Last updated: March 6, 2026
What is NDC 45802-0103?
NDC 45802-0103 refers to a specific drug listed under the National Drug Code system. This code identifies Cerezyme (imiglucerase), a recombinant enzyme used in the treatment of Gaucher disease. Manufactured by Sanofi, Cerezyme is a biologic therapy primarily administered via intravenous infusion.
Market Overview
Therapeutic Area and Patient Population
Gaucher disease is a rare genetic disorder characterized by lipid accumulation within macrophages, causing organomegaly, hematologic abnormalities, and skeletal issues. The disease presents with varying severity and is classified into types 1, 2, and 3, with type 1 being most common.
- Estimated prevalence: 1 per 40,000 to 60,000 live births globally.
- U.S. diagnosed patient base: approximately 2,000 individuals, with some estimates suggesting a similar number in Europe and other markets.
Market Size and Growth Drivers
- The global Gaucher disease market size was valued at approximately USD 500 million in 2022.
- Expected compound annual growth rate (CAGR): 4-6% through 2027, driven by increased diagnosis rates and expanding indication use.
- Market entry barriers: High manufacturing costs, complex delivery logistics, and strict regulatory pathways for biologics.
Key Competitors
| Product |
Manufacturer |
Indication |
Price (per infusion) |
Market Share (2022) |
| Cerezyme |
Sanofi |
Gaucher disease |
USD 20,000 – USD 25,000 |
~70% |
| Vpriv |
Takeda |
Gaucher disease |
USD 15,000 – USD 20,000 |
~20% |
| Elelyso |
Pfizer |
Gaucher disease |
USD 18,000 – USD 22,000 |
~10% |
Pricing and Reimbursement
- Estimated inpatient and outpatient reimbursement rates align with list prices, adjusted for discounts, insurance negotiations, and patient assistance programs.
- US list price (2023): USD 25,000 per infusion cycle (average), assuming weekly infusions for a month.
- Reimbursement coverage depends on payer policies; government programs like Medicaid and Medicare account for significant volumes.
Price Projections
Short-term (Next 2 Years)
- Stable pricing with minimal discounts.
- Pressure for price reductions expected from payers due to overall rising healthcare costs.
- Potential for increased costs related to supply chain disruptions and manufacturing expenses.
Medium-term (3-5 Years)
- Price stabilization anticipated, with possible modest increases linked to inflation and increased R&D costs for biosimilars.
- Entry of biosimilar competitors could pressure prices downward by 10-20% over 3-5 years, subject to approval and market acceptance.
Long-term (Beyond 5 Years)
- Biosimilar market penetration likely to increase, potentially reducing prices by 20-30%.
- Innovation in gene therapies and alternative treatments could influence demand and pricing dynamics.
- Pricing could decrease further if biologic manufacturing costs decline or if payers negotiate deeper discounts.
Regulatory and Market Risks
- FDA approval of biosimilars or new therapies may impact market share and prices.
- Policy changes regarding biologic drug pricing, including potential legislative caps, could influence pricing strategies.
- Manufacturing shortages or supply chain issues could elevate costs temporarily but might not significantly alter long-term pricing.
Summary of Key Data
| Parameter |
Value / Projection |
| Current annual market size |
USD 500 million |
| Approximate price per infusion |
USD 25,000 |
| Market growth rate |
4-6% CAGR (2022-2027) |
| Biosimilar impact on price |
10-20% reduction over 3-5 years |
| Number of treated patients |
~2,000 (US), similar globally |
Key Takeaways
- NDC 45802-0103 (Cerezyme) dominates the Gaucher disease biologic market with approximately 70% market share.
- Prices are stable but face downward pressure from biosimilar competition and payer negotiations.
- Market growth remains steady, supported by increased diagnosis and broader indications.
- Long-term prices could decline by approximately 20-30% due to biosimilar market entry and potential advances in alternative therapies.
FAQs
Q1: How does biosimilar entry affect Cerezyme's market share?
Biosimilars could capture 20-30% of the market within 3-5 years, reducing overall pricing power for Cerezyme.
Q2: What factors influence the pricing of biologic drugs like Cerezyme?
Manufacturing costs, regulatory environment, market competition, reimbursement policies, and payer negotiations.
Q3: Are there any upcoming regulatory changes that could impact prices?
Potential legislation introducing price caps or expanding biosimilar approvals could influence future prices.
Q4: How does the prevalence of Gaucher disease influence market potential?
Limited patient population constrains total market size; increased diagnosis rates may expand patients eligible for therapy.
Q5: What is the significance of supply chain stability for pricing?
Disruptions can raise costs temporarily; long-term, stable supply chains support predictable pricing strategies.
References
[1] IQVIA. (2022). Global Biologic Market Report.
[2] FDA. (2023). Biosimilar Product Information.
[3] Sanofi. (2023). Cerezyme Pricing and Market Data.
[4] Evaluate Pharma. (2023). Biologic Drug Market Forecast.
