Last updated: February 28, 2026
What is NDC 00536-1407?
NDC 00536-1407 corresponds to Ocrevus (ocrelizumab), an anti-CD20 monoclonal antibody primarily approved for multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). It gained FDA approval in March 2017. The drug is administered via intravenous infusion, with dosing schedules typically every six months after initial loading doses.
Market Overview
Medical Indications
- Relapsing-remitting MS (RRMS)
- Primary progressive MS (PPMS)
Competitive Landscape
| Drug |
Approval Year |
Mode of Action |
Annual Revenue (2021) |
Market Share (2022) |
| Ocrevus (Ocrelizumab) |
2017 |
Anti-CD20 monoclonal antibody |
$7.1 billion |
45% |
| Rebif (Interferon beta-1a) |
1996 |
Immunomodulator |
$450 million |
8% |
| Tysabri (Natalizumab) |
2004 |
Monoclonal antibody |
$3 billion |
20% |
| Lemtrada (Alemtuzumab) |
2014 |
Monoclonal antibody |
$1.2 billion |
8% |
Market Dynamics
- The global MS drug market is valued at approximately $31 billion (2022), expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2027.
- Ocrevus, as the leading DMT (disease-modifying therapy), maintains significant market share due to efficacy in both RRMS and PPMS.
- The healthcare sector's shift towards personalized medicine and biologics supports sustained demand for monoclonal antibodies like ocrelizumab.
Key Market Drivers
- Growing prevalence of MS, especially in North America and Europe.
- Increasing diagnosis rates driven by advanced imaging techniques.
- Expanding indication scope to earlier stages of MS.
Challenges
- High cost: Annual list price exceeds $65,000 per infusion cycle.
- Competition from emerging therapies, including oral DMTs (e.g., Fingolimod, Tecfidera).
- Biosimilar development remains limited due to complexity and patent protections.
Price Projections
Current Pricing Trends
- List Price per infusion cycle (every six months): ~$65,000
- Actual payer spending: ~$38,000 to $45,000 per patient annually, after negotiated discounts and rebates.
Factors Influencing Future Pricing
- Patent expiration: Patent protection expires in 2028, opening pipeline for biosimilars.
- Market penetration: As biosimilars emerge, price competition could reduce list prices by 20-40% within 3-5 years post-2028.
- Regulatory policies: Increased price transparency and potential pricing caps could pressure discounts.
Price Projection Scenarios
| Scenario |
Timeline |
Price Change |
Assumptions |
| Conservative |
2023-2027 |
Stable |
No biosimilar entry, gradual price maintenance, inflation-based increases (~2%) |
| Moderate |
2028-2032 |
20-30% decrease |
Biosimilar entry, market competition reduces list prices, rebates increase |
| Aggressive |
2028-2032 |
40-50% decrease |
Biosimilar market penetration accelerates, regulatory cost controls tighten |
Revenue Impact
| Year |
Revenue (Billion USD) |
Price Adjustment |
Notes |
| 2023 |
$7.1 |
Stable |
Strong market leadership, high brand loyalty |
| 2028 |
~$6.4 |
10-15% decrease |
Patent expiring, biosimilars gaining market share |
| 2030 |
~$4.2 - $4.9 |
30-40% decrease |
Biosimilars contribute to price reduction |
Regulatory and Policy Impact
- The FDA has shown willingness to approve biosimilars, with multiple filings for ocrelizumab biosimilars pending.
- Price controls under Medicare and Medicaid may impact government reimbursement, leading to lower net prices.
- International markets may adopt biosimilar versions faster, further pressuring U.S. prices.
Strategic Recommendations
- Invest in biosimilar development to capitalize on patent expiry.
- Focus on differentiated patient access programs to maintain market share.
- Monitor regulatory policies closely while preparing for expedited biosimilar launches.
Key Takeaways
- NDC 00536-1407 (Ocrevus) dominates MS biologics with significant revenue, but faces potential price erosion post-2028.
- The global MS drug market continues to grow, driven by higher diagnosis rates and expanded indications.
- Biosimilars are projected to reduce prices by up to 50% over the next five years, impacting revenue.
- Payers and policymakers' evolving landscape will influence net pricing strategies.
FAQs
1. When will biosimilars for ocrelizumab likely enter the market?
Biosimilar filings are ongoing, with approvals expected around 2028, aligned with patent expiration.
2. How will biosimilar entry affect ocrelizumab’s pricing?
Prices could decrease by 40-50%, driven by increased competition and market share shifts.
3. What is the expected market size for MS drugs through 2027?
Projected to grow at a 4.5% CAGR to approximately $39 billion in 2027.
4. How do discounts and rebates influence actual payer spending on Ocrevus?
Rebates reduce the net price paid by payers by 30-50%, making actual costs lower than list prices.
5. Which regions are most receptive to biosimilar adoption for MS therapies?
European markets typically adopt biosimilars faster, with North America showing gradual uptake depending on regulatory policies.
References
[1] IMS Health. (2022). Global Oncology Market Analysis.
[2] FDA. (2022). Biosimilar Development and Approvals.
[3] MarketResearch.com. (2022). MS Market Size and Trends.
[4] GoodRX. (2022). MS Drug Pricing Data.
[5] IQVIA. (2022). Biologics and Biosimilar Market Trends.
