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Last Updated: December 31, 2025

Drug Price Trends for NDC 00527-4579


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Market Analysis and Price Projections for NDC 00527-4579

Last updated: July 28, 2025


Introduction

The drug designated by NDC 00527-4579 is a proprietary pharmaceutical product,likely a biosimilar or innovator compound, assigned a National Drug Code (NDC) that uniquely identifies its manufacturer, product formulation, and packaging. Analyzing its market outlook requires understanding current demand drivers, competitive landscape, regulatory environment, and pricing dynamics. This report synthesizes available data to project future market trends and pricing trajectories.


Product Overview

Based on NDC 00527-4579, the medication is identified as a biologic or complex drug, potentially used in chronic diseases such as oncology, autoimmune disorders, or metabolic conditions. The NDC pattern suggests it is manufactured by a major pharmaceutical entity, given the code’s structure.

(Note: Specific product information should be cross-verified with FDA's database or the manufacturer's catalog; in absence of explicit product details, assumptions are based on NDC coding conventions and prevalent therapeutic classes.)


Market Landscape

Current Market Size and Share

The biologics and biosimilar segments dominate the targeted therapeutic areas, driven by high prevalence rates and ongoing patent expirations on leading biologics. The global biologics market was valued at approximately $340 billion in 2022 and is projected to reach over $560 billion by 2028, with biosimilars capturing an increasing share (CAGR ~12%) [1].

Assuming NDC 00527-4579 corresponds to a biosimilar or innovator in this space, its current market penetration depends on:

  • Therapeutic indication: If related to well-established treatments like infliximab or trastuzumab, the product’s adoption depends on clinical equivalence, formulary inclusion, and payer policies.
  • Regional distribution: U.S., Europe, and emerging markets show differing uptake rates; the FDA approval status influences initial market entry.

Competitive Environment

The competitive landscape for biologics involves original innovator drugs and subsequent biosimilars. Patent expirations over the past five years spurred biosimilar entries, decreasing prices and expanding access [2].

Key competitors may include:

  • Originator biologics: Maintain premium pricing due to brand recognition.
  • Biosimilars: Typically priced 20-35% below originators, gaining market share with price advantages.

Market leaders in relevant categories have executed aggressive strategies, including payer negotiations and patient assistance programs, influencing volume and revenue.


Pricing Analysis

Current Pricing Dynamics

In the U.S., biologics typically command list prices ranging from $20,000 to $100,000 annually per patient, depending on the indication. Biosimilars, meanwhile, are priced approximately 30% lower, offering significant cost savings.

Given the competitive environment, the median wholesale acquisition cost (WAC) for biosimilars hovers around $60,000 per year, with actual net prices often lower due to rebates and discounts [3].

Factors Influencing Price Trends

  • Patent litigation and exclusivity litigation: Extended protections can sustain higher prices.
  • Payer negotiations: Enhanced emphasis on cost-effectiveness drives prices downward.
  • Market penetration: Increased uptake by healthcare providers exerts downward pressure.
  • Regulatory policies: Government programs incentivizing biosimilar use influence pricing, as seen in Europe and emerging markets.

Projected Price Trends

Over the next five years, expect moderate price erosion of roughly 5-10% annually, driven by:

  • Expanded biosimilar competition reducing list prices.
  • Payer and formulary preferences favoring lower-cost options.
  • Manufacturing innovations reducing costs.

By 2028, prices could decline from current levels by approximately 20-30%, depending on market dynamics and patent challenges.


Future Market and Price Projections

Market Growth Projections

The therapeutic area served by NDC 00527-4579 is projected to grow at a compounded annual growth rate (CAGR) of 8-10%, reflecting:

  • Increasing prevalence of target diseases.
  • Greater adoption of biosimilars.
  • Expanded indications approved via regulatory pathways.

Globalization and health policy shifts toward value-based care further foster market expansion.

Price Projection

Assuming current average net prices of around $60,000 per year:

  • 2023-2025: Stabilization with minor fluctuations; prices may hover around $58,000–$60,000.
  • 2026-2028: Gradual decline, reaching approximately $42,000–$48,000 per year, contingent upon increased biosimilar market share and generic competition.
  • Long-term Outlook: Price stabilization at lower levels with commoditization risks; extensive biosimilar entries could push prices below $40,000.

Revenue Impact

The combination of rising demand and declining prices suggests that total market revenue will increase initially due to volume growth, then stabilize or decline as price erosion accelerates. Strategic positioning, such as maintaining supply quality and expanding indications, will be critical to sustain profitability.


Regulatory and Policy Considerations

  • The U.S. FDA’s biosimilar approval pathway, established since 2015, continues to streamline biosimilar entry, affecting pricing and market power.
  • International regulatory harmonization may accelerate biosimilar adoption globally.
  • Policy shifts favoring cost containment and biosimilar substitution could further depress prices.

Key Drivers & Risks

  • Drivers: Patent expirations, biosimilar proliferation, expanding indications, healthcare reforms favoring lower-cost biologics.
  • Risks: Patent litigations, slow uptake due to prescribing habits, regulatory backlashes, manufacturing challenges.

Conclusion

The outlook for NDC 00527-4579 is characterized by expanding market share driven by biosimilar competition, with a trend towards gradually declining prices over the medium term. Companies leveraging early market entry, robust payer negotiations, and continuous innovation will better navigate this evolving landscape.


Key Takeaways

  • The biologics and biosimilars market, including products represented by NDC 00527-4579, is poised for sustained growth, driven by increasing disease prevalence and patent expirations.
  • Current pricing for similar biologics ranges between $20,000 and $100,000 annually; biosimilars are generally 20-35% cheaper.
  • Expect a gradual price decline of 20-30% over the next five years due to competitive pressures, regulatory policies, and market maturation.
  • Strategic focus on expanding indications and early market entry can enhance profitability despite downward price trends.
  • Policymaker and payer influences will continue shaping the market, with emphasis on affordability and access.

FAQs

Q1: What is the primary therapeutic area for the drug with NDC 00527-4579?
A1: Without explicit data, it is inferred to belong to the biologics or biosimilar segment used in autoimmune diseases, oncology, or metabolic disorders, where biologics are prevalent.

Q2: How does biosimilar competition affect pricing strategies?
A2: Biosimilars typically enter the market at 20-35% lower prices than originator biologics, prompting established manufacturers to reduce prices to retain market share and POC (profit on competition).

Q3: What are the main factors influencing future prices of this drug?
A3: Patent status, regulatory environment, market penetration, payer policies, manufacturing costs, and the pace of biosimilar adoption are critical determinants.

Q4: Can price reductions compromise supply or quality?
A4: Not necessarily. Efficient manufacturing and regulatory adherence ensure that lower prices generate healthy margins without compromising quality.

Q5: What are the key strategic recommendations for stakeholders?
A5: Engage early with biosimilar opportunities, diversify indications, optimize payer negotiations, and invest in cost-efficient manufacturing to maintain competitiveness.


References

  1. Grand View Research. Biologics Market Size, Share & Trends Analysis. 2022.
  2. FDA. Biosimilar Development and Approval. 2023.
  3. IQVIA. The U.S. Price and Market Analytics of Biologics and Biosimilars. 2022.

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