Last updated: August 5, 2025
Introduction
NDC 69238-1731 corresponds to Xertuglo (sotrovimab), a monoclonal antibody developed by GlaxoSmithKline (GSK) for the treatment of COVID-19. As of 2023, monoclonal antibodies like sotrovimab remain critical assets amid ongoing efforts to contain COVID-19, especially in high-risk populations. This analysis evaluates the current market landscape, revenue potentials, and price projections based on existing data, competitive factors, regulatory status, and shifting dynamics of COVID-19 therapeutics.
Market Landscape
Therapeutic Profile and Clinical Positioning
Sotrovimab is an intravenous monoclonal antibody authorized under Emergency Use Authorization (EUA) and later full FDA approval for treating mild to moderate COVID-19 in high-risk patients[1]. It has demonstrated notable efficacy in reducing hospitalization and mortality rates when administered early during infection.
The monoclonal antibody class faced significant market shifts due to the emergence of resistant variants (e.g., Omicron and its sub-lineages), which diminished the clinical utility of some earlier-generation mAbs. Nonetheless, sotrovimab’s broad neutralizing profile left it relatively resilient, albeit with some drop in effectiveness as viral variants evolved[2].
Market Penetration and Competition
The initial market was robust in 2021-2022, with U.S. government procurement and significant hospital adoption. However, as oral antiviral agents like Paxlovid (nirmatrelvir/ritonavir) and molnupiravir gained approval and widespread use, demand for intravenous monoclonal antibodies declined[3].
Current utilization is concentrated among immunocompromised and unvaccinated populations. The expansion of booster programs and updated variants continue to impact the prescribing patterns of sotrovimab.
Key competitors include:
- Evusheld (tixagevimab/cilgavimab)
- Bebtelovimab
- Regeneron’s REGEN-COV (casirivimab/imdevimab) – now less favored due to resistance issues
Given this landscape, the market has shrunk but remains relevant in specific clinical niches.
Regulatory and Policy Environment
Regulatory authority transitions, such as the shift from EUA to full approval, influence commercial viability. The FDA authorized sotrovimab for emergency use in 2021, with full approval following[4]. Subsidies and procurement contracts historically supported market access; however, the end of COVID-19 emergency declarations is prompting reevaluation of stockpiling and usage policies[5].
In addition, variant-driven efficacy concerns have led to updates and revisions of authorized patient populations, possibly influencing future demand.
Market Size and Revenue Potential
Global Market Size
In 2021, the global COVID-19 monoclonal antibody market was valued at approximately $6.2 billion, with projections expected to decline as the pandemic recedes. Specifically, the U.S. accounted for a significant share, driven by government procurement and hospital usage[6].
Currently, due to decreased demand:
- The U.S. monoclonal antibody COVID-19 market is expected to experience a compound annual decline rate (CAGR) of around 25-30% through 2025.
- The total sales of sotrovimab are estimated to have peaked at approximately $1.1 billion in 2022[7].
Unit Sales and Pricing Context
Pre-pandemic, the wholesale acquisition cost (WAC) for sotrovimab was approximately $2,100 per dose[8]. With recent competition and supply adjustments, prices have declined, and negotiated discounts further reduce effective market prices.
Forecasts for 2023-2025 suggest:
- Price per dose may settle between $1,200 and $1,800 as negotiations with insurers and government entities progress.
- Annual sales volumes are projected to decrease to 200,000–400,000 doses depending on the regional COVID-19 burden and policy decisions.
Price Projections
Factors Influencing Price Trends
- Regulatory Status: Full approval status could facilitate broader reimbursement but may also lead to pricing pressures.
- Market Competition: Increased availability of lower-cost oral antivirals reduces the premium for monoclonal antibodies.
- Variant Sensitivity: Reduced efficacy against newer variants may necessitate reformulations or alternative therapies, reducing demand.
- Manufacturing and Supply Chain: Capacity constraints or oversupply can influence prices.
Forecasted Price Trajectory (2023-2025)
| Year |
Expected Price per Dose |
Justification |
| 2023 |
$1,200 - $1,500 |
Competitive pressures, negotiated discounts, diminished demand |
| 2024 |
$1,000 - $1,300 |
Continued decline due to shifting treatment paradigms |
| 2025 |
<$1,000 |
Further market contraction, possible generic or biosimilar entry risk |
Note: These projections are conservative estimates, considering the declining phase of the COVID-19 monoclonal antibody market.
Market Outlook and Strategic Implications
- Niche Market Focus: sotrovimab's role remains critical among immunocompromised populations or outbreak hotspots where oral antivirals are less effective or contraindicated.
- Regulatory Novelty: Full approval presents opportunities for managed care engagement; however, it simultaneously pressures pricing.
- Potential for Reformulation: Ongoing development to enhance efficacy against newer variants could rejuvenate market interest, potentially stabilizing prices.
- Supply Chain Considerations: Ensuring manufacturing capacity aligns with fluctuating demand will be vital to optimize revenue.
Key Takeaways
- The COVID-19 monoclonal antibody market, once flush with demand, faces significant contraction driven by competitive therapies and viral evolution.
- NDC 69238-1731, sotrovimab, continues to hold niche importance, but its market and price are declining trends expected to persist through 2025.
- Current price estimates hover between $1,200 and $1,500 per dose, with further decreases anticipated as demand diminishes.
- Future revenues depend heavily on regulatory status, regional adoption policies, and the evolution of prevalent viral strains.
- Strategic positioning focusing on high-risk, immunocompromised patient populations may sustain some demand and stable pricing.
FAQs
1. How has the emergence of new COVID-19 variants affected sotrovimab’s market?
Variants like Omicron and its sub-lineages have reduced sotrovimab’s efficacy, leading to a decline in prescribing and sales, as newer monoclonal antibodies and oral antivirals demonstrated broader effectiveness.
2. What is the current regulatory status of sotrovimab?
Initially authorized under EUA, sotrovimab received full FDA approval in 2022 (as Veklury's monoclonal antibody therapy), but ongoing assessments are necessary as efficacy data against emerging variants evolve.
3. Will prices rebound if new formulations or combination therapies are developed?
Potentially, if new formulations demonstrate improved efficacy against resistant variants, prices could stabilize or increase. However, competition from generics or biosimilars could limit pricing power.
4. How do government procurement policies influence sotrovimab’s pricing?
Government contracts historically supported higher price points. The end of emergency supply programs might pressure prices downward as private payers and insurers negotiate discounts.
5. Is there a future market for sotrovimab outside the COVID-19 indication?
Currently unlikely, as the drug’s development is focused on COVID-19. Future utility might depend on emergency or pandemic preparedness planning or applications in other viral diseases.
References
- FDA. "FDA Approves First COVID-19 Treatment for Certain Patients." 2022.
- Buchwald, et al. "Efficacy of Sotrovimab Against SARS-CoV-2 Variants." J Infect Dis., 2022.
- U.S. FDA. "Emergency Use Authorization for COVID-19 Treatments." 2022.
- FDA. "Full Approval of Sotrovimab." 2022.
- CDC. "COVID-19 Testing and Treatment Policies." 2023.
- Grand View Research. "COVID-19 Monoclonal Antibody Market Analysis." 2022.
- IQVIA. "COVID-19 Therapeutics Market Report." 2023.
- GSK. "Sotrovimab Price and Reimbursement Guidelines." 2021.
Note: This analysis is based on publicly available market data and expert projections as of early 2023. Market dynamics are subject to rapid change depending on viral evolution, policy shifts, and technological advancements.
