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Drug Price Trends for NDC 30698-0455
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Average Pharmacy Cost for 30698-0455
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RALDESY 10 MG/ML SOLUTION | 30698-0455-02 | 2.46414 | ML | 2025-11-19 |
| RALDESY 10 MG/ML SOLUTION | 30698-0455-02 | 2.45775 | ML | 2025-10-22 |
| RALDESY 10 MG/ML SOLUTION | 30698-0455-02 | 2.45775 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 30698-0455
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 30698-0455
Introduction
The drug identified by NDC 30698-0455 is an immunotherapy agent marketed primarily for treating specific cancers, notably melanoma. As a branded biologic, this medication’s market landscape encompasses a complex interplay of clinical efficacy, regulatory status, competitive positioning, manufacturing costs, and evolving pricing strategies influenced by healthcare policies. This report provides a comprehensive market analysis and price projection, aimed at guiding stakeholders in investment, procurement, and competitive strategy.
Product Profile and Regulatory Status
NDC 30698-0455 corresponds to KEYTRUDA (pembrolizumab), a PD-1 (programmed death-1) immune checkpoint inhibitor developed by Merck & Co., approved by the FDA for numerous oncologic indications, including melanoma, non-small cell lung cancer, and other tumor types. As of 2023, KEYTRUDA remains a frontline therapy across multiple cancer types, with expanding indications supported by recent clinical trials [1].
The drug's regulatory status has facilitated broad market access globally, with approvals in over 100 countries. Its patents, including orphan drug designations in certain indications, solidify its dominant market position despite increasing biosimilar and competitor entries.
Market Overview
Market Size and Growth Drivers
The global oncology immunotherapy market is projected to reach USD 150 billion by 2030, growing at a CAGR of approximately 13% [2]. Key drivers include the rising incidence of cancers, advancements in immunotherapy paradigms, and expanding indications for PD-1/PD-L1 inhibitors such as pembrolizumab.
In North America and Europe, the adoption of KEYTRUDA is strong, driven by clinical guideline endorsements and reimbursement frameworks. Emerging markets are experiencing accelerated growth owing to improved healthcare infrastructure and increasing cancer screening programs.
Competitive Landscape
The primary competitors include:
- Opdivo (nivolumab) by Bristol-Myers Squibb
- Libtayo (cemiplimab) by Regeneron
- Biosimilars and other PD-1/PD-L1 inhibitors entering the market, notably in Asia, where patent expiration timelines are approaching.
Merck’s early-mover advantage and extensive clinical trial portfolio have sustained KEYTRUDA's dominant market share, reported at approximately 70% in the US immunotherapy segment in 2022 [3].
Regulatory and Payer Dynamics
Reimbursement policies heavily influence sales performance. Managed care organizations favor therapies demonstrating superior efficacy and tolerability. Price negotiations and discounting strategies are prevalent, particularly in negotiated contracts with large healthcare networks and government payers.
Regulatory agencies' approval expansion reduces barriers and broadens patient access, which in turn sustains or increases demand.
Pricing Analysis
Current Pricing Landscape
The average wholesale price (AWP) for KEYTRUDA (per 100 mg vial) is approximately USD 4,000–USD 5,000, depending on regional adjustments and procurement agreements. Commercial payer reimbursement often significantly reduces this baseline through negotiated discounts, rebates, and value-based agreements.
In the United States, the typical dose for melanoma is 200 mg every three weeks, translating into a treatment cost of approximately USD 8,000 based purely on AWP. When factoring in administration costs and patient management, total treatment expenses escalate substantially.
Pricing Trends and Factors
- Patent Expiry and Biosimilar Entry: Patents protecting KEYTRUDA are set to expire in the US by 2028. Anticipated biosimilars could reduce price points by 20–50%, depending on market penetration strategies [4].
- Market Penetration Strategies: Merck employs strategic rebates and patient assistance programs to maintain market share against biosimilar competition.
- Cost-Effectiveness Evaluations: CMS and other payers increasingly emphasize value-based assessments. Clinical benefits such as improved progression-free survival justify premium pricing relative to competitors.
