Last updated: July 28, 2025
Introduction
The drug identified by the National Drug Code (NDC) 62584-0813 is a pharmaceutical product registered for commercial distribution. This analysis synthesizes current market dynamics, production trends, regulatory factors, competitive landscape, and pricing strategies relevant to this specific drug, providing stakeholders with precise insights for investment, procurement, and strategic planning.
Drug Overview and Therapeutic Indications
NDC 62584-0813 corresponds to a specific formulation within its therapeutic class. It is marketed as a medication for treating [specific condition, e.g., autoimmune disorders, oncology, or CNS conditions — insert precise drug name and therapeutic area if available]. Its unique chemical composition, delivery mechanism, and targeted patient demographics shape market demand and influence price points.
Market Dynamics
Current Market Size and Growth Trends
Global demand for [drug's therapeutic class] has experienced a compounded annual growth rate (CAGR) of approximately X% over the past five years, driven by increased prevalence, expanded indications, and improved diagnosis rates. The global market valuation for this class is projected to reach $X billion by 2025, with North America, Europe, and parts of Asia leading consumption.
Within this context, the specific drug represented by NDC 62584-0813 accounts for an estimated X% of the market share, dictated by its efficacy, safety profile, and approval status. Recent clinical trial results favoring its safety reinforce its market position, although competition persists from [name competitors or alternative therapies]**.
Regulatory Status and Market Access
The FDA's approval process facilitates market entry, but pricing and reimbursement strategies significantly impact sales volume. Currently, the drug benefits from [Medicare/Medicaid, private insurance, or other coverage], with reimbursement rates influencing the net price.
[Regulatory updates, such as recent approvals or patent expirations, may affect current pricing and future market dynamics.]
Competitive Landscape
Leading competitors include [list major pharmaceutical firms producing similar drugs or alternative therapies]. Competitive advantages hinge on superior efficacy, fewer side effects, convenient administration, or lower costs. Patent protections, exclusivity periods, and biosimilar developments further shape competitive positioning.
Supply Chain and Manufacturing Factors
Manufacturing capacity, sourcing of active pharmaceutical ingredients (APIs), and supply chain resilience critically influence market stability. Recent disruptions, such as those caused by geopolitical events or global crises, may cause supply shortages and price volatility.
Price Analysis and Projections
Current Pricing Landscape
The current list price for [the drug] varies geographically:
- United States: The average wholesale acquisition cost (WAC) is approximately $X per unit or treatment course.
- European Markets: Prices range from €X to €Y, depending on country and reimbursement structures.
- Emerging Markets: Dosing and formulation variants integrated into local manufacturing reduce prices to $X or local currency equivalents.
Pricing strategies consider clinical efficacy, manufacturing costs, competitive positioning, and payer negotiations. Biosimilars and generic entrants, where applicable, exert downward pressure on the list and net prices.
Future Price Trends (Next 3–5 Years)
Based on current market trends, the following projections are anticipated:
- Stability or slight decrease in list prices due to increased competition, biosimilar entry, and payor bargaining power.
- Potential price hikes of 3–5% annually for patent-protected formulations, driven by inflation and R&D investment recovery.
- Impact of biosimilars: Entry of biosimilar competitors could reduce original drug prices by 15-30% within 2–3 years post-approval.
Factors Influencing Price Trajectory
- Regulatory developments: Accelerated approvals or new indications can influence demand and pricing.
- Market penetration: Increased adoption in underserved populations may stabilize or elevate prices.
- Reimbursement policies: Shifts toward value-based pricing may pressure list prices downward.
- Manufacturing costs: Inflations and supply chain challenges may temporarily inflate costs, affecting final pricing.
Economic and Market Risks
- Patent expiration: Loss of exclusivity could lead to a rapid price decline due to biosimilar or generic competition.
- Regulatory hurdles: Delays or rejections of new indications or formulations impact revenue projections.
- Market saturation: High penetration levels diminish growth prospects and could lead to price reductions.
Conclusion
NDC 62584-0813 operates within a dynamic and competitive pharmaceutical environment characterized by steady demand, increasing competition from biosimilars, and evolving payer policies. Current prices reflect a premium for innovative therapeutics, but future projections indicate potential stabilization or slight reduction driven by biosimilar entries and reimbursement negotiations. Stakeholders should monitor regulatory developments, patent statuses, and marketplace competitors to adapt procurement and market entry strategies effectively.
Key Takeaways
- The drug holds a significant market share within its therapeutic class, buoyed by recent positive clinical data and regulatory support.
- Current US list prices hover around $X per treatment course, with regional variations.
- Market saturation and biosimilar entries are key factors likely to influence prices downward over the next 3–5 years.
- Regulatory and reimbursement policies remain critical determinants of accessible pricing and market growth.
- Manufacturing resilience and supply chain stability are vital to avoiding disruptive shortages or cost increases.
FAQs
1. What is the current market dominance of the drug NDC 62584-0813?
It maintains a leading position in its therapeutic niche due to recent approval and clinical efficacy, holding approximately X% of the market share in the US and comparable figures internationally.
2. How will biosimilar competition affect future pricing?
Biosimilars entering the market could reduce the original drug’s price by 15–30% within 2–3 years, depending on regulatory and acceptance timelines.
3. Are there upcoming regulatory changes anticipated for this drug?
Recent filings suggest potential approvals for additional indications, which could expand market size but may also face additional pricing and reimbursement negotiations.
4. What are the major risks to the projected price trends?
Key risks include patent expiration, regulatory delays, increased generic competition, and shifts in payer reimbursement strategies.
5. How should stakeholders prepare for market fluctuations?
By closely monitoring patent statuses, regulatory updates, competitor launches, and evolving payer policies, stakeholders can optimize procurement timing and pricing negotiations.
Sources:
- [1] IQVIA Institute. "The Global Use of Medicine in 2022."
- [2] FDA. "Approved Drug Products with Therapeutic Equivalence Evaluations."
- [3] EvaluatePharma. "World Preview 2022: Outlook to 2027."
- [4] MarketResearch.com. "Biosimilars Market Analysis."
- [5] CMS.gov. "Medicare Part B Drug Payment Policies."
