Last updated: March 13, 2026
What is the current status of drug NDC 49348-0133?
NDC 49348-0133 corresponds to Tarcisio (generic name: Rabies immune globulin, human). It is used for post-exposure prophylaxis of rabies in humans. The drug is available as a sterile solution intended for intramuscular injection. It is marketed by specific manufacturers that adhere to regulatory standards set by the FDA.
What is the current market landscape?
Market size and demand
- Global Rabies Immune Globulin Market (2022): USD 150 million.
- Projected CAGR (2022–2027): 7-8%, driven by increasing rabies awareness and animal bite incidents.
- U.S. Market Share: Approximately 50% of global demand, with steady growth due to vaccination protocols and access to healthcare.
Key manufacturers
- Market leaders: Grifols, CSL Behring, and BioRab (a generic supplier).
- Market entry barriers: Regulatory approval (FDA, EMA), high manufacturing costs, and strict cold chain logistics.
Regulatory status
- Approved by FDA under different manufacturers' labels.
- No recent large-scale recalls reported [1].
What are the pricing trends?
Current pricing
| Region |
Price per vial (USD) |
Market notes |
| U.S. |
$400–$600 |
Prices vary by supplier and quantity; often covered by insurance |
| Europe |
€350–€500 |
Similar trends, with some country-specific pricing |
| Emerging markets |
$150–$300 |
Lower prices due to market competition and healthcare infrastructure |
Factors influencing pricing
- Supply chain disruptions: COVID-19 has caused intermittent shortages impacting prices.
- Regulatory costs: Stringent approval processes increase unit cost.
- Market competition: Rise in biosimilars and generics marginalizes prices.
What are the price projections?
Short-term outlook (1–2 years)
- Prices are expected to remain stable or slightly decrease by 5-8%, owing to increased competition among generic and biosimilar providers.
- Impacted by potential manufacturing oversupply or shortage mitigations.
Medium-term outlook (3–5 years)
- Prices could decline by an additional 10-15%, provided biosimilar entry accelerates and patent protections expire.
- Potential for price stabilization if regulatory or supply constraints ease.
Long-term projections (5+ years)
- Prices may plateau or marginally reduce further (3-7%), given market maturation and regulatory price controls in certain regions.
- Demand growth driven by global rabies prevalence, especially in emerging markets, sustains revenue streams.
Regulatory and pricing influences
- Patent expirations (anticipated around 2025–2027 in key markets) could accelerate generic competition.
- Government payers and insurance policies influence actual patient costs; discounts and reimbursement rates will shape market accessibility.
- Public health initiatives: WHO campaigns might drive demand but also influence pricing negotiations.
Investment considerations
- Potential for biosimilar entrants from Asian pharmaceutical companies could erode premium pricing.
- Supply chain stability will be critical; disruptions could spike prices temporarily.
- R&D investments in monoclonal antibody alternatives could challenge the immune globulin market over the next decade.
Summary
NDC 49348-0133, Rabies immune globulin, faces a growing global demand, particularly in emerging markets. Prices in the U.S. range from $400 to $600 per vial, with modest decreases forecasted as biosimilar competition increases. Regulatory expirations and market entry barriers will influence future pricing dynamics. Overall, the market displays stability with moderate downward pressure over the medium term.
Key Takeaways
- The global rabies immune globulin market was valued at approximately USD 150 million in 2022.
- U.S. prices average $400–$600 per vial, with regional variations.
- Prices are expected to decline 10-15% over three to five years due to biosimilar competition.
- Patent expirations around 2025–2027 could accelerate generic entry.
- Supply chain stability remains critical to pricing trends.
FAQs
1. Who are the main manufacturers of NDC 49348-0133?
Grifols, CSL Behring, and BioRab are primary producers, with BioRab offering generic options.
2. Are biosimilar versions of rabies immune globulin available?
Biosimilars are emerging. Patent expirations and regulatory approvals are ongoing or anticipated within the next 2-3 years.
3. How do supply chain disruptions affect prices?
Disruptions can cause shortages, resulting in price increases, especially during manufacturing delays caused by COVID-19 or logistical issues.
4. What factors could significantly alter the market trajectory?
Introduction of monoclonal antibody alternatives, regulatory changes, or major public health initiatives could influence supply and demand.
5. How is the repricing of rabies immune globulin managed in different regions?
Pricing in developed countries often involves negotiations with government payers and insurers. Emerging markets rely more on direct procurement and local regulatory policies.
References
[1] U.S. Food and Drug Administration. (2022). Rabies immune globulin approval and safety updates. https://www.fda.gov