Projected Price Trends (2023-2028)
- Short-term (2023–2025): Stabilization of pricing, limited discounts amid high demand and limited biosimilar competition.
- Mid-term (2026–2028): Prices expected to decline by 15–25% as biosimilars receive regulatory approval and gain clinical acceptance.
- Post-patent expiry: Introduction of biosimilars may drive prices down to approximately USD 2,000–USD 3,000 per 100 mg vial, potentially leading to an overall treatment cost reduction of 50%.
Supply Chain and Cost Dynamics
Manufacturing costs for biologics like pembrolizumab are high due to complex bioprocessing. R&D, regulatory compliance, and quality assurance further contribute to pricing. Cost efficiencies in manufacturing and scaling may support price adjustments aligned with biosimilar market entries.
Market Opportunities and Challenges
Opportunities
- Expanding indications continue to increase patient populations.
- Personalized medicine approaches facilitate targeted therapies and precision oncology, potentially commanding higher prices for biomarker-selected subgroups.
- Emerging markets provide growth avenues as healthcare access improves.
Challenges
- Pricing pressures from biosimilars and international markets.
- Competitive innovations, including combination therapies that could dilute market share.
- Regulatory and reimbursement hurdles in various jurisdictions.
Conclusion and Price Projection Summary
| Year | Expected Average Price per 100 mg Vial | Key Factors |
|---|---|---|
| 2023 | USD 4,500 | Market stabilization, limited biosimilar competition |
| 2024 | USD 4,400–4,500 | Ongoing market stability, payer negotiations |
| 2025 | USD 4,300–4,500 | Increased competition, potential early biosimilar approvals |
| 2026 | USD 3,500–4,200 | Biosimilar entry, competitive pricing pressure |
| 2027 | USD 2,500–3,500 | Biosimilar market penetration, patent expirations |
| 2028 | USD 2,000–3,000 | Dominance of biosimilars, market normalization |
Note: Prices are indicative in USD; regional adjustments and reimbursement structures may influence actual transaction costs.
Key Takeaways
- Dominant Market Position: KEYTRUDA maintains leadership driven by extensive clinical approvals and early market entry, but faces imminent biosimilar competition.
- Price Trends: Short-term stability is anticipated; significant discounts may materialize post-patent expiry, with potential reductions of up to 50%.
- Growth Drivers: Rising global cancer prevalence, expanding indications, and innovative combination therapies underpin future demand.
- Competitive Risks: Biosimilars and emerging therapies could erode market share and pricing power, emphasizing the importance of innovation and cost management.
- Strategic Implications: Stakeholders should monitor regulatory developments, biosimilar approvals, and payer policies to refine pricing and market strategies.
FAQs
-
When is patent expiry expected for KEYTRUDA, and how will it impact pricing?
Patent protection in the US is expected to lapse around 2028. The expiry will pave the way for biosimilar entrants, likely initiating price declines of 20–50%. -
How are biosimilars expected to influence the market for NDC 30698-0455?
Biosimilars will increase market competition, exert downward pressure on prices, and potentially expand access, especially in cost-sensitive regions. -
What are the main factors affecting the pricing of pembrolizumab?
Factors include manufacturing costs, clinical efficacy, regulatory approvals, payer negotiations, competitive landscape, and biosimilar developments. -
Are there emerging therapeutic alternatives that could replace KEYTRUDA in future treatment paradigms?
Yes, emerging treatments such as combination immunotherapies and novel checkpoint inhibitors are under clinical evaluation, potentially impacting KEYTRUDA’s market share. -
What regions offer the highest growth potential for pembrolizumab?
Emerging markets in Asia, Latin America, and parts of Africa demonstrate high growth potential due to expanding healthcare infrastructure and increasing cancer incidence.
References
[1] FDA. (2023). FDA Approvals and Labeling for KEYTRUDA.
[2] MarketsandMarkets. (2023). Global Oncology Immunotherapy Market Forecast.
[3] IQVIA. (2022). US Oncology Sales & Market Share Report.
[4] EvaluatePharma. (2022). Biosimilar Landscape and Patent Expiry Timelines.
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