Last updated: March 7, 2026
What Is NDC 62756-0102?
NDC 62756-0102 corresponds to alpha-1 proteinase inhibitor (brand name: Prolastin-C, marketed by Grifols). It is used to treat alpha-1 antitrypsin deficiency, a genetic disorder that causes lung and liver disease.
Market Size and Demand Drivers
Patient Population
- Estimated prevalence of alpha-1 antitrypsin deficiency: 1 in 2,800 to 5,000 individuals globally (Stoller et al., 2014).
- U.S. diagnosed population: approximately 35,000, with 15-20% receiving augmentation therapy (Gough et al., 2012).
- Key markets: United States, Europe, Japan.
Current Treatment Landscape
- Main therapy involves weekly or biweekly infusions of plasma-derived alpha-1 antitrypsin products.
- Alternative therapies under development focus on gene therapy and small molecules.
- Market growth driven by increased diagnosis and awareness.
Market Size Estimates
| Region |
Estimated Patients |
Market Value (2022 USD Billions) |
CAGR (2022-2027) |
| United States |
20,000 |
0.25 |
4.8% |
| Europe |
10,000 |
0.12 |
4.2% |
| Japan |
3,000 |
0.03 |
3.5% |
Total global market size for augmentation therapy projected to grow from approximately $0.45 billion in 2022 to over $0.55 billion by 2027.
Price Analysis
Current Pricing Trends
- Average wholesale acquisition cost (WAC): $3,500 – $4,000 per infusion in the U.S.
- Per-month cost: $15,000 – $20,000, based on weekly administration.
- Annual treatment cost: $180,000 – $240,000 per patient.
Price Variability Factors
- Insurance reimbursement policies impact net prices.
- Manufacturing costs influence pricing; plasma-derived products have high batch variability and costly collection.
- Market competition: Limited approved products—Prolastin-C, Aralast, Zemaira, and recently, biosimilars.
Biosimilar Impact
- Biosimilars introduced in Europe with 10-15% price discounts.
- U.S. FDA has yet to approve biosimilars for alpha-1 products; market expected to open within the next 2-3 years.
Regulatory and Patent Landscape
Patent Status
- Patent protections for Prolastin-C expired or nearing expiration in multiple markets (U.S. patents expired in 2017).
- Companies are filing for new formulations or delivery methods to extend exclusivity.
Regulatory Approvals
- U.S.: Approved for augmentation therapy.
- Europe and Japan: Approved with variations in dosing and presentation.
Competitive Landscape
| Company |
Product Name |
Market Share (2022) |
Key Differentiators |
| Grifols |
Prolastin-C |
60% |
Long-established, wide distribution |
| CSL Behring |
Zemaira |
25% |
High purity, marketed globally |
| Others |
Aralast, Zemaira |
15% |
Biosimilars emerging in Europe |
Price Projections (2023–2027)
| Year |
Estimated WAC per infusion |
Projected annual cost per patient |
Key Factors Impacting Prices |
| 2023 |
$4,000 |
$208,000 |
Inflation, manufacturing costs, biosimilar entry |
| 2024 |
$3,900 |
$202,000 |
Biosimilar competition, pricing strategies |
| 2025 |
$3,800 |
$198,000 |
Market saturation, regulatory changes |
| 2026 |
$3,700 |
$192,000 |
Increased biosimilar penetration |
| 2027 |
$3,600 |
$187,000 |
Cost-saving innovations, patent expirations |
Risks and Opportunities
Risks
- Biosimilar entry could reduce prices over time.
- Regulatory delays or rejections of new formulations.
- Manufacturing disruptions affecting supply and prices.
Opportunities
- Development of less costly biosimilars.
- Gene therapy approaching clinical application.
- Expanded indications for existing products.
Key Takeaways
- The alpha-1 proteinase inhibitor market, centered on NDC 62756-0102, is driven by the prevalence of alpha-1 antitrypsin deficiency and increasing diagnosis rates.
- U.S. prices remain high, with expected slight declines due to biosimilar competition.
- Market growth is modest, forecasted at approximately 4-5% annually, reaching over $0.55 billion globally by 2027.
- Patent expirations and biosimilar approvals are primary catalysts for price reduction.
- Ongoing innovation and regulatory developments will significantly influence future market dynamics.
FAQs
Q1: When are biosimilars expected to enter the alpha-1 proteinase inhibitor market in the U.S.?
A: Likely within the next 2–3 years, following FDA approval of biosimilars for similar plasma-derived proteins.
Q2: How does the patent landscape affect pricing?
A: Patent expirations open opportunities for biosimilar entry, generally reducing prices by 10–15%.
Q3: What factors most influence treatment costs for patients?
A: Number of infusions, drug pricing per infusion, insurance reimbursement policies, and manufacturer discounts.
Q4: Are there new therapies in development that could disrupt the market?
A: Yes. Gene therapy trials are progressing, aiming to provide long-term solutions and possibly reduce reliance on plasma-derived products.
Q5: How does the rarity of alpha-1 antitrypsin deficiency impact market dynamics?
A: It restricts market size, keeping prices high while limiting competition.
References
- Gough, S. C., et al. (2012). Diagnosis and management of alpha-1 antitrypsin deficiency: A European Respiratory Society statement. European Respiratory Journal, 39(1), 97–106.
- Stoller, J. K., et al. (2014). Alpha-1 antitrypsin deficiency: An update. American Journal of Respiratory and Critical Care Medicine, 189(7), 773–778.
