Last updated: July 31, 2025
Introduction
This report offers a detailed market analysis and price projection for the drug associated with NDC 59762-5000. As an analyst specializing in pharmaceutical patents and market dynamics, the focus is on providing actionable insights to investors, healthcare providers, and industry stakeholders. The drug’s unique positioning within its therapeutic class, competitive landscape, regulatory environment, and market demand are key determinants shaping its future valuation.
Product Overview
The National Drug Code (NDC) 59762-5000 corresponds to Amivantamab-vmjw (Rybrevant), a monoclonal antibody developed for targeted cancer therapy. Approved by the FDA in 2021, Amivantamab is primarily indicated for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, positioning it within the precision oncology segment.
Market Landscape
Therapeutic Area and Unmet Needs
NSCLC with EGFR exon 20 insertions represents a subset of lung cancers characterized by limited treatment options and poor prognosis. Standard therapies historically include chemotherapy and immunotherapy, but these often exhibit limited efficacy in this mutation subgroup. Amivantamab offers a targeted approach, filling an unmet clinical need for an effective, mutation-specific therapy.
Market Size and Growth Potential
The global NSCLC market exceeds USD 20 billion as of 2022, with the subset of EGFR exon 20 insertion mutations estimated at approximately 15% of NSCLC cases (roughly 150,000 annual cases worldwide) [1]. Assuming a conservative prevalence rate and diagnosis rate, the addressable market for Amivantamab could reach USD 3-4 billion globally.
Key drivers include:
- Rising lung cancer incidence
- Increased biomarker testing for EGFR exon 20 insertions
- Growing adoption of targeted therapies
- Expanded indications and combination therapies
Competitive Landscape
Currently, no direct competitors possess FDA-approved therapies explicitly targeted at EGFR exon 20 insertions. Mainland competitors include:
- Mobocertinib (Egaten): Approved for similar indications
- Amgen's tarifertinib (under clinical trials): Emerging potential competitor
The lack of direct equivalents grants Amivantamab a significant market advantage, reinforcing its pricing power and revenue potential.
Pricing Dynamics
Current Pricing Context
The wholesale acquisition cost (WAC) for Amivantamab is approximately USD 16,000 per 1g vial, with typical treatment courses potentially costing USD 150,000–200,000 per patient annually. Pricing strategies reflect:
- Monoclonal antibody production costs
- The drug’s novelty and exclusivity
- Targeted therapy premium positioning
Reimbursement Environment
In the U.S., Amivantamab benefits from favorable insurance coverage due to its FDA approval and designated niche therapy status. However, reimbursement rates and patient access depend on negotiated discounts, formulary inclusion, and regional healthcare policies.
Pricing Trends and Future Projections
Based on current uptake, the following projections are made:
- Year 1-2: Stable pricing with slight discounts (~USD 14,000–15,500 per vial) to facilitate market penetration.
- Year 3-5: Potential price stabilization or modest increase (~USD 15,500–USD 17,000) due to inflation, increased demand, and potential label expansions.
- Long-term (5-10 years): Potential for value-based pricing models, especially if combination therapies prove superior; prices may fluctuate accordingly.
Market Penetration and Revenue Forecasts
Assumptions:
- Rapid adoption driven by clinical efficacy
- Moderate market share growth within the first 3 years
- Penetration rate reaching 20-30% of eligible patients in the U.S. by Year 5
Forecast Summary:
| Year |
Estimated Patients Treated |
Revenue (USD millions) |
Price per Treatment Course |
| 2023 |
5,000 |
750 |
USD 150,000 |
| 2024 |
8,000 |
1,200 |
USD 150,000 |
| 2025 |
12,000 |
1,800 |
USD 150,000 |
| 2026 |
15,000 |
2,250 |
USD 150,000 |
| 2027+ |
Growth driven by expansion |
Up to USD 2.5-3 billion |
Increasing or stable |
Note: These figures are projections subject to market dynamics, regulatory changes, competition, and clinical outcomes.
Regulatory and Pricing Influences
The future pricing strategy may be influenced by:
- FDA Label Expansion: Potential approvals in additional indications could justify price increases.
- Pricing Regulations: U.S. policies aiming at drug affordability and value-based pricing may impose downward pressure.
- International Markets: Prices vary globally; emerging economies practice lower pricing, affecting global revenue.
Key Market Risks
- Competitive Entry: Prospect of new targeted agents or combination therapies could erode market share.
- Regulatory Hurdles: Approval delays or label restrictions restrict market size.
- Pricing Constraints: Policy shifts towards lower drug prices, especially in public healthcare markets.
- Clinical Outcomes: Efficacy and safety profiles directly impact physician adoption and pricing.
Conclusion
NDC 59762-5000, representing Amivantamab, stands at a strategic inflection point. Its unique position in addressing a significant unmet clinical need ensures strong market potential, with a projected revenue stream stabilizing around USD 2-3 billion over the next five years. Price projections indicate a cautious approach—maintaining premium per-dose pricing while navigating regulatory and competitive landscapes. Continued innovation, broadening indications, and value-based pricing models will shape its long-term market trajectory.
Key Takeaways
- Market Potential: A rapidly growing niche within the NSCLC space, driven by unmet needs and biomarker-driven precision medicine.
- Pricing Strategy: Current high-end monoclonal antibody pricing (~USD 150,000 per treatment course) is expected to remain stable with slight adjustments, influenced by payer negotiations and clinical advancements.
- Revenue Forecast: Anticipated to reach upwards of USD 2.5 billion annually by Year 5, contingent on market penetration and regulatory approvals.
- Competitive Edge: No direct FDA-approved equivalents in the initial indication, granting Amivantamab a dominant market position.
- Risks and Opportunities: Monitoring clinical trial outcomes, regulatory developments, and pricing policies are critical to optimizing investment decisions.
FAQs
1. What are the primary indications for NDC 59762-5000 (Amivantamab)?
Primarily indicated for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations, filling a significant unmet medical need.
2. How does the current pricing of Amivantamab compare to similar therapies?
It aligns with other monoclonal antibody-based cancer treatments, typically ranging from USD 150,000 to USD 200,000 per treatment course, reflecting its targeted mechanism and clinical value.
3. What factors could influence future price adjustments?
Regulatory approvals for expanded indications, competitive therapies entering the market, value-based pricing negotiations, and healthcare policy reforms.
4. How significant is the market opportunity for this drug globally?
Substantial, especially in North America and Europe, with emerging opportunities in Asia-Pacific regions where lung cancer prevalence is high.
5. What are the main risks to achieving projected revenues?
Market entry of new competitors, regulatory hurdles, pricing pressurization, and variability in clinical outcomes.
References
- GlobalData. “NSCLC Market Size and Trends 2022.”
- FDA. “Amivantamab (Rybrevant) Approval Details.”
- IQVIA. “Pharmaceutical Market Overview 2022.”
- ClinicalTrials.gov. “Studies on EGFR exon 20 insertion mutations.”
- Industry analysis reports.
This market analysis provides a comprehensive overview to support strategic decision-making regarding the drug associated with NDC 59762-5000. Continuous monitoring of regulatory, clinical, and competitive developments is advised to refine projections.