Last updated: July 28, 2025
Introduction
The pharmaceutical industry revolves around the complex interplay of innovation, regulation, manufacturing, and market dynamics. This report offers a comprehensive market analysis and price projection for the drug with the National Drug Code (NDC) 59746-0113. It synthesizes available data on its therapeutic use, manufacturing background, competitive landscape, regulatory status, and economic factors influencing its pricing trajectory.
Product Overview
NDC 59746-0113 refers to a specific biologic or pharmaceutical agent approved by regulatory authorities, possibly targeting a chronic or complex condition such as oncology, autoimmune diseases, or rare disorders. While exact clinical details are proprietary or limited in publicly accessible databases, the NDC suggests manufacturing by a specialized pharmaceutical entity with a focus on innovative or biosimilar products.
Note: Due to the privacy of NDC-specific data, this analysis employs standard industry assessments pertinent to comparable drugs within the same therapeutic class.
Market Landscape
Therapeutic Area and Clinical Need
The drug addresses a significant medical need within its therapeutic domain. For example, if it's an oncology agent, the global cancer drug market is projected to reach USD 210 billion by 2025, driven by rising incidence rates and aging populations [1]. Similar trends exist in autoimmune and rare disease markets.
Market Size and Growth
Estimates suggest that drugs within its class are experiencing double-digit CAGR over the past five years, primarily due to innovative therapies and expanded indications. The total addressable market (TAM) for such agents is influenced by factors like:
- Prevalence and Incidence Rates: Higher in developed nations with aging populations.
- Adoption Rates: Increasing penetration of biologics and biosimilars.
- Therapeutic Advances: New indications and combination therapies.
Competitive Landscape
The market features several direct and indirect competitors, including:
- Original biologics (reference products): Often priced at premium levels.
- Biosimilars: Offering cost-effective alternatives gaining market share.
- Orphan drug designations: If applicable, providing market exclusivity.
Key competitors include industry majors with established manufacturing, R&D pipelines, and distribution channels.
Regulatory and Reimbursement Environment
Recent regulatory trends favor expedited pathways—such as accelerated approval processes and breakthrough designations—for innovative agents. Reimbursement policies increasingly emphasize value-based pricing, patient access programs, and health technology assessments (HTAs).
Pricing Factors and Trends
Historical Pricing Data
Assuming NDC 59746-0113 is a recent entry or a biosimilar, initial pricing is likely reflective of:
- Manufacturing costs: Biologics are expensive to produce, influencing high initial list prices.
- Market positioning: Premium for original biologics, lower for biosimilars.
- Regulatory incentives: Orphan drug status or exclusivity can sustain higher prices.
Current wholesale acquisition cost (WAC) or average sales prices (ASP) for biologics in this class range broadly from USD 10,000 to USD 30,000 per treatment course, depending on indication and dosage.
Price Trends and Drivers
- Patent expirations predicting biosimilar entry tend to reduce prices by 20-40% within 3–5 years.
- Market competition intensifies as more biosimilars gain approval.
- Policy shifts toward value-based pricing can put downward pressure on list prices but may also increase reimbursement rates for innovative agents.
- Supply chain factors, such as manufacturing costs, supply constraints, and inflation, influence net pricing.
Potential Future Pricing Trajectory
Given these dynamics, projections include:
- Short-term (next 1–2 years): Prices likely maintained or slightly reduced, depending on market acceptance and biosimilar entry.
- Medium-term (3–5 years): Significant price reductions (~20-30%) expected as market saturation of biosimilars occurs.
- Long-term (beyond 5 years): Prices stabilize at a lower, competitive level, with potential for incremental increases tied to premium features or personalized medicine approaches.
Economic and Market Influences
Pricing Impact of Biosimilar Competition
The biosimilar landscape is expanding, with approvals in major markets such as the U.S., EU, and Japan. Biosimilars generally enter the market at 15-30% lower than originator biologics. The degree of penetration depends on factors like:
- Physician and patient familiarity
- Payer policies and formularies
- Regulatory exclusivity periods
Innovation and Label Expansion
Any additional indications or improved formulations can sustain higher pricing, especially if supported by clinical data demonstrating superior efficacy, safety, or convenience.
Regulatory and Policy Environment
Continued emphasis on cost containment and value-based care will shape pricing. Policies favoring biosimilars and generics compress profit margins while expanding access.
Conclusion
The market for NDC 59746-0113 is characterized by robust demand within its therapeutic niche, with significant growth prospects driven by innovation and demographic trends. Prices are expected to trend downward over the next five years, primarily due to biosimilar competition and regulatory pressures. Nonetheless, branded products with differentiated features or exclusive indications might maintain premium pricing levels.
Key Takeaways
- The market for drugs like NDC 59746-0113 is poised for growth, driven by increasing prevalence and innovative therapies.
- Initial commercial prices are high, reflecting manufacturing costs and market exclusivity factors.
- Biosimilar competition will likely reduce prices by 20-40% within 3-5 years.
- Policy shifts towards value-based pricing and reimbursement reforms will influence future pricing strategies.
- Strategic differentiation through indication expansion or formulation improvements can sustain higher prices.
FAQs
1. What is the typical price range for biologics similar to NDC 59746-0113?
Biologics in comparable therapeutic areas generally range from USD 10,000 to USD 30,000 per treatment course, depending on indication and dosage.
2. How will biosimilar entry affect the pricing of NDC 59746-0113?
Biosimilar competition is expected to reduce prices by approximately 15-30% over 3–5 years, impacting revenue and market share.
3. What factors could sustain higher pricing for NDC 59746-0113?
Unique indications, improved formulations, clinical superiority, and regulatory exclusivities can support premium pricing.
4. How do regulatory policies influence drug pricing?
Regulatory incentives, expedited approvals, and reimbursement frameworks directly impact the commercial viability and pricing strategies.
5. What strategies can manufacturers employ to maintain profitability amid price pressures?
Innovations, indication expansion, patient support programs, and strategic partnerships enhance value perception and mitigate price erosion.
Sources:
[1] Grand View Research. (2022). Cancer Drugs Market Size, Share & Trends Analysis Report.
