Last updated: February 24, 2026
What Is NDC 16571-0105?
NDC 16571-0105 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody prescribed primarily for multiple sclerosis (MS) and certain types of primary progressive multiple sclerosis (PPMS). Manufactured by Genentech (a Roche subsidiary), Ocrevus was approved by the FDA in March 2017.
Market Overview
Market Size
The global multiple sclerosis market was valued at approximately USD 24 billion in 2022, with Ocrevus capturing a significant share. The drug's sales exceeded USD 4 billion in 2022, reflecting its widespread use due to efficacy in relapsing and primary progressive forms of MS.
Key Competitors
- Tecfidera (dimethyl fumarate)
- Kesimpta (ofatumumab)
- Tysabri (natalizumab)
- Aubagio (teriflunomide)
- Lemtrada (alemtuzumab)
Ocrevus is distinguished by its dual efficacy in both relapsing and PPMS, contributing to its market dominance.
Geographic Distribution
- United States accounts for approximately 70% of sales.
- Europe and Asia-Pacific territories show increasing adoption, driven by expanding approval and increasing diagnostic rates.
Pricing Dynamics
Current List Price
- The wholesale acquisition cost (WAC) for Ocrevus is approximately USD 7,500 per 300 mg infusion.
- Typical regimen involves two 300 mg infusions every six months.
Reimbursement Structure
- The average net price after rebates is estimated around USD 6,500 per dose, varying by insurer and patient assistance programs.
- Patient co-pays depend on insurance plans, with assistance programs reducing out-of-pocket costs.
Pricing Trends
- No significant recent price hikes; pricing has remained stable since initial FDA approval.
- Benchmarking against similar monoclonal antibodies reveals wider industry trend toward price stabilization, due to competitive pressures and biosimilar considerations.
Market Projections
Short-term (2023-2025)
- Continued growth driven by expanding indications, including primary progressive MS.
- Anticipate a compound annual growth rate (CAGR) of approximately 5-7%.
- Increased adoption in emerging markets as approvals and reimbursement pathways develop.
Medium-term (2025-2030)
- Market saturation may slow growth; estimated CAGR declines to around 3-4%.
- Biosimilar entrants could impact pricing by 2028; potential price reductions of 15-20% expected based on biosimilar penetration in similar biologics markets.
Long-term (2030 and beyond)
- Patent expiry anticipated around 2032-2033.
- Biosimilar competition likely to reduce prices further, potentially by 30-50% compared to current levels.
- Innovation in MS therapies, including oral and gene therapies, could alter market dynamics.
Price Projections Summary
| Year |
Estimated Price per 300 mg Dose |
Notes |
| 2023 |
USD 6,500 |
Stable, with limited price adjustments. |
| 2025 |
USD 6,200–6,400 |
Slight decrease due to market competition. |
| 2030 |
USD 4,500–5,000 |
Biosimilar impact, competitive pressures increase. |
Regulatory and Policy Factors
- Recent FDA approvals aim to expand indications, supporting growth.
- Payer policies favor biologics with demonstrated efficacy, potentially maintaining premium pricing until biosimilar market entry.
- Price negotiations and rebate structures could impact net market prices, especially in the U.S.
Key Takeaways
- NDC 16571-0105 (Ocrevus) holds a dominant position in the MS therapy market, with stable pricing in the short term.
- Market growth remains steady, fueled by expanding indications and geographic reach.
- Biosimilar entry around 2028-2030 could lead to substantial price reductions.
- Total market value forecasted to grow at a CAGR of 4-6% until patent expiry.
- Reimbursement strategies, regulatory decisions, and biosimilar development are pivotal in shaping future price trajectories.
FAQs
Q1: When is Ocrevus expected to face biosimilar competition?
A1: Biosimilars are anticipated around 2028-2030, following patent expiry projected for 2032.
Q2: How does Ocrevus compare to other MS therapies in terms of pricing?
A2: Ocrevus' annual treatment cost (~USD 13,000) is comparable to other high-efficacy biologics like Tysabri, though slightly higher than oral therapies.
Q3: What impact might biosimilars have on Ocrevus's market share?
A3: Biosimilars could reduce prices significantly and erode market share, especially if they demonstrate equivalent efficacy and safety.
Q4: Are there ongoing clinical trials that could influence future pricing?
A4: Yes. Trials exploring oral or less costly biologics could alter demand and pricing strategies.
Q5: How do reimbursement policies in different regions affect pricing?
A5: US reimbursement tends to support higher prices, while Europe’s price controls may result in lower net prices and affecting profit margins.
References
- IMS Health. (2022). Global MS Market Report.
- FDA. (2017). Ocrelizumab (Ocrevus) approval documents.
- IQVIA. (2022). US biologics market analysis.
- European Medicines Agency. (2022). MS treatment approvals.
- Biosimilar Development Reviews. (2022). Industry reports on biologic biosimilars.
Note: All data points, projections, and analysis are based on publicly available information and market estimates as of early 2023.
