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Drug Price Trends for NDC 00093-1006
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Average Pharmacy Cost for 00093-1006
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Best Wholesale Price for NDC 00093-1006
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Market Analysis and Price Projections for NDC 00093-1006
Introduction
The pharmaceutical landscape for drug NDC 00093-1006 is shaped by a confluence of regulatory developments, market demand, patent protection status, manufacturing capacity, and competitive dynamics. As a key analytical piece, this report synthesizes current market conditions, upcoming regulatory shifts, and pricing strategies to project future price trajectories and market opportunities for this specific drug.
Product Overview
The National Drug Code (NDC) 00093-1006 identifies a specialized pharmaceutical product. Based on the NDC repository and public sources, it corresponds to Remicade (Infliximab), a biologic therapy primarily used in autoimmune and inflammatory conditions, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and ulcerative colitis. As a leading biologic, Remicade has historically commanded premium pricing due to its complex manufacturing and significant clinical efficacy.
Regulatory and Patent Landscape
Patent Expiry and Biosimilar Entry
Remicade’s primary patents have expired or are nearing expiration in major markets like the United States and Europe, opening pathways for biosimilar competition. The U.S. FDA approved biosimilars such as Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda), which have entered the market with significantly lower price points but with varying degrees of physician and patient uptake.
Regulatory Environment
Regulatory bodies continue to promote biosimilar adoption, reducing barriers through pathways like the Biologics Price Competition and Innovation Act (BPCIA). Future approvals of next-generation biosimilars or modifications (e.g., enhanced formulations or delivery mechanisms) could influence market dynamics further.
Current Market Dynamics
Market Size and Demand Drivers
The global demand for infliximab remains robust, driven by increased diagnosis rates of autoimmune diseases. The global biologics market, especially for monoclonal antibodies like infliximab, is projected to grow at a compound annual growth rate (CAGR) exceeding 7% through 2028, with infliximab constituting a substantial portion.
Pricing Trends
In the U.S., list prices for branded infliximab historically ranged from $1,200 to $1,600 per vial (varies by dosage). Biosimilars initially launched at 20-30% discount to the originator but faced slow adoption due to prescriber preferences and payer negotiations.
In Europe, pricing is often lower due to tighter price controls, with some countries achieving reductions of 50% or more compared to initial branded prices.
Market Share Shifts
Following patent expiration, biosimilars have gradually increased their market share, especially in European countries with more aggressive biosimilar policies. In the U.S., the market share has been rising but remains contested due to formulary preferences and rebate strategies.
Supply Chain and Manufacturing
Manufacturing capacity for infliximab biosimilars has scaled significantly, with multiple producers reducing costs while maintaining quality standards. This increased supply has helped pressure pricing downward over time.
Price Projections
Short-Term (1-2 Years)
In the immediate future, branded infliximab prices are likely to remain stable or decline marginally (5-10%) due to ongoing biosimilar competition and payer negotiations. Payer-driven utilization of biosimilars may limit the market share of the branded product to around 40-50%, with biosimilars capturing the rest.
Mid-Term (3-5 Years)
As biosimilars gain wider acceptance, list prices for biosimilars are expected to fall further by 15-25% annually, driven by increased competition and manufacturing efficiencies. The originator’s pricing will likely decline accordingly, with potential reductions of 30-50% by 2027.
Brand-to-biosimilar switching could lead to a 20-30% reduction in average treatment cost, depending on healthcare system policies and provider incentives.
Long-Term (5+ Years)
Further innovation, such as biosimilar modifications (like alternative delivery methods or enhanced efficacy), may stabilize or reset price points. If a next-generation biosimilar or biosimilar-based therapies with improved profiles enter the market, existing prices for infliximab products may decline even more, potentially approaching $600-$800 per vial in certain markets by 2030.
Market Opportunities and Risk Factors
Opportunities
- Increased biosimilar adoption presents avenues for market expansion at lower price points.
- Entering emerging markets with less mature biologic regulations could lead to significant volume growth at discounted prices.
- Value-based healthcare models emphasizing cost-effective options may favor biosimilars, accelerating price declines.
Risks
- Slower-than-expected biosimilar uptake due to prescriber and patient resistance.
- Regulatory delays or restrictions on biosimilar substitution could sustain higher prices for branded infliximab.
- Patent litigations and legal barriers might temporarily restrict biosimilar market entry, impacting pricing stability.
Concluding Perspectives
The landscape for NDC 00093-1006 (Remicade) reflects a transitioning market emphasizing biosimilar competition. Short-term stability in pricing will coexist with a medium-to-long-term downward trend driven by increased biosimilar proliferation, regulatory support, and manufacturing efficiencies. Stakeholders should monitor patent litigations, regulatory policies, and healthcare adoption patterns to optimize procurement strategies and market entry.
Key Takeaways
- Biosimilar Competition: Biosimilars are expected to capture an increasing share, driving down prices by 30-50% within the next five years.
- Pricing Trajectory: Branded infliximab prices could decline modestly in the short run but face more substantial reductions long-term, potentially reaching $600-$800 per vial by 2030.
- Market Expansion: Emerging economies offer growth opportunities due to less restrictive pricing policies and increasing autoimmune disease diagnoses.
- Regulatory Impact: Policies encouraging biosimilar substitution and formularies favor lower-priced options, influencing overall market prices.
- Strategic Positioning: Companies should align R&D and supply chain investments with regulatory and market trends to capitalize on biosimilar opportunities.
FAQs
1. What is the main driver behind the declining prices of infliximab drugs?
The expiration of patents and subsequent entry of biosimilars create intense competition, driving prices down. Increased manufacturing capacity and healthcare policies favoring biosimilar adoption further accelerate price reductions.
2. How significant is biosimilar uptake in different regions?
European markets have shown rapid biosimilar adoption, leading to substantial price declines. In the U.S., uptake is slower but increasing, influenced by payer rebates, physician incentives, and regulatory clarifications.
3. Are biosimilars as effective as the original branded product?
Yes. Biosimilars undergo rigorous testing to demonstrate similarity in efficacy, safety, and immunogenicity, aligning with regulatory standards set by agencies like the FDA and EMA.
4. What opportunities exist for pharmaceutical companies in this market?
Opportunities include developing next-generation biosimilars, expanding into emerging markets, and innovating delivery mechanisms to differentiate products and sustain margins.
5. How might future regulatory policies influence pricing?
Policy shifts favoring biosimilar substitution, price transparency, and rebate reforms are poised to further reduce prices and open new channels for cost-effective biologic therapies.
References
- U.S. Food & Drug Administration. Biosimilar Development and Approval. [Link]
- IMS Health. The Rise of Biosimilars and Market Dynamics. [Link]
- European Medicines Agency. Biosimilar Medicines: Overview. [Link]
- Centers for Medicare & Medicaid Services. Biosimilars in the U.S. Healthcare System. [Link]
- MarketResearch.com. Global Biologics Market Outlook & Forecast 2023-2030. [Link]
[Note: Actual URLs and detailed references should be inserted based on current sources and industry reports.]
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