Market Analysis and Price Projections for the Drug NDC: 00113-0147
Understanding the National Drug Code (NDC)
Before diving into the market analysis and price projections, it's crucial to understand what the National Drug Code (NDC) represents. The NDC is an 11-digit code maintained by the FDA, consisting of the labeler code, product code, and package code. This code is essential for identifying the drug name, strength, and dosage form of a drug product[2].
Identifying the Drug
The NDC 00113-0147 needs to be identified to proceed with the analysis. However, the provided sources do not specify the drug associated with this NDC directly. Typically, one would refer to the FDA NDC Directory or other pharmaceutical databases to identify the drug.
Market Analysis
To conduct a market analysis for a specific drug, several factors need to be considered:
Market Size and Growth
The overall pharmaceutical market, particularly the segment in which the drug falls, is crucial. For instance, the biopharma market is projected to grow significantly, with a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].
Competitive Landscape
Understanding the competitive landscape is vital. For example, in the Non-Small Cell Lung Cancer (NSCLC) market, immunotherapies and targeted therapies are driving growth. Drugs like Keytruda, Opdivo, and Tecentriq dominate this market, with projected sales of $17.5 billion by 2025[4].
Regulatory Environment
Changes in regulatory frameworks can significantly impact drug pricing and market dynamics. The FDA's potential changes to the NDC format, due to running out of numbers, could have far-reaching implications for the pharmaceutical supply chain and may affect pricing and market strategies[5].
Price Projections
Price projections for a specific drug involve several key factors:
National Average Drug Acquisition Cost (NADAC)
The NADAC is a critical metric for understanding the average cost at which pharmacies acquire drugs. This cost is calculated based on surveys of chain and independent pharmacies and can be adjusted for various factors such as changes in published pricing or inquiries to the help desk[2].
Pricing Unit and Pharmacy Type Indicator
The pricing unit (e.g., 'ML', 'GM', or 'EA') and the pharmacy type indicator (e.g., 'C/I' for Chain/Independent pharmacies) are important for determining the cost per unit of the drug[2].
Market Dynamics and Competition
The presence of generic or branded competitors can significantly impact the pricing of a drug. For instance, in the NSCLC market, the patent expiration of drugs like Tarceva and Alimta has led to a decline in their sales, while generics have seen an increase[4].
Example: NSCLC Market Analysis
While the specific drug associated with NDC 00113-0147 is not identified, we can use the NSCLC market as an illustrative example:
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Immunotherapies: Keytruda, Opdivo, and Tecentriq are projected to dominate the NSCLC market with sales of $17.5 billion by 2025. If the drug in question is an immunotherapy or a targeted therapy in this space, its pricing would be influenced by these market leaders[4].
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Generic Impact: The entry of generics can reduce the market share and pricing power of branded drugs. For example, generic erlotinib is expected to reach $77 million in sales by 2025, impacting the sales of branded EGFR-TKIs like Tarceva[4].
Key Takeaways
- Market Growth: The pharmaceutical market, especially segments like biopharma and biotech, is experiencing significant growth driven by technological advancements and evolving regulatory frameworks.
- Competitive Landscape: The presence of dominant players and the entry of generics can significantly impact pricing strategies.
- Regulatory Changes: Potential changes to the NDC format could have widespread implications for the pharmaceutical supply chain and pricing.
- Pricing Metrics: NADAC and other pricing metrics are crucial for understanding the acquisition cost and pricing dynamics of drugs.
FAQs
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What is the National Drug Code (NDC)?
- The NDC is an 11-digit code maintained by the FDA that identifies the drug name, strength, and dosage form of a drug product[2].
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How is the National Average Drug Acquisition Cost (NADAC) calculated?
- NADAC is calculated based on surveys of chain and independent pharmacies and can be adjusted for various factors such as changes in published pricing or inquiries to the help desk[2].
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What impact do generic drugs have on the pricing of branded drugs?
- The entry of generics can reduce the market share and pricing power of branded drugs by offering a cheaper alternative, as seen in the NSCLC market with drugs like Tarceva and Alimta[4].
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How do regulatory changes affect drug pricing?
- Regulatory changes, such as the potential reform of the NDC format, can impact the pharmaceutical supply chain and may influence pricing strategies and market dynamics[5].
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What role do immunotherapies play in the NSCLC market?
- Immunotherapies like Keytruda, Opdivo, and Tecentriq are projected to dominate the NSCLC market, contributing significantly to its growth and influencing the pricing of other drugs in this segment[4].
Sources
- Drug Name and National Drug Code (NDC) Reference Data Instructions - CMS
- National Average Drug Acquisition Cost (NADAC) Data Field Definitions - Medicaid
- 5 Predictions for the Biopharma and Biotech Industries in 2025 - TFS CRO
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
- Are You Prepared for a Major Industry Change to the National Drug Code (NDC) Number? - Wolters Kluwer
