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
Walter Reed Army Institute of Research (WRAIR)	Phase 4
Kansas State University	Phase 4
State University of New York - Upstate Medical University	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
China	102936284
Croatia	P20140271
Canada	2596697
Canada	3067168
Mexico	2007009273

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

Last updated: March 7, 2026

Rabies immune globulin (HRIG) is a critical post-exposure prophylactic (PEP) for rabies, a nearly universally fatal disease once symptoms manifest. Its market landscape is shaped by epidemiological factors, regulatory policies, manufacturing capacity, and emerging alternatives. Financial projections are influenced by demand patterns, patent statuses, production costs, and competitive pressures.

Market Overview

The global rabies immune globulin (HRIG) market was valued at approximately USD 100 million in 2022, with a compound annual growth rate (CAGR) of around 5% projected through 2030. Key geographic markets include North America, Europe, and emerging economies in Asia-Pacific.

Main factors driving growth:

• Rising awareness of rabies exposure risks.
• Increasing dog bite incidents in Asia and Africa.
• Expanding vaccination programs for at-risk populations.
• Regulatory updates enhancing access and distribution.

Epidemiological Drivers

Rabies kills an estimated 59,000 people annually, primarily in Africa and Asia [1]. Post-exposure prophylaxis with HRIG remains vital for categories at risk such as unvaccinated individuals bitten by potentially rabid animals.

The incidence of bites:

Region	Estimated annual bites	Percentage receiving HRIG
Asia	800 million	<10%
Africa	200 million	<5%
North America	100 million	~80%

Access to HRIG is limited in resource-poor regions, constraining growth but also providing opportunities for market expansion.

Regulatory and Supply Chain Factors

Regulatory agencies like FDA and EMA approve multiple HRIG products, often under fast-track mechanisms, given rabies' severity. The market has seen increased approval of human-derived and recombinant blood product-based HRIG, affecting market dynamics.

Production capacity worldwide is concentrated among a handful of large players:

• Guangdong (China)
• CSL Behring (Australia)
• Takeda (Japan)
• Pfizer (USA)

Manufacturing costs are high due to plasma collection, purification, and strict safety standards. Supply constraints occasionally lead to shortages, notably during outbreaks or periods of increased demand.

Competitive Landscape

The market is characterized by a few large biologics manufacturers and emerging regional players. Key companies include:

Company	Product Portfolio	Market Share (Est.)	Key Developments
CSL Behring	HyperRab S	50%	Recently expanded plasma collection operations
Takeda	Linko-Vac	25%	Developing recombinant alternatives
Guangdong Biologic	Rabimune	15%	Increasing exports to Africa and Southeast Asia
Others	Various	10%	Entry of biosimilar candidates

Patent expirations of certain products, like CSL’s HyperRab, may encourage biosimilar entry, reducing prices and increasing accessibility.

Market Challenges and Opportunities

Challenges:

• High manufacturing costs limit profitability.
• Limited supply in high-demand regions.
• The emergence of recombinant HRIG could disrupt traditional plasma-derived products.
• Market entry barriers for biosimilars due to regulatory complexity.

Opportunities:

• Expansion into low-income markets through subsidized programs.
• Development of recombinant HRIG with lower production costs and improved safety profiles.
• Adoption of pooled plasma collection to enhance supply.
• Integration with rabies vaccines for combined prophylaxis.

Financial Trajectory

Projections indicate a steady growth, with the following key points:

• Revenue growth driven by increased demand in Asia-Pacific and Africa.
• Average product prices vary; HRIG costs range from USD 70 to 200 per dose depending on market and formulation.
• Cost of goods sold (COGS) remains high—estimated at 40-60% of sales—limiting margins.

Future revenue estimates (2023–2030):

Year	Estimated Market Size (USD million)	CAGR	Notes
2023	100	5%	Current baseline
2025	125		Growing demand and expansion in resource-limited regions
2030	165		Market maturity, biosimilars emergence

Key Takeaways

1. The HRIG market will grow modestly due to epidemiological tremors, supply constraints, and regulatory support.
2. High manufacturing costs and plasma dependency limit profit margins but also attract investments into recombinant technology.
3. Emerging markets in Asia and Africa present significant opportunities with expanded access initiatives.
4. Patent expirations and biosimilar development could lower prices and broaden geographic reach.
5. Supply security remains a constraint, impacting availability during rabies outbreaks.

FAQs

Q1: What factors impact the pricing of HRIG globally?
Pricing depends on manufacturing costs, regulatory approval, supply chain efficiency, and market demand. Resource-limited regions have lower prices due to subsidies or procurement policies.

Q2: How could recombinant HRIG change the market?
Recombinant HRIG offers potential for lower production costs, enhanced safety, and greater scalability. Its adoption depends on regulatory approvals and clinical validation.

Q3: Which regions have the highest unmet needs for HRIG?
Africa and parts of Asia exhibit significant unmet needs, characterized by low access rates and high rabies mortality.

Q4: Are biosimilars a threat to current HRIG leaders?
Yes. Biosimilars could reduce prices and increase accessibility, especially if regulatory pathways are streamlined internationally.

Q5: What are the key regulatory hurdles for new HRIG products?
Safety, efficacy, and manufacturing process validation pose primary challenges, especially for recombinant and biosimilar variants.

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Citations:
[1] Centers for Disease Control and Prevention (CDC). (2020). Rabies – Epidemiology and Prevention. Retrieved from https://www.cdc.gov/rabies/epidemiology.html