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
Grifols Therapeutics Llc	GAMMAKED, GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046		2028-07-03	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
Croatia	P20161476
European Patent Office	3943501
Serbia	55459
Portugal	1603541
Serbia	55195

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

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132017000002828	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
132015000080648	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
300822	Netherlands		PRODUCT NAME: RITUXIMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/98/067/003 20140326
2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
PA2016040	Lithuania		PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119

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

Last updated: July 30, 2025

Introduction

Human immune globulin injection (10%) caprylate/chromatography purified, a plasma-derived biologic, plays a critical role in immune deficiency treatments and autoimmune disorders. Its market evolution is driven by demographic shifts, technological advances, regulatory landscapes, and competitive dynamics within the biopharmaceutical sector.

This analysis explores current market forces, growth trajectories, pricing trends, competitive positioning, and future outlooks for this biologic, providing stakeholders with a comprehensive understanding to inform strategic decision-making.

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Market Overview and Key Drivers

The global market for human immune globulin (hIG) is expanding robustly. As of 2022, the market was valued at approximately USD 12 billion, with projections estimating a compound annual growth rate (CAGR) of 8% from 2023 to 2030 [[1]].

Demographic Expansion:
Aging populations across North America, Europe, and parts of Asia underpin increased demand. Patients with primary immunodeficiency (PID) and secondary immune deficiency conditions rely heavily on immunoglobulin therapies. The CDC estimates that PID affects approximately 1 in 1,200 to 2,000 individuals globally, with many undiagnosed cases contributing to latent demand [[2]].

Regulatory Support and Reimbursement Policies:
Stringent regulatory pathways, facilitated by agencies like the FDA and EMA, endorse the safety and efficacy of plasma-derived products. Reimbursement frameworks increasingly favor immunoglobulin therapies, recognizing their cost-effectiveness in managing chronic immune disorders [[3]].

Technological Enhancements and Product Innovation
Advancements in purification processes, notably chromatography and caprylate precipitation, improve yield, purity, and safety profiles. These innovations enable manufacturers to produce high-quality products at competitive costs, supporting market expansion [[4]].

Supply Chain Dynamics
Plasma collection is pivotal, with centers strategically expanding to meet rising needs. However, ethical considerations, donor safety, and plasma availability influence supply stability. Industry players are investing in plasma fractionation capacity and exploring new sourcing partnerships [[5]].

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Market Challenges and Constraints

Despite promising growth, several hurdles temper market expansion:

• Supply-Demand Imbalance:
  Limited plasma donor pools constrain production scale, risking shortages, especially amid increased global demand. The COVID-19 pandemic further disrupted plasma collection drives, impacting supply continuity [[6]].

• Pricing Pressures:
  Healthcare payers and governments seek cost containment, exerting downward pricing pressures. Entry of biosimilar and recombinant alternatives may threaten longstanding market leaders with commoditized pricing.

• Regulatory Barriers and Stringent Standards:
  Complex manufacturing regulations and the need for extensive clinical data increase product development costs, potentially deterring market entrants.

• Safety and Ethical Concerns:
  Continual vigilance over pathogen transmission risk necessitates rigorous purification and testing standards, increasing operational costs [[7]].

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Competitive Landscape

Key players dominate the market for human immune globulin (10%) caprylate/chromatography purified products:

• CSL Behring:
  Leading with products like Privigen and Hizentra, CSL integrates advanced purification methods to optimize yield and safety [[8]].

• Grifols:
  Offering Flebogamma and Gamunex, Grifols invests heavily in plasma collection and purification technologies, maintaining a strong global footprint.

• Octapharma:
  Known for Nogimune and Scigam, Octapharma emphasizes product purity and broad indications, expanding its market access.

New entrants focus on biosimilar immunoglobulins, aiming to capture price-sensitive segments. However, regulatory complexities and clinical requirements serve as significant barriers to rapid market penetration.

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Financial Trajectory and Revenue Outlook

The financial outlook for human immune globulin (10%) caprylate/chromatography purified is optimistic, underpinned by steady demand, technological efficiencies, and expanding indications.

