Overview of Humira and NDC 00074-1539
Humira, with the National Drug Code (NDC) 00074-1539, is a prescription drug manufactured by AbbVie Inc. and falls under the category of biologic medications. It contains the active ingredient adalimumab, which is used to treat various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, and others[5].
Market Size and Growth
The global Humira market has been experiencing significant growth driven by several factors. As of 2023, the Humira drug market size was valued at $9.19 billion and is projected to grow to $9.86 billion in 2024, with a compound annual growth rate (CAGR) of 7.3%. By 2028, the market is expected to reach $13.05 billion[4].
Drivers of Market Growth
Several key factors are driving the growth of the Humira market:
- Introduction of Biologics and Biotechnology Advancements: The introduction of biologic medications like Humira has revolutionized the treatment of autoimmune diseases, leading to increased demand and market growth[4].
- Patient Demand and Physician Adoption: The effectiveness of Humira in treating chronic conditions has led to high patient demand and strong physician adoption and prescribing patterns[4].
- Incidence Rate of Autoimmune Diseases: The rising incidence of autoimmune diseases such as lupus, Crohn’s disease, and ulcerative colitis is a significant driver. For instance, 1 in 15 people in the U.S. have an autoimmune disease, contributing to the increased demand for Humira[4].
- Healthcare Policy Changes and Cost-Effectiveness: Changes in healthcare policies and a focus on cost-effectiveness are also expected to drive the market forward[4].
Market Segmentation
The Humira market is segmented by type, application, and end-users:
- By Type: Humira is available in two main forms - Humira Syringe and Humira Pen. Both forms are widely used, with the Humira Pen being particularly popular due to its ease of use[4].
- By Application: Humira is used to treat various conditions including ankylosing spondylitis, rheumatoid arthritis, Crohn's disease, and other applications. Rheumatoid arthritis and Crohn's disease are among the most common indications[4].
- By End-Users: The primary end-users are hospitals and specialty clinics, where these medications are frequently prescribed and administered[4].
Price Projections
The cost of Humira is significant and can vary based on the form and dosage. Here are some aggregate cost figures for Humira from recent data:
- Aggregate Costs: In 2021, the aggregate cost for Humira Pen (NDC 00074055402) was $14,738,523.44, and for Humira (NDC 00074024302), it was $1,894,083.95[2].
- Future Pricing Trends: While specific price projections for NDC 00074-1539 are not available, the overall trend suggests that the cost will remain high due to the drug's efficacy and the lack of generic alternatives. However, the entry of biosimilars in the market could potentially impact pricing by introducing more cost-effective options[4].
Impact of Biosimilars
The entry of biosimilars into the market is expected to be a significant factor in the future pricing and market dynamics of Humira. Biosimilars are biologic products that are highly similar to an already-approved biologic product, and they can offer more affordable alternatives. This could lead to a reduction in the market share and pricing power of Humira, although the exact impact will depend on various factors including regulatory approvals, market acceptance, and pricing strategies of the biosimilars[4].
Regulatory and Reporting Considerations
The FDA's National Drug Code (NDC) Directory plays a crucial role in tracking and regulating drugs like Humira. The NDC Directory contains information on all finished and unfinished drugs, including those manufactured by AbbVie Inc. This ensures that all drugs, including Humira, are properly identified and reported, and their marketing start and end dates are tracked[1].
Conclusion
The market for Humira, identified by NDC 00074-1539, is robust and growing, driven by strong demand for effective treatments for autoimmune diseases. While the cost of Humira remains high, the introduction of biosimilars and changes in healthcare policies could influence future pricing trends. As the pharmaceutical industry continues to evolve with advancements in biotechnology and the adoption of AI, the market dynamics for drugs like Humira are expected to remain dynamic.
Key Takeaways
- Market Growth: The Humira market is expected to grow significantly, reaching $13.05 billion by 2028.
- Drivers: The growth is driven by biotechnology advancements, patient demand, and the rising incidence of autoimmune diseases.
- Segmentation: The market is segmented by type (Humira Syringe and Humira Pen), application (e.g., rheumatoid arthritis, Crohn's disease), and end-users (hospitals and specialty clinics).
- Price Projections: The cost of Humira is expected to remain high, but the entry of biosimilars could introduce more affordable alternatives.
- Regulatory Considerations: The FDA's NDC Directory ensures proper tracking and regulation of Humira and other drugs.
FAQs
What is the primary use of Humira?
Humira is primarily used to treat various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease.
What is the NDC for Humira?
The NDC for Humira can vary, but one common NDC is 00074-1539.
How is the Humira market expected to grow?
The Humira market is expected to grow to $13.05 billion by 2028, with a CAGR of 7.3%.
What factors drive the growth of the Humira market?
The growth is driven by biotechnology advancements, patient demand, the rising incidence of autoimmune diseases, and healthcare policy changes.
Will the entry of biosimilars affect Humira's market share?
Yes, the entry of biosimilars could potentially reduce Humira's market share and pricing power by offering more affordable alternatives.
Where can I find more information about the NDC Directory?
The FDA's National Drug Code (NDC) Directory contains detailed information about finished and unfinished drugs, including Humira, and can be accessed through the FDA's website[1].
