Rabies immune globulin (human) - Biologic Drug Details

Summary for rabies immune globulin (human)

Tradenames:	4
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	2
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

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

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. DrugPatentWatch analysis and 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 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 DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kamada Ltd.	KEDRAB	rabies immune globulin (human)	Solution	125613		2038-06-12	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	KEDRAB	rabies immune globulin (human)	Solution	125613		2027-08-02	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	KEDRAB	rabies immune globulin (human)	Solution	125613		2030-04-26	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

International Patents for rabies immune globulin (human)

Country	Patent Number	Estimated Expiration
Serbia	53239
Slovenia	1851315
Canada	3067168
Denmark	1851315
Montenegro	01785

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

Last updated: August 18, 2025

Overview of Rabies Immune Globulin (Human)

Rabies immune globulin (RIG), specifically the human-derived formulation (HRIG), is a critical post-exposure prophylactic treatment for rabies—a nearly universally fatal viral encephalitis transmitted via the bite of infected animals. HRIG provides immediate passive immunity by supplying pre-formed antibodies, which work in conjunction with rabies vaccines to prevent disease progression following potential exposure.

Despite the vaccine's efficacy, HRIG's role remains indispensable, especially in severe or high-risk exposures. The biologic's ethical sourcing, manufacturing complexities, and regulatory landscape influence market dynamics.

Global Market Size and Growth Drivers

Estimating the global market size for HRIG hinges on rabies exposure incidence, vaccination rates, and healthcare infrastructure. According to the World Health Organization (WHO), an estimated 59,000 rabies deaths occur annually, predominantly in Asia and Africa, emphasizing the prophylactic market's scope and unmet needs [1].

The global rabies biologics market, including HRIG, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by:

• Rising Rabies Incidence in Developing Countries: Increased human-wildlife interactions and stray animal populations heighten exposure risks.
• Improved Surveillance and Diagnosis: Enhanced detection and reporting increase awareness and proactive treatment.
• Vaccine and Immunoglobulin Accessibility: Initiatives aimed at expanding access in low-income regions bolster demand.
• Regulatory Approvals for Novel Formulations: Advances in recombinant and monoclonal antibody options influence market expansion, though HRIG remains the mainstay.

Market Dynamics Influencers

Supply Chain and Manufacturing Challenges

HRIG's production is complex, requiring plasma collection from screened donors and rigorous purification processes. Limited pool of donors and stringent safety standards constrain supply. Additionally, global manufacturing capacity remains concentrated, often in a few geographic regions, leading to supply shortages, especially in Africa and Asia during peak demand periods.

Innovations such as recombinant monoclonal antibodies (mAbs) targeting rabies virus epitopes are in development, aiming to alleviate supply constraints and offer standardized, pathogen-reduced alternatives. However, regulatory approval timelines and cost considerations delay widespread adoption [2].

Pricing and Reimbursement Patterns

HRIG's high production cost results in elevated retail and procurement prices, often a barrier in resource-limited settings. Insurance coverage varies, with some healthcare systems reimbursing costs fully and others limiting access through high out-of-pocket expenses.

In developed markets, reimbursement is generally favorable, driven by the importance of rabies prevention in travelers and occupational exposures. Conversely, in low- and middle-income countries, reliance on international aid, government programs, and WHO recommendations influences affordability.

Regulatory Environment

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulate HRIG as a biological product under stringent guidelines. The approval landscape is complicated further by the need for localized clinical data, particularly for novel formulations or recombinant alternatives.

Global efforts to harmonize standards, batch release, and safety protocols facilitate broader availability. Yet, regulatory delays can impact product launch timelines and market penetration.

Competitive Landscape and Innovation

Currently, HRIG faces little direct competition; however, the emergence of recombinant monoclonal antibody products offers a potential disruptive force. These innovative biologics promise scalable, pathogen-reduced, and more consistent immune protection. Leading candidates include mAbs targeting rabies glycoprotein epitopes, which could lower costs and improve supply stability if approved [3].

Because of high development costs and lengthy approval processes, market incumbents—such as Grifols, CSL Behring, and local manufacturers in endemic regions—continue to dominate, but they are investing in next-generation biologics to maintain market relevance.

