Last updated: February 15, 2026
What is NDC 00955-1048?
NDC 00955-1048 corresponds to Kybella (deoxycholic acid), a prescription injectable used to reduce submental fat (double chin). Approved by the FDA in 2015, Kybella is marketed by Allergan (now part of AbbVie). It is the only FDA-approved injectable treatment for submental fat reduction.
Market Overview
Market Size:
The global fat reduction market was valued at approximately $4.5 billion in 2022, with the non-invasive and minimally invasive segments growing annually at about 7%.
Key Drivers:
- Rising demand for aesthetic procedures.
- Increasing prevalence of obesity and obesity-related concerns.
- Growing acceptance of non-surgical fat reduction treatments.
- FDA approvals for additional indications for injectable fat reduction agents.
Competition:
Primarily competing products include CoolSculpting (cryo-lipolysis), liposuction, and other emerging injectable agents. Kybella holds a dominant position due to its status as first FDA-approved injectable specifically for submental fat.
Market Penetration:
Kybella's penetration in the U.S. remains high, with approximately 1 million treatments administered since approval. Still, potential exists for growth in international markets, especially in Europe and Asia.
Price Dynamics and Revenue
Average Price per Treatment:
Typically ranges between $600 and $1,200 depending on geography, provider, and case complexity. The recommended dose for submental fat ranges from 50 to 100 mg per session, with an average treatment course involving 2-4 sessions.
Revenue Trajectory:
According to industry reports, Kybella generated approximately $370 million globally in 2022, up from around $325 million in 2021 ([1]).
Pricing Trends:
Prices have remained relatively stable over the past 2-3 years, although there is some variability. Hospitals and clinics may offer discounts for bulk or repeat treatments.
Market Growth and Price Projections (Next 5 Years)
Growth Forecast:
Estimated compound annual growth rate (CAGR) of 8% in the fat reduction injectable segment.
Projection of Revenues:
By 2028, revenue for NDC 00955-1048 could reach $600 million to $700 million globally, assuming continued growth and market expansion.
Price Trends:
Average treatment costs are projected to decline slightly, approximately 2-3% annually, driven by increased competition, new entrants, and falling costs of delivery. Nonetheless, dollar-value per treatment is expected to stay within the $600-$1,200 range, considering inflation and new technology.
Regulatory and Market Expansion Considerations
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Expanding Indications:
Potential approvals for broader fat reduction applications, such as subcutaneous fat in other body areas, could drive increased demand.
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International Market Development:
Markets outside North America present significant growth opportunities, with regulatory approvals in Europe and Asia still pending or recently granted.
-
Emerging Competitors:
The arrival of alternative injectables or non-invasive technologies could pressure pricing.
Key Challenges & Risks
- Off-label use restrictions.
- Competition from non-injectable devices.
- Potential safety concerns leading to regulatory scrutiny.
- Cost containment pressures among insurers and payers.
Summary Table
| Aspect |
Data/Projection |
| Estimated global revenue |
$370 million (2022); projected $600-$700 million (2028) |
| Price per treatment |
$600 - $1,200 |
| Treatment sessions avg. |
2-4 |
| Market CAGR |
8% (2022-2028) |
| International potential |
Significant, with regulatory approvals increasing |
Key Takeaways
- Kybella (NDC 00955-1048) has established a leading position in submental fat reduction.
- The market is expected to grow at an 8% CAGR, with revenues reaching approximately $600-$700 million globally by 2028.
- Treatment prices are relatively stable but may slightly decline due to increased competition and technological advances.
- Expansion into international markets and broader indications are key growth opportunities.
- Competitive pressures and regulatory scrutiny remain ongoing risks.
FAQs
1. What factors influence the price per treatment of Kybella?
Treatment costs vary based on provider pricing strategies, geographic location, treatment volume, and patient-specific factors such as fat amount and treatment area.
2. How does Kybella compare to alternative fat reduction methods?
Kybella offers a non-surgical, injectable option with a treatment course typically completed within a few sessions. Alternatives like CoolSculpting are non-invasive but may require more sessions, while liposuction is surgical with higher upfront costs and recovery time.
3. Are there emerging competitors for NDC 00955-1048?
Yes, new injectable agents and non-invasive devices are in development or gaining regulatory approval, which could impact market share and pricing.
4. What is the potential for international market growth?
Large markets in Europe and Asia show high demand, but regulatory approvals and local reimbursement policies influence growth. Currently, the U.S. dominates sales.
5. How might future regulatory changes affect prices and market size?
Approval of additional indications or formulations might increase demand, while stricter regulations or safety concerns could limit market expansion or lead to pricing adjustments.
References
- IQVIA. "Market Analytics for Aesthetic Treatments," 2022.
- Statista. "Global Fat Reduction Market," 2022.
- FDA. "Kybella (deoxycholic acid) FDA approval," 2015.
