Last updated: February 26, 2026
What is the Therapy and Indication for NDC 00548-2311?
NDC 00548-2311 corresponds to Sotrovimab, a monoclonal antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology. It is authorized for emergency use to treat mild-to-moderate COVID-19 in high-risk patients, particularly those at risk of progressing to severe disease or hospitalization.
Current Market Landscape
Market Size
- The COVID-19 therapeutic market size for monoclonal antibodies (mAbs) was approximately $10 billion globally in 2022.
- The U.S. accounted for roughly 60% of this revenue.
- The market is expected to decline by 25% annually post-pandemic peak unless new variants sustain demand.
Product Portfolio
- Sotrovimab competes primarily with other mAbs, including Regeneron's Casirivimab and Imdevimab and Eli Lilly's Baricitinib.
- These products are authorized for similar indications, though some have limited efficacy against emerging variants.
Regulatory Status
- FDA issued Emergency Use Authorization (EUA) in May 2021.
- As of late 2022, the EUA was revoked due to reduced efficacy against new SARS-CoV-2 variants (e.g., Omicron subvariants).
- Limited use persists in select jurisdictions; full approval is pending.
Distribution and Utilization Trends
- Utilization has declined significantly with the advent of oral antivirals (e.g., Paxlovid).
- Administration is intravenous, requiring infusion centers, limiting deployment in outpatient settings.
- Supply is finite, constrained by manufacturing capacity and regulatory constraints.
Price Environment
Current Pricing
- Wholesale Acquisition Cost (WAC) for a single 500 mg infusion dose is approximately $2,100.
- Patient out-of-pocket costs vary depending on insurance coverage and administration fees.
- The average reimbursement rate for hospitals ranges from $2,000 to $2,500 per dose.
Price Trends
- During the peak of the pandemic, prices were negotiated downward.
- Pricing remained relatively stable through 2022 due to manufacturing costs and limited competition.
- Post-2022, with Phase-out of EUA usage, prices may decline further or shift toward residual or emergency procurement contracts.
Future Market and Price Projections
Short-Term Outlook (2023-2024)
| Year |
Estimated Market Size |
Price Range per Dose |
Key Drivers |
| 2023 |
<$1 billion |
$1,500 - $2,000 |
Decline in usage, supply constraints |
| 2024 |
<$500 million |
$1,000 - $1,500 |
Reduced demand, contractual stockpiles |
- Market contraction driven by emergence of oral therapeutics.
- Reduced EUA declarations limit new allocations.
- Some residual demand persists in immunocompromised populations.
Long-Term Outlook (2025+)
| Year |
Estimated Market Size |
Price Range per Dose |
Key Factors |
| 2025 |
<$200 million |
$500 - $1,000 |
End of COVID-19 emergency use, generic development, stockpile depletion |
- Prices may decline as demand diminishes, especially if biosimilar or generic versions are developed.
- Camera-ready applications for authorized use unlikely to return to pre-pandemic levels.
Price Projections: Comparisons and Assumptions
| Scenario |
Market Size |
Price per Dose |
Total Revenue |
Rationale |
| Optimistic |
$500 million |
$2,000 |
$250 million (125,000 doses) |
Emergency use in targeted high-risk groups, supply persists |
| Moderate |
$200 million |
$1,500 |
$75 million |
Narrow indications, residual government stockpiles |
| Pessimistic |
$50 million |
$1,000 |
$12.5 million |
Near-total decline, primarily residual orders |
Key Market Risks
- Variant evolution reducing efficacy.
- Regulatory withdrawal or restriction.
- The growth of oral antiviral options reducing demand.
- Manufacturing bottlenecks delaying supply.
Regulatory and Policy Impact
- The U.S. FDA revoked emergency use authorization in May 2022.
- Some countries continue to permit use under different protocols.
- Future reforms or approvals for other indications could alter the market path.
Key Takeaways
- NDC 00548-2311 (Sotrovimab) experienced a rapid market expansion during COVID-19.
- Market demand has declined sharply due to variant resistance and alternative therapies.
- Current prices hover around $2,000 per dose, with projections indicating potential reductions to below $1,000.
- Market size is expected to contract substantially by 2025, driven by decreased need and regulatory shifts.
- Long-term value largely tied to residual demand in specific patient populations and potential new indications.
FAQs
Q1: Will Sotrovimab return to the market for COVID-19 treatment?
A1: Unlikely, as EUA was revoked in May 2022; future availability depends on new efficacy data and regulatory approvals.
Q2: How does the price of Sotrovimab compare to other monoclonal antibodies?
A2: Prices are comparable; WAC is around $2,100 per dose, similar to Regeneron and Lilly products.
Q3: Are biosimilars involved in this market?
A3: No biosimilars are currently available, but development may occur if demand stabilizes or demand increases for other indications.
Q4: What factors could affect future price declines?
A4: Reduced demand, increased competition from oral therapeutics, supply abundance, or regulatory restrictions.
Q5: What is the primary driver for Sotrovimab's declining market?
A5: Reduced efficacy against new variants, alternative oral treatments, and the shift away from emergency authorized therapies.
