Last updated: February 13, 2026
What is NDC 59746-0281?
The National Drug Code (NDC) 59746-0281 is a proprietary drug product identified as Anifrolumab (Saphnelo), manufactured by AstraZeneca. Anifrolumab is a monoclonal antibody approved by the FDA for the treatment of systemic lupus erythematosus (SLE).
Market Overview
Market Size & Demand Drivers
- Target Population: SLE affects approximately 1.5 million Americans, with around 60,000 to 100,000 qualifying for biologic therapy like Anifrolumab.
- Treatment Landscape: Currently, available therapies include immunosuppressants and corticosteroids. Biologics like Anifrolumab offer targeted therapy options, with clinical trials showing improved disease control.
- Market Penetration: As a relatively new entrant (FDA approval in August 2021), Anifrolumab's market share remains focused on specialized rheumatology centers. Its growth depends on clinical adoption, insurance reimbursement, and physician familiarity.
Competition
| Product |
Indication |
Market Share (2022) |
Price Range (per dose) |
Manufacturer |
| Belimumab (Benlysta) |
SLE |
Dominates biologic market |
$3,000–$3,500 (weekly doses) |
GSK |
| Rituximab |
Off-label for SLE |
Varies |
$2,000–$4,000 per infusion |
Genentech (Roche) |
| Anifrolumab (Saphnelo) |
SLE |
Emerging |
$31,000 annually (approx.) |
AstraZeneca |
Pricing & Reimbursement Factors
- Price set at approximately $31,000 annually, based on current wholesale acquisition costs (WAC) and customary dosing regimens.
- Reimbursement depends on payer policies, with Medicare and Medicaid covering biologics for SLE under most cases.
Price Projection Analysis
Historical Pricing Trends
- Biologics for autoimmune diseases have shown a trend of steady price increases averaging 3-5% annually over the past decade.
- Initial launch price for Anifrolumab (2021) was close to $30,000 annually, aligning with market expectations for monoclonal antibodies.
Projection Models
| Year |
Estimated Price (USD) |
Basis |
| 2023 |
$31,000 |
Stable, with slight inflation (2%) |
| 2025 |
$32,000–$33,000 |
Average 3-5% increase |
| 2030 |
$36,500–$38,000 |
Continued inflation and market maturation |
Assumptions: Price adjustments primarily driven by inflation, R&D costs, and competitive dynamics. Market access expansion and payer negotiations could influence lower wholesale prices.
Market Penetration and Volume Effects
- Estimated treatment volume in 2023: 2,000–3,000 patients.
- Growth rate forecast: 12–15% annually over five years, reflecting increased adoption, expanded indications, and improved physician familiarity.
Revenue Forecasts
| Year |
Estimated Revenue (USD millions) |
Assumptions |
| 2023 |
$62–$93 |
2,000–3,000 patients, $31K/year |
| 2025 |
$125–$177 |
3,000–4,500 patients, increasing volume |
| 2030 |
$245–$342 |
Further volume growth and slight price inflation |
Key Market Risks and Opportunities
- Risks: Reimbursement challenges, patent expiration (~2034), potential biosimilar entry, and clinical development setbacks.
- Opportunities: Expanded label indications, combination therapies, improved physician education, and favorable payer coverage.
Key Takeaways
- NDC 59746-0281 (Anifrolumab) market is in early growth, with a current annual treatment price of approximately $31,000.
- Market expansion hinges on increased physician adoption and payer coverage.
- Price growth is projected at 2–5% annually, aligned with industry trends for biologics.
- Revenue prospects reflect rising treatment volume, expected to grow at 12–15% annually over the next five years.
- Competition from established biologics like Belimumab limits immediate market share; however, Anifrolumab's targeted mechanism offers differentiated value.
FAQs
1. How does the price of Anifrolumab compare to similar biologics?
It is comparable to Belimumab, which costs $3,000–$3,500 per week ($30,000–$36,000 annually). Anifrolumab's annual cost (~$31,000) aligns with these market standards.
2. What factors could influence price fluctuations?
Inflation, market competition, negotiating power of payers, and manufacturing costs. Patent expiration and biosimilar entry could also drive prices downward.
3. How significant is treatment volume for revenue projections?
Treatment volume greatly impacts revenue. A 1,000-patient increase increases revenue by approximately $31 million annually at current pricing.
4. Are there upcoming regulatory or market changes that could affect Anifrolumab?
Potential label expansions or additional indications may boost sales. Conversely, biosimilar development could pressure prices after patent expiration.
5. What is the likelihood of market share growth for Anifrolumab?
Moderate; early adoption suggests potential, but it depends on clinical guidelines, payer acceptance, and competition. Anticipated higher-volume use over five years supports positive growth forecasts.
References
- FDA. Saphnelo (Anifrolumab-fnia) Prescribing Information. 2021.
- IQVIA. Biologic Market Analysis. 2022.
- GSK, Belimumab Pricing Data. 2022.
- AstraZeneca. Saphnelo U.S. Launch Report. 2021.
- MarketWatch. Biologic Therapies Price Trends. 2022.
