Last updated: December 7, 2025
Executive Summary
This report provides a comprehensive market analysis and price projection for the drug identified by NDC 59651-0899. As a specialized pharmacological agent, NDC 59651-0899 (hereafter referred to as the "drug") is positioned within a competitive landscape guided by regulatory, clinical, and economic dynamics. The analysis underscores current market demand, competitive positioning, regulatory environment, pricing trends, and future price trajectories through 2028.
Key Highlights:
- The drug is a biological therapeutic approved for multiple sclerosis (MS).
- Market size is driven by the prevalence of MS (~2.8 million globally) and expanding indications.
- Current list price ranges between $65,000 – $80,000 per year, with significant variability based on payer negotiations.
- The market is influenced by patent status, biosimilar entry, and regulatory policies.
- Price projections suggest a modest decrease (~5-10%) over 5 years owing to biosimilar competition and evolving reimbursement frameworks.
What Is NDC 59651-0899?
NDC 59651-0899 refers to Ocrelizumab (Ocrevus)—a monoclonal antibody immunotherapy developed by Genentech (a Roche subsidiary). It targets CD20-positive B cells, thereby modulating immune responses in MS.
| Parameter |
Details |
| Therapeutic Class |
Monoclonal antibody, Disease-modifying agent |
| Approved Indications |
Relapsing-remitting MS (RRMS), Primary Progressive MS (PPMS) |
| FDA Approval Date |
March 2017 (RRMS and PPMS) |
| Market Authorization |
U.S. FDA, EMA, other global regulators |
| Molecular Composition |
Humanized IgG1 monoclonal antibody |
Market Overview
Global and U.S. Market Context
| Parameter |
Data / Reference |
| Global MS prevalence |
~2.8 million (2020, MS International Federation) |
| U.S. MS prevalence |
~1 million (National MS Society, 2022) |
| U.S. MS diagnosed patients |
~200,000–300,000 on DMTs (Multiple Sclerosis Foundation) |
| Major competitors |
Ocrelizumab, Natalizumab, Fingolimod, Alemtuzumab |
Market Segmentation
| Segment |
Description |
Market Share (%) (2022) |
Key Players |
| RRMS |
Relapsing-remitting MS |
~70% |
Ocrelizumab (35%), Other DMTs |
| PPMS |
Primary progressive MS |
~10-15% |
Ocrelizumab (dominant), others |
| Clinical Trial/Expanded Use |
Emerging indications |
N/A |
Various experimental therapies |
Drivers & Barriers
| Drivers |
Barriers |
| Increasing prevalence of MS |
High treatment costs |
| FDA approval of PPMS indication |
Competition from biosimilars |
| Advancements in biologics |
Payer restrictions and formularies |
| Expansion into new indications |
Patent cliffs and patent expiry |
Pricing Dynamics and Current Market Prices
Price Benchmarks
| Pricing Tier |
Approximate Range ($/year) |
Notes |
| List Price |
$65,000 – $80,000 |
Official wholesale acquisition cost (WAC) |
| Negotiated Net Price |
$45,000 – $60,000 |
After rebates and payor discounts |
| Patient Out-of-Pocket |
Variable, $0–$10,000 |
Dependent on insurance and copay assistance |
Sources:
- SSR Health (2022): Average net price per script ~$47,000
- Industry reports (e.g., IQVIA, 2022)
Reimbursement and Payer Landscape
| Payer Type |
Coverage Trends |
Reimbursement Challenges |
| Commercial insurers |
Typically formulary-placed, prior authorization |
High cost sharing, step therapy |
| Medicare/Medicaid |
Favorable formulary placement, negotiated prices |
Policy restrictions, DRG impacts |
| Patient assistance programs |
Co-pay cards, 340B discounts |
Regulatory scrutiny |
Market Trends and Competitive Landscape
Patent and Biosimilar Outlook
| Year |
Patent Expiry |
Potential Biosimilar Entry |
Impact on Pricing |
| 2027 |
2028 (expected) |
Multiple biosimilar applicants (e.g., Sandoz, Amgen) |
Likely price erosion of 15–30% post-entry |
Regulatory & Policy Trends
- Pricing transparency initiatives expanding (HHS, 2021)
- Encouragement of biosimilar adoption by CMS and FDA
- Potential value-based contracting emerging
Market Growth Projections (2023–2028)
| Metric |
2023 |
2028 (Projection) |
CAGR (%) |
| Global MS drug market |
~$22B |
~$33B |
8-9% |
| Ocrelizumab share |
35–40% of DMT market |
Slight decline due to biosimilars |
Slight decrease (~3-5%) as newer agents emerge |
Price Projection Analysis (2023–2028)
Factors Influencing Price Trends
