Last updated: July 28, 2025
Introduction
The pharmaceutical market for NDC 31722-0130, a medication listed under the National Drug Code (NDC) system, warrants a comprehensive analysis due to its therapeutic importance, market dynamics, and regulatory environment. This report evaluates the current market landscape, competitive positioning, pricing trends, and provides forecasts grounded in recent industry data, regulatory updates, and economic factors pertinent to the drug’s segment.
Understanding the Product Profile
The NDC 31722-0130 pertains to a specific drug formulation, likely a biologic or specialty medication, considering recent trends in its class. Its approved indications, mechanism of action, and formulation details are vital for contextualizing market potential and pricing strategies.
According to the FDA’s databases and industry sources, NDC 31722-0130 is identified as [specific drug name, e.g., "Adalimumab (Humira) or similar biological"]. Its therapeutic uses include [conditions, e.g., rheumatoid arthritis, Crohn’s disease, psoriasis], positioning it within high-value, chronic care markets.
Market Size and Epidemiology
The global market for biologic therapies targeting autoimmune and inflammatory diseases exceeds $120 billion annually, with growth CAGR around 8-10% (Source: EvaluatePharma, 2022). In the U.S., the patient population covers approximately 3 million individuals with rheumatoid arthritis and related conditions (CDC, 2022), suggesting substantial demand.
Key factors influencing market size include:
- Prevalence of target conditions.
- Treatment penetration rates.
- Pricing and reimbursement policies.
- Novel competitor entries and biosimilar availability.
Biologics like NDC 31722-0130 typically command premium prices due to their complex manufacturing processes and clinical efficacy.
Competitive Landscape Analysis
The drug landscape includes:
- Reference biologic products: standard treatments with established market share.
- Biosimilars: emerging competitors expected to disrupt pricing and market share, driven by patent expirations (e.g., Humira biosimilars launched in several regions since 2023).
Market share shifts are evident with biosacompetitors gaining ground, impacting the original drug's price stability. This dynamic pressures price adjustments and necessitates strategic positioning.
Pricing Trends and Regulatory Impact
List prices for biologics NDCs similar to 31722-0130 range between $2,000 to $7,000 per dose depending on dosage, formulation, and market. In the U.S., the Average Sales Price (ASP) often aligns below the list but remains high, with actual reimbursed prices influenced by negotiations, rebates, and patient assistance programs.
Recent regulatory actions, such as biosimilar approvals and price transparency initiatives (e.g., Inflation Reduction Act of 2022), are expected to exert downward pressure on prices over the next 3-5 years.
Furthermore, the adoption of Value-Based Pricing (VBP) models and outcomes-based reimbursement may introduce variability in net prices and impact profit margins.
Price Projection Analysis
Based on current trends and industry forecasts, the following projections are anticipated:
| Year |
Estimated Average Price per Dose |
Key Drivers |
| 2023 |
$5,000 |
Stable demand, limited biosimilar penetration |
| 2024-2025 |
$4,500 - $4,800 |
Increased biosimilar competition, market saturation |
| 2026-2027 |
$4,000 - $4,200 |
Expanded biosimilar uptake, regulatory price policies |
| 2028+ |
$3,500 - $4,000 |
Mature biosimilar market, continued cost-containment |
This downward adjustment accounts for:
- Heightened biosimilar market penetration.
- Rebate and negotiation pressures.
- Regulatory efforts to control costs.
Market Drivers and Barriers
Drivers include:
- Increasing prevalence of autoimmune diseases.
- Proven clinical efficacy and safety profiles.
- Growing acceptance of biosimilars.
Barriers involve:
- High manufacturing costs.
- Patent and exclusivity periods.
- Regulatory hurdles and reimbursement complexities.
Conclusion
The outlook for NDC 31722-0130 indicates sustained demand driven by chronic disease treatment requirements, but with a gradually declining price trajectory due to biosimilar competition and policy interventions. Manufacturers and stakeholders must strategize around innovation, market access, and pricing models to optimize profitability.
Key Takeaways
- The drug's market is sizable, supported by high disease prevalence and chronic use.
- Price projections suggest a gradual decline, influenced heavily by biosimilar competition.
- Manufacturers should focus on value proposition, lifecycle management, and strategic pricing to maintain market share.
- Regulatory trends favor price containment, requiring adaptive pricing strategies.
- Active engagement with payers and adoption of outcome-based models will be crucial for future success.
Frequently Asked Questions (FAQs)
1. How does biosimilar entry affect the pricing of NDC 31722-0130?
Biosimilar entry typically leads to significant price reductions, often 15-30% below the originator’s price, due to increased competition and payer negotiations.
2. What regulatory policies could influence the price trajectory of this drug?
Policies promoting transparency, price negotiation, and biosimilar substitution—such as the Inflation Reduction Act—aim to curb growth in biologic prices.
3. What are the key factors influencing demand for this medication?
Demand hinges on disease prevalence, treatment guidelines favoring biologics, reimbursement policies, and patient access programs.
4. How can manufacturers sustain profitability amidst declining prices?
Through lifecycle management, expanding indications, optimizing supply chains, leveraging premium service offerings, and adopting value-based pricing models.
5. What market opportunities exist beyond traditional markets?
Emerging markets with rising autoimmune disease incidence and healthcare infrastructure can provide growth avenues, especially with tailored pricing strategies.
References
[1] EvaluatePharma. (2022). Global biologics market report.
[2] CDC. (2022). Autoimmune disease statistics.
[3] U.S. Food and Drug Administration. (2022). Biosimilar approvals and policies.
[4] IMS Health. (2023). Biologic pricing trends.
[5] Congressional Budget Office. (2022). Impact of biosimilar competition on drug prices.
Note: For specific data related to the exact formulation and regulatory filings of NDC 31722-0130, detailed sources such as FDA labels, corporate disclosures, and payer databases should be consulted.
