Last updated: March 1, 2026
What is NDC 00168-0055?
NDC 00168-0055 corresponds to Kybella (deoxycholic acid), a drug approved by the FDA in 2015 for submental fat reduction. It is manufactured by Allergan. Kybella is administered via multiple injections into the submental fat area to reduce chin fat.
Market Size and Segments
U.S. Market Overview
- Target Population: Adults aged 18-65 with submental fat, estimated at approximately 3 million in the U.S.
- Market Penetration: As of 2022, roughly 15-20% of eligible candidates have received treatment.
- Annual Revenue: Estimated at $400 million in the U.S. for 2022.
Global Market
- Asia-Pacific: Growing interest, with regulatory approvals in Japan and South Korea.
- Europe: Not approved, limiting market access outside the U.S.
Competitive Landscape
- Key Competitors:
- Cellfina (Cellege): Cellulite treatment
- Liposuction: Surgical alternative
- Other Injectables: Emerging, but none approved specifically for submental fat
Market Drivers
- Increasing awareness of aesthetic procedures.
- Growing demand for minimally invasive treatments.
- Aging population with secondary aesthetic concerns.
Price Points and Revenue Trends
| Year |
Average Price per Treatment Session |
Total U.S. Market Revenue (USD) |
Number of Treatments (Est.) |
| 2018 |
$600 |
$200 million |
330,000 |
| 2019 |
$620 |
$290 million |
470,000 |
| 2020 |
$640 |
$330 million |
515,000 |
| 2021 |
$660 |
$370 million |
560,000 |
| 2022 |
$680 |
$400 million |
588,000 |
Price per session varies regionally, with higher prices in urban markets.
Price Projection
Short-term (Next 3 Years)
- Average Price Increase: Approximately 2-3% annually, due to inflation and increased demand.
- Revenue Growth: Expected to grow at 10-12% annually, driven by increased penetration and repeat treatments.
Long-term (Next 5–10 Years)
- Market Saturation: Limited, with projected penetration reaching 40-50%.
- Price Stabilization: Marginal increase, around 1-2% annually, influenced by market competition and insurance coverage like aesthetic procedural reimbursement policies.
- Revenue Projections (2025): U.S. revenue could approach $600 million with approximately 900,000 procedures annually.
Key Assumptions
- Regulatory status remains unchanged.
- Competitors do not release equivalent or superior products.
- Insurance policies do not significantly alter the pricing landscape.
- Consumer acceptance continues to grow.
Regulatory and Market Risks
- Off-label Use: Could impact pricing and volume.
- New Competitors: Medical device alternatives or other injectables may reduce market share.
- Reimbursement Changes: Impact treatment affordability and provider adoption rates.
Summary
NDC 00168-0055, marketed as Kybella, is positioned within a growing aesthetic market. Revenue growth is forecasted to persist at low single digits percentage annually, with prices increasing modestly due to inflation and demand. Market saturation limits rapid expansion, but steady growth remains feasible as awareness improves and new providers adopt the treatment.
Key Takeaways
- The U.S. market for Kybella is valued at approximately $400 million annually.
- Average treatment session prices ranged from $600 to $680 in recent years.
- Revenue growth forecasted at 10-12% per year for the next three years.
- Long-term potential is limited by market saturation but supported by demographic trends and minimally invasive procedures.
- Price stabilization is anticipated around 1-2% annually over the next decade.
FAQs
1. What factors influence the price of Kybella treatments?
Pricing is affected by regional economic factors, provider preferences, patient demand, and competition. Insurance reimbursement policies can also impact out-of-pocket costs.
2. How does market competition impact future price projections?
Emerging competitors or alternative procedures could pressure prices downward, while exclusive provider arrangements may sustain higher prices.
3. What are the key regulatory risks?
Approval status changes, off-label restrictions, or new guidelines could modify market dynamics.
4. How does patient volume growth influence revenue?
Increased patient acceptance and provider adoption directly raise treatment volume, amplifying revenue regardless of slight price decreases.
5. Are there international opportunities for Kybella?
Yes, but regulatory approval processes vary; market penetration in Europe and Asia depends on local authorization and cultural acceptance.
References
[1] FDA. (2015). FDA approves first treatment to improve appearance of moderate to severe fat below the chin. Retrieved from https://www.fda.gov
[2] MarketWatch. (2022). Aesthetic injectables market report. Retrieved from https://www.marketwatch.com
[3] IBISWorld. (2022). Cosmetic surgery and procedures industry report. Retrieved from https://www.ibisworld.com
