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Last Updated: February 16, 2025

Rabies immune globulin (human) - Biologic Drug Details


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Summary for rabies immune globulin (human)
Tradenames:4
High Confidence Patents:0
Applicants:3
BLAs:3
Suppliers: see list3
Recent Clinical Trials: See clinical trials for rabies immune globulin (human)
Recent Clinical Trials for rabies immune globulin (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
State University of New York - Upstate Medical UniversityPhase 4
Walter Reed Army Institute of Research (WRAIR)Phase 4
Kansas State UniversityPhase 4

See all rabies immune globulin (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
  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 rabies immune globulin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Rabies Immune Globulin (Human)

Introduction to Rabies Immune Globulin (HRIG)

Rabies immune globulin (HRIG) is a biologic drug used in conjunction with the rabies vaccine to prevent rabies infection after exposure to the rabies virus. This passive immunization provides immediate protection until the body can produce its own antibodies against the virus[2].

Market Size and Growth Projections

The global market for HRIG has been experiencing significant growth and is projected to continue this trend. As of 2023, the HRIG market was valued at several hundred million dollars, with forecasts indicating substantial expansion.

  • The global human rabies immunoglobulin market was valued at USD 396 million in 2021 and is expected to reach USD 726.21 million by 2031, growing at a CAGR of 6.2% during this period[4].
  • Similarly, the rabies antiserum market, which includes HRIG, was valued at USD 1.24 billion in 2023 and is projected to grow at a CAGR of 3.3% to reach USD 1.56 billion by 2030[3].

Market Segmentation

The HRIG market is segmented based on several key factors:

Type

  • HRIG is available in different concentrations, such as 200IU and 500IU, catering to various exposure categories and patient needs[1].

Application

  • The primary applications are categorized into Category II and Category III exposures, which define the severity of exposure to the rabies virus. Category III exposures, which include bites or scratches that break the skin, require immediate and intensive treatment[1].

Geographical Regions

  • The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region, particularly countries like India, China, and the Philippines, dominates the market due to higher disease prevalence[3].

Drivers of Market Growth

Several factors are driving the growth of the HRIG market:

Increasing Prevalence of Rabies

  • Rabies remains a significant public health issue, especially in developing countries. According to the World Health Organization (WHO), rabies causes approximately 59,000 human deaths annually, with 95% of these cases occurring in Africa and Asia[3].

Rising Awareness and Government Initiatives

  • Growing awareness about rabies prevention and government initiatives to improve healthcare infrastructure in developing countries are boosting the demand for HRIG[3].

Presence of Prominent Players

  • The market is supported by prominent pharmaceutical companies such as CSL Behring, Grifols, Sanofi, and others, which contribute to the availability and quality of HRIG products[4].

Challenges and Restraints

Despite the growth, the HRIG market faces several challenges:

High Cost of Treatment

  • The high cost of HRIG compared to vaccines is a significant barrier, particularly in developing countries where access to affordable healthcare is limited[3].

Limited Shelf Life and Access

  • The limited shelf life of HRIG products and the lack of access to these products in remote areas further complicate the distribution and administration of this biologic[3].

Competition from Vaccination

  • The increasing adoption of rabies vaccination as a preventive measure is expected to limit the growth of the HRIG market, as vaccines offer long-term immunity and are often more cost-effective[3].

Key Players and Products

The HRIG market is dominated by several key players:

  • Sanofi Pasteur: Offers Imogam Rabies HT[5].
  • Grifols: Produces HyperRab, replacing the earlier HyperRabS/D[5].
  • Kamada: Known for its KEDRAB product, available in the U.S.[5].
  • Other Players: Include CSL Behring, Sichuan Yuanda Shuyang, CNBG, and others[4].

Financial Assistance and Patient Programs

Given the high cost of HRIG, various financial assistance programs are available:

  • Manufacturer’s Patient Assistance Programs: Companies like Sanofi Pasteur and Novartis offer programs to provide biologics to underinsured or uninsured patients[5].
  • Hospital Charity Care: Some hospitals offer charity care programs based on the patient's income level relative to the Federal Poverty Level[5].

Regional Market Dynamics

The regional dynamics play a crucial role in the HRIG market:

  • Asia-Pacific: Dominates the market due to high disease prevalence in countries like India, China, and the Philippines[3].
  • Africa: Expected to be one of the fastest-growing regional markets due to the high burden of rabies in this region[3].
  • North America and Europe: These regions have more established healthcare systems but still contribute significantly to the global market[1].

Future Outlook and Opportunities

The future of the HRIG market looks promising with several opportunities:

  • Research & Development: Ongoing R&D for more effective and low-cost biosimilars will provide significant opportunities in the long run[3].
  • Government Initiatives: Continued government efforts to control rabies and improve healthcare infrastructure will drive market growth[3].

Key Takeaways

  • The HRIG market is expected to grow significantly, driven by increasing prevalence of rabies and government initiatives.
  • High costs and limited access are major challenges.
  • Prominent players and financial assistance programs are crucial for market growth.
  • Asia-Pacific and Africa are key regions driving market expansion.
  • Ongoing R&D for biosimilars offers future growth opportunities.

FAQs

What is the projected market size of the HRIG market by 2031?

The HRIG market is expected to reach USD 726.21 million by 2031[4].

What is the CAGR of the HRIG market from 2023 to 2031?

The HRIG market is expected to grow at a CAGR of 6.2% from 2023 to 2031[4].

Which regions dominate the HRIG market?

The Asia-Pacific region currently dominates the market, with Africa expected to be one of the fastest-growing regions[3].

What are the main challenges facing the HRIG market?

High cost of treatment, limited shelf life, and lack of access in remote areas are significant challenges[3].

Which companies are key players in the HRIG market?

Key players include CSL Behring, Grifols, Sanofi, Kamada, and others[4].

Sources

  1. Market Research Intellect: Global Human Rabies Immune Globulin (HRIG) Market Size, Scope ...
  2. Mayo Clinic: Rabies immune globulin (intramuscular route)
  3. Coherent Market Insights: Rabies Antiserum Market Size, Trends and Forecast to 2030
  4. Business Research Insights: Human Rabies Immunoglobulin Market - 2031 Report
  5. NC DHHS: Rabies Biologics and Patient Assistance Programs

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