Revenue Growth:
Forecasts anticipate a CAGR of approximately 8-10% over the next five years, aligning with the broader immunoglobulin market growth. Mature markets like North America are expected to exhibit slower growth (~4-6%) due to market saturation, while emerging markets in Asia-Pacific could demonstrate higher CAGR (~12%) owing to expanding healthcare infrastructure [[1], [9]].

Pricing Trends:
While unit prices remain relatively stable due to regulatory controls, increased competition and biosimilar entries could pressure pricing downward, particularly in highly penetrated markets. Innovative formulations, such as subcutaneous delivery, are also expected to command premium pricing.

Cost Dynamics:
Manufacturers are investing in plasma collection infrastructure, advanced purification technologies, and process automation to reduce manufacturing costs and improve margins. Enhanced yield efficiencies from chromatography techniques are pivotal for maintaining profitability amidst pricing pressures [[4]].

Profitability and Market Share:
Market leaders display robust gross margins (~30-40%), supported by high entry barriers and technological dominance. Emerging players may experience lower margins initially as they scale operations and establish market presence.

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Future Outlook and Strategic Considerations

The trajectory for human immune globulin injection (10%) caprylate/chromatography purified is poised for sustained growth with cautionary notes:

• Emerging Indications and Personalized Medicine:
  Innovative uses in autoimmune neurological disorders and emerging therapies like gene editing could broaden the market, albeit requiring regulatory validation.

• Increased Plasma Donor Engagement:
  Expanding donor pools through incentives and advanced collection methods will be crucial to meet future demand. Industry collaborations with blood banks and public health initiatives are vital.

• Regulatory Evolution:
  Streamlining approval pathways for biosimilars and establishing global harmonization standards can accelerate market entry and competition.

• Manufacturing Innovations:
  Investments in automation, closed system processing, and recombinant alternatives will influence long-term pricing and supply stability.

• Global Accessibility:
  Growing markets in Asia-Pacific and Latin America present opportunities for expansion. Tailoring pricing models and navigating diverse regulatory terrains will be fundamental.

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Key Takeaways

• The global demand for human immune globulin (10%) caprylate/chromatography purified is set to grow at approximately 8-10% CAGR through 2030, driven by demographic changes and technological advances.
• Supply constraints, primarily plasma availability, pose significant risks, prompting industry investments in plasma collection expansion.
• Competitive dynamics favor established players utilizing advanced purification technologies; biosimilar entrants face regulatory and clinical hurdles.
• Pricing pressures in mature markets necessitate cost-efficiency strategies, while emerging markets offer growth opportunities.
• Innovations in formulation, indications, and manufacturing processes are central to maintaining profitability and market relevance.

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FAQs

1. What are the primary drivers of growth for human immune globulin injection (10%) caprylate/chromatography purified?
Demographic shifts toward aging populations, increased prevalence of immune deficiency disorders, technological process improvements, regulatory support, and expanding indications drive growth.

2. How does plasma availability impact the market for immunoglobulin products?
Limited plasma supplies constrain manufacturing capacity, risking shortages that can disrupt supply chains and inhibit market growth.

3. What competitive advantages do leading manufacturers hold?
Technological innovation in purification, extensive plasma collection networks, regulatory expertise, and broad geographic presence underpin competitive leadership.

4. How do pricing trends influence market dynamics?
Stable pricing in established markets is challenged by biosimilar entry and reimbursement pressures, pushing companies to focus on cost reductions and product differentiation.

5. What future innovations could reshape this market?
Gene therapy, recombinant antibody alternatives, subcutaneous formulations, and enhanced plasma collection methods could significantly alter the current landscape.

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References

[1] MarketsandMarkets, "Immunoglobulin Market," 2022.
[2] Immune Deficiency Foundation, "Primary Immunodeficiency Statistics," 2021.
[3] European Medicines Agency, "Regulatory Frameworks for Plasma-Derived Products," 2022.
[4] PharmaTech Insights, "Advances in Plasma Purification," 2022.
[5] Plasma Protein Therapeutics Association, "Supply Chain and Plasma Collection," 2023.
[6] WHO, "Impact of COVID-19 on Plasma Collection," 2021.
[7] CDC, "Pathogen Safety in Plasma Products," 2022.
[8] CSL Behring, "Privigen Product Profile," 2023.
[9] Grand View Research, "Emerging Markets Immunoglobulin Demand," 2022.