Varicella zoster immune globulin (human) - Biologic Drug Details

Summary for varicella zoster immune globulin (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for varicella zoster immune globulin (human)

Recent Clinical Trials for varicella zoster immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Cangene Corporation
National Eye Institute (NEI)	Phase 2

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

No patents found based on brand-side litigation

2) High Certainty: US Patents for varicella zoster 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.	VARIZIG	varicella zoster immune globulin (human)	For Injection	125430	8,609,088	2032-05-07	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	VARIZIG	varicella zoster immune globulin (human)	For Injection	125430	8,637,014	2032-06-26	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	VARIZIG	varicella zoster immune globulin (human)	For Injection	125430	9,061,042	2031-01-31	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	VARIZIG	varicella zoster immune globulin (human)	Injection	125430	8,609,088	2032-05-07	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	VARIZIG	varicella zoster immune globulin (human)	Injection	125430	8,637,014	2032-06-26	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for varicella zoster 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 varicella zoster immune globulin (human)

Country	Patent Number	Estimated Expiration
Mexico	2010000981
South Korea	20110042294
South Korea	101630888
Canada	2697159
Japan	2016117762

Market Dynamics and Financial Trajectory for Varicella Zoster Immune Globulin (Human)

Last updated: March 12, 2026

What is the Current Market Size and Growth Potential?

Varicella Zoster Immune Globulin (Human) (VZIG) is a passive immunization agent for varicella zoster virus (VZV), used primarily for post-exposure prophylaxis in immunocompromised patients and neonates. The global market for VZIG was valued at approximately $150 million in 2022 with a compound annual growth rate (CAGR) of around 4% predicted through 2030 (Markets and Markets, 2022).

Key Drivers

• Rising incidence of herpes zoster and varicella in immunocompromised populations.
• Increased awareness of passive immunization options.
• FDA and EMA approvals expanding indications.
• Limited competition as few manufacturers produce VZIG.

Market Challenges

• Limited number of approved products.
• High manufacturing costs associated with plasma-derived products.
• Stringent regulatory frameworks for plasma-derived biologics.
• Preference shift toward newer antiviral pharmaceuticals in some regions.

Who Are the Major Players in the VZIG Market?

Company	Product Name	Market Share (Estimate, 2022)	Key Notes
CSL Behring	VariZIG	60%	Approved in U.S., major supplier globally
Grifols	VZIG (discontinued)	Less than 10%	Ceased production; some supply gaps
Other Manufacturers	Limited	30% or less	Small players, emerging markets

CSL Behring dominates the global supply of VariZIG, accounting for approximately 60% of the market share as of 2022, owing to its approved status and extensive plasma collection network.

What Are the Key Regulatory and Policy Developments?

• U.S. FDA approval granted in 2008 for VariZIG.
• EU approval for similar indications obtained in 2015.
• Post-pandemic push for increased plasma collection to support hyperimmune globulin production.
• Some countries are considering regulatory updates to facilitate alternative monoclonal antibody therapies.

What Is the R&D and Product Pipeline?

The pipeline for varicella zoster immune globulins remains limited, with some companies exploring hyperimmune globulin formulations with broader VZV activity and longer shelf life. No major players have announced new biologic variants or biosimilar development specifically targeting VZIG as of 2022.

How Will Market Dynamics Influence Financial Trajectories?

Revenue Trends

• Steady growth projection driven by aging populations and rising immunocompromised patient rates.
• Recovery of supply post-COVID-19 pandemic disruptions.
• Potential price increases due to plasma collection costs.

Investment Implications

• High barriers to entry preserve market share for established players.
• Opportunities exist for biosimilar development if regulatory pathways simplify.
• Supply chain resilience is critical, as plasma donation is geographically concentrated.

Cost Structure Analysis

• Manufacturing costs dominate due to plasma sourcing, screening, and fractionation.
• Research investment mainly directed toward improving yield and reducing production costs.

What Are the Future Market Opportunities and Risks?

Opportunities	Risks
Expansion into developing markets	Regulatory uncertainties for new products
Development of monoclonal antibody alternatives	Plasma supply shortages in key collection regions
Enhancing plasma collection infrastructure	Pricing pressures due to healthcare payers

Key Takeaways

• The global VZIG market was valued at approximately $150 million in 2022 with a CAGR of 4%.
• CSL Behring leads with VariZIG, dominating global supply.
• Market growth is primarily driven by rising immunocompromised populations and increasing awareness.
• The R&D pipeline for VZIG remains limited; no significant biosimilars are publicly announced.
• Supply chain and plasma donation are critical factors affecting product availability and pricing.
• Regulatory standards and plasma collection capacity pose potential barriers and opportunities.

FAQs

1. What distinguishes VariZIG from other passive immunoglobulin products?
VariZIG is specifically formulated for varicella zoster virus, with regulatory approval based on its efficacy in post-exposure prophylaxis, whereas other immunoglobulins target broader pathogens.

2. Are biosimilars a viable future for VZIG?
Currently, no biosimilars are in late-stage development; high dependency on plasma sources and regulatory hurdles slow biosimilar entry.

3. How has COVID-19 impacted VZIG supply and market?
Pandemic-related plasma donation disruptions temporarily reduced supply, but recovery has been underway since 2021, stabilizing the market.

4. What regions present the most growth opportunities?
Emerging markets in Asia-Pacific and Latin America offer growth potential due to rising healthcare infrastructure and immunization program expansion.

5. What regulatory developments could influence market future?
Easing of plasma donation regulations and approval pathways for monoclonal alternatives could reshape the landscape.

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References

[1] Markets and Markets. (2022). Plasma-derived products market report.
[2] U.S. Food and Drug Administration. (2008). VariZIG approval documentation.
[3] European Medicines Agency. (2015). Marketing authorization for VZIG.