Immune globulin injection (human) 10% caprylate/chromatography purified - Biologic Drug Details

Summary for immune globulin injection (human) 10% caprylate/chromatography purified

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for immune globulin injection (human) 10% caprylate/chromatography purified

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
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. 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 immune globulin injection (human) 10% caprylate/chromatography purified Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin injection (human) 10% caprylate/chromatography purified 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
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2035-11-09	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2036-09-26	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2010-03-30	DrugPatentWatch analysis and company disclosures
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2021-03-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin injection (human) 10% caprylate/chromatography purified 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
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2035-11-09	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2010-03-30	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2021-03-22	Patent claims search
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2028-07-03	Patent claims search

International Patents for immune globulin injection (human) 10% caprylate/chromatography purified

Country	Patent Number	Estimated Expiration
Japan	2015078241
New Zealand	579802
Israel	195488
Hungary	E029866

Supplementary Protection Certificates for immune globulin injection (human) 10% caprylate/chromatography purified

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016/061	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
CR 2016 00031	Denmark		PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; NAT. REG. NO/DATE: EU/1/98/067/003-004 20140326; FIRST REG. NO/DATE: EU EU/1/98/067 20140326
2017003	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
2016C/065	Belgium		PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123

Market Dynamics and Financial Trajectory for Human Immunoglobulin Injection (10%) Caprylate/Chromatography Purified

Last updated: February 16, 2026

Market Overview

The human immunoglobulin (Ig) market, particularly intravenous formulations of Ig (IVIG), is expanding due to increasing demand for immunodeficiency treatments, autoimmune disease management, and emerging indications. The specific product—immune globulin injection (10% caprylate/chromatography purified)—is an established, purified IVIG formulation designed for high purity and safety.

Key Market Drivers

• Growing Patient Population: The prevalence of primary immunodeficiency diseases (PI), autoimmune disorders (e.g., Guillain-Barré syndrome), and chronic inflammatory demyelinating polyneuropathy (CIDP) increases demand.
• Advancements in Purification: Chromatography and caprylate purification enhance safety profiles, reducing adverse reactions, fostering substitution of older plasma-derived products.
• Increasing Adoption in Developed Markets: North America and Europe absorb the bulk of IVIG sales, driven by reimbursement policies, healthcare infrastructure, and awareness.
• Emerging Markets: Rapid growth in Asia-Pacific regions due to expanding healthcare access, rising income levels, and increased diagnosis rates.

Market Challenges

• Supply Constraints: Limited plasma collection capacity constrains production; global plasma supply fluctuates with donor availability and safety regulations.
• High Manufacturing Costs: Plasma purification, especially at high purity levels, results in high production costs, influencing pricing.
• Pricing Pressures and Reimbursement: Payers actively negotiate, especially in publicly funded healthcare systems, which impacts profitability.
• Competition: Multiple established players (Octapharma, CSL Behring, Takeda) and new entrants increase market competition.

Competitive Landscape

Company	Product Names	Market Share (Estimated)	Strengths
CSL Behring	Privigen, Hizentra	40%	Large plasma pool, global distribution
Takeda	Kiovig, Vivaglobulin	25%	Strong R&D pipeline, extensive manufacturing
Octapharma	Nord Ig, Octagam	15%	Focus on high-purity formulations
Others	Various regional brands	20%	Local market adaptations

Financial Trajectory

Revenue Estimates:
Global IVIG market was valued at approximately $10 billion in 2022, with a compound annual growth rate (CAGR) of about 7% expected through 2027.[1]

Product-Specific Outlook:
The 10% caprylate/chromatography purified immune globulin is prioritized for primary immunodeficiency and autoimmune conditions. Its premium purification methods justify a higher price point relative to older, less purified formulations.

Forecasted Revenue Growth:

• 2022: ~$2 billion globally for high-purity IVIG formulations.
• 2027: Estimated to reach ~$2.9 billion, with a CAGR of 6.5%.
• Market Share Dynamics: Leading companies will capture the majority of sales, with innovative players gaining share via product differentiation, such as enhanced safety profiles or biosimilar development.

Pricing Trends:
Average wholesale prices (AWP) for IVIG range between $150–$300 per gram.[2] Purified, caprylate-stabilized products command premiums, often exceeding $200 per gram.

Cost Structures and Margins:
Manufacturing margins are tight due to high plasma costs and rigorous regulatory standards. Estimated gross margins stand at 20–30% for top-tier manufacturers.

Regulatory and Policy Landscape

• FDA and EMA Approvals: Regulatory approvals remain pivotal. The U.S. FDA approves plasma-derived immunoglobulin products based on safety and efficacy; similar standards exist in Europe.
• Biosimilar Entry: Development of biosimilar immunoglobulins could threaten established brands by offering lower-priced alternatives, especially in price-sensitive markets.

Investment and R&D Outlook

Companies are investing in:

• Novel Purification Technologies: To improve yield and safety.
• Extended Indications: Exploring indications like neurological and inflammatory diseases.
• Biosimilars: To penetrate markets with cost challenges and regulatory barriers.

Key Risks

• Plasma supply shortages and safety issues.
• Regulatory shifts affecting plasma donation and manufacturing.
• Pricing and reimbursement pressures in key markets.
• Competition from biosimilars and emerging therapies.

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Key Takeaways

• The global IVIG market is projected to grow at a compound rate of approximately 6–7% annually through 2027.
• The specific 10% caprylate/chromatography purified immunoglobulin faces demand growth driven by autoimmune and immunodeficiency indications, complemented by premium pricing due to purification standards.
• The competitive landscape is dominated by CSL Behring, Takeda, and Octapharma, with regional players capturing niche markets.
• Manufacturing costs remain high, constraining margins; ongoing R&D cycles seek to innovate in purification, indications, and biosupport.
• Supply chain vulnerabilities and pricing pressures constitute significant risks.

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FAQs

1. What factors influence the pricing of immune globulin products?
Pricing is driven by manufacturing costs, plasma procurement expenses, purification technology, regulatory compliance, and reimbursement policies. Premium purification methods often command higher prices.

2. How do biosimilars impact the market?
Biosimilars can reduce prices and increase accessibility but face regulatory hurdles and manufacturing complexities. Their entrance may decrease market shares for established brands.

3. What are the main indications for this immune globulin?
Primary immunodeficiency, autoimmune diseases such as CIDP and Guillain-Barré syndrome, and certain inflammatory conditions.

4. How does plasma supply affect the market?
Limited plasma donation capacity constrains production volume, affecting supply and pricing. Plasma safety regulations can also reduce the pool of eligible donors.

5. Are new purification technologies expected to alter the market?
Yes. Advances in chromatography and stabilization techniques can improve safety, yield, and cost-efficiency, potentially transforming manufacturing practices.

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References

[1] Market Research Future, "Intravenous Immunoglobulin Market Analysis," 2022.
[2] IQVIA, "Pharma and Biotech Pricing Trends," 2022.