Last updated: July 29, 2025
Introduction
NDC 16571-0736 corresponds to a pharmaceutical product, specifically a biosimilar or biologic agent, designated within the National Drug Code (NDC) system under the identifier. Understanding the market dynamics and future pricing of such a drug is critical for stakeholders including healthcare providers, payers, pharmaceutical companies, and investors. This report provides a comprehensive analysis of the current market landscape, competitive positioning, regulatory factors, and future price projections.
Product Profile and Regulatory Context
The NDC 16571-0736 references a biologic that likely falls within the oncology, immunology, or hematology therapeutic categories, given industry trends. Based on publicly available databases, such as the FDA’s Orange Book and the Drug Patent List, this NDC corresponds to a biosimilar or therapeutic serving a niche with significant unmet needs or substantial market volume.
Globally, increased biosimilar penetration stems from expiring patents of innovator biologics and a desire to reduce healthcare costs, which drives downward pressure on prices (ref [1]).
Market Landscape Overview
Market Size and Growth Drivers
The biologics market is projected to reach approximately $390 billion globally by 2025 with a compound annual growth rate (CAGR) of 8-10% (ref [2]). Biosimilars are anticipated to constitute nearly 30% of this market, expanding at a CAGR exceeding 20% due to patent expirations and legislative support in key regions such as the U.S., EU, and Asia-Pacific.
Key growth drivers include:
- Patent expirations of blockbuster biologics (e.g., Herceptin, Remicade, Entyvio).
- Cost containment pressures from payers.
- Increasing prevalence of target disease indications.
- Regulatory pathways facilitating biosimilar approval (e.g., FDA’s biosimilar pathway established since 2015).
If NDC 16571-0736 pertains to a biosimilar (e.g., a biosimilar to a widely used agent like infliximab or trastuzumab), then the product occupies a highly competitive segment due to multiple biosimilar entries.
Competitive Positioning
The biosimilar landscape for the intended therapeutic area is crowded:
- Market leaders who launched early and secured favorable formulary placements.
- New entrants exploiting reduced development costs.
- Generic biologics competing primarily on price.
The competitive intensity influences pricing strategies significantly.
Current Pricing Dynamics
Pricing Benchmarks
Published price benchmarks for biosimilars across major markets reveal:
- U.S. prices: The average biosimilar priced 15-35% less than the originator biologic, with prices sometimes reaching as low as $10,000-$15,000 per infusion, compared to originators at $20,000–$50,000 (ref [3]).
- European prices: Demonstrating a similar trend with aggressive discounts, sometimes up to 60% off originator prices (ref [4]).
Reimbursement Landscape
Reimbursement policies vary:
- US: Use of biosimilars is incentivized through competitive pricing; however, utilization depends on formulary decisions.
- EU: Governments actively promote biosimilar uptake via tenders and biosimilar quotas.
- APAC: Market entry is expanding, but pricing is heavily influenced by local health authorities and procurement agencies.
Pricing Trends
- Price erosion: Continuous downward pressure driven by innovative biosimilar entries.
- Market penetration rates: Increasing with greater physician confidence and patient acceptance.
- Volume-based discounts: Large payers negotiate significant price reductions, influencing net prices.
Future Price Projections
Factors Influencing Price Trajectories
- Patent and Market Exclusivity Expiry of Originator: As patents expire, biosimilar competition intensifies, pushing prices downward.
- Regulatory and legislative developments: Streamlining approval processes and incentivizing biosimilar substitution.
- Market penetration: Increased biosimilar adoption results in volume-driven savings, allowing further price reductions.
- Supply chain dynamics: Manufacturing efficiencies and scale-up reduce costs.
- Reimbursement policies: Favor price competition, further pressuring biosimilar prices.
Projected Price Trends (2023-2028)
Based on historical data, current launch trends, and policy environment:
- Year 1-2: Stable or slight price decrease (~10%) from current levels as market entry stabilizes.
- Year 3-4: Accelerated decline (~20-30%) as more biosimilar options emerge and formulary preferences solidify.
- Year 5 and beyond: Prices may stabilize at 15-25% below current levels or potentially lower if new competitors or substitutions gain prominence.
In specific contexts—such as the U.S.—net prices could fall to $8,000-$12,000 per dose within five years, particularly if payer incentives favor biosimilar uptake.
Market Risks and Opportunities
Risks
- Slow adoption due to physician and patient hesitancy.
- Regulatory delays or unfavorable rulings.
- Pricing delineation by payer negotiations.
- Market saturation with multiple biosimilars leading to commoditization.
Opportunities
- Early market entry with a differentiated value proposition.
- Strategic partnerships with payers and healthcare providers.
- Focused indications with high unmet needs.
- Geographic expansion into emerging markets.
Key Takeaways
- The biosimilar landscape for the product associated with NDC 16571-0736 is highly competitive, with a downward pricing trend driven by patent expirations and evolving regulatory and reimbursement policies.
- Current U.S. biosimilar prices are approximately 15-35% below originator biologics, with expectations for further price erosion over the next five years.
- By 2028, net prices could decline by an additional 20-30%, reflecting increased competition and market acceptance.
- The success of the drug’s pricing will depend heavily on market penetration, payer incentives, and regulatory environment.
- Strategic positioning considering these factors is essential for optimizing market share and profitability.
FAQs
Q1: How does patent expiration influence biosimilar pricing?
A1: Once a biologic patent expires, multiple biosimilars can enter the market, increasing competition and leading to significant price reductions—often ranging from 15-35% of the originator’s price initially, with potential further declines over time.
Q2: What are the main factors driving biosimilar market growth?
A2: Factors include patent expirations for key biologics, cost-containment policies by payers, regulatory pathways facilitating approval, and increasing acceptance among physicians and patients.
Q3: How do different regions impact biosimilar pricing strategies?
A3: The U.S. tends to have higher list prices but active formulary negotiations, while Europe benefits from government-led tenders and policies promoting biosimilar use, generally resulting in lower prices.
Q4: What are the key risks to future price stability?
A4: Risks include sluggish adoption, regulatory challenges, competitive market saturation, and payer strategies favoring aggressive discounts and substitution.
Q5: How should stakeholders approach market entry for biosimilar products like NDC 16571-0736?
A5: Focus on early market entry, building strong payer and provider relationships, demonstrating value through clinical evidence, and aligning with evolving regulatory and reimbursement policies.
References
[1] IMS Institute for Healthcare Informatics. The Global Use of Medicines. 2018.
[2] Grand View Research. Biologics Market Size, Share & Trends Analysis Report, 2021.
[3] IQVIA. Biosimilar Price Trends and Market Penetration. 2022.
[4] European Medicines Agency. Biosimilar Market Data, 2022.
