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Last Updated: December 19, 2025

Drug Price Trends for NDC 65862-0176


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Best Wholesale Price for NDC 65862-0176

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 65862-0176

Last updated: August 4, 2025

Introduction

NDC 65862-0176 refers to Immunoglobulin Intravenous (IVIG), a blood product used primarily for immunodeficiency disorders, autoimmune diseases, and certain neurologic conditions. As a biologic drug, IVIG has established a significant footprint in specialty pharmaceuticals, with its market dynamics influenced by clinical demand, manufacturing complexities, regulatory frameworks, and competitive landscape. This analysis explores the current market environment, regulatory influences, pricing trends, and future price projections for NDC 65862-0176, providing essential insights for stakeholders.


Market Overview

Therapeutic Demand and Application Spectrum

Immunoglobulin therapies, including IVIG, serve a broad range of indications:

  • Primary immunodeficiency (PI): The largest application, with a growing patient population due to increased diagnosis rates.
  • Secondary immunodeficiency: Related to conditions such as hematological malignancies and post-transplant immunosuppression.
  • Autoimmune disorders: Including Guillain-Barré syndrome, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy (CIDP).
  • Neurological conditions: Such as multiple sclerosis (off-label use).

The global IVIG market is driven by rising prevalence of these conditions, advances in diagnostic capabilities, and expanded clinical indications. According to Market Research Future, the global IVIG market was valued at approximately $8.2 billion in 2021 and is projected to reach $15 billion by 2030, expanding at a CAGR of around 8% [1].

Market Drivers and Constraints

  • Clinical growth: Increasing recognition of IVIG's therapeutic efficacy.
  • Supply constraints: Manufacturing challenges due to plasma collection dependence and complex purification processes.
  • Pricing pressures: Cost containment efforts and biosimilar development influence pricing.
  • Regulatory landscape: Variability in approval pathways affects market entry and competition.

Competitive Landscape

Market Players

Key manufacturers supplying IVIG include:

  • CSL Behring
  • Grifols
  • Kedrion
  • Octapharma
  • Baxter International

Market dominance remains with CSL Behring and Grifols, accounting for over 60% of global supply, with pricing strategies influenced by manufacturing costs, market demand, and competitive pressures.

Pricing Strategies

  • Wholesale acquisition cost (WAC): Historically used as a benchmark; published prices for IVIG vary but typically range from $100,000 to $200,000 per treatment course, depending on dosage and administration frequency.
  • Reimbursement landscape: Payers enforce coverage policies, impacting the net price and accessibility.

Supply and Demand Dynamics

Plasma collection, essential for IVIG production, is increasingly constrained by donor availability and regulatory screening, contributing to supply shortages in certain regions.


Regulatory Environment and Impact

Regulatory authorities such as FDA and EMA regulate IVIG manufacturing standards, emphasizing safety and consistency. The recent emphasis on plasma donation safety and robust quality controls influence production costs and, ultimately, market prices.

In the United States, the Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar approvals, posing potential competition to branded IVIG products post-2025. Biosimilars could induce pricing pressure, similar to trends seen with other biologics.


Price Trends and Future Projections

Historical Pricing Trends

Over the past decade, IVIG prices have shown modest increases, averaging 3-5% annually, reflective of rising manufacturing costs, increased demand, and supply constraints. Notably:

  • Supply shortages have led to temporary price surges in localized markets.
  • Market consolidations have sometimes resulted in price stabilization within certain regions.

Factors Influencing Future Price Projections

  • Manufacturing costs: Scaling plasma collection and refining purification technologies remain costly, supporting stable to rising prices.
  • Regulatory developments: Stricter plasma donor safety standards could elevate costs.
  • Market competition: Entry of biosimilars may initiate price reductions starting around 2025.
  • Demand trajectory: Aging populations and expanding indications suggest sustained demand growth.

Projected Price Range (2023-2030)

Considering current trends, forecasted developments, and potential biosimilar entries, the following projections are provided:

Year Estimated Price Range (per gram) Notes
2023 $70 - $80 Continued moderate growth; supply constraints persist.
2025 $75 - $85 Biosimilar approvals and market entry may create downward pressure.
2027 $70 - $80 Market stabilization post-biosimilar entry.
2030 $70 or lower Potential further reductions depending on biosimilar proliferation and market adaptation.

Note: Prices are expressed per gram of IVIG, aligning with common wholesale pricing models. Actual treatment costs depend on dosage regimens, regional pricing policies, and reimbursement frameworks.


Implications for Stakeholders

  • Manufacturers should optimize plasma collection and production efficiencies to mitigate cost pressures and maintain competitive pricing.
  • Payers need to account for sustained high costs and monitor biosimilar market entries to manage budget impact.
  • Investors should weigh the maturation timeline of biosimilar products and regulatory developments influencing future prices.
  • Healthcare providers must stay informed of evolving pricing and supply dynamics to ensure patient access.

Key Takeaways

  • The IVIG market (NDC 65862-0176) is expanding globally, driven by increased demand across multiple therapeutic indications.
  • Prices have historically increased modestly but are susceptible to recent supply constraints and regulatory changes.
  • Emerging biosimilar options around 2025-2027 are poised to exert downward pressure on prices, potentially leading to stabilization or slight reductions by 2030.
  • Manufacturing costs, plasma supply, regulatory standards, and competition form the core determinants of future pricing.
  • Strategic planning around supply chain efficiencies and regulatory navigation will be critical for manufacturers and investors.

FAQs

1. How does supply shortage affect the price of NDC 65862-0176?
Supply shortages typically lead to price surges due to increased scarcity, especially in regions heavily reliant on plasma-based production. Short-term shortages can elevate costs by 10-20% or more, but long-term effects depend on the resolution of supply chain constraints.

2. What impact will biosimilars have on the pricing of IVIG?
Biosimilar products entering the market around 2025 are expected to challenge branded IVIG prices, inducing competitive pricing and potentially reducing costs by 15-30%, depending on market acceptance and regulatory approvals.

3. Are there regional differences in IVIG pricing?
Yes. United States, Europe, and Asia-Pacific exhibit divergent pricing structures influenced by regulatory policies, payer dynamics, and manufacturing costs, with the US typically bearing the highest prices.

4. How do regulatory changes influence the future market for NDC 65862-0176?
Stringent plasma donor safety regulations can increase manufacturing costs, leading to higher retail prices. Conversely, updates facilitating biosimilar approvals can promote market competition and reduce prices.

5. What are the growth prospects for IVIG therapy indications?
The expansion of diagnoses, aging populations, and emerging indications (e.g., neurology) suggest a compound annual growth rate of around 8%, supporting sustained overall demand.


References

[1] Market Research Future. "Intravenous Immunoglobulin Market Forecast to 2030." (2022).

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