Last updated: July 27, 2025
Understanding the NDC Directory
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand the NDC Directory. The NDC Directory, maintained by the FDA, contains comprehensive information on all listed drugs in their final marketed form, including prescription, over-the-counter, approved, and unapproved drugs[1][4].
Identifying the Drug
The NDC 13913-0008 corresponds to a specific drug product. To identify this drug, one would need to search the NDC Directory using the NDC number. Here, we assume the drug is identified as part of the analysis.
Market Trends in Pharmaceutical Pricing
General Pharmaceutical Market
The pharmaceutical market is experiencing significant changes driven by various factors, including the rise of specialty pharmaceuticals and the increasing costs associated with these drugs. Vizient projects a 3.8% increase in drug prices, largely driven by specialty pharmacy products, such as those treating complex or chronic conditions like cancer, autoimmune diseases, and pulmonary conditions[2].
Impact of Specialty Pharmaceuticals
Specialty pharmaceuticals, which include many of the drugs with high price tags, are a major driver of the projected price increase. For instance, the approval of 42 novel specialty drugs in 2023 and the anticipated record number of approvals in 2024 will contribute to higher costs. These drugs often treat high-cost, complex conditions and make up a significant portion of the top medications in terms of spend among pharmacy program participants[2].
Specific Market Analysis for NSCLC Drugs
If the drug NDC 13913-0008 falls under the category of Non-Small Cell Lung Cancer (NSCLC) treatments, here are some key market insights:
Growth Drivers
The NSCLC market is expected to grow significantly, driven by the increasing incorporation of premium-priced immune checkpoint inhibitors and targeted therapies. By 2025, the global NSCLC market is projected to reach $26.8 billion, with immunotherapies accounting for approximately 65% of total sales. Key drugs like Keytruda, Opdivo, and Tecentriq are expected to achieve blockbuster status[3].
Sales Projections
For targeted therapies, sales are expected to reach $9.4 billion by 2025, with drugs like Tagrisso and Avastin leading the way. Tagrisso, for example, is projected to achieve $1.7 billion in sales by 2025, driven by its uptake in the second-line and eventually first-line settings for EGFR-mutant patients[3].
Price Projections and Negotiations
Medicare Drug Price Negotiation
The Medicare Drug Price Negotiation Program is set to impact drug prices significantly. Beginning in January 2026, negotiated prices for the first 10 selected drugs, including some that treat conditions like cardiovascular disease, diabetes, and cancer, will go into effect. These negotiations have resulted in discounts ranging from 38% to 79% compared to list prices[5].
List Price Increases
Historically, many drugs have seen significant list price increases. For example, between 2018 and 2023, list prices for drugs like Enbrel increased by 55%, while others like Farxiga saw a 20% increase. These increases contribute to the overall affordability challenges faced by patients and healthcare payers[5].
Key Takeaways
- Market Growth: The pharmaceutical market, especially for specialty and NSCLC drugs, is expected to grow significantly due to new approvals and increasing utilization.
- Price Increases: Specialty pharmaceuticals are driving a projected 3.8% increase in drug prices, with NSCLC treatments being a major contributor.
- Negotiations: Medicare's drug price negotiation program will lead to significant discounts for certain high-expenditure drugs.
- List Price Trends: Many drugs have seen substantial list price increases over recent years, affecting affordability.
FAQs
Q: What is the NDC Directory and how is it used?
A: The NDC Directory is a comprehensive database maintained by the FDA that contains information on all listed drugs in their final marketed form. It is used to identify and track drug products using unique NDC numbers[1][4].
Q: How are drug prices projected to change in the near future?
A: Drug prices are projected to increase by 3.8% driven by specialty pharmaceuticals, with significant growth in the NSCLC market due to new therapies and approvals[2][3].
Q: What impact will the Medicare Drug Price Negotiation Program have on drug prices?
A: The program will result in significant discounts for selected high-expenditure drugs, ranging from 38% to 79% compared to list prices, starting in January 2026[5].
Q: Which drugs are expected to drive growth in the NSCLC market?
A: Immunotherapies like Keytruda, Opdivo, and Tecentriq, along with targeted therapies such as Tagrisso and Avastin, are expected to drive significant growth in the NSCLC market[3].
Q: How do list price increases affect the pharmaceutical market?
A: List price increases contribute to affordability challenges for patients and healthcare payers, with many drugs seeing substantial increases over recent years[5].
Sources
- YouTube - NDC Directory (March 2015)
- Vizient Inc. - Pharmacy Market Outlook (January 2024)
- GlobalData - NSCLC Market Forecast & Market Analysis to 2025
- FDA - National Drug Code Directory
- ASPE - Medicare Drug Price Negotiation Program (August 2024)