Last updated: February 14, 2026
Product Overview
NDC 00310-6250 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody approved for multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). It was approved by the FDA in 2017. Ocrevus is marketed primarily by Roche.
Market Size and Adoption
The MS treatment market was valued at approximately $30 billion globally in 2022, with Ocrevus securing a significant market share. Factors influencing adoption include efficacy, safety profile, and reimbursement policies.
- U.S. MS patient population estimated at 1 million in 2022, with about 40% on DMTs (disease-modifying therapies).
- Ocrevus captured roughly 25% of the U.S. MS DMT market in 2022, translating to an annual sales volume of approximately $6 billion in the U.S. alone.
Competitor Landscape
Key competitors include:
- Eli Lilly’s Tysabri (nivolumab)
- Biogen’s Tecfidera (dimethyl fumarate)
- Novartis’s Gilenya (fingolimod)
- Novartis’s Kesimpta (ofatumumab)
- Biogen’s Avonex (interferon beta-1a)
Ocrevus's position is strengthened by its efficacy in both relapsing and primary progressive MS.
Pricing and Reimbursement
The wholesale acquisition cost (WAC) for Ocrevus is approximately $7,000 per infusion, with doses recurring every six months.
- Estimated price per annual therapy: $14,000, based on two infusions.
- Insurance coverage and payer negotiations influence actual patient costs, sometimes reducing net pricing.
Pricing Trends and Projection Factors
- Price stability: Maintenance of current infusion pricing appears likely, given FDA approval and market dominance.
- Payer pressures: Increasing price scrutiny may influence future negotiations, but no significant downward trends are anticipated within the next 3-5 years.
- Market expansion: Additional approvals for pediatric MS or earlier intervention may increase patient access, driving revenue.
Forecast (2023-2028)
Risks to Price and Market Projections
- Generic and biosimilar competition: No biosimilar for ocrelizumab currently available, but patent expiry could introduce biosimilar options by 2030.
- Regulatory changes: Policy changes affecting drug pricing or approval pathways could impact revenue streams.
- Market dynamics: Emergence of new therapies or gene editing techniques may limit growth.
Key Takeaways
- Ocrevus remains a dominant MS therapy with stable pricing and strong market share in 2023.
- Annual revenue is projected around $6-7 billion worldwide, reaching up to $8 billion with accelerated adoption scenarios.
- Pricing is influenced by infusion costs, payer negotiations, and evolving market strategies.
- Competition from biosimilars and new entrants could affect long-term profitability.
- Regulatory and policy developments could alter market dynamics in the next five years.
FAQs
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What is the current pricing structure for NDC 00310-6250?
The average annual cost is approximately $14,000, based on two infusions per year at $7,000 each.
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How competitive is Ocrevus in the MS market?
It holds about 25% of the U.S. DMT market, with notable efficacy in relapsing and primary progressive MS.
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What factors could influence future price reductions?
Biosimilar competition, increased payer pressure, and regulatory policies could lead to price adjustments.
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Are there upcoming approvals that could impact sales?
Possible expansion to pediatric MS and earlier stages of MS may broaden the patient base, supporting revenue growth.
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When are biosimilars expected to enter the market?
Biosimilars for ocrelizumab could potentially enter around 2030, depending on patent expirations and regulatory pathways.
Sources
[1] FDA. Ocrevus (ocrelizumab) approval and label information.
[2] IQVIA. U.S. MS market report, 2022.
[3] MarketWatch. Global multiple sclerosis therapeutics market size and forecasts.
[4] Roche Annual Report 2022.
[5] Price Pharma News. Infusion costs and reimbursement trends, 2023.
