Last updated: February 16, 2026
Market Analysis and Price Projections for NDC 64980-0340
Product Overview
NDC 64980-0340 refers to Ocrevus (ocrlizumab), a monoclonal antibody used for multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). It is marketed by Genentech, a subsidiary of Roche.
Market Landscape
Indications and Approved Uses
- Relapsing forms of multiple sclerosis
- Primary progressive multiple sclerosis (PPMS)
Market Size & Growth
- The global MS market was valued at approximately $23 billion in 2022.
- It is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030 [1].
- Ocrevus holds a significant market share within this segment, estimated at 50%-60% for MS biologics [2].
Competitive Environment
- Key competitors: Gilenya (Novartis), Tecfidera (Biogen), Mavenclad (Eisai), Tysabri (Biogen).
- Ocrevus’s unique positioning stems from its dual labeling for both relapsing MS and PPMS.
Patent & Patent Expiry
- Patent protection initially granted until approximately 2029–2030.
- Biosimilar entry expected post-2030, which may drive price reductions and market share shifts.
Pricing Analysis
Current Pricing
- The average wholesale price (AWP) for Ocrevus is approximately $7,500 per 300 mg infusion [3].
- Typical dosing schedule involves 600 mg (two 300 mg doses) every six months, leading to an annual cost of roughly $15,000 per patient.
Market Penetration & Revenue
- In 2022, estimated revenue from Ocrevus was around $4.08 billion globally.
- Revenue is projected to grow modestly at a CAGR of 3–5% until patent expiry, influenced by market penetration and competitive dynamics.
Price Projections
| Year |
Estimated Price per 600 mg Dose |
Factors Influencing Price |
| 2023 |
$15,000 |
Stable pricing due to patent protection; payer negotiations |
| 2025 |
$14,500 |
Slight downward pressure from biosimilar threat, discounting strategies |
| 2030 |
$12,000 – $14,000 |
Post- patent expiry price drops, biosimilar competition increases |
| 2035 |
$10,000 or lower |
Potential generic biosimilar market entry; biosimilars priced 20-30% below originator |
Biosimilar Impact
- Biosimilar versions could reduce price by 20%-30% upon entry.
- Entry is susceptible to regulatory, patent-litigation delays, and market acceptance.
Regulatory & Market Dynamics Affecting Pricing
- Price-setting strategies depend on reimbursement policies, payer negotiations, and regional pricing regulations.
- US prices are highest among developed markets, with negotiated discounts lowering net prices.
- European markets tend to have regulated, often lower prices.
Risks & Opportunities
- Patent litigations could delay biosimilar entry.
- Market growth depends on expanding indications, especially PPMS, which is less treated.
- Pricing strategies will evolve based on biosimilar developments and policy changes.
Key Takeaways
- Ocrevus remains a dominant biologic for MS therapy, with stable revenue streams and high market penetration.
- Pricing is around $15,000 annually per patient in the US, with potential reductions post-patent expiry.
- Biosimilar competition is expected to reduce prices 20-30% upon approval and market entry, likely post-2030.
- The market growth projection is moderate, influenced by expanding indications, patent protections, and competitive pressures.
- Regulatory policies and negotiations will heavily influence future pricing and uptake.
FAQs
1. When will biosimilars for Ocrevus likely enter the market?
Post-2030, contingent on patent litigation, regulatory approvals, and market acceptance.
2. How does Ocrevus compare pricing-wise to similar MS biologics?
It is among the higher-priced MS biologics, with annual costs around $15,000; competitors like Gilenya and Tecfidera are generally slightly less costly.
3. What regional differences impact Ocrevus pricing?
US prices are highest due to less regulation; European prices are lower and subject to national reimbursement policies.
4. What factors could influence Ocrevus's market share?
Emergence of biosimilars, new therapies, and expanded indications could impact market share.
5. How does patent expiry affect future revenue projections?
Patent expiry around 2029-2030 could lead to generic biosimilar competition, decreasing revenue unless differentiated through new indications or formulations.
References
[1] IQVIA. "Global Multiple Sclerosis Market Report," 2022.
[2] EvaluatePharma. "2019-2029 MS Market Outlook," 2022.
[3] Red Book. "Average Wholesale Price Data," 2022.
