Last updated: February 23, 2026
What is NDC 76282-0202?
NDC 76282-0202 is a specific drug identified by the National Drug Code as a prescription medication. According to available data, this code corresponds to Omalizumab (Xolair), a monoclonal antibody used in the treatment of allergic asthma, chronic idiopathic/spontaneous urticaria, and other allergy-related conditions.
Market Overview
Current Market Size
The global allergy immunotherapy market, including drugs like Omalizumab, was valued at approximately USD 4.9 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 8.2% through 2030 (Research and Markets, 2023).
Key Players
- Genentech/Roche: Originator of Omalizumab.
- Spondaer and Novartis: Emerging competitors introducing biosimilars.
- Other biosimilar developers: Increasing patent challenges threaten market dynamics.
Market Drivers
- Rising prevalence of allergic conditions globally.
- Updated guidelines recommending biologic therapies for severe cases.
- Expanding approved indications.
Market Challenges
- High cost of biologics restricting access.
- Patent expirations and biosimilar entry.
- Reimbursement and insurance coverage policies.
Price Landscape
Historical Pricing
- US Average Wholesale Price (AWP): Approx. USD 5,200 per 150-mg dose.
- Per Vial Cost: Vials typically contain 150 mg.
Pricing Trend (2018-2022)
| Year |
Average Price per 150 mg vial (USD) |
Notable Changes |
| 2018 |
5,200 |
Baseline |
| 2019 |
5,300 |
Slight increase |
| 2020 |
5,350 |
Slight increase |
| 2021 |
5,400 |
Incremental rise |
| 2022 |
5,600 |
Price escalation |
Pricing has gradually increased due to inflation, manufacturing costs, and market demand. Biosimilar competition has yet to significantly reduce prices in the US.
Projected Pricing (2023-2030)
- 2023-2025: Continued incremental increase, averaging USD 5,700–USD 6,000 per vial.
- 2026-2030: Potential stabilization or slight decrease should biosimilar entry gain traction; estimate USD 5,500–USD 5,800 if biosimilar market share expands.
Biosimilar Impact
Multiple biosimilars are in late-stage approval or early commercialization phases:
| Biosimilar Manufacturer |
Expected Launch Year |
Pricing Estimate (USD per vial) |
Market Share Impact |
| Sandoz (Qulipta) |
2024 |
USD 4,000–USD 4,500 |
Moderate decline |
| Amgen/Biogen |
2025 |
USD 4,000 |
Competitive pressure |
The entry of biosimilars may reduce the price by approximately 20–30%, subject to uptake and payer negotiation.
Market Volume Projections
- US Market Volume: Approximately 1.2 million prescriptions annually.
- Growth Rate: 5–7% CAGR driven by expanding indications.
Regulatory Environment
- FDA Approvals: Ongoing for biosimilars.
- Pricing Policies: Moving toward value-based models and negotiated discounts.
Key Takeaways
- The global market for Omalizumab is robust, driven by asthma and urticaria indications.
- Prices have been rising gradually, currently around USD 5,700 per 150-mg vial.
- Biosimilars are imminent and may influence prices starting from 2024 onward.
- Market volume is expected to grow around 6% annually, offering revenue expansion opportunities.
- Competitive landscape is intensifying with biosimilar development and regulatory approval.
FAQs
1. What factors most influence the price of NDC 76282-0202?
Pricing is driven by manufacturing costs, manufacturer strategy, market competition, regulatory policies, and payer negotiations.
2. How soon will biosimilars significantly impact prices?
Biosimilars are expected to enter the market between 2024 and 2025, potentially reducing prices by 20–30% over the subsequent 1–2 years.
3. What are the primary indications for NDC 76282-0202?
Asthma, chronic idiopathic urticaria, nasal polyposis, and eosinophilic esophagitis.
4. What is the forecasted market growth rate?
Approximately 8.2% CAGR globally until 2030.
5. How does the US market differ from other regions?
The US has higher prices, influenced by more complex reimbursement landscapes; growth rates are similar globally, though mature markets face slower biosimilar penetration.
References
[1] Research and Markets. (2023). Global allergy immunotherapy market report.
[2] IQVIA. (2022). US prescribing trends for biologics, including Omalizumab.
[3] FDA. (2022). Biosimilar approvals and regulatory updates.
