Immune globulin intravenous, human-slra - Biologic Drug Details

Summary for immune globulin intravenous, human-slra

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

Pharmacology for immune globulin intravenous, human-slra

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 intravenous, human-slra Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin intravenous, human-slra Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for immune globulin intravenous, human-slra Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Human-Sourced Immune Globulin Intravenous (IGIV)

Last updated: March 2, 2026

What Is the Current Market Size and Growth of Human Immune Globulin Intravenous (IGIV)?

The global IgIV market was valued at approximately USD 7.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8.5% from 2023 to 2030, reaching an estimated USD 13.2 billion by 2030. Growth is driven by increasing indications, rising awareness of immune deficiency conditions, and expanding approval for new indications.

Key Market Drivers:

• Higher prevalence of primary immunodeficiency diseases (PID)
• Growing use in autoimmune diseases (e.g., Guillain-Barré syndrome, myasthenia gravis)
• Expanded approvals for off-label and new therapeutic uses
• Advances in plasma fractionation and manufacturing processes

How Does the Production and Supply Chain Impact Market Dynamics?

Production depends on plasma donation. The process involves large-scale plasmapheresis, followed by purification and viral inactivation. Global plasma collection centers supply raw plasma, with top collection regions in the US, Germany, and Brazil.

Supply chain issues, such as plasma shortages and disruptions in manufacturing due to regulatory shifts or pandemic-related constraints, can constrain market expansion. As of 2022, plasma donor collections increased 3.2% globally, yet demand outpaces supply in some regions.

Key Players:

• CSL Behring
• Grifols
• Takeda Pharmaceuticals
• Biotest AG

These companies control 85% of global plasma collection pools, emphasizing market concentration risks.

What Are the Regulatory and Pricing Factors Affecting Market Trajectory?

Regulatory policies influence approval pathways, pricing, and reimbursement. US Food and Drug Administration (FDA) approvals for new indications or formulations can accelerate growth.

Pricing varies significantly:

• In the US, average wholesale price (AWP) for IGIV units ranges from USD 200 to USD 300 per gram.
• Reimbursement policies are evolving, with insurance coverage more favorable in developed markets but limited access in low- and middle-income countries.

Regulatory events in 2022 included tightening of plasma donation criteria in some regions, impacting supply capacity.

What Emerging Trends and Innovations Are Shaping the Market?

1. Extended-interval dosing formulations: New formulations aim to reduce infusion frequency.
2. Subcutaneous IgIV (SCIG): Growing preference for subcutaneous formulations for convenience and home administration.
3. Biobetter development: Efforts to enhance half-life and reduce immunogenicity.
4. Plasma-derived vs. recombinant alternatives: Focus on increasing plasma supply efficiency versus developing recombinant immunoglobulin products, which face scientific and regulatory hurdles.

How Are Financials Evolving for Leading Manufacturers?

Company	2022 Revenue (USD millions)	Market Share (%)	Notes
CSL Behring	3,250	44	Largest by revenue, extensive plasma collection
Grifols	2,950	40	Focus on expanding plasma capacity
Takeda	950	13	Growth through new indications
Biotest AG	250	3	Smaller, niche focus

Revenue growth correlates with plasma collection capacity, product portfolio expansion, and increasing indications.

What Are the Risks and Opportunities?

Risks:

• Plasma shortages inhibit growth.
• Regulatory restrictions on plasma donation.
• Patent expirations of key formulations could intensify price competition.
• Counterfeit or substandard plasma products risk market quality.

Opportunities:

• Emerging markets with expanding healthcare infrastructure.
• Development of recombinant immunoglobulin products.
• Strategic partnerships for plasma collection expansion.

Key Takeaways

• The IGIV market displays robust growth driven by increasing indications and expanded use cases.
• Supply chain and plasma availability are primary constraints; production capacity must scale.
• Regulatory landscape influences product approval and pricing strategies.
• Innovation focuses on improving delivery, dosing convenience, and product longevity.
• Leading companies exhibit revenue growth aligned with plasma collection capacity and pipeline development.

FAQs

1. What are the main clinical applications of IGIV?
Primarily used for primary immunodeficiency, autoimmune diseases, and sometimes in secondary immunodeficiencies.

2. Which regions dominate the IGIV market?
North America accounts for approximately 50% of sales, followed by Europe at 30%, with emerging markets showing increasing demand.

3. How does plasma donation impact the IGIV supply?
Plasma donation quantity and quality directly influence product availability; shortages lead to supply constraints.

4. What innovations could disrupt the IGIV market?
Recombinant immunoglobulin development and improved formulations with longer half-life could reduce dependency on plasma.

5. What are the regulatory hurdles for new IGIV products?
Demonstrating equivalence or superiority to existing products, ensuring safety and consistency, and navigating plasma collection regulations.

References

[1] MarketResearch.com. (2023). Global Immunoglobulin Market Report.
[2] Grand View Research. (2023). Human Immune Globulin Market Size & Trends.
[3] FDA. (2022). Guidance for Industry: Plasma Collection Standards.
[4] IBISWorld. (2023). Plasma Collection and Product Manufacturing Industry Overview.
[5] IQVIA. (2022). Immunoglobulin Market Data Report.