Hepatitis b immune globulin (human) - Biologic Drug Details

Summary for hepatitis b immune globulin (human)

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for hepatitis b immune globulin (human)

Recent Clinical Trials for hepatitis b immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Pennsylvania	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	N/A

See all hepatitis b immune globulin (human) clinical trials

Pharmacology for hepatitis b immune globulin (human)

Mechanism of Action	Virus Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin
Chemical Structure	Immunoglobulins

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 (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

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

Market Overview

The market for Hepatitis B Immune Globulin (Human) is a significant segment within the broader hepatitis B treatment market. This biologic drug plays a crucial role in preventing and treating hepatitis B virus (HBV) infections, particularly in high-risk individuals.

Market Size and Growth

As of 2023, the Human Hepatitis B Immunoglobulin Market was valued at USD 4.4 billion. It is projected to grow to USD 5.57 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 3.65% from 2024 to 2031[3].

Segmentation

The market is segmented based on several key factors:

By Application

• The primary application of Hepatitis B Immune Globulin is as a polyclonal antibody for prophylaxis and treatment of HBV infections[3].

By Product

• The market includes products for Hepatitis B Prophylaxis, Hepatitis B Treatment, and Immunodeficiency Disorders[3].

By Distribution Channel

• Distribution channels include Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies[1].

By Region

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][3].

Drivers of Market Growth

Several factors are driving the growth of the Hepatitis B Immune Globulin market:

Increasing Public Health Awareness

• Growing public health awareness campaigns and educational programs about the importance of hepatitis B vaccination and post-exposure prophylaxis are fostering market demand[3].

Government Initiatives

• Government bodies worldwide are implementing stricter vaccination policies and expanding immunization programs, which is creating a surge in demand for immunoglobulins[3].

Rising Geriatric Population

• The increasing geriatric population, which is particularly vulnerable to severe hepatitis B complications, is necessitating increased use of immunoglobulins for prophylaxis and treatment[3].

Advancements in Diagnostic Techniques and New-Generation Immunoglobulins

• Ongoing research and development efforts are leading to the introduction of more effective and longer-lasting immunoglobulin formulations, further propelling market growth[3].

Key Players

The market is dominated by several major players, including:

• Grifols
• CSL Behring
• Kedrion Biopharma
• Octapharma
• China Biologic Products
• Baxter International
• LFB Biomedicaments
• Takeda Pharmaceutical Company
• Emergent BioSolutions
• Biotest AG
• Shire (now part of Takeda)[3].

Usage and Efficacy

Hepatitis B Immune Globulin (Human) is indicated for postexposure prophylaxis in various situations:

Acute Exposure

• It is used for acute exposure to blood containing HBsAg, such as accidental needlestick injuries or direct mucous membrane contact. A regimen combining Hepatitis B Immune Globulin with hepatitis B vaccine provides both short- and long-term protection[2].

Perinatal Exposure

• It is also used for perinatal exposure of infants born to HBsAg-positive mothers. This helps in preventing the transmission of HBV from mother to child[2].

Financial Projections

The financial trajectory of the Hepatitis B Immune Globulin market is promising:

• The market is expected to grow from USD 4.4 billion in 2023 to USD 5.57 billion by 2031, with a CAGR of 3.65% during the forecast period[3].

Competitive Landscape

The competitive landscape of the Hepatitis B Immune Globulin market is characterized by:

• High competition among established players such as Grifols, CSL Behring, and Kedrion Biopharma.
• Continuous innovation in product development, such as the introduction of new-generation immunoglobulins.
• A detailed analysis using Porter’s Five Forces, which includes buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition within the market[3].

Regional Market Dynamics

The United States has the largest patient pool for hepatitis B and represents the biggest market for its treatment. This is due to the increasing prevalence of HBV infections and rising awareness of the disease’s impact on public health. According to the CDC, approximately 862,000 people in the United States are living with chronic HBV infection, driving the need for robust diagnosis, management, and treatment strategies[4].

Advancements in Antiviral Therapies

The broader hepatitis B market is also driven by advancements in antiviral therapies and vaccines. For instance, Dynavax Technologies’ Heplisav-B vaccine has been gaining traction due to its efficacy and simplified dosing regimen. VBI Vaccines’ PreHevbrio is another example, offering comprehensive protection against all known subtypes of the HBV[4].

Conclusion

The market for Hepatitis B Immune Globulin (Human) is poised for significant growth, driven by increasing public health awareness, government initiatives, and advancements in diagnostic techniques and product development. As the global healthcare landscape continues to evolve, this market is expected to play a critical role in preventing and treating HBV infections.

Key Takeaways

• The Human Hepatitis B Immunoglobulin Market is projected to reach USD 5.57 billion by 2031.
• The market is driven by public health awareness, government initiatives, and a rising geriatric population.
• Key players include Grifols, CSL Behring, and Kedrion Biopharma.
• The market is segmented by application, product, and geography.
• Advancements in diagnostic techniques and new-generation immunoglobulins are propelling market growth.

FAQs

What is the current market size of the Human Hepatitis B Immunoglobulin Market?

The current market size of the Human Hepatitis B Immunoglobulin Market was valued at USD 4.4 billion in 2023[3].

What is the projected growth rate of the Human Hepatitis B Immunoglobulin Market?

The market is expected to grow at a CAGR of 3.65% from 2024 to 2031[3].

What are the primary drivers of the Human Hepatitis B Immunoglobulin Market?

The primary drivers include increasing public health awareness, government initiatives for vaccination programs, and a growing geriatric population susceptible to complications from the virus[3].

Who are the major players in the Human Hepatitis B Immunoglobulin Market?

Major players include Grifols, CSL Behring, Kedrion Biopharma, Octapharma, and others[3].

What are the indications for using Hepatitis B Immune Globulin (Human)?

It is indicated for postexposure prophylaxis in situations such as acute exposure to blood containing HBsAg and perinatal exposure of infants born to HBsAg-positive mothers[2].

Sources

1. Datam Intelligence: Hepatitis B Treatment Market Size Share Growth and Report 2024.
2. HyperHEP B: Hepatitis B Immune Globulin (Human) HyperHEP B®.
3. Market Research Intellect: Global Human Hepatitis B Immunoglobulin Market Size and Projections.
4. BioSpace: Hepatitis B Market Estimated to Reach USD 4.9 Billion by 2034.