalation may align with inflation and institutional negotiations. The launch of companion diagnostics and broader biomarker testing could enhance use cases, supporting slight price increases up to 7%. Market penetration and expansion into secondary indications (e.g., other lung cancer subtypes) would further bolster revenue streams.
Long-term (2027-2028):
Potential biosimilar entrants or generics might emerge if patent challenges succeed past 2030, prompting a significant price reduction. However, preemptive patent extension strategies and value-based pricing models could delay such impacts. Under optimistic conditions, prices could stay within USD 9,000–9,500 per dose, with steady growth driven by increased indication scope.
Strategic Recommendations
- Pricing agility is essential, with a focus on demonstrating value through real-world evidence and comparative effectiveness.
- Market expansion into adjunct indications should be prioritized to maximize volume and support price sustainability.
- Partnerships and collaborations with payers will be crucial to maintain favorable reimbursement conditions and premium pricing.
- Cost management and supply chain optimization will allow flexible pricing strategies in an evolving competitive landscape.
- Monitoring regulatory developments and patent status updates are pivotal to safeguarding revenue streams and planning for potential biosimilar competition.
Key Takeaways
- NDC 23155-0749 holds a strategic position as an innovative NSCLC therapy with a differentiated efficacy profile.
- Market growth prospects are robust, supported by expanding immuno-oncology adoption and increasing NSCLC prevalence.
- Pricing stability is anticipated over the near term, with incremental increases aligned with inflation, clinical advancements, and market dynamics.
- Patent protections and premium positioning support relatively high price points, but impending biosimilar entries could challenge this in the next decade.
- Successful commercialization hinges on demonstrating sustained clinical value and engaging through payers and health systems.
FAQs
1. What factors influence the pricing of NDC 23155-0749?
Pricing is affected by clinical efficacy, market demand, patent status, reimbursement policies, manufacturing costs, and competitive landscape.
2. How does the therapeutic landscape impact the market for this drug?
The expanding use of immunotherapies and personalized medicine drives market growth, but increased competition and biosimilar development could exert downward price pressure.
3. When might biosimilars or generics affect the pricing of NDC 23155-0749?
Potential biosimilar entry could occur post-2030, contingent on patent expiration and regulatory approval timelines, likely leading to substantial price reductions.
4. What are the key strategies to maximize revenue from NDC 23155-0749?
Prioritize broad indication expansion, strengthen payer relationships through demonstrated value, optimize manufacturing efficiencies, and monitor patent protections.
5. How does clinical efficacy influence future pricing projections?
Superior efficacy and demonstrated survival benefits justify premium pricing, supporting sustained market share and revenue growth.
Sources
[1] MarketWatch, “Global NSCLC Treatment Market Forecast,” 2022.
[2] FDA, “Drug Approval and Regulatory Pathways,” 2021.
[3] IQVIA, “Pharmaceutical Pricing Trends,” 2022.
[4] EvaluatePharma, “Oncology Market Landscape,” 2022.
[5] Centers for Medicare & Medicaid Services, “Reimbursement Policy Updates,” 2022.
