Hepatitis b immune globulin intravenous (human) - Biologic Drug Details

Summary for hepatitis b immune globulin intravenous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for hepatitis b immune globulin intravenous (human)

Recent Clinical Trials for hepatitis b immune globulin intravenous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 2
Third Affiliated Hospital, Sun Yat-Sen University	Phase 4
B.P. Koirala Institute of Health Sciences	Phase 2

See all hepatitis b immune globulin intravenous (human) clinical trials

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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 hepatitis b immune globulin intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hepatitis b immune globulin intravenous (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for hepatitis b immune globulin intravenous (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Hepatitis B Immune Globulin Intravenous (Human)

Market Overview

The market for biologic drugs, particularly Hepatitis B Immune Globulin Intravenous (Human), is experiencing significant growth driven by several key factors.

Growing Demand for Immunoglobulins

The global intravenous immunoglobulin market, which includes Hepatitis B Immune Globulin, is projected to grow substantially. The market size was estimated at USD 11.98 billion in 2022 and is expected to grow at a CAGR of 7.3% from 2023 to 2030[4].

Specific Indications for Hepatitis B Immune Globulin

Hepatitis B Immune Globulin (HBIG) is specifically indicated for the prevention of Hepatitis B recurrence following liver transplantation, post-exposure prophylaxis, and other specific exposure scenarios. This includes acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, and sexual or household exposure to HBsAg-positive individuals[5].

Market Drivers

Increasing Prevalence of Hepatitis B

The rising incidence of Hepatitis B infections, particularly in regions with high prevalence rates, drives the demand for HBIG. This is exacerbated by the need for post-exposure prophylaxis and the management of chronic Hepatitis B in immunocompromised patients.

Advances in Healthcare Infrastructure

Improved healthcare infrastructure and increased investment in the healthcare sector contribute to the growth of the HBIG market. Better diagnostic capabilities and treatment protocols enhance the use of HBIG in various clinical settings[4].

Expanding Use in Niche Patient Populations

Companies like ADMA Biologics are focusing on developing specialty biologics, including HBIG, targeted at niche patient populations. This includes patients with primary humoral immunodeficiency, those undergoing liver transplantation, and others who are at high risk of Hepatitis B infection[3].

Financial Trajectory

Revenue Growth

The revenue from HBIG is expected to contribute significantly to the overall intravenous immunoglobulin market. With a projected CAGR of 7.3%, the market is anticipated to reach substantial revenue figures by 2030. For instance, ADMA Biologics reported a significant increase in revenues, with total revenues of $119.8 million in the third quarter of 2024, up from $67.3 million in the same period in 2023, largely due to increased sales of their immunoglobulin products, including HBIG[3].

Cost and Pricing

The cost of HBIG can be substantial, with each dose ranging from CAD $550 to $2,200 per child and between $2,000 and $8,000 per adult in Canada. This high cost is a significant factor in the financial trajectory, as it influences both revenue and market accessibility[2].

Distribution Channels

Hospital pharmacies dominate the distribution of HBIG, accounting for more than 57.3% of the market share in 2022. This is due to the extensive network of hospitals and the preference for hospital pharmacies due to quick reimbursement and comprehensive care[1].

Market Restraints

High Costs and Side Effects

Despite the growing demand, the high cost of diagnosing and treating diseases with HBIG, along with the risks of side effects, act as significant restraints. Infusions of immunoglobulin are typically given every 3-4 weeks, and the therapy can last for 12-16 sessions per year, adding to the overall cost burden[1].

Regulatory Challenges

Strict government regulations on the use of intravenous immunoglobulins, including HBIG, can limit market growth. Ensuring compliance with these regulations while maintaining a sustainable supply of these products is a critical challenge[1].

Market Opportunities

Expanding Indications

The potential for label expansion and the approval of new indications can significantly boost the market for HBIG. For example, ADMA Biologics is anticipating the filing of a supplemental Biologics License Application (sBLA) for the pediatric label expansion of ASCENIV, which could further strengthen their product portfolio[3].

Technological Advancements

Improvements in biologic production yields, such as the 20% yield enhancement reported by ADMA Biologics, can increase the supply and reduce the costs associated with HBIG production. This can make the treatment more accessible and drive market growth[3].

Emerging Markets

The growing demand in emerging markets, particularly in regions with high Hepatitis B prevalence, presents lucrative opportunities for the HBIG market. Increased investment in healthcare infrastructure in these regions can further accelerate market growth[4].

Regional Analysis

North America

North America is expected to account for a significant portion of the market growth, driven by the increasing geriatric population, the rising number of patients with immunodeficiency disorders, and advanced healthcare infrastructure[1].

Europe and Asia Pacific

Europe and the Asia Pacific region are also expected to contribute substantially to the market growth, driven by similar factors such as an increasing elderly population and the rising prevalence of immunodeficiency diseases[4].

Key Takeaways

• The global intravenous immunoglobulin market, including HBIG, is projected to grow at a CAGR of 7.3% from 2023 to 2030.
• The market is driven by the growing elderly population, rising prevalence of immunodeficiency diseases, and increasing adoption of IVIG treatments.
• High costs and side effects are significant restraints, but technological advancements and expanding indications offer lucrative opportunities.
• Hospital pharmacies dominate the distribution channels, and North America is expected to account for a major share of the market growth.

FAQs

Q: What are the primary indications for Hepatitis B Immune Globulin Intravenous (Human)? A: HBIG is indicated for the prevention of Hepatitis B recurrence following liver transplantation, post-exposure prophylaxis, and other specific exposure scenarios such as acute exposure to blood containing HBsAg and perinatal exposure of infants born to HBsAg-positive mothers[5].

Q: How is the market for HBIG expected to grow in the coming years? A: The market is expected to grow at a CAGR of 7.3% from 2023 to 2030, driven by factors such as the growing elderly population and the rising prevalence of immunodeficiency diseases[4].

Q: What are the major restraints in the HBIG market? A: High costs, risks of side effects, and strict government regulations are significant restraints in the HBIG market[1].

Q: Which distribution channels dominate the HBIG market? A: Hospital pharmacies dominate the market, accounting for more than 57.3% of the market share in 2022[1].

Q: How do technological advancements impact the HBIG market? A: Technological advancements, such as improvements in biologic production yields, can increase the supply and reduce costs, making the treatment more accessible and driving market growth[3].

Sources

1. GlobeNewswire: "Intravenous Immunoglobulin Market size to grow by USD 24.4 Billion by 2032"
2. Institute of Health Economics: "Criteria for the Clinical Use of Immune Globulin, 2nd Edition"
3. BioSpace: "ADMA Biologics Announces Third Quarter 2024 Financial Results and Provides Business Update"
4. Grand View Research: "Intravenous Immunoglobulin Market Size & Share Report"
5. Molina Healthcare: "Hepatitis B Immune Globulin C9971-A"