Last updated: March 2, 2026
What is the Drug Identified by NDC 00093-7474?
The National Drug Code (NDC) 00093-7474 refers to Tocilizumab (brand name Actemra). It is an immunosuppressive drug administered intravenously or subcutaneously. It is approved primarily for rheumatoid arthritis, juvenile idiopathic arthritis, and certain cytokine release syndromes, including those associated with COVID-19.
Market Overview
Current Market Landscape
| Segment |
Details |
| Therapeutic Use |
Rheumatoid arthritis, juvenile arthritis, cytokine storm |
| Key Competitors |
Sarilumab (Kevzara), Anakinra (Kineret), Sarilumab (Kevzara) |
| Market Size (2022) |
$1.2 billion globally |
| Major Regions |
United States, Europe, Asia-Pacific |
| Approval Status (US) |
FDA-approved for rheumatoid arthritis, cytokine storm |
| Sales Growth (2020–2022) |
CAGR approximately 8% |
Market Dynamics
- COVID-19 Pandemic Impact: Increased demand for immunomodulators like Tocilizumab during acute cytokine storm management.
- Rheumatoid Arthritis: Stable demand driven by repositioning and expanded indications.
- Biosimilar Entry: Biosimilar versions are in late-stage development, impacting pricing and market share.
- Regulatory Developments: Pending approvals for subcutaneous formulations expand usage options.
Regulatory Environment
| Year |
Development |
Impact |
| 2017 |
FDA approved subcutaneous Tocilizumab |
Expanded administration options |
| 2022 |
EU approval for biosimilars |
Increased competition, potential price reduction |
| 2023 |
Ongoing trials for new indications |
Potential expansion of market |
Price Analysis
Current Pricing (US)
| Formulation |
Average Wholesale Price (AWP) |
Estimated List Price (2023) |
| IV Tocilizumab (40 mg/mL) |
$4,200 per 200 mg dose |
$4,300 per dose |
| Subcutaneous (162 mg/0.9 mL) |
$1,150 per prefilled syringe |
$1,200 per syringe |
These prices vary by pharmacy, insurer discounts, and negotiated rebates.
Biosimilar Impact
| Biosimilar Name |
Approximate Price Reduction |
Expected Market Entry |
| Actemra biosimilar 1 |
15-20% below originator |
Late 2024 |
| Actemra biosimilar 2 |
25-30% below originator |
2025–2026 |
Price Trends Forecast (Next 5 Years)
| Year |
Expected Average Price (US) |
Key Drivers |
| 2023 |
$1,200 per syringe |
Current market, biosimilar competition |
| 2024 |
$1,100 per syringe |
Biosimilar entry, increased market competition |
| 2025 |
$1,000 per syringe |
Wider biosimilar adoption, potential price pressures |
| 2026 |
$950 per syringe |
More biosimilars, payer negotiations |
| 2027 |
$900 per syringe |
Market stabilization, improved biosimilar penetration |
Market Projections
- Global Market Size: Projected to reach $2.2 billion by 2027, with a CAGR of 9% from 2022 to 2027.
- US Market: Expected to sustain around $850–$950 million annually, driven by expanding indications and biosimilar uptake.
- Emerging Markets: Rapid growth anticipated, with Asia-Pacific CAGR near 12%, fueled by increasing access and healthcare infrastructure improvements.
Critical Factors Influencing Future Prices and Market Share
- Biosimilar Competition: Entry of biosimilars is forecasted to decrease prices by 15-30%, affecting revenue margins.
- Regulatory Approvals: Expanded indications and new administration routes could drive volume increases.
- Reimbursement Policies: Payer strategies to negotiate prices could dampen growth if biosimilar cost savings are prioritized.
- Manufacturing Costs: Potential reductions due to process improvements could influence pricing strategies.
Summary Table: Key Data Points
| Variable |
Data/Projection |
| Current global market value |
$1.2 billion in 2022 |
| Forecast (2027) |
$2.2 billion |
| US market share |
~70% of global sales in 2022 |
| Price range (2023) |
$1,150–$4,300 per dose |
| Biosimilar price reduction |
15-30% compared to originator |
| Biosimilar market entry |
2024–2026 |
| CAGR (2022–2027) |
9% |
Key Takeaways
- The Tocilizumab market is growing steadily, driven by rheumatoid arthritis and cytokine storm treatment.
- Biosimilars will exert downward pressure on prices starting around 2024–2025.
- US market dominance persists, but emerging regions offer growth opportunities.
- Price reductions are likely as biosimilars gain adoption, with a projected decline of approximately 10–20% annually after 2023.
- Expanding indications and improved formulations could offset some price pressures through increased volume.
FAQs
1. What factors most impact Tocilizumab pricing?
Biosimilar entry, regulatory approvals, and payer negotiations influence pricing. Volume increases due to expanded indications also affect revenue.
2. How soon will biosimilars significantly affect prices?
Biosimilars are expected to enter the market between 2024 and 2026, with three to five years needed to substantially erode originator sales.
3. What regions offer the highest growth potential?
Asia-Pacific exhibits the highest CAGR at around 12%, driven by increasing healthcare access and affordability.
4. Are there new indications that could extend market longevity?
Yes, current clinical trials target conditions like giant cell arteritis and certain autoimmune disorders, potentially broadening its use.
5. How do updates in regulatory policies influence market projections?
Stricter reimbursement frameworks and accelerated approvals can both promote market expansion and exert pricing pressures.
[1] U.S. Food and Drug Administration. (2022). Actemra (tocilizumab) Highlights.
[2] MarketWatch. (2022). Global Tocilizumab Market Size, Share & Trends.
[3] IQVIA. (2023). Biologic Market Report.
