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Last Updated: January 2, 2025

GAMMAKED, GAMUNEX-C Drug Profile


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Summary for Tradename: GAMMAKED, GAMUNEX-C
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for GAMMAKED, GAMUNEX-C
Mechanism of ActionAntigen Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin G
Chemical StructureImmunoglobulins
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for GAMMAKED, GAMUNEX-C Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GAMMAKED, GAMUNEX-C Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for GAMMAKED, GAMUNEX-C Derived from Patent Text Search

These patents were obtained by searching patent claims

GAMMAKED, GAMUNEX-C Market Analysis and Financial Projection

The Biologics Market: Understanding the Dynamics and Financial Trajectory of Gammaked and Gamunex-C

Introduction to Biologics

Biologics are a class of drugs that are derived from living organisms, such as cells, and are used to treat a wide range of diseases, including chronic conditions and rare disorders. The biologics market has been experiencing significant growth, driven by several key factors.

Global Biologics Market Outlook

The global biologics market was valued at USD 349.6 billion in 2023 and is projected to reach USD 699.5 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.8% during the forecast period[1].

Key Drivers of the Biologics Market

Several factors are driving the growth of the biologics market:

  • Increasing Burden of Chronic Diseases: The high prevalence of chronic diseases is a significant driver, as biologics offer targeted and often more effective treatments compared to traditional drugs[1].
  • Technological Advancements: Continuous advancements in drug delivery systems and the development of novel therapies such as gene therapy, antisense, and RNAi therapies are expanding the market[1].
  • Growing Adoption of Biosimilars: The increasing acceptance and approval of biosimilars are reducing costs and making biologic treatments more accessible[1].
  • Improved Healthcare Infrastructure: Better healthcare infrastructure and favorable reimbursement policies are also contributing to the market's growth[1].

Gammaked and Gamunex-C: Overview

What are Gammaked and Gamunex-C?

Gammaked and Gamunex-C are brand names for intravenous immune globulin (IVIG) products. These drugs are made from immunoglobulins (IGs), which are antibodies that the body naturally produces to fight infections[4].

Manufacturer and FDA Approval

Both Gammaked and Gamunex-C are manufactured by Grifols Therapeutics, Inc., and have the same FDA-approved indications. They are used to treat conditions such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy (CIDP), and certain types of immune thrombocytopenia purpura (ITP)[4].

Differences Between Gammaked and Gamunex-C

While both products are similar in many aspects, there are some differences:

  • IgA Content: Gamunex-C has a slightly higher IgA content compared to Gammaked[4].
  • pH Range: Both products have a pH range of 4.0-4.5 and the same plasma source and half-life (35 hours)[4].

Market Dynamics for IVIG Products

Market Size and Growth

The biologics market, which includes IVIG products like Gammaked and Gamunex-C, is expected to see significant growth. The global market for biological therapeutic drugs is projected to increase from $452.9 billion in 2023 to $823.4 billion by 2028, with a CAGR of 12.7% during the forecast period[5].

Competitive Environment

The IVIG market is competitive, with several brands available, including Gammagard Liquid and Gammaplex. Each brand has its unique characteristics, such as the presence or absence of certain additives and the concentration of the solution[3].

Pricing and Cost

The cost of Gammaked and Gamunex-C can vary based on the quantity and concentration of the solution. For example, the average cost of Gammaked infusion for a 10% injectable solution starts from $176 for 10ml at most U.S. pharmacies[4].

Financial Trajectory

Revenue Projections

Given the overall growth of the biologics market, IVIG products like Gammaked and Gamunex-C are expected to contribute significantly to the revenue of their manufacturers. The increasing demand for biologic treatments, coupled with the expanding patient base due to the rising prevalence of chronic diseases, will drive revenue growth.

Cost and Pricing Strategies

The pricing strategy for these products is crucial. Manufacturers must balance the cost of production with the need to make these treatments accessible to patients. The presence of biosimilars and generic versions can also impact pricing and market share.

Regulatory Environment

Approvals and Compliance

Regulatory approvals play a critical role in the market dynamics of biologic drugs. Both Gammaked and Gamunex-C have received FDA approval, which is essential for their market presence. Continuous compliance with regulatory standards is necessary to maintain market share and ensure patient safety[4].

Patient Access and Reimbursement

Healthcare Infrastructure and Reimbursement Policies

The availability of favorable reimbursement policies and improved healthcare infrastructure are key factors in making biologic treatments accessible to a wider patient base. This accessibility drives demand and contributes to the financial trajectory of these products[1].

Technological Advancements

Impact on Market Growth

Technological advancements in drug delivery systems and the development of novel biologic therapies are expected to further drive the market growth. These advancements can improve the efficacy and safety of treatments, making them more attractive to both patients and healthcare providers[1].

Competitive Landscape

Market Leaders and Innovators

The biologics market is highly competitive, with several market leaders and innovators. Companies like Grifols Therapeutics, Inc., which manufactures Gammaked and Gamunex-C, are continuously investing in research and development to stay ahead in the market. New products and technologies are regularly being introduced, influencing the current standard of care and driving market expansion[5].

Conclusion

The biologics market, including IVIG products like Gammaked and Gamunex-C, is poised for significant growth driven by the increasing burden of chronic diseases, technological advancements, and favorable regulatory and reimbursement environments. Understanding the market dynamics and financial trajectory of these products is crucial for both manufacturers and healthcare providers.

Key Takeaways

  • The global biologics market is expected to reach USD 699.5 billion by 2032.
  • Gammaked and Gamunex-C are IVIG products used to treat various immune-related conditions.
  • These products are manufactured by Grifols Therapeutics, Inc., and have similar FDA-approved indications.
  • The market is driven by the rising prevalence of chronic diseases and technological advancements.
  • Pricing and reimbursement policies play a critical role in patient access and market growth.

FAQs

What is the projected growth rate of the biologics market?

The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[1].

What are the key drivers of the biologics market?

Key drivers include the increasing burden of chronic diseases, technological advancements, growing adoption of biosimilars, and improved healthcare infrastructure[1].

How do Gammaked and Gamunex-C differ?

Gammaked and Gamunex-C differ slightly in their IgA content, with Gamunex-C having a higher IgA content[4].

What is the average cost of Gammaked infusion?

The average cost of Gammaked infusion for a 10% injectable solution starts from $176 for 10ml at most U.S. pharmacies[4].

What role do regulatory approvals play in the biologics market?

Regulatory approvals are crucial for the market presence of biologic drugs, ensuring compliance with safety and efficacy standards[4].

Sources

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
  2. Make Smarter Trades - Learn Stock Market Gamma - Markets.com
  3. IVIG Brands: In-Depth Guide - AmeriPharma Specialty Pharmacy
  4. What is Gammaked? - AmeriPharma Specialty Care
  5. Biologic Therapeutic Drugs: Technologies and Global Markets - BCC Research

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