Market Analysis and Price Projections for the Drug NDC: 42291-0821
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand what the NDC represents. The NDC is a unique, three-segment number that identifies the labeler, product, and trade package size of a drug product. For the NDC 42291-0821, each segment provides specific information: the labeler code, the product code, and the package code[5].
Identifying the Drug
The NDC 42291-0821 can be broken down as follows:
- Labeler Code: 42291
- Product Code: 082
- Package Code: 1
Using the FDA's National Drug Code Directory, you can identify the specific drug product associated with this NDC. This directory contains information on active and certified finished and unfinished drugs submitted to the FDA in structured product labeling (SPL) electronic listing files[1].
Market Trends and Pricing
Global Pricing Disparities
The pharmaceutical market, particularly in the U.S., is characterized by significantly higher drug prices compared to other regions. For instance, the average price per unit in the U.S. is 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as in the rest of the world (excluding the U.S.)[4].
Price Increases and Negotiations
Many prescription drugs, including those with high usage and significant price increases, are subject to price negotiations. For example, the Medicare Drug Price Negotiation Program has resulted in substantial discounts for certain drugs. Between 2018 and 2023, many drugs saw list price increases ranging from 20% to 55%, while negotiated prices under Medicare Part D resulted in discounts ranging from 38% to 79%[2].
Specific Drug Analysis
To analyze the market and price projections for the drug with NDC 42291-0821, you would need to identify the specific drug and its market segment.
Market Segment
- If the drug falls under a category like biologics or small molecule drugs, it is important to note that biologic products have seen significant growth in the U.S. market, with a 61% increase in sales revenues between certain periods[4].
Price History and Projections
- Historical price data can be obtained from the FDA's NDC Directory and other market analysis reports. For example, if the drug has seen price increases similar to other drugs in its category, it might continue to follow this trend unless affected by external factors like price negotiations or regulatory changes.
- Price Negotiations: If the drug is selected for price negotiation under programs like Medicare Part D, its list price could see significant reductions. For instance, drugs selected for the first cycle of negotiation saw list price increases between 20% and 55% from 2018 to 2023, but negotiated prices resulted in substantial discounts[2].
Regulatory Landscape
The regulatory environment plays a crucial role in drug pricing and market dynamics. Here are some key points:
Evolving Regulatory Frameworks
- The biopharma and biotech industries are experiencing rapid changes due to evolving regulatory frameworks. These changes can impact drug development, approval, and pricing. For example, accelerated clinical trial designs and a shift towards patient-centered care are expected to shape the future of medicine[3].
FDA Oversight
- The FDA's oversight, including the requirement for drug establishments to provide a current list of all drugs manufactured or processed, ensures that drugs are identified and reported accurately using the NDC. This oversight can influence market dynamics and pricing transparency[1].
Market Size and Growth
The biopharma and biotech markets are experiencing significant growth. Here are some key statistics:
Biopharma Market Size
- The biopharma market size was estimated to be over $400 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].
Biotech Market Size
- The biotech market size was nearly $500 billion in 2020, with an estimated CAGR of 9.4% between 2021 and 2027[3].
Consumer and Payer Impact
High prescription drug prices create affordability challenges for patients, health care payers, and taxpayers. Here are some points to consider:
Affordability Challenges
- Price increases for existing drugs have added to affordability challenges. For instance, the ten drugs selected for the first cycle of Medicare Part D negotiations accounted for $56.2 billion in total Part D gross covered prescription drug costs in 2023[2].
Cost Sharing
- Patients often face cost-sharing mechanisms such as copayments and coinsurance, which can be affected by negotiated prices. For example, negotiated prices under Medicare Part D can significantly reduce the cost burden on patients[2].
Key Takeaways
- NDC Identification: The NDC 42291-0821 uniquely identifies a drug product, including its labeler, product, and package details.
- Global Pricing Disparities: U.S. drug prices are significantly higher than in other regions.
- Price Negotiations: Programs like Medicare Part D can result in substantial discounts for selected drugs.
- Regulatory Impact: Evolving regulatory frameworks and FDA oversight influence drug development, approval, and pricing.
- Market Growth: The biopharma and biotech markets are experiencing rapid growth, driven by technological advancements and shifting regulatory landscapes.
FAQs
1. What does the National Drug Code (NDC) represent?
The NDC is a unique, three-segment number that identifies the labeler, product, and trade package size of a drug product.
2. How do global pricing disparities affect drug prices in the U.S.?
Drug prices in the U.S. are significantly higher than in other regions, with prices being 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as in the rest of the world (excluding the U.S.)[4].
3. What impact do price negotiations have on drug prices?
Price negotiations, such as those under Medicare Part D, can result in substantial discounts, ranging from 38% to 79% compared to list prices[2].
4. How do regulatory changes affect the biopharma and biotech industries?
Evolving regulatory frameworks, including accelerated clinical trial designs and a shift towards patient-centered care, are shaping the future of medicine and impacting drug development and pricing[3].
5. What are the affordability challenges posed by high prescription drug prices?
High prescription drug prices create significant affordability challenges for patients, health care payers, and taxpayers, with price increases for existing drugs adding to these challenges[2].
Sources
- FDA's National Drug Code Directory - FDA
- Medicare Drug Price Negotiation Program - ASPE - HHS.gov
- 5 Predictions for the Biopharma and Biotech Industries in 2025 - TFS CRO
- International Market Size and Prices - ASPE
- National Drug Code Database Background Information - FDA
