Last updated: January 3, 2025
Overview of Leucovorin Calcium
Leucovorin Calcium, with the NDC code 25021-816, is a human prescription drug manufactured by Sagent Pharmaceuticals. It is an injection, powder, lyophilized, for solution, and is administered intramuscularly or intravenously. Leucovorin is a folate analog used as an antidote to drugs that act as folic acid antagonists, such as methotrexate, and in the treatment of certain cancers and megaloblastic anemia[1][5].
Market Size and Growth
The biopharma market, which includes drugs like Leucovorin Calcium, is projected to grow significantly. As of 2024, the biopharma market size was estimated to be over $400 billion, with a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. The biotechnology sector, closely related to biopharma, had a market size of nearly $500 billion in 2020 and is expected to grow at a CAGR of 9.4% between 2021 and 2027[3].
Pricing and Cost Considerations
Current Pricing
The pricing of Leucovorin Calcium can vary based on several factors, including the dosage form, strength, and the entity purchasing the drug. As of the latest available data, the active ingredient strength of Leucovorin Calcium under NDC 25021-816 is 350 mg/17.5 mL[1].
Medicare Drug Price Negotiation Program
The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act, is set to impact drug prices significantly. Although Leucovorin Calcium is not listed among the initial 10 drugs selected for negotiation, the program's overall impact on the pharmaceutical market could indirectly affect pricing. For example, negotiated prices for other drugs could lead to a broader market adjustment, potentially influencing the prices of other medications, including Leucovorin Calcium. The program is expected to save an estimated $6 billion in net covered prescription drug costs in 2023 if the negotiated prices had been in effect, and it will save an estimated $1.5 billion for people with Medicare Part D coverage when the negotiated prices go into effect in 2026[2].
Regulatory Landscape
The regulatory landscape is evolving to keep pace with innovation in the biopharma and biotech industries. In 2025, regulatory frameworks are expected to become more adaptive to support the rapid development of new therapies. This evolution could impact the approval and pricing of drugs like Leucovorin Calcium by ensuring that regulatory processes are more streamlined and efficient, potentially reducing development costs and time to market[3].
Clinical Trial Innovations
Accelerated clinical trial designs are reshaping drug development. While Leucovorin Calcium is already an established drug, the innovations in clinical trial designs could influence the development of new indications or formulations of the drug. These innovative designs aim to make clinical trials more efficient, reducing the time and cost associated with bringing new treatments to market. This could indirectly affect the pricing and market positioning of Leucovorin Calcium by making it more competitive or by opening up new therapeutic areas where it could be used[3].
Precision Medicine and Technological Advancements
The biopharma and biotech industries are moving towards precision medicine and leveraging AI/ML technologies. While Leucovorin Calcium is not a precision medicine per se, the overall trend towards personalized healthcare could lead to more targeted and effective use of the drug. Technological advancements, such as AI in drug development and patient management, could also optimize the use of Leucovorin Calcium, potentially affecting its market demand and pricing[3].
Market Projections
Given the current market trends and regulatory environment:
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Short-term Projections: The price of Leucovorin Calcium is likely to remain stable in the short term, influenced by existing market dynamics and the absence of significant changes in its regulatory status or direct inclusion in price negotiation programs.
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Long-term Projections: As the biopharma market continues to grow and regulatory frameworks evolve, there could be indirect impacts on the pricing of Leucovorin Calcium. The overall trend towards cost savings and efficiency in healthcare, driven by programs like the Medicare Drug Price Negotiation Program, may lead to a more competitive pricing environment. Additionally, advancements in clinical trial designs and precision medicine could enhance the drug's market position and potentially influence its pricing.
Key Takeaways
- Market Growth: The biopharma market is expected to grow significantly, driven by technological advancements and evolving regulatory frameworks.
- Pricing Dynamics: The Medicare Drug Price Negotiation Program and other cost-saving initiatives could indirectly influence the pricing of Leucovorin Calcium.
- Regulatory Evolution: Regulatory changes are expected to support innovation and efficiency in drug development.
- Clinical Trial Innovations: New clinical trial designs could make drug development more efficient, potentially affecting the market positioning of established drugs.
- Precision Medicine and Technology: The move towards precision medicine and the use of AI/ML technologies could optimize the use of Leucovorin Calcium.
FAQs
Q: What is Leucovorin Calcium used for?
A: Leucovorin Calcium is used as an antidote to drugs that act as folic acid antagonists and in the treatment of certain cancers and megaloblastic anemia[5].
Q: How is Leucovorin Calcium administered?
A: It is administered intramuscularly or intravenously[1].
Q: What is the impact of the Medicare Drug Price Negotiation Program on Leucovorin Calcium?
A: While Leucovorin Calcium is not directly included in the initial negotiation cycle, the program's overall impact on the pharmaceutical market could indirectly affect its pricing[2].
Q: How are regulatory changes affecting the biopharma industry?
A: Regulatory frameworks are evolving to support innovation and efficiency in drug development, which could influence the market positioning and pricing of drugs like Leucovorin Calcium[3].
Q: What role do technological advancements play in the biopharma industry?
A: Technological advancements, such as AI/ML technologies, are optimizing drug development and patient management, potentially affecting the market demand and pricing of drugs like Leucovorin Calcium[3].
Sources
- FDA.report: NDC 25021-816 Intramuscular - FDA.report
- CMS: Medicare Drug Price Negotiation Program - CMS
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025
- SEER: 25021-0821 Methylprednisolone acetate - CanMED: NDC
- DailyMed: LEUCOVORIN CALCIUM injection, powder, lyophilized, for solution