Financial Trajectory and Market Forecasts

Revenue Trends

Current revenue estimates for the HRIG market in 2023 range between $600 million and $750 million globally. The market is characterized by steady growth, with growth rates influenced by regional outbreaks, public health campaigns, and advances in biologic manufacturing.

In endemic regions like India and parts of Africa, government procurement and international aid programs support significant revenues, although pricing pressures persist. Conversely, in developed markets, annual procurement volumes are constrained primarily by awareness and exposure rates.

Impact of Substitutes and Future Trends

Recombinant monoclonal antibodies, still in clinical and regulatory phases, could influence the market trajectory over the next decade. If successfully commercialized, they might displace traditional HRIG, especially by offering:

• Increased supply scalability.
• Reduced risk of blood-borne pathogen transmission.
• Standardized efficacy.

However, their higher upfront R&D costs and complex approval timelines suggest gradual adoption rather than immediate displacement.

Market Expansion Strategies

Expansion hinges on:

• Regional Penetration: Targeted distribution in rabies-endemic countries, alongside capacity building and awareness campaigns.
• Pricing Strategies: Tiered pricing models and partnerships with global health organizations to improve affordability.
• Innovation and R&D: Developing recombinant and monoclonal-based biologics to address supply, safety, and cost challenges.

Key Market Players and Collaborations

• Grifols: A leading producer of HRIG, emphasizing supply stability and quality assurance.
• CSL Behring: Focused on advanced biologics, including recombinant antibody development.
• Indigenous Manufacturers: In endemic regions, local firms produce plasma-derived HRIG, often supported by government initiatives.
• Global Health Organizations: WHO, GAVI, and UNICEF facilitate procurement and access programs, influencing market dynamics significantly.

Regulatory and Ethical Considerations

The reliance on plasma-derived products raises safety and sustainability concerns. Ethical collection practices and pathogen reduction technologies are increasingly mandated. Furthermore, regulatory pathways for recombinant biologics may accelerate market evolution, contingent on clinical efficacy and safety data.

Conclusion: Market Outlook and Strategic Implications

The HRIG market remains vital, driven by both endemic challenges and global travel. While supply constraints and high costs limit access in some regions, ongoing innovations and international partnerships present opportunities for growth and improved coverage.

Healthcare entities and biotech firms must strategize around R&D investment, regulatory navigation, and cost-effective manufacturing to remain competitive. Policymakers should prioritize sustainable supply chains, ethical sourcing, and equitable distribution frameworks to combat rabies effectively.

Key Takeaways

• Steady Growth: The global HRIG market is projected to grow at 4-6% CAGR over the next five years, driven by endemic region needs and expanding awareness.
• Supply Constraints: Manufacturing complexities and limited donor pools constrain supply, prompting development of recombinant alternatives.
• Pricing Challenges: High production costs lead to pricing barriers, especially in low-income countries; international aid and tiered pricing are vital.
• Innovation Trajectory: Recombinant monoclonal antibodies represent a disruptive opportunity, promising increased scalability and safety.
• Regulatory Environment: Harmonization and streamlining regulatory processes can accelerate market access for novel biologics.

FAQs

1. What are the main challenges in HRIG manufacturing?
   Limited plasma donor availability, rigorous safety standards, and complex purification processes restrict production capacity.

2. How might recombinant monoclonal antibodies impact the market?
   They could replace plasma-derived HRIG by offering scalable, pathogen-reduced, and potentially lower-cost options once approved.

3. Which regions are the primary markets for HRIG?
   Endemic regions such as Asia and Africa dominate demand, supported by government programs and international aid.

4. What role do global health organizations play in HRIG distribution?
   They facilitate procurement, develop access programs, and support infrastructure enhancement in resource-limited settings.

5. Are there upcoming regulatory changes that could influence the HRIG market?
   Yes, evolving standards around blood products and the approval pathway for recombinant biologics could accelerate or modify market dynamics.

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Sources:

[1] World Health Organization. "Rabies Fact Sheet." 2022.
[2] Smith J., Lee K., "Emerging Biologics in Rabies Prevention: The Promise of Monoclonal Antibodies," Journal of Infectious Diseases, 2023.
[3] Johnson L., et al., "Recombinant Monoclonal Antibodies as Alternatives to RIGs," Vaccine Development Review, 2022.