Last updated: February 24, 2026
What is NDC 69584-0674?
NDC 69584-0674 refers to Ravulizumab-cwvz (Ultomiris), a complement inhibitor used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and other complement-mediated disorders. It was approved by the FDA in 2018.
Market Size and Key Players
Market Size (2022-2027)
| Year |
Market Outlook (USD millions) |
CAGR |
Key Drivers |
| 2022 |
250 |
- |
High unmet need, rare disease focus |
| 2023 |
275 |
10% |
Expanded FDA label, increased adoption |
| 2024 |
308 |
12% |
New indications, competitive positioning |
| 2025 |
347 |
13% |
Market penetration, pricing strategies |
| 2026 |
395 |
14% |
Global expansion, pricing adjustments |
| 2027 |
442 |
12% |
Price stabilization, competitive landscape |
Source: MarketWatch, 2022-2027 projections. The rare disease nature of PNH and aHUS underpins steady growth.
Primary Market Segments
- PNH treatment constitutes approximately 70% of revenue.
- aHUS accounts for 25%.
- Other complement-mediated diseases account for 5%.
Major Competitors
| Drug |
Manufacturer |
Approval Year |
Indication(s) |
Price per Vial (USD) |
| Eculizumab (Soliris) |
Alexion / AstraZeneca |
2007 |
PNH, aHUS |
6,800 |
| Ravulizumab (Ultomiris) |
Alexion / AstraZeneca |
2018 |
PNH, aHUS |
6,300 |
| Crovalimab |
Roche |
Phase 3 |
Complement disorders, upcoming |
N/A |
Pricing Dynamics and Cost Analysis
Ravulizumab's approximate wholesale acquisition cost (WAC) per vial is $6,300, slightly below eculizumab due to dosing interval benefits. The annual treatment cost per patient averages between $430,000 and $550,000, depending on dosing and indications.
Pricing Trends
- Price stabilization occurred post-reimbursement approval, with slight reductions in recent years.
- Market pressures include biosimilar exploration and payer negotiations.
- Cost reduction efforts focus on dose optimization and longer dosing intervals.
Regulatory and Reimbursement Environment
- FDA approval came in 2018.
- CMS and private insurers reimburse based on high-cost drug management, with prior authorization critical.
- Global markets (EU, Japan) have approved Ravulizumab, with regional pricing varying significantly.
Market Entry Barriers and Opportunities
- Barriers: High R&D costs, small patient populations, complex manufacturing.
- Opportunities: Expansion into additional rare diseases, early diagnosis protocols, combination therapies.
Price Projections (2023-2027)
| Year |
Estimated Price per Vial (USD) |
Rationale |
| 2023 |
6,300 |
Stable post-launch, negotiation influence |
| 2024 |
6,200 |
Competitive pressures, biosimilar threats |
| 2025 |
6,100 |
Cost containment, increased biosimilar trials |
| 2026 |
6,000 |
Price consolidation, market saturation |
| 2027 |
6,000 |
Flat pricing; market maturity |
Key Takeaways
- The global rare disease market for Ravulizumab is projected to grow at a CAGR of 11-14% over five years.
- Pricing remains stable with potential minor decreases driven by biosimilar competition.
- The landscape is characterized by high treatment costs balanced by reimbursement strategies and limited competition.
- Market expansion depends on added indications, improved diagnosis, and global distribution.
FAQs
Q1: Are biosimilars for Ravulizumab available?
A: No biosimilars are currently approved or marketed, but biosimilar pathways are ongoing in major markets, which could impact pricing beyond 2027.
Q2: What factors influence pricing negotiations?
A: Efficacy data, reimbursement policies, treatment duration, competition, and payer leverage.
Q3: Will new indications affect market size?
A: Yes. Broader patient eligibility can expand demand; approved new indications tend to improve market value.
Q4: How does the dosing interval affect costs?
A: Longer dosing intervals reduce administration frequency, lowering overall treatment costs per year for patients.
Q5: Are global markets expected to follow US pricing trends?
A: Not necessarily. Europe and Asia vary due to different regulatory, reimbursement, and pricing mechanisms.
References
- MarketWatch. (2022). Global Rare Disease Market Outlook, 2022-2027.
- FDA. (2018). Approval of Ravulizumab (Ultomiris).
- AstraZeneca. (2022). Ultomiris Prescribing Information.
- IQVIA. (2022). Pharmaceutical Market Data.
- European Medicines Agency. (2021). Approval and pricing details for Ravulizumab.
[Note: Actual current prices, market sizes, and data points should be verified with up-to-date industry reports and official filings.]
