Last updated: February 13, 2026
What is NDC 51407-0019?
NDC 51407-0019 is the National Drug Code for Ocrevus (ocrelizumab), an approved treatment for multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). It is developed by Roche and marketed as a monoclonal antibody targeting CD20-positive B cells.
Market Size and Growth Dynamics
Global MS Treatment Market:
- Estimated at $22.8 billion in 2022.
- Compound annual growth rate (CAGR) projected at 4-5% through 2030 [1].
- Ocrevus captured approximately 20% of the MS segment in the U.S. in 2022.
Key Market Drivers:
- Increasing prevalence of MS: worldwide, approximately 2.8 million people affected.
- Extended approval for PPMS in late 2017 widens the commercial scope.
- Growing adoption of high-efficacy therapies like Ocrevus driven by positive clinical trial outcomes.
Competitive Landscape:
- Main competitors include siponimod (Mayzent), natalizumab (Tysabri), and other monoclonal antibodies such as rituximab.
- Ocrevus has maintained a competitive advantage due to its efficacy profile and dosing frequency (biannual infusion).
Price Trends and Projections
Current Pricing (U.S.):
- Average wholesale price (AWP): approximately $6,850 per 300 mg vial.
- Typical regimen: four doses annually (two doses per infusion cycle), costing about $27,400 per year per patient [2].
Market Penetration and Revenue:
- Roche reported global sales for Ocrevus of approximately $4.6 billion in 2022 [3].
- U.S. sales accounted for about 70% of total revenue.
Price Trends:
- Price has remained relatively stable since launch in 2017.
- Payer negotiations have led to targeted discounts and rebates, reducing net prices.
Future Price Projections (2023-2028):
- No significant price increases expected within the next two years.
- Trends suggest stabilization due to market saturation and reimbursement negotiations.
- Possible slight reductions in net price due to generic competition in the longer-term (by 2028), especially if biosimilars enter markets outside the U.S.
Long-term Outlook:
- As biosimilars for ocrelizumab are being developed (e.g., by Samsung Bioepis, Celltrion), price competition could lower effective prices by 10-30% over five years.
- Price erosion likely to be mitigated in the U.S. by brand loyalty and reimbursement protections.
Regulatory Environment & Policy Factors
- The U.S. FDA approved Ocrevus in March 2017.
- CMS and private insurers cover Ocrevus with negotiated formulary placement.
- Potential for price controls or value-based agreements as healthcare costs increase.
Risks to Market and Pricing
- Biosimilar entry could reduce prices.
- Changes in reimbursement policies could lead to pricing adjustments.
- Emerging therapies with similar efficacy and different mechanisms may impact market share.
Summary of Key Data
| Metric |
Data Point |
Source |
| 2022 Global MS Market |
$22.8B |
[1] |
| Roche Ocrevus Sales (2022) |
$4.6B |
[3] |
| Approximate U.S. Price Per Year |
$27,400 |
[2] |
| Price Stability Period |
2017–2023 |
NDC/Market Data |
| Biosimilar Development Start |
2021–2022 |
PhRMA, industry reports |
Key Takeaways
- NDC 51407-0019 (Ocrevus) is a leading treatment for MS and PPMS with stable pricing since launch.
- The product commands a premium, roughly $27,400 annually per patient in the U.S.
- Market growth hinges on increasing MS prevalence and expanding indications, with ongoing biosimilar development presenting potential downward pressure on prices.
- Roche's current pricing is supported by high efficacy and market penetration, but long-term projections suggest moderate price erosion due to biosimilars and policy changes.
FAQs
1. How does Ocrevus’s price compare globally?
Prices vary due to healthcare system differences but generally align with U.S. levels, adjusted for local rebate and reimbursement structures.
2. What is the expected timeline for biosimilar entry?
Biosimilars for ocrelizumab are in early development stages; regulatory approval is anticipated between 2024 and 2026.
3. Will Roche reduce Ocrevus prices?
Not immediately; price reductions are more probable if biosimilars gain approval and market share expands.
4. What factors could influence future market size?
Emerging therapies, reform policies, MS prevalence, and broader access expansion.
5. Are rebates and discounts included in price projections?
No; net prices are typically lower than AWP after rebates, but precise figures are proprietary.
References
[1] MarketWatch, "Multiple Sclerosis Treatment Market Report," 2022.
[2] Wolters Kluwer Health, "Ocrevus Pricing," 2023.
[3] Roche Annual Report, 2022.
