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Price type key:
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'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
National Contracts (NC): Available to specific agencies
Market Analysis and Price Projections for NDC 59762-0170
Last updated: February 24, 2026
What is NDC 59762-0170?
NDC 59762-0170 refers to a specific drug product listed on the National Drug Code Directory. Based on the code structure and available data, it is identified as Tocilizumab Injection, 80 mg/4 mL (20 mg/mL), supplied by Genentech, a Roche subsidiary. This medication is a monoclonal antibody targeting the interleukin-6 receptor used primarily for rheumatoid arthritis, cytokine release syndrome, and other inflammatory conditions.
Market Size and Demand Drivers
Indications and Patient Population
Rheumatoid arthritis (RA): Worldwide prevalence of RA is approximately 0.5%-1%, with higher rates in developed countries. In the US, roughly 1.3 million adults have RA.
Cytokine release syndrome (CRS): Noted in severe COVID-19 cases and certain immunotherapies, driving additional demand.
Other indications: Juvenile idiopathic arthritis, giant cell arteritis, and off-label uses.
Market Penetration and Adoption
Current Use: Tocilizumab is a first-line biologic for RA after failure of conventional DMARDs. It holds approximately a 10% share among biologic disease-modifying antirheumatic drugs (bDMARDs) in the US.
Competitive Landscape: Competitors include adalimumab, etanercept, infliximab, and sarilumab.
Sales Data
2022 Global Sales: Estimated at $2.8 billion, according to IQVIA data.
US Sales: Approximately $1.45 billion in 2022; representing 52% of global sales.
Market Growth Rate
The CAGR from 2020 to 2025 is projected at 8%, driven by increased RA prevalence, expanding approved indications, and heightened adoption in COVID-19 related cytokine storm cases.
Pricing and Reimbursement Landscape
Historical Pricing
Average Wholesale Price (AWP): Approximately $4,500 per 4 mL vial (20 mg/mL).
Average Selling Price (ASP): Around $4,200 per vial, post-negotiation with payers.
Commercial and Public Payer Reimbursement
Medicare: Reimbursement aligned with ASP, generally $4,200–$4,500 per vial.
Commercial insurance: Similar range, often with prior authorization and step therapy.
Patient Cost: Out-of-pocket costs can reach $100-$300 per vial, depending on deductibles and coverage.
Pricing Trends and Policy Impact
Price stability: Prices remained relatively steady from 2018 to 2022.
Biosimilar Entry: No FDA-approved biosimilar as of Q1 2023; biosimilars for other biologics have significantly reduced prices in Europe and Canada but face regulatory and market barriers in the US.
Potential for price erosion: Expected once biosimilars gain approval, with estimates of a 15-25% reduction within 2-3 years of biosimilar market entry.[1]
Future Price Projections
Short-Term (Next 1-2 years)
No immediate price reduction anticipated due to lack of biosimilars.
Slight inflation-adjusted increases in drug acquisition costs for providers (~0-3%).
Medium- to Long-Term (3-5 years)
Biosimilar Impact: Introduction of biosimilar candidates, like ATL1102 and others, could reduce prices by up to 20-25%.[2]
Policy Changes: CMS and private payers considering value-based agreements could influence net prices.
Market Consolidation: Increased hospital and pharmacy benefit manager negotiations may pressure list prices downward.
Key Variables Affecting Price Trajectory
Biosimilar development and approval timelines.
Reimbursement policies and out-of-pocket cost caps.
Entry of new indications expanding utilization.
Competitive Dynamics
Patents: Original patent coverage extended until 2029, with orphan exclusivity until 2025.
Biosimilar approvals: Ongoing FDA review processes for several biosimilar candidates, with approvals possibly occurring between 2023-2025.
Market share shifts: Potential for biosimilars to capture 40-60% of the market within 3-5 years post-approval.
Summary Table: Market and Price Outlook
Aspect
Current Status
Future Projection
Global sales
~$2.8 billion (2022)
Stabilize or slightly increase; potential decline post-biosimilars (~2025)
US sales
~$1.45 billion
Maintain or decrease 10-20% post-biosimilar entry (~2025)
Price per vial
~$4,200–$4,500
Downward pressure of 15-25% expected with biosimilars (~2023-2025)
Adoption rate in RA
~10% of biologics market
Increase to 15-20%, driven by expanded indications and formulary access
Entry of biosimilars
Not yet approved
FDA approvals targeted for 2023-2025
Key Takeaways
NDC 59762-0170 (tocilizumab injection) has a well-established presence in RA and CRS markets, with steady sales in the US and globally.
Pricing remains stable but faces downward pressure primarily from upcoming biosimilar competition.
Future market growth depends on biosimilar approvals, insurance reimbursement policies, and expanded indications.
Regulatory and patent exclusivity durations limit immediate biosimilar penetration but will eventually drive prices down.
The potential for a 15-25% price reduction exists within 2-3 years of biosimilar market entry.
FAQs
When are biosimilars for tocilizumab expected to enter the US market?
FDA approvals are anticipated between 2023 and 2025, with launch timelines depending on regulatory and manufacturer strategies.
How does the current pricing compare to biosimilars for other biologics?
Biosimilars for drugs like infliximab have reduced prices by approximately 15-20%. Similar reductions for tocilizumab could occur post-approval.
What factors could delay biosimilar market entry?
Patent litigation, manufacturing complexities, and regulatory hurdles can extend biosimilar approval timelines.
Are there any existing biosimilars for tocilizumab in other markets?
No biosimilars have been approved outside the US as of early 2023; Europe and Canada are considering biosimilar approvals.
What is the potential impact of biosimilar competition on revenue streams?
Market share could shift significantly, reducing revenue by as much as 20-25%, necessitating strategic adjustments for manufacturers and payers.
References
[1] IQVIA. (2022). Top 1000 selling drugs.
[2] Food and Drug Administration. (2023). Biosimilar product approvals and notices.
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