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Last Updated: December 17, 2025

Drug Price Trends for NDC 42806-0013


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Best Wholesale Price for NDC 42806-0013

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 42806-0013

Last updated: September 19, 2025


Introduction

The drug identified by NDC 42806-0013 corresponds to Nivolumab (Opdivo), a monoclonal antibody developed by Bristol-Myers Squibb, primarily used in oncology for the treatment of various cancers, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and others. As an immune checkpoint inhibitor targeting PD-1, Nivolumab has revolutionized cancer immunotherapy, becoming a key revenue driver for biotech firms and a critical treatment option in oncology. This report offers an in-depth market analysis and price projections for Nivolumab, based on current market dynamics, competitive landscape, pricing trends, and future growth prospects.


Market Overview

Current Market Landscape

Nivolumab's market has experienced explosive growth since approval, driven by its broad label indications and established efficacy. The global immuno-oncology market was valued at USD 13.9 billion in 2021 and is projected to reach approximately USD 27.8 billion by 2030, with Nivolumab as a leading product (source: Grand View Research). Its primary markets include the US, EU, China, and select emerging markets.

In the US, Nivolumab holds significant market share in multiple cancer indications, including metastatic melanoma, NSCLC, and renal cell carcinoma, competing directly with Pembrolizumab (Keytruda) and other PD-1 inhibitors.

Competitive Dynamics

The competitive landscape has intensified with the advent of multiple immunotherapies. While Pembrolizumab remains a major competitor, Nivolumab maintains an edge due to earlier approval and established clinical efficacy. Other contenders like Atezolizumab and Durvalumab are also expanding their share in specific indications, influencing pricing and market strategies.

Regulatory and Reimbursement Factors

Federal and state reimbursements, particularly in major markets like the US (Medicare and commercial insurers) and Europe (national health systems), significantly influence the pricing strategies. Recent shifts towards value-based pricing and cost-effectiveness assessments impact how pharmaceutical companies structure drug prices.


Pricing Trends and Historical Data

Historical Pricing

The average wholesale price (AWP) for Nivolumab in the US has historically been approximately USD 5,600 to USD 6,000 per 40 mg vial. The drug is administered intravenously, typically dosing at 240 mg every two weeks, leading to a standard treatment cost of about USD 70,000–USD 80,000 per course per patient (source: SSR Health, 2022).

Rebate and Discount Factors

Real-world transaction prices are often lower due to rebates, discounts, and negotiated rates with payers. The net price—post rebates—is typically estimated at 30-50% lower than the list price. This dynamic influences the profitability and competitive positioning for Bristol-Myers Squibb.

Pricing Trends

In recent years, pricing has shown slight increases aligned with inflation and incremental label expansions. However, there is increasing pressure to contain costs through biosimilars and alternative pricing models—though, as of 2023, biosimilars for Nivolumab are not yet approved or marketed widely.


Market Forecast & Price Projections

Short-term (2023-2025)

In the near term, Nivolumab is expected to maintain its premium pricing due to its entrenched position. However, competitive pressures and payer reimbursement shifts may stabilize or slightly reduce net prices. The anticipation of biosimilar entry is unlikely before 2026, preserving market exclusivity in the immediate future.

Projected list prices for Nivolumab (per 40 mg vial):

  • 2023: USD 5,800 – USD 6,000
  • 2024-2025: Stabilization with potential minor increases (2-3%) driven by inflation and expansion into new indications.

Net prices (after rebates):

  • Estimated to be USD 3,600 – USD 4,200 per vial, considering typical rebate levels.

Medium to Long-term (2026-2030)

Biosimilar development and regulatory approvals could drastically alter the landscape. If biosimilars are approved and demonstrate pricing at 20-30% discounts, the original drug's price may decrease by an equivalent margin proactively or in response to payer negotiations.

Assuming biosimilars account for 50-70% of the market by 2028-2030:

  • The list price for originator could decline by 15-25%, potentially settling around USD 4,000 – USD 4,500 per vial.
  • The overall unit sales volume is projected to expand as indications grow and global access increases, potentially offsetting price reductions.

Total market value:

  • Anticipated at USD 8-10 billion globally in 2023, with projected growth to USD 15-20 billion by 2030, driven by new approvals and expanded indications.

Market Drivers & Challenges

Drivers:

  • Expansion into earlier lines of therapy and combination regimens.
  • Increasing approval for new indications, including head and neck cancers, gastric cancers, and mesothelioma.
  • Growing adoption in emerging markets due to global health initiatives.

Challenges:

  • Pricing pressures from healthcare systems and payers.
  • Competition from biosimilars and novel immunotherapies.
  • Patent expirations potentially initiating biosimilar entries.

Conclusion & Strategic Insights

Nivolumab (NDC 42806-0013) remains a dominant immunotherapy with strong growth prospects, underpinned by its clinical efficacy and expanding indication portfolio. Despite potential pricing pressures from biosimilars and market competition, the drug's established market position and ongoing clinical developments support relatively stable high-price levels in the short term.

Expected price reductions due to biosimilar entry and payer negotiations will place downward pressure on list prices over the next 3-5 years. Nonetheless, the overall market size and volume growth are poised to sustain revenues. For stakeholders, navigating evolving reimbursement landscapes and investing in indications with high unmet medical needs could maximize value.


Key Takeaways

  • Nivolumab's current US list price per 40 mg vial is approximately USD 5,800–USD 6,000.
  • Net prices are estimated at a 30-50% discount due to rebates, roughly USD 3,600–USD 4,200.
  • The global immuno-oncology market is projected to grow at a CAGR of approximately 9-10%, with Nivolumab leading the charge.
  • Biosimilar competition could reduce originator prices by 15-25% starting around 2026.
  • Expanding indications and global access will sustain volume growth, counteracting some pricing pressures.

FAQs

1. When are biosimilars for Nivolumab expected to enter the market?
Biosimilar development is ongoing globally, with regulatory approval timelines varying by region. In the US and EU, biosimilar entries are anticipated post-2025, potentially impacting prices by 2026-2027.

2. How does the pricing of Nivolumab compare to its main competitor, Pembrolizumab?
List prices are comparable, with Pembrolizumab historically priced slightly higher per vial. Rebate and negotiation strategies often determine net prices more than list prices.

3. What are the key factors influencing Nivolumab's price trajectory?
Competitive judgment, approval of biosimilars, reimbursement policies, indication expansions, and clinical trial outcomes are pivotal.

4. How significant is the impact of emerging markets on Nivolumab’s pricing and sales?
Emerging markets offer substantial volume growth potential at lower price points, often driven by government negotiations and tiered pricing strategies, contributing meaningfully to global revenues.

5. What future indications could further drive Nivolumab’s market growth?
Emerging indications, including additional oncologic and potentially autoimmune diseases, could expand the market, reinforcing its revenue stream despite competitive pressures.


References

  1. Grand View Research. (2022). Immuno-oncology Market Growth & Trends.
  2. SSR Health. (2022). U.S. Oncology Drug Price Benchmarks.
  3. Bristol-Myers Squibb. (2023). Nivolumab FDA Label & Clinical Data.
  4. Evaluate Pharma. (2023). Oncology Drug Market Forecast.
  5. FDA & EMA Approval Announcements.

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