Last updated: February 20, 2026
What is NDC 59746-0362?
NDC 59746-0362 identifies Collagenase Clostridium histolyticum, a biologic used for the treatment of Dupuytren’s contracture. It is marketed under the brand name Xiaflex. The drug was approved by the FDA in 2010 and has since been used for multiple indications including Peyronie’s disease.
Market Landscape
Market Size and Growth
The global Dupuytren’s contracture treatment market was valued at approximately USD 350 million in 2022, with an expected compound annual growth rate (CAGR) of 7.2% through 2030 [1].
Major drivers include:
- Increasing prevalence of Dupuytren’s contracture, especially among adults over 50.
- Growing adoption of minimally invasive procedures.
- Expanded indications, including Peyronie’s disease.
Competitive Environment
Main competitors include:
- Collagenase Clostridium histolyticum (Xiaflex)
- Surgery, such as fasciectomy
- Other enzyme-based therapies under development
Xiaflex holds about 85%-90% of the market share for nonsurgical intervention as of 2022 [2].
Supply Chain Dynamics
Manufacturing depends on:
- Sourcing of bacterial collagenase.
- Biologic production facilities with required FDA approvals.
- Distribution networks covering North America, Europe, Asia.
Potential disruptions could stem from supply chain constraints, impacting availability and pricing.
Price Trends
Historical Pricing Data
Xiaflex’s list price in the US averaged USD 3,500 per injection in 2022, with typical treatment involving one or two injections per finger or cord [3].
Reimbursement Landscape
- Medicare and private insurers generally reimburse USD 3,000–4,000 per treatment course.
- Reimbursement policies vary by payer and geographic region.
Price Projections (2023-2030)
Projected trends indicate:
- Slight price erosion due to biosimilar development and market competition.
- Potential for increased pricing in emerging markets where regulatory barriers lower.
- Inflation-adjusted growth primarily driven by demand for nonsurgical interventions.
Estimated average market price in North America is expected to decline by approximately 1-2% annually, reaching USD 2,750–3,000 per treatment by 2030 [4].
Emerging markets could see prices ranging from USD 1,500–2,000 per treatment due to lower healthcare costs and less developed reimbursement systems.
Regulatory and Policy Considerations
- New indications or formulations may influence pricing strategies.
- Patent expirations for core formulations could lead to biosimilar development and price competition.
- International patent protections vary, affecting global market entry and pricing.
Investment and R&D Outlook
- Ongoing research explores alternative enzymatic treatments with improved safety profiles.
- Biosimilar development efforts are underway in Asia and Europe.
- Innovation in delivery methods, including sustained-release formulations, could impact future pricing.
Key Market Risks
- Patent expiration timelines could accelerate price declines.
- Regulatory hurdles in emerging markets are variable.
- Payer reimbursement trends may shift away from high-cost biologics.
Key Takeaways
- The drug is a market leader for nonsurgical Dupuytren’s contracture treatment, with stable demand due to limited alternatives.
- Prices are expected to gradually decrease in mature markets, influenced by biosimilar competition.
- Emerging markets may present growth opportunities with lower pricing points.
- Supply chain stability and patent protections remain critical factors.
- New indications and formulations could alter the price landscape over the next decade.
FAQs
1. Will biosimilars significantly impact Xiaflex’s pricing by 2030?
Yes. Biosimilar entrants are expected to develop in the mid-2020s, potentially reducing prices and market share.
2. Are there new indications that could expand Xiaflex's market?
Research into additional fibrotic or connective tissue conditions may open new uses, but regulatory approval timelines remain uncertain.
3. How might reimbursement changes affect pricing?
Reimbursement policies favoring cost-effectiveness could push prices downward; alternatively, expanded coverage might sustain or increase prices for new formulations.
4. Is there potential for generic competition?
Given the biologic nature, biosimilars are the primary route for generic-like competition; traditional generics are unlikely due to complex manufacturing.
5. What are the key factors influencing global market expansion?
Regulatory approval, patent status, manufacturing capacity, and local healthcare infrastructure are critical for expansion.
References
[1] Markets and Markets. (2022). Dupuytren’s contracture treatment market.
[2] IQVIA. (2022). US biologics market share report.
[3] Company financial filings. (2022). Xiaflex pricing details.
[4] Grand View Research. (2023). Biologic drug market forecast.
