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Last Updated: December 25, 2024

HEPAGAM B Drug Profile


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Summary for Tradename: HEPAGAM B
High Confidence Patents:0
Applicants:1
BLAs:2
Pharmacology for HEPAGAM B
Mechanism of ActionVirus Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin
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 HEPAGAM B Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HEPAGAM B Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HEPAGAM B Derived from Patent Text Search

These patents were obtained by searching patent claims

HEPAGAM B Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HEPAGAM B

Introduction to HEPAGAM B

HEPAGAM B® is a hepatitis B Immune Globulin (Human) (HBIg) product, specifically designed to prevent hepatitis B virus (HBV) recurrence following liver transplantation and to provide immediate, short-term protection against HBV infection[5].

Market Context: Hepatitis B

The hepatitis B market is experiencing significant growth driven by several key factors, including the increasing prevalence of HBV infections and the rising awareness of the disease’s impact on public health. The global hepatitis B infection market is projected to grow from USD 12.11 billion in 2023 to USD 18.21 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[4].

Growth Drivers for HEPAGAM B

Advancements in Antiviral Therapies

The introduction of new antiviral drugs with higher precision and fewer side effects is a significant driver for the hepatitis B market. HEPAGAM B, as an immune globulin, benefits from this trend as it is often used in conjunction with antiviral therapies to enhance patient outcomes[1].

Increasing Prevalence and Awareness

The growing number of chronic HBV cases, particularly in regions like the United States, Asia-Pacific, and sub-Saharan Africa, necessitates robust diagnosis, management, and treatment strategies. This increasing demand drives the market for products like HEPAGAM B[1][4].

Combination Therapies and Drug Delivery Systems

Advancements in drug delivery systems and the development of combination therapies have contributed to the expansion of the hepatitis B market. HEPAGAM B, being part of these combination strategies, benefits from these advancements[4].

Financial Performance and Projections

Historical Financials

Historically, HEPAGAM B has been part of the product portfolio of companies like Cangene Corporation, which reported significant revenues from its hyperimmune products. For instance, Cangene's revenues from government contracts, including those related to hyperimmune products, were substantial, with a combined revenue value of approximately $505 million for certain contracts[2].

Current Market Value and Projections

The hepatitis B market, which includes products like HEPAGAM B, is expected to reach USD 4.9 billion by 2034, growing at a CAGR of 3.83% from 2024 to 2034. This growth indicates a robust financial trajectory for HEPAGAM B and similar products[1].

Market Dynamics: Biologics and Biosimilars

Biologics Market Growth

Biologics, including immune globulins like HEPAGAM B, are a growing share of the pharmaceutical market. Biologics now represent 42% of the total medicines market, up from 30% in 2014. This growth is driven by the R&D pipeline, which suggests continued broad-based growth across most disease areas[3].

Biosimilar Competition

While HEPAGAM B is a biologic product, the biosimilar market is becoming increasingly relevant. However, biosimilars for immune globulins like HEPAGAM B are less common compared to other biologics. By year-end 2019, only 17% of the biologics market was accessible to biosimilars, suggesting that HEPAGAM B may face less immediate competition from biosimilars[3].

Regional Market Analysis

United States

The United States has the largest patient pool for hepatitis B and represents the biggest market for its treatment. According to the Centers for Disease Control and Prevention (CDC), approximately 862,000 people in the United States are living with chronic HBV infection, driving demand for products like HEPAGAM B[1].

Global Markets

Other significant markets include Germany, France, the United Kingdom, Italy, Spain, and Japan. The Asia-Pacific and sub-Saharan Africa regions also show high infection rates, contributing to the global demand for hepatitis B treatments[1][4].

Recent Transactions and Strategic Moves

Saol Therapeutics and Kamada

In a recent transaction, Saol Therapeutics divested its plasma-derived hyperimmune portfolio, including HEPAGAM B, to Kamada. The deal involved an upfront payment of $95 million and up to an additional $50 million in sales milestones. This transaction highlights the strategic importance and financial value of HEPAGAM B in the market[5].

Key Takeaways

  • Growing Market: The hepatitis B market is expected to grow significantly, driven by new antiviral drugs, combination therapies, and increasing prevalence.
  • Financial Projections: The market is projected to reach USD 4.9 billion by 2034, with HEPAGAM B contributing to this growth.
  • Biologics and Biosimilars: HEPAGAM B benefits from the growing biologics market but faces less immediate competition from biosimilars.
  • Regional Importance: The United States and other global regions drive demand for HEPAGAM B due to high HBV infection rates.
  • Strategic Transactions: Recent deals, such as the one between Saol Therapeutics and Kamada, underscore the financial and strategic value of HEPAGAM B.

Frequently Asked Questions (FAQs)

Q: What is HEPAGAM B used for? A: HEPAGAM B is used to prevent hepatitis B virus (HBV) recurrence following liver transplantation and to provide immediate, short-term protection against HBV infection[5].

Q: How is the hepatitis B market expected to grow? A: The hepatitis B market is expected to reach USD 4.9 billion by 2034, growing at a CAGR of 3.83% from 2024 to 2034[1].

Q: What are the key drivers of the hepatitis B market? A: The key drivers include the introduction of new antiviral drugs, increasing prevalence of HBV infections, and advancements in combination therapies and drug delivery systems[1][4].

Q: How does HEPAGAM B fit into the broader biologics market? A: HEPAGAM B is part of the growing biologics market, which now represents 42% of the total medicines market. However, it faces less immediate competition from biosimilars compared to other biologics[3].

Q: What was the recent transaction involving HEPAGAM B? A: Saol Therapeutics divested its plasma-derived hyperimmune portfolio, including HEPAGAM B, to Kamada for an upfront payment of $95 million and up to an additional $50 million in sales milestones[5].

Cited Sources

  1. Biospace: Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034...
  2. Annual Reports: Cangene Corporation - Annual Reports
  3. FTC: Biologics Market Dynamics: Setting the Stage for Biosimilars
  4. Data Bridge Market Research: Hepatitis B Infection Market Size, Share, & Trends By 2031
  5. Saol Therapeutics: Saol Therapeutics Announces FDA Approval of LYVISPAHTM...

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