| Factor |
Impact |
Mitigation / Enhancers |
| Biosimilar Competition |
Downward pressure (~15–30%) |
Strategic partnership, brand differentiation |
| Regulatory Policies |
Potential price controls (~5–10% reduction) |
Advocacy, policy engagement |
| Clinical demand & indications |
Sustained or increased demand for expanded uses |
Continuous innovation and label expansion |
| Manufacturing costs |
Slight decline due to process improvements |
Investment in cost-efficiency |
Estimated Price Trajectory
| Year |
Predicted List Price ($/year) |
Notes |
| 2023 |
$70,000 – $80,000 |
Current market levels |
| 2024 |
$66,500 – $76,000 |
Slight reduction due to early biosimilar market entry |
| 2025 |
$63,000 – $72,000 |
Increased biosimilar competition, price negotiations intensify |
| 2026 |
$60,000 – $68,000 |
Continued erosion, market stabilization |
| 2027 |
$58,000 – $65,000 |
Patent expiry approaches, biosimilar competition peaks |
| 2028 |
$55,000 – $62,000 |
Biosimilar market solidifies, further competition |
Comparative Analysis with Similar Biologics
| Drug Name |
Indications |
Current Price Range ($/year) |
Patent Status |
Key Differentiator |
| Natalizumab (Tysabri) |
MS, Crohn's disease |
$72,000 |
Patent active until ~2027 |
Different mechanism, less risk of PML |
| Alemtuzumab (Lemtrada) |
MS |
$70,000 |
Patents expiring early |
More infusion-related adverse events |
| Ofatumumab (Arzerra) |
MS, Leukemia |
$63,000 |
Biosimilar entry imminent |
Subcutaneous administration |
Regulatory & Market Risks
| Risk Factor |
Description |
Mitigation Strategies |
| Patent expiration |
Biosimilar competition from 2028 |
Early pipeline diversification |
| Regulatory changes |
Potential price controls or formulary restrictions |
Engagement with policymakers |
| Clinical efficacy/safety concerns |
Post-marketing safety issues |
Robust pharmacovigilance |
| Market saturation |
Increased competition reduces demand |
LabelExpansion, new indications |
Key Takeaways
- Market Position: NDC 59651-0899 (Ocrelizumab) dominates the MS biologic DMT segment with a current list price around $70,000 per year.
- Pricing Outlook: Expect a moderate decline (~5-10%) over the next five years primarily due to biosimilar competition and market maturation.
- Competitive Factors: Patent expiry around 2028 will accelerate biosimilar entry, pressuring prices.
- Growth Drivers: Rising MS prevalence, expanded indications, and advancements in biologics will sustain demand.
- Risks: Regulatory intervention, patent cliffs, and market saturation pose potential downside risks.
FAQs
Q1: When is biosimilar entry expected for Ocrelizumab, and how will it affect pricing?
A: Biosimilar competition is anticipated around 2028, following patent expiry. Entry could reduce list prices by roughly 15–30%, forcing Ocrelizumab to adapt pricing strategies.
Q2: How does the current reimbursement environment influence net prices?
A: Negotiated net prices are typically 30-40% lower than list prices, influenced by payor discounts, rebates, and patient assistance programs, often stabilizing net revenue despite list price declines.
Q3: What are the primary factors that could accelerate price erosion beyond projections?
A: Immediate biosimilar market entry, regulatory pricing controls, or significant shifts in treatment paradigms could accelerate erosion.
Q4: Are there emerging indications that could sustain or increase Ocrelizumab's market share?
A: Yes; ongoing research into additional autoimmune indications and expanded MS patient populations could bolster demand.
Q5: How does Ocrelizumab compare to its biosimilar competitors in terms of efficacy and safety?
A: Biosimilars are developed to match the reference product in efficacy and safety. However, minor differences in manufacturing can influence immunogenicity profiles, requiring continued post-market surveillance.
References
- MS International Federation. "The Multiple Sclerosis Report 2020."
- SSR Health. "Biologic Market Intelligence," 2022.
- IQVIA Institute. "The Global Use of Medicines," 2022.
- U.S. FDA. "Ocrelizumab (Ocrevus) Official Approval Letter," March 2017.
- National MS Society. "MS Prevalence Data," 2022.
- CMS policy documentation and biosimilar market forecasts.
- HHS. "Pricing Transparency and Biosimilar Policies," 2021.
